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117-s-4314 | II 117th CONGRESS 2d Session S. 4314 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Toomey (for himself and Mr. Bennet ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to modify the eligible age for the exemption from the retirement plan early withdrawal penalty for public safety officers.
1. Short title This Act may be cited as the Protecting Public Safety Employees' Timely Retirement Act of 2022 . 2. Modification of eligible age (a) In general Subparagraph (A) of section 72(t)(10) of the Internal Revenue Code of 1986 is amended by striking age 50 and inserting age 50 or 25 years of service under the plan, whichever is earlier . (b) Effective date The amendment made by this section shall apply to taxable years beginning after the date of the enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4314is/xml/BILLS-117s4314is.xml |
117-s-4315 | II 117th CONGRESS 2d Session S. 4315 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Cornyn (for himself, Mr. Cardin , and Mr. Hagerty ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To address the foreign production of precursor chemicals that are used for the illicit production of narcotics and psychotropic drugs and other controlled substances, and for other purposes.
1. Short title This Act may be cited as the Protecting America from Narcotics and Illicit Chemicals Act of 2022 or the PANIC Act of 2022 . 2. Modified definition of major illicit drug producing country Section 481(e)(2) of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2291(e)(2) ) is amended— (1) in subparagraph (C), by striking ; or and inserting a semicolon; (2) in subparagraph (D), by inserting or after the semicolon; and (3) by adding at the end the following new subparagraph: (E) that is a direct source of covered synthetic drugs or psychotropic drugs or other controlled substances, including precursor chemicals, when those precursor chemicals are used in the production of such drugs and substances, significantly affecting the United States; . | https://www.govinfo.gov/content/pkg/BILLS-117s4315is/xml/BILLS-117s4315is.xml |
117-s-4316 | II 117th CONGRESS 2d Session S. 4316 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Markey (for himself, Mr. Blumenthal , and Ms. Warren ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To direct the Secretary of Health and Human Services to update and clarify its rule on substances generally recognized as safe and to establish within the Center for Food Safety and Applied Nutrition of the Food and Drug Administration the Office of Food Chemical Safety Reassessment, and for other purposes.
1. Short title This Act may be cited as the Ensuring Safe and Toxic-Free Foods Act of 2022 . 2. Directed rulemaking regarding substances generally recognized as safe (a) Definitions In this section: (1) GRAS The term GRAS , with respect to the use of a substance in food, has the meaning given the term generally recognized as safe for use in food in section 409A(a) of the Federal Food, Drug, and Cosmetic Act, as added by section 3. (2) Reproductive or developmental toxicity The term reproductive or developmental toxicity has the meaning given such term in such section 409A(a). (3) Secretary The term Secretary means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs. (4) Vulnerable human populations The term vulnerable human population has the meaning given such term in such section 409A(a). (b) Directed rulemaking (1) In general The Secretary shall— (A) not later than 1 year after the date of enactment of this Act, publish a proposed revision to the final rule titled Substances Generally Recognized as Safe , published by the Food and Drug Administration on August 17, 2016 (81 Fed. Reg. 54960); (B) not later than 180 days after the close of the period for public comment on the revision proposed under subparagraph (A), publish a final revision to such final rule; and (C) not later than 180 days after the date of enactment of this Act, finalize the draft guidance titled Best Practices for Convening a GRAS Panel , issued by the Food and Drug Administration in November 2017. (2) Contents The revision required by subparagraphs (A) and (B) of paragraph (1) shall include each of the following: (A) The revision shall prohibit a manufacturer from marketing a substance as GRAS, or manufacturing or selling food that contains a substance the manufacturer has determined to be GRAS, unless— (i) the Secretary has made a final determination, which is conveyed to the manufacturer in writing, that the Secretary has received sufficient notice that the manufacturer has determined such substance to be GRAS under the conditions of its intended use; and (ii) the manufacturer has provided the Secretary with supporting information sufficient to understand the basis of the determination, including— (I) the cumulative effects of the substance, as required under section 409 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348 ); (II) an adequately protective use of safety factors, as required under such section 409, including safety factors to account for the particular sensitivities of vulnerable human populations to the extent that data are available to derive safety factors for each vulnerable human population; (III) information indicating that the weight of evidence shows the substance has not been found to induce cancer when ingested by humans or animals; and (IV) information indicating that the weight of evidence shows the substance has not been found to induce reproductive or developmental toxicity when ingested by humans or animals, including through an endocrine mode of action. (B) The revision shall require— (i) the Secretary to make each determination that is submitted pursuant to subparagraph (A)(i), and the supporting information submitted pursuant to subparagraph (A)(ii), publicly available on the website of the Food and Drug Administration; (ii) a period of at least 90 days for the Secretary and the public to review each such determination and object, if appropriate, in order to ensure that the substance involved is safe taking into account the factors listed in subparagraph (A) and in paragraphs (3) through (5) of section 409(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(c) ); and (iii) the Secretary’s objection, or decision not to object, to be considered final agency action. (C) The revision shall clarify that substances that are known (or reasonably anticipated) to cause cancer in humans identified by the National Toxicology Program cannot be GRAS. (D) The revision shall clarify that substances that show clear evidence (or some evidence) of human reproductive or developmental toxicity identified by the National Toxicology Program cannot be GRAS. (E) The revision shall clarify that any substance that was not marketed for use in foods in the United States before issuance of the revised rule cannot be GRAS and shall be approved by the Secretary through a food additive petition as required by section 409(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 348(c) ) prior to being marketed in food. (F) The revision shall— (i) incorporate standards prohibiting conflict of interests among experts providing data for substances submitted for GRAS review; and (ii) incorporate measures to strengthen the recommendations in the guidance described in paragraph (1)(C). (G) The revision shall create a process that requires the Secretary to systematically reassess any substance that was determined to be GRAS if the initial determination did not meet the revised standards for such a determination, in accordance with the procedures and resources in section 409A of the Federal Food, Drug, and Cosmetic Act, as added by section 3. 3. Office of Food Chemical Safety Reassessment Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ) is amended by inserting after section 409 ( 21 U.S.C. 348 ) the following: 409A. Office of Food Chemical Safety Reassessment (a) Definitions In this section: (1) Food contact substance The term food contact substance has the meaning given such term in section 409(h)(6). (2) Generally recognized as safe for use in food The term generally recognized as safe for use in food means, with respect to the use of a substance in food, that the substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use, as described in section 201(s). (3) Prior-sanctioned substance The term prior-sanctioned substance means a substance described in paragraph (4) of section 201(s). (4) Reproductive or developmental toxicity The term reproductive or developmental toxicity means— (A) adverse effects on the reproductive systems of female or male humans or animals, that may include alterations to the female or male reproductive system development, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions that are dependent on the integrity of the reproductive system; or (B) adverse effects on developing organisms that result from exposure prior to conception, during the prenatal period, or until the time of sexual maturity. (5) Vulnerable human population The term vulnerable human population means a human population that is subject to the potential for disproportionate exposure to, or the potential for disproportionate adverse effects from exposure to, a chemical substance or mixture, including— (A) infants, children, and adolescents; (B) pregnant or breastfeeding women; (C) the elderly; (D) individuals with preexisting medical conditions; (E) workers who may be exposed to chemical substances and mixtures; (F) residents in communities subject to disproportionate exposures or adverse effects; and (G) members of any other appropriate population identified by the Secretary. (b) Establishment Not later than 1 year after the date of the enactment of this section, the Secretary shall establish within the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, an office to be known as the Office of Food Chemical Safety Reassessment (referred to in this section as the Office ), to conduct reassessments of the safety, within the meaning of section 409, of substances and classes of substances including food additives, food contact substances, substances generally recognized as safe for use in food, color additives, and prior-sanctioned substances. (c) Safety reassessments Not less frequently than once every 3 years beginning in calendar year 2023, the Office shall— (1) reassess the safety of not less than 10 of the substances or classes of substances described in subsection (b); and (2) issue final regulations— (A) determining that any such substance or class of substance is safe within the meaning of section 409 and establishing the conditions of use, if any, under which any such substance or class of substances can be used safely within the meaning of such section; or (B) determining that any such substance or class of substances is unsafe within the meaning of such section. (d) Considerations In determining, for the purposes of this section, whether a substance or class of substances is unsafe within the meaning of section 409, the Secretary shall consider among other relevant factors— (1) the cumulative effects of the substance, as described under such section 409; (2) an adequately protective use of safety factors, as described under such section 409 including safety factors to account for the particular sensitivities of vulnerable human populations to the extent that data are available to derive safety factors for each vulnerable human population. (e) Unsafe A substance or class of substances shall be deemed unsafe under this section within the meaning of section 409 if— (1) the substance or class has been found to induce cancer when ingested by man or animal; or (2) the substance or class has been found to induce reproductive or developmental toxicity when ingested by man or animal, including through an endocrine mode of action. (f) First substances subject to reassessment The first 10 substances or classes of substances reassessed by the Secretary under subsection (b) shall be the following: (1) Perfluoroalkyl substances and polyfluoroalkyl substances. (2) Ortho-phthalates. (3) The class of bisphenols. (4) Titanium dioxide. (5) Potassium bromate. (6) Perchlorate. (7) Butylated hydroxyanisole (BHA). (8) Butylated hydroxytoluene (BHT). (9) Brominated vegetable oil (BVO). (10) Propyl paraben. (g) Subsequent substances Prior to selecting subsequent substances or classes of substances to reassess in addition to those listed in subsection (f), the Secretary shall post a notice in the Federal Register requesting information and recommendations on which substances and classes should be reassessed. The information shall include substance or class name, uses, and data relating to the actual and potential hazards and impact on public health. (h) Notice prior to commencement Prior to commencing a reassessment of a substance or class of substances under subsection (f) or (g), the Secretary shall post a notice in the Federal Register requesting information on any uses of such substance or class in food, including as a prior-sanctioned substance, food contact substance, or substance that is generally recognized as safe for use in food. The information requested shall include when the uses commenced, the specific conditions of use, how they were determined to be safe, scientific evidence relevant to the safety of the substance that has become available since its use in food commenced, and the anticipated amounts that may be found in food. (i) Food Chemical Committee of the Science Board Not later than 180 days after the date of enactment of this section, the Secretary shall establish a standing Food Chemical Committee (referred to in this subsection as the Committee ) within the Science Board to the Food and Drug Administration and provide resources and staffing as are necessary for the Committee to meet regularly and complete their work. The Committee shall advise the Secretary with respect to— (1) the standards for reassessments conducted under this section; and (2) the process and methods necessary to complete the work of the Office. (j) Rule of construction Nothing in this section alters the authority or duties of the Secretary with respect to the administration and enforcement of section 409. . | https://www.govinfo.gov/content/pkg/BILLS-117s4316is/xml/BILLS-117s4316is.xml |
117-s-4317 | II 117th CONGRESS 2d Session S. 4317 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Duckworth introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To amend title 10, United States Code, to codify certain clean energy targets of the Department of Defense, and for other purposes.
1. Short title This Act may be cited as the Depend On Domestic Clean Energy Act or the DOD Clean Energy Act . 2. Findings Congress finds the following: (1) The Department of Defense, the agency charged with protecting the national security of the United States, observed as early as 1990 that climate change threatens the readiness of the Armed Forces of the United States. (2) As of 2019, the Department of Defense is the single largest consumer of energy in the United States and the single largest institutional consumer of petroleum in the world. (3) Since 2001, the Department of Defense has consistently consumed between 77 and 80 percent of all energy consumption of the United States Government. (4) As climate change brings more extreme weather, water and soil stress, sea-level rise, ocean acidification, glacial melt, and pollution, greater global tensions over food and water insecurity, resource scarcity, living patterns, and climate-related migration will emerge. 3. Sense of Congress It is the sense of Congress that any unobligated amounts for the Energy Resilience and Conservation Investment Program of the Department of Defense at the end of fiscal year 2022 should remain available for obligation by the Department after such fiscal year for deserving projects so that the Department is able to appropriately vet those projects while increasing staffing. 4. Codification of certain Department of Defense clean energy targets (a) Codification Section 2911(g) of title 10, United States Code, is amended— (1) by striking the subsection heading and inserting the following Clean energy targets and policy ; (2) by redesignating paragraph (3) as paragraph (4); (3) by striking paragraphs (1) and (2) and inserting the following new paragraphs: (1) It shall be the target of the Department of Defense, with respect to the activities, personnel, resources, and facilities of the Department located within the United States— (A) to achieve not less than 40 percent carbon pollution-free electricity on a net annual basis by 2024 within all such facilities; (B) to achieve 100 percent carbon pollution-free electricity on a net annual basis by 2030 within all such facilities; (C) to reduce emissions from installation procurement by not less than 20 percent by 2024 and to achieve net-zero emissions from installation procurement by 2050; (D) to reduce emissions from buildings on installations of the Department by not less than 50 percent by 2032 and to achieve net-zero emissions from such buildings by 2045; (E) to reduce emissions from operations of the Department by not less than 65 percent by 2030 and to support the achievement of net-zero emissions from such operations by 2050; and (F) to achieve 100 percent zero-emission vehicle acquisitions for non-tactical vehicles by 2035, including 100 percent zero-emission light-duty vehicle acquisitions by 2027, and to work towards 100 percent zero-emission tactical vehicle acquisitions by 2045. (2) The Secretary of Defense may issue an exemption to the targets under paragraph (1) with respect to an activity of an agency of the Department of Defense, and any related personnel, resources, and facilities, if the Secretary— (A) determines that the exemption is in the national security interests of the United States; and (B) submits to the congressional defense committees notice in writing of the exemption within 30 days of issuing the exemption. (3) (A) The Secretary of Defense shall submit to the congressional defense committees an annual report on the progress the Department of Defense has made towards achieving the targets under paragraph (1). (B) Each report under subparagraph (A) shall cover activities conducted during the year preceding the date of the submittal of the report to achieve the targets under paragraph (1) and shall include— (i) an identification of outstanding funding and staffing resources needed to implement such activities; (ii) a description of any planned activities the Secretary intends to carry out to meet such targets, including how the Office of the Secretary of Defense, the military departments, and Defense agencies plan to collaborate to implement such activities; and (iii) a plan to increase production of renewable energy on installations of the Department of Defense and pursue any energy reduction or conservation efforts. (C) Each report under subparagraph (A) shall be made publicly available on an appropriate website of the Department of Defense. ; and (4) by adding at the end the following new paragraph: (5) The Secretary of Defense shall delegate the responsibility for carrying out this subsection to the Assistant Secretary of Defense for Energy, Installations, and Environment. . (b) Non-Domestic application of targets The Secretary of Defense may apply, in whole or in part, the targets set forth in section 2911(g)(1) of title 10, United States Code, as amended by subsection (a), with respect to the activities, personnel, resources, and facilities of the Department of Defense located outside of the United States if the Secretary determines such application to be in the interest of the United States. 5. Direct hire authority for positions supporting Department of Defense energy independence and climate resilience efforts (a) In general Chapter 81 of title 10, United States Code, is amended by adding at the end the following new section: 1599j. Direct hire authority for positions supporting Department of Defense energy independence and climate resilience efforts (a) Authority The Secretary of Defense may appoint in the Department of Defense, without regard to the provisions of subchapter I of chapter 33 of title 5, other than sections 3303 and 3328 of such title, qualified candidates to positions described in subsection (b) who possess skills and experience the Secretary determines are necessary to support the sustainability efforts of the Department of Defense. (b) Positions The positions described in this subsection are all positions involved in supporting the energy independence and climate resilience efforts of the Department, including the following: (1) Any position under the supervision of the Assistant Secretary of Defense for Energy, Installations, and Environment. (2) Any position that supports the remediation or response efforts of the Department with respect to perfluoroalkyl substances and polyfluoroalkyl substances. (3) Any position that supports the environmental stewardship programs of the Department. (4) Any position that supports the efforts of the Department to meet the energy resilience and security requirements or goals outlined in— (A) section 203 of the Energy Policy Act of 2005 ( 42 U.S.C. 15852 ); (B) the Energy Independence and Security Act of 2007 ( 42 U.S.C. 17001 et seq. ); or (C) section 2911(g) of this title. (5) Any position that supports the Chief Sustainability Officer of the Department. (6) Any other position the Secretary determines is essential to advancing the energy independence and climate resilience efforts of the Department. . (b) Clerical amendment The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 1599i the following new item: 1599j. Direct hire authority for positions supporting Department of Defense energy independence and climate resilience efforts. . 6. Investment in and development of energy efficient technology by Department of Defense (a) Authorities of Department relating to climate and energy resilience (1) Charging and refueling stations for alternative fuel vehicles (A) In general The Secretary of Defense may carry out the development of charging or refueling stations for alternative fuel vehicles on installations of the Department of Defense under the authorities, and using the funding methods, specified in subparagraph (B). (B) Authorities specified The authorities and funding methods specified in this subparagraph are the following: (i) The authorities under sections 2805 and 2912 of title 10, United States Code. (ii) The authority under section 2913(d) of such title to enter into agreements with utilities for the purpose of providing or operating charging or refueling stations described in subparagraph (A). (iii) The authority under section 2914 of such title (known as the Energy Resilience and Conservation Investment Program). (iv) Energy savings performance contracts. (v) Utility energy services contracts. (vi) Other funding mechanisms financed by non-Department entities for the deployment of alternative fuel vehicles and related charging or refueling infrastructure. (2) Renewable energy utilities for power management at installations The Secretary of Defense, in carrying out the Energy Resilience and Conservation Investment Program under section 2914 of title 10, United States Code, may enter into public-private partnerships with nongovernmental entities determined appropriate by the Secretary under such Program for the purpose of developing renewable energy utilities for power management at installations of the Department of Defense. (b) Review of investment by Department in alternatively fueled vehicles (1) In general The Secretary of Defense, acting through the Director of Cost Assessment and Program Evaluation of the Department of Defense, shall conduct a strategic review of the investment by the Department of Defense in alternative fuel vehicles. (2) Elements The review under paragraph (1) shall include the following: (A) An assessment of funding levels for investment by the Department in alternative fuel vehicles and associated trends for such investment across programs of the Department and military departments. (B) An assessment of any duplication of efforts relating to such investment across programs of the Department and military departments. (C) An assessment of the long-term availability to the Department of internal combustion engines and spare parts for such engines. (D) An assessment of the relative tactical benefits and limitations of each type of vehicle propulsion (such as speed, acceleration, noise production, time to refuel or recharge, range, and operational duration), across the various types of military missions. (E) An assessment of the relative tactical benefits and limitations of each type of vehicle propulsion with respect to the provision of support to other tactical systems requiring electricity. (F) An assessment of how the propulsion systems of electrical and other alternative fuel vehicles may be fueled on the battlefield and what investments may be necessary to maintain such a fueling system. (G) A comparison of the relative risk to personnel of the Department and to the supply chain between different fuel types to determine the tradeoffs associated with the adoption of any given fuel type. (H) A projected timeline of when a potential conversion to the use of alternative fuel vehicles as tactical vehicles could reasonably occur without causing a significant effect on the readiness of the Armed Forces, as determined by the Secretary. (I) The projected costs of converting (or replacing) and sustaining alternative fuel vehicles as tactical vehicles, to include training, in total and for the two-year period following the date of the review. (J) An assessment of any national security implications relating to— (i) the use of alternative fuel vehicles; and (ii) the effects of the use of such vehicles on the supply chain for such vehicles and the source materials of such vehicles. (K) Recommendations for further coordination of efforts of the Department and any legislative or organizational changes that may improve the coordination or alignment of investment by the Department in the operationalization of alternative energy sources. (L) Such other elements as the Secretary considers appropriate. (3) Report Not later than two years after the date of the enactment of this Act, the Secretary shall submit to the Committee on Armed Services of the Senate and the Committee on Armed Services of the House of Representatives a report on the review under paragraph (1). (c) Authorizations of appropriations (1) Defense Innovation Unit There is authorized to be appropriated to the Department of Defense $8,000,000 for fiscal year 2023 for the purpose of carrying out activities under the energy division of the Defense Innovation Unit of the Department to leverage advancements in energy and materials technology, enhance capabilities, and strengthen energy resilience across military installation and distributed operations, including with respect to alternative fuel vehicles and the fuel efficiency of vehicles. (2) Sustainable Technology Evaluation and Demonstration program There is authorized to be appropriated to the Department of Defense $5,000,000 for fiscal year 2023 for the purpose of carrying out activities under the Sustainable Technology Evaluation and Demonstration program of the Department for the evaluation and demonstration of, and the transition to, more sustainable products for use by the Department. (3) Strategic Environmental Research and Development Program There is authorized to be appropriated to the Department of Defense $18,000,000 for fiscal year 2023 for the purpose of carrying out activities under the Installation Energy and Water program, or any successor program, of the Strategic Environmental Research and Development program of the Department. (d) Definitions In this section: (1) Alternative fuel vehicle The term alternative fuel vehicle includes a vehicle that uses— (A) a fuel or power source described in the first sentence of section 241(2) of the Clean Air Act ( 42 U.S.C. 7581(2) ); or (B) propane. (2) Energy savings performance contract The term energy savings performance contract has the meaning given that term in section 804(3) of the National Energy Conservation Policy Act ( 42 U.S.C. 8287c(3) ). 7. Independent study on scope 3 emissions resulting from certain Department of Defense activities (a) Independent study Not later than 30 days after the date of the enactment of this Act, the Secretary of Defense shall seek to enter into a contract with a federally funded research and development center to conduct a study on the scope 3 emissions resulting from certain activities of the Department of Defense, including such activities carried out under contracts or other agreements, in accordance with the guidance of the Environmental Protection Agency titled Scope 3 Inventory Guidance (relating to scope 3 emissions), or any successor guidance. (b) Elements The study conducted under subsection (a) shall include a comprehensive review and assessment of the following: (1) Any contracts or other agreements entered into by the Secretary relating to manufacturing. (2) The extent to which, in performing work under such contracts or other agreements, contractors and other partners track greenhouse gas emissions. (3) The known greenhouse gas emissions that occur within the supply chain of the Department. (c) Report (1) Submission to Secretary The terms of the contract under subsection (a) shall include a requirement that the federally funded research and development center that conducts the study under the contract submit to the Secretary of Defense a report on the results of the study, which shall include an identification of the following: (A) Considerations and recommendations for the reduction of greenhouse gas emissions of contractors and other partners performing work under contracts or other agreements with the Department. (B) Any existing alternatives that produce lower greenhouse gas emissions while still aligning with the national security interests of the United States and the priorities set forth in the national defense strategy. (C) Any recommendations for legislative action to— (i) support and facilitate implementation of the national defense strategy with respect to climate- and environmental-related goals; or (ii) reduce greenhouse gas emissions through modernization of the supply chain of the Department. (2) Submission to Congress (A) In general Upon receiving the report on the results of the study under paragraph (1), the Secretary of Defense shall submit to the congressional defense committees an unedited copy of such report, together with the written perspectives of the Secretary of Defense and the Chairman of the Joint Chiefs of Staff with respect to those results. (B) Form The report submitted under subparagraph (A) shall be submitted in unclassified form, but may include a classified annex. (d) Definitions In this section: (1) Congressional defense committee The term congressional defense committees has the meaning given that term in section 101(a)(16) of title 10, United States Code. (2) National defense strategy The term national defense strategy means the review of the defense programs and policies of the United States that is carried out every four years under section 113(g) of title 10, United States Code. (3) Scope 3 emissions The term scope 3 emissions means emissions that result from activities of a Federal department or agency but are generated from sources that are neither owned nor controlled by the Federal department or agency. | https://www.govinfo.gov/content/pkg/BILLS-117s4317is/xml/BILLS-117s4317is.xml |
117-s-4318 | II 117th CONGRESS 2d Session S. 4318 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Leahy introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to disallow any deduction for punitive damages, and for other purposes.
1. Short title This Act may be cited as the No Tax Write-offs for Corporate Wrongdoers Act . 2. Disallowance of deduction for punitive damages (a) Disallowance of deduction (1) In general Section 162(g) of the Internal Revenue Code of 1986 is amended— (A) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively; (B) by striking If and inserting: (1) Treble damages If ; and (C) by adding at the end the following new paragraph: (2) Punitive damages No deduction shall be allowed under this chapter for any amount paid or incurred for punitive damages in connection with any judgment in, or settlement of, any action. . (2) Conforming amendment The heading for section 162(g) of such Code is amended by inserting or Punitive Damages after Laws . (b) Inclusion in income of punitive damages paid by insurer or otherwise (1) In general Part II of subchapter B of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: 92. Punitive damages compensated by insurance or otherwise Gross income shall include any amount paid to or on behalf of a taxpayer as insurance or otherwise by reason of the taxpayer’s liability (or agreement) to pay punitive damages. . (2) Reporting requirements Section 6041 of such Code is amended by adding at the end the following new subsection: (h) Section To apply to punitive damages compensation This section shall apply to payments by a person to or on behalf of another person as insurance or otherwise by reason of the other person’s liability (or agreement) to pay punitive damages. . (3) Conforming amendment The table of sections for part II of subchapter B of chapter 1 of such Code is amended by adding at the end the following new item: Sec. 92. Punitive damages compensated by insurance or otherwise. . (c) Effective Date The amendments made by this section shall apply to damages paid or incurred on or after the date of the enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4318is/xml/BILLS-117s4318is.xml |
117-s-4319 | II 117th CONGRESS 2d Session S. 4319 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Cassidy (for himself and Mr. Blumenthal ) introduced the following bill; which was read twice and referred to the Committee on Veterans' Affairs A BILL To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to regularly promote programs under chapter 31 of such title.
1. Short title This Act may be cited as the Informing Veterans on Education for Transitioning Servicemembers Act of 2022 or the Informing VETS Act of 2022 . 2. Information campaign regarding Veteran Readiness and Employment Program Section 3116 of title 38, United States Code, is amended by adding at the end the following new subsection: (c) The Secretary shall regularly promote programs under this chapter by— (1) sending a letter to each veteran entitled to such a program that explains the educational benefits of such programs; and (2) providing a side-by-side comparison of benefits between such programs and educational assistance under chapter 33 of this title— (A) with each letter under paragraph (1); and (B) on a publicly accessible website of the Department. . | https://www.govinfo.gov/content/pkg/BILLS-117s4319is/xml/BILLS-117s4319is.xml |
117-s-4320 | II 117th CONGRESS 2d Session S. 4320 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Risch introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To enhance security at United States diplomatic facilities, and for other purposes.
1. Short title This Act may be cited as the Secure Embassy Construction and Counterterrorism Act of 2022 . 2. Findings Congress makes the following findings: (1) The Secure Embassy Construction and Counterterrorism Act of 1999 (title VI of division A of appendix G of Public Law 106–113 ) was a necessary response to bombings on August 7, 1998, at the United States embassies in Nairobi, Kenya, and in Dar es Salaam, Tanzania that were destroyed by simultaneously exploding bombs. The resulting explosions killed 220 persons and injured more than 4,000 others. Twelve Americans and 40 Kenyan and Tanzanian employees of the United States Foreign Service were killed in the attacks. (2) Those bombings, followed by the expeditionary diplomatic efforts in Iraq and Afghanistan, demonstrated the need to prioritize the security of United States posts and personnel abroad above other considerations. (3) Between 1999 and 2022, the risk calculus of the Department of State has swung too far toward the elimination of risk, leading to a marked decrease in the ability of United States diplomats around the world to advance the interests of the United States through access to local populations, leaders, and places. (4) America’s competitors and adversaries do not have the same restrictions that United States diplomats have, especially in critically important medium-threat and high-threat posts. (5) The Department of State’s 2021 Overseas Security Panel report states that— (A) the requirement for setback and collocation of diplomatic posts under paragraphs (2) and (3) of section 606(a) of the Secure Embassy Construction and Counterterrorism Act of 1999 has led to sky-rocketing costs of new embassies and consulates; and (B) the locations of such posts have become less desirable, creating an extremely suboptimal nexus that further hinders United States diplomats who are willing to accept more risk in order to advance United States interests. 3. Sense of Congress It is the sense of Congress that— (1) the setback and collocation requirements referred to in section 2(5)(A), even with available waivers, no longer provide the security such requirements used to provide because of advancement in technologies, such as remote controlled drones, that can evade walls and other such static barriers; (2) the Department of State should focus on creating performance security standards that— (A) attempt to keep the setback requirements of diplomatic posts as limited as possible; and (B) provide diplomats access to local populations as much as possible, while still providing a necessary level of security; (3) collocation of diplomatic facilities is often not feasible or advisable, particularly for public diplomacy spaces in countries with repressive governments, since such spaces are required to permit the foreign public to enter and exit the space easily and openly; (4) the Bureau of Diplomatic Security should— (A) fully utilize the waiver process provided under paragraphs (2)(B) and (3)(B) of section 606(a) of the Secure Embassy Construction and Counterterrorism Act of 1999; and (B) appropriately exercise such waiver process as a tool to right-size the appropriate security footing at each diplomatic post rather than only approving waivers in extreme circumstances; (5) the return of great power competition requires— (A) United States diplomats to do all they can to outperform our adversaries; and (B) the Department of State to better utilize taxpayer funding to advance United States national interests; and (6) this Act will rebalance the Department of State’s risk and provide United States diplomats the tools they need to compete in the 21st century, while saving United States taxpayers potentially billions of dollars in reduced property and maintenance costs at embassies and consulates abroad. 4. Definition of United States diplomatic facility Section 603 of the Secure Embassy Construction and Counterterrorism Act of 1999 (title VI of division A of appendix G of Public Law 106–113 ) is amended to read as follows: 603. United States diplomatic facility defined In this title, the terms United States diplomatic facility and diplomatic facility — (1) mean any chancery, consulate, or other office considered diplomatic or consular premises, consistent with the Vienna Convention on Diplomatic Relations, done at Vienna April 18, 1961, and the Vienna Convention on Consular Relations, done at Vienna April 24, 1963, or otherwise subject to a publicly available bilateral agreement with the host government (contained in the records of the United States Department of State) that recognizes the official status of the United States Government personnel present at the facility; and (2) do not include— (A) U.S. Customs and Border Protection preclearance facilities, as established pursuant to section 629 of the Tariff Act of 1930 ( 19 U.S.C. 1629 ) and section 103(a)(7) of the Immigration and Nationality Act ( 8 U.S.C. 1103(a)(7) ) and Open Source Centers; (B) contractor-owned facilities; and (C) facilities at which United States Government personnel will be present not more than 60 consecutive days and where the Secretary determines that operational conditions, security considerations, and mission goals support exclusion. . 5. Security requirements for United States diplomatic facilities Section 606(a) of the Secure Embassy Construction and Counterterrorism Act of 1999 (title VI of division A of appendix G of Public Law 106–113 ) is amended— (1) in paragraph (1)(A), by striking the threat and inserting a range of threats, including that ; (2) in paragraph (2)— (A) in subparagraph (A)— (i) by striking abroad and inserting in a high risk, high threat post ; and (ii) by inserting and Voice of America correspondents on official assignment after military commander ; and (B) in subparagraph (B)— (i) in clause (i), by inserting if applicable, after at the site, ; (ii) in clause (ii)— (I) in subclause (I), by inserting at a post designated as high risk, high threat under section 104 of the Omnibus Diplomatic Security and Antiterrorism Act of 1986 ( 22 U.S.C. 4803 ) before the period at the end; and (II) in subclause (II), by inserting at a post designated as high risk, high threat under such section 104 after consulate building ; and (iii) in clause (iii), by striking waivers and inserting instances of split operations in which United States diplomatic facilities are not colocated ; and (3) in paragraph (3)— (A) by amending subparagraph (A) to read as follows: (A) Requirement (i) In general Each newly acquired United States diplomatic facility shall be constructed or modified to meet the measured building blast performance standard applicable to a facility sited not less than 100 feet from the perimeter. (ii) Leased facilities If the Department of State is required to commence or restart diplomatic operations in a country or city without a previously constructed diplomatic facility and there is insufficient time to construct a facility before such commencement, the Secretary of State— (I) shall make every effort to lease an existing facility with the maximum setback and security features that can be reasonably expected; and (II) shall submit a setback waiver, with a period of 1 year after leased occupancy to process the setback waiver. ; and (B) in subparagraph (B)(ii)— (i) in subclause (I), by inserting at a post designated as high risk, high threat under section 104 of the Omnibus Diplomatic Security and Antiterrorism Act of 1986 ( 22 U.S.C. 4803 ) before the period at the end; (ii) in subclause (II), by inserting at a post designated as high risk, high threat under such section 104 after consulate building ; and (iii) in subclause (III), by striking an annual and inserting a quarterly . | https://www.govinfo.gov/content/pkg/BILLS-117s4320is/xml/BILLS-117s4320is.xml |
117-s-4321 | II 117th CONGRESS 2d Session S. 4321 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Sullivan (for himself, Mr. Whitehouse , and Mr. Menendez ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To amend the Save Our Seas 2.0 Act to improve the administration of the Marine Debris Foundation, to amend the Marine Debris Act to improve the administration of the Marine Debris Program of the National Oceanic and Atmospheric Administration, and for other purposes.
1. Short title This Act may be cited as the Save Our Seas 2.0 Amendments Act . 2. Modifications to the Marine Debris Foundation (a) Status of Foundation Section 111(a) of the Save Our Seas 2.0 Act ( 33 U.S.C. 4211(a) ) is amended, in the second sentence, by striking organization and inserting corporation . (b) Board of Directors (1) Appointments and removal Section 112(b) of such Act ( 33 U.S.C. 4212(b) ) is amended— (A) in paragraph (1), in the matter preceding subparagraph (A), by inserting and such other criteria as the Under Secretary may establish after subsection (a) ; (B) in paragraph (5), by inserting the Administrator of the United States Agency for International Development, after Service, ; (C) by redesignating subparagraphs (2) through (5) as subparagraphs (3) through (6), respectively; and (D) by inserting after paragraph (1) the following: (2) Recommendations of Board regarding appointments For appointments made under paragraph (1) other than the initial appointments, the Board shall submit to the Under Secretary recommendations on candidates for appointment. . (2) General powers Section 112(g) of such Act ( 33 U.S.C. 4212(g) ) is amended— (A) in paragraph (1)(A), by striking officers and employees and inserting the initial officers and employees of the Board ; and (B) in paragraph (2)(B)(i), by striking chief operating officer and inserting chief executive officer . (3) Chief executive officer Section 112 of such Act ( 33 U.S.C. 4212 ) is amended by adding at the end the following: (h) Chief executive officer (1) Appointment; removal; review The Board shall appoint and may remove and review the performance of the chief executive officer of the Board. (2) Powers The chief executive officer of the Board may appoint, remove, and review the performance of any officer or employee of the Foundation. . (c) Powers of Foundation Section 113(c)(1) of such Act ( 33 U.S.C. 4213(c)(1) ) is amended, in the matter preceding subparagraph (A)— (1) by inserting nonprofit before corporation ; and (2) by striking acting as a trustee and inserting formed . (d) Principal office Section 113 of such Act ( 33 U.S.C. 4213 ) is amended by adding at the end the following: (g) Principal office The Board may locate the principal office of the Foundation outside the District of Columbia and is encouraged to locate that office in a coastal State. . (e) Use of funds Section 118 of such Act ( 33 U.S.C. 4218 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking and State and local government agencies and inserting , State and local government agencies, United States and international nongovernmental organizations, regional organizations, and foreign government entities ; and (B) in paragraph (3)— (i) in the paragraph heading, by striking Prohibition and inserting Limitation ; and (ii) by striking subparagraph (B) and inserting the following: (B) Salaries The Foundation may use Federal funds described in subparagraph (A) to pay for salaries only during the 24-month period beginning on the date of the enactment of this Act. The Secretary shall not require reimbursement from the Foundation for any such Federal funds used to pay for such salaries. ; and (2) in subsection (b)(2), by striking and State and local government agencies and inserting , State and local government agencies, United States and international nongovernmental organizations, regional organizations, and foreign government entities . 3. Modifications to the Marine Debris Program of the National Oceanic and Atmospheric Administration (a) Grants, cooperative agreements, contracts, and other agreements Section 3(d) of the Marine Debris Act ( 33 U.S.C. 1952(d) ) is amended— (1) in the subsection heading, by striking and contracts and inserting contracts, and other agreements ; (2) in paragraph (1), by striking and contracts and inserting , contracts, and other agreements ; (3) in paragraph (2)— (A) in subparagraph (B)— (i) by striking part of the and inserting part of a ; and (ii) by inserting or (C) after subparagraph (A) ; and (B) in subparagraph (C), in the matter preceding clause (i), by inserting and except as provided in subparagraph (B) after subparagraph (A) ; and (4) by adding at the end the following: (7) In-kind contributions With respect to any project carried out pursuant to a contract or other agreement entered into under paragraph (1) that is not a cooperative agreement or an agreement to provide financial assistance in the form of a grant, the Administrator may contribute on an in-kind basis the portion of the costs of the project that the Administrator determines represents the amount of benefit the National Oceanic and Atmospheric Administration derives from the project. . (b) Receipt and expenditure of funds; use of resources Section 3 of the Marine Debris Act ( 33 U.S.C. 1952 ) is amended by adding at the end the following: (e) Receipt and expenditure of funds In order to accomplish the purpose set forth in section 2, the Administrator, acting through the Program, may receive and, only to the extent provided in advance in appropriations Acts, expend funds made available by— (1) any department, agency, or instrumentality of the United States; (2) any State, local, or tribal government (or any political subdivision thereof); (3) any foreign government or international organization; (4) any public or private organization; or (5) any individual. (f) Use of resources In order to accomplish the purpose set forth in section 2, the Administrator, acting through the Program, may use, with consent, with reimbursement, and subject to the availability of appropriations, the land, services, equipment, personnel, and facilities of— (1) any department, agency, or instrumentality of the United States; (2) any State, local, or tribal government (or any political subdivision thereof); (3) any foreign government or international organization; (4) any public or private organization; or (5) any individual. . | https://www.govinfo.gov/content/pkg/BILLS-117s4321is/xml/BILLS-117s4321is.xml |
117-s-4322 | II 117th CONGRESS 2d Session S. 4322 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Cotton (for himself and Mr. Hagerty ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To require disclosure of foreign government subsidies in the premerger notification process, and for other purposes.
1. Short title This Act may be cited as the Foreign Merger Subsidy Disclosure Act . 2. Mergers involving foreign government subsidies (a) Definition In this section, the term foreign entity of concern has the meaning given the term in section 40207 of the Infrastructure Investment and Jobs Act ( 42 U.S.C. 18741(a) ). (b) Accounting for foreign government subsidies A person required to file a notification under section 7A of the Clayton Act ( 15 U.S.C. 18a ) that received a subsidy from a foreign entity of concern shall include in such notification content regarding such subsidy. (c) Authority of antitrust regulators The Federal Trade Commission, with the concurrence of the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice, and in consultation with the Chairperson of the Committee on Foreign Investment in the United States, the Secretary of Commerce, the Chair of the United States International Trade Commission, the United States Trade Representative, and the heads of other appropriate agencies, and by rule in accordance with section 553 of title 5, United States Code, consistent with purposes of this section shall require that the notification required under subsection (b) be in such form and contain such documentary material and information relevant to a proposed acquisition as is necessary and appropriate to enable the Federal Trade Commission and the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice to determine whether such acquisition may, if consummated, violate the antitrust laws. (d) Effective date This section shall take effect on the date on which the rule described in subsection (c) takes effect. | https://www.govinfo.gov/content/pkg/BILLS-117s4322is/xml/BILLS-117s4322is.xml |
117-s-4323 | II 117th CONGRESS 2d Session S. 4323 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Smith (for herself and Mr. Lankford ) introduced the following bill; which was read twice and referred to the Committee on Indian Affairs A BILL To amend the Indian Health Care Improvement Act to establish an urban Indian organization confer policy for the Department of Health and Human Services.
1. Short title This Act may be cited as the Urban Indian Health Confer Act . 2. Urban Indian organization confer policy Section 514(b) of the Indian Health Care Improvement Act ( 25 U.S.C. 1660d(b) ) is amended to read as follows: (b) Requirement The Secretary shall ensure that the Service and the other agencies and offices of the Department confer, to the maximum extent practicable, with urban Indian organizations in carrying out— (1) this Act; and (2) other provisions of law relating to Indian health care. . | https://www.govinfo.gov/content/pkg/BILLS-117s4323is/xml/BILLS-117s4323is.xml |
117-s-4324 | II 117th CONGRESS 2d Session S. 4324 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Thune (for himself, Mr. Cassidy , Mr. Moran , Mr. Tillis , and Mr. Lankford ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To clarify that convictions for kidnapping or sexual abuse are grounds for inadmissibility and deportability under the Immigration and Nationality Act.
1. Short title This Act may be cited as the Reverse Entry for Migrant Offenders and Violence Expulsion Act . 2. Grounds for inadmissibility Section 212(a)(2)(F) of the Immigration and Nationality Act ( 8 U.S.C. 1182(a)(2)(F) ) is amended to read as follows: (F) Kidnapping; sexual abuse Any alien who has been convicted of— (i) any offense under chapter 55 of title 18, United States Code (related to kidnapping); or (ii) any offense under chapter 109A of such title (related to sexual abuse), is inadmissible. . 3. Grounds for deportation Section 237(a)(2)(D)(i) of the Immigration and Nationality Act ( 8 U.S.C. 1227(a)(2)(D)(i) ) is amended— (1) by inserting chapter 55 (relating to kidnapping), after espionage), ; and (2) by inserting chapter 109A (relating to sexual abuse), after sabotage), . | https://www.govinfo.gov/content/pkg/BILLS-117s4324is/xml/BILLS-117s4324is.xml |
117-s-4325 | II 117th CONGRESS 2d Session S. 4325 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Sinema (for herself, Mr. Hagerty , Mr. Padilla , and Mr. Tillis ) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs A BILL To amend the Federal Credit Union Act to modify the frequency of board of directors meetings, and for other purposes.
1. Short title This Act may be cited as the Credit Union Board Modernization Act . 2. Frequency of board of directors meetings Section 113 of the Federal Credit Union Act ( 12 U.S.C. 1761b ) is amended— (1) in paragraph (15), by striking monthly each place the term appears; (2) in the matter preceding paragraph (1), by striking The board of directors shall meet at least once a month and and inserting the following: (a) In general The board of directors ; and (3) by adding at the end the following: (b) Meetings The board of directors shall meet as follows: (1) Except as provided in paragraphs (2) and (3), not less frequently than 6 times annually, with not fewer than 1 meeting held during each fiscal quarter. (2) Not less frequently than monthly during the 5-year period beginning on the date on which the charter is issued. (3) Not less frequently than monthly with respect to a Federal credit union with composite rating of 4 or 5 under the Uniform Financial Institutions Rating System (or an equivalent rating under a comparable rating system). . | https://www.govinfo.gov/content/pkg/BILLS-117s4325is/xml/BILLS-117s4325is.xml |
117-s-4326 | II 117th CONGRESS 2d Session S. 4326 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Portman (for himself and Ms. Hassan ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To authorize the Director of U.S. Immigration and Customs Enforcement to pay stipends to members of Transnational Criminal Investigative Units who have been properly vetted.
1. Short title This Act may be cited as the Transnational Criminal Investigative Unit Stipend Act . 2. Homeland Security Investigations Transnational Criminal Investigative Units (a) In general Subtitle H of title VIII of the Homeland Security Act of 2002 ( 6 U.S.C. 451 et seq. ) is amended by adding at the end the following: 890C. Transnational Criminal Investigative Units (a) In general The Secretary shall operate Transnational Criminal Investigative Units within United States Immigration and Customs Enforcement, Homeland Security Investigations. (b) Composition Each Transnational Criminal Investigative Unit shall be composed of trained foreign law enforcement officials who shall collaborate with Homeland Security Investigations to investigate and prosecute individuals involved in transnational criminal activity. (c) Vetting requirement (1) In general Upon entry into a Transnational Criminal Investigative Unit, and at periodic intervals while serving in such a unit, foreign law enforcement officials shall be required to pass certain security evaluations, which may include a background check, a polygraph examination, a urinalysis test, or other measures that the Director of U.S. Immigration and Customs Enforcement determines to be appropriate. (2) Report The Director of U.S. Immigration and Customs Enforcement shall submit a report to the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Homeland Security of the House of Representatives that describes— (A) the procedures used for vetting Transnational Criminal Investigative Unit members; and (B) any additional measures that should be implemented to prevent personnel in vetted units from being compromised by criminal organizations. (d) Monetary stipend The Director of U.S. Immigration and Customs Enforcement is authorized to pay vetted members of a Transnational Criminal Investigative Unit a monetary stipend in an amount associated with their duties dedicated to unit activities. . (b) Clerical amendment The table of contents for the Homeland Security Act of 2002 (6 U.S.C. note) is amended by inserting after the item relating to section 890B the following: Sec. 890C. Transnational Criminal Investigative Units. . | https://www.govinfo.gov/content/pkg/BILLS-117s4326is/xml/BILLS-117s4326is.xml |
117-s-4327 | II 117th CONGRESS 2d Session S. 4327 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Padilla (for himself, Mrs. Feinstein , Mr. Luján , Mr. Heinrich , and Mrs. Murray ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide hazard mitigation assistance for mitigating and preventing post-wildfire flooding and debris flow, and for other purposes.
1. Short title This Act may be cited as the Post-Fire Flooding and Debris Flow Act of 2022 . 2. Amendments to improve hazard mitigation assistance (a) In general Section 404 of the Robert T. Stafford Disaster Relief And Emergency Assistance Act ( 42 U.S.C. 5170c ) is amended— (1) in subsection (a), by striking The President may contribute up to 75 percent of the cost and inserting The Federal share of assistance under this section shall be not less than 75 percent of the cost ; and (2) in subsection (f)— (A) in paragraph (13), by striking and at the end; (B) in paragraph (14), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following: (15) with respect to any area affected by a wildfire, mitigating and preventing post-wildfire flooding and debris flow. . (b) Application The amendments made by subsection (a) shall apply with respect to assistance provided under section 404 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5170c ) on or after the date of enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4327is/xml/BILLS-117s4327is.xml |
117-s-4328 | II 117th CONGRESS 2d Session S. 4328 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Padilla (for himself, Mrs. Feinstein , Mr. Luján , Mr. Heinrich , and Mrs. Murray ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To modify the fire management assistance cost share, and for other purposes.
1. Short title This Act may be cited as the Fire Suppression Improvement Act . 2. Fire management assistance cost share and eligible activities (a) In general Section 420 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5187 ) is amended— (1) by redesignating subsection (e) as subsection (g); and (2) by inserting after subsection (d) the following: (e) Federal share The Federal share of assistance under this section shall be not less than 75 percent of the eligible cost of such assistance. (f) Eligible expense A State or local government may use assistance provided under this section for the predeployment of assets and resources. . (b) Applicability The amendments made by subsection (a) shall only apply to amounts appropriated on or after the date of enactment of this Act. 3. Rulemaking Not later than 3 years after the date of enactment of this Act, the President, acting through the Administrator of the Federal Emergency Management Agency, shall conduct and complete a rulemaking to provide criteria for the circumstances under which the Administrator may recommend the President increase the Federal cost share for section 420 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5187 ). | https://www.govinfo.gov/content/pkg/BILLS-117s4328is/xml/BILLS-117s4328is.xml |
117-s-4329 | II 117th CONGRESS 2d Session S. 4329 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Cortez Masto (for herself, Mrs. Feinstein , Mr. Brown , and Ms. Baldwin ) introduced the following bill; which was read twice and referred to the Committee on Energy and Natural Resources A BILL To require the Secretary of Energy to carry out a program to provide grants and loans to support and expand the domestic solar component manufacturing supply chain, and for other purposes.
1. Short title This Act may be cited as the Reclaiming the Solar Supply Chain Act of 2022 . 2. Solar component manufacturing supply chain assistance (a) Definitions In this section: (1) Advanced solar technology The term advanced solar technology means any new or emerging technology, system, or mechanism, or component thereof, that uses solar radiation to generate electrical energy. (2) Direct current optimizer The term direct current optimizer means a product that converts direct current electricity from 1 or more solar modules or advanced solar technologies to a different direct current voltage that is matched to the input requirements of an inverter. (3) Direct loan The term direct loan has the meaning given the term in section 502 of the Federal Credit Reform Act of 1990 ( 2 U.S.C. 661a ). (4) Eligible entity The term eligible entity means a private entity, including a manufacturer, or a partnership of private entities. (5) Employee; employer The terms employee and employer have the meanings given such terms in section 2 of the National Labor Relations Act ( 29 U.S.C. 152 ). (6) Forced labor The term forced labor has the meaning given the term in section 307 of the Tariff Act of 1930 ( 19 U.S.C. 1307 ). (7) Integrated module The term integrated module means a solar module produced by a single manufacturer through the conversion of a photovoltaic wafer or other semiconductor material into an end product that— (A) is suitable to generate electricity when exposed to sunlight; and (B) is ready for installation without additional manufacturing processes. (8) Inverter The term inverter means a product that converts direct current electricity from 1 or more solar modules or advanced solar technologies into alternating current electricity. (9) Labor organization The term labor organization has the meaning given the term in section 2 of the National Labor Relations Act ( 29 U.S.C. 152 ). (10) Photovoltaic cell The term photovoltaic cell means the smallest semiconductor element of a solar module that performs the immediate conversion of light into electricity. (11) Photovoltaic wafer The term photovoltaic wafer means a thin slice, sheet, or layer of semiconductor material of at least 240 square centimeters produced by a single manufacturer— (A) (i) directly from molten solar grade polysilicon or deposition of solar grade thin film semiconductor photon absorber layer; or (ii) through formation of an ingot from molten polysilicon and subsequent slicing; and (B) that comprises the substrate or absorber layer of 1 or more photovoltaic cells. (12) Program The term program means the program established under subsection (c). (13) Racking The term racking means a structural steel or aluminum support element, of any cross-section shape and that may be assembled from individually manufactured segments, spanning longitudinally, on which solar modules are supported. (14) Secretary The term Secretary means the Secretary of Energy. (15) Solar component The term solar component means— (A) an integrated module; (B) a photovoltaic cell; (C) a photovoltaic wafer; (D) solar grade polysilicon; (E) a solar module; (F) an inverter; (G) racking; (H) a tracker; (I) a direct current optimizer; and (J) any advanced solar technology for which the Secretary has issued a written finding under subsection (g). (16) Solar grade polysilicon The term solar grade polysilicon means silicon that— (A) is suitable for use in photovoltaic manufacturing; and (B) is purified to a minimum purity of 99.999999 percent silicon by mass. (17) Solar module The term solar module means the connection and lamination of photovoltaic cells into an environmentally protected final assembly that— (A) is suitable to generate electricity when exposed to sunlight; and (B) is ready for installation without an additional manufacturing process. (18) Tracker The term tracker means— (A) a structural steel support on which solar modules are supported; and (B) the mechanism by which that support is oriented to varying angles with respect to the position of the sun. (19) Traditional solar component The term traditional solar component means— (A) an integrated module; (B) a photovoltaic cell; (C) a photovoltaic wafer; (D) solar grade polysilicon; and (E) a solar module. (b) Findings Congress finds that it is in the interest of the United States— (1) to have a viable solar component manufacturing supply chain; and (2) to reduce the reliance of United States manufacturers on solar components made in the People's Republic of China. (c) Establishment Not later than 180 days after the date of enactment of this Act, the Secretary shall establish a program to award grants and direct loans to eligible entities to carry out projects in the United States for— (1) the construction of new facilities that manufacture solar components; and (2) retooling, retrofitting, or expanding existing facilities that manufacture, or have the ability to manufacture, solar components. (d) Application To be eligible to receive a grant or direct loan under the program, an eligible entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (e) Selection In awarding grants and direct loans under the program, the Secretary shall take into consideration whether a project proposed by an eligible entity— (1) is strategically located near manufacturers in the solar component manufacturing supply chain to create a geographic concentration of manufacturers in the solar component manufacturing supply chain; (2) has potential to materially reduce the reliance of United States manufacturers on solar components, including photovoltaic cells and photovoltaic wafers, made in the People's Republic of China; (3) has potential for direct and indirect domestic job creation, including jobs for low-income communities, dislocated workers, and workers from groups that are underrepresented in the manufacturing industry; and (4) will result in economic development or economic diversification in economically distressed regions or localities. (f) Direct loan conditions A direct loan made under the program shall— (1) bear interest at a rate that does not exceed a level that the Secretary determines appropriate; and (2) be subject to such other terms and conditions as the Secretary determines appropriate. (g) Advanced solar technology finding The Secretary may issue a written finding that an advanced solar technology has significant potential to reduce the reliance of United States manufacturers on traditional solar components made in the People's Republic of China. (h) Prohibition In carrying out the program, the Secretary may not award a grant or direct loan for a project that will source solar components from, or supply solar components to, facilities that use forced labor. (i) Cost sharing for grants Section 988(c) of the Energy Policy Act of 2005 ( 42 U.S.C. 16352(c) ) shall apply to a grant made under the program. (j) Prevailing wages (1) In general Any laborer or mechanic employed by any contractor or subcontractor in the performance of work funded directly, or assisted in whole or in part, by the Federal Government pursuant to this section shall be paid wages at rates not less than those prevailing on work of a similar character in the locality, as determined by the Secretary of Labor, in accordance with subchapter IV of chapter 31 of part A of subtitle II of title 40, United States Code (commonly referred to as the Davis-Bacon Act ). (2) Authority With respect to the labor standards specified in paragraph (1), the Secretary of Labor shall have the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (5 U.S.C. App.) and section 3145 of title 40, United States Code. (k) Labor-Management cooperation (1) In general Notwithstanding any contrary provision of law, including the National Labor Relations Act ( 29 U.S.C. 151 et seq. ), this subsection shall apply with respect to any funding recipient under this section who is an employer and any labor organization who represents, or seeks to represent, employees of such a funding recipient. (2) Labor peace Any employer receiving funds under this section shall recognize for purposes of collective bargaining a labor organization that demonstrates that a majority of the employees in a unit appropriate for such purposes who perform or will perform work funded by this section have signed valid authorizations designating the labor organization as their bargaining representative and that no other individual or labor organization is currently certified or recognized as the exclusive representative of any of the employees in the unit who perform or will perform such work pursuant to the National Labor Relations Act ( 29 U.S.C. 151 et seq. ). Upon such showing of majority status, the employer shall notify the labor organization and the National Labor Relations Board that the employer— (A) has determined that the labor organization represents a majority of the employees in such unit who perform or will perform such work; and (B) is recognizing the labor organization as the exclusive representative of the employees in such unit who perform or will perform such work for the purposes of collective bargaining pursuant to section 9 of the National Labor Relations Act ( 29 U.S.C. 159 ). (3) Certification If a dispute over majority status or the appropriateness of the unit described in paragraph (2) arises between the employer and the labor organization, either party may request that the National Labor Relations Board investigate and resolve the dispute. If the Board finds that a majority of the employees in a unit appropriate for purposes of collective bargaining who perform or will perform work funded under this section has signed valid authorizations designating the labor organization as their bargaining representative and that no other individual or labor organization is currently certified or recognized as the exclusive representative of any of the employees in the unit who perform or will perform such work pursuant to the National Labor Relations Act, the Board shall not direct an election but shall certify the labor organization as the representative described in section 9(a) of the National Labor Relations Act ( 29 U.S.C. 159(a) ) with respect to such employees. (4) Commencement of collective bargaining Not later than 10 days after an employer receiving funding under this section receives a written request for collective bargaining from a recognized or certified labor organization representing employees who perform or will perform work funded under this section, or within such period as the parties agree upon, the labor organization and employer shall meet and commence to bargain collectively and shall make every reasonable effort to conclude and sign a collective bargaining agreement. (5) Mediation If the parties have failed to reach an agreement before the date that is 90 days after the date on which bargaining is commenced under paragraph (4), or any later date agreed upon by both parties, either party may notify the Federal Mediation and Conciliation Service of the existence of a dispute and request mediation. Upon receiving such a request, the Director of the Federal Mediation and Conciliation Service shall promptly communicate with the parties and use best efforts, by mediation and conciliation, to bring them to agreement. (6) Arbitration (A) In general If the Federal Mediation and Conciliation Service is not able to bring the parties to agreement by mediation or conciliation before the date that is 30 days after the date on which a request for mediation is made under paragraph (5), or any later date agreed upon by both parties, the Service shall refer the dispute to a tripartite arbitration panel established in accordance with such regulations as may be prescribed by the Service. (B) Members A tripartite arbitration panel established under this paragraph with respect to a dispute shall be composed of 1 member selected by the labor organization, 1 member selected by the employer, and 1 neutral member mutually agreed to by the parties. The labor organization and employer shall each select the members of the tripartite arbitration panel within 14 days of the Service’s referral. Any member not so selected by such date shall be selected by the Service. (C) Dispute settlement A majority of a tripartite arbitration panel established under this paragraph with respect to a dispute shall render a decision settling the dispute as soon as practicable, and (absent extraordinary circumstances or by agreement or permission of the parties) not later than 120 days after the establishment of such panel. Such a decision shall be binding upon the parties for a period of 2 years, unless amended during such period by written consent of the parties. Such decision shall be based on— (i) the employer's financial status and prospects; (ii) the size and type of the employer's operations and business; (iii) the employees' cost of living; (iv) the employees' ability to sustain themselves, their families, and their dependents on the wages and benefits they earn from the employer; and (v) the wages and benefits that other employers in the same business provide their employees. (7) Subcontractors Any employer receiving funds under this section shall require any subcontractor whose employees perform, or will perform, work funded under this section to comply with the requirements set forth in this subsection. (l) Funds (1) Authorization of appropriations There is authorized to be appropriated to the Secretary to carry out this section $600,000,000 for each of fiscal years 2022 through 2026. (2) Costs of direct loans The Secretary may use any amounts made available under paragraph (1) to pay the costs of providing direct loans under the program. (3) Set aside Not less than $20,000,000 of the amount made available to carry out this section each fiscal year under paragraph (1) shall be used to award grants or direct loans under the program to eligible entities that are small businesses located in economically disadvantaged communities. | https://www.govinfo.gov/content/pkg/BILLS-117s4329is/xml/BILLS-117s4329is.xml |
117-s-4330 | II 117th CONGRESS 2d Session S. 4330 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Rosen (for herself and Mr. Wicker ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to authorize a loan repayment program to encourage specialty medicine physicians to serve in rural communities experiencing a shortage of specialty medicine physicians, and for other purposes.
1. Short title This Act may be cited as the Specialty Physicians Advancing Rural Care Act or the SPARC Act . 2. Findings Congress finds the following: (1) According to a June 2021 study by the Association of American Medical Colleges, titled The Complexities of Physician Supply and Demand: Projections From 2019 to 2034 , the projected demand for physicians continues to exceed projected supply, with a projected shortage of between 37,800 and 124,000 physicians by 2034. Further, the study projects a shortage of between 21,000 and 77,100 nonprimary care physicians by 2034. (2) A July 25, 2019, article, titled Implications of an Aging Rural Physician Workforce , published in the New England Journal of Medicine, estimates that the size of the workforce held relatively steady at about 12 physicians per 10,000 population in rural areas from 2000 to 2017, but such workforce is forecast to decrease by 23 percent by 2030. (3) According to the report by the Association of American Medical Colleges, titled Medical Student Education: Debt, Costs, and Loan Repayment Fact Card for the Class of 2020 , the percentage of medical school graduates with education debt is 73 percent and the average education debt amount for a medical school graduate is $207,003. Medical school debt accounts for 70 percent of overall student loan debt, and the median stipend for a medical graduate's first year after earning a medical degree is $58,305. 3. Specialty medical practitioners workforce in rural communities Title VII of the Public Health Service Act ( 42 U.S.C. 292 et seq. ) is amended— (1) by redesignating part G ( 42 U.S.C. 795j et seq. ) as part H; and (2) by inserting after part F ( 42 U.S.C. 295h ) the following new part: G Specialty medicine workforce in rural communities 782. Loan repayment program (a) In general (1) Program for specialty medicine physicians The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall carry out a program under which— (A) the Secretary enters into agreements with specialty medicine physicians to make payments in accordance with subsection (b) on the principal of and interest on any eligible loans described in subsection (c); and (B) the specialty medicine physicians each agree to complete a period of obligated service described in subsection (d) as a specialty medicine physician in the United States in a rural community experiencing a shortage of specialty medicine physicians. (2) Program for non-physician specialty health care providers The Secretary, acting through the Administrator of the Health Resources and Services Administration, may carry out a program under which— (A) the Secretary enters into agreements with non-physician specialty health care providers to make payments in accordance with subsection (b) on the principal of and interest on any eligible loans described in subsection (c); and (B) the non-physician specialty health care providers each agree to complete a period of obligated service described in subsection (d) as a non-physician specialty health care provider in the United States in a rural community experiencing a shortage of such providers. (b) Payments For each year of obligated service by a specialty medicine physician pursuant to an agreement under subsection (a)(1) or by a non-physician specialty health care provider pursuant to an agreement under subsection (a)(2), the Secretary shall make a payment to such physician or provider as follows: (1) Service in shortage area The Secretary shall pay— (A) for each year of obligated service by a specialty medicine physician or non-physician specialty health care provider pursuant to an agreement under paragraph (1) or (2) of subsection (a), 1/6 of the principal of and interest on each eligible loan of the physician or provider which is outstanding on the date the physician or provider began service pursuant to the agreement; and (B) for completion of the sixth and final year of such service, the remainder of such principal and interest. (2) Maximum amount The total amount of payments under this section to any specialty medicine physician or non-physician specialty health care provider shall not exceed $250,000. (c) Eligible loans The loans eligible for repayment under this section are each of the following: (1) Any loan for education in specialty medicine or specialty health care. (2) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965). (3) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965. (4) Any other Federal loan as determined appropriate by the Secretary. (d) Period of obligated service Any specialty medicine physician or non-physician specialty health care provider receiving payments under this section as required by an agreement under paragraph (1) or (2) of subsection (a) shall agree to a 6-year commitment to full-time employment, with no more than 1 year passing between any 2 years of covered employment, as a specialty medicine physician or non-physician specialty health care provider, as applicable, in the United States in a rural community experiencing a shortage of specialty medicine physicians or non-physician specialty health care providers, as applicable. (e) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations or a loan repayment under both— (1) this section; and (2) any federally supported loan forgiveness program, including under section 338B, 338I, or 846 of this Act, or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965. (f) Breach (1) Liquidated damages formula The Secretary may establish a liquidated damages formula to be used in the event of a breach of an agreement entered into under paragraph (1) or (2) of subsection (a). (2) Limitation The failure by a specialty medicine physician or a non-physician specialty health care provider to complete the full period of service obligated pursuant to such an agreement, taken alone, shall not constitute a breach of the agreement, so long as the physician or provider completed in good faith the years of service for which payments were made to the physician or provider under this section. (g) Special rules for non-Physician specialty health care providers Non-physician specialty health care providers participating in the program under this section are not eligible for other Federal loan forgiveness programs specific to health care providers. Not more than 15 percent of amounts made available to carry out this section for a fiscal year may be allocated to awards to non-physician specialty health care providers. (h) Reports to Congress Not later than 5 years after the date of enactment of this section, and not less than every other year thereafter through fiscal year 2030, the Secretary shall report to Congress on— (1) the practice location of special medicine physicians and non-physician specialty health care providers participating, or who have participated, in the loan repayment program under this section; and (2) the impact of the loan repayment program under this section on the availability of specialty medicine or specialty health care services in the United States in rural communities experiencing a shortage of specialty medicine physicians or non-physician specialty health care providers. (i) Data updates The Administrator of the Health Resources and Services Administration shall update publicly available data on the supply of specialty medicine physicians and non-physician specialty health care providers, as appropriate. (j) Definitions In this section: (1) Non-physician specialty health care provider The term non-physician specialty health care provider means a health professional other than a physician who is licensed to provide patient care other than primary care services. (2) Specialty medicine physician The term specialty medicine physician means a physician practicing in— (A) a specialty identified in the report of the Health Resources and Services Administration, titled Projecting the Supply of Non-Primary Care Specialty and Subspecialty Clinicians: 2010–2025 ; (B) hospice and palliative medicine; (C) geriatric medicine; or (D) another medical specialty, if the Secretary determines that there is evidence demonstrating a significant shortage of providers in the medical specialty and limited patient access to care. (k) Authorization of appropriations To carry out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2022 through 2031. . | https://www.govinfo.gov/content/pkg/BILLS-117s4330is/xml/BILLS-117s4330is.xml |
117-s-4331 | II 117th CONGRESS 2d Session S. 4331 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Duckworth (for herself, Ms. Rosen , Mr. Tillis , Mr. Blumenthal , Mrs. Fischer , and Mr. Wicker ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To require a plan on emergency military assistance to Taiwan and other support to Taiwan's defensive capabilities, and for other purposes.
1. Short title This Act may be cited as the Strengthen Taiwan's Security Act of 2022 . 2. Annual report on the ability of the United States to support defensive capabilities of Taiwan (a) In general Not later than 180 days after the date of the enactment of this Act, and annually thereafter through fiscal year 2027, the Secretary of Defense shall submit to the appropriate committees of Congress, a report on the ability of the United States to support the defensive capabilities of Taiwan. (b) Elements (1) In general The elements described in this paragraph are the following: (A) An assessment of the implications of current levels of pre-positioned war reserve materiel on the ability of the United States to respond to a natural disaster in or military invasion of Taiwan, with respect to— (i) providing military or nonmilitary aid to the Government of Taiwan; and (ii) sustaining military installations and other infrastructure of the United States in the Indo-Pacific region. (B) An evaluation of the use by the United States Government of privileges available with respect to Taiwan under the Foreign Assistance Act of 1961 ( 22 U.S.C. 2151 et seq. ), including war reserve stockpiles for allies and pre-positioned facilities. (C) An assessment of ways the United States Government could employ such privileges to support the defensive capabilities of Taiwan in the event of a military invasion. (D) An assessment of the current intelligence, surveillance, and reconnaissance capabilities of Taiwan and any existing gaps in such capabilities. (E) An evaluation of options to enhance such capabilities, that includes for each such option— (i) a description of— (I) the gaps addressed; (II) the resources required for implementation; and (III) the potential constraints with respect to implementation; (ii) projected timeline for implementation; and (iii) any other consideration the Secretary of Defense considers necessary. (2) Initial report The initial report required by subsection (a) shall include the following: (A) The elements described in paragraph (1). (B) The plan required by subsection (c). (3) Additional reports The second and any subsequent report required by subsection (a) shall include the following: (A) The elements described in paragraph (1). (B) A summary of changes to pre-positioned war reserve materiel of the United States in the Indo-Pacific region as reported by the Armed Forces since the preceding report. (C) A summary of investments made by Taiwan in intelligence, surveillance, and reconnaissance capabilities since the preceding report. (D) Any updates to the plan required by subsection (c), as determined by the Secretary of Defense. (c) Plan for emergency military assistance (1) In general The Secretary of Defense, in close consultation with the Taiwan Ministry of Defense of Taiwan and the military forces of Taiwan, shall develop a plan for the United States to use, to the maximum extent practicable, existing authorities or programs to expedite military assistance to Taiwan necessary for Taiwan to defend itself in the event of a military invasion. (2) Elements The plan required by paragraph (1) shall include the following: (A) A list of defense articles of the United States that may, with pre-approved authority, be transferred to Taiwan during a military invasion. (B) A list of measures to be prioritized to assist Taiwan during a military invasion, including— (i) prioritization of delivery of excess defense articles to Taiwan; (ii) use by the Secretary of Defense of the lease authority and the Special Defense Acquisition Fund established under section 51 of the Arms Export Control Act ( 22 U.S.C. 2795 ); (iii) use of the presidential drawdown authority under section 506(a) of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2318(a) ); (iv) use of presidential authority to lend or lease defense articles to the Government of Taiwan; and (v) temporary expedited congressional review of arms sales to Taiwan. (C) An assessment of methods that could be used to deliver aid to Taiwan during a military invasion of Taiwan, including— (i) the feasibility of employing such methods in different scenarios; and (ii) recommendations for improving the ability of the Armed Forces to deliver assistance to Taiwan. (D) An assessment of additional assistance that could be provided to Taiwan if additional authority is granted. (d) Form Each report required by subsection (a) shall be submitted in unclassified form, but may include a classified annex. 3. Definitions In this Act: (1) Appropriate committees of Congress The term appropriate committees of Congress means— (A) the Committee on Armed Services, the Committee on Foreign Relations, and the Select Committee on Intelligence of the Senate; and (B) the Committee on Armed Services, the Committee on Foreign Affairs, and the Permanent Select Committee on Intelligence of the House of Representatives. (2) Military invasion The term military invasion includes— (A) an amphibious landing or assault; (B) an airborne operation or air assault; (C) an aerial bombardment or blockade; (D) missile attacks, including rockets, ballistic missiles, cruise missiles, and hypersonic missiles; and (E) a naval bombardment or blockade. (3) Natural disaster The term natural disaster means a disaster caused by natural forces, including extreme weather events, sea-level rise, or extreme drought conditions. | https://www.govinfo.gov/content/pkg/BILLS-117s4331is/xml/BILLS-117s4331is.xml |
117-s-4332 | II 117th CONGRESS 2d Session S. 4332 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. King (for himself and Ms. Murkowski ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to support research and programmatic efforts that will build on previous research on the effects of adverse childhood experiences.
1. Short title; findings (a) Short title This Act may be cited as the Improving Data Collection for Adverse Childhood Experiences Act . (b) Findings Congress finds the following: (1) Certain negative events, circumstances, or maltreatment to which children may be exposed, known as adverse childhood experiences (commonly referred to as ACEs ), are associated with negative health outcomes. (2) Childhood psychological, physical, or sexual abuse; household challenges such as violence, substance use, mental illness, separation or divorce, or incarceration of a family member; historical trauma; and emotional or physical neglect have been shown to negatively impact a person’s long-term health and well-being. (3) Adverse childhood experiences and associated conditions such as living in under-resourced or racially segregated neighborhoods, frequently moving, experiencing food insecurity, and other instability can cause toxic stress, a prolonged activation of the stress-response system. (4) Experiencing one or more adverse childhood experiences is associated with higher risks of some of the leading causes of death and disability in the United States. (5) More than half of all people in the United States have experienced one or more adverse childhood experiences. (6) The Centers for Disease Control and Prevention has recognized adverse childhood experiences as a major public health concern and made it a priority area for focus in the National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention. (7) Further research is needed to better define adverse childhood experiences, understand the causal pathway between adverse childhood experiences and physical health outcomes, and identify protective factors against adverse childhood experiences and their effects, in order to inform and improve current programs and future efforts to promote public health. (8) Evidence-based and culturally informed prevention and mitigation strategies to address adverse childhood experiences have been identified, but efforts are needed to facilitate implementation in communities. (9) American Indian and Alaska Native communities have experienced traumatic events that have had long-lasting consequences for communities. More research on the critical connections between historically traumatic events, contemporary stressors, and adverse childhood experiences is needed. 2. Supporting research on adverse childhood experiences Part J of title III of the Public Health Service Act ( 42 U.S.C. 280b et seq. ) is amended by inserting after section 393D ( 42 U.S.C. 280b–1f ) the following: 393E. Supporting research on preventing or remediating adverse childhood experiences (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may, in cooperation with the States, collect and report data on adverse childhood experiences through the Behavioral Risk Factor Surveillance System, the Youth Risk Behavior Surveillance System, or other relevant public health surveys or questionnaires to contribute to a longitudinal study that— (1) builds on previous literature, including the seminal CDC–Kaiser Permanente Adverse Childhood Experiences (ACE) Study, on the biology and neuroscience of childhood adversity that establishes the links between adverse childhood experiences and negative outcomes; and (2) focuses on elements not included in the study referred to in paragraph (1), including— (A) the inclusion of a diverse nationally representative sample of participants; (B) the strength of the relationship between individual, specific adverse childhood experiences and negative health outcomes; (C) the intensity and frequency of adverse childhood experiences; (D) the relative strength of particular risk and protective factors; (E) the impact of historical trauma in communities disproportionately impacted, as identified by the Secretary, such as American Indians and Alaska Natives, as well as the intersections between historical trauma and adverse childhood experiences scores; and (F) the effect of social, economic, and community conditions on health and well-being . (b) Technical assistance The Secretary may, directly or through awards of grants or contracts to public or nonprofit private entities or Tribal organizations or Indian Tribes, provide technical assistance with respect to the collection and reporting of data as described in subsection (a). (c) Definitions In this section— (1) the term historical trauma means the cumulative, transgenerational, collective experience of emotional and psychological injury in communities; and (2) the terms Indian Tribe and Tribal organization have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act. (d) Authorization of appropriations There are authorized to be appropriated to carry out this section $7,000,000 for each of fiscal years 2023 through 2028. . | https://www.govinfo.gov/content/pkg/BILLS-117s4332is/xml/BILLS-117s4332is.xml |
117-s-4333 | II 117th CONGRESS 2d Session S. 4333 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Smith (for herself and Mr. Marshall ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To deem certain products regulated by the Food and Drug Administration as drugs.
1. Short title This Act may be cited as the Consistent Legal Evaluation And Regulation of Medical Products Act or the CLEAR Act . 2. Regulation of certain products as drugs (a) In general Section 503 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353 ) is amended by adding at the end the following: (h) Deeming certain products as drugs (1) In general Any contrast agent, radioactive drug, OTC monograph drug, or ophthalmic drug article shall be deemed to be a drug under section 201(g) and not a device under section 201(h). (2) Definitions For purposes of this subsection— (A) the term contrast agent means an article that is intended for use in conjunction with an applicable medical imaging device, and— (i) is a diagnostic radiopharmaceutical, as defined in section 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or (ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid; (B) the term ophthalmic drug article means any eye cup, eye dropper, or other non-invasive and non-implanted dispenser intended for ophthalmic use if packaged with the drug with which such article is intended to be used; (C) the term OTC monograph drug has the meaning given such term in section 744L; and (D) the term radioactive drug has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include— (i) implants or articles similar to an implant; (ii) articles that apply radiation from outside of the body; or (iii) the radiation source of an article described in clause (i) or (ii). (3) No effect on determinations regarding other drugs or devices Paragraph (1) shall not be construed as bearing on, or being relevant to, the question of whether any product other than a drug described in such paragraph is a device as defined by section 201(h) or a drug as defined by section 201(g). . (b) Application The amendment made by subsection (a) shall apply to any application submitted under subsection (b) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) and to any application submitted under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), whether such submission was prior to, on, or after the date of enactment of this Act, and shall apply to all actions pending on the day of enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4333is/xml/BILLS-117s4333is.xml |
117-s-4334 | II 117th CONGRESS 2d Session S. 4334 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Menendez (for himself, Mr. Blunt , Mr. Kaine , Mr. Wicker , Mr. Cardin , and Mr. Moran ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To support the advancement of inclusive economic growth, democratic governance, peace, and security in Colombia, and for other purposes.
1. Short title; table of contents (a) Short title This Act may be cited as the United States-Colombia Bicentennial Alliance Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. Sec. 3. Designation of Colombia as a major non-NATO ally. TITLE I—Supporting inclusive economic growth Sec. 101. Colombian-American Enterprise Fund. Sec. 102. Strategy for promoting and strengthening nearshoring in the Western Hemisphere. Sec. 103. United States-Colombia Labor Compact. Sec. 104. Supporting efforts to combat corruption. Sec. 105. Increasing English language proficiency. Sec. 106. Partnership for STEM education. Sec. 107. Supporting women and girls in science and technology. TITLE II—Advancing peace and democratic governance in Colombia Sec. 201. Supporting peace and justice. Sec. 202. Advancing integrated rural development. Sec. 203. Empowering Afro-Colombian and Indigenous communities in Colombia. Sec. 204. Protecting human rights defenders. TITLE III—Strengthening security cooperation Sec. 301. Establishment of United States-Colombia security consultative committee. Sec. 302. Cooperation on cyber defense and combating cyber crimes. Sec. 303. Classified report on the activities of certain terrorist and criminal groups. Sec. 304. Counternarcotics and rural security strategy. Sec. 305. Classified report on the malicious activities of state actors in the Andean region. Sec. 306. Protecting and countering illicit activities in tropical forests. Sec. 307. Public-private partnership to build responsible gold value chains. TITLE IV—Addressing humanitarian needs Sec. 401. Colombia Relief and Development Coherence Strategy. Sec. 402. Assessment of healthcare infrastructure needs in rural areas. 2. Findings Congress makes the following findings: (1) On June 19, 2022, the United States and Colombia will celebrate 200 years of formal diplomatic relations, commemorating the United States Congress’ recognition of the independence of Colombia. (2) On May 15, 2022, the United States and Colombia will celebrate 10 years since the entry into force of the United States-Colombia Trade Promotion Agreement, which has contributed to economic growth in both the United States and Colombia. (3) On July 13, 2000, the United States and Colombia launched Plan Colombia, an ambitious bilateral strategy that strengthened Colombia’s institutions and capacity to combat drug trafficking, organized crime, and violence, and promote rule of law. (4) On February 4, 2016, the United States and Colombia launched a new chapter in bilateral security cooperation between the two countries through the announcement of Peace Colombia, the successor strategy to Plan Colombia aimed at supporting Colombia’s consolidation of peace, democratic governance, and security. (5) To implement Plan Colombia and its successor strategies, the United States Congress has appropriated more than $12,000,000,000 since 2000. The Government of Colombia has contributed more than 90 percent of the total costs of the implementation of Plan Colombia. (6) Increased military and security cooperation through Plan Colombia and Peace Colombia has helped Colombia expand and professionalize its police and armed forces. (7) The United States and Colombia have entered into formal partnerships with governments throughout Latin America and the Caribbean to bolster hemispheric security cooperation through the United States-Colombia Action Plan on Regional Security Cooperation (USCAP). (8) In May 2017, Colombia became the first Latin American partner of the North Atlantic Treaty Organization. (9) Colombia is the second most biodiverse country on Earth and is home to 10 percent of the world’s flora and fauna. (10) Colombia hosts more than 1,800,000 refugees from Venezuela. In addition, Colombia has a population of 8,100,000 registered victims of internal displacement since 1985. (11) Colombia is the United States third largest trade partner in Latin America, with United States goods and services trade with Colombia totaling an estimated $40,700,000,000 in 2019. (12) The Government of Colombia is a strong advocate for democratic governance in Latin America and the Caribbean, publicly condemning ongoing violations of civil liberties and human rights in Cuba, Nicaragua, and Venezuela. (13) The Government of Colombia has been an active participant in global peacekeeping and peacebuilding missions, including the United Nations Stabilization Mission in Haiti (MINUSTAH), the United Nations Integrated Peacebuilding Office in Sierra Leone (UNOSIL), and the Multinational Force and Observers in the Sinai, since 1979. (14) In February 2021, Colombian President Ivan Duque announced he would grant temporary protected status to nearly 1,800,000 Venezuelan refugees in the country. 3. Designation of Colombia as a major non-NATO ally Section 517 of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2321k ) is amended by adding at the end the following new subsection: (c) Additional designations (1) In general Effective on the date of the enactment of the United States-Colombia Bicentennial Alliance Act , Colombia is designated as a major non-NATO ally for purposes of this Act, the Arms Export Control Act ( 22 U.S.C. 2751 et seq. ), and section 2350a of title 10, United States Code. (2) Notice of termination of designation The President shall notify Congress in accordance with subsection (a)(2) before terminating the designation of a country specified in paragraph (1). . I Supporting inclusive economic growth 101. Colombian-American Enterprise Fund (a) Designation The President shall designate a private, nonprofit organization (to be known as the Colombian-American Enterprise Fund ) to receive funds and support made available under this section after determining that such organization has been designated for the purposes specified in subsection (b). The President shall make such designation only after consultation with the leadership of the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives. (b) Purposes The purposes are this section are the purposes described in section 1421(g)(3) of the BUILD Act of 2018 ( 22 U.S.C. 9621(g)(3) ). (c) Board of Directors (1) Appointment The Colombian-American Enterprise Fund shall be governed by a Board of Directors pursuant to paragraphs (5) and (6) of section 1421(g) of the BUILD Act of 2018 ( 22 U.S.C. 9621(g) ). (2) United States Government liaison to the Board The President shall appoint the United States Ambassador to Colombia, or the Ambassador’s designee, as a liaison to the Board. The liaison appointed under this paragraph shall not have any voting authority. (3) Nongovernment liaisons to the Board (A) In general Upon the recommendation of the Board of Directors, the President may appoint up to 2 additional liaisons to the Board of Directors in addition to the liaison specified in paragraph (2), of which not more than 1 may be a noncitizen of the United States. A liaison appointed under this subparagraph shall not have any voting authority. (B) NGO community One of the additional liaisons to the Board should be from the nongovernmental organization community, with significant prior experience in development financing and an understanding of development policy priorities for Colombia. (C) Technical expertise One of the additional liaisons to the Board should have extensive demonstrated industry, sector, or technical experience and expertise in a priority investment sector described in subsection (e) for the Colombia-American Enterprise Fund. (d) Grants The President is authorized to use $200,000,000 in funds appropriated by any Act, in this fiscal year or prior fiscal years, making appropriations for the Department of State, foreign operations, and related programs, including funds previously obligated, that are otherwise available for such purposes, notwithstanding any other provision of law— (1) to carry out the purposes set forth in subsection (b) through the Colombian-American Enterprise Fund in accordance with section 1421(g)(4)(A) of the BUILD Act of 2018 ( 22 U.S.C. 9621(g)(4)(A) ); and (2) to pay for the administrative expenses of the Colombian-American Enterprise Fund, in accordance with the limitation under section 1421(g)(4)(B) of the BUILD Act of 2018 ( 22 U.S.C. 9621(g)(4)(B) ). (e) Prioritization In carrying out the purposes of the Colombian-American Enterprise Fund described in subsection (b), the Board of Directors shall not be prohibited from making investments, grants, and expenditures in any economic sector, but shall prioritize such activities in the following sectors: (1) Not less than 35 percent of the investments, grants, and expenditures of the Colombian-American Enterprise Fund shall go to projects and activities of small- and medium-sized businesses in Colombia working to close the digital divide, enabling digital transformation, and developing and applying advanced digital technologies, including big data, artificial intelligence, and the Internet of things. (2) Not less than 50 percent of the investments, grants, and expenditures, of the Colombian-American Enterprise Fund shall go to small- and medium-sized businesses owned by women. (3) Small- and medium-sized businesses dedicated to advancing the growth, sustainability, modernization, and formalization of Colombia’s agriculture sector. (f) Notification Not later than 15 days before designating an organization to operate as the Colombia-American Enterprise Fund pursuant to subsection (a), the President shall notify the Chairmen and Ranking Members of the appropriate congressional committees of— (1) the identity of the organization to be designated to operate as the Colombian-American Enterprise Fund; (2) the names and qualifications of the individuals who will comprise the initial Board of Directors; and (3) the amount of the grant intended to fund the Colombian-American Enterprise Fund. (g) Briefing Not later than one year after the designation of the Fund, and annually thereafter, the President shall brief the appropriate congressional committees on— (1) a summary of the Fund’s beneficiaries; (2) progress by the Fund in achieving the purposes set forth in subsection (b); (3) recommendations on how the Fund can better achieve the purposes set forth in subsection (b); and (4) the reporting requirements described in subsection (h). (h) Compliance The Colombian-American Enterprise Fund shall be subject to the reporting and oversight requirements described in paragraphs (7) and (8) of section 1421(g) of the BUILD Act of 2018 ( 22 U.S.C. 9621(g) ), respectively. (i) Best practices (1) In general To the maximum extent practicable, the Board of Directors of the Colombian-American Enterprise Fund should adopt the best practices and procedures used by other American Enterprise Funds, including those for which funding has been made available pursuant to section 201 of the Support for East European Democracy (SEED) Act of 1989 ( 22 U.S.C. 5421 ). (2) Implementation In implementing this section, the President shall ensure that the articles of incorporation of the Colombia-American Enterprise Fund (including provisions specifying the responsibilities of the Board of Directors of the Fund) and the terms of United States Government grant agreements with the Fund are, to the maximum extent practicable, consistent with the articles of incorporation and the terms of grant agreements established for other American Enterprise Funds, including those established pursuant to section 201 of the Support for East European Democracy (SEED) Act of 1989 ( 22 U.S.C. 5421 ) and comparable provisions of law. (j) Return of funds to Treasury Any funds resulting from the liquidation, dissolution, or winding up of the Colombian-American Enterprise Fund, in whole or in part, shall be returned to the Treasury of the United States. (k) Termination The Colombian-American Enterprise Fund shall terminate on— (1) the date that is 10 years after the date of the first expenditure of amounts from the fund; or (2) the date on which the fund is liquidated. 102. Strategy for promoting and strengthening nearshoring in the Western Hemisphere (a) Strategy The Secretary of State, in coordination with the United States Agency for International Development and the United States International Development Finance Corporation, and the heads of all other relevant Federal departments and agencies, shall develop and implement a strategy to increase supply chain resiliency and security by promoting and strengthening nearshoring efforts to foster economic growth in the Americas and relocate supply chains from the People’s Republic of China to the Western Hemisphere. (b) Elements The strategy required under subsection (a) shall— (1) be informed by consultations with— (A) the governments of allies and partners in the Western Hemisphere; and (B) labor organizations, trade unions, and companies and other private sector enterprises in the United States; (2) provide a description of how reshoring and nearshoring initiatives can be pursued in a complementary fashion to strengthen United States national interests, including an assessment of how nearshoring initiatives can expand opportunities for coproduction and other cooperative business ventures between United States and regional entities; (3) include an assessment of the status and effectiveness of current efforts by regional governments, multilateral development banks, and the private sector to promote nearshoring to the Western Hemisphere, major challenges hindering such efforts, and how the United States can strengthen the effectiveness of such efforts; (4) identify countries and sectors within Latin America and the Caribbean with comparative advantages for sourcing and manufacturing critical goods and countries with the greatest nearshoring opportunities; (5) identify how activities by the United States Agency for International Development and the United States International Development Finance Corporation can effectively be leveraged to strengthen and promote nearshoring to Latin America and the Caribbean; (6) require that the Department of the Treasury and the United States Trade and Development Agency work with United States firms to identify barriers that inhibit them from committing capital or financing projects and provide a description for how the United States Government can work with Latin American and Caribbean countries to address these barriers; (7) advance diplomatic initiatives to secure specific national commitments by governments in Latin America and the Caribbean to undertake efforts to create favorable conditions for nearshoring in the region, including commitments to develop formalized national nearshoring strategies, address corruption and rule of law concerns, modernize digital and physical infrastructure, lower trade barriers, raise labor and environmental standards, improve ease of doing business, and finance and incentivize nearshoring initiatives; (8) advance diplomatic initiatives to harmonize standards and regulations, especially among existing United States free trade partners, expedite customs operations, facilitate economic integration in the region, strengthen legal regimes and monitoring and enforcement measures relating to labor standards, and ensure that nearshoring initiatives are consistent with efforts to improve supply chain energy efficiency, reduce the energy used to transport global goods, and advance environmental sustainability; and (9) develop and implement programs to finance, incentivize, or otherwise promote nearshoring to the Western Hemisphere in accordance with the findings made pursuant to paragraphs (3), (4), and (5), including, at minimum, programs to develop physical and digital infrastructure, promote transparency in procurement processes, provide technical assistance in implementing national nearshoring strategies, support capacity building to strengthen labor and environmental standards, mobilize private investment, and secure commitments by private entities to relocate supply chains from the People’s Republic of China to the Western Hemisphere. (c) Coordination with multilateral development banks In implementing the strategy required under subsection (a), the Secretary of State and the heads of all other relevant Federal departments and agencies shall coordinate with the United States Executive Directors of the Inter-American Development Bank and the World Bank. (d) Prioritization As part of the effort described in this section, the Secretary of State shall prioritize Colombia. (e) Annual report Not later than 180 days after the date of the enactment of this Act, and annually thereafter for a period of 5 years, the Secretary of State shall submit to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives a report on the strategy required under subsection (a) and progress made in its implementation. 103. United States-Colombia Labor Compact (a) Compact authority The Secretary of State, in coordination with the Secretary of Labor and the United States Trade Representative, is authorized to enter into a bilateral agreement of not less than 7 years in duration with the Government of Colombia to continue strengthening labor rights, labor policies, and labor competitiveness in the country. The agreement shall be known as the United States-Colombia Labor Compact (referred to in this section as the Compact ). (b) Compact elements The Compact shall establish a multi-year strategy to— (1) address the findings in the 2021 Executive Report of the Misión de Empleo de Colombia; (2) further advance the objectives set forth under the related goals of the 2016 peace accord and the Colombian Action Plan Related to Labor Rights of April 7, 2011 (referred to in this section as the Labor Action Plan ); (3) promote labor formalization in Colombia; (4) protect internationally recognized labor rights, including with respect to freedom of association, elimination of all forms of forced or compulsory labor, prohibitions on child labor, and acceptable work conditions; (5) address and prevent violence against labor organizations and trade unions and prosecute the perpetrators of such violence; and (6) promote competitive labor for Colombia at the level of other international markets, allowing increased job opportunities. (c) Strategy requirements The strategy required under subsection (c) shall— (1) be informed by consultations with labor organizations, trade unions, and companies and other private sector enterprises in the United States and Colombia; (2) be informed by assessments, including assessments by the Department of Labor’s International Labor Affairs Bureau, of the areas in Colombia experiencing the highest incidence of labor rights violations and violence against labor organizations and trade unions; (3) identify clear and measurable goals, objectives, and benchmarks under the Compact to detect, deter, and respond to labor rights violations and violence against labor leaders; (4) set out clear roles, responsibilities, and objectives under the Compact, which shall include a description of policies and financial commitments of the United States Government and the Government of Colombia; (5) provide for the conduct of an impact evaluation not later than 1 year after the conclusion of the negotiations of the Compact and biannually thereafter; (6) provide for a full accounting of all United States funds expended under the Compact, which shall include full audit authority for the Office of the Inspector General of the Department of State, the Office of the Inspector General of the United States Agency for International Development, and the Government Accountability Office, as appropriate; and (7) enhance the bilateral coordination through the relevant agencies and the United States labor attaché in Bogota, to facilitate progress in the implementation of the strategy. (d) Establishment of Task Force The President shall establish an interagency task force to advance, monitor, enforce, and evaluate the negotiation and signing of the Compact (referred to in this section as the Labor Task Force ), which shall consist of— (1) the Secretary of State, who shall serve as the Chair; (2) the Administrator of the United States Agency for International Development; (3) the Secretary of Labor; (4) the United States Trade Representative; and (5) any other Federal officials as may be designated by the President. (e) Activities of the Labor Task Force The Labor Task Force shall— (1) engage with the Government of Colombia to design and implement the Compact; (2) engage in consultation and advocacy with nongovernmental organizations, including labor organizations and trade unions in the United States and Colombia, to advance the purposes of this section; (3) assess efforts by the United States Government and the Government of Colombia to implement the Compact; and (4) establish regular meetings of the Labor Task Force to ensure closer coordination across departments and agencies in the development of policies regarding the Compact. (f) Specific focus The activities described in subsection (f) shall include an in-depth analysis of the impact of the United States-Colombia Trade Promotion Agreement on vulnerable populations, including women and Afro-Colombian, Indigenous, and migrant communities, and recommendations on ways to ensure that those communities are better assisted and protected. (g) Congressional notification Not later than 15 days after entering into a Compact with the Government of Colombia, the Secretary of State, in coordination with the Administrator of the United States Agency for International Development and the Secretary of Labor, shall submit to the Committee on Foreign Relations of the Senate, the Committee on Finance of the Senate, the Committee on Ways and Means of the House of Representatives, and the Committee on Foreign Affairs of the House of Representatives— (1) a copy of the proposed Compact; and (2) a copy of any annexes, appendices, or implementation plans related to the Compact. (h) Reports Not later than 1 year after entering into a Compact, and annually during the period in which the Compact is in effect, the Secretary of State, in coordination with the Administrator of the United States Agency for International Development, shall submit a report to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives that describes the progress made under the Compact and includes recommendations for strengthening United States implementation of the Compact. 104. Supporting efforts to combat corruption (a) Technical assistance The Secretary of State shall engage with the Government of Colombia for the purpose of developing and implementing a multi-year strategy, including through the provision of technical assistance, to combat corruption and address the misuse of public resources. The Secretary of State shall consult with the Administrator of the United States Agency for International Development and the Secretary of the Treasury in the development of the strategy. (b) Elements The strategy required under subsection (a) shall— (1) assess the scope of public and private sector corruption in Colombia, including specific cases of significant corruption; (2) provide technical assistance for the purposes of combating corruption and increasing transparency in Colombia; (3) develop and implement programming at the national and local levels to support investigative journalism, protection of journalists reporting on public and private sector corruption, civil society anti-corruption initiatives; (4) consult and advocate with nongovernmental organizations and the private sector to advance the purposes of this section; and (5) establish regular United States interagency meetings to ensure closer coordination across United States departments and agencies in the development of policies regarding transparency and corruption in Colombia. (c) Briefings Not later than 180 days after the date of the enactment of this Act, the Secretary of State shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives on the strategy required under subsection (a). Not later than 1 year after the briefing on the strategy, and annually thereafter, the Secretary of State shall brief the committees on the implementation of the strategy. 105. Increasing English language proficiency (a) Partnership authorized The Secretary of State and the Administrator of the United States Agency for International Development are authorized to establish a 5-year public-private partnership to support— (1) innovative in-country solutions for improving English language proficiency among primary and secondary school teachers in Colombia; (2) the creation of English language accelerator courses, including specialized courses in business and technology; and (3) increased educational exchanges between universities in the United States and Colombia. (b) Elements In designing and implementing the partnership authorized under subsection (a), the Secretary of the State and the Administrator of the United States Agency for International Development shall— (1) complement ongoing efforts by the Ministry of Education of Colombia and other relevant institutions; (2) target teachers from schools in low-income communities and underrepresented communities, including Afro-Colombian and Indigenous communities; and (3) consult with the Government of Colombia, civil society, and academia. (c) Purpose The purpose of the partnership authorized under subsection (a) is to increase English language proficiency among primary and secondary school teachers, enhance teachers’ use of emerging digital technologies for English language learning, and ensure continuity of teacher development, thereby increasing student outcomes and the ability of Colombian youth to access higher education and higher quality livelihoods. (d) Authorization of appropriations There is authorized to be appropriated to the United States Agency for International Development $12,000,000 for each of fiscal years 2023 through 2027 for the creation of the partnership authorized under subsection (a). (e) Monitoring and evaluation framework Not later than 1 year after the date of the enactment of this Act, the Secretary of State and the Administrator of the United States Agency for International Development shall jointly submit to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives a monitoring and evaluation framework that includes objectives and indicators related to the partnership authorized under subsection (a). (f) Assessments of partnership impact Not later than 2 years and 5 years after the date of the enactment of this Act, the Secretary of State and the Administrator of the United States Agency for International Development shall jointly submit to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives a comprehensive assessment on the impact of the partnership authorized under subsection (a) that uses the monitoring and evaluation framework submitted pursuant to subsection (e). (g) Briefing Not later than 180 days after the date of the enactment of this Act, the Secretary of State and the Administrator of the United States Agency for International Development shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives regarding the progress achieved in advancing the partnership authorized under subsection (a). 106. Partnership for STEM education (a) In general The United States Administrator of the United States Agency for International Development shall support Colombia’s Ministry of Education in the development of K–12 STEM curricula, the development of a STEM teacher education and degree program at public schools, and the training of 10,000 new K–12 public school educators, including in underrepresented and Afro-Colombian and Indigenous communities. (b) Coordination In designing and implementing the program required under subsection (a), the Administrator of the United States Agency for International Development shall coordinate with the Chief Executive Officer of the Millennium Challenge Corporation and the Chief Executive Officer of the Peace Corps. (c) Authorization of appropriations There is authorized to be appropriated to the United States Agency for International Development $10,000,000 for each of fiscal years 2023 through 2027 for the creation of the program authorized under subsection (a). (d) Briefings Not later than 180 days after the date of the enactment of this Act, and annually thereafter, the Administrator of the United States Agency for International Development shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives on the results of the program required under subsection (a). 107. Supporting women and girls in science and technology (a) In general The Secretary of State shall establish TechWomen and TechGirls programs designed to empower and inspire women and girls from Latin America and the Caribbean to advance careers in science and technology. (b) Participation In carrying out subsection (a), the Secretary of State shall— (1) during the first 5 years of the programs, prioritize the participation of Colombian women and girls; and (2) take steps to include underrepresented women and girls from across Latin America and the Caribbean, including women from low income and underrepresented communities, including Afro-Colombian and Indigenous communities, in the programs. (c) Authorization of appropriations There is authorized to be appropriated $1,000,000 for fiscal year 2023 to carry out this section. II Advancing peace and democratic governance in Colombia 201. Supporting peace and justice (a) Policy It is the policy of the United States to support peace, justice, and democratic governance in Colombia, including the full and timely implementation of the 2016 peace accord. (b) Evaluation framework (1) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of State, in consultation with the Administrator of the United States Agency for International Development, shall submit to the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives an evaluation framework that assesses the impact of United States diplomatic engagement and foreign assistance programming in support of the peace process in Colombia. (2) Consultation The Secretary of State, in consultation with the Administrator of the United States Agency for International Development, shall consult with the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives on the development of the evaluation framework required under paragraph (1). 202. Advancing integrated rural development (a) Supporting agricultural cooperatives The Secretary of State, in coordination with the Administrator of the United States Agency for International Development, the Chief Executive Officer of the United States International Development Finance Corporation, and the Secretary of Commerce, and in consultation with the Chief Executive Officer of the Inter-American Foundation, shall develop and implement programs to support the ability of rural cooperatives in conflict-affected areas of Colombia to bring products into national and international markets by— (1) supporting research; (2) developing new skills; (3) building resilience capacities, including capacity to adapt to the effects of climate change; (4) integrating best practices in sustainable agriculture; (5) promoting standardization and quality control; (6) supporting commercialization; (7) enabling access to financing; and (8) promoting access to markets. (b) Prioritization Programs required under subsection (a) shall prioritize communities seeking to shift away from illicit economies, including such economies related to the trafficking of narcotics, wildlife, minerals and other natural resources, and other goods. (c) Consultation In developing the programs required under subsection (a), the Secretary of State shall consult with representatives of the Government of Colombia, the private sector, human rights, labor, and humanitarian organizations, and underrepresented populations including women, Indigenous populations, and Afro-Colombians. (d) Authorization of appropriations There is authorized to be appropriated to the Secretary of State and the Administrator of the United States Agency for International Development $10,000,000 for each of fiscal years 2023 and 2024 to carry out the programs required under subsection (a). (e) Briefings Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter, the Secretary of State, the Administrator of the United States Agency for International Development, and the Chief Executive Officer of the United States International Development Finance Corporation shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives regarding the progress achieved in advancing the programs required under subsection (a). 203. Empowering Afro-Colombian and Indigenous communities in Colombia (a) In general The Secretary of State, in coordination with the Administrator of the United States Agency for International Development and the Chief Executive Officer of the United States International Development Finance Corporation, and in consultation with the Chief Executive Officer of the Inter-American Foundation, shall develop and implement initiatives to— (1) support the implementation of the ethnic chapter of Colombia’s 2016 peace accord, which safeguards the rights of the Indigenous and Black populations of Colombia; (2) provide technical assistance and capacity-building support to Afro-Colombian community councils in Colombia; (3) increase the participation of individuals from Afro-Colombian and Indigenous communities in existing bilateral initiatives and in educational and cultural exchange programs of the Department of State and the United States Agency for International Development; and (4) increase access to finance and credit for small- and medium-sized businesses owned by Afro-Colombian and Indigenous entrepreneurs, particularly those in communities historically prone to violence and insecurity. (b) Prioritization During the 5-year period beginning on the date of the enactment of this Act— (1) the Administrator of the United States Agency for International Development shall dedicate not less than 10 percent of the amounts appropriated to the United States Agency for International Development and allocated for Colombia to programs that empower and support Afro-Colombian and Indigenous communities in Colombia; and (2) not less than 50 percent of the funding dedicated under paragraph (1) shall be directly provided to Afro-Colombian and Indigenous-led organizations to implement the programs described in that paragraph. 204. Protecting human rights defenders (a) Authorization of appropriations There is authorized to be appropriated $20,000,000 for each of fiscal years 2022 through 2026 to provide critical assistance to human rights defenders and anti-corruption activists in Colombia through the Department of State Human Rights Defenders Fund. (b) Report Not later than 180 days after the date of the enactment of this Act, and annually thereafter through the end of 2024, the Secretary of State, in cooperation with the Administrator of the United States Agency for International Development, shall submit a report to Congress that includes— (1) details regarding Department of State and United States Agency for International Development programs to— (A) support the work of human rights defenders, anti-corruption activists, and other civil society actors in Colombia; and (B) provide assistance when such individuals are under threat, including specific processes by which such individuals can request assistance from United States embassies; (2) detailed information contained in the Country Reports on Human Rights Practices regarding the intimidation of, and attacks against, such individuals and the response of the foreign government; (3) a strategy for any increased engagement and measures of success toward defending human rights defenders and anti-corruption activists; and (4) an accounting of funds used to execute the Human Rights Defender Fund. III Strengthening security cooperation 301. Establishment of United States-Colombia security consultative committee (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of State and the Secretary of Defense shall establish a consultative committee to include the Government of Colombia to develop a strategy for jointly strengthening Colombia’s national security and defense institutions, and capacity to carry out operations across the territory of Colombia, including in rural and urban areas, related to— (1) counterterrorism and counterinsurgency; (2) counternarcotics and countering other forms of illicit trafficking; (3) cyberdefense and cybercrimes; (4) border and maritime security and air defense; and (5) stabilization. (b) Additional elements The consultative committee shall evaluate existing technologies, equipment, and weapons systems, as well as necessary upgrades to such technologies, equipment, and systems of Colombia’s national security and defense institutions in order to ensure the continued defense of the national sovereignty and national territory of Colombia. (c) Bilateral security and defense cooperation Not later than 180 days after the establishment of the consultative committee required under subsection (a), the Secretary of State, in coordination with the Secretary of Defense, is authorized to enter into consultations with the Government of Colombia to strengthen existing, or establish new, bilateral security and defense cooperation or lines of effort to address capacity-building and resource needs identified by the consultative committee. (d) Briefings (1) Consultative committee Not later than 30 days after the establishment of the United States-Colombia Security Consultative Committee required under subsection (a), and not later than 15 days after any meeting of the Consultative Committee thereafter, the Secretary of State and the Secretary of Defense shall jointly brief any of the appropriate congressional committees on progress made under the committee, pursuant to a request by any one of the appropriate congressional committees. (2) Bilateral security and defense cooperation Not later than 30 days after the completion of any consultations with the Government of Colombia pursuant to subsection (c), the Secretary of State and the Secretary of Defense shall brief the appropriate congressional committees on the implementation of the agreed upon areas of cooperation or lines of effort. (e) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Foreign Relations of the Senate; (2) the Committee on Armed Services of the Senate; (3) the Committee on Foreign Affairs of the House of Representatives; and (4) the Committee on Armed Services of the House of Representatives. 302. Cooperation on cyber defense and combating cyber crimes (a) Diplomatic engagement The Secretary of State, in coordination with the Attorney General of the United States, shall engage with the Government of Colombia to support and facilitate Colombia’s adoption of improved standards to address cyber crimes, especially such crimes that are state-directed, including— (1) supporting the development of Colombia’s strategies to deter, investigate, and prosecute cybercrime, to protect critical infrastructure, and to promote the use of new technologies, as part of a broader and more coordinated effort to protect the information technology systems and networks of citizens, businesses, and governments; (2) supporting the development of protocols that allow cyber preparedness and ensure protection and resilience to critical infrastructure; (3) supporting the Government of Colombia in the implementation of relevant international conventions, such as the Budapest Convention on Cybercrime, of which Colombia is a party; (4) continuing to develop partnerships among foreign partners, including in Latin America and the Caribbean, responsible for preventing, investigating, and prosecuting such crimes, and the private sector, in order to streamline and improve the procurement of timely information in the context of mutual assistance proceedings; (5) working, in cooperation with like-minded democracies in international organizations, to advance standards for digital governance and promote a secure, reliable, free, and open internet; (6) supporting the adoption of new technologies to enhance the technical capabilities of cybersecurity agencies in Colombia; and (7) supporting the efforts of the Government of Colombia and Colombian civil society to build national resilience against foreign disinformation efforts. (b) Digital infrastructure access and security strategy Not later than 180 days after the date of the enactment of this Act, the Secretary of State, in coordination with relevant Federal agencies, shall develop and implement a strategy for leveraging United States expertise to share best practices and lessons learned and assist the Government of Colombia. The strategy shall— (1) improve and secure its digital infrastructure, including critical infrastructure; (2) protect technological assets, including data privacy, digital evidence, and electronically store information; (3) advance cybersecurity to protect against cybercrime and cyberespionage; (4) promote exchanges and technical training programs, including know-how transfer in cybersecurity and disinformation and misinformation; (5) promote the adoption or development of new technologies to enhance protection against cybercrime and cyberespionage; (6) promote digital hygiene programs; and (7) build capacity to identify and expose foreign disinformation and misinformation. (c) Authorization of appropriations There is authorized to be appropriated to the Secretary of State for the development and implementation of the strategy required under subsection (b) $3,000,000 for each of fiscal years 2023 through 2025. (d) Semiannual briefing requirement Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter until the date that is 5 years after such date of enactment, the Secretary of State shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives regarding the implementation of the diplomatic engagement described in subsection (a) and the implementation of the strategy described in subsection (b). 303. Classified report on the activities of certain terrorist and criminal groups (a) Finding On November 30, 2021, the United States designated the Revolutionary Armed Forces of Colombia-People’s Army (FARC–EP) and Segunda Marquetalia as foreign terrorist organizations under section 219(a) of the Immigration and Nationality Act ( 8 U.S.C. 1189(a) ). (b) Reports required Not later than 180 days after the date of the enactment of this Act, and annually thereafter for 5 years, the Secretary of State, acting through the Assistant Secretary of State for the Bureau of Intelligence and Research of the Department of State, and in coordination with the Secretary of Defense, the Director of National Intelligence, and the Director of the Central Intelligence Agency, shall submit to the appropriate congressional committees a classified report detailing the activities of the Revolutionary Armed Forces of Colombia-EP, Segunda Marquetalia, the Ejército de Liberación Nacional, Clan del Golfo, and other Colombian organized criminal groups. (c) Elements Each report required by subsection (b) shall include— (1) the name or names of each group covered by the report; (2) a description of each group and the geographic presence of the group; (3) a description of the leadership and structure of each group; (4) the operating modalities and capabilities of each group; (5) the rate of growth and recruitment strategies of each group; and (6) any linkages between such groups and any other countries, including the regime of Nicolás Maduro in Venezuela. (d) Appropriate congressional committees defined In this section, the term appropriate congressional committees means— (1) the Committee on Foreign Relations of the Senate; (2) the Select Committee on Intelligence of the Senate; (3) the Committee on Armed Services of the Senate; (4) the Committee on Foreign Affairs of the House of Representatives; (5) the Permanent Select Committee on Intelligence of the House of Representatives; and (6) the Committee on Armed Services of the House of Representatives. 304. Counternarcotics and rural security strategy (a) In general The Secretary of State shall develop and implement a strategy and related programs to support the Government of Colombia’s efforts to counter narcotics trafficking and transnational organized crime, including human trafficking, illicit trafficking in arms, wildlife, and cultural property, environmental crimes, migrant smuggling, corruption, money laundering, the illicit smuggling of bulk cash, the licit use of financial systems for malign purposes, and other new and emerging forms of crime, by supporting— (1) the eradication of illicit coca crops and the destruction of laboratories used to produce illicit narcotics; (2) the interdiction of illicit narcotics and other forms contraband; (3) efforts to disrupt illicit financial networks, including through technical assistance to financial intelligence units, including the enhancement of anti-money laundering and asset forfeiture programs; (4) civilian law enforcement agencies, including support for— (A) the enhancement of management of complex, multi-actor criminal cases; (B) the enhancement of intelligence collection capacity and training on civilian intelligence collection (including safeguards for privacy and basic civil liberties), investigative techniques, forensic analysis, and evidence preservation; and (C) port, airport, and border security officials, agencies, and systems, including— (i) improvements to computer infrastructure and data management systems, secure communications technologies, nonintrusive inspection equipment, and radar and aerial surveillance equipment; and (ii) assistance to canine units; (5) justice sector institutions to enhance efforts to successfully prosecute drug trafficking organizations, transnational criminal organizations, and individuals and entities involved in money laundering and financial crimes related to narcotics trafficking and other illicit economies; (6) the inclusion of human rights in law enforcement training programs; and (7) advancing rural security initiatives, including the protection of community leaders and members of organized civil society who promote the rule of law and democratic governance. (b) Prioritization During the 5-year period beginning on the date of the enactment of this Act, the Secretary of State shall dedicate— (1) not less than 10 percent of the amounts appropriated to the International Narcotics Control and Law Enforcement account for Colombia to combating money laundering and financial crimes; and (2) not less than 10 percent of the amounts appropriated to the International Narcotics Control and Law Enforcement account for Colombia to research, innovation initiatives, and new technologies that can be utilized to combat illicit trafficking and all forms of transnational organized crime, as described in subsection (a). (c) Briefings Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter, the Secretary of State shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives regarding the progress achieved in advancing the programs required under subsection (a). 305. Classified report on the malicious activities of state actors in the Andean region (a) Report required Not later than 90 days after the date of the enactment of this Act, and annually thereafter for 5 years, the Secretary of State, acting through the Assistant Secretary of State for the Bureau of Intelligence and Research of the Department of State, and in coordination with the Director of National Intelligence, the Director of the Central Intelligence Agency, and the Director of the Defense Intelligence Agency, shall submit a classified report to the appropriate congressional committees detailing the malicious activities of state actors in the Andean region, including— (1) disinformation, misinformation, and all other information operations; (2) election interference; (3) cyberattacks and aggressions; (4) sales or donations of weapons or military equipment; (5) security cooperation; (6) the direct and indirect supply of technologies, equipment, and weapons to irregular armed actors operating in the Andean region; (7) the provision of technologies, equipment, and weapons systems to the regime of Nicolas Maduro in Venezuela and the implications for the security of countries in the Andean region; and (8) other threats to United States national interests and national security. (b) Establishment of position The Secretary of State shall establish a watcher position in the Andean region as necessary to fulfill the requirements detailed under subsection (a). (c) Annual briefing requirement Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the official designated for the watcher position established pursuant to subsection (b) shall brief the appropriate congressional committees on— (1) the steps that United States embassies in the Andean region have taken to advance the issues described in subsection (a); and (2) the nature and extent of the extra-regional diplomatic, economic, security, defense, and intelligence presence and influence in the Andean region. 306. Protecting and countering illicit activities in tropical forests (a) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of State and the Administrator of the United States Agency for International Development, in consultation with the Chief of the Forest Service of the Department of Agriculture, shall develop and implement a joint 3-year strategy, in coordination with the Government of Colombia, which shall be known as the Strategy for Protecting Colombia’s Tropical Forests (referred to in this section as the strategy ), to protect the biodiversity of Colombia and address deforestation. (b) Elements The strategy shall describe how the United States will— (1) empower and fund local communities, especially Indigenous and Afro-Colombian communities, to manage natural resources, address deforestation and forest degradation, and combat illegal activities causing environmental harm in their communities, including drug-trafficking activities and illegal logging, mining, fishing, and wildlife trade; (2) protect social and environmental activists and whistleblowers; (3) strengthen community-based prevention mechanisms and support community-led efforts to address illegal activities related to natural resources, including those activities described in paragraph (1); (4) advance the development of markets to promote alternatives to activities related to drug trafficking and illegally obtained wood, fish, wildlife, or minerals, as appropriate; (5) promote transparency in product sourcing and responsible supply chains; (6) prevent, detect, investigate, and prosecute crimes related to natural resources; (7) promote partnerships with nongovernmental organizations, international organizations, and the private sector; (8) work within the United States interagency process to end the import of illegally or unsustainably sourced wildlife, timber, agricultural commodities, or fish, or illegally sourced gold or other minerals into the United States from Colombia; and (9) consult with civil society to address the drivers of deforestation and forest degradation, and promote the conservation of intact forests. (c) Regional diplomatic coordination The United States shall work with the Government of Colombia, and in cooperation with international organizations, to support the development of partnerships among Latin American and Caribbean officials responsible for preventing, investigating, and prosecuting environmental crimes, and in cooperation with the private sector, to protect the region’s biodiversity and address deforestation and forest degradation. (d) Authorization of appropriations There is authorized to be appropriated to the Secretary of State and the United States Agency for International Development for the development and implementation of the strategy— (1) $5,000,000 for fiscal year 2023; (2) $7,000,000 for fiscal year 2024; and (3) $8,000,000 for fiscal year 2025. (e) Briefings Not later than 180 days after the date of the enactment of this Act, the Secretary of State and the Administrator of the United States Agency for International Development shall brief the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives on the strategy. Not later than one year after the briefing on the strategy, and annually thereafter, the Secretary of State shall brief the committees on the implementation of the strategy. 307. Public-private partnership to build responsible gold value chains (a) Best practices The Administrator of the United States Agency for International Development, in coordination with the Government of Colombia, shall consult with the Government of Switzerland regarding best practices developed through their public-private partnership, the Swiss Better Gold Initiative, which aims to improve transparency and traceability in the international gold trade. (b) In general The Administrator of the United States Agency for International Development shall coordinate with the Government of Colombia to establish a public-private partnership to advance the best practices described in subsection (a), including supporting programming in Colombia that will— (1) support formalization and compliance with appropriate environmental and labor standards in artisanal and small-scale gold mining (ASGM); (2) increase access to financing for ASGM miners committed to taking significant steps to formalize their operations and comply with labor and environmental standards; (3) enhance the traceability and support the establishment of a certification process for ASGM gold; (4) support a public relations campaign to promote responsibly sourced gold; (5) facilitate contact between Colombian vendors of responsibly sourced gold and United States companies; and (6) promote policies and practices in Colombia that are conducive to the formalization of ASGM and improvement of environmental and labor standards in ASGM. (c) Meeting The Secretary of State, the Administrator of the United States Agency for International Development, or the President’s Special Envoy for Climate Change should, without delegation and in coordination with the Government of Colombia, host a meeting with senior representatives of the private sector and international governmental and nongovernmental partners and make commitments to improve due diligence and increase the responsible sourcing of gold. IV Addressing humanitarian needs 401. Colombia Relief and Development Coherence Strategy (a) Strategy required The Secretary of State, in coordination with the Administrator of the United States Agency for International Development, shall develop and implement a strategy, to be known as the Colombia Relief and Development Coherence Strategy , to support Colombia’s responses to the separate but related challenges of assisting internally displaced persons, refugees, vulnerable migrants, and people affected by natural disasters. The strategy shall— (1) be publicly available in English and Spanish; (2) describe concurrent efforts and clarify United States agency responsibilities in Colombia for assisting— (A) asylum seekers; (B) refugees; (C) internally displaced persons; and (D) vulnerable migrants; (3) include a description of the assistance that shall be provided for the populations described in paragraph (2), including— (A) emergency assistance, protection, water, sanitation, hygiene, food, shelter, emergency education, and psychosocial assistance; and (B) integration programs in the education, health, livelihoods, shelter, and social protection sectors; (4) include a description of the technical assistance and capacity-building efforts to be provided for civil society organizations and relevant institutions in Colombia, such as the Victims Unit of the Government of Colombia and relevant government ministries; (5) describe outreach, coordination, and programming with the private sector to support the populations described in paragraph (2); and (6) describe how the Department of State and the United States Agency for International Development will mobilize additional donor contributions towards humanitarian appeals. (b) Description of interagency coordination efforts The strategy developed under subsection (a) shall include a description of how the Department of State will lead interagency coordination efforts in implementing the strategy, including a description of mechanisms to coordinate programming, advocacy, monitoring and evaluation, communications, participation in international fora, and funding announcements. 402. Assessment of healthcare infrastructure needs in rural areas (a) Assessment The Director of the Centers for Disease Control and Prevention, in coordination with the Department of State, shall conduct an assessment with the Government of Colombia to identify initiatives to strengthen public health infrastructure and increase access to health services in conflict-affected communities in Colombia. The assessment shall include specific recommendations on ways to increase access to healthcare services for survivors of gender-based violence and Afro-Colombian and Indigenous populations. (b) Submission The Director of the Centers for Disease Control and Prevention shall submit the assessment conducted under subsection (a) to the Committee on Foreign Relations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Foreign Affairs and the Committee on Energy and Commerce of the House of Representatives. | https://www.govinfo.gov/content/pkg/BILLS-117s4334is/xml/BILLS-117s4334is.xml |
117-s-4335 | II 117th CONGRESS 2d Session S. 4335 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Klobuchar (for herself, Mr. Blumenthal , Mr. Wyden , Mr. Leahy , Mr. Casey , Ms. Smith , Ms. Warren , Ms. Hirono , and Mr. Booker ) introduced the following bill; which was read twice and referred to the Committee on Rules and Administration A BILL To improve voter access to the ballot box through automatic voter registration, and for other purposes.
1. Short title This Act may be cited as the Register America to Vote Act of 2022 . 2. Findings and purpose (a) Findings and purpose (1) Findings Congress finds that— (A) the right to vote is a fundamental right of citizens of the United States; (B) it is the responsibility of Federal and State governments to ensure that every eligible citizen is registered to vote; (C) existing voter registration systems can be inaccurate, costly, inaccessible, and confusing, with damaging effects on voter participation in elections for Federal office and disproportionate impacts on young people, individuals with disabilities, and racial and ethnic minorities; and (D) voter registration systems must be updated with 21st Century technologies and procedures to maintain their security. (2) Purpose It is the purpose of this Act— (A) to establish that it is the responsibility of government to ensure that all eligible citizens are registered to vote in elections for Federal office; (B) to enable the State governments to register all eligible citizens to vote with accurate, cost-efficient, and up-to-date procedures; (C) to modernize voter registration and list maintenance procedures with electronic and internet capabilities; and (D) to protect and enhance the integrity, accuracy, efficiency, and accessibility of the electoral process for all eligible citizens. 3. Definitions In this Act, the following definitions apply: (1) The term chief State election official means, with respect to a State, the individual designated by the State under section 10 of the National Voter Registration Act of 1993 ( 52 U.S.C. 20509 ) to be responsible for coordination of the responsibilities under that Act. (2) The term State means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. 4. Automatic registration of individuals turning 18 years of age (a) Requirement Except as provided in subsection (b), the chief State election official of each State shall establish and operate a system of automatic registration for the registration of any eligible individual on the date on which the individual turns 18 in order that the individual may vote in elections for Federal office in the State. (b) Exception The requirement under paragraph (1) shall not apply to a State in which, under a State law in effect continuously on and after the date of the enactment of this section, there is no voter registration requirement for individuals in the State with respect to elections for Federal office. 5. Automatic registration of eligible individuals (a) In general The National Voter Registration Act of 1993 ( 52 U.S.C. 20504 ) is amended by inserting after section 5 the following new section: 5A. Automatic registration by State motor vehicle authority (a) Definitions In this section— (1) Applicable agency The term applicable agency means, with respect to a State, the State motor vehicle authority responsible for motor vehicle driver's licenses under State law. (2) Applicable transaction The term applicable transaction means— (A) an application to an applicable agency for a motor vehicle driver's license; and (B) any other service or assistance (including for a change of address) provided by an applicable agency. (3) Automatic registration The term automatic registration means a system that registers an individual to vote and updates existing voter registration in elections for Federal office in a State, if eligible, by electronically transferring the information necessary for registration from the applicable agency to election officials of the State in order that, unless the individual affirmatively declines to be registered or to update any voter registration, the individual will be registered to vote in those elections. (4) Eligible individual The term eligible individual means, with respect to an election for Federal office, an individual who is otherwise qualified to vote in that election. (5) Register to vote The term register to vote includes updating the existing voter registration of an individual. (b) Establishment (1) In general The chief State election official of each State shall establish and operate a system of automatic registration for the registration of eligible individuals to vote for elections for Federal office in the State, in accordance with the provisions of this section. (2) Registration of voters based on new agency records (A) In general The chief State election official shall— (i) subject to subparagraph (B), ensure that each eligible individual who completes an applicable transaction and does not decline to register to vote is registered to vote— (I) in the next election for Federal office (and subsequent elections for Federal office), if an applicable agency transmits information under subsection (c)(1)(E) with respect to the individual not later than the applicable date; and (II) in subsequent elections for Federal office, if an applicable agency transmits information under subsection (c)(1)(E) with respect to the individual after the applicable date; and (ii) not later than 60 days after the receipt of information described in subsection (c)(1)(E) with respect to an individual, send written notice to the individual, in addition to other means of notice established under this section, of the voter registration status of the individual. (B) Applicable date For purposes of this subsection, the term “applicable date” means, with respect to any election for Federal office, the later of— (i) the date that is 28 days before the date of the election; or (ii) the last day of the period provided by State law for voter registration with respect to such election. (C) Clarification Nothing in this subsection shall prevent a chief State election official from registering an eligible individual to vote in the next election for Federal office in the State, including if an applicable agency transmits information under subsection (c)(1)(E) with respect to the individual after the applicable date. (3) Treatment of individuals under 18 years of age (A) In general Except as provided in subparagraph (B), a State may not refuse to treat an individual as an eligible individual for purposes of this section on the grounds that the individual is less than 18 years of age on the date on which an applicable agency receives information with respect to the individual, provided that the individual is not less than 16 years of age at that time. (B) Exception Nothing in subparagraph (A) may be construed to require a State to permit an individual who is less than 18 years of age on the date of an election for Federal office to vote in the election. (c) Applicable agency responsibilities (1) Instructions on automatic registration for agencies collecting citizenship information (A) In general Except as otherwise provided in this section, in the case of any applicable transaction for which an applicable agency (in the normal course of the operations) requests (either directly or as part of the overall application submitted for the applicable transaction) that an individual affirm that the individual is a United States citizen, the applicable agency shall inform each such individual who is a citizen of the United States of the following: (i) Unless the individual declines to register to vote, or is found ineligible to vote— (I) the individual will be registered to vote; or (II) if applicable, the voter registration of the individual will be updated. (ii) With respect to the qualification to register to vote— (I) the substantive qualifications of an elector in the State as listed in the mail voter registration application form for elections for Federal office prescribed pursuant to section 9; (II) the consequences of false registration; and (III) how the individual should decline to register to vote if the individual does not meet requirements for eligibility to vote in a Federal election. (iii) In the case of a State in which affiliation or enrollment with a political party is required in order to participate in an election for Federal office to select the candidate of the political party, the requirement that the individual must, in registering to vote, affiliate or enroll with a political party in order to participate in such an election. (iv) With respect to voter registration by an individual— (I) voter registration is voluntary; (II) whether the individual registers or declines to register to vote shall not affect the availability of any service or benefit; and (III) information relating to whether the individual registers or declines to register to vote may not be used for other purposes. (B) Individuals with limited English proficiency (i) Covered individual For purposes of this subparagraph, the term covered individual means an individual conducting an applicable transaction— (I) who is a member of a group that constitutes not less than 3 percent of the overall population of the State, as determined by the United States Census Bureau, served by the applicable agency; and (II) who is limited English proficient. (ii) Requirement In providing information pursuant to subparagraph (A), an applicable agency shall provide the information to any covered individual served by the applicable agency in a language understood by the covered individual. (C) Clarification of procedures for ineligible voters An applicable agency may not provide an individual who did not affirm United States citizenship, or for whom the applicable agency has conclusive documentary evidence obtained through the normal course of operations of the applicable agency that the individual is not a United State citizen, the opportunity to register to vote under subparagraph (A). (D) Opportunity to decline registration required (i) In general Except as otherwise provided in this section, each applicable agency shall ensure that each applicable transaction described in subparagraph (A) may not be completed unless the individual is given the opportunity to decline to be registered to vote. (ii) Language requirement If an individual is a covered individual, as defined in subparagraph (B)(i), the covered individual shall be given the opportunity to decline to be registered to vote in a language understood by the covered individual. (E) Information transmittal Not later than 10 days after an applicable transaction with an eligible individual, if the eligible individual did not decline to be registered to vote, the applicable agency shall electronically transmit to the appropriate State election official the following information with respect to the eligible individual: (i) The given name and surname of the eligible individual. (ii) The date of birth of the eligible individual. (iii) The residential address of the individual. (iv) Information showing that the individual is a citizen of the United States. (v) The date on which information pertaining to the eligible individual was collected or most recently updated. (vi) If available, the signature of the eligible individual in electronic form. (vii) In the case of a State in which affiliation or enrollment with a political party is required in order to participate in an election to select the candidate of the political party in an election for Federal office, information relating to the affiliation or enrollment of the eligible individual with a political party, if the eligible individual provides that information. (viii) Any additional information listed in the mail voter registration application form for elections for Federal office prescribed pursuant to section 9, including, if the eligible individual provides such information— (I) the valid driver’s license number of the eligible individual; and (II) the last 4 digits of the social security number of the eligible individual. (F) Provision of information relating to participation in primary elections In the case of a State in which affiliation or enrollment with a political party is required in order to participate in an election to select the candidate of a political party in an election for Federal office, if the information transmitted under subparagraph (E) with respect to an eligible individual does not include information regarding the affiliation or enrollment with a political party of the eligible individual, the chief State election official shall— (i) notify the eligible individual that such affiliation or enrollment is required to participate in any primary election for Federal office; and (ii) provide an opportunity for the eligible individual to update the registration of the eligible individual to denote the party affiliation or enrollment of the eligible individual. (G) Clarification Nothing in this section shall be construed to require an applicable agency to transmit to an election official the information described in subparagraph (E) with respect to an individual who is ineligible to vote in an election for Federal office in the State, except to the extent required to pre-register a citizen between 16 and 18 years of age. (2) Alternate procedure for certain other applicable agencies With each applicable transaction for which an applicable agency (in the normal course of the operations of the applicable agency) does not request an individual to affirm United States citizenship (either directly or as part of the overall application for service or assistance), the applicable agency shall— (A) complete the requirements under section 5; (B) ensure that each transaction by an individual with the applicable agency may not be completed unless the individual indicates whether the individual wishes to register to vote or declines to register to vote in elections for Federal office held in the State; and (C) for each individual who wishes to register to vote, transmit the information relating to the individual described in paragraph (1)(E), unless the applicable agency has conclusive documentary evidence obtained through the normal course of operations of the applicable agency that the individual is not a United States citizen. (3) Required availability of automatic registration opportunity with each application for service or assistance Each applicable agency shall offer each eligible individual, in conducting each applicable transaction, the opportunity to register to vote as prescribed by this section without regard to whether the individual previously declined an opportunity to register to vote. (d) Voter protection (1) Protection of information by applicable agencies Nothing in this section may be construed to authorize an applicable agency to collect, retain, transmit, or publicly disclose any of the following, except as necessary to comply with title III of the Civil Rights Act of 1960 ( 52 U.S.C. 20701 et seq. ): (A) The decision of an individual to decline to register to vote. (B) The decision of an individual not to affirm the citizenship of the individual. (C) Any information that an applicable agency transmits pursuant to subsection (c)(1)(E), except in carrying out the ordinary course of business of the applicable agency. (2) Protection of information by elections officials (A) Public disclosure prohibited (i) In general Except as provided in clause (ii), with respect to any individual with respect to whom any appropriate State election official receives information from an applicable agency, the State election official shall not publicly disclose— (I) any information not necessary to voter registration; (II) any information of the individual otherwise protected from disclosure pursuant to section 8(a) or State law; (III) any portion of the social security number of the individual; (IV) any portion of the motor vehicle driver’s license number of the individual; (V) the signature of the individual; (VI) the telephone number of the individual; or (VII) the email address of the individual. (ii) Special rule for individuals registered to vote The prohibition on public disclosure under clause (i) shall not apply with respect to the telephone number or email address of any individual— (I) for whom any State election official receives information from the applicable agency; and (II) who, on the basis of such information, is registered to vote in the State under this section. (e) Miscellaneous provisions (1) Accessibility of registration services Each applicable agency shall ensure that the voter registration services the applicable agency provides under this section are made available to individuals with disabilities to the same extent as services are made available to all other individuals. (2) Transmission through secure third party permitted Nothing in the Register America to Vote Act of 2022 or this section shall be construed to prevent an applicable agency from contracting with a third party to assist the applicable agency in meeting the information transmittal requirements under this section, provided that the information transmittal complies with the applicable requirements of this section, including provisions relating privacy and security. (3) Nonpartisan, nondiscriminatory provision of services The services made available by applicable agencies under this section shall be made in a manner consistent with paragraphs (4), (5), and (6)(C) of section 7(a). (4) Notices (A) Electronic notices Each State may send notices under this section via electronic mail if the individual has provided an electronic mail address and consented to electronic mail communications for election-related materials. (B) Response Any notice sent pursuant to this section that requires a response shall offer the individual to whom the notice is sent the opportunity to respond to the notice at no cost to the individual. (5) Registration at other State offices permitted Nothing in this section may be construed to prohibit a State from offering voter registration services described in this section at offices of the State other than the State motor vehicle authority. (f) Applicability (1) In general This section shall not apply to an exempt State. (2) Exempt State The term exempt State means a State that, under law that is in effect on or after the date of enactment of this Act, either— (A) has no voter registration requirement for any voter in the State with respect to a Federal election; or (B) operates a system of automatic registration (as defined in subsection (a))— (i) at the motor vehicle authority of the State; or (ii) a Permanent Dividend Fund of the State under which an individual is provided the opportunity to decline to register to vote— (I) during the transaction; or (II) by notice sent by mail or electronically after the transaction. . (b) Conforming amendments (1) Section 4(a) of the National Voter Registration Act of 1993 ( 52 U.S.C. 20503(a)(1) ) is amended by— (A) redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and (B) inserting after paragraph (1) the following: (2) by application made simultaneously with an application for a motor vehicle driver's license pursuant to section 5A; . (2) Section 4(b) of the National Voter Registration Act of 1993 ( 52 U.S.C. 20503(b) ) is amended— (A) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and indenting appropriately; (B) by striking States .—This Act and inserting “ States .— (1) In general Except as provided in paragraph (2), this Act ; and (C) by adding at the end the following new paragraph: (2) Application of automatic registration requirements Section 5A shall apply to a State described in paragraph (1), unless the State is an exempt State as defined in subsection (f)(2) of that section. . (3) Section 8(a)(1) of the National Voter Registration Act of 1993 ( 52 U.S.C. 20507(a)(1) ) is amended by redesignating subparagraphs (B), (C), and (D) as subparagraphs (C), (D), and (E), respectively, and by inserting after subparagraph (A) the following: (B) in the case of registration under section 5A, within the period provided in section 5A(b)(2); . 6. Voter protection and security in automatic registration (a) Protections for errors in registration An individual shall not be prosecuted under any Federal or State law, adversely affected in any civil adjudication concerning immigration status or naturalization, or subject to an allegation in any legal proceeding that the individual is not a citizen of the United States for any of the following reasons: (1) The individual notifies an election office of the individual’s automatic registration to vote. (2) The individual is not eligible to vote in elections for Federal office but was automatically registered to vote due to individual or applicable agency error. (3) The individual was automatically registered to vote at an address that is not the correct residential address of the individual. (4) The individual declined the opportunity to register to vote or did not make an affirmation of citizenship when registering to vote, including through automatic registration. (b) Limits on use of automatic registration The automatic registration (as defined in section 5A of the National Voter Registration Act of 1993) of any individual, or the fact that an individual declined the opportunity to register to vote or did not make an affirmation of citizenship (including through automatic registration), may not be used as evidence against that individual in any State or Federal law enforcement proceeding or any civil adjudication concerning immigration status or naturalization, and the lack of knowledge or willfulness of the individual in such registration may be demonstrated by the testimony of the individual alone. (c) Protection of election integrity Nothing in subsection (a) or (b) shall be construed to prohibit or restrict any action under color of law against an individual who— (1) knowingly and willfully makes a false statement to effectuate or perpetuate automatic voter registration by any individual; or (2) casts a ballot knowingly and willfully in violation of State law or the laws of the United States. (d) Protection of information by elections officials (1) Voter record changes Each State shall maintain for at least 2 years, and shall make available for public inspection (and, where available, photocopying at a reasonable cost), including in electronic form and through electronic methods, all records of changes to voter records, including removals, the reasons for removals, and updates. (2) Database management standards Not later than 1 year after the date of enactment of this Act, the Director of the National Institute of Standards and Technology, in consultation with State and local election officials representing geographic and socio-economic diversity, and the Election Assistance Commission, shall, after providing the public with notice and the opportunity to comment— (A) establish standards governing the comparison of data for voter registration list maintenance purposes, identifying as part of those standards the specific data elements, the matching rules used, and how a State may use the data to determine and deem that an individual is ineligible under State law to vote in an election, or to deem a record to be a duplicate or outdated; (B) ensure that the standards developed under this paragraph are uniform and nondiscriminatory and are applied in a uniform and nondiscriminatory manner; (C) not later than 45 days after the deadline for public notice and comment; (i) publish the standards developed under this paragraph on the website of the National Institute of Standards and Technology; and (ii) make the standards developed under this paragraph available in written form upon request; and (D) ensure that the standards developed under this paragraph are maintained and updated in a manner that reflects innovations and best practices in the security of database management. (3) Security policy (A) In general Not later than 1 year after the date of enactment of this Act, the Director of the National Institute of Standards and Technology shall, after providing the public with notice and the opportunity to comment, publish privacy and security standards for voter registration information not later than 45 days after the deadline for public notice and comment. (B) Requirement The standards developed under this paragraph shall require the chief State election official of each State to adopt a policy that shall specify— (i) each class of users who have authorized access to the computerized statewide voter registration list— (I) specifying for each class the permission and levels of access to be granted; and (II) setting forth other safeguards to protect the privacy, security, and accuracy of the information on voter registration lists; and (ii) security safeguards to protect personal information transmitted through— (I) the information transmittal processes of section 5A(b) of the National Voter Registration Act of 1993; (II) any telephone interface; (III) the maintenance of the voter registration database; and (IV) any audit procedure to track access to the system. (C) Maintenance and updating The Director of the National Institute of Standards and Technology shall ensure that the standards developed under this paragraph are maintained and updated in a manner that reflects innovations and best practices in the privacy and security of voter registration information. (4) State compliance with national standards (A) Certification Each chief State election official of the State shall annually file with the Election Assistance Commission a statement certifying to the Director of the National Institute of Standards and Technology that the State is in compliance with the standards developed under paragraphs (2) and (3), which requirement may be met if the chief State election official submits to the Election Assistance Commission a statement that states, _____ hereby certifies that _____ is in compliance with the standards referred to in paragraphs (2) and (3) of section 6(d) of the Register America to Vote Act of 2022 . , with the blank spaces to be completed with the name of the relevant State. (B) Publication of policies and procedures The chief State election official of a State shall— (i) publish on the website of the chief State election official the policies and procedures established under this section; and (ii) make those policies and procedures available in written form upon public request. (C) Funding dependent on certification If a State does not timely file the certification required under subparagraph (A), it shall not receive any payment under this Act for the upcoming fiscal year in which the State fails to make such certification. (D) Compliance of States that require changes to State law In the case of a State that requires State legislation to carry out an activity covered by any certification submitted under this paragraph— (i) for a period of not more than 2 years, the State shall be permitted to make the certification notwithstanding that the legislation has not been enacted on the date on which the State submits the certification; and (ii) the State shall submit an additional certification once such legislation is enacted. (e) Restrictions on use of information No person acting under color of law may discriminate against any individual based on, or use for any purpose other than voter registration, election administration, juror selection, or enforcement relating to an election crime, any of the following: (1) Voter registration records. (2) The declination of an individual to register to vote or complete an affirmation of citizenship under section 5A of the National Voter Registration Act of 1993. (3) The voter registration status of an individual. (f) Prohibition on the use of voter registration information for commercial purposes (1) In general Information collected under this Act or the amendments made by this Act shall not be used for commercial purposes. (2) Dissemination for political purposes Nothing in this subsection shall be construed to prohibit the transmission, exchange, or dissemination of information for political purposes, including the support of campaigns for election for Federal, State, or local public office or the activities of political committees (including committees of political parties) under the Federal Election Campaign Act of 1971 ( 52 U.S.C. 30101 et seq. ). 7. Payments and grants (a) In general The Election Assistance Commission shall make grants to each eligible State under subsection (b) to assist the State in implementing the requirements of this Act and the amendments made by this Act (or, in the case of an exempt State, in implementing the existing automatic voter registration program of the exempt State or expanding the automatic voter registration program of the State in a manner consistent with the requirements of this Act) with respect to the offices of the State motor vehicle authority and any other offices of the State at which the State offers voter registration services as described in this Act and the amendments made by this Act. (b) Eligibility; application A State is eligible to receive a grant under this section if the State submits to the Election Assistance Commission, at such time and in such form as the Election Assistance Commission may require, an application containing— (1) a description of the activities the State will carry out with the grant; (2) an assurance that the State shall carry out such activities without partisan bias and without promoting any particular point of view regarding any issue; and (3) any other information and assurances as the Election Assistance Commission may require. (c) Amount of grant; priorities (1) Amount The Commission shall determine the amount of a grant made to an eligible State under this section. (2) Priorities In determining the amount of a grant, the Election Assistance Commission shall give priority to providing funds for those activities that are most likely to accelerate compliance with the requirements of this Act (or, in the case of an exempt State, that are most likely to enhance the ability of the exempt State to automatically register individuals to vote through the existing automatic voter registration program of the exempt State), including— (A) investments supporting electronic information transfer, including electronic collection and transfer of signatures, between applicable agencies (as defined in section 5A of the National Voter Registration Act of 1993) and the appropriate State election officials; (B) updates to online or electronic voter registration systems already operating as of the date of the enactment of this Act; (C) introduction of online voter registration systems in jurisdictions in which those systems did not previously exist; and (D) public education on the availability of new methods of registering to vote, updating registration, and correcting registration. (d) Exempt State For purposes of this section, the term exempt State — (1) has the meaning given that term under section 5A(f)(2) of the National Voter Registration Act of 1993; and (2) includes a State in which, under law in effect on or after the date of the enactment of the National Voter Registration Act of 1993, there is no voter registration requirement for any voter in the State with respect to an election for Federal office. (e) Authorization of appropriations (1) Authorization There are authorized to be appropriated to carry out this section— (A) $3,000,000,000 for fiscal year 2023; and (B) such sums as may be necessary for each succeeding fiscal year. (2) Continuing availability of funds Any amounts appropriated pursuant to this subsection shall remain available without fiscal year limitation until expended. 8. Miscellaneous provisions (a) Enforcement Section 11 of the National Voter Registration Act of 1993 ( 52 U.S.C. 20510 et seq. ), relating to civil enforcement and the availability of private rights of action, shall apply with respect to this Act in the same manner as such section applies to the National Voter Registration Act of 1993 ( 52 U.S.C. 20510 et seq. ). (b) Relation to other laws Except as provided, nothing in this Act or the amendments made by this Act may be construed to authorize or require conduct prohibited under, or to supersede, restrict, or limit the application of any of the following: (1) The Voting Rights Act of 1965 ( 52 U.S.C. 10301 et seq. ). (2) The Uniformed and Overseas Citizens Absentee Voting Act ( 52 U.S.C. 20301 et seq. ). (3) Except as provided by the amendment made under section 5 of this Act, the National Voter Registration Act of 1993 ( 52 U.S.C. 20501 et seq. ). (4) The Help America Vote Act of 2002 ( 52 U.S.C. 20901 et seq. ). (5) The Americans with Disabilities Act of 1990 ( 42 U.S.C. 12101 et seq. ). 9. Effective date (a) In general Except as provided in subsection (b), this Act and the amendments made by this Act shall apply on and after January 1, 2024. (b) Waiver If a State certifies to the Elections Assistance Commission not later than January 1, 2024, that the State will not meet the deadline described in subsection (a) because it would be impracticable to do so and includes in the certification the reasons for the failure to meet that deadline, subsection (a) shall apply to the State as if the reference in such subsection to January 1, 2024 were a reference to January 1, 2026 . | https://www.govinfo.gov/content/pkg/BILLS-117s4335is/xml/BILLS-117s4335is.xml |
117-s-4336 | II 117th CONGRESS 2d Session S. 4336 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Rosen (for herself and Mr. Young ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Secretary of Health and Human Services, in consultation with the Director of the Cybersecurity and Infrastructure Security Agency, to annually review and as appropriate update guidance for industry and Food and Drug Administration staff on medical device cybersecurity, and for other purposes.
1. Short title This Act may be cited as the Strengthening Cybersecurity for Medical Devices Act . 2. Guidance for industry and FDA staff on medical device cybersecurity (a) In general Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter, the Secretary of Health and Human Services (referred to in this Act as the Secretary ), in consultation with the Director of the Cybersecurity and Infrastructure Security Agency, shall review and, as appropriate and after soliciting and receiving feedback from medical device manufacturers, health care providers, and patient advocates, update the guidance entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (or a successor document). (b) Updating specific provisions In updating the guidance under subsection (a), the Secretary may update specific provisions of the guidance, after notice and comment, without reissuing the guidance. 3. Resources regarding cybersecurity of medical devices Not later than 180 days after the date of enactment of this Act, and not less than annually thereafter, the Secretary shall update public information provided by the Food and Drug Administration, including through the webpage on medical devices on the website of the Food and Drug Administration, with information regarding improving cybersecurity of medical devices. Such information shall include information on identifying and addressing cyber vulnerabilities for health care providers, health systems, and medical device manufacturers, and how such entities may access support through the Cybersecurity and Infrastructure Security Agency and other Federal entities, including the Department of Health and Human Services, to improve cybersecurity of medical devices. 4. GAO report Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall publish a report identifying challenges in cybersecurity for medical devices, including legacy devices that may not support certain software security updates. Through such report, the Comptroller General shall examine— (1) challenges for medical device manufacturers, health care providers, health systems, and patients in accessing Federal support to address vulnerabilities across Federal agencies; and (2) how Federal agencies can strengthen coordination to better support cybersecurity for medical devices. | https://www.govinfo.gov/content/pkg/BILLS-117s4336is/xml/BILLS-117s4336is.xml |
117-s-4337 | II 117th CONGRESS 2d Session S. 4337 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Lankford (for himself, Mr. King , Mr. Inhofe , and Ms. Sinema ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To amend title 5, United States Code, to authorize the appointment of spouses of members of the Armed Forces who are on active duty, disabled, or deceased to positions in which the spouses will work remotely.
1. Short title This Act may be cited as the Military Spouse Employment Act . 2. Appointment of military spouses Section 3330d of title 5, United States Code, is amended— (1) in subsection (a)— (A) by redesignating paragraph (3) as paragraph (4); and (B) by inserting after paragraph (2) the following: (3) The term remote work refers to a work flexibility arrangement under which an employee— (A) is not expected to physically report to the location from which the employee would otherwise work, considering the position of the employee; and (B) performs the duties and responsibilities of such employee’s position, and other authorized activities, from an approved worksite— (i) other than the location from which the employee would otherwise work; (ii) that may be inside or outside the local commuting area of the location from which the employee would otherwise work; and (iii) that is typically the residence of the employee. ; (2) in subsection (b)— (A) in paragraph (1), by striking or at the end; (B) in paragraph (2), by striking the period at the end and inserting ; or ; and (C) by adding at the end the following: (3) a spouse of a member of the Armed Forces who is on active duty, or a spouse of a disabled or deceased member of the Armed Forces, to a position in which that individual will engage in remote work. ; and (3) in subsection (c)(1), by striking subsection (a)(3) and inserting subsection (a)(4) . | https://www.govinfo.gov/content/pkg/BILLS-117s4337is/xml/BILLS-117s4337is.xml |
117-s-4338 | II 117th CONGRESS 2d Session S. 4338 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Hassan (for herself and Mr. Paul ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for increased transparency in generic drug applications.
1. Short title This Act may be cited as the Increasing Transparency in Generic Drug Applications Act . 2. Increasing transparency in generic drug applications (a) In general Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(3) ) is amended by adding at the end the following: (H) (i) Upon request (in controlled correspondence or otherwise) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is generally required by regulation or recommended in guidance to contain the same inactive ingredients in the same concentration as the listed drug referred to or for which there is a scientific justification that an in vitro approach can be used to demonstrate bioequivalence based on certain qualitative or quantitative criteria with respect to an inactive ingredient, or on the Secretary’s own initiative during the review of an application under this subsection for such a drug, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. (ii) If the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— (I) the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug; and (II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. (iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless— (I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or (II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified. (iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i). (v) The disclosures required by this subparagraph are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. . (b) Guidance (1) In general Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters. (2) Process In issuing guidance under this subsection, the Secretary of Health and Human Services shall— (A) publish draft guidance; (B) provide a period of at least 60 days for comment on the draft guidance; and (C) after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance. (c) Applicability Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized. | https://www.govinfo.gov/content/pkg/BILLS-117s4338is/xml/BILLS-117s4338is.xml |
117-s-4339 | II 117th CONGRESS 2d Session S. 4339 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Cornyn (for himself, Ms. Sinema , Mr. Cruz , Mr. Kelly , Mr. Lankford , and Mr. Padilla ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To support remediation of illicit cross-border tunnels, and for other purposes.
1. Short title This Act may be cited as the DHS Illicit Cross-Border Tunnel Defense Act . 2. Counter illicit cross-border tunnel operations (a) Counter illicit cross-Border tunnel operations strategic plan (1) In general Not later than 180 days after the date of the enactment of this Act, the Commissioner of U.S. Customs and Border Protection, in coordination with the Under Secretary for Science and Technology, and, as appropriate, other officials of the Department of Homeland Security, shall develop a counter illicit cross-border tunnel operations strategic plan (in this section referred to as the strategic plan ) to address the following: (A) Risk-based criteria to be used to prioritize the identification, breach, assessment, and remediation of illicit cross-border tunnels. (B) Promote the use of innovative technologies to identify, breach, assess, and remediate illicit cross-border tunnels in a manner that, among other considerations, reduces the impact of such activities on surrounding communities. (C) Processes to share relevant illicit cross-border tunnel location, operations, and technical information. (D) Indicators of specific types of illicit cross-border tunnels found in each U.S. Border Patrol sector identified through operations to be periodically disseminated to U.S. Border Patrol sector chiefs to educate field personnel. (E) A counter illicit cross-border tunnel operations resource needs assessment that includes consideration of the following: (i) Technology needs. (ii) Staffing needs, including the following: (I) A position description for counter illicit cross-border tunnel operations personnel. (II) Any specialized skills required of such personnel. (III) The number of such full-time personnel, disaggregated by U.S. Border Patrol sector. (2) Report to Congress on strategic plan Not later than one year after the development of the strategic plan, the Commissioner of U.S. Customs and Border Protection shall submit to the Committee on Homeland Security of the House of Representatives and the Committee on Homeland Security and Governmental Affairs of the Senate a report on the implementation of the strategic plan. (b) Authorization of appropriations There is authorized to be appropriated to the Commissioner of U.S. Customs and Border Protection $1,000,000 for each of fiscal years 2023 and 2024 to carry out— (1) the development of the strategic plan; and (2) remediation operations of illicit cross-border tunnels in accordance with the strategic plan to the maximum extent practicable. | https://www.govinfo.gov/content/pkg/BILLS-117s4339is/xml/BILLS-117s4339is.xml |
117-s-4340 | II 117th CONGRESS 2d Session S. 4340 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Manchin (for himself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs.
1. Short title This Act may be cited as the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act or the EFFECTIVE Act . 2. Requirement for approval of new opioid analgesics Section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) is amended by adding at the end the following: (6) Notwithstanding any other provision of this section, the Secretary may deny approval of an application submitted under subsection (b) for an opioid analgesic drug if the Secretary determines that such drug does not provide a significant advantage or clinical superiority, in terms of greater safety or effectiveness, compared to an appropriate comparator drug, as determined by the Secretary. . | https://www.govinfo.gov/content/pkg/BILLS-117s4340is/xml/BILLS-117s4340is.xml |
117-s-4341 | II 117th CONGRESS 2d Session S. 4341 IN THE SENATE OF THE UNITED STATES May 26, 2022 Ms. Rosen (for herself and Mr. Romney ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require the Government Accountability Office to issue a report on nonprofit pharmaceutical organizations.
1. Short title This Act may be cited as the Advancing Affordable Medicines for Families Act . 2. GAO report on nonprofit pharmaceutical organizations The Comptroller General of the United States shall submit a report to Congress on the following: (1) The potential impact of nonprofit pharmaceutical organizations on the availability and cost of drugs, including on drug shortages, consumer costs, and costs to Federal programs. (2) The potential of nonprofit pharmaceutical organizations to accelerate development of new drugs, generic drugs, new biological products, biosimilar biological products, cell-based therapies, and devices. (3) Existing barriers to the success of nonprofit pharmaceutical organizations, including the ability of such organizations to obtain tax-exempt status, access to capital, and access to markets. (4) Potential actions by Congress that would allow nonprofit pharmaceutical organizations to deliver benefits to the pharmaceutical market. | https://www.govinfo.gov/content/pkg/BILLS-117s4341is/xml/BILLS-117s4341is.xml |
117-s-4342 | II 117th CONGRESS 2d Session S. 4342 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Whitehouse introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Higher Education Act of 1965 to authorize a new student loan forgiveness program.
1. Short title This Act may be cited as the Affording Students A Path to Forgiveness Act or the ASAP Forgiveness Act . 2. Loan forgiveness program for employment Section 455 of the Higher Education Act of 1965 ( 20 U.S.C. 1087e ) is amended by adding at the end the following: (r) Loan forgiveness for employment (1) In general The Secretary shall cancel not more than $30,000 of interest and principal due, in accordance with paragraph (2), on any eligible Federal Direct Loan that is in repayment status on or after the date of enactment of this subsection for a borrower who— (A) has made not less than 60 monthly payments on the eligible Federal Direct Loan pursuant to any repayment plan authorized under this Act; and (B) has been employed, on a full-time or part-time basis, for 10 years after graduating from, or otherwise leaving, the institution of higher education for which the loan was made to enable the borrower to enroll. (2) Loan cancellation amount After the conclusion of the employment period described in paragraph (1), the Secretary shall cancel the obligation to repay not more than $30,000 of principal and interest due as of the time of such cancellation, on the eligible Federal Direct Loans made to the borrower under this part. (3) Eligible federal direct loan In this subsection, the term eligible Federal Direct Loan means a Federal Direct Stafford Loan, Federal Direct PLUS Loan, or Federal Direct Unsubsidized Stafford Loan, or a Federal Direct Consolidation Loan. (4) Ineligibility for double benefits No borrower may, for the same service, receive a reduction of loan obligations under both this subsection and subsection (m) or section 428J, 428K, 428L, or 460. . | https://www.govinfo.gov/content/pkg/BILLS-117s4342is/xml/BILLS-117s4342is.xml |
117-s-4343 | II 117th CONGRESS 2d Session S. 4343 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Johnson (for himself, Mr. Barrasso , Mr. Braun , Mr. Cotton , Mr. Cruz , Mr. Grassley , Mr. Hagerty , Mr. Hoeven , Mrs. Hyde-Smith , Mr. Lee , Mr. Marshall , Mr. Rubio , Mr. Scott of Florida , Mr. Tuberville , Mr. Daines , and Mr. Tillis ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To require any convention, agreement, or other international instrument on pandemic prevention, preparedness, and response reached by the World Health Assembly to be subject to Senate ratification.
1. Short title This Act may be cited as the No WHO Pandemic Preparedness Treaty Without Senate Approval Act . 2. Findings Congress makes the following findings: (1) On May 18, 2020, President Donald Trump sent a letter to World Health Organization (referred to in this Act as WHO ) Director-General Tedros Adhanom Ghebreyesus (referred to in this Act as the Director-General ), announcing that— (A) United States contributions to WHO would be halted due its mismanagement of the COVID–19 outbreak and its lack of independence from the People’s Republic of China; and (B) the United States would withdraw from WHO if it did not commit to substantive improvements within 30 days. (2) President Trump’s May 18 letter cited numerous instances of WHO mismanagement of the COVID–19 pandemic, including— (A) unjustified delays informing member states about a potentially serious disease outbreak in Wuhan, China; and (B) repeated grossly inaccurate or misleading claims about the transmissibility of the virus and about the Government of China’s handling of the outbreak. (3) On June 30, 2020, Secretary of State Mike Pompeo formally notified the United Nations of the United States decision to withdraw from WHO, which would have taken effect on July 6, 2021, under the terms of a joint resolution adopted by Congress on June 14, 1948 ( Public Law 80–643 ; 62 Stat. 441). (4) A Pew Research Center survey conducted in April and May 2020 indicated that 51 percent of Americans felt that WHO had done a poor or fair job in managing the COVID–19 pandemic. (5) On January 20, 2021, President Joseph Biden sent United Nations Director-General António Guterres a letter retracting the United States notice of withdrawal from WHO. (6) On December 1, 2021, at the second special session of the World Health Assembly (referred to in this Act as the WHA ) decided— (A) to establish . . . an intergovernmental negotiating body . . . (the INB ) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, with a view to adoption under Article 19, or under other provisions of the WHO Constitution . . . . ; and (B) that the INB shall submit a progress report to the Seventy-sixth WHA and a working draft of the convention for consideration by the Seventy-seventh WHA, which is scheduled to take place beginning on March 18, 2024. (7) On February 24 and March 14 and 15, 2022, the INB held its inaugural meeting at which the Director-General proposed the following 5 themes to guide the INB’s work in drafting the Convention: (A) Building national, regional, and global capacities based on a whole-of-government and whole-of-society approach. (B) Establishing global access and benefit sharing for all pathogens, and determining a global policy for the equitable production and distribution of countermeasures. (C) Establishing robust systems and tools for pandemic preparedness and response. (D) Establishing a long-term plan for sustainable financing to ensure support for global health threat management and response systems. (E) Empowering WHO to fulfill its mandate as the directing and coordinating authority on international health work, including for pandemic preparedness and response. (8) Section 723.3 of title 11 of the Department of State’s Foreign Affairs Manual states that when determining whether any international agreement should be brought into force as a treaty or as an international agreement other than a treaty, the utmost care is to be exercised to avoid any invasion or compromise of the constitutional powers of the President, the Senate, and the Congress as a whole and includes the following criteria to be considered when determining whether an international agreement should take the form of a treaty or an executive agreement: (A) The extent to which the agreement involves commitments or risks affecting the nation as a whole . (B) Whether the agreement is intended to affect state laws . (C) Whether the agreement can be given effect without the enactment of subsequent legislation by the Congress . (D) Past U.S. practice as to similar agreements . (E) The preference of the Congress as to a particular type of agreement . (F) The degree of formality desired for an agreement . (G) The proposed duration of the agreement, the need for prompt conclusion of an agreement, and the desirability of concluding a routine or short-term agreement . (H) The general international practice as to similar agreements . 3. Sense of the Senate It is the sense of the Senate that— (1) a significant segment of the American public is deeply skeptical of the World Health Organization, its leadership, and its independence from the pernicious political influence of certain member states, including the People's Republic of China; (2) the Senate strongly prefers that any agreement related to pandemic prevention, preparedness, and response adopted by the World Health Assembly pursuant to the work of the INB be considered a treaty requiring the advice and consent of the Senate, with two-thirds of Senators concurring; (3) the scope of the agreement which the INB has been tasked with drafting, as outlined by the Director-General, is so broad that any application of the factors referred to in section 2(8) will weigh strongly in favor of it being considered a treaty; and (4) given the level of public distrust, any relevant new agreement by the World Health Assembly which cannot garner the two-thirds vote needed for Senate ratification should not be agreed to or implemented by the United States. 4. Any World Health Agency convention or agreement or other international instrument resulting from the International Negotiating Body’s final report deemed to be a treaty subject to advice and consent of the Senate Notwithstanding any other provision of law, any convention, agreement, or other international instrument on pandemic prevention, preparedness, and response reached by the World Health Assembly pursuant to the recommendations, report, or work of the International Negotiating Body established by the second special session of the World Health Assembly is deemed to be a treaty that is subject to the requirements of article II, section 2, clause 2 of the Constitution of the United States, which requires the advice and consent of the Senate, with two-thirds of Senators concurring. | https://www.govinfo.gov/content/pkg/BILLS-117s4343is/xml/BILLS-117s4343is.xml |
117-s-4344 | II 117th CONGRESS 2d Session S. 4344 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Whitehouse introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish a temporary program for the refinancing of certain Federal and private student loans, and for other purposes.
1. Short title This Act may be cited as the Zero-Percent Student Loan Refinancing Act . 2. Temporary program for refinancing student loans (a) Program authority Section 451(a) of the Higher Education Act of 1965 ( 20 U.S.C. 1087a(a) ) is amended— (1) by striking and (2) and inserting (2) ; and (2) by inserting ; and (3) to make loans under section 460A and section 460B after section 459A . (b) Refinancing program Part D of title IV of the Higher Education Act of 1965 ( 20 U.S.C. 1087a et seq. ) is amended by adding at the end the following: 460A. Temporary program for the refinancing of Federal Direct loans and other Federal student loans (a) Definitions In this section: (1) Covered non-part D loan The term covered non-part D loan means a loan— (A) made, insured, or guaranteed under part B and for which the first disbursement was made, or the application for the consolidation loan was received, before July 1, 2010; (B) made under part E; or (C) made under— (i) subpart II of part A of title VII of the Public Health Service Act ( 42 U.S.C. 292q et seq. ); or (ii) part E of title VIII of the Public Health Service Act ( 42 U.S.C. 297a et seq. ). (2) Covered period The term covered period means the period beginning on August 1, 2022, and ending at the close of December 31, 2025. (3) Original loan The term original loan means a loan for which a borrower’s liability is discharged by a refinanced loan issued in accordance with this section. (4) Qualified borrower The term qualified borrower means a borrower of a loan under this part, or a covered non-part D loan, for which the first disbursement was made, or the application for a consolidation loan was received, before January 1, 2026. (b) In general Beginning on August 1, 2022, the Secretary shall carry out a program under which the Secretary makes interest-free refinancing loans to qualified borrowers in accordance with this section. (c) Refinancing Direct loans (1) Federal Direct Loans (A) In general Beginning on August 1, 2022, the Secretary shall cancel the obligation of a qualified borrower to repay a Federal Direct Stafford Loan, a Federal Direct Unsubsidized Stafford Loan, a Federal Direct PLUS Loan, or a Federal Direct Consolidation Loan for which the first disbursement was made, or the application for the consolidation loan was received, before January 1, 2025, and issue to such borrower in accordance with this section a refinanced Federal Direct Stafford Loan, a refinanced Federal Direct Unsubsidized Stafford Loan, a refinanced Federal Direct PLUS Loan, or a refinanced Federal Direct Consolidation Loan, respectively, in an amount equal to the sum of the unpaid principal, accrued unpaid interest, and late charges of the original loan. (B) Information The Secretary shall notify each qualified borrower of a loan refinanced under subparagraph (A) regarding the refinancing and the benefits the refinancing provides to the qualified borrower. (2) Refinancing covered non-part D loans as refinanced Federal Direct loans Upon application of a qualified borrower of any covered non-part D loan, the Secretary shall make a loan under this part, in an amount equal to the sum of the unpaid principal, accrued unpaid interest, and late charges of the original loan to the borrower in accordance with the following: (A) The Secretary shall pay the proceeds of such loan to the holder of the covered non-part D loan, in order to discharge the borrower from any remaining obligation with respect to the original loan. (B) Any Federal student loan made under this section the proceeds of which are used to discharge a loan that was made, insured, or guaranteed— (i) under section 428 shall be a Federal Direct Stafford Loan; (ii) under section 428B shall be a Federal Direct PLUS Loan; (iii) under section 428H shall be a Federal Direct Unsubsidized Stafford Loan; and (iv) under section 428C shall be a Federal Direct Consolidation Loan. (C) Any Federal student loan made under this section the proceeds of which are used to discharge a loan described in subparagraph (B) or (C) of subsection (a)(1) shall be a Federal Direct Consolidation Loan. (3) Application deadline To be eligible to receive a refinancing loan under paragraph (2) a qualified borrower shall submit an application to the Secretary during the covered period. A borrower who submits an application after the expiration of the covered period shall not be eligible to receive a refinancing loan under such paragraph. (d) Terms and conditions of loans (1) In general A loan made under this section shall have the same terms and conditions as the original loan, except as otherwise provided in this section. (2) Interest rates No interest shall accrue on a loan that is made under this section. (3) No automatic extension of repayment period A loan made under this section shall not result in the extension of the duration of the repayment period of the loan, and the borrower shall retain the same repayment term that was in effect on the original loan. Nothing in this paragraph shall be construed to prevent a borrower from electing a different repayment plan at any time in accordance with section 455(d)(3). (4) Special rule for refinanced Perkins and health loans Notwithstanding paragraph (1), in the case of a loan that is made under this section as a Federal Direct Consolidation Loan the proceeds of which are used to discharge a loan described in subparagraph (B) or (C) of subsection (a)(1)— (A) the refinanced Federal Direct Consolidation Loan shall have the same terms and conditions as a Federal Direct Consolidation Loan, except as otherwise provided in this section; and (B) the Secretary may adjust such terms and conditions as necessary to enable the borrower to access loan forgiveness or other benefits available to the borrower under the loan before refinancing under this section, in any case where such benefits are more generous than provided under a Federal Direct Consolidation Loan. (5) Rule of construction Nothing in this section shall be construed to prevent a borrower of a Federal student loan described in subparagraph (B) or (C) of subsection (a)(1) from consolidating such loans with other loans eligible for consolidation under this section, or to require such a borrower to consolidate such loans with other Federal student loans into a single consolidation loan under this section. (e) Notification to borrowers The Secretary, in coordination with the Director of the Bureau of Consumer Financial Protection, shall undertake a campaign to alert borrowers of covered non-part D loans that are eligible for refinancing under this section that the borrowers are eligible to apply for such refinancing. The campaign shall include the following activities: (1) Developing consumer information materials about the availability of Federal student loan refinancing. (2) Requiring servicers of loans under part B to provide such consumer information to borrowers in a manner determined appropriate by the Secretary, in consultation with the Director of the Bureau of Consumer Financial Protection. 460B. Temporary program for refinancing of private education loans (a) Definitions In this section: (1) Covered period The term covered period means the period beginning on August 1, 2022, and ending at the close of December 31, 2025. (2) Eligible private education loan The term eligible private education loan means a private education loan, as defined in section 140(a) of the Truth in Lending Act ( 15 U.S.C. 1650(a) ), that— (A) was disbursed to the borrower before January 1, 2026; and (B) was for the borrower’s own postsecondary educational expenses for an eligible program at an institution of higher education participating in the loan program under this part, as of the date that the loan was disbursed. (3) Federal Direct Refinanced Private loan The term Federal Direct Refinanced Private Loan means a loan issued under subsection (b)(1). (4) Private educational lender The term private educational lender has the meaning given that term in section 140(a) of the Truth in Lending Act ( 15 U.S.C. 1650(a) ). (5) Qualified borrower The term qualified borrower means an individual who has an eligible private education loan. (b) Program authorized (1) In general Beginning on August 1, 2022, the Secretary, in consultation with the Secretary of the Treasury, shall carry out a program under which the Secretary, upon application by a qualified borrower who has an eligible private education loan, shall issue such borrower a loan under this part in accordance with the following: (A) The loan issued under this program shall be in an amount equal to the sum of the unpaid principal, accrued unpaid interest, and late charges of the private education loan. (B) The Secretary shall pay the proceeds of the loan issued under this program to the private educational lender of the private education loan, in order to discharge the qualified borrower from any remaining obligation to the lender with respect to the original loan. (C) The Secretary shall require that the qualified borrower undergo loan counseling that provides all of the information and counseling required under clauses (i) through (ix) of section 485(b)(1)(A) before the loan is refinanced in accordance with this section, and before the proceeds of such loan are paid to the private educational lender. (D) The Secretary shall issue the loan as a Federal Direct Refinanced Private Loan, which shall have the same terms, conditions, and benefits as a Federal Direct Unsubsidized Stafford Loan, except as otherwise provided in this section. (2) Private educational lenders Not later than August 1, 2022, the Secretary, in consultation with the Secretary of the Treasury and the Director of the Bureau of Consumer Financial Protection, shall establish eligibility requirements to preclude windfall profits for private educational lenders. (c) Application deadline To be eligible to receive a Federal Direct Refinanced Private Loan under this section a qualified borrower shall submit an application to the Secretary during the covered period. A borrower who submits an application after the expiration of the covered period shall not be eligible to receive a Federal Direct Refinanced Private Loan under this section. (d) Interest rate No interest shall accrue on a Federal Direct Refinanced Private Loan under this section. (e) No inclusion in aggregate limits The amount of a Federal Direct Refinanced Private Loan, or a Federal Direct Consolidated Loan to the extent such loan was used to repay a Federal Direct Refinanced Private Loan, shall not be included in calculating a borrower’s annual or aggregate loan limits under section 428 or 428H. (f) Special rule for eligibility for service-Related repayment Notwithstanding sections 428K(a)(2), 428L(b)(2), 455(m)(3)(A), and 460(b), a Federal Direct Refinanced Private Loan shall be eligible for any loan repayment or loan forgiveness program under section 428K, 428L, or 460, or for the repayment plan for public service employees under section 455(m), but only with respect to any balance due, payments made, or service completed, after the date on which such Federal Direct Refinanced Private Loan was issued. (g) Private educational lender reporting requirement (1) Reporting required Not later than August 1, 2022, the Secretary, in consultation with the Secretary of the Treasury and the Director of the Bureau of Consumer Financial Protection, shall establish a requirement that private educational lenders report the data described in paragraph (2) to the Secretary, to Congress, to the Secretary of the Treasury, and to the Director of the Bureau of Consumer Financial Protection, in order to allow for an assessment of the private education loan market. (2) Contents of reporting The data that private educational lenders shall report in accordance with paragraph (1) shall include each of the following about private education loans (as defined in section 140(a) of the Truth in Lending Act ( 15 U.S.C. 1650(a) )): (A) The total amount of private education loan debt the lender holds. (B) The total number of private education loan borrowers the lender serves. (C) The average interest rate on the outstanding private education loan debt held by the lender. (D) The proportion of private education loan borrowers who are in default on a loan held by the lender. (E) The proportion of the outstanding private education loan volume held by the lender that is in default. (F) The proportions of outstanding private education loan borrowers who are 30, 60, and 90 days delinquent. (G) The proportions of outstanding private education loan volume that is 30, 60, and 90 days delinquent. (h) Notification to borrowers The Secretary, in coordination with the Secretary of the Treasury and the Director of the Bureau of Consumer Financial Protection, shall undertake a campaign to alert borrowers about the availability of private student loan refinancing under this section. . (c) Income-Contingent repayment Section 455(e) of the Higher Education Act of 1965 ( 20 U.S.C. 1087e(e) ) is amended by adding at the end the following new paragraph: (9) Special rule for refinanced loans For purposes of paragraph (7), the period of time during which a borrower of a loan that is refinanced under section 460A or 460B has made monthly payments shall be calculated in the manner described in section 493C(f) for the applicable type of loan. . (d) Income-Based repayment Section 493C of the Higher Education Act of 1965 ( 20 U.S.C. 1098e ) is amended by adding at the end the following: (f) Special rule for refinanced loans (1) Refinanced Federal Direct, FFEL, and Plus loans In calculating the period of time during which a borrower of a loan (with the exception of a Federal Direct Consolidation Loan) that is refinanced under section 460A has made monthly payments for purposes of subsection (b)(7), the Secretary shall deem the period to include all monthly payments made for the original loan, and all monthly payments made for the refinanced loan, that otherwise meet the requirements of this section. (2) Refinanced Federal Direct Consolidation Loans In calculating the period of time during which a borrower of a Federal Direct Consolidation Loan that is refinanced under section 460A has made monthly payments for the purposes of subsection (b)(7), the Secretary shall— (A) review the borrower’s payment history to identify each component loan of such Federal Direct Consolidation Loan; (B) for each such component loan— (i) calculate the weighted factor of the component loan, which shall be the factor that represents the portion of such Federal Direct Consolidation Loan that is attributable to such component loan; and (ii) determine the number of qualifying monthly payments made on such component loan before consolidation; (C) calculate the number of qualifying monthly payments determined under subparagraph (B)(ii) with respect to a component loan that shall be deemed as qualifying monthly payments made on the Federal Direct Consolidation Loan by multiplying— (i) the weighted factor of such component loan as determined under subparagraph (B)(i); by (ii) the number of qualifying monthly payments made on such component loan as determined under subparagraph (B)(ii); and (D) calculate and inform the borrower of the total number of qualifying monthly payments with respect to the component loans of the Federal Direct Consolidation Loan that shall be deemed as qualifying monthly payments made on the refinanced Federal Consolidation Loan, by— (i) adding together the result of each calculation made under subparagraph (C) with respect to each such component loan; and (ii) rounding the number determined under clause (i) to the nearest whole number. (3) Federal Direct Refinanced Private Loans In calculating the period of time during which a borrower of a Federal Direct Refinanced Private Loan under section 460B has made monthly payments for purposes of subsection (b)(7), the Secretary shall include only payments— (A) that are made after the date of the issuance of the Federal Direct Refinanced Private Loan; and (B) that otherwise meet the requirements of this section. (4) Component loan defined In this subsection, the term component loan , used with respect to a Federal Direct Consolidation Loan, means a loan for which the liability was discharged by the proceeds of such Federal Direct Consolidation Loan. . (e) Conforming amendments The Higher Education Act of 1965 ( 20 U.S.C. 1001 et seq. ) is amended— (1) in section 428C(a)(3)(B)(i)(V) ( 20 U.S.C. 1078–3(3)(B)(i)(V) )— (A) by striking or at the end of item (bb); (B) by striking the period at the end of item (cc) and inserting ; or ; and (C) by adding at the end the following: (dd) for the purpose of obtaining a refinancing loan under section 460A. ; (2) in section 428J(c)(2) ( 20 U.S.C. 1078–10(c)(2) ), by inserting a Federal Direct Refinanced Private Loan, after a Federal Direct Unsubsidized Stafford Loan, ; (3) in section 455 ( 20 U.S.C. 1087e )— (A) in subsection (b), by striking (b) Interest rate.— and inserting the following: (b) Interest rate Except as otherwise provided in sections 460A and 460B, the terms and conditions of interest for loans made under this part are as follows: ; (B) in subsection (f)(1)(B), by inserting a Federal Direct Refinanced Private Loan, after a Federal Direct Unsubsidized Stafford Loan, ; and (C) in subsection (m)(3)(A), by striking or Federal Direct Unsubsidized Stafford Loan, and inserting Federal Direct Unsubsidized Stafford Loan, or Federal Direct Refinanced Private Loan, ; and (4) in section 460 ( 20 U.S.C. 1087j )— (A) in subsection (b), by striking and Federal Direct Unsubsidized Stafford Loans and inserting Federal Direct Unsubsidized Stafford Loans, and Federal Direct Refinanced Private Loans ; and (B) in subsection (c)— (i) in paragraph (1), by striking or a Federal Direct Unsubsidized Stafford Loan and inserting , a Federal Direct Unsubsidized Stafford Loan, or a Federal Direct Refinanced Private Loan ; and (ii) in paragraph (2), by inserting a Federal Direct Refinanced Private Loan, after a Federal Direct Unsubsidized Stafford Loan, . | https://www.govinfo.gov/content/pkg/BILLS-117s4344is/xml/BILLS-117s4344is.xml |
117-s-4345 | II 117th CONGRESS 2d Session S. 4345 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Whitehouse (for himself and Mr. Merkley ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Higher Education Act of 1965 to amend the public service loan forgiveness program.
1. Short title This Act may be cited as the Simplifying and Strengthening Public Service Loan Forgiveness Act . 2. Public service loan forgiveness reform (a) Reducing payments (1) In general Section 455(m)(1) of the Higher Education Act of 1965 ( 20 U.S.C. 1087e(m)(1) ) is amended— (A) in subparagraph (A), by striking 120 and inserting 60 ; and (B) in subparagraph (B)(ii), by striking 120 and inserting 60 . (2) Effective date The amendments made by paragraph (1) shall apply with respect to any eligible Federal Direct Loan which is in repayment status on or after the date of enactment of this Act. (b) Making waivers permanent Section 455(m) of the Higher Education Act of 1965 ( 20 U.S.C. 1087e(m) ) is amended by adding at the end the following: (5) Counting prior payments; simplifying program Notwithstanding paragraph (1), in carrying out this section, the Secretary shall comply with the following: (A) The Secretary shall consider as a monthly payment under this subsection, any monthly payment made while the borrower was employed in a public service job on a loan made, insured, or guaranteed under this title before, on, or after the date of enactment of this paragraph pursuant to any repayment plan authorized under this Act. (B) The Secretary shall consider as a monthly payment under this subsection, a payment described in subparagraph (A) that was late or was for less than the full amount of the monthly payment. (C) The Secretary shall count as a monthly payment under this subsection, a month for which a borrower is serving on active duty (as described in section 101(d)(1) of title 10, United States Code) or serving in the Peace Corps, even if the borrower's loan was in deferment or forbearance and not in active repayment. (D) The Secretary shall allow a borrower of a Federal PLUS Loan, made on behalf of a dependent student, under section 428B who is employed in a public service job to consolidate such loan into a Federal Direct Consolidation Loan in order to receive loan cancellation pursuant to this subsection. (E) The Secretary shall allow the borrowers of a Joint Consolidation Loan or a Joint Direct Consolidation Loan who are employed in a public service job to consolidate such loan into a Federal Direct Consolidation Loan in order to receive loan cancellation pursuant to this subsection. . | https://www.govinfo.gov/content/pkg/BILLS-117s4345is/xml/BILLS-117s4345is.xml |
117-s-4346 | II 117th CONGRESS 2d Session S. 4346 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mr. Blumenthal (for himself, Mr. Murphy , Mrs. Feinstein , and Ms. Warren ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to allow a credit against income tax for qualified conservation contributions which include National Scenic Trails.
1. Short title This Act may be cited as the Complete America’s Great Trails Act . 2. National Scenic Trail conservation credit (a) In general Subpart B of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: 30E. National Scenic Trail conservation credit (a) Allowance of credit There shall be allowed as a credit against the tax imposed by this chapter for the taxable year an amount equal to the fair market value of any National Scenic Trail conservation contribution of the taxpayer for the taxable year. (b) National Scenic Trail conservation contribution For purposes of this section— (1) In general The term National Scenic Trail conservation contribution means any qualified conservation contribution— (A) to the extent the qualified real property interest with respect to such contribution includes a National Scenic Trail (or portion thereof) and its trail corridor, and (B) with respect to which the taxpayer makes an election under this section. (2) National Scenic Trail The term National Scenic Trail means any trail authorized and designated under section 5 of the National Trails System Act ( 16 U.S.C. 1244 ), but only if such trail is at least 200 miles in length. (3) Trail corridor (A) In general The term trail corridor means so much of the corridor of a trail as is— (i) subject to subparagraph (B), not less than 150 feet wide on each side of such trail, and (ii) not greater than 2,640 feet wide. (B) Exceptions (i) Less than 150 feet wide on a side of the trail In the case of an interest in real property of the taxpayer which includes less than 150 feet on either side of the trail, the trail corridor shall include the entire distance with respect to such interest on such side. (ii) Building and structures near the trail In the case of an interest in real property of the taxpayer which includes a residence or structure owned by the taxpayer which is located less than 150 feet from the trail, the trail corridor for the side of the trail on which the residence or structure is located shall include such distance from the trail as is determined appropriate by the taxpayer. (4) Qualified conservation contribution; qualified real property interest The terms qualified conservation contribution and qualified real property interest have the respective meanings given such terms by section 170(h), except that paragraph (2)(A) thereof shall be applied without regard to any qualified mineral interest (as defined in paragraph (6) thereof). (c) Special rules (1) Fair market value Fair market value of any National Scenic Trail conservation contribution shall be determined in the same manner as qualified conservation contributions under section 170, except that in any case, to the extent practicable, fair market value shall be determined by reference to the highest and best use of the real property with respect to such contribution. (2) Election irrevocable An election under this section may not be revoked. (3) Denial of double benefit No deduction shall be allowed under this chapter with respect to any qualified conservation contribution with respect to which an election is made under this section. (d) Application with other credits (1) Business credit treated as part of general business credit So much of the credit which would be allowed under subsection (a) for any taxable year (determined without regard to this subsection) that is attributable to property used in a trade or business or held for the production of income shall be treated as a credit listed in section 38(b) for such taxable year (and not allowed under subsection (a)). (2) Personal credit For purposes of this title, the credit allowed under subsection (a) for any taxable year (determined after the application of paragraph (1)) shall be treated as a credit allowable under subpart A for such taxable year. (e) Carryforward of unused credit (1) In general If the credit allowable under subsection (a) exceeds— (A) the limitation imposed by section 26(a) for any taxable year, reduced by (B) the sum of the credits allowable under subpart A (other than this section) for the taxable year, such excess shall be carried to the succeeding taxable year and added to the credit allowable under subsection (a) for such succeeding taxable year. (2) Limitation No credit may be carried forward under this subsection to any taxable year following the tenth taxable year after the taxable year in which the credit arose. For purposes of the preceding sentence, credits shall be treated as used on a first-in first-out basis. . (b) Continued use not inconsistent with conservation purposes A contribution of an interest in real property shall not fail to be treated as a National Scenic Trail conservation contribution (as defined in section 30E(b) of the Internal Revenue Code of 1986) solely by reason of continued use of the real property, such as for recreational or agricultural use (including motor vehicle use related thereto), if, under the circumstances, such use does not impair significant conservation interests and is not inconsistent with the purposes of the National Trails System Act ( 16 U.S.C. 1241 et seq. ). (c) Study regarding efficacy of National Scenic Trail conservation credit (1) In general The Secretary of the Interior shall, in consultation with the Secretary of the Treasury, study— (A) the efficacy of the National Scenic Trail conservation credit under section 30E of the Internal Revenue Code of 1986 in completing, extending, and increasing the number of National Scenic Trails (as defined in section 30E(b) of such Code), and (B) the feasibility and estimated costs and benefits of— (i) making such credit refundable (in whole or in part), and (ii) allowing transfer of such credit. (2) Report Not later than 4 years after the date of the enactment of this Act, the Secretary of the Interior shall submit a report to Congress on the results of the study conducted under this subsection. (d) Conforming amendment The table of sections for subpart B of part IV of subchapter A of chapter 1 of such Code is amended by adding at the end the following new item: 30E. National Scenic Trail conservation credit. . (e) Effective date The amendments made by this section shall apply to contributions made after the date of the enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4346is/xml/BILLS-117s4346is.xml |
117-s-4347 | II 117th CONGRESS 2d Session S. 4347 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mrs. Murray (for herself, Ms. Hirono , Ms. Cortez Masto , Mr. Brown , Ms. Baldwin , Mr. Reed , Mr. Schatz , Mr. Blumenthal , Mr. Markey , Ms. Smith , Mr. Menendez , Mr. Kaine , Mr. Merkley , Mr. Sanders , Ms. Cantwell , Mr. Whitehouse , Mrs. Gillibrand , Mr. Heinrich , Ms. Klobuchar , Mr. Wyden , Ms. Stabenow , Mr. Booker , Ms. Rosen , Ms. Warren , Mrs. Shaheen , Ms. Duckworth , Ms. Hassan , Mr. Bennet , and Mrs. Feinstein ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives.
1. Short title This Act may be cited as the Affordability is Access Act . 2. Purpose The purpose of this Act is to ensure timely access to affordable birth control by requiring coverage without cost-sharing for oral birth control for routine, daily use that is approved by, or otherwise legally marketed under regulation by, the Food and Drug Administration for use without a prescription. 3. Findings The Senate finds the following: (1) Birth control is critical health care that almost all women will use at some point in their lifetimes. (2) Access to the full range of reproductive health care, including birth control coverage as guaranteed under Federal law, provides people with the opportunity to lead healthy lives and get the care they need to reach their goals. (3) Family planning has well-documented health benefits for women, newborns, families, and communities and can lower the risk of harm to maternal and infant health. (4) An estimated 72,000,000 women of reproductive age (ages 15 through 44) live in the United States, of which nearly 70 percent are at risk of having an unintended pregnancy. Sixty-five percent of women of reproductive age are using a contraceptive method and 12 percent of women at risk for unintended pregnancy are not using contraception. The rates of non-use of contraception are highest among those between 15 and 19 years old. (5) The birth control benefit enacted under the Patient Protection and Affordable Care Act ( Public Law 111–148 ) has been a crucial step forward in advancing access to birth control and has helped ensure 62,100,000 women have the power to decide for themselves if and when to start a family. (6) Despite legal requirements for birth control coverage and access to services, gaps remain for millions of people. A national survey found that 1 in 3 women have struggled to afford birth control at some point in their lives, and as a result, have used birth control inconsistently. Access to birth control is particularly difficult for people who live in contraceptive deserts and lack reasonable access to a health center that offers the full range of contraceptive methods. (7) Health disparities persist among people with low incomes, people of color, LGBTQ people, immigrants, and people who lack access to health coverage and health care providers. (8) There are numerous social and economic barriers that make it harder to access birth control, including rising income and wealth inequality, gaps in insurance coverage and challenges accessing health providers. (9) Leading health experts support over-the-counter birth control pills. 4. Sense of the Senate It is the sense of the Senate that— (1) in order to increase access to oral birth control, such birth control must be both easier to obtain and affordable and, to make such birth control either easier to obtain or more affordable, but not both, is to leave unacceptable barriers in place; (2) it is imperative that the entities that research and develop oral birth control and whose medical and scientific experts have developed clinical and other evidence that oral birth control for routine, daily use is safe and effective when sold without a prescription, apply to the Food and Drug Administration for review and approval for sale of such birth control without a prescription; (3) upon the receipt of such an application, the Food and Drug Administration should determine whether the oral birth control meets the rigorous safety, efficacy, and quality standards for over-the-counter use under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), and if the product meets those standards, the Food and Drug Administration should approve the application without delay; and (4) if and when the Food and Drug Administration approves an oral birth control that is available over-the-counter, such birth control should be covered by health insurance, without a prescription and without cost-sharing. 5. Clarifying coverage requirements The Secretaries of Health and Human Services, Labor, and the Treasury shall clarify that coverage of contraceptives pursuant to section 2713(a)(4) of the Public Health Service Act ( 42 U.S.C. 300gg–13(a)(4) ) includes coverage of over-the-counter contraceptive methods approved by the Food and Drug Administration, even if the enrollee does not have a prescription for the contraceptive. 6. Rules of construction (a) Non-Interference with FDA regulation Nothing in this Act shall be construed to modify or interfere with Food and Drug Administration processes to review or approve, or otherwise determine the safety and efficacy of, and make available, non-prescription drugs or devices, modify or interfere with the scientific and medical considerations of the Food and Drug Administration, or alter any other authority of the Food and Drug Administration. (b) Non-Preemption Nothing in this Act preempts any provision of Federal or State law to the extent that such Federal or State law provides protections for consumers that are greater than the protections provided for in this Act. 7. Duties of retailers to ensure access to oral birth control for use without a prescription (a) In general Any retailer that stocks oral birth control for routine, daily use that is approved by, or otherwise legally marketed under regulation by, the Food and Drug Administration for use without a prescription may not interfere with an individual's access to or purchase of such birth control or access to medically accurate, comprehensive information about such birth control. (b) Limitation Nothing in this section shall prohibit a retailer that stocks oral birth control for routine, daily use from refusing to provide an individual with such oral birth control that is approved by, or otherwise legally marketed under regulation by, the Food and Drug Administration if the individual is unable to pay for the birth control, directly or through insurance coverage. | https://www.govinfo.gov/content/pkg/BILLS-117s4347is/xml/BILLS-117s4347is.xml |
117-s-4348 | II 117th CONGRESS 2d Session S. 4348 IN THE SENATE OF THE UNITED STATES May 26, 2022 Mrs. Murray (for herself and Mr. Burr ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.
1. Short title; table of contents (a) Short title This Act may be cited as the Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Reauthorization; reporting requirement. Sec. 105. Sunset dates. Sec. 106. Effective date. Sec. 107. Savings clause. TITLE II—Fees relating to devices Sec. 201. Short title; finding. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Accreditation programs. Sec. 205. Sunset dates. Sec. 206. Effective date. Sec. 207. Savings clause. TITLE III—Fees relating to generic drugs Sec. 301. Short title; finding. Sec. 302. Authority to assess and use human generic drug fees. Sec. 303. Reauthorization; reporting requirements. Sec. 304. Sunset dates. Sec. 305. Effective date. Sec. 306. Savings clause. TITLE IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Definitions. Sec. 403. Authority to assess and use biosimilar biological product fees. Sec. 404. Reauthorization; reporting requirements. Sec. 405. Sunset dates. Sec. 406. Effective date. Sec. 407. Savings clause. TITLE V—Improving regulation of drugs and biological products Sec. 501. Alternatives to animal testing. Sec. 502. Safer disposal of opioids. Sec. 503. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products. Sec. 504. Improvements to the Purple Book. Sec. 505. Therapeutic equivalence evaluations. Sec. 506. Modernizing accelerated approval. TITLE VI—Other reauthorizations Sec. 601. Reauthorization of the critical path public-private partnership. Sec. 602. Reauthorization of the best pharmaceuticals for children program. Sec. 603. Reauthorization of the humanitarian device exemption incentive. Sec. 604. Reauthorization of the pediatric device consortia program. Sec. 605. Reauthorization of provision pertaining to drugs containing single enantiomers. Sec. 606. Reauthorization of orphan drug grants. Sec. 607. Reauthorization of certain device inspections. TITLE VII—Enhancing FDA hiring authorities Sec. 701. Enhancing FDA hiring authority for scientific, technical, and professional personnel. Sec. 702. Strategic workforce plan and report. TITLE VIII—Advancing regulation of cosmetics, dietary supplements, and laboratory developed tests Subtitle A—Cosmetics Sec. 801. Short title. Sec. 802. Amendments to cosmetic requirements. Sec. 803. Enforcement and conforming amendments. Sec. 804. Records inspection. Sec. 805. Talc-containing cosmetics. Sec. 806. PFAS in cosmetics. Sec. 807. Funding. Subtitle B—Dietary supplements Sec. 811. Regulation of dietary supplements. Subtitle C—In vitro clinical tests Sec. 821. Short title; table of contents. Sec. 822. Definitions. Sec. 823. Regulation of in vitro clinical tests. Sec. 824. Enforcement and other provisions. Sec. 825. Transition. Sec. 826. Emergency use authorization. Sec. 827. Antimicrobial susceptibility tests. Sec. 828. Combination products. Sec. 829. Resources. Sec. 830. Authorization of appropriations. TITLE IX—Other provisions Sec. 901. Facilities management. Sec. 902. Annual report on inspections. Sec. 903. User fee program transparency and accountability. Sec. 904. OTC hearing aids final rule. Sec. 905. Enhance intra-agency coordination and public health assessment with regard to compliance activities. I Fees relating to drugs 101. Short title; finding (a) Short title This title may be cited as the Prescription Drug User Fee Amendments of 2022 . (b) Finding Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g et seq. ), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 102. Definitions Section 735 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g ) is amended— (1) in paragraph (1), in the matter following subparagraph (B), by striking an allergenic extract product, or and inserting does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to ; (2) in paragraph (3), in the matter following subparagraph (C)— (A) by inserting licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, after an allergenic extract product ; (B) by adding at the end the following: If a written request to place a product in the discontinued section of either of the lists described in subparagraph (C) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then, for purposes of assessing the prescription drug program fee under section 736(a)(2), the Secretary shall consider such product to have been included in the discontinued section on the later of (i) the date such request was received, or (ii) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. For purposes of subparagraph (C), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale. ; and (C) by adding at the end the following: (12) The term skin-test diagnostic product — (A) means a product— (i) for prick, scratch, intradermal, or subcutaneous administration; (ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect; (iii) not intended to be a preventive or therapeutic intervention; and (iv) intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of— (I) an allergy to an antimicrobial agent; (II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or (III) infection with fungal or mycobacterial pathogens; and (B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A). . 103. Authority to assess and use drug fees (a) Types of fees Section 736(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(a) ) is amended— (1) in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; (2) in paragraph (1)— (A) in subparagraph (A), by striking subsection (c)(5) each place it appears and inserting subsection (c)(6) ; (B) in subparagraph (C), by inserting prior to approval after or was withdrawn ; and (C) by adding at the end the following: (H) Exception for skin-test diagnostic products A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A). ; and (3) in paragraph (2)— (A) in subparagraph (A)— (i) by striking subsection (c)(5) and inserting subsection (c)(6) ; (ii) by striking Except as provided and inserting the following: (i) Payment of fees Except as provided ; and (iii) by adding at the end the following: (ii) Previously discontinued drug products If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list identified in section 735(3), and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for a fiscal year in which the fee is payable. ; and (B) by amending subparagraph (B) to read as follows: (B) Exception for certain prescription drug products A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is— (i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 505(j)(7); (ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)), to another product on the list of products compiled under section 505(j)(7) (not including the discontinued section of such list); or (iii) a skin-test diagnostic product. . (b) Fee revenue amounts Section 736(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(b) ) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking 2018 through 2022 and inserting 2023 through 2027 ; (B) by redesignating subparagraphs (C) through (F) as subparagraphs (D) through (G), respectively; (C) by inserting after subparagraph (B) the following: (C) The dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2)); ; (D) in subparagraph (D), as so redesignated, by striking (c)(2) and inserting (c)(3) ; (E) in subparagraph (E), as so redesignated, by striking (c)(3) and inserting (c)(4) ; (F) in subparagraph (F), as so redesignated, by striking (c)(4) and inserting (c)(5) ; and (G) in subparagraph (G), as so redesignated, by striking clauses (i) through (v) and inserting the following: (i) $65,773,693 for fiscal year 2023. (ii) $25,097,671 for fiscal year 2024. (iii) $14,154,169 for fiscal year 2025. (iv) $4,864,860 for fiscal year 2026. (v) $1,314,620 for fiscal year 2027. ; and (2) in paragraph (3)— (A) in subparagraph (A), by striking 2018, $878,590,000 and inserting 2023, $1,151,522,958 ; and (B) in subparagraph (B)— (i) by striking 2019 through 2022 and inserting 2024 through 2027 ; and (ii) by striking subsection (c)(3) or (c)(4) and inserting subsection (c)(4) or (c)(5) . (c) Adjustments; annual fee setting Section 736(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(c) ) is amended— (1) in paragraph (1)(B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; (2) by redesignating paragraphs (2) through (6) as paragraphs (3) through (7), respectively; (3) by inserting after paragraph (1) the following: (2) Strategic hiring and retention adjustment For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees— (A) for fiscal year 2023, by $9,000,000; and (B) for fiscal year 2024 and each subsequent fiscal year, by $4,000,000. ; (4) in paragraph (3), as so redesignated— (A) in subparagraph (A)— (i) by striking for inflation ; and (ii) by striking paragraph (1) and inserting paragraphs (1) and (2) ; (B) by amending subparagraph (B) to read as follows: (B) Methodology For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled Prescription Drug User Fee Rates for Fiscal Year 2021 (85 Fed. Reg. 46651; August 3, 2020). The workload categories used in forecasting shall include only the activities described in such notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in forecasting any non-core review activities, including any activities that the Secretary referenced for potential future use in such notice but did not utilize in the setting fees for fiscal year 2021. ; (C) by striking subparagraph (C); (D) by redesignating subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively; (E) in subparagraph (C), as so redesignated— (i) by striking year) and and inserting year), ; and (ii) by inserting , and subsection (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment). ; and (F) in subparagraph (D), as so redesignated, by striking paragraph (5) and inserting paragraph (6) ; (5) in paragraph (4), as so redesignated— (A) by amending subparagraph (A) to read as follows: (A) Increase For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least the following amounts of operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year, as follows: (i) For fiscal year 2023, at least 8 weeks of operating reserves. (ii) For fiscal year 2024, at least 9 weeks of operating reserves. (iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves. ; and (B) in subparagraph (C), by striking paragraph (5) and inserting paragraph (6) ; (6) by amending paragraph (5), as so redesignated, to read as follows: (5) Additional direct cost adjustment The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees— (A) for fiscal year 2023, by $44,386,150; and (B) for fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington–Arlington–Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021— (i) for fiscal year 2024, $60,967,993; (ii) for fiscal year 2025, $35,799,314; (iii) for fiscal year 2026, $35,799,314; and (iv) for fiscal year 2027, $35,799,314. ; and (7) in paragraph (6), as so redesignated, by striking 2017 and inserting 2022 . (d) Crediting and availability of fees Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(g)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . (e) Written requests for waivers, reductions, and refunds Section 736(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(i) ) is amended to read as follows: (i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver, reduction, exemption, or return not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made. . (f) Orphan drugs Section 736(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(k) ) is amended— (1) in paragraph (1)(B), by striking during the previous year and inserting , as determined under paragraph (2) ; and (2) in paragraph (2), by striking that its gross annual revenues and all that follows through the period at the end and inserting supported by tax returns submitted to the Internal Revenue Service, or, as necessary, by other appropriate financial information, that its gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. . 104. Reauthorization; reporting requirement Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 ) is amended— (1) by striking 2018 each place it appears and inserting 2023 ; (2) by striking Prescription Drug User Fee Amendments of 2017 each place it appears and inserting Prescription Drug User Fee Amendments of 2022 ; (3) in subsection (a)(4), by striking 2020 and inserting 2023 ; and (4) in subsection (f), by striking 2022 each place it appears and inserting 2027 . 105. Sunset dates (a) Authorization Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g ; 379h) shall cease to be effective October 1, 2027. (b) Reporting requirements Section 736B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 ) shall cease to be effective January 31, 2028. (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 104 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) are repealed. 106. Effective date The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g et seq. ) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act. 107. Savings clause Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379g et seq. ), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023. II Fees relating to devices 201. Short title; finding (a) Short title This title may be cited as the Medical Device User Fee Amendments of 2022 . (b) Finding Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 202. Definitions Section 737 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i ) is amended— (1) in paragraph (9)— (A) in the matter preceding subparagraph (A), by striking and premarket notification submissions and inserting premarket notification submissions, and de novo classification requests ; (B) in subparagraph (D), by striking and submissions and inserting submissions, and de novo classification requests ; (C) in subparagraph (F), by striking and premarket notification submissions and inserting premarket notification submissions, and de novo classification requests ; (D) in subparagraphs (G) and (H), by striking or submissions each place it appears and inserting submissions, or requests ; and (E) in subparagraph (K), by striking or premarket notification submissions and inserting premarket notification submissions, or de novo classification requests ; and (2) in paragraph (11), by striking 2016 and inserting 2021 . 203. Authority to assess and use device fees (a) Types of fees Section 738(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(a) ) is amended— (1) in paragraph (1), by striking 2018 and inserting 2023 ; and (2) in paragraph (2)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking 2017 and inserting 2022 ; (ii) in clause (iii), by striking 75 percent and inserting 80 percent ; and (iii) in clause (viii), by striking 3.4 percent and inserting 4.5 percent ; (B) in subparagraph (B)(iii), by striking or premarket notification submission and inserting premarket notification submission, or de novo classification request ; and (C) in subparagraph (C), by striking or periodic reporting concerning a class III device and inserting periodic reporting concerning a class III device, or de novo classification request . (b) Fee amounts Section 738(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(b) ) is amended— (1) in paragraph (1), by striking 2018 through 2022 and inserting 2023 through 2027 ; (2) by amending the table in paragraph (2) to read as follows: Fee Type Fiscal Year 2023 Fiscal Year 2024 Fiscal Year 2025 Fiscal Year 2026 Fiscal Year 2027 Premarket Application $425,000 $435,000 $445,000 $455,000 $470,000 Establishment Registration $6,250 $6,875 $7,100 $7,575 $8,465 ; and (3) in paragraph (3), by amending subparagraphs (A) through (E) to read as follows: (A) $312,606,000 for fiscal year 2023. (B) $335,750,000 for fiscal year 2024. (C) $350,746,400 for fiscal year 2025. (D) $366,486,300 for fiscal year 2026. (E) $418,343,000 for fiscal year 2027. . (c) Annual fee setting; adjustments Section 738(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(c) ) is amended— (1) in paragraph (1), by striking 2017 and inserting 2022 ; (2) in paragraph (2)— (A) by striking 2018 each place it appears and inserting 2023 ; (B) in subparagraph (B)(ii), by striking 2016 and inserting 2022 ; (C) in subparagraph (C)(i)(II), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; and (D) in subparagraph (D), by striking 2022 and inserting 2027 ; (3) in paragraph (3), by striking 2018 through 2022 and inserting 2023 through 2027 ; (4) by redesignating paragraphs (4) and (5) as paragraphs (7) and (8), respectively; and (5) by inserting after paragraph (3) the following: (4) Performance improvement adjustment (A) In general For each of fiscal years 2025 through 2027, after the adjustment under paragraph (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year, equal to the following amounts, as applicable: (i) For fiscal year 2025, the product of— (I) the amount determined under subparagraph (B)(i)(I); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (ii) For fiscal year 2026, the product of— (I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (iii) For fiscal year 2027, the product of— (I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (B) Amounts (i) Presubmission amount For purposes of subparagraph (A), with respect to the presubmission written feedback goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2025, $15,396,600 if the goal for fiscal year 2023 is met. (II) For fiscal year 2026— (aa) $15,396,600 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or (bb) $36,792,200 if the goal for fiscal year 2024 is met. (III) For fiscal year 2027— (aa) $15,396,600 if the goal for fiscal year 2023 is met and the goal for each of fiscal years 2024 and 2025 is missed; (bb) $36,792,200 if the goal for fiscal year 2024 is met and the goal for fiscal year 2025 is missed; or (cc) $40,572,600 if the goal for fiscal year 2025 is met. (ii) De novo classification request amount For purposes of subparagraph (A), with respect to the de novo decision goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2026, $6,323,500 if the goal for fiscal year 2023 is met. (II) For fiscal year 2027— (aa) $6,323,500 if the goal for fiscal year 2023 is met and the goal for fiscal year 2024 is missed; or (bb) $11,765,400 if the goal for fiscal year 2024 is met. (iii) Premarket notification and premarket approval amount For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met. (II) For fiscal year 2027— (aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 is missed; or (bb) $3,906,000 if the 4 goals for fiscal year 2024 are met. (C) Performance calculation For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and based on data available as of the applicable dates as follows: (i) The performance of the presubmission written feedback goal— (I) for fiscal year 2023, shall be based on data available as of March 31, 2024; (II) for fiscal year 2024, shall be based on data available as of March 31, 2025; and (III) for fiscal year 2025, shall be based on data available as of March 31, 2026. (ii) The performance of the de novo decision goal, 510(k) decision goal, 510(k) shared outcome total time to decision goal, PMA decision goal, and PMA shared outcome total time to decision goal— (I) for fiscal year 2023, shall be based on data available as of March 31, 2025; and (II) for fiscal year 2024, shall be based on data available as of March 31, 2026. (D) Definitions For purposes of this paragraph, the terms presubmission written feedback goal , de novo decision goal , 510(k) decision goal , 510(k) shared outcome total time to decision goal , PMA decision goal , and PMA shared outcome total time to decision goal have the meanings given such terms in the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022. (5) Hiring adjustment (A) In general For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (3) and (4), if applicable, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (B), if the number of hires to support the process for the review of device applications falls below the following thresholds for the applicable fiscal years: (i) For fiscal year 2025, 85 percent of the hiring goal specified in subparagraph (C) for fiscal year 2023. (ii) For fiscal year 2026, 90 percent of the hiring goal specified in subparagraph (C) for fiscal year 2024. (iii) For fiscal year 2027, 90 percent of the hiring goal specified in subparagraph (C) for fiscal year 2025. (B) Hiring adjustment amount The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of— (i) the number of hires by which the hiring goal specified in subparagraph (C) for the fiscal year before the prior fiscal year was missed; (ii) $72,877; and (iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was missed. (C) Hiring goals (i) In general For purposes of subparagraph (B), the hiring goals for each of fiscal years 2023 through 2025 are as follows: (I) For fiscal year 2023, 144 hires. (II) For fiscal year 2024, 42 hires. (III) For fiscal year 2025— (aa) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or (bb) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i). (ii) Number of hires For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary, as set forth in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022. (6) Operating reserve adjustment (A) In general For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves. (B) Designated amount Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of— (i) 13 weeks of operating reserves of carryover user fees; and (ii) the 1 month of operating reserves described in paragraph (8). (C) Excluded amount For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A). . (d) Small businesses Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended— (1) in subsection (d)(2)(B)(iii), by inserting , if extant, after national taxing authority ; and (2) in subsection (e)(2)(B)(iii), by inserting , if extant, after national taxing authority . (e) Conditions Section 738(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g) ) is amended— (1) in paragraph (1)(A), by striking $320,825,000 and inserting $398,566,000 ; and (2) in paragraph (2), by inserting de novo classification requests, after class III device, . (f) Authorization of appropriations Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(h)(3) ) is amended to read as follows: (3) Authorization of appropriations (A) In general For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined in subparagraph (B), less the amount of reductions determined in subparagraph (C). (B) Revenue amount For purposes of this paragraph, the revenue amount for each fiscal year is the sum of— (i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under subsection (c)(2); and (ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4)(A), if applicable. (C) Amount of reductions For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of— (i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and (ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable. . 204. Accreditation programs (a) Accreditation scheme for conformity assessment Section 514(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d(d) ) is amended— (1) in the subsection heading, by striking Pilot ; (2) in paragraph (1)— (A) in the matter preceding subparagraph (A), by striking pilot ; (B) in subparagraph (A)— (i) by inserting meeting criteria specified by the Secretary in guidance after testing laboratories ; (ii) by inserting in guidance after by the Secretary ; and (iii) by striking assess the conformance of a device with and inserting conduct testing to support the assessment of the conformance of a device to ; and (C) in subparagraph (B)— (i) by striking determinations and inserting results ; (ii) by inserting to support after so accredited ; and (iii) by striking a particular such determination and inserting particular such results ; (3) in paragraph (2)— (A) in the paragraph heading, by striking determinations and inserting results ; (B) in subparagraph (A)— (i) by striking determinations by testing laboratories and all that follows through such determinations or and inserting results by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the ; (ii) by inserting a comma after or testing laboratories ; (iii) by inserting or recognition of an accreditation body after accreditation of such testing laboratory ; and (iv) by striking such device and inserting a device ; and (C) in subparagraph (B)— (i) by striking by a testing laboratory so accredited and inserting under this subsection ; and (ii) by inserting or recognition of an accreditation body before under paragraph (1)(A) ; (4) in paragraph (3)(C)— (A) in the subparagraph heading, by inserting and transition after initiation ; and (B) by adding at the end the following: After September 30, 2023, such pilot program will be considered to be completed, and the Secretary shall have the authority to continue operating a program consistent with this subsection. ; and (5) by striking paragraph (4). (b) Accredited persons Section 523(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360m(c) ) is amended by striking 2022 and inserting 2027 . 205. Sunset dates (a) Authorization Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i ; 379fj) shall cease to be effective October 1, 2027. (b) Reporting requirements Section 738A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1 ) shall cease to be effective January 31, 2028. (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 210 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) are repealed. 206. Effective date The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i et seq. ) shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2022, regardless of the date of the enactment of this Act. 207. Savings clause Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379i et seq. ), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023. III Fees relating to generic drugs 301. Short title; finding (a) Short title This title may be cited as the Generic Drug User Fee Amendments of 2022 . (b) Finding The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 302. Authority to assess and use human generic drug fees (a) Types of fees Section 744B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(a) ) is amended— (1) in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; (2) in paragraph (2)(C), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; (3) in paragraph (3)(B), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; (4) in paragraph (4)(D), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 ; and (5) in paragraph (5)(D), by striking fiscal years 2018 through 2022 and inserting fiscal years 2023 through 2027 . (b) Fee revenue amounts Section 744B(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(b) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the heading, by striking 2018 and inserting 2023 ; (ii) by striking 2018 and inserting 2023 ; and (iii) by striking $493,600,000 and inserting $582,500,000 ; and (B) in subparagraph (B)— (i) in the heading, by striking 2019 through 2022 and inserting 2024 through 2027 ; (ii) by striking For each and inserting the following: (i) In general For each ; (iii) by striking 2019 through 2022 and inserting 2024 through 2027 ; (iv) by striking $493,600,000 and inserting the base revenue amount under clause (ii) ; and (v) by adding at the end the following: (ii) Base revenue amount The base revenue amount for a fiscal year is the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3). ; and (2) in paragraph (2)— (A) in subparagraph (C), by striking one-third the amount and inserting 24 percent ; (B) in subparagraph (D), by striking Seven and inserting Six ; and (C) in subparagraph (E)(i), by striking Thirty-five and inserting Thirty-six . (c) Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(c) ) is amended— (1) in paragraph (1)— (A) in the matter preceding subparagraph (A)— (i) by striking 2019 and inserting 2024 ; and (ii) by striking the product of the total revenues established in such notice for the prior fiscal year and inserting the base revenue amount for the fiscal year determined under subsection (b)(1)(B)(ii) ; and (B) in subparagraph (C), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington-Arlington-Alexandria, DC–VA–MD–WV ; and (2) by striking paragraph (2) and inserting the following: (2) Capacity planning adjustment (A) In general Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities. (B) Capacity planning methodology The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall— (i) be derived from the methodology and recommendations made in the report titled Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations as announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and (ii) incorporate approaches and attributes determined appropriate by the Secretary, including those made in such report recommendations, except the workload categories used in forecasting resources shall only be those specified in section VIII.B.2.e. of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 . (C) Limitations (i) In general Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year). (ii) Additional limitation An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if— (I) for purposes of an adjustment for fiscal year 2024, the Secretary determines that, during the period from April 1, 2021, through March 31, 2023— (aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 ); (II) for purposes of an adjustment for fiscal year 2025, the Secretary determines that, during the period from April 1, 2022, through March 31, 2024— (aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); (III) for purposes of an adjustment for fiscal year 2026, the Secretary determines that, during the period from April 1, 2023, through March 31, 2025— (aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and (IV) for purposes of an adjustment for fiscal year 2027, the Secretary determines that, during the period from April 1, 2024, through March 31, 2026— (aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined). (D) Publication in federal register The Secretary shall publish in the Federal Register notice under subsection (a), the fee revenue and fees resulting from the adjustment and the methodology under this paragraph. (3) Operating reserve adjustment (A) In general For fiscal year 2024 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B). (B) Number of weeks The number of weeks specified in this subparagraph is— (i) 8 weeks for fiscal year 2024; (ii) 9 weeks for fiscal year 2025; and (iii) 10 weeks for each of fiscal year 2026 and 2027. (C) Decrease If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves. (D) Rationale for adjustment If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved. . (d) Annual fee setting Section 744B(d)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(d)(1) ) is amended— (1) in the heading, by striking 2018 through 2022 and inserting 2023 through 2027 ; (2) by striking more and inserting later ; and (3) by striking 2018 through 2022 and inserting 2023 through 2027 . (e) Effect of failure To pay fees The heading of paragraph (3) of section 744B(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(g) ) is amended by striking and prior approval supplement fee . (f) Crediting and availability of fees Section 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(i)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . 303. Reauthorization; reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 ) is amended— (1) in subsection (a)— (A) by striking 2018 each place it appears and inserting 2023 ; and (B) by striking Generic Drug User Fee Amendments of 2017 each place it appears and inserting Generic Drug User Fee Amendments of 2022 ; (2) in subsection (b), by striking 2018 and inserting 2023 ; (3) in subsection (c)— (A) by striking 2018 and inserting 2023 ; and (B) by striking Generic Drug User Fee Amendments of 2017 each place it appears and inserting Generic Drug User Fee Amendments of 2022 ; and (4) in subsection (f)— (A) in paragraph (1), by striking 2022 and inserting 2027 ; and (B) in paragraph (5), by striking January 15, 2022 and inserting January 15, 2027 . 304. Sunset dates (a) Authorization Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–41 ; 379j–42) shall cease to be effective October 1, 2027. (b) Reporting requirements Section 744C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43 ) shall cease to be effective January 31, 2028. (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 305 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) are repealed. 305. Effective date The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act. 306. Savings clause Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act ( 21 U.S.C. 355(j)(5)(A) ), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023. IV Fees relating to biosimilar biological products 401. Short title; finding (a) Short title This title may be cited as the Biosimilar User Fee Amendments of 2022 . (b) Finding Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 et seq. ), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 402. Definitions Section 744G of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 ) is amended— (1) in paragraph (1)— (A) by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; (B) by striking October of and inserting September of ; and (C) by striking October 2011 and inserting September 2011 ; and (2) in paragraph (4)(B)(iii)— (A) by striking subclause (II); and (B) by redesignating subclauses (III) and (IV) as subclauses (II) and (III), respectively. 403. Authority to assess and use biosimilar biological product fees (a) Types of fees Section 744H(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(a) ) is amended— (1) in the matter preceding paragraph (1), by striking 2018 and inserting 2023 ; (2) in paragraph (1)— (A) in subparagraph (A)— (i) in clause (iv)(I), by striking 5 days and inserting 7 days ; and (ii) in clause (v)(II), by striking 5 days and inserting 7 days ; (B) in subparagraph (B)— (i) in clause (i), by inserting except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee before the period; (ii) in clause (iii)— (I) in subclause (I), by striking ; or and inserting a semicolon; (II) in subclause (II), by striking the period and inserting ; or ; and (III) by adding at the end the following: (III) been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v). ; and (iii) in clause (iv), by striking accepted for filing on or after October 1 of such fiscal year and inserting subsequently accepted for filing ; (C) in subparagraph (D)— (i) in clause (i)— (I) in the matter preceding subclause (I), by striking shall, if the person seeks to resume participation in such program, pay and inserting or who has been administratively removed from such program for a product under subparagraph (E)(v) shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and ; (II) in subclause (I)— (aa) by striking 5 days and inserting 7 days ; and (bb) by inserting or the date of administrative removal, as applicable after discontinued ; and (III) in subclause (II), by inserting or the date of administrative removal, as applicable after discontinued ; and (ii) in clause (ii), by inserting except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee or successor shall pay the annual biosimilar biological product development fee before the period at the end; and (D) in subparagraph (E), by adding at the end the following: (v) Administrative removal from the biosimilar biological product development program If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal. ; (3) in paragraph (2)(D), by inserting prior to approval after withdrawn ; (4) in paragraph (3)— (A) in subparagraph (A)— (i) in clause (i), by striking ; and and inserting a semicolon; (ii) by redesignating clause (ii) as clause (iii); and (iii) by inserting the following after clause (i): (ii) may be dispensed only under prescription pursuant to section 503(b); and ; and (B) by adding at the end the following: (E) Movement to discontinued list (i) Written request to place on discontinued list (I) In general If a written request to place a product on the list of discontinued biosimilar biological products referred to in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of— (aa) the date such request was received; or (bb) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale. (II) Withdrawn from sale defined For purposes of this clause, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale. (ii) Products removed from discontinued list If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list of discontinued biosimilar biological products referred to in subparagraph (A)(iii), and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in the biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for each fiscal year. ; and (5) by striking paragraph (4). (b) Fee revenue amounts Section 744H(b) of the Federal Food, Drug, and Cosmetic Act (( 21 U.S.C. 379j–52(b) ) is amended— (1) by striking paragraph (1); (2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively; (3) in paragraph (1), as so redesignated— (A) in the paragraph heading, by striking Subsequent fiscal years and inserting In general ; (B) in the matter preceding subparagraph (A), by striking 2019 through 2022 and inserting 2023 through 2027 ; (C) in subparagraph (A), by striking paragraph (4) and inserting paragraph (3) ; (D) by redesignating subparagraphs (C) and (D) as subparagraphs (D) and (E), respectively; (E) by inserting after subparagraph (B) the following: (C) the dollar amount equal to the strategic hiring and retention adjustment (as determined under subsection (c)(2)); ; (F) in subparagraph (D), as so redesignated, by striking subsection (c)(2)); and and inserting subsection (c)(3)); ; (G) in subparagraph (E), as so redesignated, by striking subsection (c)(3)). and inserting subsection (c)(4)); and ; and (H) by adding at the end the following: (F) for fiscal years 2023 and 2024, additional dollar amounts equal to— (i) $4,428, 886 for fiscal year 2023; and (ii) $320,569 for fiscal year 2024. ; (4) in paragraph (2), as so redesignated— (A) in the paragraph heading, by striking ; limitations on fee amounts ; (B) by striking subparagraph (B); and (C) by redesignating subaparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and (5) by amending paragraph (3), as so redesignated, to read as follows: (3) Annual base revenue For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— (A) for fiscal year 2023, $43,376,922; and (B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4). . (c) Adjustments; annual fee setting Section 744H(c) of the Federal Food, Drug, and Cosmetic Act (( 21 U.S.C. 379j–52(c) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by striking subsection (b)(2)(B) and inserting subsection (b)(1)(B) ; and (ii) in clause (i), by striking subsection (b) and inserting subsection (b)(1)(A) ; and (B) in subparagraph (B)(ii), by striking Washington-Baltimore, DC–MD–VA–WV and inserting Washington–Arlington–Alexandria, DC–VA–MD–WV ; (2) by striking paragraph (4); (3) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; (4) by inserting after paragraph (1) the following: (2) Strategic hiring and retention adjustment For each fiscal year beginning in fiscal year 2023, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000. ; (5) in paragraph (3), as so redesignated— (A) in subparagraph (A)— (i) by striking Beginning with the fiscal year described in subparagraph (B)(ii)(II) and inserting For each fiscal year ; and (ii) by striking adjustment under paragraph (1), further increase and inserting adjustments under paragraphs (1) and (2), further adjust ; and (B) by amending subparagraph (B) to read as follows: (B) Methodology For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled Biosimilar User Fee Rates for Fiscal Year 2021 (85 Fed. Reg. 47220; August 4, 2020). The workload categories used in forecasting shall include only the activities described in such notice and, as feasible, additional activities that are also directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types and the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in forecasting any non-core review activities, including any activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021. ; and (C) in subparagraph (C)— (i) by striking subsections (b)(2)(A) and inserting subsections (b)(1)(A) ; (ii) by striking and (b)(2)(B) and inserting , (b)(1)(B) ; and (iii) by inserting , and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment) before the period at the end; (6) by amending paragraph (4), as so redesignated, to read as follows: (4) Operating reserve adjustment (A) Increase For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications. (B) Decrease (i) Fiscal year 2023 For fiscal year 2023, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves. (ii) Fiscal year 2024 For fiscal year 2024, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves. (iii) Fiscal year 2025 and subsequent fiscal years For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves. (C) Federal register notice If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved. ; and (7) in paragraph (5), in the matter preceding subparagraph (A), by striking 2018 and inserting 2023 . (d) Crediting and availability of fees Section 744H(f)(3) of the Federal Food, Drug, and Cosmetic Act (( 21 U.S.C. 379j–52(f)(3) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . (e) Written requests for waivers and refunds Subsection (h) of section 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52 ) is amended to read as follows: (h) Written requests for waivers and returns; disputes concerning fees To qualify for consideration for a waiver under subsection (d), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made. . 404. Reauthorization; reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 ) is amended— (1) by striking 2018 each place it appears and inserting 2023 ; (2) by striking Biosimilar User Fee Amendments of 2017 each place it appears and inserting Biosimilar User Fee Amendments of 2022 ; (3) in subsection (a)(4), by striking 2020 and inserting 2023 ; and (4) in subsection (f), by striking 2022 each place it appears and inserting 2027 . 405. Sunset dates (a) Authorization Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 , 379j–52 ) shall cease to be effective October 1, 2027. (b) Reporting requirements Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 ) shall cease to be effective January 31, 2028. (c) Previous sunset provision Effective October 1, 2022, subsections (a) and (b) of section 405 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) are repealed. 406. Effective date The amendments made by this title shall take effect on October 1, 2022, or the date of the enactment of this Act, whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 et seq. ) shall be assessed for all biosimilar biological product applications received on or after October 1, 2022, regardless of the date of the enactment of this Act. 407. Savings clause Notwithstanding the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–51 et seq. ), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023. V Improving regulation of drugs and biological products 501. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended— (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests ; and (B) in paragraph (2)(B), by striking animal and inserting nonclinical tests ; and (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or computer models. . (b) Biosimilar biological product applications Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act ( 42 U.S.C. 262(k)(2)(A)(i)(I) ) is amended to read as follows: (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and . 502. Safer disposal of opioids Section 505–1(e)(4)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(e)(4)(B) ) is amended by striking for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) . 503. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products Section 351(k)(6) of the Public Health Service Act ( 42 U.S.C. 262(k)(6) ) is amended— (1) in the matter preceding subparagraph (A)— (A) by striking Upon review of and inserting The Secretary shall not make licensure as an interchangeable biological product effective with respect to ; (B) by striking relying on and inserting that relies on ; and (C) by striking the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use ; and (2) in the flush text that follows subparagraph (C), by striking the period and inserting , and the term first interchangeable biosimilar biological product means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference product. . 504. Improvements to the Purple Book (a) In general Section 506I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356i ) is amended— (1) in subsection (a)— (A) by striking The holder of an application approved under subsection (c) or (j) of section 505 and inserting The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act ; (B) in paragraph (2), by inserting (in the case of a biological product, the proper name) after established name ; and (C) in paragraph (3), by striking or abbreviated application number and inserting , abbreviated application number, or biologics license application number ; and (2) in subsection (b)— (A) in the matter preceding paragraph (1), by striking The holder of an application approved under subsection (c) or (j) and inserting The holder of an application approved under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act ; (B) in paragraph (1), by inserting (in the case of a biological product, the proper name) after established name ; and (C) in paragraph (2), by striking or abbreviated application number and inserting , abbreviated application number, or biologics license application number . (b) Additional one-Time report Subsection (c) of section 506I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356i ) is amended to read as follows: (c) Additional one-Time report Within 180 days of the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, all holders of applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act shall review the information in the list published under section 351(k)(9)(A) and shall submit a written notice to the Secretary— (1) stating that all of the application holder’s biological products in the list published under section 351(k)(9)(A) that are not listed as discontinued are available for sale; or (2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder’s biological products that are in the list published under section 351(k)(9)(A) and not listed as discontinued, but have been discontinued from sale or never have been available for sale. . (c) Purple book Section 506I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356i ) is amended— (1) in subsection (d)— (A) by striking or (c), the Secretary and inserting “or (c)— (1) the Secretary ; (B) by striking the period at the end, and inserting ; and ; and (C) by adding at the end the following: (2) the Secretary may identify the application holder’s biological products as discontinued in the list published under section 351(k)(9)(A) of the Public Health Service Act, except that the Secretary shall remove from the list in accordance with section 351(k)(9)(B) of such Act any biological product for which a license has been revoked or suspended for reasons of safety, purity, or potency. ; and (2) in subsection (e)— (A) by inserting after the first sentence the following: The Secretary shall update the list published under section 351(k)(9)(A) of the Public Health Service Act based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that any biological product for which the license has been revoked or suspended for reasons of safety, purity, or potency shall be removed from the list in accordance with section 351(k)(9)(B) of the Public Health Service Act. ; and (B) in the last sentence— (i) by striking updates to the list and inserting updates to the lists published under section 505(j)(7)(A) of this Act and section 351(k)(9)(A) of the Public Health Service Act ; and (ii) by striking update the list and inserting update such lists . 505. Therapeutic equivalence evaluations Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7)(A) ) is amended by adding at the end the following: (v) (I) With respect to an application submitted pursuant to subsection (b)(2) for a drug that is subject to section 503(b) for which the sole difference from a listed drug relied upon in the application is a difference in inactive ingredients not permitted under clause (iii) or (iv) of section 314.94(a)(9) of title 21, Code of Federal Regulations (or successor regulations), the Secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to another approved drug product in the prescription drug product section of the list under this paragraph as follows: (aa) With respect to such an application submitted after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, the evaluation shall be made with respect to a listed drug relied upon in the application under subsection (b)(2) that is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug in the application under subsection (b)(2) at the time of approval of such application or not later than 180 days after the date of such approval, provided that the request for such a determination is made in the original application (or in a resubmission to a complete response letter), and all necessary data and information are submitted in the original application (or in a resubmission in response to a complete response letter) for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary. (bb) With respect to such an application submitted prior to the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022, with respect to an application approved on or after the date of enactment of such Act, the evaluation shall be made not later than 180 days after receipt of a request for a therapeutic equivalence evaluation submitted as part of a supplement to such application; or with respect to an application that was not approved as of the date of enactment of such Act, the evaluation shall be made not later than 180 days after the date of approval of such application if a request for such evaluation is submitted to the application, provided that— (AA) such request for a therapeutic equivalent evaluation is being sought with respect to a listed drug relied upon in the application, and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) to the drug for which a therapeutic equivalence evaluation is sought; and (BB) the initial submission containing such request, or the relevant application, includes all necessary data and information for the therapeutic equivalence evaluation, including information to demonstrate bioequivalence, in a form and manner prescribed by the Secretary. (II) When the Secretary makes an evaluation under subclause (I), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug. . 506. Modernizing accelerated approval (a) In general Section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) ) is amended— (1) in paragraph (2)— (A) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly; (B) by striking Approval of a product and inserting the following: (A) In general Approval of a product ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking appropriate postapproval studies and inserting an appropriate postapproval study or studies (which may be augmented or supported by real world evidence) ; and (D) by adding at the end the following: (B) Studies not required If the Secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph, the Secretary shall publish on the website of the Food and Drug Administration the rationale for why such study is not appropriate or necessary. (C) Postapproval study conditions Not later than the time of approval of a product under accelerated approval, the Secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product, which may include enrollment targets, the study protocol, and milestones, including the target date of study completion. (D) Studies Begun Before Approval The Secretary may require such study or studies to be underway prior to approval. ; and (2) in paragraph (3)— (A) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively and adjusting the margins accordingly; (B) by striking The Secretary may and inserting the following: (A) In general The Secretary may ; (C) in clause (i) of such subparagraph (A), as so redesignated, by striking drug with due diligence and inserting product with due diligence, including with respect to conditions specified by the Secretary under paragraph (2)(C) ; (D) in clause (iii) of such subparagraph (A), as so redesignated, by inserting shown to be after product is not ; and (E) by adding at the end the following: (B) Expedited procedures described Expedited procedures described in this subparagraph shall consist of, prior to the withdrawal of accelerated approval— (i) providing the sponsor with— (I) due notice; (II) an explanation for the proposed withdrawal; (III) an opportunity for a meeting with the Commissioner or the Commissioner’s designee; and (IV) an opportunity for written appeal to— (aa) the Commissioner; or (bb) a designee of the Commissioner who has not participated in the proposal withdrawal of approval (other than a meeting pursuant to subclause (III)) and is not subordinate of an individual (other than the Commissioner) who participated in such proposed withdrawal; (ii) providing an opportunity for public comment on the proposing to withdrawal approval; (iii) the publication of a summary of the public comments received, and the Secretary’s response to such comments, on the website of the Food and Drug Administration; and (iv) convening and consulting an advisory committee on issues related to the proposed withdrawal, if requested by the sponsor and if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request. . (b) Reports of postmarketing studies Section 506B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356b(a) ) is amended— (1) by redesignating paragraph (2) as paragraph (3); and (2) by inserting after paragraph (1) the following: (2) Accelerated approval Notwithstanding paragraph (1), a sponsor of a drug approved under accelerated approval shall submit to the Secretary a report of the progress of any study required under section 506(c), including progress toward enrollment targets, milestones, and other information as required by the Secretary, not later than 180 days after the approval of such drug and not less frequently than every 180 days thereafter, until the study is completed or terminated. . (c) Enforcement Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 824, is further amended by adding at the end the following: (ll) The failure of a sponsor of a product approved under accelerated approval pursuant to section 506(c)— (1) to conduct with due diligence any postapproval study required under section 506(c) with respect to such product; or (2) to submit timely reports with respect to such product in accordance with section 506B(a)(2). . (d) Guidance (1) In general The Secretary of Health and Human Services shall issue guidance describing— (A) how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the Food and Drug Administration; (B) the use of novel clinical trial designs that may be used to conduct appropriate post-approval studies as may be required under section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a); (C) the expedited procedures described in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act; and (D) considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under 506(c)(1)(A), including considerations in evaluating the evidence related to any such endpoints. (2) Final guidance The Secretary shall issue— (A) a draft guidance under paragraph (1) not later than 18 months after the date of enactment of this Act; and (B) final guidance not later than 1 year after the close of the public comment period on such draft guidance. (e) Rare disease endpoint advancement pilot (1) In general The Secretary of Health and Human Services shall establish a pilot program under which the Secretary will establish procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through— (A) determining eligibility of participants for such program; and (B) developing and implementing a process for applying to, and participating in, such a program. (2) Public workshops The Secretary shall conduct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics relevant to the development of endpoints for rare diseases, which may include discussions about— (A) novel endpoints developed through the pilot program established under this subsection; and (B) as appropriate, the use of real world evidence and real work data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases. (3) Report Not later than September 30, 2027, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the outcomes of the pilot program established under this subsection. (4) Guidance Not later than September 30, 2027, the Secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases. (5) Sunset The Secretary may not accept any new application or request to participate in the program established by this subsection on or after October 1, 2027. (f) Accelerated approval council (1) General Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall establish an intra-agency coordinating council within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) ). (2) Membership The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers: (A) The Director of the Center for Drug Evaluation and Research. (B) The Director of the Center for Biologics Evaluation and Research. (C) The Director of the Oncology Center of Excellence. (D) The Director of the Office of New Drugs. (E) The Director of the Office of Orphan Products Development. (F) The Director of the Office of Tissues and Advanced Therapies. (G) The Director of the Office of Medical Policy. (H) At least 3 directors of review division overseeing products approved under accelerated approval, including at least one director of a review division within the Office of Neuroscience. (3) Duties of the council (A) Meetings The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval. (B) Policy development The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such activities may include— (i) developing guidance for Food and Drug Administration staff and best practices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval; (ii) providing training for product review teams; and (iii) advising review divisions on product-specific development, review, and withdrawal of products under accelerated approval. (4) Publication of a report Not later than 1 year after the date of enactment of this Act, and annually thereafter, the council shall publish on the public website of the Food and Drug Administration a report on the activities of the council. (g) Rule of construction Nothing in this section (including the amendments made by this section) shall be construed to affect products approved under 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) ) prior to the date of enactment of this Act. VI Other reauthorizations 601. Reauthorization of the critical path public-private partnership Section 566(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–5(f) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . 602. Reauthorization of the best pharmaceuticals for children program Section 409I(d)(1) of the Public Health Service Act ( 42 U.S.C. 284m(d)(1) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . 603. Reauthorization of the humanitarian device exemption incentive Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(m)(6)(A)(iv) ) is amended by striking 2022 and inserting 2027 . 604. Reauthorization of the pediatric device consortia program Section 305(e) of the Food and Drug Administration Amendments Act of 2007 ( Public Law 110–85 ; 42 U.S.C. 282 note) is amended by striking $5,250,000 for each of fiscal years 2018 through 2022 and inserting $7,000,000 for each of fiscal years 2023 through 2027 . 605. Reauthorization of provision pertaining to drugs containing single enantiomers Section 505(u) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(u) ) is amended by— (1) in paragraph (1)(A)(ii)(II), by adding (other than bioavailability studies) after any clinical investigations ; and (2) in paragraph (4), by striking October 1, 2022 and inserting October 1, 2027 . 606. Reauthorization of orphan drug grants Section 5(c) of the Orphan Drug Act ( 21 U.S.C. 360ee(c) ) is amended by striking 2018 through 2022 and inserting 2023 through 2027 . 607. Reauthorization of certain device inspections Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(g)(11) ) is amended by striking 2022 and inserting 2027 . VII Enhancing FDA hiring authorities 701. Enhancing FDA hiring authority for scientific, technical, and professional personnel Section 714A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379d–3a ) is amended— (1) in subsection (a)— (A) by inserting , including cross-cutting operational positions, after professional positions ; and (B) by inserting and the regulation of food after medical products ; and (2) in subsection (d)(1)— (A) in the matter preceding subparagraph (A)— (i) by striking the 21st Century Cures Act and inserting the Food and Drug Administration Safety and Landmark Advancements Act of 2022 ; and (ii) by striking that examines the extent and all that follows through , including and inserting that addresses ; (B) in subparagraph (A)— (i) by inserting updated before analysis ; and (ii) by striking ; and and inserting a semicolon; (C) by redesignating subparagraph (B) as subparagraph (C); (D) by inserting after subparagraph (A) the following: (B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and ; and (E) in subparagraph (C), as so redesignated, by striking a recruitment and inserting an updated recruitment . 702. Strategic workforce plan and report Chapter VII of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371 et seq. ) is amended by inserting after section 714A the following: 714B. Strategic workforce plan and report (a) In general Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated strategy and report to provide direction for the activities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the development, review, and regulation of medical products. Each such report shall be known as the Food and Drug Administration Strategic Workforce Plan . (b) Use of the food and drug administration strategic workforce plan Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plan developed and updated under this subsection. (c) Contents of the food and drug administration strategic workforce plan Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall— (1) include agency-wide strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Administration; (2) establish specific activities the Secretary will take to achieve its strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years; (3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the activities the Secretary will undertake to overcome those challenges and mitigate those risks; (4) establish metrics and milestones that the Secretary will use to measure progress in achieving its strategic goals and priorities; and (5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce. (d) Considerations In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider— (1) the number of employees, employee expertise, and employing center of employees, including senior leadership and non-senior leadership employees, eligible for retirement; (2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates; (3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results; (4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve strategic goals and priorities; and (5) the statutory hiring authorities used to hire Food and Drug Administration employees, and the time to hire across different hiring authorities. (e) Evaluation of progress Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful recruitment, hiring, training, development, and retention activities; and whether such actions improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in the previous Food and Drug Administration Strategic Workforce Plan. (f) Additional considerations The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID–19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, including protecting such workforce during public health emergencies. . VIII Advancing regulation of cosmetics, dietary supplements, and laboratory developed tests A Cosmetics 801. Short title This subtitle may be cited as the Modernization of Cosmetics Regulation Act of 2022 . 802. Amendments to cosmetic requirements Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq. ) is amended by adding at the end the following: 604. Definitions In this chapter: (1) Adverse event The term adverse event means any health-related event associated with the use of a cosmetic product that is adverse. (2) Cosmetic product The term cosmetic product means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product. (3) Facility (A) In general The term facility includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. (B) Such term does not include any of the following: (i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location. (ii) Cosmetic product retailers, including individual sales representatives, direct sellers, retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location. (iii) Hospitals, physicians’ offices, and health care clinics. (iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer. (v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services. (vi) Trade shows and other venues where cosmetic product samples are provided free of charge. (vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale. (viii) An establishment that solely performs one or more of the following with respect to cosmetic products: (I) Labeling. (II) Relabeling. (III) Packaging. (IV) Repackaging. (V) Holding. (VI) Distributing. (C) Clarification For the purposes of subparagraph (B)(viii), the terms packaging and repackaging do not include filling a product container with a cosmetic product. (4) Responsible person The term responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act. (5) Serious adverse event The term serious adverse event means an adverse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; or (vi) significant disfigurement (including serious and persistent rashes or infections, second- or third-degree burns, significant hair loss, or permanent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). 605. Adverse events (a) Serious adverse event reporting requirements The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person. (b) Submission of reports (1) Serious adverse event report The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person. (2) New medical information The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person. (3) Consolidation of reports The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event. (c) Exemptions The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health. (d) Contact information The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 609(a). (e) Maintenance and inspection of adverse event records (1) Maintenance The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years. (2) Inspection (A) In general The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704. (B) Authorized person For purposes of this paragraph, the term authorized person means an officer or employee of the Department of Health and Human Services who has— (i) appropriate credentials, as determined by the Secretary; and (ii) been duly designated by the Secretary to have access to the records required under this section. (f) Fragrance and flavor ingredients If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a complete list of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. Information submitted to the Secretary under this subsection that is confidential commercial or trade secret information shall be exempt from disclosure under section 552 of title 5, United States Code. (g) Protected information A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (a)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered to be— (1) a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and (2) a record about an individual under section 552a of title 5, United States Code (commonly referred to as the Privacy Act of 1974 ) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the Freedom of Information Act ), and shall not be publicly disclosed unless all personally identifiable information is redacted. (h) Effect of section (1) In general Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision. (2) Personally identifiable information Notwithstanding any other provision of law, personally identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not— (A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or (B) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary. (3) Use of reports Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with this section. (4) Rule of construction The submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event. 606. Good manufacturing practice (a) In general The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 601. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph during an inspection conducted under section 704. (b) Considerations In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary. (c) Timeframe The Secretary shall publish a notice of proposed rulemaking not later than 2 years after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 and shall publish a final such rule not later than 3 years after such date of enactment. 607. Registration and product listing (a) Submission of registration (1) Initial registration (A) Existing facilities Every person that, on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 , owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after date of enactment of such Act. (B) New facilities Every person that owns or operates a facility that first engages, after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 , in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later. (2) Biennial renewal of registration A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially. (3) Contract manufacturers If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility. (4) Updates to content A person that is required to register under subsection (a)(1) shall notify the Secretary within 60 days of any changes to information required under subsection (b)(2). (5) Abbreviated renewal registrations The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2). (b) Format; contents of registration (1) In general Registration information under this section may be submitted at such time and in such manner as the Secretary may prescribe. (2) Contents The registration under subsection (a) shall contain— (A) the facility’s name, physical address, email address, and telephone number; (B) with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information; (C) the facility registration number, if any, previously assigned by the Secretary under subsection (d); (D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and (E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility. (c) Cosmetic product listing (1) In general For each cosmetic product, the responsible person shall submit, or ensure is submitted, to the Secretary a cosmetic product listing, at such time and in such manner as the Secretary may prescribe. (2) Cosmetic product listing The responsible person of a cosmetic product that is marketed on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 shall submit to the Secretary a cosmetic product listing not later than 1 year after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 , or for a cosmetic product that is first marketed after the date of enactment of such Act, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5). (3) Abbreviated renewal The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing. (4) Contents of listing (A) In general Each such cosmetic product listing shall include— (i) the facility registration number of each facility where the cosmetic product is manufactured or processed; (ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label; (iii) the applicable cosmetic category or categories for the cosmetic product; (iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name adopted in regulations promulgated by the Secretary, if any, or by the common or usual name of the ingredient; and (v) the product listing number, if any previously assigned by the Secretary under subsection (d). (B) Flexible listings A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents. (5) Updates to content A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually. (6) Submission A responsible person may submit product listing information as part of a facility registration or separately. (d) Facility registration and product listing numbers At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1), the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available. (e) Confidentiality Information submitted to the Secretary under this section that is confidential commercial or trade secret information shall be exempt from disclosure under section 552 of title 5, United States Code, including all information submitted under subsection (b)(2)(D) or (c)(4)(A)(i). (f) Suspensions (1) Suspension of registration of a facility The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. (2) Notice of suspension Before suspending a facility registration under this section, the Secretary shall provide— (A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility should be suspended; and (B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration. (3) Hearing on suspension The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration. (4) Post-hearing corrective action plan If, after providing opportunity for an informal hearing under paragraph (3), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective action plan or such other time period as determined by the Secretary, in consultation with the registrant. (5) Vacating of order; reinstatement Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility. (6) Effect of suspension If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility. (7) No delegation The authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner. 608. Safety substantiation (a) Substantiation of safety A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product. (b) Coal-Tar hair dye Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 601(a). A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product. (c) Definitions For purposes of this section: (1) Adequate substantiation of safety The term adequate substantiation of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe. (2) Safe The term safe means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof. 609. Labeling (a) General requirement Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product. (b) Fragrance allergens The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 , and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations. (c) Cosmetic products for professional use (1) Definition of professional For purposes of this subsection, the term professional means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics. (2) Professional use labeling A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that— (A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and (B) is in conformity with the requirements of the Secretary for cosmetics labeling under this Act and section 4(a) of the Fair Packaging and Labeling Act. 610. Records (a) In general If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales). (b) Protection of sensitive information The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section. (c) Rule of construction Nothing in this section shall be construed to limit the authority of the Secretary to inspect records or require establishment and maintenance of records under any other provision of this Act, including section 605 or 606. 611. Mandatory recall authority (a) In general If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary deems necessary, such person to immediately cease distribution of such article. (b) Hearing The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order. (c) Order resolution After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)— (1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order; (2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or (3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall. (d) Action following order Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order. (e) Notice to persons affected If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. (f) Public notification In conducting a recall under this section, the Secretary shall— (1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification— (A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and (B) that includes, at a minimum— (i) the name of the cosmetic subject to the recall; (ii) a description of the risk associated with such article; and (iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and (2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available. (g) No delegation The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner. (h) Effect Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this chapter. 612. Small businesses (a) In general Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607. (b) Requirements applicable to all manufacturers and processors of cosmetics The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products: (1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual. (2) Cosmetic products that are injected. (3) Cosmetic products that are intended for internal use. (4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual. 613. Exemption for certain products and facilities (a) In general Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of chapter V shall be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611. (b) Exception A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of chapter V shall not be exempt from the requirements of sections 605, 606, 607, 608, 609(a), 610, and 611, with respect to such cosmetic products. 614. Preemption (a) In general No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this chapter with respect to registration and product listing, good manufacturing practice, recordkeeping, recalls, adverse event reporting, or safety substantiation. (b) Limitation Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in an cosmetic product. (c) Savings Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 , nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law. (d) Rule of construction Nothing in this section shall be construed to amend, expand, or limit the provisions under section 752. . 803. Enforcement and conforming amendments (a) In general (1) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— (A) by adding at the end the following: (fff) The failure to register or submit listing information in accordance with section 607. (ggg) The refusal or failure to follow an order under section 611. ; and (B) in paragraph (d), by striking or 564 and inserting , 564, or 607 . (2) Adulterated products Section 601 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 ) is amended by adding at the end the following: (f) If it has been manufactured or processed under conditions that do not meet good manufacturing practice regulations, as prescribed by the Food and Drug Administration in accordance with section 606. (g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in section 608(c). . (3) Misbranded cosmetics Section 602(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 362(b) ) is amended— (A) by striking and (2) and inserting (2) ; and (B) by inserting after numerical count the following: ; and (3) the information required under section 609 . (4) Adverse event reporting The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended— (A) in section 301(e) ( 21 U.S.C. 331(e) )— (i) by striking 564, 703 and inserting 564, 605, 703 ; and (ii) by striking 564, 760 and inserting 564, 605, 611, 760 ; (B) in section 301(ii) ( 21 U.S.C. 331(ii) )— (i) by striking 760 or 761) or and inserting 604, 760, or 761) or ; and (ii) by inserting or required under section 605(a) after report (as defined under section 760 or 761 ; (C) in section 801(a) ( 21 U.S.C. 381(a) )— (i) by striking under section 760 or 761 and inserting under section 605, 760, or 761 ; (ii) by striking defined in such section 760 or 761 and inserting defined in section 604, 760, or 761 ; (iii) by striking of such section 760 or 761 and inserting of such section 605, 760, or 761 ; and (iv) by striking described in such section 760 or 761 and inserting described in such section 605, 760, or 761 ; and (D) in section 801(b) ( 21 U.S.C. 381(b) )— (i) by striking requirements of sections 760 or 761, and inserting requirements of section 605, 760, or 761 ; (ii) by striking as defined in section 760 or 761 and inserting as defined in section 604, 760, or 761 ; and (iii) by striking with section 760 or 761 and inserting with section 605, 760, or 761 . (b) Effective date The amendments made by subsection (a) shall take effect on the date that is 1 year after the date of enactment of this Act. 804. Records inspection Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(1) ) is amended by inserting after the second sentence the following: In the case of a facility (as defined in section 604) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 605, 606, and 610, when the standard for records inspection under such section applies. . 805. Talc-containing cosmetics The Secretary of Health and Human Services— (1) not later than one year after the date of enactment of this Act, shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and (2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations. 806. PFAS in cosmetics (a) In general The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research. (b) Report Not later than 2 years after enactment of this Act, the Secretary shall publish on the website of the Food and Drug Administration a report summarizing the results of the assessment conducted under subsection (a). 807. Funding There is authorized to be appropriated $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of the fiscal years 2025 through 2027, for purposes of conducting the activities under this subtitle (including the amendments made by this subtitle) and hiring personnel required to carry out this subtitle (including the amendments made by this subtitle). B Dietary supplements 811. Regulation of dietary supplements (a) In general Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ) is amended by adding after section 403C of such Act ( 21 U.S.C. 343–3 ) the following: 403D. Dietary supplement listing requirement (a) In general Beginning on the date specified in subsection (b)(4), each dietary supplement shall be listed with the Secretary in accordance with this section. Each such listing shall include, with respect to the dietary supplement, the information specified in subsection (b)(1). (b) Requirements (1) In general The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 403(e)(1)) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the responsible person ), or if the responsible person is a foreign entity, the United States agent of such person, shall submit to the Secretary in accordance with this section the following information for a dietary supplement that is marketed: (A) Any name of the dietary supplement and the statement of identity, including brand name and specified flavors, if applicable. (B) The name and address of the responsible person and the name and email address of the owner, operator, or agent in charge of the responsible person. (C) The name, domestic address, and email address for the United States agent, if the responsible person is a foreign entity. (D) The business name and mailing address of all locations at which the responsible person manufactures, packages, labels, or holds the dietary supplement. (E) A list of all ingredients in each such dietary supplement required under sections 101.4 and 101.36, title 21, Code of Federal Regulations (or any successor regulations) to appear on the label of a dietary supplement, including— (i) where applicable, ingredients in a proprietary blend as described in section 101.36(c) of title 21, Code of Federal Regulations (or any successor regulations); (ii) the amount per serving of each listed dietary ingredient; (iii) if required by section 101.36 of title 21, Code of Federal Regulations (or any successor regulations), the percent of the daily value of each listed dietary ingredient; and (iv) the amount per serving of dietary ingredients within a proprietary blend. (F) The number of servings per container for each container size of the identical formulation. (G) The directions for use. (H) Warnings, notice, and safe handling statements, as required by section 101.17 of title 21, Code of Federal Regulations (or any successor regulations). (I) Allergen statements for major food allergens (pursuant to sections 403(w) and 403(x)). (J) The form of the dietary supplement (such as tablets, capsules). (K) Any health claims or structure or function claims. (L) The dietary supplement product listing number for the product provided by the Secretary in accordance with subsection (c) for that product. (2) Format The Secretary may require that a listing submitted under paragraph (1) be submitted in an electronic format. Upon receipt of a complete listing under paragraph (1), the Secretary shall promptly notify the responsible person of the receipt of such listing. (3) Listing content A single listing submission for a dietary supplement under paragraph (1) may include multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives, or flavorings, whether offered in a single package size or in multiple package sizes. (4) Timing (A) In general (i) Dietary supplements on the market In the case of a dietary supplement that is being offered in interstate commerce on or before January 1, 2024, a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce shall be submitted by the responsible person to the Secretary under this subsection not later than 18 months after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 . (ii) New dietary supplements In the case of a dietary supplement that is not being offered in interstate commerce on or before January 1, 2024, a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce that has not been included in any listing previously submitted by the responsible person to the Secretary under this subsection shall be submitted to the Secretary at the time of introduction into interstate commerce. (B) Discontinued dietary supplements The responsible person shall notify the Secretary within one year of the date of discontinuance of a dietary supplement required to be listed with the Secretary under paragraph (1) for which the responsible person has discontinued commercial marketing. (C) Changes to existing listings The responsible person shall submit to the Secretary a change or modification to listing information submitted under paragraph (1) included on the label for a dietary supplement at the time the dietary supplement with the change or modification is introduced into interstate commerce. (5) Additional information The responsible person shall provide upon request from the Secretary, within 10 calendar days of such request, the full business name and physical and mailing address from which the responsible person receives a dietary ingredient or combination of dietary ingredients that the responsible person uses in the manufacture of the dietary supplement or, if applicable, from which the responsible person receives the dietary supplement. (c) Product listing number and dietary supplement electronic database (1) Dietary supplement product listing number The Secretary shall provide each dietary supplement listed in accordance with subsection (b)(1) a dietary supplement product listing number, which may apply to multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives, or flavorings, including dietary supplements offered in a single package size or in multiple package sizes. The Secretary shall provide a process for a responsible person to reserve dietary supplement listing numbers in advance of listing under subsection (b)(1). (2) Electronic database Not later than 2 years after the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 , the Secretary shall establish and maintain an electronic database that is publicly available and contains information submitted under subsection (b)(1) (except for the information submitted under subparagraphs (D) and (E)(iv) of such subsection). The Secretary shall make such information maintained in the electronic database publicly searchable, including by dietary supplement product listing number, and by any field of information or combination of fields of information provided under subsection (b)(1). (d) Rule of construction Nothing in this section shall be construed— (1) to limit the authority of the Secretary to inspect or copy records or to require the establishment and maintenance of records under any other provision of this Act; or (2) to authorize the disclosure of trade secret or confidential commercial information subject to section 552(b)(4) of title 5, United States Code, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code, including information provided to the Secretary under subsection (b)(1)(D) or (b)(1)(E)(iv). (e) Authorization of appropriations There is authorized to be appropriated $7,498,080 for fiscal year 2023, and $6,300,000 for each of fiscal years 2024 through 2027, for purposes of conducting the activities under this section and hiring personnel required to carry out this section. . (b) Guidance Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish final guidance related to the draft guidance titled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability (81 Fed. Reg. 53486; August 12, 2016), consistent with section 403D of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). (c) Inspections for certain dietary supplements The Secretary of Health and Human Services shall direct resources to inspections of facilities, suppliers, and dietary supplement types that present a high risk to public health (as identified by the Secretary). (d) Misbranding Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: (z) If it is a dietary supplement for which a responsible person is required under section 403D to file a listing, file a change to an existing listing, or provide additional information to the Secretary, and such person has failed to comply with any such requirements under section 403D with respect to such dietary supplement. . (e) New prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 803(a), is further amended by adding at the end the following: (hhh) The introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section 201(ff). (iii) The introduction or delivery for introduction into interstate commerce of a dietary supplement that has been prepared, packed, or held using the assistance of, or at the direction of, a person debarred under section 306. . C In vitro clinical tests 821. Short title; table of contents (a) Short title This subtitle may be cited as the Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the VALID Act of 2022 . (b) Table of contents The table of contents of this subtitle is as follows: SUBCHAPTER C—In Vitro Clinical Tests Sec. 821. Short title; table of contents. Sec. 822. Definitions. Sec. 823. Regulation of in vitro clinical tests. SUBCHAPTER J—In Vitro Clinical Tests SUBCHAPTER J. In Vitro Clinical Tests Sec. 587. Definitions. Sec. 587A. Regulation of in vitro clinical tests. Sec. 587B. Premarket review. Sec. 587C. Exemptions. Sec. 587D. Technology certification. Sec. 587E. Mitigating measures. Sec. 587F. Regulatory pathway designation. Sec. 587G. Grandfathered in vitro clinical tests. Sec. 587H. Advisory committees. Sec. 587I. Breakthrough in vitro clinical tests. Sec. 587J. Registration and listing. Sec. 587K. Test design and quality requirements. Sec. 587L. Labeling requirements. Sec. 587M. Adverse event reporting. Sec. 587N. Corrections and removals. Sec. 587O. Restricted in vitro clinical tests. Sec. 587P. Appeals. Sec. 587Q. Accredited persons. Sec. 587R. Recognized standards. Sec. 587S. Investigational use. Sec. 587T. Collaborative communities for in vitro clinical tests. Sec. 587U. Comprehensive test information system. Sec. 587V. Preemption. Sec. 587W. Adulteration. Sec. 587X. Misbranding. Sec. 587Y. Postmarket surveillance. Sec. 587Z. Electronic format for submissions. Sec. 587AA. Postmarket remedies. Sec. 587BB. Applicability. Sec. 587CC. Judicial review. Sec. 824. Enforcement and other provisions. Sec. 825. Transition. Sec. 826. Emergency use authorization. Sec. 827. Antimicrobial susceptibility tests. Sec. 828. Combination products. Sec. 829. Resources. 822. Definitions (a) In general Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— (1) by adding at the end the following: (ss) (1) The term in vitro clinical test means an article specified in subparagraph (2) that is intended by its developer (as defined in section 587) to be used in the collection, preparation, analysis, or in vitro clinical examination of specimens taken or derived from the human body for the purpose of— (A) identifying or diagnosing a disease or condition; (B) providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health; or (C) selecting, monitoring, or informing therapy or treatment for a disease or condition. (2) An article specified in this subparagraph is— (A) a test kit; (B) a test system; (C) a test protocol or laboratory test protocol; (D) an instrument (as defined in section 587(11)); (E) a specimen receptacle (as defined in section 587(17)); (F) software, excluding software that is excluded by section 520(o) from the definition of a device under section 201(h), that— (i) is a component or part of another in vitro clinical test or analyzes, processes, or interprets a signal or pattern from another in vitro clinical test; and (ii) does not analyze, process, or interpret a signal, pattern, or medical image from a device; and (G) subject to subparagraph (3), a component or part of a test, a test protocol, an instrument, an article, or software described in any of clauses (A) through (D) of such subparagraph, whether alone or in combination, including reagents, calibrators, and controls. (3) Notwithstanding subparagraph (2)(G), an article intended to be used as a component or part of an in vitro clinical test described in subparagraph (1) is excluded from the definition in subparagraph (1) if the article consists of any of the following: (A) Blood, blood components, or human cells or tissues, from the time of acquisition, donation, or recovery of such article, including determination of donor eligibility, as applicable, until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article. (B) An article used for invasive sampling, a needle, or a lancet, except to the extent such article, needle, or lancet is an integral component of an article for holding, storing, or transporting a specimen. (C) General purpose laboratory equipment, including certain pre-analytical equipment, as determined by the Secretary. (D) An article used solely for personal protection during the administering, conducting, or otherwise performing of test activities. ; (2) by adding at the end of section 201(g) the following: (3) The term drug does not include an in vitro clinical test. ; and (3) in section 201(h)(1), in the matter following clause (C), by striking section 520(o) and inserting section 520(o) or an in vitro clinical test . (b) Exclusion from definition of biological product Section 351(i)(1) of the Public Health Service Act ( 42 U.S.C. 262(i)(1) ) is amended— (1) by striking (1) The term biological product means and inserting (1)(A) The term biological product means ; and (2) by adding at the end the following: (B) The term biological product does not include an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act. . (c) In vitro clinical test definition In this Act, the term in vitro clinical test has the meaning given such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). 823. Regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended— (1) by amending the heading of chapter V to read as follows: Drugs, Devices, and In Vitro Clinical Tests ; and (2) by adding at the end of chapter V the following: J In Vitro Clinical Tests 587. Definitions In this subchapter: (1) Analytical validity The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (or assist in such identification, measurement, detection, calculation, or analysis of) one or more analytes, biomarkers, substances, or other targets intended to be identified, measured, detected, calculated, or analyzed by the test. (2) Applicable standard The term applicable standard , with respect to an in vitro clinical test, means a reasonable assurance of analytical and clinical validity for its indications for use, and a reasonable assurance of safety for individuals who come into contact with such in vitro clinical test, except that such term, with respect to specimen receptacles and test instruments, means a reasonable assurance of analytical validity for its indications for use and safety for individuals who come into contact with such specimen receptacle or test instrument. (3) Clinical use The term clinical use means the operation, application, or functioning of an in vitro clinical test for the purpose for which it is intended as described in section 201(ss)(1). (4) Clinical validity The term clinical validity means the ability of an in vitro clinical test to achieve the purpose for which it is intended as described in section 201(ss)(1). (5) Component or part The term component or part means a substance, piece, part, raw material, software, firmware, labeling, or assembly, including reagents, that is intended by the developer to be included as an aspect of an in vitro clinical test described in section 201(ss)(1). (6) Develop The term develop , with respect to an in vitro clinical test, means— (A) designing, validating, producing, manufacturing, remanufacturing, labeling, advertising, propagating, or assembling an in vitro clinical test; (B) modifying an in vitro clinical test, including modifying the indications for use of the in vitro clinical test, or modifying an article to be in an in vitro clinical test; or (C) establishing a test system as described or included in a test protocol developed by another entity unless such test protocol is listed as an in vitro clinical test in the comprehensive test information system established under section 587T by that other entity. (7) Developer The term developer means a person who engages in development as described in paragraph (6), except the term does not include a laboratory that— (A) is certified by the Secretary under section 353 of the Public Health Service Act; and (B) assembles for use solely within that laboratory, without otherwise developing, an in vitro clinical test appropriately listed in the comprehensive test information system established under section 587T by a different person. (8) First-of-a-kind The term first-of-a-kind , with respect to an in vitro clinical test, means that such test has any novel combination of the elements specified in paragraph (10) that differs from in vitro clinical tests that already are legally available in the United States, except for such tests offered under section 587C(a)(3), 587C(a)(4), or 587G. (9) High-risk The term high-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that an undetected inaccurate result from such test, or such category of tests, when used as intended— (A) (i) has the substantial likelihood to result in serious or irreversible harm or death to a patient or patients, or would otherwise cause serious harm to the public health; or (ii) is reasonably likely to result in the absence, significant delay, or discontinuation of life-supporting or life-sustaining medical treatment; and (B) sufficient mitigating measures are not able to be established and applied to prevent, mitigate, or detect the inaccurate result, or otherwise mitigate the risk resulting from an undetected inaccurate result described in subparagraph (A), such that the test would be moderate-risk or low-risk. (10) Indications for use The term indications for use , with respect to an in vitro clinical test, means the following elements: (A) Substance or substances measured by the in vitro clinical test, such as an analyte, protein, or pathogen. (B) Test method. (C) Test purpose or purposes, as described in section 201(ss)(1). (D) Diseases or conditions for which the in vitro clinical test is intended for use, including intended patient populations. (E) Context of use, such as in a clinical laboratory, in a health care facility, prescription home use, over-the-counter use, or direct-to-consumer testing. (11) Instrument (A) In general The term instrument means an analytical or pre-analytical instrument. (B) Analytic instrument The term analytic instrument means an in vitro clinical test that is hardware intended by the hardware developer to be used with one or more other in vitro clinical tests to generate a clinical test result, including software used to effectuate the functionality of the hardware. (C) Pre-analytical instrument The term pre-analytical instrument means an in vitro clinical test that is hardware intended by the hardware’s developer solely to generate an output for use exclusively with one or more analytical instruments as defined in subparagraph (B) and which does not itself generate a clinical test result. Such term may include software used to effectuate the hardware’s functionality. (12) Instrument family The term instrument family means more than one instrument developed by the same developer for which the developer demonstrates and documents, with respect to all such instruments, that all— (A) have the same basic architecture, design, and performance characteristics; (B) have the same indications for use and capabilities; (C) share the same measurement principles, detection methods, and reaction conditions, as applicable; and (D) produce the same or similar analytical results from samples of the same specimen type or types. (13) Low-risk The term low-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that an undetected inaccurate result from such in vitro clinical test, or such category of in vitro clinical tests, when used as intended— (A) would cause only minimal or immediately reversible harm, and would lead to only a remote risk of adverse patient impact or adverse public health impact; or (B) sufficient mitigating measures are able to be established and applied such that the in vitro clinical test meets the standard described in subparagraph (A). (14) Mitigating measures The term mitigating measures — (A) means controls, standards, and other requirements that the Secretary determines, based on evidence, are necessary— (i) for an in vitro clinical test, or a category of in vitro clinical tests, to meet the applicable standard; or (ii) to mitigate the risk of harm ensuing from an undetected inaccurate result or misinterpretation of a result; and (B) may include, as required by the Secretary, as appropriate, applicable requirements regarding labeling, conformance to performance standards and consensus standards, performance testing, submission of clinical data, advertising, website posting of information, clinical studies, postmarket surveillance, user comprehension studies, training, and confirmatory laboratory, clinical findings, or testing. (15) Moderate-risk The term moderate-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that, when used as intended, such test or category of tests— (A) meets the criteria specified in paragraph (9) for classification as high-risk, but one or more mitigating measures are able to be established and applied to prevent or detect an inaccurate result or otherwise sufficiently mitigate such risk, but are not sufficient such that the test is low-risk; or (B) (i) an undetected inaccurate result for the intended use of the test would cause only non-life-threatening harm, harm that is medically reversible, or the absence, significant delay, or discontinuation of necessary treatment that is not life-supporting or life-sustaining; and (ii) mitigating measures are not able to be established and applied to prevent or detect such inaccurate result or otherwise sufficiently mitigate the risk of such inaccurate result such that the test would be low-risk. (16) Specimen receptacle The term specimen receptacle means an in vitro clinical test intended for taking, collecting, holding, storing, or transporting of specimens derived from the human body or for in vitro examination for purposes described in subparagraph (A) or (B) of section 201(ss)(1). (17) Technology The term technology — (A) means a set of control mechanisms, energy sources, or operating principles— (i) that do not differ significantly among multiple in vitro clinical tests; and (ii) for which design and development (including analytical and clinical validation, as applicable) of the tests would be addressed in a similar manner or through similar procedures; and (B) may include clot detection, colorimetric (non-immunoassay), electrochemical (non-immunoassay), enzymatic (non-immunoassay), flow cytometry, fluorometry (non-immunoassay), immunoassay, mass spectrometry or chromatography, microbial culture, next generation sequencing, nephlometric or turbidimetric (non-immunoassay), singleplex or multiplex non-NGS nucleic acid analysis, slide-based technology, spectroscopy, and any other technology, as the Secretary determines appropriate. (18) Test The term test , unless otherwise provided, means an in vitro clinical test. (19) Valid scientific evidence The term valid scientific evidence — (A) means, with respect to an in vitro clinical test, evidence that— (i) has been generated and evaluated by persons qualified by training or experience to do so, using procedures generally accepted by other persons so qualified; and (ii) forms an appropriate basis for concluding by qualified experts whether the applicable standard has been met by the in vitro clinical test; and (B) may include evidence described in subparagraph (A) consisting of— (i) peer-reviewed literature; (ii) clinical guidelines; (iii) reports of significant human experience with an in vitro clinical test; (iv) bench studies; (v) case studies or histories; (vi) clinical data; (vii) consensus standards; (viii) reference standards; (ix) data registries; (x) postmarket data; (xi) real world data; (xii) clinical trials; and (xiii) data collected in countries other than the United States if such data are demonstrated to be appropriate for the purpose of making a regulatory determination under this subchapter. 587A. Regulation of in vitro clinical tests (a) In general No person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test, unless— (1) an approval of an application filed pursuant to subsection (a) or (b) of section 587B is effective with respect to such in vitro clinical test; (2) a technology certification order is in effect under section 587D; or (3) the test is exempt under sections 587C or 587G from the requirements of section 587B. (b) Transfer or sale of In vitro clinical tests (1) Transfer and assumption of regulatory obligations If ownership of an in vitro clinical test is sold or transferred in such manner that the developer transfers the regulatory submissions and obligations applicable under this subchapter with respect to the test, the transferee or purchaser becomes the developer of the test and shall have all regulatory obligations applicable to such a test under this subchapter. The transferee or purchaser shall update the registration and listing information under section 587J for the in vitro clinical test. (2) Transfer or sale of premarket approval (A) Notice required If a developer of an in vitro clinical test transfers or sells the approval of the in vitro clinical test, the transferor or seller shall— (i) submit a notice of the transfer or sale to the Secretary and update the registration and listing information under section 587J for the in vitro clinical test; and (ii) submit a supplement to an application if required under section 587B(h). (B) Effective date of approval transfer A transfer or sale described in subparagraph (A) shall become effective upon completion of a transfer or sale described in paragraph (1) or the approval of a supplement to an application under section 587B(h) if required, whichever is later. The transferee or purchaser shall update the registration and listing information under section 587J for the in vitro clinical test within 15 calendar days of the effective date of the transfer or sale. (3) Transfer or sale of technology certification (A) Requirements for transfer or sale of technology certification An unexpired technology certification can be transferred or sold if the transferee or purchaser— (i) is an eligible person under section 587D(a)(2); and (ii) maintains, upon such transfer or sale, test design and quality requirements, processes and procedures under the scope of technology certification, and scope of the technology certification identified in the applicable technology certification order. (B) Notice required If a developer of an in vitro clinical test transfers or sells a technology certification order that has not expired, the transferor or seller shall submit a notice of the transfer or sale to the Secretary and shall update the registration and listing information under section 587J for all in vitro clinical tests covered by the technology certification. (C) Effective date of technology certification transfer The transfer of a technology certification shall become effective upon completion of a transfer or sale described in subparagraph (A). The transferee or purchaser shall update the registration and listing information under section 587J for the in vitro clinical test within 30 calendar days of the effective date of the technology certification transfer. (D) New technology certification required If the requirements of subparagraph (A)(ii) are not met, the technology certification order may not be transferred and the transferee or purchaser of an in vitro clinical test is required to submit an application for technology certification and obtain a technology certification order prior to offering the test for clinical use. (c) Regulations The Secretary may issue regulations to implement this subchapter. 587B. Premarket review (a) Application (1) Filing Any developer may file with the Secretary an application for premarket approval of an in vitro clinical test under this subsection. (2) Transparency and predictability If a developer files a premarket application under this section and provides any additional documentation required under section 587D, the in vitro clinical test that is the subject of the premarket application may be utilized as the representative in vitro clinical test reviewed by the Secretary to support a technology certification order under section 587D. (3) Application content An application submitted under paragraph (1) shall include the following, in such format as the Secretary specifies: (A) General information regarding the in vitro clinical test, including— (i) the name and address of the applicant; (ii) the table of contents for the application and the identification of the information the applicant claims as trade secret or confidential commercial or financial information; (iii) a description of the test’s design and intended use, including the indications for use; and (iv) a description regarding test function and performance characteristics. (B) A summary of the data and information in the application for the in vitro clinical test, including— (i) a brief description of the foreign and domestic marketing history of the test, if any, including a list of all countries in which the test has been marketed and a list of all countries in which the test has been withdrawn from marketing for any reason related to the ability of the in vitro clinical test to meet the applicable standard, if known by the applicant; (ii) a description of benefit and risk considerations related to the in vitro clinical test, including a description of any applicable adverse effects of the test on health and how such adverse effects have been, or will be, mitigated; (iii) a risk assessment of the test; and (iv) a description of how the data and information in the application constitute valid scientific evidence and support a showing that the test meets the applicable standard under section 587(2). (C) The signature of the developer filing the premarket application or an authorized representative. (D) A bibliography of applicable published reports relied upon by the applicant and a description of any studies conducted, including any unpublished studies related to such test, that are known or that should reasonably be known to the applicant, and a description of data and information relevant to the evaluation of whether the test meets the applicable standard. (E) Applicable information regarding the methods used in, and the facilities or controls used for, the development of the test to demonstrate compliance with the applicable quality requirements under section 587K. (F) Information demonstrating compliance with any relevant and applicable— (i) mitigating measures under section 587E; and (ii) standards established or recognized under section 514 prior to the date of enactment of the VALID Act of 2022 , or, after applicable standards are established or recognized under section 587Q, with such standards. (G) Valid scientific evidence to support that the test meets the applicable standard, which shall include— (i) summary information for all supporting validation studies performed, including a description of the objective of the study, a description of the experimental design of the study, a description of any limitations of the study, a brief description of how the data were collected and analyzed, a brief description of the results of each study, and conclusions drawn from each study; (ii) new raw data for each study, which may include, as applicable, tabulations of data and results as required under section 814.20(b)(6)(ii) of title 21, Code of Federal Regulations (or any successor regulations); and (iii) for nonclinical laboratory studies involving the test, if applicable, a statement that studies were conducted in compliance with applicable good laboratory practices. (H) To the extent the application seeks authorization to make modifications to the test within the scope of the approval that are not otherwise permitted without premarket review under this subchapter, a proposed change protocol that includes validation procedures and acceptance criteria for anticipated modifications that could be made to the test within the scope of the approval. (I) Proposed labeling, in accordance with the requirements of section 587L. (J) Such other data or information as the Secretary may require in accordance with the least burdensome requirements under section 587AA(c). (4) Guidance for premarket and abbreviated premarket applications In accordance with section 825 of the VALID Act of 2022 , the Secretary shall issue draft guidance detailing the information to be provided in a premarket application and abbreviated premarket application under this section. The Secretary shall issue final guidance detailing the information to be provided in a premarket application and abbreviated premarket application under this section not later than 1 year prior to the effective date of such Act. (5) Refuse to file a premarket or abbreviated premarket application The Secretary may refuse to file an application under this section only for lack of completeness or legibility of the application. If, after receipt of an application under this section, the Secretary refuses to file such an application, the Secretary shall provide to the developer, within 60 calendar days of receipt of such application, a description of the reason for such refusal, and identify the information required, if any, to allow for the filing of the application. (6) Substantive review for deficient application If, after receipt of an application under this section, the Secretary determines that any portion of such application is materially deficient, the Secretary shall provide to the applicant a description of such material deficiencies and the information required to resolve such deficiencies. (7) Inspections With respect to an application under paragraph (1), preapproval inspections authorized by an employee of the Food and Drug Administration or a person accredited under section 587Q need not occur unless requested by the Secretary. (b) Abbreviated premarket review (1) In general Any developer may file with the Secretary an application for abbreviated premarket approval for— (A) an instrument; (B) a specimen receptacle; (C) an in vitro clinical test that is moderate-risk; or (D) an in vitro clinical test that is determined by the Secretary to be eligible for abbreviated premarket review under section 587F(a)(1)(B). (2) Application content An application under paragraph (1) shall include— (A) the information required for applications submitted under subsection (a)(2), except that applications under paragraph (1) need not include— (i) quality requirement information; or (ii) raw data, unless explicitly requested by the Secretary; and (B) data, as applicable, to support software validation, electromagnetic compatibility, and electrical safety, and information demonstrating compliance with maintaining quality systems documentation. (3) Safety information The developer of an in vitro clinical test specimen receptacle reviewed under this subsection shall maintain safety information for such specimen receptacle. (4) Inspections With respect to an application under paragraph (1), preapproval inspections authorized by an employee of the Food and Drug Administration or a person accredited under section 587Q need not occur unless requested by the Secretary. (c) Instruments and instrument families (1) In general A developer of an instrument family shall file with the Secretary an application for premarket approval of one version of an instrument under this subsection. Any modified versions of the instrument that generate a new instrument within the same instrument family shall be exempt from premarket review requirements of this section, provided that the developer of such instrument or instrument family— (A) maintains documentation that the new instrument is part of the instrument family, as defined in section 587; (B) performs, documents, and maintains a risk assessment (as described in subsection (a)(2)(B)(iv)) of the new instrument compared to the instrument approved under subsection (b) and no new risks are identified; (C) performs, documents, and maintains validation and verification activities for the new instrument; (D) makes such documentation available to the Secretary upon request; and (E) registers and lists the new instrument in accordance with section 587J. (2) Test kits and test protocols A test kit or test protocol that is approved under this section for use on an approved instrument or an instrument exempt from premarket review, including an instrument within an instrument family under this section, a submission under this section shall not be required for such test kit or test protocol in order for it to be used on a new instrument within its instrument family, provided that— (A) use of the test kit or test protocol with the new instrument does not— (i) change the claims for the test kit or test protocol, except as applicable, claims regarding an instrument or instruments that can be used with such test kit or test protocol; (ii) adversely affect performance of the test kit or test protocol; or (iii) cause the test kit or test protocol to no longer conform with performance standards required under section 587R or comply with any applicable mitigating measures under section 587E, conditions of approval under subsection (e)(2)(B), or restrictions under section 587O; (B) the test developer does not identify any new risks for the test kit or test protocol when using the new instrument; (C) the test developer validates the use of the new instrument with the test kit or test protocol and maintains validation documentation; (D) the test kit or test protocol is not intended for use— (i) at the point of care setting or in settings for which a certificate of waiver is in effect under section 353 of the Public Health Service Act; (ii) without a prescription; (iii) at home; or (iv) in testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products; (E) the test developer makes the documentation described under subparagraph (C) available to the Secretary upon request; and (F) the test developer updates the listing information for the test kit or test protocol, as applicable. (d) Amendments to an application An applicant shall amend an application submitted under subsection (a), (b), or (f) if the applicant becomes aware of information that could reasonably affect an evaluation under subsection (e) of whether the approval standard has been met. (e) Action on an application for premarket approval (1) Review (A) Disposition As promptly as possible, but not later than 90 calendar days after an application under subsection (a) is accepted for submission (unless the Secretary determines that an extension is necessary to review one or more major amendments to the application), or not later than 60 calendar days after an application under subsection (b) is accepted for submission or a supplemental application under subsection (f) is accepted for submission, the Secretary, after considering any applicable report and recommendations pursuant to advisory committees under section 587H, shall issue an order approving the application, unless the Secretary finds that the grounds for approval in paragraph (2) are not met. (B) Reliance on proposed labeling In determining whether to approve or deny an application under paragraph (1), the Secretary shall rely on the indications for use included in the proposed labeling, provided that such labeling is not false or misleading based on a fair evaluation of all material facts. (2) Approval of an application (A) In general The Secretary shall approve an application submitted under subsection (a) or (b) with respect to an in vitro clinical test if the Secretary finds that the applicable standard is met, and— (i) the applicant is in compliance with applicable quality requirements in section 587K; (ii) the application does not contain a false statement or misrepresentation of material fact; (iii) based on a fair evaluation of all material facts, the proposed labeling is truthful and non-misleading and complies with the requirements of section 587L; (iv) the applicant permits, if requested, authorized employees of the Food and Drug Administration and persons accredited under section 587Q an opportunity to inspect pursuant to section 704; (v) the test conforms with any applicable performance standards required under section 587R and any applicable mitigating measures under section 587E; (vi) all nonclinical laboratory studies and clinical investigations involving human subjects that are described in the application were conducted in a manner that meets the applicable requirements of this subchapter; and (vii) other data and information the Secretary may require under subsection (a)(2)(K) support approval. (B) Conditions of approval An order approving an application pursuant to this section may require reasonable conditions of approval for the in vitro clinical test, which may include conformance with applicable mitigating measures under section 587E, restrictions under section 587O, and performance standards under section 587R. (C) Publication The Secretary shall publish an order for each application approved pursuant to this paragraph on the public website of the Food and Drug Administration and make publicly available a summary of the data used to approve such application, except to the extent the Secretary determines that such order— (i) contains commercially confidential or trade secret information; or (ii) if published, would present a risk to national security. (3) Review of denials An applicant whose application submitted under this section has been denied approval under this subsection may, by petition filed not more than 60 calendar days after the date on which the applicant receives notice of such denial, obtain review of the denial in accordance with section 587P. (f) Supplements to an approved application (1) Risk analysis Prior to implementing any modification to an in vitro clinical test, the holder of the application approved under subsection (a) or (b) for such test shall perform risk analyses in accordance with this subsection, unless such modification is included in the change protocol submitted by the applicant and approved under this section or exempt under section 587C. (2) Supplement requirement (A) In general If the holder of an application of an approved in vitro clinical test makes a modification to such in vitro clinical test, except as provided in subparagraph (C), or otherwise specified by the Secretary, the holder of the application approved under subsection (e) for an in vitro clinical test shall submit a supplemental application to the Secretary. The holder of the application may not implement such modification to the in vitro clinical test until such supplemental application is approved. The information required in a supplemental application is limited to what is needed to support the change. (B) Adjustments to change protocol The holder of an approved application may submit under this paragraph a supplemental application to modify the change protocol of the test at any time after the application is submitted under subsection (a) or (b). (C) Exceptions Notwithstanding subparagraphs (A) and (B), and so long as the holder of an approved application submitted under subsection (a) or (b) for an in vitro clinical test does not add a manufacturing site, or change activities at an existing manufacturing site, with respect to the test, the holder of an approved application may, without submission of a supplemental application, implement the following modifications to the test: (i) Modifications in accordance with an approved change protocol under subsection (a)(3)(H). (ii) Modifications that are exempt under section 587C(b). (iii) Labeling changes that are appropriate to address a safety concern, except such labeling changes that include any of the following, remain subject to subparagraph (A): (I) A change to the indications for use of the test. (II) A change to the performance claims made with respect to the test. (III) A change that adversely affects performance of the test. (D) Reporting for certain modifications made pursuant to a change protocol The holder of an application approved under subsection (e), with an approved change protocol under subsection (a)(2)(H) for such in vitro clinical test shall— (i) report any modification to such test made pursuant to such change protocol approved under subsection (a)(2)(H) in a submission under section 587J(c)(2)(B); and (ii) include in such report— (I) a description of the modification; (II) the rationale for implementing such modification; and (III) as applicable, a summary of the evidence supporting that the test, as modified, meets the applicable standard, complies with performance standards required under section 587Q, and complies with any mitigating measures established under section 587E and any restrictions under section 587O. (E) Reporting for certain safety related labeling changes The holder of the application for an in vitro clinical test approved under subsection (a) or (b) pursuant to subsection (e) shall— (i) report to the Secretary any modification to the test described in subparagraph (C)(iii) not more than 30 days after the date on which the test, with the modifications, is introduced into interstate commerce; and (ii) include in the report— (I) a description of the change or changes; (II) the rationale for implementing such change or changes; and (III) a description of how the change or changes were evaluated. (3) Contents of supplement Unless otherwise specified by the Secretary, a supplement under this subsection shall include— (A) for modifications other than manufacturing site changes requiring a supplement— (i) a description of the modification; (ii) data relevant to the modification to demonstrate that the applicable standard is met, not to exceed data requirements for the original submission; (iii) acceptance criteria; and (iv) any revised labeling; and (B) for manufacturing site changes— (i) the information listed in subparagraph (A); and (ii) information regarding the methods used in, or the facilities or controls used for, the development of the test to demonstrate compliance with the applicable quality requirements under section 587K. (4) Additional data The Secretary may require, when necessary, data to evaluate a modification to an in vitro clinical test that is in addition to the data otherwise required under the preceding paragraphs if the data request is in accordance with the least burdensome requirements under section 587AA(c). (5) Conditions of approval In an order approving a supplement under this subsection, the Secretary may require conditions of approval for the in vitro clinical test, including compliance with restrictions under section 587O and conformance to performance standards under section 587R. (6) Approval The Secretary shall approve a supplement under this subsection if— (A) the data demonstrate that the modified in vitro clinical test meets the applicable standard; and (B) the holder of the application approved under subsection (e) for the test has demonstrated compliance with applicable quality and inspection requirements, as applicable and appropriate. (7) Publication The Secretary shall publish on the public website of the Food and Drug Administration notice of any order approving a supplement under this subsection, except that such publication shall exclude— (A) commercial confidential or trade secret information; and (B) any other information that the Secretary determines to relate to national security or countermeasures or to be restricted from disclosure pursuant to another provision of law. (8) Review of denial An applicant whose supplement under this subsection has been denied approval may, by petition filed on or before the 60th calendar day after the date upon which the applicant receives notice of such denial, obtain review of the denial in accordance with section 587P. (g) Withdrawal and temporary suspension of approval (1) Order withdrawing approval (A) In general The Secretary may, after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section, issue an order withdrawing approval of the application if the Secretary finds that— (i) the grounds for approval under subsection (e) are no longer met; (ii) there is a reasonable likelihood that the test would cause death or serious adverse health consequences, including by causing the absence, significant delay, or discontinuation of life-saving or life sustaining medical treatment; (iii) the holder of the approved application— (I) has failed to, or repeatedly or deliberately failed to, maintain records to make reports, as required under section 587M; (II) has refused to permit access to, or copying or verification of such records, as required under section 704; (III) has not complied with the requirements of section 587K; or (IV) has not complied with any mitigating measure required under section 587E or restriction under section 587O; or (iv) the labeling of such in vitro clinical test, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact. (B) Content An order under subparagraph (A) withdrawing approval of an application shall state each ground for withdrawal and shall notify the holder of such application 60 calendar days prior to issuing such order. (C) Publication The Secretary shall publish any order under subparagraph (A) on the public website of the Food and Drug Administration, except that such publication shall exclude— (i) commercial confidential or trade secret information; and (ii) any other information that the Secretary determines, if published, would present a risk to national security. (2) Order of temporary suspension If, after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section, the Secretary determines, based on scientific evidence, that there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences, such as by causing the absence, significant delay, or discontinuation of life-saving or life-sustaining medical treatment, the Secretary shall, by order, temporarily suspend the approval of the application. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw approval of such application. (3) Appeal withdrawing approval and orders of temporary suspensions An order of withdrawal or an order of temporary suspension may be appealed under 587P. 587C. Exemptions (a) In general The following in vitro clinical tests are exempt from premarket review under section 587B, and may be lawfully marketed subject to other applicable requirements of this Act: (1) Tests exempt from section 510(k) (A) Exemption An in vitro clinical test is exempt from premarket review under section 587B and may be lawfully marketed subject to the other applicable requirements of this Act, if the developer of the in vitro clinical test— (i) maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in subparagraph (B); and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as specified in subparagraph (A) if such test— (i) (I) was offered for clinical use prior to the date of enactment of the VALID Act of 2022 ; (II) immediately prior to such date of enactment was exempt pursuant to subsection (l) or (m)(2) of section 510 from the requirements for submission of a report under section 510(k); or (III) (aa) was not offered for clinical use prior to such date of enactment; (bb) is not an instrument; and (cc) falls within a category of tests that was exempt from the requirements for submission of a report under section 510(k) as of such date of enactment (including class II devices and excluding class I devices described in section 510(l)); (ii) meets the applicable standard as described in section 587(2); (iii) is not offered with labeling and advertising that is false or misleading; and (iv) is not likely to cause or contribute to serious adverse health consequences. (C) Effect on special controls For any in vitro clinical test, or category of in vitro clinical tests, that is exempt from premarket review based on the criteria in subparagraph (B), any special control that applied to a device within a predecessor category immediately prior to the date of enactment of the VALID Act of 2022 shall be deemed a mitigating measure applicable under section 587E to an in vitro clinical test within the successor category, except to the extent such mitigating measure is withdrawn or changed in accordance with section 587E. (D) Near-patient testing Not later than 1 year after the date of enactment of the VALID Act of 2022 , the Secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section 587B when offered for near-patient testing (point of care), which were not exempt from submission of a report under section 510(k) pursuant to subsection (l) or (m)(2) of section 510 and regulations imposing limitations on exemption for in vitro devices intended for near-patient testing (point of care). (2) Low-risk tests (A) Exemption An in vitro clinical test is exempt from premarket review under section 587B and may be lawfully marketed subject to the other applicable requirements of this Act, including section 587J(b)(6), if such test meets the definition of low-risk under section 587 and if the developer of the test— (i) maintains documentation demonstrating that the in vitro clinical test meets and continues to meet the criteria set forth in paragraph (2); and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as specified in subparagraph (A) if— (i) the in vitro clinical test meets the applicable standard as described in 587(2); (ii) the labeling and advertising are not false or misleading; (iii) the in vitro clinical test is not likely to cause or contribute to serious adverse health consequences; and (iv) the in vitro clinical test is listed pursuant to section 587J or falls within a category of tests listed as described in subparagraph (C). (C) List of low-risk tests (i) In general The Secretary shall maintain, and make publicly available on the website of the Food and Drug Administration, a list of in vitro clinical tests, and categories of in vitro clinical tests, that are low-risk in vitro clinical tests for purposes of the exemption under this paragraph. (ii) Inclusion The list under clause (i) shall consist of— (I) all in vitro clinical tests and categories of in vitro clinical tests that are exempt from premarket review pursuant to subsection (d)(1) or (d)(3); and (II) all in vitro clinical tests and categories of in vitro clinical tests that are designated by the Secretary pursuant to subparagraph (C) as low-risk for purposes of this paragraph. (D) Designation of tests and categories Without regard to subchapter II of chapter 5 of title 5, United States Code, the Secretary may designate, in addition to the tests and categories described in subparagraph (C)(i), additional in vitro clinical tests, and categories of in vitro clinical tests, as low-risk in vitro clinical tests for purposes of the exemption under this paragraph. The Secretary may make such a designation on the Secretary’s own initiative or in response to a request by a developer pursuant to subsection (a) or (b) of section 587F. In making such a designation for a test or category of tests, the Secretary shall consider— (i) whether the test, or category of tests, is low-risk; (ii) the existence of and ability to develop mitigating measures sufficient for such test category to meet the low-risk standard; and (iii) such other factors as the Secretary determines to be appropriate for the protection of the public health. (3) Humanitarian test exemption (A) In general An in vitro clinical test that meets the criteria under subparagraph (B) is exempt from premarket review under section 587B and may be lawfully offered subject to the other applicable requirements of this subchapter, if the developer of the test— (i) maintains documentation (which may include literature citations in specialized medical journals, textbooks, specialized medical society proceedings, and governmental statistics publications, or, if no such studies or literature citations exist, credible conclusions from appropriate research or surveys) demonstrating that such test meets and continues to meet the criteria described in this subsection; and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as described in subparagraph (A) if— (i) the in vitro clinical test is intended by the developer for use for a diagnostic purpose for a disease or condition that affects not more than 10,000 (or such other higher number determined by the Secretary) individuals in the United States per year; and (ii) the in vitro clinical test meets the applicable standard described in section 587(2); (iii) the labeling and advertising for the in vitro clinical test are not false or misleading; (iv) the in vitro clinical test is not likely to cause or contribute to serious health consequences; and (v) the in vitro clinical test is not intended for screening. (C) Exception for certain tests An in vitro clinical test intended to inform the use of a specific individual or specific type of biological product, drug, or device shall be eligible for an exemption from premarket review under this subsection only if, the developer submits a request under subsection (m) for informal feedback and the Secretary determines that such in vitro clinical test is eligible for an exemption from premarket review under this subsection. (4) Custom tests and low-Volume tests An in vitro clinical test is exempt from premarket review under section 587B, quality requirements under section 587K, and listing requirements under section 587J, and may be lawfully marketed subject to the other applicable requirements of this Act, if— (A) such in vitro clinical test— (i) is a test protocol performed for not more than 5 patients per year (or such other higher number determined by the Secretary), in a laboratory certified by the Secretary under section 353 of the Public Health Service Act that— (I) meets the requirements to perform tests of high-complexity in which the test protocol was developed; or (II) meets the requirements to perform tests of high-complexity within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which such test protocol was developed; or (ii) is an in vitro clinical test developed or modified to diagnose a unique pathology or physical condition of a specific patient or patients, upon order of a health professional or other specially qualified person designated under regulations, for which no other in vitro clinical test is commercially available in the United States, and is— (I) not intended for use with respect to more than 5 (or such other higher number determined by the Secretary) other patients; and (II) after the development of such test, not included in any test menu or template test report or other promotional materials, and is not otherwise advertised; and (B) the developer of the in vitro clinical test— (i) maintains documentation demonstrating that such test meets the applicable criteria described in subparagraph (A); (ii) makes such documentation, such as a prescription order requesting the custom test for an individual patient, available to the Secretary upon request; and (iii) informs the Secretary, on an annual basis, in a manner prescribed by the Secretary by guidance, that such test was offered. (5) In vitro clinical tests under a technology certification order An in vitro clinical test that is within the scope of a technology certification order, as described in section 587D(a), is exempt from premarket review under section 587B. . (6) Modified tests (A) In general An in vitro clinical test that is modified is exempt from premarket review under section 587B if— (i) (I) the modification is made by— (aa) the developer that obtained premarket approval for the unmodified version of the test under section 587B; or (bb) a clinical laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements for performing high complexity testing, to a lawfully offered in vitro clinical test, including another developer’s lawfully offered in vitro clinical test, excluding investigational in vitro clinical tests offered under section 587S, and the modified test is performed— (AA) in the same clinical laboratory in which it was developed for which a certification is still in effect under section 353 that meets the requirements to perform tests of high complexity; (BB) by another clinical laboratory for which a certificate is in effect under section 353 that meets the requirements to perform tests of high complexity, is within the same corporate organization, and has common ownership by the same parent corporation as the laboratory in which the test was developed; or (CC) by a clinical laboratory for which a certificate is in effect under section 353 that meets the requirements to perform tests of high complexity and is within a public health laboratory network coordinated [or managed] by the Centers for Disease Control and Prevention, if the test was developed by the Centers for Disease Control and Prevention or another laboratory within such public health laboratory network; or (II) the modification does not— (aa) constitute a significant change to the indications for use; (bb) cause the test to no longer comply with applicable mitigating measures under section 587E or restrictions under section 587O; (cc) significantly change performance claims or significantly and adversely change performance, unless provided for under an approved change protocol under section 587(a)(2)(H); or (dd) constitute an adverse change in the safety of the in vitro clinical test for individuals who come in contact with the in vitro clinical test; (ii) the test meets the applicable standard as described in section 587(2); (iii) the labeling and advertising are not false or misleading; and (iv) the test is not likely to cause or contribute to serious adverse health consequences. (B) Certain modifications A modification to extend specimen stability is exempt from premarket review under section 587B if the modified test meets the requirements in clauses (iii) through (v) of subparagraph (A). (C) Modifications under a change protocol Notwithstanding subparagraph (A), a modification made under a change protocol pursuant to subsection (a)(2)(H) of section 587B is exempt from review under such section. (D) Documentation A person who modifies an in vitro clinical test in a manner that is a modification described in subparagraph (A) shall— (i) document the modification that was made and the basis for determining that the modification, considering the changes individually and collectively, is a type of modification described in subparagraph (A), (B), or (C); and (ii) provide such documentation to the Secretary upon request or inspection. (E) Guidance Not later than 30 months after the date of enactment of the VALID Act of 2022 , the Secretary shall issue guidance regarding the in vitro clinical tests that are modified and exempt from premarket review under section 587B pursuant to this paragraph. (b) Manual tests (1) Exemption An in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct, manual observation, without the use of automated instrumentation or software for intermediate or final interpretation, by a qualified laboratory professional, and such in vitro clinical test— (A) is designed, developed, and used within a single clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing; (B) is not a specimen receptacle, instrument, or an in vitro clinical test that includes an instrument or specimen receptacle that is not approved under or exempt from section 587B; (C) is not a high-risk test, or is a high-risk test that the Secretary has determined meets at least one condition in paragraph (2) and is otherwise appropriate for this exemption; and (D) is not intended for testing donors, donations, or recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products. (2) High-risk test limitation or condition A high-risk test may be exempt under paragraph (1) from the requirements of this subchapter only if— (A) no component or part of such test, including any reagent, is introduced into interstate commerce under the exemption under paragraph (5), and any article for taking or deriving specimens from the human body used in conjunction with the test remains subject to the requirements of this subchapter; or (B) the test has been developed in accordance with the applicable test design and quality requirements under section 587J. (c) Public health surveillance activities (1) In general The provisions of this subchapter shall not apply to a test intended by the developer to be used solely for public health surveillance activities. (2) Exclusion An in vitro clinical test used for public health surveillance activities is not excluded from the provisions of this subchapter pursuant to this subsection if such test is intended for use in making clinical decisions for individual patients. (d) General laboratory equipment Any instrument that does not produce an analytical result, and that functions as a component of pre-analytical procedures related to in vitro clinical tests, is not subject to the requirements of this subchapter, provided that the instrument is operating in a clinical laboratory that is certified under section 353 of the Public Health Service Act. (e) Components and Parts (1) In general Subject to paragraph (2), a component or part described in section 201(ss)(2)(E) is— (A) exempt from the requirements of this subchapter if it is intended for further development as described in paragraph (3); or (B) subject to the requirements of this subchapter and regulated based on its risk when used as intended by the developer, notwithstanding its subsequent use by a developer as a component, part, or raw material of another in vitro clinical test. (2) Inapplicability to other tests Notwithstanding paragraph (1), an in vitro clinical test that is described in section 201(ss)(1)(B) and that uses a component or part described in such subparagraph shall be subject to the requirements of this subchapter, unless the test is otherwise exempt under this section. (3) Further development A component, part, or raw material (as described in paragraph (1)) is intended for further development (for purposes of such paragraph) if— (A) it is intended solely for use in the development of another in vitro clinical test; and (B) in the case of such a test that is introduced or delivered for introduction into interstate commerce after the date of enactment of the VALID Act of 2022 , the labeling of such test bears the following statement: This product is intended solely for further development of an in vitro clinical test and is exempt from FDA regulation. This product must be evaluated by the in vitro clinical test developer if it is used with or in the development of an in vitro clinical test. . (f) General exemption authority The Secretary may, by order published in the Federal Register following notice and an opportunity for comment, exempt a class of persons from any section under this subchapter upon a finding that such exemption is appropriate for the protection of the public health and other relevant considerations. (g) Exemption An in vitro clinical test that is intended solely for use in forensic analysis or law enforcement activity is exempt from the requirements of this subchapter. An in vitro clinical test that is intended for use in making clinical decisions for individual patients, or whose individually identifiable results may be reported back to an individual patient or the patient’s health care provider, even if also intended for forensic analysis or law enforcement purposes, is not intended solely for forensic analysis or law enforcement for purposes of this subsection. (h) Revocation (1) In general The Secretary may revoke any exemption with respect to in vitro clinical tests with the same indications for use if new clinical information indicates that the exemption of an in vitro clinical test or tests from premarket review under section 587B has a reasonable probability of severe adverse health consequences, including the absence, delay, or discontinuation of appropriate medical treatment. (2) Process Any action under paragraph (1) shall be made by publication of a notice of such proposed action on the website of the Food and Drug Administration, the consideration of comments to a public docket on such proposal, and publication of a final action on such website within 60 calendar days of the close of the comment period posted to such public docket, notwithstanding subchapter II of chapter 5 of title 5, United States Code. (i) Pre-Analytical instrument A pre-analytical instrument is exempt from premarket review under section 587B and may be lawfully offered subject to the other applicable requirements of this Act, if either of the following applies: (1) Such instrument provides additional information regarding the sample or performs an action on the sample but is not preparing or processing the sample and does not perform any function of an analytical instrument. Such types of pre-analytical instruments include barcode readers, sample movers, and sample identifiers. (2) Such instrument processes or prepares the sample prior to use on an analytical instrument, does not perform any function of an analytical instrument, and does not select, isolate, or prepare a part of a sample based on specific properties. Such types of pre-analytical instruments may include sample mixers, DNA extractors and those used to dilute samples. 587D. Technology certification (a) Definitions In this section: (1) Eligible in vitro clinical test The term eligible in vitro clinical test means an in vitro clinical test that is not— (A) a component or part of an in vitro clinical test as described in section 201(ss)(2)(E); (B) an instrument under section 201(ss)(2)(B) or an in vitro clinical test that includes an instrument that is not approved under, or exempt from, section 587B; (C) a specimen receptacle under section 201(ss)(2)(C) or an in vitro clinical test that includes a specimen receptacle that is not approved under, or exempt from, section 587B; (D) an in vitro clinical test, including reagents used in such tests, intended for use for testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products; (E) high-risk; (F) a combination product unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section 587F, or as described in subsection (k); or (G) a first-of-a-kind in vitro clinical test, unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section 587F, or as described in subsection (k). (2) Eligible person The term eligible person means an in vitro clinical test developer unless such developer— (A) is a laboratory subject to section 353 of the Public Health Service Act and does not have in effect a certificate applicable to the category of laboratory examination or other procedure; (B) was a laboratory, or an owner or operator or any employee of a laboratory, found to have committed a significant violation of section 353 of the Public Health Service Act that resulted in a suspended, revoked, or limited certificate within the 2-year period preceding the date of the submission of the application for a technology certificate under subsection (c) and such violation has not been resolved; or (C) has been found to have submitted information to the Secretary, or otherwise disseminated information, that— (i) made false or misleading statements relevant to the requirements of this subchapter; or (ii) violated any requirement of this Act, where such violation exposed individuals to serious risk of illness, injury, or death, unless— (I) such violation has been resolved; or (II) such violation is not pertinent to any in vitro clinical test within the scope of the technology certification that such developer seeks. (b) Applicability (1) In general An in vitro clinical test is not subject to section 587B and may be introduced into interstate commerce if the in vitro clinical test— (A) is an eligible in vitro clinical test; (B) is developed by an eligible person; (C) falls within the scope of a technology certification order issued under this section and that is in effect; (D) complies with the conditions of the technology certification order, including with applicable mitigating measures under section 587E, restrictions under section 587O, and performance standards under section 587R; and (E) meets the applicable standard described in section 587(2). (2) Scope (A) In general Subject to subparagraph (B), the scope of a technology certification order issued under this section shall apply to multiple in vitro clinical tests utilizing the technology do not significantly differ in control mechanisms, energy sources, or operating principles and for which development, including design, and analytical and clinical validation, of the in vitro clinical tests would be addressed through similar procedures, and be no broader than— (i) a single technology type; or (ii) a fixed combination of technologies. (B) Technology type A technology type described in this paragraph may include clot detection, colorimetric (non-immunoassay), electrochemical (non-immunoassay), enzymatic (non-immunoassay), flow cytometry, fluorometry (non-immunoassay), immunoassay, mass spectrometry or chromatography, microbial culture, next generation sequencing, nephlometric or turbidimetric (non-immunoassay), singleplex or multiplex non-NGS nucleic acid analysis, slide-based technology, spectroscopy, and any other technology, as the Secretary determines appropriate. (c) Application for technology certification (1) In general A developer seeking a technology certification order shall submit an application under this subsection, which shall contain the information specified under paragraph (2). (2) Content of application A developer that submits an application for a technology certification shall include all necessary information to make a showing that all eligible in vitro clinical tests developed within the scope of the technology certification order will meet the applicable standard, including— (A) the name and address of the developer; (B) a table of contents for the application and the identification of the information the developer claims as trade secret or confidential commercial or financial information; (C) the signature of the individual filing the application or an authorized representative; (D) a statement identifying the scope of the proposed technology certification intended to be introduced into interstate commerce under the application; (E) information establishing that the developer submitting the application is an eligible person; (F) quality procedures showing that eligible in vitro clinical tests covered under the technology certification will conform to the applicable quality requirements of section 587K with respect to— (i) design controls, including related purchasing controls and acceptance activities; (ii) complaint investigation, adverse event reporting, and corrections and removals; and (iii) process validation, as applicable; (G) procedures for analytical and clinical validation, including all procedures for validation, verification, and acceptance criteria, and an explanation as to how such procedures, when used, provide a showing of analytical validity of eligible in vitro clinical tests within the proposed scope of the technology certification order that is analytically and clinically valid; (H) procedures that provide a showing that in vitro clinical tests covered by the proposed scope of the technology certification order will be safe for individuals who come into contact with in vitro clinical tests covered by such order; (I) a proposed listing submission under section 587J(b) for in vitro clinical tests that the developer intends to introduce into interstate commerce upon receiving a technology certification order, which shall not be construed to limit the developer from introducing additional tests not included in such submission under the same technology certification order; (J) information concerning one or more representative in vitro clinical tests, including— (i) a test within the scope of the technology certification application with the appropriate analytical complexity at the time of the submission of the application under this section to serve as the representative test and validate and run within the developer’s stated scope; (ii) the information specified in subsection (a) or (b) of section 587B, as applicable, for the representative in vitro clinical test or tests, including information and data required pursuant to subsection (a)(2)(G) of section 587B, unless the Secretary determines that such information is not necessary; (iii) a summary of a risk assessment of the in vitro clinical test; (iv) an explanation of the choice of the representative in vitro clinical test or tests for the technology certification application and how such test adequately demonstrates the range of procedures that the developer includes in the application under subparagraphs (F), (G), (H), and (I); and (v) a brief explanation of the ways in which the procedures included in the application under subparagraphs (F), (G), (H), and (I) have been applied to the representative in vitro clinical test or tests; and (K) such other information necessary to make a determination on a technology certification application as the Secretary may determine necessary. (3) Reference to existing applications With respect to the content requirements in the technology certification application described in paragraph (2), a developer may incorporate by reference any content of an application previously submitted by the developer. (d) Action on an application for technology certification (1) Secretary response (A) In general As promptly as practicable, and not later than 90 days after receipt of an application under subsection (c), the Secretary shall— (i) issue a technology certification order granting the application, which shall specify the scope of the technology certification, if the Secretary finds that all of the grounds in paragraph (3) are met; or (ii) deny the application if the Secretary finds (and sets forth the basis of such finding as part of or accompanying such denial) that one or more grounds for granting the application specified in paragraph (3) are not met. (B) Extension The timeline described in subparagraph (A) may be extended by mutual agreement between the Secretary and the applicant. (2) Deficient applications (A) In general If, after receipt of an application under this section, the Secretary determines that any portion of such application is deficient, the Secretary, not later than 60 days after receipt of such application, shall provide to the applicant a description of such deficiencies and identify the information required to resolve such deficiencies. (B) Converting to premarket applications When responding to the deficiency letter, the developer may convert the application for technology certification under subsection (c) into a premarket application under section 587B. (3) Technology certification order The Secretary shall issue an order granting a technology certification under this section if, on the basis of the information submitted to the Secretary as part of the application and any other information with respect to such applicant, the Secretary finds that— (A) there is a showing that in vitro clinical tests within the scope of the technology certification order will meet the applicable standard; (B) the methods used in, and the facilities or controls used for, the development of eligible in vitro clinical tests covered by the proposed scope of the technology certification conform to the applicable requirements of section 587K with respect to— (i) design controls, including related purchasing controls and acceptance activities; (ii) complaint investigation, adverse event reporting, and corrections and removals; and (iii) process validation, as applicable; (C) based on a fair evaluation of all material facts, the applicant’s proposed labeling and advertising are not false or misleading in any particular; (D) the application does not contain a false statement of material fact; (E) there is a showing that the representative in vitro clinical test or tests— (i) meet the applicable standard; and (ii) reasonably represent the range of procedures required to be submitted in the application; (F) the applicant has agreed to permit, upon request, authorized employees of the Food and Drug Administration or persons accredited, or recognized under this Act, an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment, finished and unfinished materials, containers, and labeling therein, including all things (including records, files, papers, and controls) bearing on whether an in vitro clinical test is adulterated, misbranded, or otherwise in violation of this Act, and permits such authorized employees or persons accredited under this Act to view and to copy and verify all records pertinent to the application and the in vitro clinical test; and (G) based on other data and information the Secretary may require under subsection (c)(2)(K), the Secretary finds that such data and information support granting a technology certification order. (4) Review of denials An applicant whose application has been denied under this subsection may obtain review of such denial under section 587P. (e) Supplements (1) Supplemental applications (A) In general With respect to any of the following changes related to an in vitro clinical test under a technology certification order, a supplemental application to a technology certification order shall be submitted by the holder of the technology certification order describing such proposed changes, prior to introducing the in vitro clinical test that is the subject of the technology certification order into interstate commerce— (i) any significant change to the procedures provided in support of the application for technology certification submitted under subparagraph (G) or (H) of subsection (c)(2); or (ii) any significant change to the procedures provided in support of the application for technology certification submitted under subparagraph (F) of subsection (c)(2). (B) Secretary action on supplemental applications Any action by the Secretary on a supplemental application shall be in accordance with subsection (d), and any order resulting from such supplement shall be treated as an amendment to a technology certification order. (2) Content of application (A) In general A supplemental application for a change to an in vitro clinical test under a technology certification order shall— (i) contain all necessary information to make a showing that any in vitro clinical test affected by such change that is within the scope of the technology certification order will meet the applicable standard; and (ii) be limited to such information that is needed to support the change. (B) Content Unless otherwise specified by the Secretary, a supplemental application under this subsection shall include— (i) a description of the change, including a rationale for implementing such change; (ii) a description of how the change was evaluated; (iii) data from a representative in vitro clinical test or tests that supports a showing that, in using the modified procedure or procedures, all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard; (iv) as applicable, information to demonstrate that the modified procedure or procedures submitted under subsection (c)(2)(F) continue to conform to applicable requirements under section 587K; and (v) any other information requested by the Secretary. (3) Changes in response to a public health risk (A) In general If the holder of a technology certification makes a change to an in vitro clinical test or tests to address a potential risk to public health by adding a new specification or test method, such holder may immediately implement such change and shall submit a notification for such change to the Secretary within 30 days. (B) Content Any notification to the Secretary under this paragraph shall include— (i) a summary of the relevant change; (ii) the rationale for implementing such change; (iii) (I) if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order, the modified procedures; or (II) if the procedures were not changed, an explanation as to why they were not changed; and (iv) if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order, data from a representative in vitro clinical test or tests that support a showing that, in using the modified procedures, all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard. (f) Temporary hold (1) In general Subject to the process specified in paragraph (2), and based on one or more findings under paragraph (4), the Secretary may issue a temporary hold prohibiting any holder of a technology certification order issued under this section from introducing into interstate commerce an in vitro clinical test that was not previously the subject of a listing under section 587J. The temporary hold shall identify the grounds for the temporary hold under paragraph (4) and the rationale for such finding. (2) Process for issuing a temporary hold If the Secretary makes a finding that a temporary hold may be warranted based on one or more grounds specified in paragraph (4), the Secretary shall promptly notify the holder of the technology certification order of such finding and provide 30 calendar days for the developer to come into compliance with or otherwise resolve the finding. (3) Written requests Any written request to the Secretary from the holder of a technology certification order that a temporary hold under paragraph (1) be removed shall receive a decision, in writing and specifying the reasons therefore, within 90 days after receipt of such request. Any such request shall include information to support the removal of the temporary hold. (4) Grounds for temporary hold The Secretary may initiate a temporary hold under this subsection upon a finding that the holder of a technology certification order— (A) is not in compliance with the conditions of the technology certification order pursuant to subsection (b)(1)(D); (B) offers one or more in vitro clinical tests with advertising or labeling that is false or misleading; (C) has reported a correction or removal of an in vitro clinical test that is offered under a technology certification order under this section and has failed to demonstrate that the issue or issues causing the correction or removal does not adversely impact the ability of other in vitro clinical tests offered under the same technology certification order to meet the applicable standard; or (D) has introduced into interstate commerce an in vitro clinical test under a technology certification order and such test is adulterated or misbranded, based on a determination by the Secretary, and has failed to demonstrate that the issue or issues causing the adulteration or misbranding does not adversely impact the ability of other in vitro clinical tests offered under the same technology certification granted under this section to meet the applicable standard. (g) Withdrawal The Secretary may, after due notice and opportunity for an informal hearing, issue an order withdrawing a technology certification order including all tests introduced into interstate commerce under the technology certification order if the Secretary finds that— (1) the application, supplement, or report under subsection (h) contains false or misleading information or fails to reveal a material fact; (2) such holder fails to correct false or misleading labeling or advertising upon the request of the Secretary; (3) in connection with a technology certification, the holder provides false or misleading information to the Secretary; or (4) the holder of such technology certification order fails to correct the grounds for a temporary hold within a timeframe specified in the temporary hold order. (h) Reports to Congress (1) In general Not later than 1 year after the effective date of the VALID Act of 2022 , and annually thereafter for the next 4 years, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the website of the Food and Drug Administration, a report containing the information described in paragraph (2). (2) Content (A) In general Each report under paragraph (1) shall address, at a minimum— (i) the total number of applications for technology certifications filed, granted, withdrawn and denied; (ii) the total number of technology certification orders the Secretary put on temporary hold under subsection (h) and the number of technology certification orders withdrawn under subsection (i); (iii) the types of technologies for which the Secretary granted technology certification orders; (iv) the total number of holders of technology certification orders that are in effect; and (v) the total number of in vitro clinical test categories that required premarket review under section 587B that were redesignated as eligible in vitro clinical tests under this section. (B) Final report The fifth report submitted under paragraph (1) shall include a summary of, and responses to, comments raised in the docket. (C) Performance reports The reports required under this section may be issued with performance reports as required under section 829 of the VALID Act of 2022 . (i) Public meeting and input (1) Public docket Not later than 30 days after the date of enactment of the VALID Act of 2022 , the Secretary shall establish a public docket to receive comments concerning recommendations for implementation of this section, including criteria and procedures for subsections (c) through (h). The public docket shall remain open for at least 1 year after the establishment of the public docket. (2) Public meeting Not later than 180 days after the date of enactment of the VALID Act of 2022 , the Secretary shall convene a public meeting to which stakeholders from organizations representing patients and consumers, academia, and the in vitro clinical test industry are invited to discuss the technology certification process including application requirements, inspections, alignment with third-party accreditors, and the definition of the term technology under section 587. (j) Regulations The Secretary shall issue regulations regarding the technology certification process, including describing criteria or procedures relating to technology certification under this section, which shall be subject to public comment for a minimum of 60 days from issuance prior to finalizing such regulations after considering the comments received. The regulation shall include an outline of the application process, opportunities to meet with officials of the Food and Drug Administration, and plans to streamline inspections. (k) Notification (1) In general Notwithstanding subsection (a)(1), a first-of-a-kind in vitro clinical test or a combination product that meets the definition of a moderate-risk test under section 587A may be introduced into interstate commerce under a technology certification order that has been issued by the Secretary, subject to other applicable requirements if— (A) the developer provides notification to the Secretary 60 days prior to introducing such tests into interstate commerce that includes information demonstrating that the test is moderate-risk and within the scope of the applicable technology certification order; and (B) the Secretary has not issued a notification to the developer under paragraph (2) before such time has elapsed. (2) Notification from Secretary The Secretary shall issue a notification to the developer that such test may not be introduced into interstate commerce under such order if the Secretary determines that— (A) such test— (i) does not meet the definition of a moderate-risk test under section 587A; (ii) is not eligible to be introduced into interstate commerce under the referenced technology certification order issued by the Secretary; or (iii) is not eligible for technology certification under subsection (b)(2); or (B) based on the information included in the notification submitted by the developer pursuant to this subsection, there is insufficient information for the Secretary to make the determinations described in clauses (i), (ii), and (iii) of subparagraph (A). 587E. Mitigating measures (a) Establishment of mitigating measures (1) Establishing, changing, or withdrawing (A) Establishment The Secretary may establish and require, on the basis of evidence, mitigating measures for any in vitro clinical test or category of in vitro clinical tests with the same indications for use that is introduced or delivered for introduction into interstate commerce after the establishment of such mitigating measures. (B) Methods of establishment The Secretary may establish mitigating measures— (i) under the process set forth in subparagraph (D); (ii) as provided under section 587F; or (iii) through a premarket approval or technology certification order, which may establish mitigating measures for an individual in vitro clinical test or a category of in vitro clinical tests. (C) Methods of change or withdrawal The Secretary may change or withdraw mitigating measures— (i) under the process set forth in subparagraph (D); or (ii) as provided under section 587F. (D) Process for establishment, change, or withdrawal Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person— (i) establish, change, or withdraw mitigating measures for an in vitro clinical test or category of in vitro clinical tests by— (I) publishing a proposed order in the Federal Register; (II) providing an opportunity for public comment for a period of not less than 30 60 calendar days; and (III) after consideration of any comments submitted, publishing a final order in the Federal Register that responds to the comments submitted, and which shall include a reasonable transition period. (E) Effect of mitigating measures on grandfathered tests A mitigating measure shall not be required by the Secretary for an in vitro clinical test subject to section 587G(a), unless otherwise provided under section 587F. (2) In vitro clinical tests previously cleared or exempt as devices with special controls (A) In general Any special controls applicable to an in vitro clinical test previously cleared or exempt under section 510(k), or classified under section 513(f)(2) prior to date of enactment of the VALID Act of 2022 , including any such special controls established during the period beginning on the date of enactment of the VALID Act of 2022 and ending on the effective date of such Act (as described in section 5(b) of such Act)— (i) shall continue to apply to such in vitro clinical test after such effective date; and (ii) are deemed to be mitigating measures as of the effective date specified in section 825(a)(1)(A) of the VALID Act of 2022 . (B) Changes Notwithstanding subparagraph (A), the Secretary may establish, change, or withdraw mitigating measures for such tests or category of tests using the procedures under paragraph (1). (b) Documentation (1) In vitro clinical tests subject to premarket review The developer of an in vitro clinical test subject to premarket review under section 587B and to which mitigating measures apply shall— (A) in accordance with section 587B(c)(2)(G)(i), submit documentation to the Secretary as part of the application for the test under subsection (c) or (d) of section 587B demonstrating that such mitigating measures have been met; (B) if such application is approved, maintain documentation demonstrating that such mitigating measures continue to be met following a test modification by the developer; and (C) make such documentation available to the Secretary upon request or inspection. (2) Other tests The developer of an in vitro clinical test that is offered under a technology certification order or other exemption from premarket review under section 587B and to which mitigating measures apply shall— (A) maintain documentation in accordance with the applicable quality requirements under section 587J demonstrating that such mitigating measures continue to be met following a test modification by the developer; (B) make such documentation available to the Secretary upon request or inspection; and (C) include in the performance summary for such test a brief description of how such mitigating measures are met, if applicable. 587F. Regulatory pathway designation (a) Pathway determinations (1) In general After considering available evidence with respect to an in vitro clinical test or category of in vitro clinical tests with the same intended use, including the identification, establishment, and implementation of mitigating measures under section 587E, as appropriate, the Secretary may, upon the initiative of the Secretary or upon request of a developer, determine that— (A) such in vitro clinical test is high-risk and subject to premarket review under section 587B; (B) such in vitro clinical tests, including a first of a kind test, is moderate-risk and subject to abbreviated premarket review under section 587B(d) or technology certification under section 587D(b)(2); or (C) such in vitro clinical test, including a first of a kind test is low-risk or otherwise exempt from premarket review under section 587B. (2) Requests (A) Submissions by developers (i) Special premarket review; technology certification A developer submitting a request that the Secretary make a determination as described in paragraph (1)(B) shall submit information to support that the in vitro clinical test is moderate-risk or propose mitigating measures, if applicable, that would support such a determination. (ii) Low-risk; exempt from premarket review A developer submitting a request that the Secretary make a determination as described in paragraph (1)(C) shall submit information that the in vitro clinical test is low-risk, or otherwise appropriate for exemption from premarket review under section 587B and propose mitigating measures, if applicable, that would support such a determination. (B) Response by the Secretary After receiving a request under clause (i) or (ii) of subparagraph (A), the Secretary shall provide a timely response describing whether or not the Secretary will initiate the process for making a determination under paragraph (1)(B) or (1)(C) as described in paragraph (4). (3) Sufficiency of mitigating measures When determining whether mitigating measures for an in vitro clinical test, or category of in vitro clinical tests, are sufficient to make such test moderate-risk or low-risk, the Secretary shall take into account the following: (A) The degree to which the technology for the intended use of the in vitro clinical test is well-characterized, taking into consideration factors that include one or more of the following: (i) Peer-reviewed literature. (ii) Practice guidelines. (iii) Consensus standards. (iv) Recognized standards of care. (v) Use of such technology, including historical use. (vi) Multiple scientific publications by different authors. (vii) Adoption by the scientific or clinical community. (viii) Real world evidence. (B) Whether the criteria for performance of the test are well-established to be sufficient for the intended use. (C) The clinical circumstances under which the in vitro clinical test is used, including whether the in vitro clinical test is the sole determinate for the diagnosis or treatment of the targeted disease, and the availability of other tests (such as confirmatory or adjunctive tests) or relevant material standards. (D) Whether such mitigating measures sufficiently mitigate the risk of harm such that the test or category of tests is moderate-risk or low-risk. (4) Process (A) In general For a test that is not first-of-a-kind, any action under paragraph (1) shall be made by publication of a notice of such proposed action on the website of the Food and Drug Administration, the consideration of comments to a public docket on such proposal, and publication of a final action on such website within 60 calendar days of the close of the comment period posted to such public docket, notwithstanding subchapter II of chapter 5 of title 5, United States Code. (B) Process for first-of-a-kind test In the case of an in vitro clinical test that is first-of-a-kind, the process is as follows: (i) Any determination that the test is subject to premarket approval or abbreviated premarket review under subparagraph (A) or (B) of paragraph (1) shall be published on the website of the Food and Drug Administration, notwithstanding subclause II of chapter 5 of title 5, United States Code, only after the in vitro clinical test is approved under section 587B. Until that time, the determination shall not be binding on other in vitro clinical tests. (ii) Any determination other than those made under clause (i) shall be made by publication of a notice of final action on the website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 of title 5, United States Code. (b) Transition period Upon a decision by the Secretary to change a regulatory pathway designation, or reclassifies an in vitro clinical test, or category of in vitro clinical tests, the Secretary shall provide an appropriate transition period with respect to any new requirements. (c) Appeals A decision by the Secretary under this section shall be deemed a significant decision subject to appeal under section 587P. (d) Advisory committee The Secretary may request recommendations from an advisory committee under section 587H pursuant to carrying out this section. (e) Request for informal feedback Before submitting a premarket application or technology certification application for an in vitro clinical test— (1) the developer of the test may submit to the Secretary a written request for a meeting, conference, or written feedback to discuss and provide information relating to the regulation of such in vitro clinical test which may include— (A) the submission process and the type and amount of evidence expected to demonstrate the applicable standard; (B) which regulatory pathway is appropriate for an in vitro clinical test; and (C) an investigation plan for an in vitro clinical test, including a clinical protocol; and (2) upon receipt of such a request, the Secretary shall— (A) if a meeting is requested— (i) within 60 calendar days after such receipt, or within such time period as may be agreed to by the developer, meet or confer with the developer submitting the request; and (ii) within 15 calendar days after such meeting or conference, provide to the developer a written record or response describing the issues discussed and conclusions reached in the meeting or conference; and (B) if written feedback is requested, provide feedback to the requestor within 75 days after such receipt. 587G. Grandfathered in vitro clinical tests (a) In general Subject to subsection (d), an in vitro clinical test is exempt from the requirements of this subchapter specified in subsection (b) if— (1) the test was first offered for clinical use before the date of enactment of the VALID Act of 2022 ; (2) the was developed by a clinical laboratory for which a certificate was in effect under section 353 of the Public Health Service Act that meets the requirements for performing tests of high complexity; (3) the test is performed— (A) in the same clinical laboratory in which the test was developed for which a certification is still in effect under section 353 of the Public Health Service Act that meets the requirements to perform tests of high complexity; (B) by another clinical laboratory for which a certificate is in effect under section 353 of such Act that meets the requirements to perform tests of high complexity, and that is within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which the test was developed; or (C) in the case of a test that was developed by the Centers for Disease Control and Prevention or another laboratory a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, by a clinical laboratory for which a certificate is in effect under section 353 of such Act that meets the requirements to perform tests of high complexity, and that is within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; (4) the test does not have in effect an approval under section 515, a clearance under section 510(k), an authorization under section 513(f)(2), or an exemption under section 520(m), or licensure under section 351 of the Public Health Service Act; (5) any modification to the test on or after the date of enactment of the VALID Act of 2022 made by the initial developer and conform with section 587C(a)(6)(A)(ii) and does not meet the criterial in subsection (d)(1); (6) the test is not for investigational use; (7) the test is offered with an order from an authorized person as required under section 353 of the Public Health Service Act, and was offered with a prescription required under section 809.30(f) of title 21, Code of Federal Regulations prior to the effective date of this subchapter; (8) the test is not for use with home specimen collection, unless the specimen is collected with a collection container, receptacle, or kit that— (A) has been approved, cleared, or authorized by the Secretary for home specimen collection and the collection is performed pursuant to the approved, cleared, or authorized labeling, including any indication for use as prescription use or over-the-counter use, or (B) is exempt from premarket review and its use is consistent with applicable limitations on the exemption; (9) is not a specimen receptacle or instrument (10) each test report template for the test bears a statement that reads as follows: This in vitro clinical test has not been reviewed by the Food and Drug Administration. ; and (11) the developer of the test— (A) maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in this subsection; and (B) makes such documentation available to the Secretary upon request. (b) Exemptions applicable to grandfathered tests An in vitro clinical test that meets the criteria specified in subsection (a) is exempt from premarket review under 587B, labeling requirements under 587L, and test design requirements and quality requirements under 587K, and may be lawfully offered subject to the other applicable requirements of this Act. (c) Modifications In the case of an in vitro clinical test that meets the criteria specified in subsection (a), such test continues to qualify for the exemptions described in subsection (b) if the test is modified and the modification is not of a type described in subsection (a)(5), and the person modifying such in vitro clinical test— (1) documents each such modification and maintains documentation of the basis for such determination; (2) provides such documentation relating to the change to the Secretary upon request or inspection; and (3) does not modify the in vitro clinical test such that it no longer meets the criteria under subsection (a). (d) Request for information (1) Criteria The criteria described in this paragraph are any of the following: (A) There is insufficient valid scientific evidence to support that the test is analytically valid or clinically valid. (B) Such in vitro clinical test is being offered by its developer with any false or misleading analytical or clinical claims. (C) It is probable that such in vitro clinical test will cause serious adverse health consequences. (2) Process (A) Written request for information The Secretary may issue a written request to a developer identifying specific scientific concerns, based on credible information, with an in vitro clinical test, which indicate that one or more of the criteria described in paragraph (1) apply to such in vitro clinical tests. Such written request shall include specific information requests pertaining to such criteria. (B) Deadline for submitting information Not later than 45 days after receiving a request for information under subparagraph (A)— (i) the developer of an in vitro clinical test— (I) may seek a teleconference prior to the submission of information under clause (ii) to discuss the Secretary's request; and (II) shall submit the information requested pursuant to subparagraph (A) within 30 days of receipt of such request; and (ii) the Secretary shall— (I) schedule a teleconference requested under clause (i)(I); and (II) hold a teleconference so requested within 10 days of the Secretary's receipt of the information requested under clause (i)(II). (C) Review deadline Upon receiving a submission under subparagraph (B), the Secretary shall— (i) review the submitted information within 45 calendar days of such receipt, which may include communication with the developer; and (ii) determine whether the criteria listed in paragraph (1) apply to the in vitro clinical test and communicate such determination to the developer as described in subparagraph (D). (D) Communication and results of determination The Secretary shall notify the developer, in writing, of the Secretary's determination under subparagraph (C), as follows: (i) If the Secretary determines that none of the criteria listed in paragraph (1) apply to the in vitro clinical test, such test shall be exempt from relevant requirements of this subchapter, as set forth in subsection (b), subject to applicable limitation. (ii) If the Secretary determines that one or more of the criteria listed in subparagraph (1) apply to the test but such a determination may be resolved within a reasonable time, and the test has not been previously subject to this subsection on the basis of the same or substantially similar scientific concerns identified in the written request issued under paragraph (d)(2)(A)— (I) the Secretary shall notify the developer of such a determination and allow the developer to seek a teleconference to discuss the finding; (II) the developer shall submit information demonstrating resolution of the determination within 15 days of receiving the notification; and (III) the Secretary shall make a determination within 30 days of the submission of information as to whether the criteria under paragraph (1) apply to the test. (iii) If the Secretary determines that none of the criteria listed in paragraph (1) apply to the test, such test shall be exempt from relevant requirements of the subchapter as set forth in subsection (b), subject to applicable limitations. (iv) If the Secretary determines that one or more of the criteria listed in paragraph (1) apply to the in vitro clinical test, such test is not exempt as set forth in this section and shall not be offered unless approved under section 587B, offered under a technology certification order under section 587D, or offered as a low-risk test. upon a determination by the Secretary pursuant to section 587F. (v) If the Secretary determines that one or more of the criteria listed in paragraph (1) apply to the in vitro clinical test and clause (ii) does not apply, the in vitro clinical test is not exempt as set forth in section and shall not be offered unless approved under section 587B, offered under a technology certification order under section 587D, or offered as a low-risk test upon a determination by the Secretary pursuant to section 587F. 587H. Advisory committees (a) In general The Secretary may establish advisory committees or use advisory committee panels of experts established before the date of enactment of the VALID Act of 2022 (including a device classification panel under section 513) for the purposes of providing expert scientific advice and making recommendations related to— (1) the approval of an application for an in vitro clinical test submitted under this subchapter, including for evaluating, as applicable, the analytical validity, clinical validity, and safety of in vitro clinical tests; (2) the potential effectiveness of mitigating measures for a determination of the applicable regulatory pathway under section 587F(b) or risk evaluation for an in vitro clinical test or tests; (3) quality requirements under section 587K or applying such requirements to in vitro clinical tests developed or imported by developers; (4) appeals under section 587P; or (5) such other purposes as the Secretary determines appropriate. (b) Appointments (1) Voting members The Secretary shall appoint to each committee established under subsection (a), as voting members, individuals who are qualified by training and experience to evaluate in vitro clinical tests referred to the committee for the purposes specified in subsection (a), including individuals with, to the extent feasible, scientific expertise in the development of such in vitro clinical tests, laboratory operations, and the use of in vitro clinical tests. The Secretary shall designate one member of each committee to serve as chair. (2) Nonvoting members In addition to the individuals appointed pursuant to paragraph (1), the Secretary shall appoint to each committee established under subsection (a), as nonvoting members— (A) a representative of consumer interests; and (B) a representative of interests of in vitro clinical test developers not directly affected by the matter to be brought before the committee. (3) Limitation No individual who is a regular full-time employee of the United States and engaged in the administration of this Act may be a member of any advisory committee established under subsection (a). (4) Education and training The Secretary shall, as appropriate, provide education and training to each new committee member before such member participates in a committee’s activities, including education regarding requirements under this Act and related regulations of the Secretary, and the administrative processes and procedures related to committee meetings. (5) Meetings The Secretary shall ensure that scientific advisory committees meet regularly and at appropriate intervals so that any matter to be reviewed by such a committee can be presented to the committee not more than 60 calendar days after the matter is ready for such review. Meetings of the committee may be held using electronic or telephonic communication to convene the meetings. (6) Compensation Members of an advisory committee established under subsection (a), while attending meetings or conferences or otherwise engaged in the business of the advisory committee— (A) shall be entitled to receive compensation at rates to be fixed by the Secretary, but not to exceed the daily equivalent of the rate in effect for positions classified above level GS–15 of the General Schedule; and (B) may be allowed travel expenses as authorized by section 5703 of title 5, United States Code, for employees serving intermittently in the Government service. (c) Guidance The Secretary may issue guidance on the policies and procedures governing advisory committees established under subsection (a). 587I. Breakthrough in vitro clinical tests (a) In general The purpose of this section is to encourage the Secretary, and provide the Secretary with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the review of, in vitro clinical tests that represent breakthrough technologies. (b) Establishment of program The Secretary shall establish a program to expedite the development of, and provide for the priority review of, in vitro clinical tests. (c) Eligibility The program developed under subsection (b) shall be available for any in vitro clinical test that— (1) provides or enables more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions compared to existing approved or cleared alternatives, including an in vitro clinical test offered under a technology certification order; and (2) is a test— (A) that represents a breakthrough technology; (B) for which no approved or cleared alternative in vitro clinical test exists, including no in vitro clinical test offered under a technology certification order; (C) that offers a clinically meaningful advantage over any existing alternative in vitro clinical test that is approved or cleared (including any in vitro clinical test offered under a technology certification order), including the potential to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or (D) the availability of which is in the best interest of patients or public health. (d) Designation (1) Request To receive breakthrough designation under this section, an applicant may request that the Secretary designate the in vitro clinical test for expedited development and priority review. Any such request for designation may be made at any time prior to, or at the time of, the submission of an application under section 587B or 587D, and shall include information demonstrating that the test meets the criteria described in subsection (c). (2) Determination Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether the in vitro clinical test that is the subject of the request meets the criteria described in subsection (c). If the Secretary determines that the test meets the criteria, the Secretary shall designate the test for expedited development and priority review. (3) Review Review of a request under paragraph (1) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration. (4) Withdrawal (A) In general The designation of an in vitro clinical test under this subsection is deemed to be withdrawn, and such in vitro clinical test shall no longer be eligible for designation under this section, if an application for approval for such test under section 587B or 587D is denied. Such test shall be eligible for breakthrough designation upon a new request for such designation. (B) Exception The Secretary may not withdraw a designation granted under this subsection based on the subsequent approval or technology certification of another in vitro clinical test that— (i) is designated under this section; or (ii) was given priority review under section 515B. (e) Actions For purposes of expediting the development and review of in vitro clinical tests under this section, the Secretary may take the actions and additional actions set forth in paragraphs (1) and (2), respectively, of section 515B(e) when reviewing such tests. Any reference or authorization in section 515B(e) with respect to a device shall be deemed a reference or authorization with respect to an in vitro clinical test for purposes of this section. (f) Guidance Not later than the date specified for final guidance under section 825 of the VALID Act of 2022 , the Secretary shall issue final guidance on the implementation of this section. Such guidance shall— (1) set forth the process by which a person may seek a designation under subsection (d); (2) provide a template for request under subsection (d); (3) identify the criteria the Secretary will use in evaluating a request for designation; and (4) identify the criteria and processes the Secretary will use to assign a team of staff, including team leaders, to review in vitro clinical tests designated for expedited development and priority review, including any training required for such personnel to ensure effective and efficient review. (g) Rules of construction Nothing in this section shall be construed to affect— (1) the criteria and standards for evaluating an application pursuant to section 587B or 587D, including the recognition of valid scientific evidence as described in section 587(17) and consideration and application of the least burdensome means described under section 587AA(c); (2) the authority of the Secretary with respect to clinical holds under section 587R; (3) the authority of the Secretary to act on an application pursuant to section 587B before completion of an establishment inspection, as the Secretary determines appropriate; or (4) the authority of the Secretary with respect to postmarket surveillance under sections 587L(d) and 587Y. 587J. Registration and listing (a) Registration requirement (1) In general Each person described in subsection (b)(1) shall— (A) during the period beginning on October 1 and ending on December 31 of each year, register with the Secretary the name of such person, places of business of such person, all establishments engaged in the activities specified under this paragraph, the establishment registration number of each such establishment, and a point of contact for each such establishment, including an electronic point of contact; and (B) submit an initial registration containing the information required under subparagraph (A) not later than— (i) the effective date of this section if such establishment is engaged in any activity described in subsection (b)(1) on such effective date, unless the Secretary establishes by guidance a date later than such implementation date for all or a category of such establishments; or (ii) 30 days prior to engaging in any activity described in subsection (b)(1), if such establishment is not engaged in any activity described in this paragraph on such effective date. (2) Registration numbers The Secretary may assign a registration number to any person or an establishment registration number to any establishment registered in accordance with this section. Registration information shall be made publicly available by publication on the website maintained by the Food and Drug Administration, in accordance with subsection (d). (3) Inspection Each person or establishment that is required to be registered with the Secretary under this section shall be subject to inspection pursuant to section 704. (b) Listing Information for In Vitro Clinical Tests (1) In general Each person who— (A) is a developer; and (B) introduces or proposes to begin the introduction or delivery for introduction into interstate commerce through an exemption under subsection (a)(1), (a)(2), (a)(3), or (g) of section 587C or section 587G or through the filing of an application under section 587B or section 587D, shall submit a listing to the Secretary containing the information described in paragraph (2), (4), or (5), as applicable, in accordance with the applicable schedule described under subsection (c). Such listing shall be prepared in such form and manner as the Secretary may specify in guidance. Listing information shall be submitted through the comprehensive test information system in accordance with section 587T, as appropriate. (2) Submissions Each developer submitting a listing under paragraph (1) shall electronically submit to the comprehensive test information system described in section 587T the following information, as applicable, for each in vitro clinical test for which such person is a developer in the form and manner prescribed by the Secretary, taking into account least burdensome principles: (A) Name of the establishment and its establishment registration number. (B) Contact information for the official correspondent for the listing. (C) Name (common name and trade name, if applicable) of the in vitro clinical test and its test listing number (when available). (D) The certificate number for any laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements to perform high-complexity testing and that is the developer of the in vitro clinical test, and the certificate number under such section for any laboratory that is performing the test, is within the same corporate organization, and has common ownership by the same parent corporation. (E) Whether the in vitro clinical test is, as applicable, offered as a test approved under section 587B, cleared to be offered under a granted technology certification order, or offered as an exempt in vitro clinical test under section 587A. (F) Indications for use information under section 587(10). (G) A brief summary of the analytical and clinical performance of the in vitro clinical test, and as applicable, the lot release criteria. (H) A brief description of conformance with any applicable mitigating measures, restrictions, and standards. (I) Representative labeling for the in vitro clinical test, as appropriate. (3) Test listing number The Secretary may assign a test listing number to each in vitro clinical test that is the subject of a listing under this section. The process for assigning test listing numbers may be established through guidance, and may include the recognition of standards, formats, or conventions developed by a third-party organization. (4) Abbreviated listing A person who is not a developer but is otherwise required to register pursuant to subsection (a) shall submit an abbreviated listing to the Secretary containing the information described in subparagraphs (A) through (C) of paragraph (2), and the name of the developer. The information shall be submitted in accordance with the applicable schedule described under subsection (c). Such abbreviated listing shall be prepared in such form and manner as the Secretary may specify through guidance. Listing information shall be submitted to the comprehensive test information system in accordance with section 587T, as appropriate. (5) Grandfathered tests A developer offering a test that is a grandfathered in vitro clinical test under section 587G(a) shall submit listing information required under subparagraphs (A) through (F) of paragraph (2), and may submit a statement of the performance specifications for such in vitro clinical tests. (6) Exempt tests A developer of an in vitro clinical test who introduces or proposes to begin the introduction or delivery for introduction into interstate commerce that is otherwise exempt from the requirement to submit listing information pursuant to an exemption under section 587C may submit listing information under this subsection. (c) Timelines for submission of listing information (1) In general The timelines for submission of registration and listing under subsections (a) and (b) are as follows: (A) For an in vitro clinical test that was listed as a device under section 510(j) prior to the effective date of this section, a person shall maintain a device listing under section 510 until such time as the system for submitting the listing information required under subsection (b) becomes available and thereafter shall submit the listing information not later than the later of 1 year after the system for submitting the listing under this section becomes available or the effective date of this section. (B) For an in vitro clinical test that is subject to grandfathering under section 587G(a) a person shall submit the listing information required under subsection (b)(5) not later that the later of 1 year after the system for submitting the listing under this section becomes available or the effective date of this section. (C) For an in vitro clinical test that is not described in subparagraph (A) or (B), a person shall submit the required listing information as follows: (i) For an in vitro clinical test that is not exempt from premarket approval under section 587B, a person shall submit the required listing information, prior to offering the in vitro clinical test and not later than 30 business days after the date of approval of the premarket approval application. (ii) For an in vitro clinical test that is exempt from premarket review under section 587C, the required listing information shall be submitted prior to offering the in vitro clinical test. (2) Updates (A) Updates after changes Each developer required to submit listing information under this section shall update such information within 10 business days of any change that causes any previously listed information to be inaccurate or incomplete. (B) Annual updates Each developer required to submit listing information under this section shall update its information annually during the period beginning on October 1 and ending on December 31 of each year. (d) Public availability of listing information (1) In general Listing information submitted pursuant to this section shall be made publicly available on the website of the Food and Drug Administration in accordance with paragraph (3). (2) Confidentiality Listing information for an in vitro clinical test that is subject to premarket approval or technology certification shall remain confidential until such date as the in vitro clinical test receives the applicable premarket approval or the developer receives a technology certification order and for subsequent tests introduced under a technology certification order until their introduction. (3) Exceptions from public availability requirements The public listing requirements of this subsection shall not apply to any registration and listing information submitted under subsection (a) or (b), if the Secretary determines that such information— (A) is a trade secret or confidential commercial information; or (B) if posted, would present a risk to national security. (e) Submission of information by accredited persons If agreed upon by the developer, the information required under this section may be submitted by a person accredited under section 587Q. 587K. Test design and quality requirements (a) Applicability (1) In general Each developer and each other person required to register under section 587I(b)(1) shall establish and maintain quality requirements in accordance with the applicable requirements set forth in subsection (b). (2) Certified laboratory requirements A developer shall establish and maintain quality requirement under subsection (b)(2) or (b)(3), as applicable, if such developer is a clinical laboratory certified by the Secretary under section 353 of the Public Health Service Act that— (A) is certified to perform high-complexity testing; (B) develops an in vitro clinical test that is for use only— (i) within the laboratory certified by the Secretary under such section 353 in which such test was developed; or (ii) within another laboratory certified by the Secretary under such section 353 if such laboratory is— (I) within the same corporate organization and has common ownership by the same parent corporation as the laboratory in which the test was developed; or (II) within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, if the test is developed by a public health laboratory or the Centers for Disease Control and Prevention; and (C) does not manufacture, produce, or distribute in vitro clinical tests other than laboratory test protocols. (3) Regulations The Secretary shall promulgate quality system regulations implementing this section. In promulgating such regulations under this section, the Secretary shall consider whether, and to what extent, international harmonization is appropriate. (4) Quality systems for hybrid developers of both laboratory test protocols and other in vitro clinical tests An entity that develops both finished products and laboratory test protocols and other in vitro clinical tests shall comply with subsection (b)(1) for activities related to the development of any in vitro clinical test that is not a laboratory test protocol product and with subsection (b)(2) or (b)(3), as applicable, for activities related to the development of any laboratory test protocol. (b) Quality requirements (1) In general The quality requirements applicable under this section shall— (A) avoid duplication of regulations under section 353 of the Public Health Service Act; and (B) shall include the following, as applicable, subject to subparagraph (A) and paragraphs (2) and (3)— (i) management responsibilities; (ii) quality audits; (iii) personnel; (iv) design controls; (v) document controls; (vi) purchasing controls; (vii) identification and traceability; (viii) production and process controls; (ix) acceptance activities; (x) nonconforming in vitro clinical tests; (xi) corrective and preventive action; (xii) labeling and packaging controls; (xiii) handling, storage, distribution, and installation; (xiv) complaints and records; (xv) servicing; and (xvi) statistical techniques. (2) Exception for laboratory test protocols Developers that are developing test protocols for use as described in subsection (a)(2)(B)(i) are exempt from the requirements under paragraph (1)(B) except for the requirements described in clauses (iv), (vi), (ix), (xi), and (xiv) of such paragraph. (3) Quality requirements for certain laboratories distributing laboratory test protocols within organizations or public health networks Quality requirements applicable to the developer who is distributing a laboratory test protocol as described in subsection (a)(2)(B)(ii) shall consist of the following: (A) Clauses (iv), (vi), (ix), (xi), (xiv), (xii) of paragraph (1)(B). (B) The requirement to maintain records of the laboratories to which the laboratory test protocol is distributed. (c) Regulations In implementing quality requirements for test developers that participate in international audit programs under this section, the Secretary shall— (1) for purposes of facilitating international harmonization, consider whether the developer participates in an international audit program in which the United States participates and recognizes compliance with, or conformance to, such standards recognized by the Secretary; and (2) ensure a least burdensome approach described in section 587AA(c) by leveraging, to the extent applicable, the quality assurance requirements applicable to developers certified by the Secretary under section 353 of the Public Health Service Act. 587L. Labeling requirements (a) In general An in vitro clinical test shall bear or be accompanied by labeling, as applicable, that meets the requirements set forth in subsections (b) and (c), unless such test is exempt under subsection (d) or (e). (b) Labels (1) In general The label of an in vitro clinical test, shall meet the requirements set forth in paragraph (2) if there is an immediate container to which the label is applied. (2) Regulations The label of an in vitro clinical test shall state the name and place of business of its developer and meet the requirements set forth in regulations promulgated in accordance with this section. (c) Labeling (1) In general Labeling of an in vitro clinical test, including labeling in the form of a package insert, website, standalone laboratory reference document, or other similar document shall include— (A) adequate directions for use and shall meet the requirements set forth in regulations promulgated under this section, except as provided in subsection (d) or (e); and (B) the information described in paragraph (2), as applicable. (2) Content Labeling of an in vitro clinical test shall include— (A) the test listing number that was provided to the developer at the time of listing; (B) information to facilitate reporting an adverse event; (C) information regarding accessing the performance summary data displayed in the listing database for the test; (D) the indications of use of the in vitro clinical test; and (E) any warnings, contraindications, or limitations. (3) Public availability of information The Secretary shall make all of the information described in paragraph (2) with respect to each in vitro clinical test available to the public, as applicable, in accordance with section 587T, except to the extent that the Secretary determines that such information— (A) is trade secret or confidential commercial information; or (B) if posted, would present a risk to national security. (4) Additional requirements Labeling for an in vitro clinical test used for immunohematology testing shall meet the applicable requirements set forth in part 660 of title 21, Code of Federal Regulations (or any successor regulations), related to the labeling of blood grouping reagents, reagent red blood cells, and anti-human globulin. (d) Exemptions and alternative requirements (1) In general (A) In general With respect to an in vitro clinical test that meets the criteria of subparagraph (B), the state in one place regulations under section 809.10(b) of title 21, Code of Federal Regulations (or any successor regulations) may be satisfied by the laboratory posting such information on its website or in multiple documents, if such documents are maintained and accessible in one place. (B) Applicable tests An in vitro clinical test meets the criteria of this subparagraph if such test is— (i) developed by a laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements to perform tests of high-complexity; and (ii) performed in— (I) the same laboratory in which such test was developed; or (II) by another laboratory certified by the Secretary under section 353 of the Public Health Service Act that— (aa) meets the requirements to perform tests of high complexity; and (bb) is under common ownership and control as the laboratory that developed the test. (2) Test instrument labeling Unless the instrument is the entire test system, the labeling for an instrument is not required to bear the information indicated in paragraphs (3), (4), (5), (7), (8), (9), (10), (11), (12), and (13) of section 809.10(b) of title 21, Code of Federal Regulations (or any successor regulations). (3) Reagent labeling For purposes of compliance with subsection (c)(1), the labeling for a reagent intended for use as a replacement in an in vitro clinical test may be limited to that information necessary to identify the reagent adequately and to describe its proper use in the test. (4) Investigational use A shipment or other delivery of an in vitro clinical test for investigational use pursuant to section 587S shall be exempt from the labeling requirements of subsections (b) and (c)(1) and from any standard promulgated through regulations, except as required under section 353 of the Public Health Service Act or section 587R of this Act. (5) General purpose laboratory reagents The labeling of general purpose laboratory reagents (such as hydrochloric acid) whose uses are generally known by persons trained in their use need not bear the directions for use required by subsection (c)(1)(A). (6) Over-the-counter test specimen receptacle labeling The labeling for over-the-counter test specimen receptacles for drugs of abuse testing shall bear the name and place of business of the developer included in the registration under section 587J and any information specified in applicable regulations promulgated under this section, in language appropriate for the intended users. (e) Tests in the strategic national stockpile (1) In general The Secretary may grant an exception or alternative to any provision listed in this section, unless explicitly required by a statutory provision outside this subchapter, for specified lots, batches, or other units of an in vitro clinical test, if the Secretary determines that compliance with such labeling requirement could adversely affect the availability of such products that are, or will be, included in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act. (2) Regulations The Secretary may issue regulations amending section 809.11 of title 21, Code of Federal Regulations (or any successor regulation) to apply in full or in part to in vitro clinical tests and in vitro clinical test developers. (f) Regulations The Secretary shall issue or revise regulations related to standardized, general content and format for in vitro clinical test labeling pursuant to this subsection. 587M. Adverse event reporting (a) In general Each in vitro clinical test developer shall establish and maintain a system for establishing and maintaining records of adverse events and reporting adverse events in accordance with this section. (b) Submission of individual reports A developer shall submit an individual adverse event not later than 5 calendar days after the developer receives or becomes aware of an adverse event that reasonably suggests that an in vitro clinical test may— (1) have caused or contributed to a patient or user death; or (2) present an imminent threat to public health. (c) Submission of quarterly reports As applicable, a developer shall submit quarterly reports that include any in vitro clinical test errors and serious injuries that occurred during the applicable quarter. Such quarterly reports shall be submitted not later than the end of the quarter following the quarter in which the developer receives or becomes aware of such adverse events. (d) Definitions For the purposes of this section— (1) the term in vitro clinical test error means a failure of an in vitro clinical test to meet its performance specifications, or to otherwise perform as intended by the developer, including an inaccurate result resulting from such failure; and (2) the term serious injury means— (A) a significant delay in a diagnosis that results in the absence, delay, or discontinuation of critical medical treatment or that irreversibly or seriously and negatively alters the course of a disease or condition; or (B) an injury that— (i) is life threatening; (ii) results in permanent impairment of a body function or permanent damage to a body structure; or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. (e) Regulations The Secretary shall promulgate regulations to implement this section. 587N. Corrections and removals (a) Regulations The Secretary shall promulgate regulations, or amend existing regulations, as appropriate, to implement this section. (b) Reports of corrections and removals (1) In general Each in vitro clinical test developer shall report to the Secretary any correction or removal of an in vitro clinical test undertaken by such developer if the correction or removal was undertaken— (A) to reduce the risk to health posed by the in vitro clinical test; or (B) to remedy a violation of this Act caused by the in vitro clinical test which may present a risk to health. (2) Exception for in vitro clinical tests offered under a technology certification order For any eligible test offered under a technology certification order under section 587D, a correction and removal report for any correction or removal of an in vitro clinical test should demonstrate that the issue or issues causing the correction or removal do not adversely impact the ability of other in vitro clinical tests offered under the same technology certification order to meet the applicable standard. (c) Timing A developer shall submit any report required under this subsection to the Secretary within 15 business days of initiating such correction or removal. (d) Recordkeeping A developer of an in vitro clinical test that undertakes a correction or removal of an in vitro clinical test which is not required to be reported under this subsection shall keep a record of such correction or removal. (e) Recall communications Upon the voluntary reporting of a correction or removal by the developer— (1) the Secretary shall classify such correction or removal under this section within 15 calendar days; and (2) not later than 45 calendar days after the developer or other responsible party notifies the Secretary that it has completed a recall action, the Secretary shall provide the developer or other responsible party with a written statement closing the recall action or stating the reasons the Secretary cannot close the recall at that time. 587O. Restricted in vitro clinical tests (a) Applicability (1) In general For the types of in vitro clinical tests described in paragraph (3) the Secretary may require, in issuing an approval of an in vitro clinical test under section 587B, granting a technology certification order under section 587D, or in issuing a determination under section 587F(a), or by issuing a regulation, that such test, or category of tests, be restricted to sale, distribution, or use upon such conditions as the Secretary may prescribe under paragraph (2). (2) Conditions The Secretary may prescribe conditions under this section, based on available evidence, with respect to an in vitro clinical test described in paragraph (3), that are determined to be needed due to the potential for harmful effect of such test (including any resulting absence, significant delay, or discontinuation of appropriate medical treatment), and are necessary to ensure that the test meets the applicable standard. (3) In vitro clinical tests subject to restrictions The restrictions or conditions authorized under this section may be applied by the Secretary to any high-risk or moderate-risk in vitro clinical test, prescription home-use in vitro clinical test, direct-to-consumer in vitro clinical test, or over-the-counter in vitro clinical test. (b) Labeling and advertising of a restricted in vitro clinical test The labeling and advertising of an in vitro clinical test to which restrictions apply under subsection (a) shall bear such appropriate statements of the restrictions as the Secretary may prescribe in an approval under section 587B, an order under section 587D, a determination under section 587F(a), or in regulation, as applicable. (c) Device restrictions An in vitro clinical test that was offered as a restricted device prior to the date of enactment of this subchapter— (1) shall continue to comply with the applicable restrictions under section 515 or section 520(e) until the this subchapter takes effect; and (2) except for in vitro clinical tests required to meet section 809.30 of title 21, Code of Federal Regulations prior to the effective date of this subchapter specified in section 825(a)(1)(A) of the VALID Act of 2022 , such restrictions shall be deemed to be restrictions under this Act as of such effective date. 587P. Appeals (a) Significant decision (1) In general The Secretary shall maintain a substantive summary of the scientific and regulatory rationale for any significant decision of the Food and Drug Administration pursuant to section 587F, regarding— (A) the submission of an application for, or a review of, an in vitro clinical test under section 587B or section 587D; (B) an exemption under section 587C; or (C) any requirements for mitigation measures to an in vitro clinical test or category of in vitro clinical tests. Such summaries shall include documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion. (2) Provision of documentation Upon request, the Secretary shall furnish a substantive summary described in paragraph (1) to the person who has made, or is seeking to make, a submission described in such paragraph. (3) Application of least burdensome requirements The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 587AA(c), as applicable. (b) Review of significant decisions (1) Request for supervisory review of significant decision A developer may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the agency official who made the significant decision. (2) Submission of request A developer requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after the decision for which the review is requested and shall indicate in the request whether such developer seeks an in-person meeting or a teleconference review. (3) Timeframe The Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the developer requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a developer who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference. (c) Advisory panels The process established under subsection (a) shall permit the appellant to request review by an advisory committee established under section 587G when there is a dispute involving substantial scientific fact. If an advisory panel meeting is held, the Secretary shall make a determination under this subsection not later than 45 days after the requested advisory committee meeting has concluded. (d) Least burdensome review Any developer who has submitted an application under section 587B or 587D may request a supervisory review of a request for additional information during an evaluation of such submission within 60 calendar days of receipt of the additional information request from the Secretary. (e) Availability of all remedies The procedures set forth in this section shall be in addition to, and not in lieu of, other remedies available to the developer. 587Q. Accredited persons (a) In general (1) Authorization Beginning on the date of enactment of the VALID Act of 2022 , the Secretary shall accredit persons for any of the following purposes: (A) Reviewing applications for premarket approval under section 587B and making findings with respect to such applications. (B) Reviewing applications for technology certification under section 587D and making recommendations to the Secretary with respect to such applications. (C) Conducting inspections as specified in subsection (c) of in vitro clinical test developers and other persons required to register pursuant to section 587I. (2) Persons submitting applications A person submitting an application for premarket approval under section 587B or an application for technology certification under section 587D may submit such application to the Secretary or to a person accredited pursuant to subparagraph (A) or (B) of paragraph (1). (b) Accredited persons application reviews, findings and recommendations (1) Requirements for premarket application (A) Review and finding requirements An accredited person receiving an application for premarket approval under section 587B shall either— (i) provide to the Secretary, together with the application for premarket approval submitted by the applicant, a finding that the criteria for approval of the application under section 587B(g)(2)(A) are met and issue a copy of such finding to the applicant, which finding shall plainly state— (I) the basis for the accredited person’s finding that the criteria under section 587B(g)(2)(A) are met; and (II) any proposed restrictions, mitigating measures, or conditions of approval under section 587B(g)(2)(B), as applicable; or (ii) provide a notification to the applicant that the accredited person cannot find that the criteria for approval of the application under section 587B(g)(2)(A) are met and the reasons for such decision. (B) Requesting missing or clarifying information After receipt of an application under this section, the Secretary may request missing or clarifying information from the applicant concerning the application, which the applicant shall promptly provide. (C) Secretary action on finding that approval criteria are met If the accredited person transmits a finding to the Secretary under clause (i) of subparagraph (A), then prior to the date that is 45 calendar days after the transmittal date the Secretary shall— (i) approve the application for premarket approval under section 587B(g)(2) with appropriate restrictions, mitigating measures, or conditions of approval, as applicable; or (ii) deny approval of the application by issuing a written notice that reflects appropriate management input and concurrence to the accredited person and the applicant detailing the scientific basis for the Secretary’s determination that the criteria for issuance of an approval under section 587B(g)(2)(A) have not been met. (D) Effect of inaction on finding If the Secretary fails to take an action under subparagraph (C) the Secretary shall— (i) within 45 calendar days after the transmittal date, provide written feedback to the applicant that— (I) includes all outstanding issues with the application preventing the Secretary from taking an action under subparagraph (B); (II) reflects appropriate management input and concurrence; and (III) includes action items for the Secretary, the applicant, or both, as appropriate, with an estimated date of completion for the Secretary and the applicant to complete their respective tasks, as applicable; and (ii) promptly schedule a meeting or teleconference to discuss the feedback provided under clause (i), unless the Secretary and applicant agree that the outstanding issues are adequately presented through written correspondence and a meeting or teleconference is not necessary. (2) Requirements for technology certification (A) Review and recommendation requirements An accredited person receiving an application for technology certification under section 587D shall either— (i) provide to the Secretary, together with the application for technology certification submitted by the applicant, a recommendation that the criteria for issuance of a technology certification order under section 587D(f)(3) are met and issue a copy of such recommendation to the applicant, which recommendation shall plainly state the basis for the accredited person’s recommendation that the criteria under section 587D(f)(3) are met; or (ii) provide a notification to the applicant that the accredited person cannot recommend that the criteria for issuance of a technology certification order under section 587D(f)(3) are met and the reasons for such decision. (B) Requesting missing or clarifying information After receipt of an application under this section, the Secretary may request missing or clarifying information from the applicant concerning the application, which the applicant shall promptly provide. (C) Secretary action on recommendation for issuance of a technology certification order If the accredited person transmits a recommendation to the Secretary under clause (i) of subparagraph (A), then prior to the date that is 60 calendar days after the transmittal date the Secretary shall— (i) issue the technology certification order under section 587D(f)(3), consistent with such recommendation from the accredited person; or (ii) deny approval of the application by issuing a written notice to the accredited person and the applicant detailing the scientific basis for a determination by the Secretary that the criteria for issuance of a technology certification order under section 587D(f)(3) have not been met. (c) Requirements for inspections (1) In general When conducting inspection, persons accredited under subparagraph (a)(1)(B) shall record in writing their specific observations and shall present their observations to the designated representative of the inspected establishment. (2) Inspection report requirements Each person accredited under this subparagraph (a)(1)(C) shall prepare and submit to the Secretary an inspection report in a form and manner designated by the Secretary for conducting inspections. Any statement or representation made by an employee or agent of an establishment to a person accredited to conduct inspections under subparagraph (a)(1)(C) shall be subject to section 1001 of title 18, United States Code. (3) Savings clause Nothing in this section affects the authority of the Secretary to inspect any in vitro clinical test developer or other person registered under section 587I or recognize inspections conducted by auditing organizations as described under section 704(g)(15). (4) Inspection limitations The Secretary shall ensure that inspections carried out under this section are not duplicative of inspections carried out under section 353 of the Public Health Service Act. Inspections under this section shall be limited to the data and information necessary— (A) for routine surveillance activities of facilities associated with an approved application under section 587B or issuance of a technology certification order under section 587D; or (B) to meet the requirements for premarket approval under section 587B or issuance of a technology certification order under section 587D, as applicable. (d) Accreditation (1) Accreditation program The Secretary may provide for accreditation under this section through programs administered by the Food and Drug Administration, by other non-Federal government agencies, or by qualified nongovernmental organizations. A person may be accredited for the review of applications submitted under sections 587B as described in subsection (a)(1)(A), for the review of applications submitted under section 587D as described in subsection (a)(1)(B) and to conduct inspection activities under subsection (a)(1)(C), or for a subset of such reviews or activities. (2) Eligible persons (A) Minimum qualifications An accredited person, at a minimum, shall— (i) not be an employee of the Federal Government; (ii) not engage in the activities of a developer, as defined in section 587(7); (iii) not be a person required to register under section 587I, unless such person has established sufficient processes and protocols to separate activities to develop in vitro clinical tests and the activities for which such person would be accredited under subsection (a) and discloses applicable information under this section; (iv) not be owned or controlled by, and shall have no organizational, material, or financial affiliation with, an in vitro clinical test developer or other person required to register under section 587I; (v) be a legally constituted entity permitted to conduct the activities for which it seeks accreditation; (vi) ensure that the operations of such person are in accordance with generally accepted professional and ethical business practices; and (vii) include in its request for accreditation a commitment to, at the time of accreditation and at any time it is performing activities pursuant to this section— (I) certify that the information reported to the Secretary accurately reflects the data or protocol reviewed, and the documented inspection findings, as applicable; (II) limit work to that for which competence and capacity are available; (III) treat information received or learned, records, reports, and recommendations as proprietary information of the person submitting such information; and (IV) in conducting the activities for which the person is accredited in respect to a particular in vitro clinical test, protect against the use of any employee or consultant who has a financial conflict of interest regarding that in vitro clinical test. (B) Waiver The Secretary may waive any requirements in clauses (i), (ii), (iii), or (iv) of subparagraph (A) upon making a determination that such person has implemented other appropriate controls sufficient to ensure a competent and impartial review. (3) Accreditation process (A) Accreditation process guidance and regulations Not later than 180 days after the date of enactment of the VALID Act of 2022 , the Secretary shall issue draft guidance specifying the process for submitting a request for accreditation and reaccreditation under this section, including the form and content of information to be submitted, including the criteria that the Secretary will consider to accredit or deny accreditation and, not later than 1 year after the close of the comment period for the draft guidance, issue final guidance. (B) Response to request The Secretary shall respond to a request for accreditation or reaccreditation within 60 calendar days of the receipt of the request. The Secretary’s response may be to accredit or reaccredit the person, to deny accreditation, or to request additional information in support of the request. If the Secretary requests additional information, the Secretary shall respond within 60 calendar days of receipt of such additional information to accredit or deny the accreditation. (C) Type of accreditation The accreditation or reaccreditation of a person shall specify the particular activity or activities under subsection (a) for which such person is accredited, and shall include any limitation to certain eligible in vitro clinical tests. (D) Public list The Secretary shall publish on the website of the Food and Drug Administration a list of persons who are accredited under this section. Such list shall be updated on at least a monthly basis. The list shall specify the particular activity or activities under this section for which the person is accredited. (E) Audit The Secretary may audit the performance of persons accredited under this section for purposes of ensuring that such persons continue to meet the published criteria for accreditation, and may modify the scope or particular activities for which a person is accredited if the Secretary determines that such person fails to meet one or more criteria for accreditation. (F) Suspension or withdrawal The Secretary may suspend or withdraw accreditation of any person accredited under this section, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or the published criteria for accreditation, or poses a threat to public health, or fails to act in a manner that is consistent with the purposes of this section. (G) Reaccreditation Accredited persons may be initially accredited for up to 3 years. After expiration of such initial period, persons may be reaccredited for unlimited additional 35-year periods, as determined by the Secretary. (e) Compensation of accredited persons Compensation of an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services. (f) International harmonization Notwithstanding any other provision of this section, to facilitate international harmonization the Secretary may recognize persons accredited or recognized by governments, who have also entered into information sharing agreements, including confidentiality commitments, with the Commissioner of Food and Drugs. (g) Information sharing agreements An accredited person may enter into an agreement with a test developer to provide information to the comprehensive test information system under section 587T, including any requirements under section 587I. (h) Reports Not later than 2 years after the effective date of the VALID Act of 2022 , and annually thereafter for the next 4 years, the Secretary shall post on the website of the Food and Drug Administration, a report describing the Secretary’s performance in implementing this section, including the Secretary’s progress in minimizing duplicative reviews of applications for which an accredited person finds the criteria for approval are met. Such reports shall include, for each period— (1) with regard to premarket approval applications— (A) the total number of findings transmitted to the Secretary under subsection (b)(1)(A)(i); (B) the total number of determinations made by the Secretary under subsection (b)(1)(B)(i) within 30 calendar days of the transmittal date to approve an application; (C) the total number of determinations made by the Secretary under subsection (b)(1)(B)(ii) within 30 calendar days of the transmittal date to deny approval of an application; and (D) the total number of applications that were approved and the total number of applications that were denied approval, after the Secretary failed to make a determination within 30 calendar days of the transmittal date under subsection (b)(1)(B); and (2) with regard to applications for technology certification— (A) the total number of recommendations transmitted to the Secretary under subsection (b)(2)(A)(i); (B) the total number of determinations made by the Secretary under subsection (b)(2)(B)(i) to issue a technology certification order, including determinations made within 30 days of the transmittal date; (C) the total number of determinations made by the Secretary under subsection (b)(2)(B)(ii) to deny the application for technology certification, including determinations made within 30 calendar days of the transmittal date; and (D) the total number of technology certification orders issued, and the total number of applications for technology certification that were denied, including applications denied after the Secretary failed to make a determination within 30 calendar days of the transmittal date under subsection (b)(2)(B). 587R. Recognized standards (a) In general The Secretary may recognize all or part of appropriate standards established by nationally or internationally recognized standards development organizations for which a person may submit a declaration of conformity in order to meet a requirement under this subchapter to which that standard is applicable. Standards for in vitro diagnostic devices previously recognized under section 514(c) shall be considered recognized standards under this section. Recognized and proposed standards shall be accessible to the public at no charge. The application of any such consensus standard shall only apply prospectively. The Secretary shall issue regulations establishing the criteria and process, for such recognition and adoption. (b) Amendment process The procedures established in this section or in regulation or guidance issued under this section shall apply to amendment of an existing standard. 587S. Investigational use (a) In general Subject to the conditions prescribed in subsections (c), (d), (e), (f), and (g) of this section, an in vitro clinical test for investigational use shall be exempt from the requirements of this subchapter other than sections 587A, 587P, 587T, and 587V. The Secretary may amend parts 50, 54, and 56 of title 21 of the Code of Federal Regulations, or any successor regulations, to apply to in vitro clinical tests to permit the investigational use of such tests by experts qualified by scientific training and experience. (b) Regulations (1) In general Not later than 2 years after the date of enactment of the VALID Act of 2022 , the Secretary shall promulgate regulations, or amend existing regulations, to implement this section. (2) Variation The requirements in the regulations promulgated under this section shall take into account variations based on— (A) the scope and duration of clinical testing to be conducted under investigation that is the subject of such application; (B) the number of human subjects that are to be involved in such testing; (C) the need to permit changes to be made to the in vitro clinical test involved during testing conducted in accordance with a plan required under subsection (c)(5); or (D) whether the clinical testing of such in vitro clinical test is for the purpose of developing data to obtain approval to offer such test. (c) Application for investigational use The following shall apply with respect to in vitro clinical tests for investigational use: (1) Significant risk and other studies In the case of an in vitro clinical test the investigational use of which poses a significant risk to the human subject, a sponsor of an investigation of such a test seeking an investigational use exemption shall submit to the Secretary an investigational use application with respect to the in vitro clinical test in accordance with paragraphs (3) and (4). For purposes of this subparagraph, the term significant risk means, with respect to an in vitro clinical test and that the use of such in vitro clinical test— (A) is of substantial importance in performing an activity or activities described in section 201(ss)(1) for, a serious or life-threatening disease or condition without confirmation of the diagnosis by a medically established diagnostic product or procedure; (B) requires an invasive sampling procedure that presents a significant risk to the human subject, provided that routine venipuncture shall not be considered an invasive sampling procedure; or (C) otherwise presents a potential for serious risk to the health of a human subject. (2) Non-significant risk studies In the case of an in vitro clinical test, the investigational use of which is not described in paragraph (1)— (A) the sponsor of such investigation shall— (i) ensure such investigation is conducted in compliance with an investigational plan approved by an institutional review committee and the labeling of the in vitro clinical test involved clearly and conspicuously states, For investigational use only , as specified in paragraph (4)(A)(ii); (ii) ensure each investigator obtains informed consent as required under part 50, 54, and 56 of title 21, Code of Federal Regulations (or any successor regulations), subject to the exceptions set forth in paragraph (6)(C); (iii) establish and maintain records with respect to all requirements in this subparagraph; (iv) maintain records and make reports as established by the Secretary in regulations issued under subsection (b); and (v) ensure that investigators monitor investigations, maintain records and make reports as established by the Secretary in regulations issued under subsection (b); and (B) the sponsor may rely on any exception or exemption described in paragraph (5)(B) or as established by the Secretary in regulations issued under subsection (b). (3) Application An investigational use application shall be submitted in such time and manner and contain such information as the Secretary may require in regulation, and shall include an investigational plan for proposed clinical testing and assurances that the sponsor submitting the application will— (A) establish and maintain records relevant to the investigation of such in vitro clinical test; and (B) submit to the Secretary annual reports of data obtained as a result of the investigational use of the in vitro clinical test during the period covered by the exemption that the Secretary reasonably determines will enable the Secretary— (i) to ensure compliance with the conditions for the exemption specified in paragraph (4); (ii) to review the progress of the investigation involved; and (iii) to evaluate the ability to meet the applicable standard. (4) Conditions for exemption (A) In general An application for an investigational use exemption with respect to a significant risk study shall be granted if each of the following conditions is met: (i) The risks to the subjects of the in vitro clinical test are outweighed by the anticipated benefits of the test to the subjects and the importance of the knowledge to be gained, and adequate assurance of informed consent is provided in accordance with paragraphs (6)(A)(iii) and (6)(B). (ii) The proposed labeling for the in vitro clinical test involved clearly and conspicuously states For investigational use only . (iii) Such other requirements the Secretary determines— (I) are necessary for the protection of the public health and safety; and (II) do not unduly delay investigation. (B) Certain significant risk studies of in vitro clinical tests for an unmet need The Secretary shall not impose a limit on the sample size for a significant risk study of an in vitro clinical test that has received breakthrough designation under section 587I. (5) Coordination with investigational new drug applications Any requirement for the submission of a report to the Secretary pursuant to an application for an investigational new drug exemption involving an in vitro clinical test shall supersede the reporting requirement in paragraph (3)(B), but only to the extent the requirement with respect to the application for exemption with respect to the drug is duplicative of the reporting requirement under such paragraph. (6) Investigational plan, procedures, and conditions With respect to an investigational plan submitted under paragraph (3), the sponsor submitting such plan shall— (A) promptly notify the Secretary of the approval or the suspension or termination of the approval of such plan by an institutional review committee; (B) in the case of an in vitro clinical test made available to investigators for clinical testing, obtain agreements from each investigator that any testing of the in vitro clinical test involving human subjects will be under such investigator’s supervision and in accordance with paragraph (C) and submit such agreements to the Secretary that ensure— (i) all investigators will comply with this section, regulations promulgated or revised under this section, and applicable human subjects regulations; and (ii) the investigator will ensure that— (I) informed consent is obtained as required under part 50 of title 21, Code of Federal Regulations (or any successor regulations), amended to apply to in vitro clinical tests; and (II) the requirements for institutional review board under part 56 of title 21 of the Code of Federal Regulations (or successor regulations), amended to apply to in vitro clinical tests, are met; and (C) assure that informed consent will be obtained from each human subject (or the representative of such subject) of proposed clinical testing involving such in vitro clinical test, except where, subject to such other conditions as the Secretary may prescribe— (i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or (ii) the investigator conducting or supervising the clinical testing determines in writing that there exists a life-threatening situation involving the human subject of such testing which necessitates the use of such in vitro clinical test and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from a representative of such subject. (7) Concurred by licensed physician The determination required by paragraph (6)(C)(ii) shall be concurred in writing by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence. (d) Review of applications (1) In general The Secretary may issue an order approving an investigation as proposed, approving it with conditions or modifications, or disapproving it. (2) Failure to act Unless the Secretary, not later than the date that is 30 calendar days after the date of the submission of an application for an investigational use exemption that meets the requirements of subsection (c), issues an order under paragraph (1) and notifies the sponsor submitting the application, the application shall be treated as approved as of such date without further action by the Secretary. (3) Denial The Secretary may deny an investigational use application submitted under this subsection if the Secretary determines that the investigation with respect to which the application is submitted does not conform to the requirements of subsection (c). A notification of such denial submitted to the sponsor with respect to such a request shall contain the order of disapproval and a complete statement of the reasons for the Secretary’s denial of the application. (e) Withdrawal of exemption (1) In general The Secretary may, by administrative order, withdraw an exemption approved under this section with respect to an in vitro clinical test, including an exemption treated as approved based on the Secretary’s failure to act pursuant to subsection (d)(2), if the Secretary determines that an investigation conducted under such an exemption does not meet the applicable conditions under subsection (c)(3) for such exemption. (2) Opportunity to be heard (A) In general Subject to subparagraph (B), an order withdrawing an investigational use exemption granted under this section may be issued only after the Secretary provides the sponsor of the in vitro clinical test with an opportunity for an informal hearing. (B) Exception An order referred to in subparagraph (A) with respect to an investigational use exemption granted under this section may be issued on a preliminary basis before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption will result in an unreasonable risk to the public health. The Secretary will provide an opportunity for an informal hearing promptly following any preliminary action under this subparagraph. (f) Changes (1) In general The regulations promulgated under subsection (b) shall provide, with respect to an in vitro clinical test for which an exemption under this subsection is in effect, procedures and conditions under which changes are allowed without the additional approval of an application for an exemption or submission of a supplement to such an application. Such regulations shall provide that such a change may be made if— (A) the sponsor determines, on the basis of credible information (as defined in regulations) that the change meets the conditions specified in paragraph (2); and (B) the sponsor submits to the Secretary, not later than 5 calendar days after making the change, a notice of the change. (2) Conditions The conditions specified in this paragraph are that— (A) in the case of developmental changes to an in vitro clinical test, including manufacturing changes, the changes— (i) do not constitute a significant change in design or in basic principles of operation; (ii) do not affect the rights, safety, or welfare of the human subjects involved in the investigation; and (iii) are made in response to information gathered during the course of an investigation; and (B) in the case of changes to clinical protocols applicable to the test, the changes do not affect— (i) the validity of data or information resulting from the completion of an approved clinical protocol, or the relationship of likely patient risk to benefit relied upon to approve a product; (ii) the scientific soundness of a plan submitted under subsection (c)(3); or (iii) the rights, safety, or welfare of the human subjects involved in the investigation. (g) Clinical hold (1) In general At any time, the Secretary may impose a clinical hold with respect to an investigation of an in vitro clinical test if the Secretary makes a written determination described in paragraph (2). The Secretary shall, in imposing such clinical hold, specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing. The applicant may immediately appeal any such determination pursuant to section 587P. (2) Determination (A) In general For purposes of paragraph (1), a determination described in this subparagraph with respect to a clinical hold is a determination that, based on credible evidence, the in vitro clinical test involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the in vitro clinical test, the design of the clinical investigation, the condition for which the in vitro clinical test is to be investigated, and the health status of the subjects involved. (B) Removal of clinical hold Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold. 587T. Comprehensive test information system (a) Establishment Not later than 2 years after the date of enactment of the VALID Act of 2022 , the Secretary shall make available a comprehensive test information system for in vitro clinical tests that is designed to— (1) provide a transparent interface on the website of the Food and Drug Administration for stakeholders, to the extent permitted by applicable law, which may include access to the— (A) regulatory pathway designation information for each in vitro clinical test or tests with the same indications for use; (B) registration and listing information provided by developers under section 587J, including the use of a link for labels; (C) adverse event reports submitted under section 587M, as appropriate; (D) reports of corrections and removals submitted under section 587N; and (E) other information pertaining to an in vitro clinical test or tests with the same indications for use, as the Secretary determines appropriate; and (2) provide a secure portal for electronic submission, including applications and other in vitro clinical test submissions, registration and listing information, and adverse event reports, which provides protections from unauthorized disclosure of information, including of— (A) trade secret or commercial confidential information; and (B) national security, countermeasure, or other information restricted from disclosure pursuant to any provision of law. (b) Submission function The comprehensive test information system shall serve as the electronic submission service for test developers submitting information for applications under sections 587B and 587D. 587U. Preemption (a) In general Except as provided in subsection (b), no State, Tribal, or local government (or political subdivision thereof) may establish or continue in effect any requirement that— (1) is different from, or in addition to, any requirement applicable to an in vitro clinical test under this Act; or (2) with respect to the analytical validity, clinical validity, or safety for individuals who come into contact with such an in vitro clinical test under this Act. (b) Exceptions Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government to do any of the following: (1) To license laboratory personnel, health care practitioners, or health care facilities or to regulate any aspect of a health care practitioner-patient relationship. (2) To enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws. (3) To authorize laboratories to develop and perform an in vitro clinical test, pursuant to a law enacted by a State prior to January 1, 2022, as long as such law does not impose requirements that are different from any requirement applicable to an in vitro clinical test under this Act. If a State has enacted such a law, the Secretary may exempt such laboratories in that State from compliance with this subchapter. (c) Clarification Nothing in this section shall be construed to— (1) modify any action for damages or the liability of any person under the law of any State; or (2) shift liability to health care practitioners or other users. 587V. Adulteration An in vitro clinical test shall be deemed to be adulterated: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance. (2) If it has been developed, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (3) If its container or package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (4) If it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 721(a). (5) If its analytical or clinical validity, as applicable, or with respect to a specimen receptacle, its safety, falls below that which it purports or is represented to possess. (6) If it is required to be, declared to be, purports to be, or is represented as being, in conformity with any performance standard established or recognized under section 587R and is not in conformity with such standard. (7) If it is required to be in compliance with mitigating measures established under section 587E and is not in conformity with such mitigating measures. (8) If it fails to have in effect an approved premarket application under section 587B unless such in vitro clinical test is in compliance with the requirements for— (A) offering without an approved premarket application under section 587D; (B) an exemption from premarket approval under section 587C or 587G; or (C) investigational use pursuant to section 587S. (9) If it is not in conformity with any condition established under section 587B or 587D. (10) If it purports to be an in vitro clinical test subject to an exemption under section 587C and it fails to meet or maintain any criteria, condition, or requirement of such exemption. (11) If it has been granted an exemption under section 587S for investigational use, and the person granted such exemption or any investigator who uses such in vitro clinical test under such exemption fails to comply with a requirement prescribed by or under such section. (12) If it fails to meet the quality requirements prescribed in or established under section 587K (as applicable), or the methods used in, or facilities or controls used for, its development, packaging, storage, or installation are not in conformity with applicable requirements established under such section. (13) If it has been developed, processed, packaged, or held in any establishment, factory, or warehouse and the owner, operator or agent of such establishment, factory, or warehouse delays, denies, or limits an inspection, or refuses to permit entry or inspection. (14) If it is not in compliance with any restriction required under section 587O. 587W. Misbranding An in vitro clinical test shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular. (2) If in a package form unless it bears a label containing— (A) the name and place of business of the test developer, packager, or distributor; and (B) an accurate statement of the quantity of contents in terms of weight, measure, or numerical count with respect to small packages, unless an exemption is granted by the Secretary by the issuance of guidance. (3) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling, including a test report, is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (4) Unless its labeling bears adequate directions for use and such adequate warnings as are necessary for the protection of users of the in vitro clinical test and recipients of the results of such in vitro clinical test, including patients, consumers, donors, and related health care professionals. Required labeling for in vitro clinical tests intended for use in health care facilities, blood establishments, or by a health care professional may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the test developer, or distributor affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost. (5) If there is a reasonable probability that it could cause serious or adverse health consequences or death, including through absence, delay, or discontinuation in diagnosis or treatment, when used in the manner prescribed, recommended, or suggested in the labeling thereof. (6) If it was developed, sterilized, packaged, repackaged, relabeled, installed, or imported in an establishment not duly registered under section 587J or it was not included in a listing under section 587J, in accordance with timely reporting requirements under this subchapter. (7) In the case of any in vitro clinical test subject to restrictions under section 587O, (1) if its advertising is false or misleading in any particular, (2) if it is offered for clinical use, sold, distributed, or used in violation of such restrictions, or (3) unless the test developer or distributor includes in all advertisements and other descriptive printed matter that such person issues or causes to be issued, a brief statement of the indications for use of the in vitro clinical test and relevant warnings, precautions, side effects, and contraindications. This subsection shall not be applicable to any printed matter that the Secretary determines to be labeling as defined in section 201(m). (8) If it is subject to a mitigating measure established under section 587E and does not bear such labeling as may be prescribed in such mitigating measure. (9) If it is subject to a standard established under section 587R and it does not bear such labeling as may be prescribed in such standard. (10) Unless it bears such labeling as may be required by or established under an applicable labeling requirement under this Act. (11) If there was a failure to comply with any requirement prescribed in or under section 587D, 587J, 587K, 587L, 587M, 587N, 587X, 587Y, 587Z, or to provide any report, material, or other information required with respect to in vitro clinical tests under this subchapter. 587X. Postmarket surveillance (a) In general (1) In general In addition to other applicable requirements under this Act, the Secretary may issue an order requiring a developer of a high-risk or moderate-risk in vitro clinical test to conduct postmarket surveillance of such in vitro clinical test, if the failure of the in vitro clinical test is reasonably likely to result in serious adverse health consequences or death from use of such in vitro clinical test. (2) Consideration In determining whether to require a developer to conduct postmarket surveillance of an in vitro clinical test, the Secretary shall take into consideration the benefits and risks for the patient and the least burdensome principles under section 587B(j). (b) Surveillance approval (1) In general Each developer required to conduct surveillance of an in vitro clinical test shall submit, within 30 days of receiving an order from the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has the appropriate qualifications and experience to undertake such surveillance and if the plan will result in useful data that can reveal unforeseen adverse events or other information necessary to protect the health of patients or the public. (2) Timeline The developer shall commence surveillance under this section not later than 15 months after the day on which the Secretary orders such postmarket surveillance, unless the Secretary determines more time is needed to commence surveillance. (3) Prospective surveillance The Secretary may order a prospective surveillance period of up to 3 years. Any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the developer or, if no agreement can be reached, upon the completion of a dispute resolution process pursuant to section 562. 587Y. Electronic format for submissions (a) In general All submissions to the Food and Drug Administration with respect to an in vitro clinical test, unless otherwise agreed to by the Secretary, shall— (1) be made electronically; and (2) with respect to the information required under sections 587B and 587D, utilize the system described in section 587U. (b) Electronic format Beginning on such date as the Secretary specifies in final guidance issued under subsection (c), submissions for in vitro clinical tests, including recommendations submitted by accredited and recognized persons under section 587Q, and any appeals of action taken by the Secretary with respect to such submissions, shall be submitted in such electronic format as specified by the Secretary in such guidance. (c) Guidance The Secretary shall issue guidance implementing this section. Such guidance may— (1) provide standards for the electronic submission required under subsection (a) or the submission in electronic format required under subsection (b); (2) set forth criteria for waivers of, or exemptions from, the requirements of subsection (a) or (b); and (3) provide any other information for the efficient implementation and enforcement of this section. 587Z. Postmarket remedies (a) Safety Notice (1) In general If the Secretary determines that an in vitro clinical test presents an unreasonable risk of substantial harm to the public health, and notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this Act (other than this section) to eliminate the risk, the Secretary may issue such order as may be necessary to ensure that adequate safety notice is provided in an appropriate form, by the persons and means best suited under the circumstances, to all health care professionals who prescribe, order, or use the in vitro clinical test and to any other person (including developers, importers, distributors, retailers, and users) who should properly receive such notice. (2) Notice to individuals An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notice. If the Secretary makes such a determination with respect to such individuals, the order shall require the health care professionals who prescribed, ordered, or used the in vitro clinical test provide notification to the individuals for whom the health professionals prescribed, ordered, or used such test, of the risk presented by such in vitro clinical test and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons required to give notice under the order. (b) Repair, Replacement, or Refund (1) Determination after an informal hearing (A) In general If, after affording opportunity for an informal hearing, the Secretary determines that— (i) an in vitro clinical test presents an unreasonable risk of substantial harm to the public health; (ii) there are reasonable grounds to believe that the in vitro clinical test was not properly developed or manufactured considering the state of the art as it existed at the time of its development; (iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a developer, importer, distributor, or retailer of the in vitro clinical test to exercise due care in the installation, maintenance, repair, or use of the in vitro clinical test; and (iv) the notice authorized by subsection (a) would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph (2) of this subsection is necessary to eliminate such risk, the Secretary may order the developer, importer, or any distributor of such in vitro clinical test, or any combination of such persons, to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph (2). An order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the Secretary determines bears the principal, ultimate financial responsibility for action taken under the plan unless the Secretary cannot determine who bears such responsibility or the Secretary determines that the protection of the public health requires that such decision be made by a person (including a health professional or user of the in vitro clinical test) other than the person the Secretary determines bears such responsibility. (B) Secretary approval of plan The Secretary shall approve a plan submitted pursuant to an order issued under subparagraph (A) unless the Secretary determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, the Secretary shall order a revised plan to be submitted within a reasonable time. If the Secretary determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii) after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a developer, importer, distributor, or retailer of the in vitro clinical test with respect to which the order was issued but to whom the order under subparagraph (A) was not directed. (2) Actions on a plan The actions which may be taken under a plan submitted under an order issued under paragraph (1)(A) are as follows: (A) To repair the in vitro clinical test so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph (1)(A) was issued. (B) To replace the in vitro clinical test with a like or equivalent test which is in conformity with all applicable requirements of this Act. (C) To refund the purchase price of the in vitro clinical test (less a reasonable allowance for use if such in vitro clinical test has been in the possession of the user for one year or more at the time of notice ordered under subsection (a), or at the time the user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph (1)(A), whichever occurs first). (3) No charge No charge shall be made to any person (other than a developer, importer, distributor or retailer) for using a remedy described in paragraph (2) and provided under an order issued under paragraph (1), and the person subject to the order shall reimburse each person (other than a developer, manufacturer, importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in using such remedy. (c) Reimbursement An order issued under subsection (b)(1)(A) with respect to an in vitro clinical test may require any person who is a developer, importer, distributor, or retailer of the in vitro clinical test to reimburse any other person who is a developer, importer, distributor, or retailer of such in vitro clinical test for such other person’s expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party. (d) Recall Authority (1) In general If the Secretary finds that there is a reasonable probability that an in vitro clinical test approved under section 587B or offered under a technology certification order under section 587D would cause serious, adverse health consequences or death, including by the absence, significant delay, or discontinuation of appropriate medical treatment, the Secretary shall issue an order requiring the appropriate person (including the developers, importers, distributors, or retailers of the in vitro clinical test)— (A) to immediately cease distribution of such in vitro clinical test; and (B) to immediately notify health professionals and applicable in vitro clinical test user facilities of the order and to instruct such professionals and facilities to cease use of such in vitro clinical test. (2) Informal hearing The order issued under paragraph (1)(A), shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 calendar days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such in vitro clinical test. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. (3) Amended order (A) In general If, after providing an opportunity for an informal hearing under paragraph (2), the Secretary determines that the order should be amended to include a recall of the in vitro clinical test with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the recall will occur and shall require periodic reports describing the progress of the recall. (B) Requirements An amended order under subparagraph (A)— (i) shall not include recall of the in vitro clinical test from individuals; (ii) shall not include recall of an in vitro clinical test from test user facilities if the Secretary determines that the risk of recalling such in vitro clinical test from the facilities presents a greater health risk than the health risk of not recalling the in vitro clinical test from use; and (iii) shall provide for notice to individuals subject to the risks associated with the use of such in vitro clinical test. In providing the notice required by this clause, the Secretary may use the assistance of health professionals who prescribed, ordered, or used such an in vitro clinical test for individuals. (4) Clarification The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c). 587AA. Applicability (a) In general An in vitro clinical test shall be subject to the requirements of this subchapter, except as otherwise provided in this subchapter. (b) Interstate commerce Any in vitro clinical test that is offered, including by making available for clinical use in the United States is deemed to be an act that constitutes introduction into interstate commerce for purposes of enforcing the requirements of this Act. (c) Least burdensome requirements (1) In general In carrying out this subchapter, the Secretary shall consider the least burdensome means necessary to meet the applicable standard, and other regulatory requirements, as determined by the Secretary. (2) Necessary defined For purposes of paragraph (1) and paragraph (3), the term necessary means the minimum required information that would support a determination by the Secretary that the application meet the applicable standard or regulatory requirement, as determined by the Secretary. (d) Service of orders Orders of the Secretary under this section with respect to applications under subsection (a) or (b) of section 587B or supplements under subsection (f) of such section shall be served— (1) in person by any officer or employee of the Department of Health and Human Services designated by the Secretary; or (2) by mailing the order by registered mail or certified mail or electronic equivalent addressed to the applicant at the last known address in the records of the Secretary. (e) Laboratories and blood and tissue establishments (1) Relation to laboratory certification pursuant to section 353 of the Public Health Service Act Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories or clinical laboratories under section 353 of the Public Health Service Act. (2) Avoiding duplication In implementing this subchapter, the Secretary shall avoid issuing or enforcing regulations or guidance that are duplicative of regulations or guidance under section 353 of the Public Health Service Act. (3) Blood and tissue Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories, establishments, or other facilities to the extent they are engaged in the propagation, manufacture, or preparation, including filling, labeling, packaging, and storage, of blood, blood components, human cells, tissues, or tissue products pursuant to any requirements under this Act or section 351 or 361 of the Public Health Service Act. (f) Not combination product A product constituted of a device and an in vitro clinical test is not a combination product and shall be regulated as a device. (g) Practice of medicine Nothing in this subchapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any lawfully offered in vitro clinical test for any condition or disease within a legitimate health care practitioner-patient relationship pursuant to applicable Federal or State law. (h) Rules of construction (1) Sale, distribution, labeling Nothing in this paragraph shall be construed to limit the authority of the Secretary to establish or enforce restrictions on the sale, distribution, or labeling of an in vitro clinical test under this Act. (2) Promotion of unapproved uses Nothing in this paragraph shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests. 587BB. Judicial review (a) In general Not later than 30 days after an order issued pursuant to sections 587B or 587D, any person adversely affected by such order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has a principal place of business for judicial review of such order, in accordance with the procedure set forth in section 517(a). (b) Application of provisions Subsections (a) through (e) of section 517 shall apply with respect to a petition under subsection (a) of this section in the same manner such subsections apply to a petition under section 517. Subsection (f) of section 517 shall apply to an order issued under section 587B or 587D. . 824. Enforcement and other provisions (a) Prohibited acts Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 811, is further amended— (1) in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), and (y), by inserting in vitro clinical test, after device, each place it appears; (2) in paragraph (g), by inserting after misbranded , , and the development within any Territory of any in vitro clinical test that is adulterated or misbranded ; (3) in paragraph (y), by inserting or 587Q after section 523 each place it appears; (4) in paragraph (ff), by striking or device and inserting , device, or in vitro clinical test ; and (5) by adding at the end, the following: (jjj) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any in vitro clinical test or container, packaging, or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test. (2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any in vitro clinical test or container, packaging, or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test. (3) The doing of any act which causes an in vitro clinical test to be a counterfeit in vitro clinical test, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit in vitro clinical test. (kkk) (1) The introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section 587B(a). (2) The making of a false, fraudulent, or deceptive statement about an in vitro clinical test that is exempt from premarket review under section 587C. (3) The failure to maintain complete and accurate documentation for an exemption as required under section 587C or the failure to provide labeling required under section 587L. (4) With respect to an in vitro clinical test, the submission of any report or listing under this Act that is false or misleading in any material respect. (5) The failure to comply with a condition of approval, or restriction required under an approved application under section 587B; the failure to perform a risk analysis required by section 587B; the failure to submit an annual update required under section 587J(c)(2)(B); or the failure to complete postmarket surveillance as required under section 587X. (6) The failure to comply with applicable requirements to submit an application or report under section 587D(e). (7) The failure to comply with applicable mitigating measures established under section 587E or to submit, maintain, or make available the documentation required under section 587E(b); or the failure to comply with applicable performance standards established under section 587R. (8) The failure to register in accordance with section 587J, the failure to provide information required under section 587J(b), or the failure to maintain or submit information required under section 587J(c). (9) The failure to comply with requirements under section 587M or 587N, the failure to comply with a restriction required under section 587O, or the failure to comply with labeling and advertising requirements under section 587O(b). (10) The failure to comply with the requirements of section 587Q. (11) The failure to comply with any requirement of section 587S; the failure to furnish any notification, information, material, or report required under section 587S; or the failure to comply with an order issued under section 587S. (12) The failure to furnish information requested by the Secretary under 587G(d)(2). . (b) Penalties Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended— (1) in subsection (b)(8), by inserting or counterfeit in vitro clinical test after counterfeit drug ; (2) in subsection (c)— (A) by striking ; or (5) and inserting ; (5) ; and (B) by inserting before the period at the end the following: ; or (6) for having violated section 301(fff)(2) if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in an in vitro clinical test being a counterfeit in vitro clinical test, or for having violated section 301(fff)(3) if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the in vitro clinical test was a counterfeit in vitro clinical test ; and (3) in subsection (f)(1)— (A) in subparagraph (A)— (i) by inserting or in vitro clinical tests after which relates to devices ; (ii) by inserting or section 587Q(a)(2) after section 704(g) ; and (iii) by inserting or in vitro clinical tests, as applicable before the period at the end of the second sentence; and (B) in subparagraph (B)(i), by striking or 520(f) and inserting , 520(f), 587K, or 587M, . (c) Seizure Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ) is amended— (1) in subsection (a)(2)— (A) by striking , and (E) and inserting , (E) ; and (B) by inserting before the period at the end the following: , and (F) Any in vitro clinical test that is a counterfeit in vitro clinical test, (G) Any container, packaging, or labeling of a counterfeit in vitro clinical test, and (H) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit in vitro clinical test ; (2) in subsection (d)(1), by inserting in vitro clinical test, after device, ; and (3) in subsection (g)— (A) in paragraph (1), by inserting , in vitro clinical test, after device each place it appears; and (B) in paragraph (2)— (i) in subparagraph (A), by inserting , in vitro clinical test, after device ; and (ii) in subparagraph (B), by inserting or in vitro clinical test after device each place it appears. (d) Debarment, temporary denial of approval, and suspension Section 306 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a ) is amended by adding at the end the following: (n) In vitro clinical tests; mandatory debarment regarding third-Party inspections and reviews (1) In general If the Secretary finds that a person has been convicted of a felony for a violation of section 301(gg) or 301(jjj)(1), the Secretary shall debar such person from being accredited under section 587Q and from carrying out activities under an agreement described in section 803(b). (2) Debarment period The Secretary shall debar a person under paragraph (1) for the following periods: (A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent. (B) The debarment of an individual shall be permanent. (3) Termination of debarment; judicial review; other matters Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph (1) to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively. . (e) Expanded access to unapproved therapies and diagnostics Section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) is amended— (1) in subsections (a) through (d)— (A) by striking or investigational devices each place it appears and inserting , investigational devices, or investigational in vitro clinical tests ; and (B) by striking or investigational device each place it appears (other than the second such place in paragraph (3)(A)) of subsection (c)) and inserting , investigational device, or investigational in vitro clinical test ; (2) in subsection (b)(4) by striking or 520(g) and inserting , 520(g), or 587S each place it appears; (3) in subsection (c)— (A) by amending the subsection heading to read: Treatment Investigational New Drug Applications, Treatment Investigational Device Exemptions, and Treatment Investigational in Vitro Clinical Test Exemptions .— ; (B) in paragraph (3)(A), by striking or investigational device exemption in effect under section 520(g) and inserting , investigational device exemption in effect under section 520(g), or investigational in vitro clinical test exemption under section 587S ; (C) by striking or treatment investigational device exemption each place it appears and inserting , treatment investigational device exemption, or treatment investigational in vitro clinical test exemption ; (D) in paragraph (5), by striking or 520(g) and inserting , 520(g), or 587S ; and (E) in the matter following paragraph (7) by striking or 520(g) each place it appears and inserting , 520(g) or 587S ; and (4) by amending subsection (e) to read as follows: (e) Definitions In this section, the terms investigational drug , investigational device , investigational in vitro clinical test , treatment investigational new drug application , treatment investigational device exemption , and treatment investigational in vitro clinical test exemption shall have the meanings given the terms in regulations prescribed by the Secretary. . (f) Optimizing global clinical trials Section 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8a(b)) is amended by inserting an in vitro clinical test, as defined in subsection (ss) of such section, before or a biological product . (g) Patient participation in medical product discussion The heading of subsection (a) of section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c ) is amended by striking Drugs and Devices and inserting Drugs, Devices, and In Vitro Clinical Tests . (h) Regulations and hearings Section 701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h)(1)(C)(ii) ) is amended by inserting and in vitro clinical tests after devices . (i) Records Section 703 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 373 ) is amended— (1) by inserting in vitro clinical tests after devices each place such term appears; and (2) by inserting in vitro clinical test after device each place such term appears. (j) Factory inspection Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) (other than subsection (g)) is amended— (1) by striking drugs or devices each place it appears and inserting drugs, devices, or in vitro clinical tests ; (2) in subsection (a)(1), in the fourth sentence, by striking or chapter IX and inserting section 587S, section 587M, section 587N, or chapter IX ; (3) after making the amendments in paragraphs (1) and (2), by inserting in vitro clinical tests, after devices, each place it appears; (4) in subsection (a)(2)(B)— (A) by inserting or in vitro clinical tests after prescribe or use devices ; and (B) by inserting or in vitro clinical tests after process devices ; (5) by inserting in vitro clinical test, after device, each place it appears; (6) in subsection (e), by inserting , or section 587M, 587N, or 587S, after section 519 or 520(g) ; (7) in subsection (f)(3)— (A) in subparagraph (A), by striking or at the end; (B) in subparagraph (B), by striking the period at the end and inserting ; or ; and (C) after subparagraph (B), by inserting the following: (C) is accredited under section 587Q. ; and (8) by adding at the end the following: (i) For purposes of this section, the term establishment includes a laboratory performing an in vitro clinical test. . (k) Publicity Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) ) is amended by inserting in vitro clinical tests, after devices, . (l) Presumption Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a ) is amended by inserting in vitro clinical test, after device, . (m) Listing and certification of color additives for foods, drugs, and cosmetics Section 721(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379e(a) ) is amended— (1) in the matter preceding paragraph (1), by inserting or in vitro clinical tests after or devices ; and (2) in the flush text following paragraph (2)— (A) by inserting or an in vitro clinical test after a device ; and (B) by inserting or in vitro clinical tests after devices . (n) Imports and exports Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended— (1) in subsection (a)— (A) by inserting in vitro clinical tests, after devices, each place it appears; and (B) by inserting in the case of an in vitro clinical test, the test does not conform to the applicable requirements of section 587K, or after requirements of section 520(f), or ; (2) in subsection (d)(3)— (A) in subparagraph (A)— (i) in the matter preceding clause (i), by inserting and no component of an in vitro clinical test or other article of in vitro clinical test that requires further processing, after health-related purposes ; (ii) in clause (i), by striking drug or device and inserting drug, device, or in vitro clinical test ; and (iii) in clause (i)(I), by inserting in vitro clinical test, after device, ; and (B) in subparagraph (B), by inserting in vitro clinical test, after device, ; (3) in subsection (e)(1), by inserting in vitro clinical test, after device, ; and (4) in subsection (o)— (A) by inserting or in vitro clinical test after device ; and (B) by inserting section 587J of each foreign establishment after section 510(i) of each establishment . (o) Office of international relations Section 803 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 383 ) is amended— (1) in subsection (b)— (A) in the matter preceding paragraph (1), by inserting and in vitro clinical tests after devices ; and (B) in paragraph (1), by inserting quality requirements established under section 587K; and at the end; and (2) in subsection (c)— (A) in paragraph (2), by inserting in vitro clinical tests, after devices, ; and (B) in paragraph (4), by inserting or in vitro clinical tests after devices . (p) Recognition of foreign government inspections Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e(a)(1) ) is amended by inserting , or of foreign establishments registered under section 587J after 510(h) . (q) Food and drug administration Section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 393(b)(2) ) is amended— (1) in subparagraph (D), by striking and at the end; (2) in subparagraph (E), by striking the semicolon at the end and inserting ; and ; and (3) by adding at the end the following: (F) in vitro clinical tests are analytically and clinically valid; . (r) Office of women’s health Section 1011(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399b(b) ) is amended— (1) in paragraph (1), by inserting in vitro clinical tests, after devices, ; and (2) in paragraph (4), by striking and device manufacturers and inserting device manufacturers, and in vitro clinical test developers, . (s) Countermeasure provisions of the public health service act Title III of the Public Health Service Act is amended— (1) in section 319F–1(a)(2)(A) (42 U.S.C. 247d–6a(a)(2)(A))— (A) in the matter preceding clause (i)— (i) by striking or device and inserting device ; and (ii) by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), after Act ( 21 U.S.C. 321(h) )), ; and (B) in each of clauses (ii) and (iii), by striking or device and inserting device, or in vitro clinical test ; (2) in section 319F–2(c)(1)(B) (42 U.S.C. 247d–6b(c)(1)(B))— (A) by striking or device and inserting device ; and (B) by inserting , or an in vitro clinical test (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )) after Act ( 21 U.S.C. 321(h) )), ; and (3) in section 319F–3(i)(7) (42 U.S.C. 247d–6d(i)(7))— (A) in the matter preceding subparagraph (A)— (i) by striking or device and inserting device ; and (ii) by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(ss) )), after Act ( 21 U.S.C. 321(h) ) ; (B) in subparagraph (A)— (i) by moving the margin of clause (iii) 2 ems to the left; and (ii) in clause (iii), by striking or device and inserting device, or in vitro clinical test ; and (C) in subparagraph (B)— (i) in clause (i), by inserting or the subject of a technology certification order after approved or cleared ; and (ii) in clause (ii), by striking or 520(g) and inserting , 520(g), or 587S . 825. Transition (a) Implementation (1) Effective date (A) In general Except as otherwise provided in this section, the amendments made by this Act shall take effect on October 1, 2027 (in this section and in subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, referred to in this section as the effective date of this Act ). (B) Exceptions (i) In general The Secretary of Health and Human Services (in this section referred to as the Secretary ) may take the actions described in paragraph (3), and may expend such funds as the Secretary determines necessary to ensure an orderly transition, including prior to the effect date of this Act. (ii) Implementation of certain provisions The Secretary may implement sections 587J and 587U of the Federal Food, Drug, and Cosmetic Act (as added by section 3) beginning on October 1, 2024, and such sections may take effect not earlier than October 1, 2027, to the extent and for the purposes indicated in such sections. In the case of a developer who, between October 1, 2024, and the effective date of this Act specified in subparagraph (A), registers under such section 587K with respect to an article that is an in vitro clinical test, such developer shall not be required to register with respect to such article under section 510 of such Act ( 21 U.S.C. 360 ). (2) Actions The Secretary— (A) shall— (i) within 1 year of the date of enactment of this Act, hold the public meetings described in section 587D(c) of the Federal Food, Drug, and Cosmetic Act (as added by section 3); (ii) within 3 years of the date of enactment of this Act, promulgate final regulations required under the amendments made by this Act; and (iii) within 30 months of the date of enactment of this Act, issue final guidance on applicability requirements under amendments made by this Act; and (B) may take additional actions after the date of enactment that the Secretary determines necessary to ensure an orderly transition, which may not take effect until after the effective date, including— (i) establishment of mitigating measures for an in vitro clinical test or category of in vitro clinical tests; and (ii) establishment of the comprehensive test information system under section 587T. (3) Applicability of guidance and regulations Notwithstanding the date on which guidance or regulations are issued under paragraph (3) and section 587K, no guidance or regulations issued pursuant to the amendments made by this Act shall be implemented or take effect until the effective date of this Act, as described in paragraph (1), except as otherwise specified in this Act (including the amendments made by this Act). (b) Application of authorities to in vitro clinical tests under review on the effective date of this act For any in vitro clinical test, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by section 822, for which a submission for approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ), clearance under section 510(k) of such Act ( 21 U.S.C. 360(k) ), authorization under section 513(f)(2) of such Act ( 21 U.S.C. 360c(f)(2) ), or licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is pending on the effective date of this Act, including transitional in vitro clinical tests as described in subsection (c), the Secretary may review and take action on such submission after the effective date of this Act according to the statutory provision under which such submission was submitted. (c) Application of authorities to transitional In vitro clinical tests (1) Definition For purposes of this section, the term transitional in vitro clinical test means an in vitro clinical test, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, that— (A) is first offered for clinical use during the period beginning on the date of enactment of this Act and ending on the effective date of this Act; (B) is developed by a clinical laboratory certified by the Secretary under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) that meets the requirements for performing high-complexity testing and performed— (i) in the same clinical laboratory in which the test was developed and for which a certification is still in effect under such section 353 that meets the requirements to perform tests of high complexity; (ii) by another laboratory for which a certificate is in effect under such section 353 that meets the requirements to perform tests of high complexity, is within the same corporate organization, and has common ownership by the same parent corporation as the laboratory in which the test was developed; or (iii) in the case of a test that was developed by the Centers for Disease Control and Prevention or another laboratory a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, by a clinical laboratory for which a certificate is in effect under section 353 of such Act that meets the requirements to perform tests of high complexity, and that is within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; and (C) when first offered, is not approved under section 515 of the Federal Food, Drug, and Cosmetic Act, cleared under section 510(k) of such Act, authorized under section 513(f)(2) of such Act, subject to a humanitarian device exemption under section 520(m) of such Act ( 21 U.S.C. 360j(m) ), subject to an exemption for investigation use under section 520(g) of such Act ( 21 U.S.C. 360j(g) ), authorized under section 564 of such Act ( 21 U.S.C. 360bbb–3 ), or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). (2) Premarket review or technology certification A transitional in vitro clinical test that is the subject of an application for premarket review under section 587B of the Federal Food, Drug, and Cosmetic Act or technology certification application under section 587D of such Act, as added by this Act, may continue to be offered, sold, or distributed until completion of the Secretary’s review of the premarket application or technology certification application, if such application is submitted no later than 90 days after the effective date of this Act. (3) Tests approved by new york state Notwithstanding paragraph (2), a transitional in vitro clinical test that has been approved by the New York State Department of Health may continue to be offered, sold, or distributed after the effective date if— (A) starting on the effective date of this Act, the in vitro clinical test complies with the requirements of subchapter J of the Federal Food, Drug, and Cosmetic Act, as added by this Act, except for sections 587B and design control provisions of section 587K; (B) each test report template for the test bears a statement of adequate prominence that reads as follows: This in vitro clinical test was developed and first introduced prior to the effective date of the VALID Act of 2022 . This test was approved by the New York State Department of Health, but the test has not been reviewed by the Food and Drug Administration. ; (C) a premarket application under section 587B or technology certification application under section 587D is submitted no later than— (i) 5 years after the effective date of this Act, if the in vitro clinical test is approved by the New York State Department of Health as a genetic testing molecular test, a microbiology molecular test, an oncology molecular test, or any other type of molecular test; or (ii) 2 years after the effective date of this Act, if the in vitro clinical test is approved by the New York State Department of Health as a type of test not described in clause (i); and (D) a test in compliance with this paragraph (3) may continue to be offered, sold, or distributed until the completion of the Secretary’s review of the premarket application or technology certification application referenced in subparagraph (C). (d) Conversion (1) Deemed premarket approval Beginning on the effective date of this Act— (A) any in vitro clinical test (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by section 822) with a premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ) or a licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is deemed to be approved pursuant to an application under section 587B(c) of the Federal Food, Drug, and Cosmetic Act, as added by this Act; and (B) any in vitro clinical test (as so defined) that was cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) or authorized under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(f)(2) ) is deemed to be approved pursuant to an application under section 587B(d) of the Federal Food, Drug, and Cosmetic Act, as added by this Act. (2) Deemed investigational use exemption Any in vitro clinical test (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by section 822) that has an investigational device exemption in effect under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) is deemed to have an investigational use exemption in effect under section 587S of such Act, as added by this Act, beginning on the effective date of this Act. (3) Deemed humanitarian device exemption Any in vitro clinical test (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by section 822) that has an approved humanitarian device exemption under section 520(m) of such Act is deemed to have a humanitarian test exemption under section 587A(g) of such Act, as added by this Act, beginning on the effective date of this Act. (4) Deemed designated breakthrough Any in vitro clinical test (as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act, as added by section 822) that has received a breakthrough device designation under section 515B(e)(1)(D) of such Act ( 21 U.S.C. 360e–3(e)(1)(D) ) is deemed to have a breakthrough in vitro clinical test designation under section 587C of such Act, as added by this Act, beginning on the effective date of this Act. (5) Deemed request for informal feedback With regard to any in vitro clinical test that is the subject of a pre-submission request described in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , issued by the Food and Drug Administration on January 6, 2021, such request is deemed to constitute a request for informal feedback under section 587F of the Federal Food, Drug, and Cosmetic Act, as added by section 823, beginning on the effective date of this Act. (e) Previously classified devices Notwithstanding section 587 of the Federal Food, Drug, and Cosmetic Act, as added by section 823, for purposes of subchapter J of chapter V of such Act, as added by section 823, the following apply: (1) In the case of an in vitro clinical test type that has been classified by the Secretary as a class I device pursuant to section 513 of such Act ( 21 U.S.C. 360c ), such in vitro clinical test shall be low-risk, unless the in vitro clinical test is a test described in section 510(l) or the test is redesignated by the Secretary pursuant to section 587F of such Act. (2) In the case of an in vitro clinical test type that has been classified by the Secretary as a class II device pursuant to section 513 of such Act ( 21 U.S.C. 360c ), such in vitro clinical test shall be moderate-risk, unless inaccurate results from the test would be immediately life threatening or the test is redesignated by the Secretary pursuant to section 587F of such Act. (3) In the case of an in vitro clinical test type that is a class III device pursuant to section 513 of such Act ( 21 U.S.C. 360c ), such in vitro clinical test shall be high-risk, unless redesignated by the Secretary pursuant to section 587F of such Act. 826. Emergency use authorization (a) In general Section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) is amended— (1) in subsection (a)— (A) in paragraphs (1) and (4)(C), by inserting in vitro clinical test, before or biological product each place such term appears; and (B) in paragraph (2)(A), by striking or 515 and inserting 515, or 587B ; (2) in subsection (e)— (A) in paragraph (3)— (i) in subparagraph (B), by striking and at the end; (ii) in subparagraph (C), by striking the period and inserting ; and ; and (iii) by adding at the end the following: (D) quality requirements (with respect to in vitro clinical tests) under section 587K. ; and (B) in paragraph (4)— (i) in subparagraph (A), by striking ; or and inserting a semicolon; (ii) in subparagraph (B), by striking the period and inserting ; or ; and (iii) by adding at the end the following: (C) with respect to in vitro clinical tests, requirements applicable to restricted in vitro clinical tests pursuant to section 587O. ; (3) in subsection (m)— (A) in the subsection heading, by striking Laboratory tests associated with devices inserting in vitro clinical tests after devices ; and (B) in paragraph (1)— (i) by striking to a device and inserting to an in vitro clinical test ; and (ii) by striking such device and inserting such in vitro clinical test . (b) Emergency use of medical products Section 564A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(2)) is amended by inserting in vitro clinical test, after device, . (c) Products held for emergency use Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended— (1) in subparagraph (A), by striking or 515 and inserting 515, or 587B ; and (2) in subparagraph (B), by striking or 520 and inserting 520, or 587S. 827. Antimicrobial susceptibility tests Section 511A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a–2 ) is amended— (1) in subsection (a)(1)(C)— (A) by striking clear under section 510(k), classify under section 513(f)(2), or approve under section 515 and inserting approve under section 587B, exempt from premarket review under section 587C, or grant a technology certification order under section 587D ; and (B) by striking testing devices and inserting in vitro clinical tests ; (2) in subsection (c)(5), by striking drug or device each place it appears and inserting drug, device, or in vitro clinical test ; (3) in subsection (e)— (A) in the heading, by striking testing devices and inserting In vitro clinical tests ; (B) in paragraph (1)— (i) by striking 510, 513, and 515, and inserting 587B, and 587D ; (ii) by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test ; and (iii) by striking such device and inserting such in vitro clinical test ; and (C) in paragraph (2)— (i) in the heading, by striking testing devices and inserting in vitro clinical tests ; (ii) in subparagraphs (A) and (B) (other than clause (iii) of such subparagraph (B)), by striking device each place it appears and inserting in vitro clinical test ; (iii) in subparagraph (B)(iii), by striking a device and inserting an in vitro clinical test ; and (iv) by amending subparagraph (C) to read as follows: (C) The antimicrobial susceptibility in vitro clinical test meets all other requirements to be approved under section 587B, exempted from premarket review under section 587C, or offered under a technology certification order under section 587D. ; (4) in subsection (f), by amending paragraph (1) to read as follows: (1) The term antimicrobial susceptibility in vitro clinical test means an in vitro clinical test that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs). ; and (5) in subsection (g)(2)— (A) by amending the matter preceding subparagraph (A) to read as follows: (2) with respect to approving an application under section 587B or granting a technology certification order under section 587D— ; and (B) in subparagraph (A)— (i) by striking device and inserting in vitro clinical test ; and (ii) by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test . 828. Combination products (a) In general Section 503(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A), by striking or biological product and inserting in vitro clinical test, or biological product (except for a product constituted of a device and an in vitro clinical test) ; (B) in subparagraph (B), by adding at the end the following: For purposes of this Act, a product that constitutes a combination of a drug and an in vitro clinical test is not a combination product within the meaning of this subsection. ; and (C) in subparagraph (D)(ii)— (i) by inserting or in vitro clinical test after device ; and (ii) by inserting and in vitro clinical tests before shall ; (2) in paragraph (3), by striking safety and effectiveness or substantial equivalence and inserting safety and effectiveness, substantial equivalence, or analytical validity and clinical validity before for the approved constituent part ; (3) in paragraph (4)— (A) in subparagraph (A), by striking or 513(f)(2) (submitted in accordance with paragraph (5)) and inserting 513(f)(2) (submitted in accordance with paragraph (5)), 587B, or 587D, or an exempt test under section 587C, as applicable ; and (B) in subparagraph (B), by inserting , 587B, or 587D after section 515 ; (4) in paragraph (5)(A), by striking or 510(k) and inserting , 510(k), 587B, or 587D ; (5) in paragraph (7), by striking or substantial equivalence and inserting , substantial equivalence, or analytical validity and clinical validity ; (6) in paragraph (8), by adding at the end the following: (I) This paragraph shall not apply to a product constituted of a device and an in vitro clinical test. ; and (7) in paragraph (9)— (A) in subparagraph (C)(i), by striking or 520(g) and inserting 520(g), 587B, or 587D ; and (B) in subparagraph (D), by striking or 520 and inserting 520, 587B, or 587D . (b) Classification of products Section 563 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–2 ) is amended by adding at the end the following: (d) Exemption This section shall not apply to a product constituted of a device and an in vitro clinical test. . 829. Resources (a) Findings Congress finds that the fees authorized by this section will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. (b) Authorization of appropriations For purposes of funding implementation of subchapter J of title V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, including undertaking activities for the development of regulations and guidances, hiring of necessary staff, and the development of technology systems to implement this subchapter in a timely, effective, and efficient manner there is authorized to be appropriated $480,000,000. (c) Establishment of user fee program (1) Development of user fees for in vitro clinical tests (A) In general Beginning not later than October 1, 2021, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall develop recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of in vitro clinical test submissions and applications under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, for the first 5 fiscal years after fiscal year 2022. In developing such recommendations, the Secretary shall consult with— (i) the Committee on Health, Education, Labor, and Pensions of the Senate; (ii) the Committee on Energy and Commerce of the House of Representatives; (iii) scientific and academic experts; (iv) health care professionals; (v) representatives of patient and consumer advocacy groups; and (vi) the regulated industry. (B) Prior public input Prior to beginning negotiations with the regulated industry on the authorization of such subchapter J, the Secretary shall— (i) publish a notice in the Federal Register requesting public input on the authorization of user fees; (ii) hold a public meeting at which the public may present its views on the authorization, including specific suggestions for the recommendations submitted under subparagraph (E); (iii) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to such subchapter J; and (iv) publish any comments received under clause (iii) on the website of the Food and Drug Administration. (C) Periodic consultation Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of the authorization under such subchapter J and to solicit suggestions to be included in the recommendations transmitted to Congress under subparagraph (E). (D) Public review of recommendations After negotiations with the regulated industry, the Secretary shall— (i) present the recommendations developed under subparagraph (A) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; (ii) publish such recommendations in the Federal Register; (iii) provide for a period of 30 days for the public to provide written comments on such recommendations; (iv) hold a meeting at which the public may present its views on such recommendations; and (v) after consideration of such public views and comments, revise such recommendations as necessary. (E) Transmittal of recommendations (i) In general Not later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under subparagraph (A), a summary of the views and comments received under such subparagraph, and any changes made to the recommendations in response to such views and comments. (ii) Recommendation requirements The recommendations transmitted under this subparagraph shall— (I) include the number of full-time equivalent employees per fiscal year that are agreed to be hired to carry out the goals included in such recommendations for each year of the 5-year period; (II) provide that the amount of operating reserve balance in the user fee program established under this section is not more than the equivalent of 10 weeks of operating reserve; (III) require the development of a strategic plan for any surplus within the operating reserve account above the 10-week operating reserve within 2 years of the establishment of the program; (IV) include an operating reserve adjustment such that, if the Secretary has an operating reserve balance in excess of 10 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 10 weeks of such operating reserves; (V) if an adjustment is made as described in subclause (IV), provide the rationale for the amount of the decrease in fee revenue and fees shall be contained in the Federal Register; and (VI) provide that the fees assessed and collected for the full-time equivalent employees at the Center for Devices and Radiological Health, with respect to which the majority of time reporting data indicates are dedicated to the process for the review of in vitro clinical test submissions and applications under paragraph (5), are not supported by the funds authorized to be collected and assessed under section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ). (F) Publication of recommendations The Secretary shall publish on the website of the Food and Drug Administration the revised recommendations under subparagraph (A), a summary of the views and comments received under subparagraphs (B) through (D), and any changes made to the recommendations originally proposed by the Secretary in response to such views and comments. (G) Minutes of negotiation meetings (i) Public availability The Secretary shall make publicly available, on the website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry not later than 30 days after such meeting. (ii) Content The minutes described under clause (i) shall summarize any substantive proposal made by any party to the negotiations, any significant controversies or differences of opinion during the negotiations, and the resolution of any such controversy or difference of opinion. (2) Establishment of user fee program Effective on October 1, 2027, provided that the Secretary transmits the recommendations under paragraph (1)(E), the Secretary is authorized to collect user fees relating to the review of in vitro clinical test submissions and applications under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act. Fees under such program shall be assessed and collected only if the requirements under paragraph (4) are met. (3) Audit (A) In general On the date that is 2 years after first receiving a user fee applicable to submission of an in vitro clinical test application submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and on a biennial basis thereafter, the Secretary shall perform an audit of the costs of reviewing such applications under such subchapter J. Such an audit shall compare the costs of reviewing such applications under such subchapter J to the amount of the user fee applicable to such applications. (B) Alteration of user fee If the audit performed under subparagraph (A) indicates that the user fees applicable to applications submitted under such subchapter J exceed 49 percent of the costs of reviewing such applications, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. (C) Accounting standards The Secretary shall perform an audit under subparagraph (A) in conformance with the accounting principles, standards, and requirements prescribed by the Comptroller General of the United States under section 3511 of title 31, United States Code, to ensure the validity of any potential variability. (4) Conditions The user fee program described in this subsection shall take effect only if the Food and Drug Administration issues draft guidance related to the review requirements for in vitro diagnostic tests that would be subject to premarket review under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 823, the review requirements for test categories eligible for technology certification under section 587D of such Act, as added by section 823, and the parameters for the test categories that would be exempt from any review under subchapter J of chapter V of such Act. (5) User fee program definitions and resource requirements (A) In general The term process for the review of in vitro clinical test submissions and applications means the following activities of the Secretary with respect to the review of in vitro clinical test premarket and technology certification applications including supplements for such applications: (i) The activities necessary for the review of premarket applications, premarket reports, technology certification applications, and supplements to such applications. (ii) Actions related to submissions in connection with in vitro clinical test development, the issuance of action letters that allow the marketing of in vitro clinical tests or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to support the development of in vitro clinical tests. (iii) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, technology certifications, and supplements. (iv) Monitoring of research conducted in connection with the review of such applications, supplements, and submissions. (v) Review of in vitro clinical test applications subject to section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and activities conducted in anticipation of the submission of such applications for investigational use under section 587S of the Federal Food, Drug, and Cosmetic Act (as added by section 823). (vi) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, technology certification applications, and supplements. (vii) The development of voluntary test methods, consensus standards, or mandatory performance standards in connection with the review of such applications, supplements, or submissions and related activities. (viii) The provision of technical assistance to in vitro clinical test developers in connection with the submission of such applications, reports, supplements, or submissions. (ix) Any activity undertaken in connection with the initial classification or reclassification of an in vitro clinical test in connection with any requirement for approval or eligibility for an exemption from premarket review of an in vitro clinical test. (x) Any activity undertaken in connection with making a pathway determination of an in vitro clinical test, including the identification, establishment, and implementation of mitigation measures. (xi) Evaluation of postmarket studies required as a condition of an approval of a premarket application of an in vitro clinical test and ensuring such studies are conducted as required. (xii) Any activity undertaken in connection with ensuring in vitro clinical tests marketed under an exemption from premarket review pursuant to section 587C or 587G meet the criteria for such exemption and the applicable standard. (xiii) Compiling, developing, and reviewing information on in vitro clinical tests necessary to identify issues with the ability of in vitro clinical tests to meet the applicable standard, as applicable. (B) Resource requirements Fees collected and assessed under this section shall be used for the process for the review of in vitro clinical test applications, as described in subparagraph (A), and shall— (i) be subject to the limitation under section 738(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g)(3) ), in the same manner that fees collected and assessed under section 737(9)(C) of such Act ( 21 U.S.C. 379i(9)(C) ) are subject to such limitation; (ii) include travel expenses for officers and employees of the Food and Drug Administration only if the Secretary determines that such travel is directly related to an activity described in subparagraph (A); and (iii) not be allocated to purposes described under section 722(a) of the Consolidated Appropriations Act, 2018 ( Public Law 115–141 ). (d) Reports (1) Performance report (A) In general (i) General requirements Beginning with fiscal year 2027, for each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. (ii) Additional information Beginning with fiscal year 2021, the annual report under this subparagraph shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including— (I) the number of premarket applications filed under section 587B of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year; (II) the number of technology certification applications submitted under section 587D of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year for each review division; (III) the number of breakthrough designations under section 587I of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year; and (IV) the number of information requests requested by the Secretary pursuant to section 587G(d) of such Act. (iii) Real-time reporting (I) In general Not later than 30 calendar days after the end of the second quarter of fiscal year 2027, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph. (II) Data The Secretary shall post the following data in accordance with subclause (I): (aa) The number and titles of draft and final regulations on topics related to the process for the review of in vitro clinical test submissions and applications, and whether such guidances were required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E). (bb) The number and titles of draft and final guidance on topics related to the process for the review of in vitro clinical test submissions and applications, and whether such guidances were issued as required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (c)(1)(E). (cc) The number and titles of public meetings held on topics related to the process for the review of in vitro clinical tests, and if such meetings were required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (c)(1)(E). (iv) Rationale for IVCT user fee program changes Beginning with fiscal year 2027, the Secretary shall include in the annual performance report under paragraph (1)— (I) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E) and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; (II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of in vitro clinical test submissions and applications, including identifying drivers of such changes; and (III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required. (v) Analysis For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following: (I) The difference between the aggregate number of premarket applications filed under section 587B or section 587D of the Federal Food, Drug, and Cosmetic Act and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for— (aa) the number of applications filed under each of sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and (bb) the aggregate number of applications under each of sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act for each fiscal year that did not meet the goals as identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E). (II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E). (III) The most common causes and trends for external or other circumstances affecting the ability of the Food and Drug Administration to meet review time and performance enhancement goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E). (B) Publication With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E), the Secretary shall make such information publicly available on the website of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. (C) Updates The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all in vitro clinical test premarket applications and technology certification orders and supplements, premarket, and technology certification notifications in the cohort. (2) Corrective action report Beginning with fiscal year 2022, for each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit a corrective action report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives. The report shall include the following information, as applicable: (A) Goals met For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(v), that each of the goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E) for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the in vitro clinical test premarket application and technology certification review process. (B) Goals missed For each of the goals identified by the letters described in recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(E) for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include— (i) a justification for such determination; (ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act missed the review goal times but were approved during the first cycle review, as applicable; (iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and (iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year. (3) Fiscal report For fiscal years 2027 and annually thereafter, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made. (A) Contents Such report shall include expenditures delineated by budget authority and user fee dollars related to administrative expenses and information technology infrastructure contracts and expenditures. (B) Operating reserve Such report shall provide the amount of operating reserve balance available each year, and any planned allocations or obligations of such balance that is above 10 weeks of operating reserve for the program. (4) Public availability The Secretary shall make the reports required under paragraphs (1) through (3) available to the public on the website of the Food and Drug Administration. (5) Enhanced communication (A) Communications with Congress Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of in vitro clinical tests shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section. (B) Participation in congressional hearing Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this section. 830. Authorization of appropriations For purposes of funding implementation of this subtitle (including the amendments made by this subtitle), including undertaking activities for the development of regulations and guidances, hiring of necessary staff, and the development of technology systems to implement this subtitle (including the amendments made by this subtitle) in a timely, effective, and efficient manner, there is authorized to be appropriated not more than $480,000,000, to remain available through the end of fiscal year 2027. IX Other provisions 901. Facilities management (a) PDUFA authority Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(g)(2) )— (1) in subparagraph (A)(ii)— (A) by striking shall be available to defray and inserting the following: “shall be available— (I) for fiscal year 2023, to defray ; (B) by striking the period and inserting ; and ; and (C) by adding at the end the following: (II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor. ; and (2) in subparagraph (B), by striking for the process for the review of human drug applications and inserting as described in subclause (I) or (II) of such subparagraph, as applicable . (b) BsUFA authority Section 744H(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–52(f)(2) ) is amended— (1) in subparagraph (B)(i)— (A) by striking available for a fiscal year beginning after fiscal year 2012 and inserting the following: “available— (I) for fiscal year 2023 ; (B) by striking the fiscal year involved. and inserting such fiscal year; and ; and (C) by adding at the end the following: (II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved. ; and (2) in subparagraph (C), by striking subparagraph (B) in any fiscal year if the costs described in such subparagraph and inserting subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable, . (c) GDUFA authority Section 744B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42 ) is amended— (1) in subsection (e)(2), by striking 744A(11)(C) and inserting 744A(12)(C) ; and (2) in subsection (i)(2)— (A) in subparagraph (A)(ii)— (i) by striking available for a fiscal year beginning after fiscal year 2012 and inserting the following: “available— (I) for fiscal year 2023; and ; (ii) by striking the fiscal year involved. and inserting such fiscal year; and ; and (iii) by adding at the end the following: (II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 744A(3) applicable to the fiscal year involved. ; and (B) in subparagraph (B), by striking for human generic activities and inserting as described in subclause (I) or (II) of such subparagraph, as applicable . (d) MDUFA authority Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended— (1) in subsection (h)(2)— (A) in subparagraph (A)(ii)— (i) by striking shall be available to defray and inserting the following: “shall be available— (I) for fiscal year 2023, to defray ; (ii) by striking the period and inserting ; and ; and (iii) by adding at the end the following: (II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor. ; and (B) in subparagraph (B)(i), in the matter preceding subclause (I), by striking for the process for the review of device applications and inserting as described in subclause (I) or (II) of such subparagraph, as applicable ; and (2) in subsection (g)(3), by striking 737(9)(C) and inserting 737(10)(C) . (e) Technical correction (1) In general Section 905(b)(2) of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) is amended by striking Section 738(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(h) ) is amended and inserting Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ), as so redesignated by section 203(f)(2)(B)(i), is amended . (2) Effective date The amendment made by paragraph (1) shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ). 902. Annual report on inspections Section 902 of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ) is amended, in the matter preceding paragraph (1)— (1) by striking March 1 of each year and inserting 120 days after the end of each fiscal year ; and (2) by striking previous calendar year and inserting previous fiscal year . 903. User fee program transparency and accountability (a) PDUFA (1) Reauthorization; reporting requirements (A) Performance report Section 736B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2(a) ) is amended— (i) in paragraph (1)— (I) in subparagraph (B)— (aa) in clause (vii), by striking ; and and inserting a semicolon; (bb) in clause (viii), by striking the period and inserting ; and ; and (cc) by adding at the end the following: (ix) the number of investigational new drug applications submitted per fiscal year, including for each review division. ; and (II) by adding at the end the following flush text: Nothing in subparagraph (B) shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret, as prohibited under section 301(j) of this Act of section 1905 of title 18, United States Code. ; and (ii) in paragraph (4)— (I) by amending subparagraph (A) to read as follows: (A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 736, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; (II) by amending subparagraph (B) to read as follows: (B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying— (i) drivers of such changes; and (ii) changes in the average total cost per full-time equivalent in the prescription drug review program; ; (III) in subparagraph (C), by striking the period and inserting ; and ; and (IV) by adding at the end the following: (D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application. . (2) Reauthorization Section 736B(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2(f) ) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively; (B) by inserting after paragraph (3) the following: (4) Updates to Congress The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the and inserting The ; and (II) by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and (ii) in subparagraph (B), by inserting , in sufficient detail, after shall summarize . (b) MDUFA (1) Reauthorization; reporting requirements (A) Reports Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a)(1)(A) ) is amended— (i) in clause (ii)— (I) in subclause (II), by striking ; and and inserting a semicolon; (II) in subclause (III), by striking the period and inserting a semicolon; (III) by adding at the end the following: (IV) the number of investigational device exemption applications submitted under section 520(g) per fiscal year, including for each review division; and (V) the number of expedited development and priority review requests and designations under section 515B per fiscal year, including for each review division. ; and (IV) by adding at the end the following flush text: Nothing in this clause shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code. ; (ii) in the first clause (iv) (relating to rationale for MDUFA program changes)— (I) by amending subclause (I) to read as follows: (I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 738, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; (II) by amending subclause (II) to read as follows: (II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying— (aa) drivers of such changes; and (bb) changes in the average total cost per full-time equivalent in the medical device review program; ; (III) in subclause (III), by striking the period and inserting ; and ; and (IV) by adding at the end the following: (IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types. ; and (iii) by redesignating the second clause (iv) (relating to analysis) as clause (v). (2) Reauthorization Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) ) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively; (B) by inserting after paragraph (3) the following: (4) Updates to Congress The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the and inserting The ; and (II) by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and (ii) in subparagraph (B), by inserting , in sufficient detail, after shall summarize . (c) GDUFA (1) Reauthorization; reporting requirements (A) Performance report Section 744C(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43(a)(3) ) is amended— (i) by amending subparagraph (A) to read as follows: (A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744B, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; (ii) by amending subparagraph (B) to read as follows: (B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including— (i) identifying drivers of such changes; and (ii) changes in the total average cost per full-time equivalent in the generic drug review program; ; (iii) in subparagraph (C), by striking the period at the end and inserting ; and ; and (iv) by adding at the end the following: (D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application. . (2) Reauthorization Section 744C(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–43(f) ) is amended— (A) by redesignating paragraphs (4) through (6) as paragraphs (5) through (7), respectively; (B) by inserting after paragraph (3) the following: (4) Updates to Congress The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and (C) in paragraph (7), as so redesignated— (i) in subparagraph (A)— (I) by striking Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the and inserting The ; and (II) by inserting , not later than 30 days after each such negotiation meeting before the period at the end; and (ii) in subparagraph (B), by inserting , in sufficient detail, after shall summarize . (d) BSUFA (1) Reauthorization; reporting requirements Section 744I(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53(a)(4) ) is amended— (A) by amending subparagraph (A) to read as follows: (A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 744H, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; ; (B) by amending subparagraph (B) to read as follows: (B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying— (i) drivers of such changes; and (ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program; ; (C) in subparagraph (C), by striking the period at the end and inserting ; and ; and (D) by adding at the end the following: (D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application. . (2) Reauthorization Section 744I(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53(f) ) is amended— (A) by redesignating paragraphs (2) and (3) as paragraphs (5) and (6), respectively; (B) by inserting after paragraph (1) the following: (2) Prior public input Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall— (A) publish a notice in the Federal Register requesting public input on the reauthorization; (B) hold a public meeting at which the public may present its views on the reauthorization; (C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and (D) publish the comments on the Food and Drug Administration’s website. (3) Periodic consultation Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2). (4) Updates to Congress The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and (C) by adding at the end the following: (7) Minutes of negotiation meetings (A) Public availability The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting. (B) Content The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution. . 904. OTC hearing aids final rule Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a final rule to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j ), as described in section 709(b) of the FDA Reauthorization Act of 2017 ( Public Law 115–52 ). 905. Enhance intra-agency coordination and public health assessment with regard to compliance activities (a) Coordination Section 506D of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356d ) is amended— (1) by adding at the end the following: (g) Coordination The Secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research's Office of Compliance and Drug Shortage Program regarding the reviews of reports shared pursuant to section 704(b)(2), and any feedback or corrective or preventive actions in response to such reports. ; and (2) by amending subsection (f) to read as follows: (f) Temporary sunset Subsection (a) shall cease to be effective on the date that is 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act. Subsections (b), (c), and (e) shall not be in effect during the period beginning 5 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act and ending on the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 . Subsections (b), (c), and (e) shall be in effect beginning on the date of enactment of the Food and Drug Administration Safety and Landmark Advancements Act of 2022 . . (b) Reporting Section 506C–1(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1(a) ) is amended— (1) by redesignating paragraphs (3) through (7) as paragraphs (4) through (8), respectively; (2) by inserting after paragraph (2) the following: (3) provides the number of reports that were required under section 704(b)(2) to be sent to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages, and the number of such reports that were sent; ; and (3) in paragraph (3)(A), by striking paragraph (7) and inserting paragraph (8) . (c) Applicability (1) Subsection (a) The amendments made by subsection (a) shall apply beginning on the date of enactment of this Act. (2) Subsection (b) The amendments made by subsection (b) shall apply beginning on the date that is 1 year after the date of enactment of this Act. (d) Reporting of mutual recognition agreements for inspections and review activities Section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) ) is amended— (1) in paragraph (6)— (A) in subparagraph (A), by striking clause (ii) and inserting the following: (ii) the number of such registered establishments in each region of interest; (iii) the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the Secretary inspected in the previous calendar year; (iv) the number of inspections to support actions by the Secretary on applications under section 505 of this Act or section 351 of the Public Health Service Act, including the number of inspections to support actions by the Secretary on supplemental applications, including changes to manufacturing processes, the Secretary conducted in the previous fiscal year; (v) the number of routine surveillance inspections the Secretary conducted in the previous fiscal year; (vi) the number of for-cause inspections the Secretary conducted in the previous fiscal year, not including inspections described in clause (iv); and (vii) the number of inspections the Secretary has recognized pursuant to an agreement entered into pursuant to section 809, or otherwise recognized, for each of the types of inspections described in clauses (v) and (vi); ; (B) in subparagraph (B), by striking ; and and inserting a semicolon; (C) in subparagraph (C), by striking the period and inserting ; and ; and (D) by adding at the end the following: (D) the status of the efforts of the Food and Drug Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section 809, including any obstacles to expanding the use of such recognition. ; and (2) by adding at the end the following: (7) Region of interest For purposes of paragraph (6)(A), the term region of interest means a foreign geographic region or country, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the Secretary determines appropriate. . (e) Enhancing transparency of drug facility inspection timelines Section 902 of the FDA Reauthorization Act of 2017 ( 21 U.S.C. 355 note) is amended to read as follows: 902. Annual report on inspections Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), approval of a device under section 515 of such Act ( 21 U.S.C. 360e ), or clearance of a device under section 510(k) of such Act ( 21 U.S.C. 360(k) ) that were conducted during the previous calendar year. Such information shall include the following: (1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, including— (A) the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(11)(A)(i) ); (B) the median time for drugs described in section 506C(a) of such Act ( 21 U.S.C. 356c(a) ) only; and (C) the median time for drugs on the drug shortage list in effect under section 506E of such Act ( 21 U.S.C. 356f ). (2) The median time from the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(b) ) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1). (3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting related to conditions observed by the Secretary during an inspection, to the time at which the Secretary concludes that corrective actions to resolve such conditions have been taken. (4) The median time spent by staff of the Food and Drug Administration at a facility during an inspection, including— (A) the median time when records were provided remotely in accordance with a request under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(a)(4) ) in advance of the inspection; and (B) the median time when a request for records pursuant to such section 704(a)(4) was not issued, or complied with, in advance of the inspection. (5) The number and type of violations identified during inspections when a request for records pursuant to such section 704(a)(4) was issued and complied with in advance of the inspection, versus when a request for records pursuant to such section 704(a)(4) was not issued or complied with. (6) The number of facilities that did not implement requested corrective or preventive actions following a report issued pursuant to such section 704(b), resulting in a withhold recommendation, including the number of such times for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1). . | https://www.govinfo.gov/content/pkg/BILLS-117s4348is/xml/BILLS-117s4348is.xml |
117-s-4349 | II 117th CONGRESS 2d Session S. 4349 IN THE SENATE OF THE UNITED STATES June 6, 2022 Mr. Marshall (for himself and Mr. Braun ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to notifications of emerging signals concerning devices.
1. Notification with respect to potentially harmful devices Section 518(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360h(a) ) is amended by adding at the end the following: (3) (A) This paragraph applies in the event that the Secretary— (i) determines that a device meets the conditions described in paragraph (1), but there are no more practicable means available under the provisions of this Act (other than this section) to eliminate the risk described in paragraph (1), and the notification described in paragraph (2) will not provide a timely and practicable means to eliminate such risk; or (ii) otherwise determines that it is necessary to notify the public about an emerging signal concerning a device in order to reduce or limit the number of patients exposed to a potential risk identified based on an emerging signal. (B) For purposes of this paragraph, the term emerging signal mean new information about a marketed device— (i) that supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events; and (ii) for which the Secretary has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions or the known benefit-risk profile of the device. (C) In considering and taking actions under this section, the Secretary shall— (i) to the extent possible, rely solely on valid scientific evidence; and (ii) in any event, base its actions on credible scientific evidence, such that information that is unconfirmed, unreliable, or lacks sufficient strength of evidence shall not constitute an emerging signal or otherwise provide a basis for notification. (D) In the circumstances described in subparagraph (A), the Secretary may issue a public notification subject to the following procedures: (i) Any public notification under this paragraph shall include a description of the device or devices to which the notification applies, and shall reflect a totality of the evidence on which the notification is based and information about the known benefits and risks of the device or devices, including information available from the manufacturer or manufacturers. (ii) To the extent credible scientific evidence is presented to the Secretary that contradicts or modifies the information that serves as a potential basis for a notification, the Secretary shall include such scientific evidence in the public notification in a manner that provides the intended audience with a complete understanding of the overall nature of information concerning the potential risk. (iii) Prior to issuance of the public notification, the Secretary shall— (I) inform the manufacturer or manufacturers of the device or devices at issue, and provide the manufacturers the credible scientific evidence that is the basis for considering a public notification and the Secretary’s initial evaluation of such evidence as described in subparagraph (B)(ii); (II) to the extent the Secretary determines that any of the credible scientific evidence described in subclause (I) cannot be provided to manufacturers because such evidence constitutes confidential commercial information or trade secret information, the Secretary shall provide the manufacturers of the device or devices at issue with a description of the withheld evidence to the extent permissible by law and also generally describe the basis for withholding such evidence; and (III) provide the manufacturers of the device or devices at issue an adequate opportunity to comment as to the nature of the potential risk and the manner and content of an applicable notification, to share information about the potential risk, and to offer recommendations as to the form and content of the proposed notification, including consideration of alternative forms of notification and risk mitigation, and the Secretary shall consider such input from the manufacturers before issuing a public notification. (iv) Provide periodic and timely updates to the notification based on new information or contrary information, including affirmative notice in the event that the emerging signal or other source of potential risk has been determined not to apply or has otherwise been resolved or mitigated, such that no additional actions are required. Information provided by manufacturers subsequent to the initial public notification should be considered by the Secretary for purposes of providing updates. (v) With regard to information provided by manufacturers, the Secretary shall inform such manufacturers how such information affects or alters the Secretary’s initial evaluation and whether the notification will be updated or rescinded as a result of such information. (vi) At least every 6 months after issuance, the Secretary shall evaluate current credible scientific evidence to determine if a public notification should be rescinded, and if such determination is made, promptly provide notice of the rescission to the same audience and in the same manner as the original notification. (E) Not later than September 30, 2023, the Secretary shall revise the Food and Drug Administration guidance titled Public Notification of Emerging Postmarket Medical Device Signals ( Emerging Signals ) , to conform with this subsection. (F) Not later than September 30, 2023, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report regarding how patients, providers, and the public interpret and comprehend risk-related information provided or ordered by the Secretary relating to devices, including reports under this section, notifications concerning recalls, and notifications concerning adverse events, and whether the relative level of risk and appropriate mitigation for such risk are adequately understood. (G) To the extent the Secretary seeks to rely on data, analysis, or other information or findings provided by third parties that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Administration in making significant decisions concerning devices or considering issuance of orders under this section or section 522, the Secretary shall— (i) obtain access to the raw datasets, inputs, clinical or other assumptions, methods, analytical code, results, and other components underlying or comprising the analysis, conclusions or other findings upon which the Secretary seeks to rely; and (ii) in the event a significant decision is made, or an order under this section or section 522 is under consideration, in reliance on such information or findings, provide the manufacturer or manufacturers subject to such decision or order the information or findings, including the underlying information described in paragraph (1), except that any such underlying information that the Secretary determines to be confidential commercial information or trade secret information may be withheld but shall be described to the manufacturer or manufacturers to the extent permissible by law. . | https://www.govinfo.gov/content/pkg/BILLS-117s4349is/xml/BILLS-117s4349is.xml |
117-s-4350 | II 117th CONGRESS 2d Session S. 4350 IN THE SENATE OF THE UNITED STATES June 6, 2022 Mrs. Gillibrand introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for the expedited and duty-free importation of infant formula that may be lawfully marketed in the European Union, Canada, Japan, or the United Kingdom, and for other purposes.
1. Short title This Act may be cited as the Emergency Infant Formula Act . 2. Expedited importation of infant formula (a) Authorization for importation and sale (1) Declaration of shortage The President may declare, in consultation with the Commissioner of Food and Drugs and through Executive order, that a shortage exists in the United States of infant formula with respect to any period specified in such order. (2) Authorization for importation and sale The President, in consultation with the Commissioner of Food and Drugs, may authorize the importation, distribution, and sale of any covered infant formula, notwithstanding the provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), if the applicable brand, manufacturer, or manufacturing plant, or the specific infant formula product, is included in the Executive order promulgated pursuant to the authority provided by paragraph (1). Such Executive order may further specify, with respect to such authorized products, specific requirements with respect to the labeling or usage guidance to be eligible for importation, distribution, and sale pursuant to the authority provided by this paragraph. (3) Labeling requirements (A) Exemption from United States labeling requirements Any provision of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) relating to labeling requirements for infant formula products imported into the United States shall not apply with respect to such products imported pursuant to the authority provided by paragraph (2). (B) Requirement with respect to foreign marketing eligibility Notwithstanding subparagraph (A), the Commissioner of Food and Drugs shall require any retailer of covered infant formula imported subject to the authority provided by paragraph (2), including an online retailer, to include in an appropriate and conspicuous place next to the product or description of the product, as applicable, a label— (i) that indicates that such product has not been approved for importation, distribution, or sale by the Commissioner of Food and Drugs and is authorized for sale only subject to the provisions of this Act; and (ii) that may additionally indicate the foreign country or countries where such product may be lawfully marketed. (4) Termination of shortage The President may, upon determining that a shortage no longer exists in the United States of infant formula, terminate a declaration described in paragraph (1). (b) Duty-Free treatment Notwithstanding any other provision of law, the President may, during any period in which an infant formula shortage is declared in accordance with subsection (a)(1), reduce or suspend any duties imposed— (1) with respect to the importation of covered infant formula; or (2) with respect to any other article used in the production of infant formula that the importer certifies is being imported for such production. (c) Priority handling of entries During any period in which an infant formula shortage is declared in accordance with subsection (a)(1), the Commissioner of U.S. Customs and Border Patrol shall give the highest priority and take any steps as may be necessary to expedite the processing of all entries of covered infant formula and articles used in the production of infant formula (as described in subsection (b)(2)). (d) Covered infant formula In this Act: (1) Covered infant formula (A) In general Subject to subparagraph (B), the term covered infant formula means any infant formula that is lawfully marketed in the European Union, Canada, Japan, the United Kingdom, and any country the President determines to have sufficient health and safety standards with respect to infant formula. (B) Exception The President may exclude from the definition of covered infant formula products that— (i) are not labeled in English or another language specified by the President; (ii) do not include instructions for the use of the product which incorporate the imperial system of measurement; or (iii) include any potential allergen identified by the President. (2) Infant formula In paragraph (1), the term infant formula has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). (e) Use of Defense Production Act authorities During any period in which an infant formula shortage is declared in accordance with subsection (a)(1); (1) the President may use authorities provided by the Defense Production Act of 1950 ( 50 U.S.C. 4501 et seq. ) in the production of infant formula; and (2) infant formula shall be deemed to meet the criteria specified in section 101(b) of such Act. (f) Sunset This Act shall cease to be effective on the date that is 5 years after the date of enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4350is/xml/BILLS-117s4350is.xml |
117-s-4351 | II 117th CONGRESS 2d Session S. 4351 IN THE SENATE OF THE UNITED STATES June 6, 2022 Mr. Romney (for himself, Ms. Hassan , Ms. Rosen , and Mr. Hickenlooper ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the Secretary of Health and Human Services can approve generic drug applications with labeling temporarily different than the brand name drug, and for other purposes.
1. Short title This Act may be cited as the Enhanced Access to Affordable Medicines Act of 2022 . 2. Enhancing access to affordable medicines Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(10)(A) ) is amended by striking clauses (i) through (iv) and inserting the following: (i) a revision to the labeling of the listed drug has been approved by the Secretary within 90 days of when the application is otherwise eligible for approval under this subsection; (ii) the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than 60 days after approval under this subsection of the application; and (iii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling. . | https://www.govinfo.gov/content/pkg/BILLS-117s4351is/xml/BILLS-117s4351is.xml |
117-s-4352 | II 117th CONGRESS 2d Session S. 4352 IN THE SENATE OF THE UNITED STATES June 6, 2022 Mr. Cramer introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require a study on the effects of travel nurse agencies on the health industry during the COVID–19 pandemic.
1. Short title This Act may be cited as the Travel Nursing Agency Transparency Study Act . 2. GAO study on travel nurse agencies The Comptroller General of the United States shall— (1) conduct a study on the effects of travel nurse agencies on the health care industry during the COVID–19 pandemic, which shall include consideration of— (A) the business practices and payment practices of such agencies, including any potential price gouging and taking of excessive profits; (B) the difference between how much such agencies charged health care institutions and how much they paid their contracted nurses; (C) the extent to which such agencies could provide more transparency regarding the payments received from health care institutions, and the payments made by the agencies to the nurses who are contracted by such agencies; (D) the specific ways in which rural areas of the United States were affected by the rise of travel nursing across the country, and subsequent workforce shortage disparities; (E) how States that imposed caps to travel nurse pay were affected by the market reaction to such caps; (F) how Federal funds, including the Provider Relief Fund and any assistance granted to a health care institution under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5 121 et seq.), were used by health care institutions to pay such agencies throughout the workforce shortages exacerbated by the COVID–19 pandemic; (G) the extent to which travel nurse agency practices contribute to workforce shortages; and (H) the extent to which travel nurse agencies have been acquired by private equity firms and the impact of such acquisitions on the profits of the agencies; and (2) not later than 1 year after the date of enactment of this Act, submit a report to Congress on such study. | https://www.govinfo.gov/content/pkg/BILLS-117s4352is/xml/BILLS-117s4352is.xml |
117-s-4353 | II 117th CONGRESS 2d Session S. 4353 IN THE SENATE OF THE UNITED STATES June 7, 2022 Mrs. Murray (for herself and Mr. Burr ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code of 1986 to improve retirement plan provisions, and for other purposes.
1. Short title; table of contents (a) Short title This Act may be cited as the Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg Act or the RISE & SHINE Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Retirement Improvement and Savings Enhancement (RISE) Sec. 101. Updating dollar limit for mandatory distributions. Sec. 102. Multiple employer 403(b) plans. Sec. 103. Performance benchmarks for asset allocation funds. Sec. 104. Pooled employer plans modification. Sec. 105. Review of pension risk transfer interpretive bulletin. Sec. 106. Review and report to Congress relating to reporting and disclosure requirements. Sec. 107. Eliminating unnecessary plan requirements related to unenrolled participants. Sec. 108. Recovery of retirement plan overpayments. Sec. 109. Improving coverage for part-time workers. TITLE II—Emergency Savings Act of 2022 Sec. 201. Short title. Sec. 202. Emergency savings accounts linked to defined contribution plans. TITLE III—Notice and disclosure Sec. 301. Defined contribution plan fee disclosure improvements. Sec. 302. Consolidation of defined contribution plan notices. Sec. 303. Information needed for Financial Options Risk Mitigation Act. Sec. 304. Defined benefit annual funding notices. TITLE IV—Modernization Sec. 401. Automatic reenrollment under qualified automatic contribution arrangements and eligible automatic contribution arrangements. Sec. 402. Incidental plan expenses. TITLE V—Amendments to plans offered by multiple employers Sec. 501. Report on pooled employer plans. Sec. 502. Annual audits for group of plans. TITLE VI—Defined benefit plan provisions Sec. 601. Cash balance. Sec. 602. Termination of variable rate premium indexing. Sec. 603. Enhancing retiree health benefits in pension plans. TITLE VII—Additional retirement enhancements Sec. 701. Provisions relating to plan amendments. Sec. 702. Worker Ownership, Readiness, and Knowledge (WORK) Act. I Retirement Improvement and Savings Enhancement (RISE) 101. Updating dollar limit for mandatory distributions (a) In general Section 203(e)(1) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1053(e)(1) ) and sections 401(a)(31)(B)(ii) and 411(a)(11)(A) of the Internal Revenue Code of 1986 are each amended by striking $5,000 and inserting $7,000 . (b) Effective date The amendments made by this section shall apply to distributions made after December 31, 2023. 102. Multiple employer 403 (b) plans (a) In general Section 3(43)(A) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002(43)(A) ) is amended— (1) in clause (ii), by striking section 501(a) of such Code or and inserting section 501(a) of such Code, a plan that consists of contracts described in section 403(b) of such Code, or ; and (2) in the flush text at the end, by striking the plan. and inserting the plan, but such term shall include any program (other than a governmental plan) maintained for the benefit of the employees of more than 1 employer that consists of contracts described in section 403(b) of such Code and that meets the requirements of subparagraph (A) or (B) of section 413(e)(1) of such Code. . (b) Conforming amendments Sections 3(43)(B)(v)(II) and 3(44)(A)(i)(I) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002(43)(B)(v)(II) and 1002(44)(A)(i)(I)) are each amended by striking section 401(a) of such Code or and inserting section 401(a) of such Code, a plan that consists of contracts described in section 403(b) of such Code, or . (c) Effective date The amendments made by this section shall apply to plan years beginning after December 31, 2022. 103. Performance benchmarks for asset allocation funds (a) In general Not later than 2 years after the date of enactment of this Act, the Secretary of Labor shall promulgate regulations providing that, in the case of a designated investment alternative that contains a mix of asset classes, the administrator of a plan may, but is not required to, use a benchmark that is a blend of different broad-based securities market indices if— (1) the blend is reasonably representative of the asset class holdings of the designated investment alternative; (2) for purposes of determining the blend’s returns for 1-, 5-, and 10-calendar-year periods (or for the life of the alternative, if shorter), the blend is modified at least once per year to reflect changes in the asset class holdings of the designated investment alternative; (3) the blend is furnished to participants and beneficiaries in a manner that is reasonably designed to be understandable; and (4) each securities market index that is used for an associated asset class would separately satisfy the requirements of such regulation for such asset class. (b) Study Not later than 3 years after the date of enactment of this Act, the Secretary of Labor shall deliver a report to the Committees on Finance and Health, Education, Labor, and Pensions of the Senate and the Committees on Ways and Means and Education and Labor of the House of Representatives regarding the utilization, effectiveness, and participants’ understanding of the benchmarking requirements under this section. 104. Pooled employer plans modification (a) In general Section 3(43)(B)(ii) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002(43)(B)(ii) ) is amended to read as follows: (ii) designate a named fiduciary (other than an employer in the plan) to be responsible for collecting contributions to the plan and require such fiduciary to implement written contribution collection procedures that are reasonable, diligent, and systematic; . (b) Effective date The amendments made by this section shall apply to plan years beginning after December 31, 2022. 105. Review of pension risk transfer interpretive bulletin Not later than 1 year after the date of enactment of this Act, the Secretary of Labor shall— (1) review section 2509.95–1 of title 29, Code of Federal Regulations (relating to the fiduciary standards under the Employee Retirement Income Security Act of 1974 when selecting an annuity provider for a defined benefit pension plan) and consult with the Advisory Council on Employee Welfare and Pension Benefit Plans (established under section 512 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1142 )), to determine whether amendments to section 2509.95–1 of title 29, Code of Federal Regulations are warranted; and (2) report to Congress on the findings of such review and consultation, including an assessment of any risk to participants. 106. Review and report to Congress relating to reporting and disclosure requirements (a) Study As soon as practicable after the date of enactment of this Act, the Secretary of Labor, the Secretary of the Treasury, and the Director of the Pension Benefit Guaranty Corporation shall review the reporting and disclosure requirements, as applicable to each such agency head, of the Employee Retirement Income Security Act of 1974 applicable to pension plans (as defined in section 3(2) of such Act ( 29 U.S.C. 1002(2) )). (b) Report (1) In general Not later than 3 years after the date of enactment of this Act, the Secretary of Labor, the Secretary of the Treasury, and the Director of the Pension Benefit Guaranty Corporation, jointly, and after consultation with a balanced group of participant and employer representatives, shall with respect to plans referenced in subsection (a) report on the effectiveness of the applicable reporting and disclosure requirements and make such recommendations as may be appropriate to the Committee on Education and Labor and the Committee on Ways and Means of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate to consolidate, simplify, standardize, and improve such requirements so as to simplify reporting for such plans and ensure that plans can furnish and participants and beneficiaries timely receive and better understand the information they need to monitor their plans, plan for retirement, and obtain the benefits they have earned. (2) Analysis of effectiveness To assess the effectiveness of the applicable reporting and disclosure requirements, the report shall include an analysis, based on plan data, of how participants and beneficiaries are providing preferred contact information, the methods by which plan sponsors and plans are furnishing disclosures, and the rate at which participants and beneficiaries (grouped by key demographics) are receiving, accessing, understanding, and retaining disclosures. (3) Collection of information The agencies shall conduct appropriate surveys and data collection to obtain any needed information. 107. Eliminating unnecessary plan requirements related to unenrolled participants (a) Amendment of Employee Retirement Income Security Act of 1974 (1) In general Part 1 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021 et seq. ) is amended by redesignating section 111 as section 112 and by inserting after section 110 the following new section: 111. Eliminating unnecessary plan requirements related to unenrolled participants (a) In general Notwithstanding any other provision of this title, with respect to any individual account plan, no disclosure, notice, or other plan document (other than the notices and documents described in paragraphs (1) and (2)) shall be required to be furnished under this title to any unenrolled participant if the unenrolled participant is furnished— (1) an annual reminder notice of such participant’s eligibility to participate in such plan and any applicable election deadlines under the plan; and (2) any document requested by such participant that the participant would be entitled to receive notwithstanding this section. (b) Unenrolled participant For purposes of this section, the term unenrolled participant means an employee who— (1) is eligible to participate in an individual account plan; (2) has been furnished— (A) the summary plan description pursuant to section 104(b); and (B) any other notices related to eligibility under the plan required to be furnished under this title, or the Internal Revenue Code of 1986, in connection with such participant’s initial eligibility to participate in such plan; (3) does not have an account balance in the plan; and (4) satisfies such other criteria as the Secretary of Labor may determine appropriate, as prescribed in guidance issued in consultation with the Secretary of the Treasury. For purposes of this section, any eligibility to participate in the plan following any period for which such employee was not eligible to participate shall be treated as initial eligibility. (c) Annual reminder notice For purposes of this section, the term annual reminder notice means a notice provided in accordance with section 2520.104b–1 of title 29, Code of Federal Regulations (or any successor regulation), which— (1) is furnished in connection with the annual open season election period with respect to the plan or, if there is no such period, is furnished within a reasonable period prior to the beginning of each plan year; (2) notifies the unenrolled participant of— (A) the unenrolled participant’s eligibility to participate in the plan; and (B) the key benefits and rights under the plan, with a focus on employer contributions and vesting provisions; and (3) provides such information in a prominent manner and calculated to be understood by the average participant. . (2) Clerical amendment The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 is amended by striking the item relating to section 111 and by inserting after the item relating to section 110 the following new items: Sec. 111. Eliminating unnecessary plan requirements related to unenrolled participants. Sec. 112. Repeal and effective date. . (b) Amendment of Internal Revenue Code of 1986 Section 414 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection: (aa) Eliminating unnecessary plan requirements related to unenrolled participants (1) In general Notwithstanding any other provision of this title, with respect to any defined contribution plan, no disclosure, notice, or other plan document (other than the notices and documents described in subparagraphs (A) and (B)) shall be required to be furnished under this title to any unenrolled participant if the unenrolled participant is furnished— (A) an annual reminder notice of such participant’s eligibility to participate in such plan and any applicable election deadlines under the plan, and (B) any document requested by such participant that the participant would be entitled to receive notwithstanding this subsection. (2) Unenrolled participant For purposes of this subsection, the term unenrolled participant means an employee who— (A) is eligible to participate in a defined contribution plan, (B) has been furnished— (i) the summary plan description pursuant to section 104(b) of the Employee Retirement Income Security Act of 1974, and (ii) any other notices related to eligibility under the plan and required to be furnished under this title, or the Employee Retirement Income Security Act of 1974, in connection with such participant’s initial eligibility to participate in such plan, (C) does not have an account balance in the plan, and (D) satisfies such other criteria as the Secretary of the Treasury may determine appropriate, as prescribed in guidance issued in consultation with the Secretary of Labor. For purposes of this subsection, any eligibility to participate in the plan following any period for which such employee was not eligible to participate shall be treated as initial eligibility. (3) Annual reminder notice For purposes of this subsection, the term annual reminder notice means the notice described in section 111(c) of the Employee Retirement Income Security Act of 1974. . (c) Effective date The amendments made by this section shall apply to plan years beginning after December 31, 2022. 108. Recovery of retirement plan overpayments (a) Overpayments under ERISA Section 206 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1056 ) is amended by adding at the end the following new subsection: (h) Special rules applicable to benefit overpayments (1) General rule In the case of an inadvertent benefit overpayment by any pension plan, the responsible plan fiduciary shall not be considered to have failed to comply with the requirements of this title merely because such fiduciary determines, in the exercise of its fiduciary discretion, not to seek recovery of all or part of such overpayment from— (A) any participant or beneficiary, (B) any plan sponsor of, or contributing employer to— (i) an individual account plan, provided that the amount needed to prevent or restore any impermissible forfeiture from any participant’s or beneficiary’s account arising in connection with the overpayment is, separately from and independently of the overpayment, allocated to such account pursuant to the nonforfeitability requirements of section 203 (for example, out of the plan’s forfeiture account, additional employer contributions, or recoveries from those responsible for the overpayment), or (ii) a defined benefit pension plan subject to the funding rules in part 3 of this subtitle B, unless the responsible plan fiduciary determines, in the exercise of its fiduciary discretion, that failure to recover all or part of the overpayment faster than required under such funding rules would materially affect the plan’s ability to pay benefits due to other participants and beneficiaries, or (C) any fiduciary of the plan, other than a fiduciary (including a plan sponsor or contributing employer acting in a fiduciary capacity) whose breach of its fiduciary duties resulted in such overpayment, provided that if the plan has established prudent procedures to prevent and minimize overpayment of benefits and the relevant plan fiduciaries have followed such procedures, an inadvertent benefit overpayment will not give rise to a breach of fiduciary duty. (2) Reduction in future benefit payments and recovery from responsible party Paragraph (1) shall not fail to apply with respect to any inadvertent benefit overpayment merely because, after discovering such overpayment, the responsible plan fiduciary— (A) reduces future benefit payments to the correct amount provided for under the terms of the plan, or (B) seeks recovery from the person or persons responsible for the overpayment. (3) Employer funding obligations Nothing in this subsection shall relieve an employer of any obligation imposed on it to make contributions to a plan to meet the minimum funding standards under part 3 of this subtitle B or to prevent or restore an impermissible forfeiture in accordance with section 203. (4) Recoupment from participants and beneficiaries If the responsible plan fiduciary, in the exercise of its fiduciary discretion, decides to seek recoupment from a participant or beneficiary of all or part of an inadvertent benefit overpayment made by the plan to such participant or beneficiary, it may do so, subject to the following conditions: (A) No interest or other additional amounts (such as collection costs or fees) are sought on overpaid amounts for any period. (B) If the plan seeks to recoup past overpayments of a non-decreasing periodic benefit by reducing future benefit payments— (i) the reduction ceases after the plan has recovered the full dollar amount of the overpayment, (ii) the amount recouped each calendar year does not exceed 10 percent of the full dollar amount of the overpayment, and (iii) future benefit payments are not reduced to below 90 percent of the periodic amount otherwise payable under the terms of the plan. Alternatively, if the plan seeks to recoup past overpayments of a non-decreasing periodic benefit through one or more installment payments, the sum of such installment payments in any calendar year does not exceed the sum of the reductions that would be permitted in such year under the preceding sentence. (C) If the plan seeks to recoup past overpayments of a benefit other than a non-decreasing periodic benefit, the plan satisfies requirements developed by the Secretary for purposes of this subparagraph. (D) Efforts to recoup overpayments are— (i) not accompanied by threats of litigation, unless the responsible plan fiduciary reasonably believes it could prevail in a civil action brought in Federal or State court to recoup the overpayments, and (ii) not made through a collection agency or similar third party, unless the participant or beneficiary ignores or rejects efforts to recoup the overpayment following either a final judgment in Federal or State court or a settlement between the participant or beneficiary and the plan, in either case authorizing such recoupment. (E) Recoupment of past overpayments to a participant is not sought from any beneficiary of the participant, including a spouse, surviving spouse, former spouse, or other beneficiary. (F) Recoupment may not be sought if the first overpayment occurred more than 3 years before the participant or beneficiary is first notified in writing of the error. (G) A participant or beneficiary from whom recoupment is sought is entitled to contest all or part of the recoupment pursuant to the plan’s claims procedures. (H) In determining the amount of recoupment to seek, the responsible plan fiduciary shall take into account the hardship that recoupment likely would impose on the participant or beneficiary. (5) Effect of culpability Subparagraphs (A) through (F) of paragraph (4) shall not apply to protect a participant or beneficiary who is culpable. For purposes of this paragraph, a participant or beneficiary is culpable if the individual bears responsibility for the overpayment (such as through misrepresentations or omissions that led to the overpayment), or if the individual knew, or had good reason to know under the circumstances, that the benefit payment or payments were materially in excess of the correct amount. Notwithstanding the preceding sentence, an individual is not culpable merely because the individual believed the benefit payment or payments were or might be in excess of the correct amount, if the individual raised that question with an authorized plan representative and was told the payment or payments were not in excess of the correct amount. With respect to a culpable participant or beneficiary, efforts to recoup overpayments shall not be made through threats of litigation, unless a lawyer for the plan makes a determination that there is a reasonable likelihood of success to recover an amount that would be greater than the cost of recovery. . (b) Effective date The amendments made by this section shall apply as of the date of enactment of this Act. (c) Certain actions before date of enactment Plans, fiduciaries, employers, and plan sponsors are entitled to rely on— (1) a good faith interpretation of then existing administrative guidance for inadvertent benefit overpayment recoupments and recoveries that commenced before the date of enactment of this Act, and (2) determinations made before the date of enactment of this Act by the responsible plan fiduciary, in the exercise of its fiduciary discretion, not to seek recoupment or recovery of all or part of an inadvertent benefit overpayment. In the case of a benefit overpayment that occurred prior to the date of enactment of this Act, any installment payments by the participant or beneficiary to the plan or any reduction in periodic benefit payments to the participant or beneficiary, which were made in recoupment of such overpayment and which commenced prior to such date, may continue after such date. Nothing in this subsection shall relieve a fiduciary from responsibility for an overpayment that resulted from a breach of its fiduciary duties. 109. Improving coverage for part-time workers (a) In general Section 202 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1052 ) is amended by adding at the end the following new subsection: (c) Special rule for certain part-Time employees (1) In general A pension plan that includes either a qualified cash or deferred arrangement (as defined in section 401(k) of the Internal Revenue Code of 1986) or a salary reduction agreement (as described in section 403(b) of such Code) shall not require, as a condition of participation in the arrangement or agreement, that an employee complete a period of service with the employer (or employers) maintaining the plan extending beyond the close of the earlier of— (A) the period permitted under subsection (a)(1) (determined without regard to subparagraph (B)(i) thereof); or (B) the first 24-month period— (i) consisting of 2 consecutive 12-month periods during each of which the employee has at least 500 hours of service; and (ii) by the close of which the employee has attained the age of 21. (2) Exception Paragraph (1)(B) shall not apply to any employee described in section 410(b)(3) of the Internal Revenue Code of 1986. (3) Coordination with other rules (A) In general In the case of employees who are eligible to participate in the arrangement or agreement solely by reason of paragraph (1)(B): (i) Exclusions An employer may elect to exclude such employees from the application of subsections (a)(4), (k)(3), (k)(12), (k)(13), and (m)(2) of section 401 of the Internal Revenue Code of 1986 and section 410(b) of such Code. (ii) Nondiscrimination rules Notwithstanding paragraph (1), section 401(k)(15)(B)(i)(I) of such Code shall apply. (iii) Time of participation The rules of subsection (a)(4) shall apply to such employees. (B) Top-heavy rules An employer may elect to exclude all employees who are eligible to participate in a plan maintained by the employer solely by reason of paragraph (1)(B) from the application of the vesting and benefit requirements under subsections (b) and (c) of section 416 of the Internal Revenue Code of 1986. (4) 12-month period For purposes of this subsection, 12-month periods shall be determined in the same manner as under the last sentence of subsection (a)(3)(A), except that 12-month periods beginning before January 1, 2022, shall not be taken into account. . (b) Vesting Section 203(b) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1053(b) ) is amended by redesignating paragraph (4) as paragraph (5) and by inserting after paragraph (3) the following new paragraph: (4) Part-time employees For purposes of determining whether an employee who is eligible to participate in a qualified cash or deferred arrangement or a salary reduction agreement under a plan solely by reason of section 202(c)(1)(B) has a nonforfeitable right to employer contributions— (A) except as provided in subparagraph (B), each 12-month period for which the employee has at least 500 hours of service shall be treated as a year of service; and (B) paragraph (3) shall be applied by substituting at least 500 hours of service for more than 500 hours of service in subparagraph (A) thereof. For purposes of this paragraph, 12-month periods shall be determined in the same manner as under the last sentence of section 202(a)(3)(A), except that 12-month periods beginning before January 1, 2022, shall not be taken into account. . (c) Effective dates Except as provided in paragraph (2), the amendments made by this section shall apply to plan years beginning at least 1 year after final regulations implementing this section are promulgated. II Emergency Savings Act of 2022 201. Short title This title may be cited as the Emergency Savings Act of 2022 . 202. Emergency savings accounts linked to defined contribution plans (a) Employee pension benefit plans Section 3 of the Employee Retirement Income Security Act ( 29 U.S.C. 1002 ) is amended— (1) in paragraph (2)(A), by inserting after the first sentence the following: A pension plan may include a pension-linked emergency savings account. ; and (2) by adding at the end the following: (45) Pension-Linked emergency savings account The term pension-linked emergency savings account means an account established or maintained by a sponsor of a defined contribution plan for purposes of offering or providing a participant of such plan the opportunity to maintain a short-term savings account that— (A) is offered as part of such defined contribution plan; (B) accepts only— (i) participant contributions which are treated in the same manner as Roth contributions for purposes of inclusion in gross income; and (ii) employer contributions which are includible in gross income of the participant for purposes of the Internal Revenue Code of 1986; and (C) meets the requirements of part 8 of subtitle B. . (b) Pension-Linked emergency savings accounts (1) In general Subtitle B of title I of the Employee Retirement Income Security Act ( 29 U.S.C. 1021 et seq. ) is amended by adding at the end the following: 8 Pension-linked emergency savings accounts 801. Pension-linked emergency savings accounts (a) In general A plan sponsor of a defined contribution plan may make available to participants of such pension plan a pension-linked emergency savings account. A plan sponsor that offers participants a pension-linked emergency savings account may deduct amounts from each participating employee's compensation in accordance with subsection (c) and deposit such amounts, and any employer contributions under such subsection, to an account that meets the requirements of subsection (b). (b) Account requirements (1) In general A pension-linked emergency savings account offered in accordance with subsection (a) shall— (A) not have a minimum account balance requirement; (B) allow for withdrawal by the participant of the account balance, in whole or in part at the discretion of the participant, at least once per calendar month and for distribution of such withdrawal to the participant as soon as practicable but, other than in exceptional circumstances, not later than 1 week from the date on which the participant elects to make such withdrawal; (C) be held as cash, in an interest-bearing deposit account, or in an investment or insurance product designed to preserve principal and provide a reasonable rate of return, whether or not such return is guaranteed, consistent with liquidity; and (D) not be subject to— (i) any unreasonable fees, restrictions, expenses, or charges in connection with such pension-linked emergency savings account; and (ii) any fees in connection with the withdrawal of funds from such pension-linked emergency savings account other than reasonable reimbursement fees imposed for paper mailings and the handling of paper checks related to such pension-linked emergency savings account. (2) Establishment and termination of account (A) Establishment of account The establishment of a pension-linked emergency savings account shall be included in the defined contribution plan document of the associated defined contribution plan. (B) Termination of account A plan sponsor may terminate the pension-linked emergency savings account feature of an associated defined contribution plan at any time. Such termination shall be treated as if a termination of employment had occurred in accordance with subsection (d), except the reasonable time described in such subsection shall be as soon as practicable not later than 60 days after the date of such termination of the pension-linked emergency savings account feature of such associated defined contribution plan. (c) Account contributions (1) Employer contributions (A) In general Subject to the maximum account balance under paragraph (3), a plan sponsor may, without regard to any election otherwise by a participant, deposit to the pension-linked emergency savings account of the participant an amount in addition to the amount contributed by the participant under paragraph (2). (B) Employer contributions Employer contributions shall be included in the gross income of a participant for purposes of the Internal Revenue Code of 1986. (2) Participant contributions (A) In general Subject to the maximum account balance under paragraph (3)— (i) a plan sponsor may automatically enroll a participant in the pension-linked emergency savings account at a participant contribution rate selected by the plan sponsor, which, unless the participant affirmatively elects a different percentage of the compensation of the participant to be contributed to the pension-linked emergency savings account, may not exceed 3 percent of the compensation of the participant; or (ii) a participant may enroll in the pension-linked emergency savings account at a participant contribution rate selected by the participant. (B) Control of transfer A participant, at any time (subject to such reasonable advance notice as is required by the plan administrator), may— (i) adjust the participant contribution rate under subparagraph (A) to the pension-linked emergency savings account of the participant; or (ii) opt out of or pause for a specified period of time such contributions. (C) Adjustment of participant contribution rate by plan sponsor A plan sponsor may adjust the participant contribution rate selected by such plan sponsor described in subparagraph (A)(i) not more than once annually. (3) Account limits (A) In general Subject to subparagraph (B), no contributions under paragraphs (1) and (2) shall be accepted to the extent such contributions would cause the balance of the pension-linked emergency savings account to exceed the lesser of— (i) $2,500; or (ii) an amount determined by the plan sponsor of the pension-linked emergency savings account. In the case of contributions made in taxable years beginning after December 1, 2023, the Secretary shall adjust the amount under clause (i) at the same time and in the same manner as the adjustment made by the Secretary of the Treasury under section 415(d) of the Internal Revenue Code of 1986, except that the base period shall be the calendar quarter beginning July 1, 2022. Any increase under the preceding sentence which is not a multiple of $100 shall be rounded to the next lowest multiple of $100. (B) Excess contributions directed to plan To the extent any elected contributions under paragraphs (1) and (2) to the pension-linked emergency savings account of a participant for a taxable year would cause the balance of the pension-linked emergency savings account to exceed the maximum account balance described in subparagraph (A)— (i) the participant may be treated as having elected to increase the participant's contributions to the associated defined contribution plan by an amount not more than the rate at which contributions were being made to the pension-linked emergency savings account, and (ii) any such contributions shall be treated as elective deferrals (as such term is defined in section 402(g)(3) of the Internal Revenue Code of 1986) under such plan and shall be contributed to the plan on behalf of the participant instead of to the pension-linked emergency savings account. (4) Disclosure by plan sponsor of transfer (A) In general Not less than 15 days prior to the date on which the first transfer under this subsection occurs, the percentage of compensation and amount of the participant's compensation transferred under paragraph (1) is adjusted, or the plan sponsor adjusts the percentage of compensation of the automatic participant contribution under paragraph (2)(A)(i), the plan sponsor shall provide to the participant notice of— (i) the purpose of the account being for short-term, emergency savings; (ii) the amount of the intended contribution or the change in the percentage of the compensation of the participant of such contribution; (iii) in accordance with paragraph (2)(B), the instructions on how to— (I) adjust the participant contribution rate under paragraph (2)(A) to the pension-linked emergency savings account of the participant; or (II) opt out of or pause for a specified period of time such contributions; (iv) how such contributions will be invested; (v) the limits on, and tax treatment of, such contributions; (vi) any fees, expenses, or charges associated with such pension-linked emergency savings account; and (vii) procedures for participant withdrawals from such pension-linked emergency savings account, including any limits on frequency. (B) Consolidated notices The required notices under subparagraph (A) may be included with any other notice under this Act, including under section 404(c)(5)(B) or 514(e)(3), or under section 401(k)(13)(E) or 414(w)(4) of the Internal Revenue Code of 1986, if such other notice is provided to the participant not less than 15 days prior to the date described in such subparagraph and not more than 60 days prior to the date on which the first transfer under this subsection occurs. (5) Employer matching contributions to a defined contribution plan for employee contributions to a pension-linked emergency savings account (A) In general If an employer makes any matching contributions to a defined contribution plan of which a pension-linked emergency savings account is part— (i) any contribution under paragraph (2) to a pension-linked emergency savings account of the participant shall be treated as an elective deferral for purposes of matching contributions by such employer to such defined contribution plan; and (ii) such employer shall make matching contributions on behalf of such participant to the associated defined contribution plan on account of such contributions under paragraph (2) at the same rate as any other matching contribution on account of an elective deferral by such participant. To the extent any such matching contribution exceeds the maximum account balance under paragraph (3)(A), such contributions shall be contributed to the plan as provided in paragraph (3)(B). (B) Definitions For purposes of subparagraph (A), the terms matching contribution and elective deferral shall have the meanings given such terms in section 401(m)(4) of the Internal Revenue Code of 1986. (d) Account balance after termination of employment Upon termination of employment of the participant, the pension-linked emergency savings account of such participant shall— (1) allow, as relevant, for transfer by the participant of the account balance of such account, in whole or in part, into the designated Roth account (within the meaning of section 402A of the Internal Revenue Code of 1986) of the participant under the associated defined contribution plan; and (2) for any amounts in such account not transferred under paragraph (1), make such amounts available within a reasonable time not later than the earlier of the date on which the employer contributing to the plan makes the final compensation payment related to such employment or 60 days after the date of such termination— (A) to the participant or the beneficiary; or (B) as a direct rollover to a Roth IRA (as defined in section 408A(b) of the Internal Revenue Code of 1986) of such participant. (e) Coordination with plan hardship rules Under the terms of the plan of which a pension-linked emergency savings account is a part, a participant shall be required to withdraw all amounts in a pension-linked emergency savings account of the participant before receiving any plan distribution which is based on financial hardship or any loan from the plan. 802. Annual notice for pension-linked emergency savings account (a) In general At least annually, the plan sponsor of a pension-linked emergency savings account shall provide to the pension-linked emergency savings account participant a notice containing such information as the Secretary may require, including a description of— (1) the purpose and tax treatment of the pension-linked emergency savings account and contributions; (2) procedures for opting out of the pension-linked emergency savings account, changing participant contribution rates for such account, and making withdrawals from such account, and limits on contributions and withdrawals; (3) designated investment options for amounts contributed to the pension-linked emergency savings account; (4) the options under section 801(d) for the account balance of the pension-linked emergency savings account after termination of the employment of the participant; (5) any fees, expenses, or charges associated with such pension-linked emergency savings account; and (6) the amount that a participant has contributed to the pension-linked emergency savings account and the amount the plan sponsor has contributed to such pension-linked emergency savings account for the plan year, and the account balance. (b) Consolidated notices The required notice under subparagraph (A) may be included with any other notice under this Act if such other notice is provided to the participant at least annually. 803. Preemption of State anti-garnishment laws Notwithstanding any other provision of law, this part shall supersede any law of a State which would directly or indirectly prohibit or restrict the use of an automatic contribution arrangement, in accordance with section 801(c)(2), for a pension-linked emergency savings account. The Secretary may promulgate regulations to establish minimum standards that such an arrangement would be required to satisfy in order for this subsection to apply with respect to such an account. 804. Reporting and disclosure requirements The Secretary shall prescribe such regulations as may be necessary to address reporting and disclosure requirements for pension-linked emergency savings accounts in order to prevent unnecessary reporting and disclosure for such accounts under this Act, including for purposes of any reporting or disclosure related to pension plans required by this title or title IV or under the Internal Revenue Code of 1986. 805. Report to Congress on maximum account balance limits The Secretary of Labor and the Secretary of the Treasury shall— (1) conduct a study on the use of emergency savings from a pension-linked emergency savings account regarding— (A) whether the maximum account balance under section 801(c)(3) is sufficient; (B) whether the limitation on contributions under sections 801(c)(2)(A)(i) are appropriate; and (C) the participation rate of such accounts by plan sponsors and participants and the resulting impact on participant retirement savings, including the impact on retirement savings leakage and the effect of such accounts on retirement plan participation by low- and moderate-income households; and (2) not later than 7 years after the date of enactment of the RISE & SHINE Act , submit to Congress a report on the findings of the study under paragraph (1). . (2) Clerical amendment The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1001 note) is amended by inserting after the item relating to section 734 the following new items: Part 8. Pension-Linked emergency savings accounts 801. Pension-linked emergency savings accounts. 802. Annual notice for pension-linked emergency savings account. 803. Preemption of State anti-garnishment laws. 804. Reporting and disclosure requirements. 805. Report to Congress on maximum account balance limits. . (c) Reporting for a pension-Linked emergency savings account (1) Alternative methods of compliance Section 110(a) of the Employee Retirement Income Security Act ( 29 U.S.C. 1030(a) ) is amended by inserting (including pension-linked emergency savings accounts offered in conjunction with a pension plan) after class of pension plans . (2) Minimized reporting burden for pension-linked emergency savings accounts Section 101 of such Act ( 29 U.S.C. 1021 ) is amended— (A) by redesignating subsection (n) as subsection (o); and (B) by inserting after subsection (m) the following: (n) Pension-Linked emergency savings accounts (1) In general The requirements of subsection (a) shall not apply to a pension-linked emergency savings account made available under section 801. (2) Simplified reporting Nothing in this subsection shall preclude the Secretary from providing, by regulations or otherwise, simplified reporting procedures or requirements for such a pension-linked emergency savings account. . (d) Fiduciary duty Section 404(c) of the Employee Retirement Income Security Act ( 29 U.S.C. 1104(c) ) is amended by adding at the end the following: (6) Default investment arrangements for a pension-linked emergency savings account For purposes of paragraph (1), a participant in a pension-linked emergency savings account shall be treated as exercising control over the assets in the account with respect to the amount of contributions and earnings which are invested in accordance with section 801(b)(1)(C). . (e) Joint regulatory authority The Secretary of Labor and the Secretary of the Treasury (or a delegate of either such Secretary) shall have authority to issue joint regulations or other guidance, or to coordinate in developing regulations or other guidance, to carry out the purposes of this title, including adjustment of the maximum benefit under section 801(c)(3) of the Employee Retirement Income Security Act, as added by this title, to account for inflation, as well as expansion of corrections programs, if necessary. III Notice and disclosure 301. Defined contribution plan fee disclosure improvements Not later than 3 years after the date of enactment of this Act, the Secretary of Labor shall— (1) review section 2550.404a–5 of title 29, Code of Federal Regulations (relating to fiduciary requirements for disclosure in participant-directed individual account plans); (2) explore, through a public request for information or otherwise, how the contents and design of the disclosures described in such section may be improved to enhance participants’ understanding of fees and expenses related to a defined contribution plan (as defined in section 3 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002 )) as well as the cumulative effect of such fees and expenses on retirement savings over time; and (3) report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Education and Labor of the House of Representatives on the findings of the exploration described in paragraph (2), including beneficial education for consumers on financial literacy concepts as related to retirement plan fees and recommendations for legislative changes needed to address such findings. 302. Consolidation of defined contribution plan notices Not later than 2 years after the date of enactment of this Act, the Secretary of Labor and the Secretary of the Treasury (or such Secretaries’ delegates) shall adopt regulations providing that a plan (as defined in section 3 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002 )) may, but is not required to, consolidate 2 or more of the notices required under sections 404(c)(5)(B) and 514(e)(3) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1104(c)(5)(B) and 29 U.S.C. 1144(e)(3) ) and sections 401(k)(12)(D), 401(k)(13)(E), and 414(w)(4) of the Internal Revenue Code of 1986 into a single notice so long as the combined notice— (1) includes the required content; (2) clearly identifies the issues addressed therein; (3) is furnished at the time and with the frequency required for each such notice; and (4) is presented in a manner that is reasonably calculated to be understood by the average plan participant and that does not obscure or fail to highlight the primary information required for each notice. 303. Information needed for Financial Options Risk Mitigation Act (a) Short title This section may be cited as the Information Needed for Financial Options Risk Mitigation Act or the INFORM Act . (b) In general Part 1 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021 et seq. ), as amended by section 107, is amended by adding at the end the following: 113. Notice and disclosure requirements with respect to lump sum windows (a) In general A plan administrator of a pension plan that amends the plan to provide a period of time during which a participant or beneficiary may elect to receive a lump sum under clause (i) of section 401(a)(9)(A) of the Internal Revenue Code of 1986, instead of future monthly payments under clause (ii) of such section, shall furnish notice— (1) to each participant or beneficiary offered such lump sum amount, in the manner in which the participant and beneficiary receives the lump sum offer from the plan sponsor, not later than 90 days prior to the first day on which the participant or beneficiary may make an election with respect to such lump sum; and (2) to the Secretary and the Pension Benefit Guaranty Corporation, not later than 30 days prior to the first day on which participants and beneficiaries may make an election with respect to such lump sum. (b) Notice to participants and beneficiaries (1) Content The notice required under subsection (a)(1) shall include the following: (A) Available benefit options, including the estimated monthly benefit that the participant or beneficiary would receive at normal retirement age (if not already in pay status), whether there is a subsidized early retirement option or qualified joint and survivor annuity that is fully subsidized (in accordance with section 417(a)(5) of the Internal Revenue Code of 1986, the monthly benefit amount if payments begin immediately, and the lump sum amount available if the participant or beneficiary takes the option. (B) An explanation of how the lump sum was calculated, including the interest rate, mortality assumptions, and whether any additional plan benefits were included in the lump sum, such as early retirement subsidies. (C) In a manner consistent with the manner in which a written explanation is required to be given under 417(a)(3) of the Internal Revenue Code of 1986, the relative value of the lump sum option for a terminated vested participant compared to the value of— (i) the single life annuity, (or other standard form of benefit); and (ii) the qualified joint and survivor annuity (as defined in section 205(d)(1)). (D) Whether it would be reasonably likely to replicate the plan’s stream of payments by purchasing a comparable retail annuity using the lump sum. (E) The potential ramifications of accepting the lump sum, including longevity risks, loss of protections guaranteed by the Pension Benefit Guaranty Corporation (with an explanation of the monthly benefit amount that would be protected by the Pension Benefit Guaranty Corporation if the plan is terminated with insufficient assets to pay benefits), loss of protection from creditors, loss of spousal protections, and other protections under this Act that would be lost. (F) General tax rules related to accepting a lump sum, including rollover options and early distribution penalties with a disclaimer that the plan does not provide tax, legal, or accounting advice, and a suggestion that participants and beneficiaries consult with their own tax, legal, and accounting advisors before determining whether to accept the offer. (G) How to accept or reject the offer, the deadline for response, and whether a spouse is required to consent to the election. (H) Contact information for the point of contact at the plan administrator for participants and beneficiaries to get more information or ask questions about the options. (2) Plain language The notice under this subsection shall be written in a manner calculated to be understood by the average plan participant. (3) Model notice The Secretary shall issue a model notice for purposes of the notice under subsection (a)(1), including for information required under subparagraphs (C) through (F) of paragraph (1). (c) Notice to the Secretary and Pension Benefit Guaranty Corporation The notice required under subsection (a)(2) shall include the following: (1) The total number of participants and beneficiaries eligible for such lump sum option. (2) The length of the limited period during which the lump sum is offered. (3) An explanation of how the lump sum was calculated, including the interest rate, mortality assumptions, and whether any additional plan benefits were included in the lump sum, such as early retirement subsidies. (4) A sample of the notice provided to participants and beneficiaries under subsection (a)(1). (d) Post-Offer report to the Secretary and Pension Benefit Guaranty Corporation Not later than 90 days after the conclusion of the limited period during which participants and beneficiaries in a plan may accept a plan’s offer to convert their annuity into a lump sum as generally permitted under section 401(a)(9) of the Internal Revenue Code of 1986, a plan sponsor shall submit a report to the Secretary and the Director of the Pension Benefit Guaranty Corporation that includes the number of participants and beneficiaries who accepted the lump sum offer and such other information as the Secretary may require. (e) Public availability The Secretary shall make the information provided in the notice to the Secretary required under subsection (a)(2) and in the post-offer reports submitted under subsection (d) publicly available in a form that protects the confidentiality of the information provided. (f) Biannual report Not later than 6 months after the date of enactment of this section and every 6 months thereafter, so long as the Secretary has received notices and post-offer reports under subsections (c) and (d), the Secretary shall submit to Congress a report that summarizes such notices and post-offer reports during the applicable reporting period. . (c) Clerical amendment The table of contents in section 1 of the Employee Retirement Income Security Act of 1974, as amended by section 107(a)(2), is further amended by inserting after the item relating to section 112 the following new item: Sec. 113. Notice and disclosure requirements with respect to lump sum windows. . (d) Enforcement Section 502 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1132 ) is amended— (1) in subsection (c)(1), by striking or section 105(a) and inserting , section 105(a), or section 112(a) ; and (2) in subsection (a)(4), by striking 105(c) and inserting section 105(c) or 112(a) . (e) Application The requirements of section 113 of the ERISA, as added by subsection (b), shall apply beginning on the applicable effective date specified in the final regulations promulgated pursuant to subsection (f). (f) Regulatory authority Not earlier than 1 year after the date of enactment of this Act, the Secretary of Labor and the Secretary of the Treasury shall jointly issue regulations to implement section 113 of the Employee Retirement Income Security Act of 1974, as added by subsection (a). Such regulations shall require plan sponsors to comply in good faith with the regulations beginning not later than 1 year after issuance of a final rule with respect to subsections (a)(1) and (b) of such section 113, and beginning not later than 6 months after issuance of a final rule with respect to subsections (a)(2), (c), (d), and (e) of such section 113. 304. Defined benefit annual funding notices (a) In general Section 101(f)(2)(B) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021(f)(2)(B) ) is amended— (1) in clause (i)(I), by striking funding target attainment percentage (as defined in section 303(d)(2)) and inserting percentage of plan liabilities funded (as described in clause (ii)(I)(bb)) ; (2) in clause (ii)(I)— (A) by striking , a statement of ; (B) by striking item (aa); (C) by redesignating item (bb) as item (aa); (D) in item (aa), as so redesignated— (i) by inserting a statement of before the value ; and (ii) by striking and at the end; and (E) by adding at the end the following: (bb) a statement of the percentage of plan liabilities funded, calculated as the ratio between the value of the plan’s assets and liabilities, as determined under item (aa), for the plan year to which the notice relates and for the 2 preceding plan years, and (cc) if the information in (aa) and (bb) is presented in tabular form, a statement that describes that in the event of a plan termination the corporation’s calculation of plan liabilities may be greater and that references the section of the notice with the information required under clause (x), and ; (3) in clause (iii), in the matter preceding subclause (I), by inserting for the plan year to which the notice relates as of the last day of such plan year and the preceding 2 plan years, in tabular format, after participants ; (4) in clause (iv)— (A) by striking plan and the asset and inserting plan, the asset ; and (B) by inserting , and the average return on assets for the plan year, after assets) ; (5) by redesignating clauses (ix) through (xi) as clause (x) through (xii), respectively; (6) by inserting after clause (viii) the following: (ix) in the case of a single-employer plan, a statement as to whether the plan’s funded status, based on the plan’s liabilities described under subclause (II) for the plan year to which the notice relates, and for the 2 preceding plan years, is at least 100 percent (and, if not, the actual percentages), that includes— (I) the plan’s assets, as of the last day of the plan year and for the 2 preceding plan years, as determined under clause (ii)(I)(aa), (II) the plan’s liabilities, as of the last day of the plan year and for the 2 preceding plan years, as determined under clause (ii)(1)(aa), and (III) the funded status of the plan, determined as the ratio of the plan’s assets and liabilities calculated under subclauses (I) and (II), for the plan year to which the notice relates, and for the 2 preceding plan years, ; and (7) in clause (x), as so redesignated, by striking the comma at the end and inserting the following: and a statement that, in the case of a single-employer plan— (I) if plan assets are sufficient to pay vested benefits that are not guaranteed by the Pension Benefit Guaranty Corporation, participants and beneficiaries may receive benefits in excess of the guaranteed amount, and (II) in determining valuation of guaranteed benefits, the Pension Benefit Guaranty Corporation uses, as of the date of enactment of the RISE & SHINE Act , a valuation methodology that— (aa) places a higher value on the future cost of benefits than any valuation methodology required under Federal statute, and (bb) makes it less likely that participants and beneficiaries will receive amounts in excess of the guaranteed amount under Federal law, . (b) Effective date The amendments made by subsection (a) shall apply with respect to plan years beginning after December 31, 2023. IV Modernization 401. Automatic reenrollment under qualified automatic contribution arrangements and eligible automatic contribution arrangements (a) Eligible automatic contribution arrangements Section 514(e)(2) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1144(e)(2) ) is amended— (1) by redesignating subparagraphs (A) through (C) as clauses (i) through (iii), respectively, and by moving such clauses 2 ems to the right; (2) by striking (2) For purposes of and inserting (2)(A) For purposes of ; and (3) by adding at the end the following: (B) In the case of an automatic contribution arrangement taking effect after December 31, 2024, the requirements of subparagraph (A)(ii) shall be treated as met only if, under the arrangement, at least every 3 plan years but not more than once annually each employee— (i) who is eligible to participate in the arrangement; and (ii) who, at the time of the determination, has in effect an affirmative election pursuant to subparagraph (A)(ii) not to have any contributions described in such subparagraph made, is treated as having made the election at the uniform percentage of compensation described in subparagraph (A)(ii) unless the employee makes a new election under such subparagraph. Such determination may be made at one time for all employees described in the preceding sentence for a plan year, regardless of individual employee dates of enrollment. . (b) Effective date The amendments made by this section shall apply to arrangements taking effect after December 31, 2024. 402. Incidental plan expenses (a) Findings Congress finds the following: (1) Retirement plan sponsors engage advisors to assist in administering their retirement plans. Such advisors and other service providers are paid via monthly or annual retainers to advise on plan administration or the investment fund lineup. Such retainers are charged to the retirement plan. (2) Other, incidental expenses incurred related to plan design, may not be charged to the plan because they are deemed settlor functions. For example, if a plan sponsor were to inquire about a beneficial plan design feature, such as automatic enrollment and reenrollment or automatic escalation, the advisor or other service provider would bill the employer a separate amount that could not be charged back to the plan. Because these inquiries result in additional costs, many employers, especially small employers, choose to forego these incidental plan design features, even when they might generate tremendous benefits for their employees. (3) According to the 2021 Plan Sponsor Council of America’s Annual Survey of Profit Sharing and 401(k) Plans, only 30.5 percent of employers with fewer than 50 workers have an automatic enrollment feature in their retirement plan, compared to over 77 percent of employers with more than 1,000 workers. Small employers need additional resources to improve their retirement plan design. (b) Facilitating the implementation of beneficial plan features (1) Plan assets Section 403(c)(1) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1103(c)(1) ) is amended by inserting (including incidental expenses solely for the benefit of the participants and their beneficiaries) before the period. (2) Fiduciary standard of care Section 404(a)(1)(A)(ii) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1104(a)(1)(A)(ii) ) is amended by inserting (including incidental expenses solely for the benefit of the participants and their beneficiaries) before the semicolon. V Amendments to plans offered by multiple employers 501. Report on pooled employer plans The Secretary of Labor shall— (1) conduct a study on the pooled employer plan (as such term is defined in section 3(43) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002(43) )) industry, including on— (A) the legal name and number of pooled employer plans; (B) the number of participants in such plans; (C) the range of investment options provided in such plans; (D) the fees assessed in such plans; (E) the manner in which employers select and monitor such plans; (F) the disclosures provided to participants in such plans; (G) the number and nature of any enforcement actions by the Secretary of Labor on such plans; (H) the extent to which such plans have increased retirement savings coverage in the United States; and (I) any additional information as the Secretary determines is necessary; and (2) not later than 5 years after the date of enactment of this Act, and every 5 years thereafter, submit to Congress and make available on a publicly accessible website of the Department of Labor, a report on the findings of the study under paragraph (1), including recommendations on how pooled employer plans can be improved, through legislation, to serve and protect retirement plan participants. 502. Annual audits for group of plans Section 202(a) of the Setting Every Community Up for Retirement Enhancement Act of 2019 ( Public Law 116–94 ; 26 U.S.C. 6058 note) is amended— (1) by striking so that all members and inserting the following: so that— (1) all members ; (2) by striking the period and inserting ; and ; and (3) by adding at the end the following: (2) any opinions required by section 103(a)(3) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1023(a)(3) ) shall relate only to each individual plan which would otherwise be subject to the requirements of such section 103(a)(3). . VI Defined benefit plan provisions 601. Cash balance (a) Amendment of Internal Revenue Code of 1986 Section 414 of the Internal Revenue Code of 1986, as amended by the preceding sections of this Act, is further amended by adding at the end the following new subsection: (bb) Projected interest crediting rate For purposes of this part, in the case of an applicable defined benefit plan (as defined in section 411(a)(13)(B)) which provides variable interest crediting rates, the interest crediting rate which is treated as in effect and as the projected interest crediting rate shall be a reasonable projection of such variable interest crediting rate, not to exceed 6 percent. . (b) Amendment of Employee Retirement Income Security Act of 1974 Section 210 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1060 ) is amended by adding at the end the following new subsection: (g) Projected interest crediting rate For purposes of this title, in the case of an applicable defined benefit plan (within the meaning of section 203(f)(3)) which provides variable interest crediting rates, the interest crediting rate which is treated as in effect and as the projected interest crediting rate shall be a reasonable projection of such variable interest crediting rate, not to exceed 6 percent. . (c) Effective date The amendments made by this section shall apply with respect to years beginning after the date of enactment of this Act. 602. Termination of variable rate premium indexing (a) In general Paragraph (8) of 4006(a) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1306(a) ) is amended by— (1) in subparagraph (A)— (A) in clause (vi), by striking and ; (B) in clause (vii), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following: (viii) for plan years beginning after calendar year 2022, $48. ; (2) in subparagraph (B), in the matter preceding clause (i), by inserting and before 2023 after 2012 ; and (3) in subparagraph (D)(vii), by inserting and before 2023 after 2019 . (b) Technical amendment Clause (i) of section 4006(a)(3)(E) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1306(a)(3)(E) ) is amended by striking subparagraph (H) and inserting subparagraph (I) . 603. Enhancing retiree health benefits in pension plans (a) Extension of transfers of excess pension assets to retiree health accounts under the Internal Revenue Code of 1986 Paragraph (4) of section 420(b) of the Internal Revenue Code of 1986 is amended by striking December 31, 2025 and inserting December 31, 2032 . (b) Extension of transfers of excess pension assets to retiree health accounts under the Employee Retirement Income Security Act of 1974 (1) Definitions Section 101(e)(3) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021(e)(3) ) is amended by striking (as in effect on the date of the enactment of the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015) and inserting (as in effect on the date of enactment of the RISE & SHINE Act ) . (2) Use of assets Section 403(c)(1) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1103(c)(1) ) is amended by striking (as in effect on the date of the enactment of the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015) and inserting (as in effect on the date of enactment of the RISE & SHINE Act ) . (3) Exemption Section 408(b)(13) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1108(b)(13) ) is amended— (A) by striking January 1, 2026 and inserting January 1, 2033 ; and (B) by striking (as in effect on the date of the enactment of the Surface Transportation and Veterans Health Care Choice Improvement Act of 2015) and inserting (as in effect on the date of enactment of the RISE & SHINE Act ) . (c) Effective date The amendments made by this section shall apply to transfers made after the date of enactment of this Act. VII Additional retirement enhancements 701. Provisions relating to plan amendments (a) In general Part 2 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021 et seq. ) is amended— (1) by redesignating section 211 as section 212; and (2) by inserting after section 210 the following new section: 211. Plan amendments due to the RISE & SHINE Act (a) In general If this section applies to any retirement plan or contract amendment— (1) such retirement plan or contract shall be treated as being operated in accordance with the terms of the plan during the period described in subsection (b)(2)(A); and (2) except as provided by the Secretary of the Treasury (or the Secretary's delegate) and the Secretary of Labor (or the Secretary's delegate), such retirement plan shall not fail to meet the requirements of section 411(d)(6) of the Internal Revenue Code of 1986 and section 204(g) of this Act by reason of such amendment. (b) Amendments to which section applies (1) In general This section shall apply to any amendment to any retirement plan or annuity contract which is made— (A) pursuant to any amendment made by the RISE & SHINE Act or pursuant to any regulation issued by the Secretary of the Treasury or the Secretary of Labor (or a delegate of either such Secretary) under the RISE & SHINE Act ; and (B) on or before the last day of the first plan year beginning on or after January 1, 2025. (2) Conditions This section shall not apply to any amendment unless— (A) during the period— (i) beginning on the date the legislative or regulatory amendment described in paragraph (1)(A) takes effect (or in the case of a plan or contract amendment not required by such legislative or regulatory amendment, the effective date specified by the plan); and (ii) ending on the date described in paragraph (1)(B) (or, if earlier, the date the plan or contract amendment is adopted), the plan or contract is operated as if such plan or contract amendment were in effect; and (B) such plan or contract amendment applies retroactively for such period. . (b) Clerical amendment The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 is amended by striking the item relating to section 211 and by inserting after the item relating to section 210 the following new items: Sec. 211. Plan amendments due to the RISE & SHINE Act. Sec. 212. Effective dates. . 702. Worker Ownership, Readiness, and Knowledge (WORK) Act (a) Short title This section may be cited as the Worker Ownership, Readiness, and Knowledge Act or the WORK Act . (b) Definitions In this section: (1) Existing program The term existing program means a program, designed to promote employee ownership, that exists on the date on which the Secretary is carrying out a responsibility authorized under this section. (2) Initiative The term Initiative means the Employee Ownership Initiative established under subsection (c). (3) New program The term new program means a program, designed to promote employee ownership, that does not exist on the date on which the Secretary is carrying out a responsibility authorized under this section. (4) Secretary The term Secretary means the Secretary of Labor. (5) State The term State has the meaning given the term under section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 ). (c) Employee ownership initiative (1) Establishment The Secretary shall establish within the Department of Labor an Employee Ownership Initiative to promote employee ownership. (2) Functions In carrying out the Initiative, the Secretary shall— (A) support within the States existing programs designed to promote employee ownership; and (B) facilitate within the States the formation of new programs designed to promote employee ownership. (3) Duties To carry out the functions enumerated in paragraph (2), the Secretary shall— (A) support new programs and existing programs by— (i) making Federal grants authorized under subsection (e); and (ii) (I) acting as a clearinghouse on techniques employed by new programs and existing programs within the States, and disseminating information relating to those techniques to the programs; or (II) funding projects for information gathering on those techniques, and dissemination of that information to the programs, by groups outside the Department of Labor; and (B) facilitate the formation of new programs, in ways that include holding or funding an annual conference of representatives from States with existing programs, representatives from States developing new programs, and representatives from States without existing programs. (d) Programs regarding employee ownership (1) Establishment of program Not later than 180 days after the date of enactment of this Act, the Secretary shall establish a program to encourage new programs and existing programs within the States to foster employee ownership throughout the United States. (2) Purpose of program The purpose of the program established under paragraph (1) is to encourage new and existing programs within the States that focus on— (A) providing education and outreach to inform employees and employers about the possibilities and benefits of employee ownership and business ownership succession planning, including providing information about financial education, employee teams, open-book management, and other tools that enable employees to share ideas and information about how their businesses can succeed; (B) providing technical assistance to assist employee efforts to become business owners, to enable employers and employees to explore and assess the feasibility of transferring full or partial ownership to employees, and to encourage employees and employers to start new employee-owned businesses; (C) training employees and employers with respect to methods of employee participation in open-book management, work teams, committees, and other approaches for seeking greater employee input; and (D) training other entities to apply for funding under this subsection, to establish new programs, and to carry out program activities. (3) Program details The Secretary may include, in the program established under paragraph (1), provisions that— (A) in the case of activities described in paragraph (2)(A)— (i) target key groups, such as retiring business owners, senior managers, labor organizations, trade associations, community organizations, and economic development organizations; (ii) encourage cooperation in the organization of workshops and conferences; and (iii) prepare and distribute materials concerning employee ownership, and business ownership succession planning; (B) in the case of activities described in paragraph (2)(B)— (i) provide preliminary technical assistance to employee groups, managers, and retiring owners exploring the possibility of employee ownership; (ii) provide for the performance of preliminary feasibility assessments; (iii) assist in the funding of objective third-party feasibility studies and preliminary business valuations, and in selecting and monitoring professionals qualified to conduct such studies; and (iv) provide a data bank to help employees find legal, financial, and technical advice in connection with business ownership; (C) in the case of activities described in paragraph (2)(C)— (i) provide for courses on employee participation; and (ii) provide for the development and fostering of networks of employee-owned companies to spread the use of successful participation techniques; and (D) in the case of training described in paragraph (2)(D)— (i) provide for visits to existing programs by staff from new programs receiving funding under this section; and (ii) provide materials to be used for such training. (4) Guidance The Secretary shall issue formal guidance, for— (A) recipients of grants awarded under subsection (e) and one-stop partners (as defined in section 3 of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3102 )) affiliated with the workforce development systems (as so defined) of the States, proposing that programs and other activities funded under this section be— (i) proactive in encouraging actions and activities that promote employee ownership of businesses; and (ii) comprehensive in emphasizing both employee ownership of businesses so as to increase productivity and broaden capital ownership; and (B) acceptable standards and procedures to establish good faith fair market value for shares of a business to be acquired by an employee stock ownership plan (as defined in section 407(d)(6) of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1107(d)(6) )). (e) Grants (1) In general In carrying out the program established under subsection (d), the Secretary may make grants for use in connection with new programs and existing programs within a State for any of the following activities: (A) Education and outreach as provided in subsection (d)(2)(A). (B) Technical assistance as provided in subsection (d)(2)(B). (C) Training activities for employees and employers as provided in subsection (d)(2)(C). (D) Activities facilitating cooperation among employee-owned firms. (E) Training as provided in subsection (d)(2)(D) for new programs provided by participants in existing programs dedicated to the objectives of this section, except that, for each fiscal year, the amount of the grants made for such training shall not exceed 10 percent of the total amount of the grants made under this section. (2) Amounts and conditions The Secretary shall determine the amount and any conditions for a grant made under this subsection. The amount of the grant shall be subject to paragraph (6), and shall reflect the capacity of the applicant for the grant. (3) Applications Each entity desiring a grant under this subsection shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may reasonably require. (4) State applications Each State may sponsor and submit an application under paragraph (3) on behalf of any local entity consisting of a unit of State or local government, State-supported institution of higher education, or nonprofit organization, meeting the requirements of this section. (5) Applications by entities (A) Entity applications If a State fails to support or establish a program pursuant to this section during any fiscal year, the Secretary shall, in the subsequent fiscal years, allow local entities described in paragraph (4) from that State to make applications for grants under paragraph (3) on their own initiative. (B) Application screening Any State failing to support or establish a program pursuant to this section during any fiscal year may submit applications under paragraph (3) in the subsequent fiscal years but may not screen applications by local entities described in paragraph (4) before submitting the applications to the Secretary. (6) Limitations A recipient of a grant made under this subsection shall not receive, during a fiscal year, in the aggregate, more than the following amounts: (A) For fiscal year 2024, $300,000. (B) For fiscal year 2025, $330,000. (C) For fiscal year 2026, $363,000. (D) For fiscal year 2027, $399,300. (E) For fiscal year 2028, $439,200. (7) Annual report For each year, each recipient of a grant under this subsection shall submit to the Secretary a report describing how grant funds allocated pursuant to this subsection were expended during the 12-month period preceding the date of the submission of the report. (f) Evaluations The Secretary is authorized to reserve not more than 10 percent of the funds appropriated for a fiscal year to carry out this section, for the purposes of conducting evaluations of the grant programs identified in subsection (e) and to provide related technical assistance. (g) Reporting Not later than the expiration of the 36-month period following the date of enactment of this Act, the Secretary shall prepare and submit to Congress a report— (1) on progress related to employee ownership in businesses in the United States; and (2) containing an analysis of critical costs and benefits of activities carried out under this section. (h) Authorizations of appropriations (1) In general There are authorized to be appropriated for the purpose of making grants pursuant to subsection (e) the following: (A) For fiscal year 2024, $4,000,000. (B) For fiscal year 2025, $7,000,000. (C) For fiscal year 2026, $10,000,000. (D) For fiscal year 2027, $13,000,000. (E) For fiscal year 2028, $16,000,000. (2) Administrative expenses There are authorized to be appropriated for the purpose of funding the administrative expenses related to the Initiative, for each of fiscal years 2022 through 2026, an amount not in excess of the lesser of— (A) $350,000; or (B) 5.0 percent of the maximum amount available under paragraph (1) for that fiscal year. | https://www.govinfo.gov/content/pkg/BILLS-117s4353is/xml/BILLS-117s4353is.xml |
117-s-4354 | II 117th CONGRESS 2d Session S. 4354 IN THE SENATE OF THE UNITED STATES June 7, 2022 Mrs. Gillibrand (for herself, Mrs. Shaheen , Mr. Blumenthal , and Ms. Hirono ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To amend title 10, United States Code, regarding restrictions on the use of funds and facilities of the Department of Defense for abortion care.
1. Short title This Act may be cited as the Military Access to Reproductive Care and Health for Military Servicemembers Act or the MARCH for Military Servicemembers Act . 2. Restoration of previous policy regarding restriction on use of medical facilities and funds of Department of Defense for abortion care (a) Repeal Section 1093 of title 10, United States Code, is repealed. (b) Clerical amendment The table of sections at the beginning of chapter 55 of such title is amended by striking the item relating to section 1093. | https://www.govinfo.gov/content/pkg/BILLS-117s4354is/xml/BILLS-117s4354is.xml |
117-s-4355 | II 117th CONGRESS 2d Session S. 4355 IN THE SENATE OF THE UNITED STATES June 7, 2022 Mr. Whitehouse (for himself, Mr. Coons , Mr. Schatz , and Mr. Heinrich ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to create a carbon border adjustment based on carbon intensity, and for other purposes.
1. Short title This Act may be cited as the Clean Competition Act . 2. Carbon intensity charge (a) In general Chapter 38 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subchapter: E Carbon intensity charge Sec. 4691. Calculation of carbon intensity. Sec. 4692. Imposition of carbon intensity charge. Sec. 4693. Rebate. Sec. 4694. Definitions. 4691. Calculation of carbon intensity (a) Reporting requirements Not later than June 30, 2025, and annually thereafter, any covered entity shall, for each eligible facility operated by such entity, report to the Secretary with respect to the following: (1) Any information required to be reported to the Administrator under the Greenhouse Gas Reporting Program (or which would be required to be reported notwithstanding any other provision of law prohibiting the implementation of or use of funds for such requirements) for the preceding calendar year. (2) The total amount of electricity used at such facility during the preceding calendar year, including— (A) whether such electricity was provided through the electric grid or a dedicated generation source, (B) the terms of any power purchase agreements with respect to such facility, and (C) with respect to any electricity which was not provided through the electric grid, the greenhouse gas emissions associated with the production of such electricity, provided that such emissions are not reported pursuant to paragraph (1). (3) The total weight (expressed in tons) of each covered primary good produced at such facility during the preceding calendar year. (b) Calculation (1) Carbon intensity (A) Eligible facility For purposes of this subchapter, for each calendar year, the carbon intensity with respect to any eligible facility shall be an amount equal to the quotient of— (i) the covered emissions (as determined under paragraph (2)) with respect to such facility, divided by (ii) the total weight (expressed in tons) of covered primary goods produced at such facility during the preceding calendar year. (B) Covered national industry For purposes of this subchapter, the carbon intensity with respect to any covered national industry shall be an amount equal to the quotient of— (i) an amount equal to the sum of the covered emissions (as determined under paragraph (2)) with respect to all eligible facilities which produce covered primary goods which are included within such industry for calendar year 2024, divided by (ii) the total weight (expressed in tons) of covered primary goods produced at all such eligible facilities during such year. (C) Petition for specific goods (i) In general In the case of any covered national industry which produces more than 1 covered primary good, a covered entity may file a petition with the Secretary to determine the carbon intensity with respect to a specific covered primary good. (ii) Review With respect to any covered primary good which is included in a petition described in clause (i), the Secretary (in coordination with the Administrator and the Secretary of Energy) shall approve such petition if— (I) the chemical, physical, or mechanical production processes for such good are substantially different as compared to other covered primary goods produced within the same covered national industry, and (II) the carbon intensity determined with respect to such good is at least 25 percent greater than the carbon intensity determined for other covered primary goods produced within the same covered national industry. (iii) Recalculation In the case of any petition described in clause (i) which is approved by the Secretary pursuant to clause (ii), the Secretary (in coordination with the Administrator) shall redetermine the carbon intensity with respect to the covered national industry which includes production of the covered primary good which is the subject of such petition by excluding any covered emissions associated with the production of such good for purposes of the determination made under subparagraph (B) for such industry. (D) Determination Any determination of carbon intensity under this paragraph shall be made by the Secretary in coordination with the Administrator and the Secretary of Energy. (2) Covered emissions (A) In general For purposes of this subsection, for each calendar year, the amount of covered emissions with respect to any eligible facility shall be an amount (as determined by the Secretary, in coordination with the Administrator) equal to— (i) the amount equal to the sum of— (I) the total greenhouse gas emissions associated with the production of covered primary goods at such facility during the preceding calendar year (as reported pursuant to subsection (a)), plus (II) the total greenhouse gas emissions associated with any electricity used at such facility for the production of such goods during the preceding calendar year, minus (ii) the total greenhouse gas emissions which are captured and disposed of in secure geological storage (in compliance with the regulations established under section 45Q(f)(2)) during the preceding calendar year. (B) Direct air capture For purposes of subparagraph (A)(ii), in the case of any greenhouse gas emissions which are captured directly from the ambient air, the operator of the facility which captured such emissions may apportion such emissions amongst any eligible facilities which are under common control of such operator. (C) Emissions for electricity used (i) In general For purposes of subparagraph (A)(i)(II), the amount of greenhouse gas emissions associated with electricity provided through the electric grid shall be determined based on the average carbon intensity for the regional grid in which the eligible facility is located for the preceding calendar year. (ii) Exception In the case of an eligible facility which is subject to a power purchase agreement which guarantees that any electricity provided under such agreement is generated not less than 15 minutes prior to use by such facility and within the same regional transmission zone as such facility— (I) clause (i) shall not apply, and (II) the amount of greenhouse gas emissions associated with such electricity shall be determined based on the average carbon intensity of the electricity provided under such agreement. (3) Imported goods (A) In general In the case of any covered primary good which is imported into the United States, the carbon intensity with respect to such good shall be determined by the Secretary (in coordination with the relevant parties) based on— (i) the carbon intensity of the general economy of the country of origin of such good, or (ii) if the Secretary (in coordination with the relevant parties) determines that transparent, verifiable, and reliable information is available with respect to any covered national industry in the country of origin of such good and that such country of origin is a transparent market economy in which inter-firm resource shuffling is unlikely to occur, the carbon intensity of the covered national industry in such country which includes production of such good. (B) Petition (i) In general In the case of any entity which imports a covered primary good for which the carbon intensity can be determined under subparagraph (A)(ii), such entity may file a petition with the Secretary to determine the charge under section 4692, if any, based on the average carbon intensity with respect to the production of such good by the manufacturer within the country of origin. (ii) Aggregation rule For purposes of this subparagraph, the average carbon intensity with respect to the production of a covered primary good shall be determined based upon greenhouse gas emission and production data from all facilities which produce such good which are under common control of the manufacturer of such good, including any subsidiary, parent company, or joint venture of such manufacturer within the country of origin. (iii) Inputs With respect to any covered primary good which is imported into the United States and for which other covered primary goods (other than petroleum, natural gas, or coal) were used as inputs by the manufacturer in the production of the imported covered primary good, any greenhouse gas emissions associated with the production of the covered primary goods used as inputs shall be included in the determination of the greenhouse gas emissions associated with production of the imported covered primary good. (iv) Data provision In the case of an entity which files a petition described in clause (i), such entity shall provide the Secretary with an environmental product declaration containing any information which would otherwise be required to be reported under subsection (a) if the facilities which produced the covered primary good to which the petition applies were subject to the reporting requirements under the Greenhouse Gas Reporting Program. (C) Carbon intensity of the general economy For purposes of this paragraph, with respect to any country, the carbon intensity of the general economy of such country shall be an amount equal to the quotient of— (i) the gross domestic product of such country for the year described in clause (ii), divided by (ii) the production-based greenhouse gas emissions of such country for the most recent year for which the Secretary determines there is reliable information. (D) Exclusion In the case of any covered primary good which is imported into the United States and was produced in a relatively least developed country (as described in section 124 of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2151v )), this paragraph shall not apply. (E) Inter-firm resource shuffling For purposes of this paragraph, the term inter-firm resource shuffling means any buying, selling, trading, exchanging, or other transfer of control of production facilities between entities based on the carbon intensity of such facilities for the purpose of creating entities with relatively lower carbon intensity and entities with relatively higher carbon intensity. (c) Publication The Secretary (in coordination with the relevant parties) shall annually publish any carbon intensity which has been determined under subsection (b) with respect to any eligible facility, covered national industry, covered primary good, foreign manufacturer, or country of origin. (d) Relevant parties For purposes of this section, the term relevant parties means— (1) the Administrator, (2) the Secretary of Energy, (3) the Secretary of Commerce, (4) the United States Trade Representative, and (5) the Chair and Vice Chair of the United States International Trade Commission. 4692. Imposition of carbon intensity charge (a) In general (1) Importation of goods (A) In general (i) Covered primary goods In the case of any covered primary good imported into the United States during any calendar year beginning after December 31, 2023, there is hereby imposed a charge in an amount equal to the product of— (I) (aa) in the case of a good for which the carbon intensity is determined under section 4691(b)(3)(A)(i), the amount (if any) by which the amount determined under clause (iii) with respect to such good exceeds an amount equal to the applicable percentage of the carbon intensity (as determined under section 4691(b)(1)(B)) for the covered national industry which includes such good, or (bb) in the case of a good for which the carbon intensity is determined under subparagraph (A)(ii) or (B) of section 4691(b)(3), the amount (if any) by which the carbon intensity determined under such subparagraph with respect to such good exceeds an amount equal to the applicable percentage of the carbon intensity (as determined under section 4691(b)(1)(B)) for the covered national industry which includes such good, multiplied by (II) the total weight (expressed in tons) of the good imported into the United States, multiplied by (III) the carbon price. (ii) Finished goods (I) In general In the case of any imported finished good which is imported into the United States during any calendar year beginning after December 31, 2025, there is hereby imposed a charge in an amount equal to the sum of the amounts determined under subclause (II) with respect to each covered primary good which is a component part of such imported finished good. (II) Components The amount determined under this subclause with respect to any covered primary good which is a component part of an imported finished good is an amount equal to the product of— (aa) the amount (if any) determined under clause (i)(I) if such clause were applied with respect to such good, multiplied by (bb) the total weight (expressed in tons) of the covered primary good, multiplied by (cc) the carbon price. (iii) Calculation for certain foreign goods For purposes of clause (i)(I)(aa), the amount determined under this clause with respect to any covered primary good shall be equal to the product of— (I) an amount equal to the quotient of— (aa) the carbon intensity of the general economy (as determined under section 4691(b)(3)(C)) of the country of origin of such good, divided by (bb) the carbon intensity of the general economy (as so determined) of the United States, multiplied by (II) an amount equal to the applicable percentage of the carbon intensity (as determined under section 4691(b)(1)(B)) for the covered national industry which includes such good. (B) Charge due The charge imposed under this paragraph with respect to any goods imported during any calendar year shall be paid by the entity which imported such goods not later than September 30 of the calendar year subsequent to such year. (C) Exclusion In the case of any covered primary good (including any covered primary good which is a component part of an imported finished good) which is imported into the United States and was produced in a relatively least developed country (as described in section 124 of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2151v )), this paragraph shall not apply. (2) Domestic production of covered primary goods (A) In general In the case of any eligible facility, for each calendar year beginning after December 31, 2023, there is hereby imposed a charge in an amount equal to the product of— (i) the amount (if any) by which the carbon intensity of such facility (as determined under subparagraph (A) of section 4691(b)(1)) exceeds— (I) an amount equal to the applicable percentage of the carbon intensity for the covered national industry (as determined under subparagraph (B) of section 4691(b)(1)) which includes any covered primary good produced by such facility, or (II) in the case of a covered primary good produced by such facility which is subject to an approved petition under subparagraph (C) of such section, an amount equal to the applicable percentage of the carbon intensity determined with respect to such good, multiplied by (ii) the total weight (expressed in tons) of any covered primary goods produced by such facility during such calendar year, multiplied by (iii) the carbon price. (B) Charge due The charge imposed under this paragraph with respect to any calendar year shall be paid by the covered entity not later than September 30 of the calendar year subsequent to such year. (b) Applicable percentage For purposes of paragraphs (1)(A) and (2)(A) of subsection (a), the applicable percentage shall be— (1) for calendar year 2024, 100 percent, (2) for calendar years 2025 through 2028, the applicable percentage for the preceding calendar year, reduced by 2.5 percentage points, and (3) for any calendar year subsequent to calendar year 2028, the applicable percentage for the preceding calendar year, reduced by 5 percentage points (but not less than zero). (c) Carbon price (1) In general For purposes of paragraphs (1)(A) and (2)(A) of subsection (a), the carbon price shall be— (A) for 2024, $55, and (B) for each calendar year subsequent to the calendar year described in subparagraph (A), an amount equal to the sum of— (i) the carbon price for the preceding year, plus (ii) an amount equal to— (I) the amount described in clause (i), multiplied by (II) the percentage by which the CPI for the preceding calendar year exceeds the CPI for the second preceding calendar year, increased by 5 percentage points. (2) CPI Rules similar to the rules of paragraphs (4) and (5) of section 1(f) shall apply for purposes of this subsection. (3) Rounding Any applicable amount determined under subsection (a) which is not a multiple of $1 shall be rounded to the nearest dollar. 4693. Rebate (a) Exports (1) In general In the case of a person who exports any covered primary good from the United States which was produced in an eligible facility for which a charge has been imposed under section 4692, a refund shall be allowed to such person in the same manner as if it were an overpayment of the charge imposed by such section in an amount equal to the amount determined under paragraph (2). (2) Recalculation In the case of a covered primary good described in paragraph (1), the amount determined under this paragraph is an amount equal to the charge that would be imposed under section 4692 with respect to such good if subsection (a)(1)(A) of such section were applied by substituting the carbon intensity of all eligible facilities (as determined under subparagraph (A) of section 4691(b)(1)) operated by the covered entity which produced the covered primary good described in section 4693(a)(1) for the carbon intensity of such facility (as determined under subparagraph (A) of section 4691(b)(1)) . 4694. Definitions For purposes of this subchapter— (1) Administrator The term Administrator means the Administrator of the Environmental Protection Agency. (2) C 02-e (A) In general Subject to subparagraph (B), the term CO2-e means, with respect to a greenhouse gas, the quantity of such gas that has a global warming potential equivalent to 1 metric ton of carbon dioxide, as determined pursuant to table A–1 of subpart A of part 98 of title 40, Code of Federal Regulations, as in effect on the date of the enactment of this subchapter. (B) Methane In the case of methane, the term CO2-e means the quantity of methane that has the same global warming potential over a 20-year period as 1 metric ton of carbon dioxide, as determined by the Administrator. (3) Covered entity The term covered entity means any entity which— (A) produces any covered primary good, and (B) is required to report emissions of greenhouse gases under the Greenhouse Gas Reporting Program (or would be required to report such emissions notwithstanding any other provision of law prohibiting the implementation of or use of funds for such requirements). (4) Covered national industry (A) In general The term covered national industry means any industry which is assigned a 6-digit NAICS code which is included in any of the following clauses: (i) 211120 (petroleum extraction). (ii) 211130 (natural gas extraction). (iii) 212112 (underground coal mining). (iv) 322110 (pulp mills). (v) 322121 (paper mills). (vi) 322122 (newsprint mills). (vii) 322130 (paperboard mills). (viii) 324110 (petroleum refineries). (ix) 324121 (asphalt paving mixture and block manufacturing). (x) 324122 (asphalt shingle and coating materials manufacturing). (xi) 324199 (all other petroleum and coal products manufacturing). (xii) 325110 (petrochemical manufacturing). (xiii) 325120 (industrial gas manufacturing). (xiv) 325193 (ethyl alcohol manufacturing). (xv) 325199 (other basic organic chemical manufacturing). (xvi) 325311 (nitrogenous fertilizer manufacturing). (xvii) 327211, 327212, 327213, or 327215 (glass). (xviii) 327310 (cement). (xix) 327410 or 327420 (lime and gypsum product manufacturing). (xx) 331110 (iron and steel). (xxi) 331313 (aluminum). (B) Exceptions (i) Industrial gas manufacturing Subparagraph (A)(xiii) shall apply only with respect to the production of hydrogen. (ii) Other basic organic chemical manufacturing Subparagraph (A)(xv) shall apply only with respect to the production of adipic acid. (5) Covered primary good The term covered primary good means any good which is produced as part of a trade or business operating within a covered national industry. (6) Eligible facility The term eligible facility means any facility (as such term is defined for purposes of the Greenhouse Gas Reporting Program) which is— (A) operated by a covered entity for the production of any covered primary good, and (B) located within the United States. (7) Greenhouse gas The term greenhouse gas has the meaning given such term under section 211(o)(1)(G) of the Clean Air Act, as in effect on the date of the enactment of this subchapter. (8) Greenhouse gas emissions The term greenhouse gas emissions means the amount of greenhouse gases, expressed in metric tons of CO2-e, which were emitted to the atmosphere. (9) Greenhouse Gas Reporting Program The term Greenhouse Gas Reporting Program means the Greenhouse Gas Reporting Program established under part 98 of title 40, Code of Federal Regulations. (10) Imported finished good (A) In general The term imported finished good means any good which— (i) is imported into the United States, and (ii) (I) for calendar year 2026 and 2027, contains greater than 500 pounds of any combination of any covered primary goods, and (II) for any calendar year after calendar year 2027, contains greater than 100 pounds of any combination of any covered primary goods. (11) NAICS The term NAICS means the North American Industrial Classification System. . (b) Clerical amendment The table of subchapters for chapter 38 of the Internal Revenue Code of 1986 is amended by adding at the end thereof the following new item: Subchapter E—Carbon intensity charge . (c) Grant program (1) In general For fiscal year 2025 and each subsequent fiscal year, there are appropriated, out of any funds in the Treasury not otherwise appropriated, to the Department of the Treasury amounts equal to applicable amount for the preceding fiscal year, with such amounts to be used by the Secretary, in conjunction with the Secretary of Energy and the Administrator of the Environmental Protection Agency, to establish a competitive grant program to award grants to eligible entities for investments in new technology— (A) in the case of an existing eligible facility, to reduce their carbon intensity, and (B) in the case of a proposed eligible facility, to ensure best-in-class carbon intensity. (2) Modeled on Diesel Emissions Reduction Act For purposes of the program described in paragraph (1), such program shall be administered in a manner similar to the national grant program of the Environmental Protection Agency under subtitle G of title VII of the Energy Policy Act of 2005 ( 42 U.S.C. 16131 et seq. ). (3) Awarding of grant amounts For purposes of awarding grants under the program described in paragraph (1), the Secretary (in conjunction with the Administrator and the Secretary of Energy) shall— (A) give preference to proposed investments— (i) that would result in the greatest decrease in carbon intensity, (ii) for facilities located in economically distressed communities that have experienced a loss of manufacturing jobs, (iii) that would maximize improvement in local air quality, or (iv) for facilities located in communities with high cumulative pollution burdens (as determined by the Administrator), and (B) allocate grant funds to eligible facilities and proposed eligible facilities which produce covered primary goods that are included within a covered national industry in approximate proportion to the share of total greenhouse gas emissions for which such industry is responsible for emitting. (4) Recapture In the case of any eligible entity which has been awarded a grant under the program described in paragraph (1) with respect to any eligible facility or proposed eligible facility, if such entity fails to— (A) within 3 years of the awarding of such grant, complete the proposed investments in new technology at such facility, or (B) during the 10-year period after such investments are placed in service— (i) in the case of an existing eligible facility, achieve and maintain the reduction in carbon intensity proposed in the application for such grant, or (ii) in the case of a proposed eligible facility, achieve and maintain the best-in-class carbon intensity proposed in the application for such grant, the Secretary shall recapture, pursuant to such regulations or other guidance issued by the Secretary, the amount of the grant awarded with respect to such facility. (5) Applicable amount For purposes of this subsection, the term applicable amount means, with respect to any fiscal year, an amount equal to 75 percent of the increase in revenues to the Treasury during such fiscal year by reason of the application of subchapter E of chapter 38 of the Internal Revenue Code of 1986 (as added by subsection (a)). (6) Definitions For purposes of this subsection— (A) In general The terms covered national industry , eligible facility , and covered primary good shall have the same meaning given such terms under section 4694 of the Internal Revenue Code of 1986 (as added by subsection (a)). (B) Best-in-class carbon intensity The term best-in-class carbon intensity means, with respect to any proposed eligible facility, that the carbon intensity of such facility would be not greater than the carbon intensity of the existing facility with the lowest carbon intensity within the relevant covered national industry (as determined of the date of the application for a grant under the program described in paragraph (1)). (C) Eligible entity The term eligible entity means any person which operates an eligible facility or will operate a proposed eligible facility. (D) Secretary The term Secretary means the Secretary of the Treasury (or the Secretary's delegate). (d) Economic Support Fund of Department of State (1) In general For fiscal year 2025 and each subsequent fiscal year, in addition to amounts otherwise available, there are appropriated, out of any funds in the Treasury not otherwise appropriated, to the Department of State an amount equal to applicable amount for the preceding fiscal year, with such amount to be made available for multilateral assistance to support climate and clean energy programs. (2) Applicable amount For purposes of this subsection, the term applicable amount means, with respect to any fiscal year, an amount equal to 25 percent of the increase in revenues to the Treasury during such fiscal year by reason of the application of subchapter E of chapter 38 of the Internal Revenue Code of 1986 (as added by subsection (a)). | https://www.govinfo.gov/content/pkg/BILLS-117s4355is/xml/BILLS-117s4355is.xml |
117-s-4356 | II 117th CONGRESS 2d Session S. 4356 IN THE SENATE OF THE UNITED STATES June 7, 2022 Ms. Lummis (for herself and Mrs. Gillibrand ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To provide for responsible financial innovation and to bring digital assets within the regulatory perimeter.
1. Short title; table of contents (a) Short title This Act may be cited as the Lummis-Gillibrand Responsible Financial Innovation Act . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. TITLE I—Definitions Sec. 101. Definitions. TITLE II—Responsible taxation of digital assets Sec. 201. Gain from disposition of digital assets. Sec. 202. Information reporting requirements imposed on brokers with respect to digital assets. Sec. 203. Sources of income. Sec. 204. Decentralized autonomous organizations. Sec. 205. Tax treatment of digital asset lending agreements and related matters. Sec. 206. Implementing effective IRS guidance. Sec. 207. Analysis of retirement investing in digital assets. Sec. 208. Digital asset mining and staking. Sec. 209. Conforming amendments. TITLE III—Responsible securities innovation Sec. 301. Securities offerings involving certain intangible assets. Sec. 302. Termination of specified periodic disclosure requirements. Sec. 303. Guidance relating to satisfactory control location. Sec. 304. Custody and customer protection rules. TITLE IV—Responsible Commodities Innovation Sec. 401. Definitions. Sec. 402. Reporting and recordkeeping. Sec. 403. CFTC jurisdiction over digital asset transactions. Sec. 404. Registration of digital asset exchanges. Sec. 405. Violations. Sec. 406. Market reports. Sec. 407. Bankruptcy treatment of digital assets. Sec. 408. Identified banking products. Sec. 409. Financial institutions definition. Sec. 410. Offsetting the costs of digital asset regulation. TITLE V—Responsible consumer protection Sec. 501. Responsible consumer protection. Sec. 502. Source code version of digital assets. Sec. 503. Settlement finality. Sec. 504. Notice to customers; enforcement. Sec. 505. Right to individual management of digital assets. Sec. 506. Technical and conforming amendments. TITLE VI—Responsible payments innovation Sec. 601. Issuance of payment stablecoins. Sec. 602. Sanctions compliance responsibilities of payment stablecoin issuers. Sec. 603. Use of the official digital currency of the People’s Republic of China on Government devices. Sec. 604. Certificate of authority to commence banking. Sec. 605. Holding company supervision of covered depository institutions. Sec. 606. Implementation rules to preserve adequate competition in payment stablecoins. Sec. 607. Financial Crimes Enforcement Network Innovation Laboratory. TITLE VII—Responsible banking innovation Sec. 701. Study on use of distributed ledger technology for reduction of risk in depository institutions. Sec. 702. Eligibility for Federal Reserve services to depository institutions. Sec. 703. Routing transit number issuance. Sec. 704. Clarifying application review times with respect to the Federal banking agencies. Sec. 705. Examination standards for digital asset activities. Sec. 706. Asset custody for depository institutions and certain other entities. Sec. 707. Reputation risk; requirements for account termination requests and orders. Sec. 708. Conforming amendments. TITLE VIII—Responsible interagency coordination Sec. 801. Timeline for interpretive guidance issued by Federal financial agencies. Sec. 802. Interstate sandbox activities. Sec. 803. State money transmission coordination relating to digital assets. Sec. 804. Information sharing among Federal and State financial regulators. Sec. 805. Analysis of decentralized finance markets and technologies. Sec. 806. Analysis of energy consumption in digital asset markets. Sec. 807. Analysis of self-regulation and registered digital asset associations. Sec. 808. Cybersecurity standards for digital asset intermediaries. Sec. 809. Advisory Committee on Financial Innovation. 2. Definitions In this Act: (1) Commodity The term commodity has the meaning given the term in section 1a of the Commodity Exchange Act ( 7 U.S.C. 1a ). (2) Digital asset; digital asset intermediary; distributed ledger technology; payment stablecoin; smart contract; virtual currency The terms digital asset , digital asset intermediary , distributed ledger technology , payment stablecoin , smart contract , and virtual currency have the meanings given the terms in section 9801 of title 31, United States Code, as added by section 101 of this Act. (3) Security Except as otherwise expressly provided, the term security has the meaning given the term in section 3(a) of the Securities Exchange Act of 1934 ( 15 U.S.C. 78c(a) ). I Definitions 101. Definitions (a) In general Subtitle VI of title 31, United States Code, is amended by adding after chapter 97 the following: 98 Digital assets Sec. 9801. Definitions. 9801. Definitions In this chapter: (1) Depository institution The term depository institution has the meaning given the term in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1) ). (2) Digital asset The term digital asset — (A) means a natively electronic asset that— (i) confers economic, proprietary, or access rights or powers; and (ii) is recorded using cryptographically secured distributed ledger technology, or any similar analogue; and (B) includes— (i) virtual currency and ancillary assets in accordance with section 2(c)(2)(F) of the Commodity Exchange Act; (ii) payment stablecoins in accordance with section 403 of the Commodity Futures Modernization Act of 2000 ( 7 U.S.C. 27a ); and (iii) any other security or commodity that meets the requirements of subparagraph (A). (3) Digital asset intermediary The term digital asset intermediary — (A) means— (i) a person who holds a license, registration, or other similar authorization, as specified by this chapter, the Commodity Exchange Act ( 7 U.S.C. 1 et seq. ), the Securities Act of 1933 ( 15 U.S.C. 77a et seq. ), the Corporation of Foreign Bondholders Act, 1933 ( 15 U.S.C. 77bb et seq. ), the Trust Indenture Act of 1939 ( 15 U.S.C. 77aaa et seq. ), the Securities Exchange Act of 1934 ( 15 U.S.C. 78a et seq. ), the Securities Investor Protection Act of 1970 ( 15 U.S.C. 78aaa et seq. ), the Investment Company Act of 1940 ( 15 U.S.C. 80a–1 et seq. ), the Investment Advisers Act of 1940 ( 15 U.S.C. 80b–1 ), and the Omnibus Small Business Capital Formation Act of 1980 ( 15 U.S.C. 80c ), that may conduct market activities relating in digital assets; or (ii) a person who is required by law to hold a license, registration, or other similar authorization described in clause (i); (B) includes— (i) a person who holds a license, registration, or other similar authorization under State or Federal law that issues a payment stablecoin; and (ii) a person who is required by law to hold a license, registration, or other similar authorization described in clause (i); and (C) does not include a depository institution. (4) Distributed ledger technology The term distributed ledger technology means technology that enables the operation and use of a ledger that— (A) is shared across a set of distributed nodes that participate in a network and store a complete or partial replica of the ledger; (B) is synchronized between the nodes; (C) has data appended to the ledger by following the specified consensus mechanism of the ledger; (D) may be accessible to anyone or restricted to a subset of participants; and (E) may require participants to have authorization to perform certain actions or require no authorization. (5) Payment stablecoin The term payment stablecoin means a digital asset that is— (A) redeemable, on demand, on a 1-to-1 basis for instruments denominated in United States dollars; (B) defined as legal tender under section 5103 or under the laws of a foreign country (excluding digital assets); (C) issued by a business entity; (D) accompanied by a statement from the issuer that the asset is redeemable, as specified in subparagraph (A), from the issuer or another identified person; (E) backed by 1 or more financial assets (excluding other digital assets), consistent with subparagraph (A); and (F) intended to be used as a medium of exchange. (6) Person who provides digital asset services The term person who provides digital asset services means— (A) a digital asset intermediary; (B) a financial institution, as defined in section 1a of the Commodity Exchange Act ( 7 U.S.C. 1a ); (C) any other person conducting digital asset activities pursuant to a Federal or State charter, license, registration, or other similar authorization; and (D) any person who is required by law to hold a license, registration, or other similar authorization described in subparagraph (C). (7) Security The term security has the meaning given the term in section 3(a) of the Securities Exchange Act of 1934 ( 15 U.S.C. 78c(a) ). (8) Smart contract The term smart contract — (A) means— (i) computer code deployed to a distributed ledger technology network that executes an instruction based on the occurrence or nonoccurrence of specified conditions; or (ii) any similar analogue; and (B) includes taking possession or control of a digital asset and transferring the asset or issuing executable instructions for these actions. (9) Source code version The term source code version — (A) means the source code version comprising a digital asset; and (B) does not include software used to manage or facilitate transactions in a digital asset. (10) Virtual currency The term virtual currency — (A) means a digital asset that— (i) is used primarily as a medium of exchange, unit of account, store of value, or any combination of such functions; (ii) is not legal tender, as described in section 5103; and (iii) does not derive value from or is backed by an underlying financial asset (except other digital assets); and (B) includes a digital asset, consistent with subparagraph (A) that is accompanied by a statement from the issuer that a denominated or pegged value will be maintained and be available upon redemption from the issuer or other identified person, based solely on a smart contract. . (b) Technical and conforming amendment The table of contents for subtitle VI of title 31, United States Code, is amended by adding at the end the following: 98. Digital assets 9801 . II Responsible taxation of digital assets 201. Gain from disposition of digital assets (a) In general Part III of subchapter B of chapter 1 of the Internal Revenue Code of 1986 is amended by inserting after section 139I the following new section: 139J. Gain or loss from sale or exchange of virtual currency (a) In general Gross income shall not include gain or loss from the sale or exchange of virtual currency in a personal transaction (as defined in section 988(e)(3)) for goods and services. (b) Limitation (1) In general The amount of gain or loss excluded from gross income under subsection (a) with respect to a sale or exchange shall not exceed $200. (2) Aggregation rule For purposes of this subsection, all sales or exchanges which are part of the same transaction (or a series of related transactions) shall be treated as one sale or exchange. (c) Other sales or exchanges Subsection (a) shall not apply to sales or exchanges in which virtual currency is sold or exchanged for cash, cash equivalents, digital assets (as defined in section 9801 of title 31, United States Code), or other securities or commodities. (d) Virtual currency For purposes of this section, the term virtual currency has the meaning given such term in section 9801 of title 31, United States Code. (e) Inflation adjustment In the case of any taxable year beginning in a calendar year after 2023, the dollar amount in subsection (b) shall be increased by an amount equal to— (1) such dollar amount, multiplied by (2) the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which the taxable year begins, determined by substituting calendar year 2022 for calendar year 2016 in subparagraph (A)(ii) thereof. Any increase determined under the preceding sentence shall be rounded to the nearest multiple of $50. . (b) Clerical amendment The table of sections for part III of subchapter B of chapter 1 of the Internal Revenue Code of 1986 is amended by inserting after the item relating to section 139I the following new item: Sec. 139J. Gain or loss from sale or exchange of virtual currency. . (c) Reporting of gains or losses The Secretary shall issue regulations providing for information returns on virtual currency transactions for which gain or loss is recognized. (d) Effective date The amendments made by this section shall apply to transactions entered into after December 31, 2022. 202. Information reporting requirements imposed on brokers with respect to digital assets (a) Clarification of definition of broker Section 6045(c)(1)(D) of the Internal Revenue Code of 1986 is amended to read as follows: (D) any person who (for consideration) stands ready in the ordinary course of a trade or business to effect sales of digital assets at the direction of their customers. . (b) Reporting of digital assets (1) Brokers (A) Definition of digital asset Section 6045(g)(3)(D) of the Internal Revenue Code of 1986 is amended to read as follows: (D) Digital asset The term digital asset has the meaning given such term in section 9801 of title 31, United States Code. . (B) Applicable date Section 6045(g)(3)(C)(iii) of such Code is amended to read as follows: (iii) January 1, 2025, in the case of any specified security which is a digital asset, and . (2) Furnishing of information Section 6045A(d) of such Code is amended to read as follows: (d) Return requirement for certain transfers of digital assets not otherwise subject to reporting Any broker, with respect to any transfer (which is not part of a sale or exchange executed by such broker) during a calendar year of a covered security which is a digital asset from an account wholly controlled and maintained by such broker to an account which is not maintained by, or an address not associated with, a person that such broker knows or has reason to know is also a broker, shall make a return for such calendar year, in such form as determined by the Secretary, showing the information otherwise required to be furnished with respect to transfers subject to subsection (a). Information reported by brokers under this section shall be limited to customer information that is voluntarily provided by the customer and held by the broker for a legitimate business purpose. . (c) Effective dates The amendments made by this section shall apply to returns required to be filed and statements required to be furnished after December 31, 2025. 203. Sources of income (a) In general Paragraph (2) of section 864(b) of the Internal Revenue Code of 1986 is amended by redesignating subparagraph (C) as subparagraph (D) and by inserting after subparagraph (B) the following new subparagraph: (C) Digital assets (i) In general Trading in digital assets through a resident broker, commission agent, custodian, digital asset exchange, or other independent agent. (ii) Trading for taxpayer’s own account Trading in digital assets for the taxpayer’s own account, whether by the taxpayer or the taxpayer's employees or through a resident broker, commission agent, custodian, digital asset exchange, or other agent, and whether or not any such employee or agent has discretionary authority to make decisions in effecting the transactions. This clause shall not apply in the case of a dealer in digital assets. (iii) Definitions For purposes of this subparagraph— (I) Digital asset exchange The term digital asset exchange means a centralized or decentralized platform which facilitates the transfer of digital assets. (II) Digital asset The term digital asset has the meaning given such term in section 9801 of title 31, United States Code. (iv) Limitation This subparagraph shall apply only if the digital assets are of a kind customarily dealt in on a digital asset exchange and if the transaction is of a kind customarily consummated at such exchange. . (b) Conforming amendment Subparagraph (D) of section 864(b)(2) of the Internal Revenue Code of 1986, as redesignated by subsection (a), is amended by striking (A)(i) and (B)(i) and inserting (A)(i), (B)(i), and (C)(i) . (c) Effective date The amendments made by this section shall apply to sales and exchanges after December 31, 2022. 204. Decentralized autonomous organizations (a) In general Section 7701(a) of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph: (51) Decentralized autonomous organizations (A) In general The default classification of a decentralized autonomous organization shall be as a business entity which is not a disregarded entity. (B) Classification of other activities The following shall not be considered a business activity of such organization for purposes of determining whether such organization is described in section 501(c)(7): (i) Treasury management, including mining and staking of digital assets (as defined in section 9801 of title 31, United States Code). (ii) Raising funds for a charitable purpose. (C) Decentralized autonomous organization The term decentralized autonomous organization means an organization— (i) which utilizes smart contracts (as defined in section 9801 of title 31, United States Code) to effectuate collective action for a business, commercial, charitable, or similar entity, (ii) governance of which is achieved primarily on a distributed basis, and (iii) which is properly incorporated or organized under the laws of a State or foreign jurisdiction as a decentralized autonomous organization, cooperative, foundation, or any similar entity. . (b) Effective date Except as provided by subsection (c), the amendments made by this section shall apply to taxable years beginning after December 31, 2022. 205. Tax treatment of digital asset lending agreements and related matters (a) In general Subsection (a) of section 1058 of the Internal Revenue Code of 1986 is amended by striking (as defined in section 1236(c)) . (b) Fixed term Paragraph (1) of subsection (b) of section 1058 of the Internal Revenue Code of 1986 is amended by inserting , including a fixed-term transfer that occurs in the ordinary course of a securities lending or investment management business after transferred . (c) Basis Subsection (c) of section 1058 of the Internal Revenue Code of 1986 is amended by adding at the end the following: All appropriate basis adjustments to an agreement under subsection (b) shall be made, as determined by the Secretary, including upon the return of the lent securities to the taxpayer. . (d) Securities Section 1058 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsections: (d) Securities For purposes of this section, the term securities has the meaning given such term by section 1236(c), except that such term includes any digital asset (as defined in section 9801 of title 31, United States Code) and, with respect to a digital asset, does not require a call option. (e) Income An amount equal to the income which would otherwise accrue to the lender but for a lending transaction under this section shall be included in gross income of the lender. . (e) Rule of construction Nothing in this section shall be construed to create any inference with respect to the classification of any digital asset as security under the Securities Act of 1933 ( 15 U.S.C. 77a et seq. ) or the Securities Exchange Act of 1934 ( 15 U.S.C. 78a et seq. ). (f) Rulemaking authority The Secretary of the Treasury (or the Secretary's delegate) may adopt rules to implement this section, including the application of this section to forks, airdrops, and similar subsidiary value. (g) Effective date The amendments made by this section shall apply to sales and exchanges after December 31, 2022. 206. Implementing effective IRS guidance (a) In general Not later than 1 year after the date of the enactment of this Act, the Secretary of the Treasury (or the Secretary's delegate) shall adopt guidance relating to the following: (1) Classification of forks, airdrops, and similar subsidiary value as taxable, contingent upon the affirmative claim and disposition of the subsidiary value by a taxpayer. Such guidance shall also permit a taxpayer to provide notification through an annual return or other appropriate means to the Internal Revenue Service relating to claim and disposition of, or disclaimer of, subsidiary value. (2) Merchant acceptance of digital assets and the tax treatment of payments and receipts, consistent with the amendments made by section 80603 of the Infrastructure Investment and Jobs Act, as amended by section 203. (3) Treatment of digital asset mining and staking, including mining and staking rewards, in which income is not realized until disposition of the assets produced or received in connection with such activity, in accordance with section 451(l) of the Internal Revenue Code of 1986 (as added by this Act). (4) Classification of charitable contributions greater than $5,000 of digital assets which are traded on established financial markets as contributions of readily valued property not requiring a qualified appraisal for purposes of section 170(f)(11)(A) of the Internal Revenue Code of 1986, as amended by this Act. (5) Characterization of payment stablecoins (as defined in section 9801 of title 31, United States Code) as indebtedness. (b) Effective date The guidance adopted under this section shall be applicable on a prospective basis for taxable years beginning after December 31, 2023. 207. Analysis of retirement investing in digital assets (a) Not later than March 1, 2023, the Comptroller General of the United States shall conduct a study and provide a report to the entities specified in subsection (b) regarding the following issues relating to retirement investing in digital assets: (1) Potential benefits to diversification and return of an investor’s retirement portfolio. (2) Appropriate asset allocations, including among other alternative investments. (3) Consumer education, financial literacy and investment advisor training relating to digital assets. (4) Risk. (5) Legal and operational barriers to effective retirement investing in digital assets. (6) Any other topic determined to be material by the Comptroller General relating to retirement investing in digital assets. (b) The Comptroller General shall provide the report required by subsection (a) to the following: (1) The Committee on Banking, Housing, and Urban Affairs of the Senate. (2) The Committee on Finance of the Senate. (3) The Committee on Health, Education, Labor, and Pensions of the Senate. (4) The Committee on Financial Services of the House of Representatives. (5) The Committee on Ways and Means of the House of Representatives. (6) The Committee on Education and Labor of the House of Representatives. (7) The Secretary of the Treasury. (8) The Secretary of Labor. 208. Digital asset mining and staking (a) In general Section 451 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection: (l) Deferral of income recognition for digital asset activities In the case of a taxpayer who conducts digital asset mining or staking activities, the amount of income relating to such activities shall not be included in the gross income of the taxpayer until the taxable year of the disposition of the assets produced or received in connection with the mining or staking activities. . (b) Effective date The amendment made by this section shall apply to taxable years beginning after December 31, 2022. 209. Conforming amendments (a) Charitable contributions (1) In general Subclause (I) of section 170(f)(11)(A)(ii) of the Internal Revenue Code of 1986 is amended by inserting , digital assets (as defined in section 9801 of title 31, United States Code) after 6050L(a)(2)(B)) . (2) Effective date The amendment made by this subsection shall apply to taxable years beginning after December 31, 2022. (b) Other conforming amendments (1) In general Title 31, United States Code, is amended— (A) in section 5312(a)(2)— (i) by redesignating subparagraphs (A) through (Z) as clauses (i) through (xxvi), respectively; (ii) in the matter preceding clause (i), as so designated, by striking institution means— and inserting institution — (A) means— ; (iii) in clause (xxvi), as so designated, by striking the period at the end and inserting ; and ; and (iv) by adding at the end the following: (B) does not include a decentralized autonomous organization, as defined in section 7701(a) of the Internal Revenue Code of 1986. ; and (B) in section 5336(a)(11)(B)(2)— (i) by redesignating clause (xxv) as clause (xxvi); and (ii) by adding after clause (xxv) the following: (xxv) A decentralized autonomous organization, as defined in section 7701(a) of the Internal Revenue Code of 1986; and . (2) Anti-Money Laundering Act of 2020 Section 6110(a) of the Anti-Money Laundering Act of 2020 (division F of Public Law 116–283 ) is amended by striking paragraph (1) and inserting the following: (A) by redesignating clauses (xxv) and (xxvi) as clauses (xxvi) and (xxvii), respectively, and adjust the margins accordingly; and (B) by inserting after clause (xxiv) the following: (Y) a person engaged in the trade of antiquities, including an advisor, consultant, or any other person who engages as a business in the solicitation or the sale of antiquities, subject to regulations prescribed by the Secretary; . . III Responsible securities innovation 301. Securities offerings involving certain intangible assets Title I of the Securities Exchange Act of 1934 ( 15 U.S.C. 78a et seq. ) is amended by adding at the end the following: 41. Securities offerings involving certain intangible assets (a) Definitions In this section: (1) Ancillary asset (A) In general The term ancillary asset means an intangible, fungible asset that is offered, sold, or otherwise provided to a person in connection with the purchase and sale of a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ). (B) Exclusion The term ancillary asset does not include an asset that provides the holder of the asset with any of the following rights in a business entity: (i) A debt or equity interest in that entity. (ii) Liquidation rights with respect to that entity. (iii) An entitlement to an interest or dividend payment from that entity. (iv) A profit or revenue share in that entity solely from the entrepreneurial or managerial efforts of others. (v) Any other financial interest in that entity. (2) Foreign private issuer The term foreign private issuer means a foreign issuer, other than a foreign government, except that the term does not include a foreign issuer that, as of the last business day of the most recently completed fiscal quarter of the issuer, satisfies the following conditions: (A) More than 50 percent of the outstanding voting securities of the issuer are directly or indirectly owned by residents of the United States. (B) Any of the following: (i) The majority of the executive officers or directors of the issuer are citizens or residents of the United States. (ii) More than 50 percent of the assets of the issuer are located in the United States. (iii) The business of the issuer is principally administered in the United States. (b) Disclosure requirements (1) Initial compliance with specified periodic disclosure requirements Subject to paragraphs (4) and (5), an issuer engaged in business in or affecting interstate commerce, or that is organized outside of the United States and is not a foreign private issuer, that offers, sells, or otherwise provides a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ), and that provides or proposes to provide any holder of the security with an ancillary asset, shall be subject to the periodic disclosure requirements under subsection (c) for the 1-year period beginning on the date that is 180 days after the first date on which the security is offered, sold, or otherwise provided by the issuer, if— (A) the average daily aggregate value of all ancillary assets offered, sold, or otherwise provided by the issuer in relation to the offer, sale, or provision of the security in all spot markets open to the public in the United States (based on the knowledge of the issuer after due inquiry) is greater than $5,000,000 for the 180-day period immediately succeeding the date of that first offer, sale, or provision; and (B) during the 180-day period described in subparagraph (A), the issuer, or any person owning not less than 10 percent of any class of equity securities of the issuer, engaged in entrepreneurial or managerial efforts that primarily determined the value of the ancillary asset. (2) Ongoing compliance with specified periodic disclosure requirements Subject to paragraphs (4) and (5), an issuer that is engaged in business in or affecting interstate commerce, or that is organized outside of the United States and is not a foreign private issuer, that offers, sells, or otherwise provides a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ), and that provides the holder of the security with an ancillary asset in connection with the acquisition of the security, shall be subject to the periodic disclosure requirements under subsection (c) for a given fiscal year of that issuer, if, in the immediately preceding fiscal year of the issuer (or any portion thereof)— (A) the average daily aggregate value of all trading in the ancillary asset in all spot markets open to the public in the United States was greater than $5,000,000, based on the knowledge of the issuer after due inquiry; and (B) the issuer, or any person owning not less than 10 percent of any class of equity securities of the issuer, engaged in entrepreneurial or managerial efforts that primarily determined the value of the ancillary asset. (3) Transition rule Subject to paragraphs (4) and (5), an issuer that is engaged in business in or affecting interstate commerce, or that is organized outside of the United States and is not a foreign private issuer, that offers, sells, or otherwise provides a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ), and that provides the holder of the security with an ancillary asset before January 1, 2023, in connection with the acquisition of the security shall be subject to the periodic disclosure requirements under subsection (c) beginning in the first fiscal year of the issuer that begins on or after that date, if, in the immediately preceding fiscal year of the issuer— (A) the average daily aggregate value of trading in the ancillary asset in all spot markets open to the public for which trading volume is generally available was greater than $5,000,000, based on the knowledge of the issuer after due inquiry; and (B) the issuer, or any person owning not less than 10 percent of any class of equity securities of the issuer, engaged in entrepreneurial or managerial efforts that primarily determined the value of the ancillary asset. (4) Treatment of ancillary assets (A) In general Notwithstanding any other provision of law, if an issuer issues a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ), is subject to paragraph (1), (2), or (3), and is in compliance with the periodic disclosure requirements under subsection (c), an ancillary asset provided directly or indirectly by the issuer shall be presumed— (i) to be a commodity, consistent with section 2(c)(2)(F) of the Commodity Exchange Act ( 7 U.S.C. 2(c)(2)(F) ); and (ii) not to be a security under— (I) section 3(a); (II) such section 2(a)(1); (III) section 2(a) of the Investment Company Act of 1940 ( 15 U.S.C. 80a–2(a) ); (IV) section 202(a) of the Investment Advisers Act of 1940 ( 15 U.S.C. 80b–2(a) ); or (V) any applicable provision of State law. (B) Other persons A person who is not an issuer, an entity controlled by an issuer (including a person that acquires an ancillary asset from such an issuer for the purpose of resale or distribution of the ancillary asset), or a person acting at the direction or on the behalf of an issuer shall be not required to treat an ancillary asset provided by an issuer as a security under this Act or any provision of law described in subparagraph (A)(ii). (C) Exception (i) In general Subparagraph (A) shall not apply to an ancillary asset if a court of the United States of competent jurisdiction, after an appropriate proceeding, issues an order finding that there is not a substantial basis for the presumption that the ancillary asset is a commodity and not a security under subparagraph (A). (ii) Rules of construction Nothing in this subparagraph shall be construed to preclude the Commission from entering into a settlement agreement relating to violations or alleged violations of this section. Compliance under this section shall not be used in any administrative or judicial proceeding that an ancillary asset is a security. (5) Calculation For the purposes of paragraphs (1), (2), and (3), the calculation of daily aggregate value shall be based on data disclosed by spot markets or otherwise available to the public for inspection. (c) Specified periodic disclosure requirements If an issuer is subject to paragraph (1), (2), or (3) of subsection (b), the issuer shall furnish, or cause the relevant affiliate to furnish, to the Commission, on a semi-annual basis, information that the Commission may, by rule, require relating to the issuer and any relevant ancillary asset, as necessary or appropriate in the public interest or for the protection of investors, which shall be exclusively comprised of the following: (1) Basic corporate information regarding the issuer, including the following: (A) The experience of the issuer in developing assets similar to the ancillary asset. (B) If the issuer has previously provided ancillary assets to purchasers of securities, information on the subsequent history of those previously provided ancillary assets, including price history, if the information is publicly available. (C) The activities that the issuer has taken in the relevant disclosure period, and is projecting to take in the 1-year period following the submission of the disclosure, with respect to promoting the use, value, or resale of the ancillary asset (including any activity to facilitate the creation or maintenance of a trading market for the ancillary asset and any network or system that utilizes the ancillary asset). (D) The anticipated cost of the activities of the issuer in subparagraph (C) and whether the issuer has unencumbered, liquid funds equal to that amount. (E) To the extent the ancillary asset involves the use of a particular technology, the experience of the issuer with the use of that technology. (F) The backgrounds of the board of directors (or equivalent body), senior management, and key employees of the issuer, the experience or functions of whom are material to the value of the ancillary asset, as well as any personnel changes relating to the issuer during the period covered by the disclosure. (G) A description of the assets and liabilities of the issuer, to the extent material to the value of the ancillary asset. (H) A description of any legal proceedings in which the issuer is engaged (including inquiries by governmental agencies into the activities of the issuer), to the extent material to the value of the ancillary asset. (I) Risk factors relating to the impact of the issuer on, or unique knowledge relating to, the value of the ancillary asset. (J) Information relating to ownership of the ancillary asset by— (i) persons owning not less than 10 percent of any class of equity security of the issuer; and (ii) the management of the issuer. (K) Information relating to transactions involving the ancillary asset by the issuer with related persons, promoters, and control persons. (L) Recent sales or similar dispositions of ancillary assets by the issuer and affiliates of the issuer. (M) Purchases or similar dispositions of ancillary assets by the issuer and affiliates of the issuer. (N) A going concern statement from the chief financial officer of the issuer or equivalent official, signed under penalty of perjury, stating whether the issuer maintains the financial resources to continue business as a going concern for the 1-year period following the submission of the disclosure, absent a material change in circumstances. (2) Information relating to the ancillary asset, including the following: (A) A general description of the ancillary asset, including the standard unit of measure with respect to the ancillary asset, the intended or known functionality and uses of the ancillary asset, the market for the ancillary asset, other assets or services that may compete with the ancillary asset, and the total supply of the ancillary asset or the manner and rate of the ongoing production or creation of the ancillary asset. (B) If ancillary assets have been offered, sold, or otherwise provided by the issuer to investors, intermediaries, or resellers, a description of the amount of assets offered, sold, or provided, the terms of each such transaction, and any contractual or other restrictions on the resale of the assets by intermediaries. (C) If ancillary assets were distributed without charge, a description of each distribution, including the identity of any recipient that received more than 5 percent of the total amount of the ancillary assets in any such distribution. (D) The amount of ancillary assets owned by the issuer. (E) For the 1-year period following the submission of the disclosure, a description of the plans of the issuer to support (or to cease supporting) the use or development of the ancillary asset, including markets for the ancillary asset and each platform or system that uses the ancillary asset. (F) Each third party not affiliated with the issuer, the activities of which may have a material impact on the value of the ancillary asset. (G) Risk factors known to the issuer that may limit demand for, or interest in, the ancillary asset. (H) The names and locations of the markets in which the ancillary asset is known by the issuer to be available for sale or purchase. (I) To the extent available to the issuer, the average daily price for a constant unit of value of the ancillary asset during the relevant reporting period, as well as the 12-month high and low prices for the ancillary asset. (J) If applicable, information relating to any external audit of the code and functionality of the ancillary asset, including the entity performing the audit and the experience of the entity in conducting similar audits. (K) If applicable, any third-party valuation report or economic analysis regarding the ancillary asset or the projected market of the ancillary asset, which shall include the entity performing the valuation or analysis and the experience of the entity in conducting similar reports or analyses. (L) If the ancillary asset is intangible, information relating to custody by the owner of the ancillary asset or a third party. (M) Information on intellectual property rights claimed or disputed relating to the ancillary asset. (N) A description of the technology underlying the ancillary asset. (O) Any material tax considerations applicable to owning, storing, using, or trading the ancillary asset. (P) Any material legal or regulatory considerations applicable to owning, storing, using, or trading the ancillary asset, including any legal proceeding that may impact the value of the ancillary asset. (Q) Any other material factor or information that may impact the value of the ancillary asset and about which the issuer is reasonably aware. (d) Application to successor entities and certain affiliates (1) In general If an issuer would otherwise be subject to specified periodic disclosure requirements under subsection (c) and is no longer in operation, any successor entity that directly or indirectly received not less than 50 percent of the proceeds raised by the sale of the related securities of that issuer, and that is engaged in entrepreneurial or managerial efforts that primarily determine the value of the applicable ancillary asset, shall furnish, or cause to be furnished, to the Commission the information required under that subsection. (2) Certain affiliates If an entity controlled by an issuer is subject to specified periodic disclosure requirements under subsection (c) and is engaged in entrepreneurial or managerial efforts that primarily determine the value of an ancillary asset, the entity may furnish to the Commission the information required under that subsection. (e) Voluntary disclosure An issuer that is not subject to the specified periodic disclosure requirements under subsection (c) and that offers or sells a security through an arrangement or scheme that constitutes an investment contract, as that term is used in section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) ), and that provides the holder of that security with an ancillary asset in connection with the acquisition of the security may voluntarily furnish to the Commission the information required under that subsection if the issuer believes that it is reasonably likely that the issuer will become subject to those requirements in the future. (f) Exemptions The Commission may, by order, exempt an ancillary asset from the specified periodic disclosure requirements under subsection (c) if the Commission determines that the public policy goals of disclosure and consumer protection are not satisfied by requiring disclosures relating to an ancillary asset. (g) Rule of construction If an issuer fails to comply with a provision of this section, an ancillary asset provided by the issuer shall not be presumed to be a security under a provision of law described in subsection (b)(4)(A)(ii), solely because of such failure. (h) Rules The Commission may adopt rules and guidance to implement this section, consistent with the statutory intent of this section. . 302. Termination of specified periodic disclosure requirements Section 41 of the Securities Exchange Act of 1934, as added by section 301 of this Act, is amended by adding at the end the following: (i) Termination of specified periodic disclosure requirements (1) In general The obligation of an issuer to furnish the information required under subsection (c) shall terminate on the date that is 90 days, or such shorter period as the Commission may determine, after the date on which the issuer files a certification described in paragraph (2). (2) Certification (A) In general A certification filed under paragraph (1) shall be supported by reasonable evidence, based on the knowledge of the issuer filing the certification, after due inquiry, that— (i) the average daily aggregate value of all trading in the applicable ancillary asset in all spot markets open to the public in the United States in the 12-month period preceding the date on which the certification is filed was not greater than $5,000,000; or (ii) during the 12-month period preceding the date on which the certification is filed, neither the applicable issuer, nor any entity controlled by the applicable issuer, engaged in entrepreneurial or managerial efforts that primarily determined the value of the ancillary asset. (B) Denial (i) In general Subject to subparagraph (C)(ii), the Commission may, by majority vote and after notice and opportunity for hearing, deny a certification filed under paragraph (1) if the Commission finds that the certification is not supported by substantial evidence. (ii) Effect The denial, under clause (i), of a certification filed under paragraph (1)— (I) shall terminate the certification so filed; and (II) shall not prevent the applicable issuer from filing another certification under paragraph (1), if the re-filed certification is filed not earlier than 180 days after the date on which the original certification is denied. (C) Pending status (i) In general Termination of the disclosure requirements described in paragraph (1) applicable to an issuer that has filed a certification under that paragraph shall be deferred pending review by the Commission of the evidence supporting the certification. (ii) Effect of delay If, as of the date that is 90 days after receiving a certification filed under paragraph (1), the Commission has not requested additional evidence with respect to the certification from the applicable issuer, the disclosure obligations that are the subject of the certification shall terminate. . 303. Guidance relating to satisfactory control location Not later than 180 days after the date of the enactment of this Act, the Securities and Exchange Commission (referred to in this title as the Commission ) shall issue guidance relating to section 240.15c3–3 of title 17, Code of Federal Regulations, or any successor regulation, providing that the requirement to designate a satisfactory control location for a digital asset that is, or may represent ownership of, a security may be satisfied by protecting the digital asset through commercially reasonable cybersecurity practices to maintain control of sufficient private key material to transfer control of the digital asset to another person, or to cause another person to obtain control of the digital asset, including by means of a smart contract that generates private key material without the involvement of a natural person. 304. Custody and customer protection rules (a) In general (1) Modernization of existing rules and adoption of new rules Not later than 18 months after the date of enactment of this Act, the Commission shall— (A) complete the multi-year study of the Commission with respect to the modernization of the rules of the Commission relating to customer protection (section 240.15c3–3 of title 17, Code of Federal Regulations) and custody of securities, digital assets, and client funds (section 275.206(4)–2 of title 17, Code of Federal Regulations); and (B) consistent with the results of the study described in subparagraph (A), adopt final rules relating to the issues described in paragraph (2). (2) Contents The final rules adopted under paragraph (1)(B) shall address the following concepts: (A) Investor protection and education with respect to digital assets. (B) Digital assets, distributed ledger technology, and use of collaborative custody or multi-signature arrangements, including distribution of private key material and resulting obligations. (C) Changes in market structure and asset characteristics, including disuse of physical securities and assets and appropriate custodial methods for electronically native assets. (D) Reduction of regulatory burden. (E) Use of technology to facilitate regulatory compliance and risk management. (F) Parity of State- and nationally chartered banks, as defined in section 202(a) of the Investment Advisers Act of 1940 ( 15 U.S.C. 80b–2(a) ), with respect to asset custody in a manner consistent with that Act ( 15 U.S.C. 80b–1 et seq. ) and other existing law. (G) Standards under which an issuer of an unregistered digital asset that is, or may represent ownership of, a security is not required to utilize a registered transfer agent. (H) Specification of the digital assets which constitute client funds under section 275.206(4)–2 of title 17, Code of Federal Regulations. (b) Digital assets and securities Not later than 270 days after the date of enactment of this Act, the Commission shall adopt final guidance permitting, for the purposes of section 240.15c3–3(b) of title 17, Code of Federal Regulations, a broker or a dealer to perform, within the same legal entity, both trading and custodial activities relating to fully paid and excess margin digital assets, including virtual currency and digital assets that are securities or may represent ownership of securities, in addition to traditional securities, client funds, and other assets permitted by the Commission to be within the control of a broker or dealer. IV Responsible Commodities Innovation 401. Definitions Section 1a of the Commodity Exchange Act ( 7 U.S.C. 1a ) is amended— (1) in paragraph (9), by striking and frozen concentrated orange juice and inserting frozen concentrated orange juice, and a digital asset (consistent with section 2(c)(2)(F)) ; (2) by inserting after paragraph (15) the following: (15A) Digital asset (A) In general Except as provided in subparagraph (B), the term digital asset has the meaning given the term in section 9801 of title 31, United States Code. (B) Exclusion The term digital asset does not include an asset that provides the holder of the asset with any of the following rights in a business entity: (i) A debt or equity interest in that entity. (ii) Liquidation rights with respect to that entity. (iii) An entitlement to an interest or dividend payment from that entity. (iv) A profit or revenue share in that entity derived solely from the entrepreneurial or managerial efforts of others. (v) Any other financial interest in that entity. (15B) Digital asset exchange The term digital asset exchange means a trading facility that lists for trading at least 1 digital asset. ; (3) in paragraph (28)(A)(i)— (A) in subclause (I)— (i) in item (aa)— (I) in subitem (EE), by striking or at the end; and (II) by adding at the end the following: (GG) the purchase or sale of a digital asset that is traded on or subject to the rules of a registered entity; ; (ii) in item (bb), by striking and and inserting or ; and (iii) by adding at the end the following: (cc) acting as a counterparty to any cash or spot agreement, contract, or transaction involving a digital asset with a person who is not an eligible contract participant, unless the activity is— (AA) conducted in compliance with the laws of the State in which the activity occurs; (BB) subject to regulation by another Federal authority; or (CC) separately regulated under this Act; and ; and (B) in subclause (II), by striking items (aa) or (bb) and inserting item (aa), (bb), or (cc) ; (4) by inserting after paragraph (39) the following: (39A) Registered digital asset exchange The term registered digital asset exchange means a digital asset exchange registered under section 5i. ; and (5) in paragraph (40)— (A) in subparagraph (E), by striking and at the end; (B) by redesignating subparagraph (F) as subparagraph (G); and (C) by inserting after subparagraph (E) the following: (F) a registered digital asset exchange; and . 402. Reporting and recordkeeping Section 4g of the Commodity Exchange Act ( 7 U.S.C. 6g ) is amended— (1) in subsection (a), by inserting digital assets or before commodities ; and (2) in subsection (d), in the second sentence, by striking commodity futures. and inserting commodities. . 403. CFTC jurisdiction over digital asset transactions (a) Commission jurisdiction over retail digital asset transactions (1) In general Section 2(c)(2) of the Commodity Exchange Act ( 7 U.S.C. 2(c)(2) ) is amended— (A) in subparagraph (D)(ii)— (i) in subclause (III), in the matter preceding item (aa), by inserting of a commodity, other than a digital asset, before that ; (ii) by redesignating subclauses (IV) and (V) as subclauses (V) and (VI), respectively; and (iii) by inserting after subclause (III) the following: (IV) a contract of sale of a digital asset that— (aa) results in actual delivery within 2 days or such other period as the Commission may determine by rule based upon the typical commercial practice in cash or spot markets for the digital asset involved; or (bb) is executed on or subject to the rules of a registered digital asset exchange or with a registered futures commission merchant; ; and (B) by adding at the end the following: (F) Commission jurisdiction over digital asset transactions (i) In general (I) Jurisdiction Subject to sections 6d and 12(e) and section 403 of the Commodity Futures Modernization Act of 2000 ( 7 U.S.C. 27a ), the Commission shall have exclusive jurisdiction over any agreement, contract, or transaction involving a contract of sale of a digital asset in interstate commerce, including ancillary assets (consistent with section 41(b)(4) of the Securities Exchange Act of 1934), except that specified periodic reporting requirements made by an issuer which provided the holder of the security with an ancillary asset under that section, and the security that constitutes an investment contract (within the meaning of section 2(a)(1) of the Securities Act of 1933 ( 15 U.S.C. 77b(a)(1) )), shall remain within the jurisdiction of the Securities and Exchange Commission. (II) Fungibility requirement The Commission shall only exercise jurisdiction over an agreement, contract, or transaction involving a contract of sale of a digital asset that is fungible, which shall not include digital collectibles and other unique digital assets. (ii) Withholding of rulemaking authority over certain transactions Notwithstanding clause (i), this subparagraph shall not be interpreted to permit the Commission to issue any rule regarding any agreement, contract, or transaction that is not offered, solicited, traded, facilitated, executed, cleared, reported, or otherwise dealt in— (I) on or subject to the rules of a registered entity; or (II) by any other entity registered by the Commission. (iii) Limitation Clause (i) shall not apply to custodial activities with respect to a digital asset of an entity supervised or regulated by a State or other Federal regulatory agency. . (2) Conforming amendment Section 2(a)(1)(A) of the Commodity Exchange Act ( 7 U.S.C. 2(a)(1)(A) ) is amended, in the first sentence, by striking section 19 of this Act and inserting subsection (c)(2)(F) or section 19 . (b) Segregation of digital assets Section 4d of the Commodity Exchange Act ( 7 U.S.C. 6d ) is amended by adding at the end the following: (i) Segregation of digital assets (1) Holding of customer assets (A) In general Each futures commission merchant shall hold customer money, assets, and property in a manner to minimize the customer’s risk of loss of, or unreasonable delay in the access to, the money, assets, and property. (B) Custodian A futures commission merchant shall hold the property of a customer of the futures commission merchant with a licensed, chartered, or registered entity subject to regulation by 1 of the following agencies: (i) The Commission. (ii) The Securities and Exchange Commission. (iii) An appropriate Federal banking agency (as defined in section 3 of the Federal Deposit Insurance Act ( 12 U.S.C. 1813 )). (iv) A State bank supervisor (as defined in that section). (v) An appropriate foreign governmental authority in the home country of the custodian. (2) Segregation of funds (A) Definition of digital asset customer In this paragraph, the term digital asset customer means a customer involved in a cash or spot, leveraged, margined, or financed digital asset transaction in which the futures commission merchant is acting as the counterparty. (B) Requirements (i) In general A futures commission merchant shall treat and deal with all money, assets, and property of any digital asset customer received as belonging to the customer. (ii) Commingling prohibited Money, assets, and property of a digital asset customer described in clause (i)— (I) shall be separately accounted for; and (II) shall not be— (aa) commingled with the funds of the futures commission merchant; or (bb) used to margin, secure, or guarantee any trades or accounts of any customer or person other than the person for whom the money, assets, or property are held. (C) Exceptions (i) Use of funds (I) In general Notwithstanding subparagraph (B), money, assets, and property of a digital asset customer may, for convenience, be commingled and deposited in the same account or accounts with an entity described in paragraph (1)(B). (II) Withdrawal Notwithstanding subparagraph (B), the share of the money, assets, and property described in subclause (I) as in the normal course of business is necessary to margin, guarantee, secure, transfer, adjust, or settle a digital asset transaction with a registered entity may be withdrawn and applied to those purposes, including the payment of commissions, brokerage, interest, taxes, storage, and other charges, lawfully accruing in connection with the digital asset transaction. (ii) Commission action Notwithstanding subparagraph (B), in accordance with such terms and conditions as the Commission may prescribe by rule or order, any money, assets, or property of a digital asset customer may be commingled and deposited in customer accounts with any other money, assets, or property received by the futures commission merchant and required by the Commission to be separately accounted for and treated and dealt with as belonging to the digital asset customer. (D) Permitted investments Money of a digital asset customer may be invested— (i) in— (I) obligations of the United States; (II) general obligations of any State or of any political subdivision of a State; (III) obligations fully guaranteed as to principal and interest by the United States; or (IV) any other investment that the Commission may by rule prescribe; and (ii) in accordance with such rules and subject to such conditions as the Commission may prescribe. (E) Prohibition It shall be unlawful for any person, including any derivatives clearing organization or depository institution, that has received any money, assets, or property for deposit in a separate account or accounts as required by subparagraph (B) to hold, dispose of, or use any of the money, assets, or property that belongs to the depositing futures commission merchant or any person other than the digital asset customer of the futures commission merchant. (3) Customer right to opt out (A) In general A customer shall have the right to waive any requirement under this subsection by affirmatively electing, in writing to the futures commission merchant, to waive the requirement. (B) Limitations The Commission may, by rule, establish notice and disclosure requirements, segregation requirements, investment limitations, and other rules relating to the waiving of any requirement under this subsection that are reasonably necessary to protect customers, including eligible contract participants, non-eligible contract participants, and any other class of customers. . (c) Limitation on futures commission merchants acting as a counterparty in digital asset transactions Section 4d of the Commodity Exchange Act ( 7 U.S.C. 6d ) (as amended by subsection (b)) is amended by adding at the end the following: (j) Limitation on futures commission merchants acting as a counterparty in digital asset transactions A registered futures commission merchant shall not act as a counterparty in any agreement, contract, or transaction involving a digital asset that has not been listed for trading on a registered digital asset exchange. . (d) Common provisions applicable to registered entities Section 5c of the Commodity Exchange Act ( 7 U.S.C. 7a–2 ) is amended— (1) in subsection (a)(1), by striking 5(d) and 5b(c)(2) and inserting 5(d), 5b(c)(2), and 5i(c) ; (2) in subsection (b), by inserting registered digital asset exchange, before derivatives each place it appears; and (3) in subsection (c)— (A) in paragraph (2), by inserting or participants before (in a ; (B) in paragraph (4)(B), by striking 1a(10) and inserting 1a(9) ; and (C) in paragraph (5), by adding at the end the following: (D) Special rules for the listing of certain digital assets (i) In general In the case of listing for trading a digital asset that has not previously been listed for trading on another registered entity— (I) paragraphs (2) and (3) shall apply as if the listing were a rule; and (II) paragraph (2) shall be applied by substituting 20 business days for 10 business days . (ii) Transitional extension During the 1-year period beginning on the date of the registration of the first digital asset exchange, the Commission shall have an additional 20 business days to review any certification under clause (i). (iii) Consideration of comments In conducting a review under clause (i), the Commission shall consider any comments provided by the Securities and Exchange Commission with respect to the legal classification of a digital asset. . 404. Registration of digital asset exchanges (a) In general The Commodity Exchange Act ( 7 U.S.C. 1 et seq. ) is amended by inserting after section 5h the following: 5i. Registration of digital asset exchanges (a) Definition of customer In this section, the term customer means any person that maintains an account for the trading of digital assets directly with a registered digital asset exchange (other than a person that is owned or controlled, directly or indirectly, by the registered digital asset exchange) on behalf of the person or any other person. (b) Registration (1) In general Any trading facility that offers or seeks to offer a market in digital assets may register with the Commission as a digital asset exchange by submitting to the Commission an application in such form and containing such information as the Commission may require for the purpose of making the determinations required for approval under subsections (d) and (f). (2) Deemed registration A registered designated contract market or registered swap execution facility that fulfills the requirements of this section may elect to be considered a registered digital asset exchange, in such form and manner as the Commission shall prescribe. (3) Additional registration A registered digital asset exchange shall be registered with the Secretary of the Treasury as a money services business. (c) Trading (1) In general A registered digital asset exchange may make available for trading any digital asset that is not readily susceptible to manipulation, subject to this subsection. (2) Rules governing margined or leveraged trading The Commission may make, promulgate, and enforce such additional rules governing margined, leveraged, or financed transactions as are reasonably necessary to protect market participants and promote the orderly settlement of transactions with respect to— (A) disclosure; (B) recordkeeping; (C) capital, margin, and other financial resources; (D) reporting; (E) business conduct; (F) documentation; and (G) such other matters as the Commission determines to be necessary. (3) Prohibition on trading derivatives products Registration as a digital asset exchange shall not permit a trading facility to offer any contract of sale of a commodity for future delivery, option, or swap for trading without also being registered as a designated contract market or swap execution facility. (d) Core principles for digital asset exchanges (1) Compliance with core principles (A) In general To be registered, and maintain registration, as a digital asset exchange, the registered digital asset exchange shall comply with— (i) the core principles described in this subsection; and (ii) any requirement that the Commission may impose by rule pursuant to section 8a(5). (B) Reasonable discretion of digital asset exchange Unless otherwise determined by the Commission by rule, a registered digital asset exchange described in subparagraph (A) shall have reasonable discretion in establishing the manner in which the registered digital asset exchange complies with the core principles described in this subsection. (2) Compliance with rules A registered digital asset exchange shall— (A) establish and enforce compliance with 1 or more rules of the registered digital asset exchange, including— (i) the terms and conditions of the trades traded or processed on or through the registered digital asset exchange; and (ii) any limitation on access to the registered digital asset exchange; (B) establish and enforce compliance with trading, trade processing, and participation rules that will deter abuses and have the capacity to detect, investigate, and enforce violations of those rules, including means— (i) to provide market participants with impartial access to the market; and (ii) to capture information that may be used in establishing whether rule violations have occurred; and (C) establish rules governing the operation of the registered digital asset exchange, including rules specifying trading procedures to be used in entering and executing orders traded or posted on the registered digital asset exchange. (3) Digital assets not readily susceptible to manipulation (A) In general A registered digital asset exchange shall permit trading only in assets that are not readily susceptible to manipulation. (B) Listing restrictions A registered digital asset exchange shall not permit trading in a digital asset if it is reasonably likely that— (i) the transaction history of the digital asset can be fraudulently altered by any person or group of persons acting collectively; or (ii) the functionality or operation of the digital asset can be materially altered by any person or group of persons under common control. (C) Considerations In assessing a digital asset under this paragraph, a registered digital asset exchange shall consider— (i) the purpose and use of the digital asset; (ii) the creation or release process of the digital asset; (iii) the consensus mechanism of the digital asset; (iv) the governance structure of the digital asset; (v) the participation and distribution of the digital asset; (vi) the current and proposed functionality of the digital asset; (vii) the legal classification of the digital asset; and (viii) any other factor required by the Commission. (4) Treatment of customer assets (A) Required standards and procedures A registered digital asset exchange shall establish standards and procedures that are designed to protect and ensure the safety of customer money, assets, and property. (B) Holding of customer assets (i) In general A registered digital asset exchange shall hold customer money, assets, and property in a manner to minimize the customer’s risk of loss of, or unreasonable delay in the access to, the money, assets, and property. (ii) Segregation of funds (I) In general A registered digital asset exchange shall treat and deal with all money, assets, and property of any customer received as belonging to the customer. (II) Commingling prohibited Money, assets, and property of a customer described in subclause (I)— (aa) shall be separately accounted for; and (bb) shall not be— (AA) commingled with the funds of the registered digital asset exchange; or (BB) used to margin, secure, or guarantee any trades or accounts of any customer or person other than the person for whom the money, assets, or property are held. (iii) Exceptions (I) Use of funds (aa) In general Notwithstanding clause (ii), money, assets, and property of customers of a registered digital asset exchange may, for convenience, be commingled and deposited with an entity described in section 4d(i)(1)(B). (bb) Withdrawal Notwithstanding clause (ii), the share of the money, assets, and property described in item (aa) as in the normal course of business is necessary to margin, guarantee, secure, transfer, adjust, or settle a digital asset transaction with a registered entity may be withdrawn and applied to those purposes, including the payment of commissions, brokerage, interest, taxes, storage, and other charges, lawfully accruing in connection with the digital asset transaction. (II) Commission action Notwithstanding clause (ii), in accordance with such terms and conditions as the Commission may prescribe by rule or order, any money, assets, or property of the customers of a registered digital asset exchange may be commingled and deposited in customer accounts with any other money, assets, or property received by the registered digital asset exchange and required by the Commission to be separately accounted for and treated and dealt with as belonging to the customer of the registered digital asset exchange. (C) Permitted investments Money described in subparagraph (B)(ii)(I) may be invested— (i) in— (I) obligations of the United States; (II) general obligations of any State or of any political subdivision of a State; (III) obligations fully guaranteed as to principal and interest by the United States; or (IV) any other investment that the Commission may by rule prescribe; and (ii) in accordance with such rules and subject to such conditions as the Commission may prescribe. (D) Misuse of customer property It shall be unlawful— (i) for any registered digital asset exchange that has received any customer money, assets, or property for custody to dispose of, or use any of the money, assets, or property as belonging to the registered digital asset exchange; or (ii) for any other person, including any other registered digital asset exchange or custodian that has received any customer money, assets, or property for deposit, to hold, dispose of, or use any of the money, assets, or property as belonging to— (I) the registered digital asset exchange that deposited the money, assets, or property; or (II) any person other than the customers of the registered digital asset exchange. (E) Customer right to opt out (i) In general A customer shall have the right to waive any requirement under subparagraph (B) by affirmatively electing, in writing to the registered digital asset exchange, to waive the requirement. (ii) Limitations The Commission may, by rule, establish notice and disclosure requirements, segregation requirements, investment limitations, and other rules relating to the waiving of any requirement under this paragraph that is reasonably necessary to protect customers, including eligible contract participants, non-eligible contract participants, or any other class of customers. (5) Monitoring of trading and trade processing (A) In general A registered digital asset exchange shall provide a competitive, open, and efficient market and mechanism for executing transactions that protects the price discovery process of trading on the registered digital asset exchange. (B) Protection of markets and market participants A registered digital asset exchange shall establish and enforce compliance with rules— (i) to protect markets and market participants from abusive practices committed by any party, including abusive practices committed by a party acting as an agent for a participant; and (ii) to promote fair and equitable trading on the registered digital asset exchange. (C) Procedures and monitoring A registered digital asset exchange shall— (i) establish and enforce compliance with rules or terms and conditions defining, or specifications detailing— (I) trading procedures to be used in entering and executing orders traded on or through the facilities of the registered digital asset exchange; and (II) procedures for trade processing of digital assets on or through the facilities of the registered digital asset exchange; and (ii) monitor trading in digital assets to prevent manipulation, price distortion, and disruptions of the delivery or cash settlement process through surveillance, and compliance, including methods for conducting real-time monitoring of trading and comprehensive and accurate trade reconstructions. (6) Ability to obtain information A registered digital asset exchange shall— (A) establish and enforce rules that will allow the registered digital asset exchange to obtain any necessary information to perform any of the functions described in this section; (B) provide the information to the Commission on request; and (C) have the capacity to carry out such international information-sharing agreements as the Commission may require. (7) Emergency authority A registered digital asset exchange shall adopt rules to provide for the exercise of emergency authority, in consultation or cooperation with the Commission or a registered entity, as is necessary and appropriate, including the authority to facilitate the liquidation or transfer of open positions in any digital asset or to suspend or curtail trading in a digital asset. (8) Reporting requirements (A) In general A registered digital asset exchange shall provide to the Commission information that is determined by the Commission to be necessary to perform any responsibility of the Commission under this Act. (B) Timely publication of trading information (i) In general (I) Publication A registered digital asset exchange shall make public timely information on price, trading volume, and other trading data on digital assets to the extent prescribed by the Commission. (II) Accessibility A registered digital asset exchange may make trading data freely accessible to the public under rules established by the Commission. (ii) Capacity of digital asset exchange A registered digital asset exchange shall be required to have the capacity to electronically capture and transmit trade information with respect to transactions executed on the registered digital asset exchange. (9) Recordkeeping and reporting (A) In general A registered digital asset exchange shall— (i) maintain records of all activities relating to the business of the registered digital asset exchange, including a complete audit trail, in a form and manner acceptable to the Commission for a period of 5 years; (ii) report to the Commission, in a form and manner acceptable to the Commission, such information as the Commission determines to be necessary or appropriate for the Commission to perform the duties of the Commission under this Act; and (iii) keep any records relating to ancillary assets open to inspection and examination by the Securities and Exchange Commission. (B) Information-sharing Subject to section 8, and on request, the Commission shall share information collected under subparagraph (A) with— (i) a self-regulatory organization; (ii) the Securities and Exchange Commission; (iii) an appropriate Federal banking agency (as defined in section 3 of the Federal Deposit Insurance Act ( 12 U.S.C. 1813 )); (iv) a State bank supervisor (as defined in that section); (v) a State securities or commodities regulator; (vi) the Financial Stability Oversight Council; (vii) the Department of Justice; and (viii) any other person that the Commission determines to be appropriate, including— (I) foreign financial supervisors (including foreign futures authorities); (II) foreign central banks; and (III) foreign ministries. (C) Confidentiality agreement Before the Commission may share information with any entity described in subparagraph (B), the Commission shall receive a written agreement from each entity stating that the entity shall abide by the confidentiality requirements described in section 8 relating to the information on digital asset transactions that is provided. (D) Providing information Each registered digital asset exchange shall provide to the Commission (including any designee of the Commission) information under subparagraph (A) in such form and at such frequency as is required by the Commission. (10) Antitrust considerations Unless necessary or appropriate to achieve the purposes of this Act, a registered digital asset exchange shall not— (A) adopt any rules or take any actions that result in any unreasonable restraint of trade; or (B) impose any material anticompetitive burden on trading. (11) Conflicts of interest A registered digital asset exchange shall— (A) establish and enforce rules to minimize conflicts of interest in the decision-making process of the registered digital asset exchange; and (B) establish a process for resolving conflicts of interest described in subparagraph (A). (12) Financial resources (A) In general A registered digital asset exchange shall have adequate financial, operational, and managerial resources, as determined by the Commission, to discharge each responsibility of the registered digital asset exchange. (B) Minimum amount of financial resources A registered digital asset exchange shall possess financial resources that, at a minimum, exceed the total amount that would enable the registered digital asset exchange to conduct an orderly wind-down of the activities of the registered digital asset exchange. (C) Additional financial resources for leverage trading The Commission may require such additional financial resources as are necessary to enable a registered digital asset exchange that offers margined, leveraged, or financed transactions to fulfill the customer obligations of the registered digital asset exchange. (13) Governance fitness standards (A) Governance arrangements A registered digital asset exchange shall establish governance arrangements that are transparent to fulfill public interest requirements. (B) Fitness standards A registered digital asset exchange shall establish and enforce appropriate fitness standards for— (i) directors; (ii) any individual or entity with direct access to the settlement activities of the registered digital asset exchange; (iii) any individual or entity with direct access to any custodian affiliated with the registered digital asset exchange; (iv) any entity offering affiliated services for the registered digital asset exchange; and (v) any party affiliated with any individual or entity described in clauses (i) through (iv). (14) System safeguards A registered digital asset exchange shall— (A) establish and maintain a program of risk analysis and oversight to identify and minimize sources of operational and security risks, through the development of appropriate controls and procedures and automated systems that— (i) are reliable and secure; and (ii) have adequate scalable capacity; (B) establish and maintain emergency procedures, backup facilities, and a plan for disaster recovery that allow for— (i) the timely recovery and resumption of operations; and (ii) the fulfillment of the responsibilities and obligations of the registered digital asset exchange; and (C) periodically conduct tests to verify that the backup resources of the registered digital asset exchange are sufficient to ensure continued— (i) order processing and trade matching; (ii) price reporting; (iii) market surveillance; and (iv) maintenance of a comprehensive and accurate audit trail. (e) Appointment of trustee (1) In general If a proceeding under section 5e results in the suspension or revocation of the registration of a digital asset exchange, or if a digital asset exchange withdraws from registration, the Commission, after providing notice to the digital asset exchange, may apply to the district court of the United States for the judicial district in which the digital asset exchange is located for the appointment of a trustee. (2) Assumption of jurisdiction If the Commission applies to a court for appointment of a trustee under paragraph (1)— (A) the court may take exclusive jurisdiction over— (i) the digital asset exchange; and (ii) the records and assets of the digital asset exchange, wherever those records and assets are located; and (B) if the court takes jurisdiction under subparagraph (A), the court shall appoint the Commission, or a person designated by the Commission, as trustee with power to take possession and continue to operate or terminate the operations of the digital asset exchange in an orderly manner for the protection of customers, subject to such terms and conditions as the court may prescribe. (f) Custodian A registered digital asset exchange shall deposit with an entity described in section 4d(i)(1)(B) each digital asset that is— (1) the property of a customer of the registered digital asset exchange; (2) required to be held by the registered digital asset exchange under subsection (c)(2) or (d)(12); or (3) otherwise required by the Commission to be so held to reasonably protect customers or promote the public interest. (g) Exemptions (1) In general To promote responsible economic or financial innovation and fair competition, or protect customers, the Commission may exempt, either unconditionally or on stated terms or conditions or for stated periods, and retroactively, prospectively, or both, a registered digital asset exchange from the requirements of this section, if the Commission determines that— (A) the exemption— (i) will be consistent with the public interest and the purposes of this Act; and (ii) will not have a material adverse effect on the ability of the Commission or the registered digital asset exchange to discharge duties under this Act; or (B) the registered digital asset exchange is subject to comparable, comprehensive regulation by the appropriate government authorities in the home country of the registered digital asset exchange. (2) Process The Commission may grant an exemption under paragraph (1)— (A) on the initiative of the Commission; or (B) after receiving an application for the exemption by the registered digital asset exchange. (h) Jurisdiction Notwithstanding any other provision of law, the Commission shall have exclusive jurisdiction over the regulation and all other activities of a registered digital asset exchange. (i) Implementation The Commission may prescribe rules to implement this section. . (b) Certain digital asset exchange functions not sufficient To trigger requirement To register as futures commission merchant Section 4f(c) of the Commodity Exchange Act ( 7 U.S.C. 6f(c) ) is amended by adding at the end the following: (12) Clarification of scope of registration requirement A registered digital asset exchange shall not be required to register as a futures commission merchant for any activity for which the registered digital asset exchange is regulated under section 5i. . 405. Violations Section 9 of the Commodity Exchange Act ( 7 U.S.C. 13 ) is amended— (1) in subsection (a)(2), by striking subsection 4c and inserting section 4c ; and (2) in subsection (e)— (A) in paragraph (1), by inserting contracts for the sale of digital assets, after options thereon, ; and (B) in paragraph (2), by inserting or contracts for the sale of digital assets after options thereon . 406. Market reports Section 16(a) of the Commodity Exchange Act ( 7 U.S.C. 20(a) ) is amended— (1) in the first sentence, by striking which are the subject of futures contracts, and inserting under the jurisdiction of the Commission, ; and (2) in the second sentence, by striking futures markets. and inserting markets under the jurisdiction of the Commission. . 407. Bankruptcy treatment of digital assets (a) In general Section 20(a) of the Commodity Exchange Act ( 7 U.S.C. 24(a) ) is amended in paragraphs (1) and (2) by inserting digital assets, after securities, each place it appears. (b) Commodity broker definition Section 101(6) of title 11, United States Code, is amended by inserting registered digital asset exchange, as defined in section 1a of the Commodity Exchange Act, before foreign . (c) Commodities contracts Section 556 of title 11, United States Code, is amended by inserting a registered digital asset exchange, as defined in section 1a of the Commodity Exchange Act, before a contract . (d) Contractual rights Section 561 of title 11, United States Code, is amended by inserting registered digital asset exchange, as defined in section 1a of the Commodity Exchange Act, after designated under the Commodity Exchange Act each place it appears. (e) Definitions Section 761 of title 11, United States Code, is amended— (1) in paragraph (4)— (A) in subparagraph (A), by inserting digital asset or a before commodity ; (B) in subparagraph (I), by striking or at the end; (C) in subparagraph (J), by adding or at the end; and (D) by adding at the end the following: (K) a contract for the sale of a digital asset by a registered digital asset exchange; ; and (2) in paragraph (10)— (A) in the matter preceding subparagraph (A)— (i) by inserting a digital asset, after a security, ; and (ii) by inserting digital asset, after cash, security, ; (B) in subparagraph (A)— (i) in clause (vi), by inserting a digital asset, after a security, ; and (ii) in clause (vii)— (I) by inserting or a digital asset before held as property ; (II) by inserting or digital asset after such security ; and (III) by inserting or digital asset after based on a security ; and (C) in subparagraph (B)— (i) by striking not including property and inserting “not including— (i) property ; (ii) in clause (i), as so designated, by adding and at the end; and (iii) by adding at the end the following: (ii) money, assets, or property with respect to which any requirement under subsection (i) of section 4d of the Commodity Exchange Act ( 7 U.S.C. 6d ) is waived pursuant to paragraph (3) of that subsection, or any requirement under subparagraph (B) of paragraph (4) of section 5i(d) of that Act is waived pursuant to subparagraph (E) of that paragraph; . (f) Voidable transfers Section 764(b)(1) of title 11, United States Code, is amended by inserting , digital assets before , or other property . (g) Treatment of customer property Section 766 of title 11, United States Code, is amended— (1) in subsection (b)(1), by striking physical commodity underlying and inserting commodity underlying ; (2) in subsection (c), by inserting digital asset, before or commodity contract each place the term appears; (3) in subsection (d), by inserting digital asset, before or commodity contract each place the term appears; (4) in subsection (f)— (A) in striking and other property and inserting digital assets, and other property ; and (B) by striking or property and inserting , digital assets, or property ; (5) in subsection (g), by striking security or property and inserting security, digital asset, or property ; and (6) in subsection (h)(2), by inserting digital assets, after customer securities, . 408. Identified banking products Section 206(a) of the Gramm-Leach-Bliley Act ( 15 U.S.C. 78c note) is amended— (1) in paragraph (5)(B)(ii), by striking or at the end; (2) in paragraph (6), by striking the period at the end and inserting ; or ; and (3) by adding at the end the following: (7) a payment stablecoin issued by a depository institution under section 722A. . 409. Financial institutions definition Section 5312(c)(1) of title 31, United States Code, is amended by adding at the end the following: (B) A registered digital asset exchange, as defined in section 1a of the Commodity Exchange Act. . 410. Offsetting the costs of digital asset regulation The Commodity Exchange Act ( 7 U.S.C. 1 et seq. ) is amended by adding at the end the following: 24. Offsetting the costs of digital asset regulation (a) Recovery of certain costs of annual appropriation (1) In general Effective beginning October 1, 2023, the Commission may, by rule, collect fees— (A) to fund expenses relating to regulation of digital asset cash and spot markets; and (B) that are designed to recover the costs to the Federal Government of the annual appropriation to the Commission by Congress. (2) Registered entities Fees under paragraph (1) shall only be imposed— (A) on registered entities engaged in cash or spot digital asset activities; and (B) in relation to the regulation of those activities under this Act. (3) Fee rates Fees under paragraph (1) shall— (A) be strictly related to the cost to the Commission of the regulation of digital asset cash and spot markets; (B) be reduced for newly registered entities with less than $100,000,000 in daily trading volume; and (C) (i) minimize negative impacts on market liquidity; and (ii) maintain the efficiency, competitiveness, and financial integrity of digital asset markets. (4) Collection of fees The Commission shall collect fees under this subsection in such manner and within such time as may be specified by the Commission by rule. (b) Fee rate orders (1) In general Not later than 60 days after the date on which a law providing a regular appropriation to the Commission for a fiscal year is enacted, the Commission shall adopt an order setting rates for fees to be collected under subsection (a) for that fiscal year. (2) Publication The Commission shall publish in the Federal Register the order adopted under paragraph (1), including— (A) projections on which the fees are based; and (B) an explanation of the method used for calculating applicable fee rates. (c) Deposit of fees (1) Offsetting collections Fees collected under subsection (a) for any fiscal year— (A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Commission; and (B) shall not be collected or available for obligation for any fiscal year except to the extent provided in advance in appropriation Acts. (2) General revenues prohibited No fees collected under subsection (a) shall be deposited and credited as general revenue of the Treasury. (d) Lapse of appropriations If a regular appropriation to the Commission has not been enacted on the first day of a fiscal year, the Commission shall continue to collect fees under this section at the rates in effect on September 30 of the preceding fiscal year. (e) Limitations (1) Leveraged, margined, or financed transactions Nothing in this section authorizes the imposition of fees on a registered entity relating to leveraged, margined, or financed transactions under this Act, including those activities relating to digital assets. (2) Other appropriations Notwithstanding any other provision of law, the Commission may use appropriations otherwise made available by law to fund expenses relating to the regulation of digital asset cash and spot markets. (f) Ceiling on Fees Unless otherwise provided by law, fees collected under this section shall not exceed $30,000,000. (g) Authorization required The authority under this section to impose and collect fees shall only be in effect during a period that a legislative authorization of the Commission is in effect, as otherwise provided by law. . V Responsible consumer protection 501. Responsible consumer protection Chapter 98 of title 31, United States Code, as added by section 101(a) of this Act, is amended by adding at the end the following: 9802. Consumer protection standards for digital assets (a) In general A person or protocol that provides digital asset services shall ensure that the scope of permissible transactions that may be undertaken with customer digital assets is disclosed clearly in a customer agreement. (b) Notice A person who provides digital asset services shall provide clear notice to each customer, and require acknowledgment, of the following: (1) Prior to the implementation of any updates, material source code version changes relating to digital assets, except in emergencies, which may include security vulnerabilities. (2) Whether customer digital assets are segregated from other customer assets and the manner of segregation. (3) How the assets of the customer would be treated in a bankruptcy or insolvency scenario and the risks of loss. (4) The time period and manner in which the person is obligated to return the digital asset of the customer upon the request of the customer. (5) Applicable fees. (6) The dispute resolution process of the person. (c) Subsidiary proceeds (1) Definitions In this subsection: (A) Subsidiary proceeds The term subsidiary proceeds includes forks, airdrops, staking, and other gains that accrue to a digital asset through market transactions, use as a financial asset, or being held in custody or safekeeping by a person who provides digital asset services. (B) Terms of service The term agreement includes the standard terms of service of the person who provides digital asset services. (2) Accrual to customer Except as otherwise specified by an agreement with a customer, all ancillary or subsidiary proceeds relating to digital asset services provided to a customer shall accrue to the benefit of the customer in accordance with paragraph (3). (3) Election A person who provides digital asset services may elect not to collect certain subsidiary proceeds if the election is disclosed in an agreement with the customer. (4) Withdrawal A customer may withdraw digital assets in a method that permits the collection of the subsidiary proceeds. (5) Agreement A person who provides digital asset services shall enter into an agreement with a customer, if desired by the customer, regarding the manner in which to invest subsidiary proceeds or other gains attributable to the digital assets of the customer. (d) Lending arrangements A person who provides digital asset services shall ensure any lending arrangements relating to digital assets are— (1) clearly disclosed to customers before any lending services take place; (2) subject to the affirmative consent of the customer; (3) fully enforceable as a matter of commercial law; (4) accompanied by full disclosures of applicable terms and risks, yield, and the manner in which the yield is calculated; (5) accompanied by appropriate disclosures relating to collateral requirements and policies, including— (A) haircuts and overcollateralization requirements; (B) collateral the person accepts when calling for additional collateral from a customer, including collateral substitution; (C) whether customer collateral is commingled with the collateral of other customers or of the person; and (D) how customer collateral is invested, and whether the yield belongs to the customer or to the person; (6) accompanied by disclosures of mark-to-market and monitoring arrangements, including— (A) the frequency of mark-to-market monitoring and how frequently the person will call for additional collateral from a customer; (B) the time period in which the customer must supply additional collateral to the person after a collateral call; and (C) whether the person permits failures to deliver such collateral, and in the event of a failure to deliver the period of time in which the customer must cure the failure to deliver before the customer’s position is closed; and (7) compliant with all applicable Federal and State laws. (e) Rehypothecation (1) Definition In this subsection, the term rehypothecation means the pledging of an asset as collateral for a financial transaction by a person after the pledging of the asset as collateral by a customer of that person. (2) Rehypothecation Before rehypothecating a digital asset, a person who provides digital asset services to a customer shall clearly disclose policies on rehypothecation to customers, including a clear definition of rehypothecation that is accessible to consumers. The person who provides digital asset services to a customer shall obtain affirmative consent and consider the following factors to appropriately mitigate risk relating to rehypothecation: (A) The liquidity and volatility of a digital asset. (B) Past failures to deliver a particular digital asset. (C) Concentration risk. (D) Whether an issuer or lender of last resort relating to a digital asset exists, including for virtual currency with a finite supply. (E) The capital, leverage and market position of the person. (F) The legal obligations of the person to customers and other persons in the market who provide digital asset services. . 502. Source code version of digital assets Chapter 98 of title 31, United States Code, as amended by section 501 of this Act, is amended by adding at the end the following: 9803. Source code version of digital assets (a) In general A customer and a person who provides digital asset services shall, at the initiation of a contractual relationship, agree in writing regarding the source code version the person will use for each digital asset and the treatment of each asset under the law, including securities and commodities laws and the Uniform Commercial Code applicable to the transaction. (b) Determination A person who provides digital asset services— (1) may periodically determine whether to implement a source code version that uses validation rules different than those of the source code version specified in a customer agreement, including in circumstances where it is not possible to predict in advance whether utilization of the different source code version will be in the best interests of the customer; (2) shall consider the nature of proposed changes to source code versions with potential effects resulting from third-party actors that may create different source code versions resulting in new networks that could create economic value for customers; (3) shall not be required to support digital assets and source code versions that the person has not entered into an agreement with customers to support; and (4) shall not capriciously redefine a digital asset or the corresponding source code or alter customer agreements with respect to this subsection. (c) Standards A person who provides digital asset services— (1) shall adopt and maintain standards for changes to digital asset source code versions that use differing validation rules than those of the source code version specified in the customer agreement, which shall include customer notice and approval, as appropriate based on the circumstances; and (2) may specify differing standards based on source code changes which occur as the result of emergencies, including security vulnerabilities. . 503. Settlement finality Chapter 98 of title 31, United States Code, as amended by section 502 of this Act, is amended by adding at the end the following: 9804. Settlement finality To promote legal certainty and customer protection, a person who provides digital asset services and a customer shall agree on the terms of settlement finality for all transactions, including the following: (1) The conditions under which a digital asset may be deemed fully transferred, provided that these legal conditions may diverge from operational conditions under which digital assets are considered transferred, based on the distributed and probabilistic nature of digital assets. (2) The exact moment of transfer of a digital asset. (3) The discharge of any obligations upon transfer of a digital asset. (4) Conformity to applicable provisions of the Uniform Commercial Code. . 504. Notice to customers; enforcement Chapter 98 of title 31, United States Code, as amended by section 503 of this Act, is amended by adding at the end the following: 9805. Notice to customers; enforcement (a) In general In providing disclosures and carrying out other duties under this chapter, a person who provides digital asset services in or affecting interstate commerce shall have a duty to provide higher standards of customer notice and acknowledgment if there is likely to be a material impact on the economic value of the digital asset of a customer. (b) Enforcement of standards The standards under this chapter shall be enforced in an appropriate manner, commensurate with other customer protection standards— (1) in the case of a digital asset intermediary, by the Federal or State licensing, registration, or chartering authority of the intermediary; and (2) in the case of a depository institution or other financial institution, by the appropriate State or Federal banking supervisor. . 505. Right to individual management of digital assets Chapter 98 of title 31, United States Code, as amended by section 504 of this Act, is amended by adding at the end the following: 9806. Right to individual management of digital assets (a) In general Except as otherwise required by law, no person shall be required to use an intermediary for the safekeeping of digital assets legally owned, and possessed or controlled, by that person. (b) Rule of construction This section shall not be construed to— (1) permit a person to engage in market activity for which authorization is required under Federal or State law; or (2) restrict a person from freely entering into an agreement for digital asset services with a third party. . 506. Technical and conforming amendments The table of sections of chapter 98, as added by section 101(a) of this Act, is amended by adding at the end the following: 9802. Consumer protection standards for digital assets. 9803. Source code version of digital assets. 9804. Settlement finality. 9805. Notice to customers; enforcement. 9806. Right to individual management of digital assets. . VI Responsible payments innovation 601. Issuance of payment stablecoins Subtitle C of title VII of the Gramm-Leach-Bliley Act ( Public Law 106–102 ; 113 Stat. 1470) is amended by adding at the end the following: 722A. Issuance of payment stablecoins (a) In general A depository institution may issue, redeem, and conduct all incidental activities relating to payment stablecoins in accordance with this section. (b) Required payment stablecoin assets A depository institution shall maintain high-quality liquid assets under this section equal to not less than 100 percent of the face amount of the liabilities of the institution on payment stablecoins issued by the institution. In the case of an insured depository institution described in subsection (m)(1)(A) that engages in on-balance sheet lending activities, assets under this subsection shall equal not less than 100 percent of the face amount of the liabilities of the institution on payment stablecoins issued by the institution, with the assets held in balances at a Federal Reserve bank (which may include a segregated balance account), or, in the case of foreign withdrawable reserves, at a foreign central bank, in a special, custodial, or trust account, other off-balance sheet account, or in another equivalent manner that ensures the segregation of the assets in the event of receivership. An insured depository institution may segregate the issuance and management of payment stablecoins into a separate depository institution affiliate under the same holding company structure. Eligible high-quality liquid assets under this section shall be comprised of the following: (1) United States coins and currency and any other instrument that is legal tender, as defined in section 5103 of title 31, United States Code. (2) Demand deposits at a depository institution, except that deposits in an insured depository institution shall not exceed the limit of deposit or share insurance available for that account, which may include pass through insurance, or shall be maintained in a special, custodial, or trust account or other off-balance sheet account held by the insured depository institution. (3) Balances held at a Federal Reserve bank, which may be held in a master account or segregated balance account. (4) Foreign withdrawable reserves, as defined in section 249.3 of title 12, Code of Federal Regulations, consistent with any foreign unit of account in which the payment stablecoin is denominated or pegged. (5) A security that is issued by, or unconditionally guaranteed as to the timely payment of principal and interest by, the Department of the Treasury, with an original maturity of 1 year or less. (6) A reserve repurchase agreement relating to a security described in paragraph (5). (7) Any other high-quality, liquid asset determined to be consistent with safe and sound banking practices, as determined by the appropriate Federal banking agency or State bank supervisor. (c) Disclosures Not later than 10 business days after the end of each month, a depository institution shall disclose, in a publicly accessible manner, a summary description of the assets backing the payment stablecoin, the value of the assets, and the number of outstanding payment stablecoins, as of the last day of the month. Such explanation shall be filed with the appropriate Federal banking agency or State bank supervisor under penalty of perjury by the chief financial officer of the institution. The depository institution shall also report on the summary description any instances in which the institution failed to comply with any requirement of subsection (b). As applicable, the appropriate Federal banking agency or State bank supervisor shall, as part of a regular examination of the depository institution, at the frequency otherwise required by law, verify the composition of the assets and the accuracy of the summary descriptions made under this subsection and reports under subsection (d). (d) Call report As applicable, the appropriate Federal banking agency or State bank supervisor shall require a depository institution that issues a payment stablecoin to report, in detail, on the composition of the assets in each periodic report of condition, or in an alternative format approved by the Federal Financial Institutions Examination Council, at the frequency otherwise required by law. (e) Permission A depository institution shall, as applicable, obtain permission from the appropriate Federal banking agency or State bank supervisor, with an application submitted not less than 6 months before intended issuance of the payment stablecoin, but which may be submitted as part of a charter application. As part of an application under this section, a depository institution shall develop a tailored recovery and resolution plan, consistent with the standards adopted under subsection (k)(1)(F), that would permit the orderly resumption of a safe and sound operation or the orderly wind-down of operations in the event of distress, including the redemption of all outstanding payment stablecoins. The application shall also contain a draft customer agreement, flow of funds explanation, a robust information technology plan and operational design of the payment stablecoin. As applicable, the appropriate Federal banking agency or State bank supervisor shall render a decision on the application within 4 months of the date of filing, and shall approve the application unless— (1) the payment stablecoin activities are not likely to be able to operate in a safe and sound manner; (2) the depository institution does not have the required resources and expertise to manage the operation of the payment stablecoin, commensurate with the size and scale of projected operations; or (3) the depository institution does not have required policies and procedures relating to material areas of the operation of the payment stablecoin activities. (f) Redemption of payment stablecoins Upon the demand of a customer, a depository institution shall redeem an outstanding payment stablecoin at par in the coins, currency, or other instruments that are legal tender, as defined in section 5103 of title 31, United States Code, or the similar laws of the jurisdiction of the unit of account in which the payment stablecoin is denominated or to which the value of the payment stablecoin is pegged. A depository institution may redeem a payment stablecoin issued by another depository institution at par, upon demand. The Board of Governors of the Federal Reserve System, through the Federal Reserve banks, shall provide for the clearing and settlement of payment stablecoin liabilities among depository institutions under this section and shall ensure competitive equality in all clearing, settlement and related services. A depository institution shall also assess its ability to fulfill large redemptions without placing downward pressure on the market value of the payment stablecoin. (g) Collateral availability in the capital markets The appropriate Federal banking agencies, in consultation with State bank supervisors, the Securities and Exchange Commission, and Commodity Futures Trading Commission, shall monitor use of the high-quality liquid assets authorized under subsection (b) and the impact on collateral availability and the efficient functioning of the capital markets. (h) Receivership priority In the event of the receivership of a depository institution that has issued a payment stablecoin under this section, a person that has a valid claim on a payment stablecoin issued by that institution shall have priority over all other claims on the institution with respect to any required payment stablecoin assets, including claims with respect to insured deposits, other than administrative costs incurred by the appropriate Federal banking agency or State bank supervisor, as applicable, relating to the receivership of the institution, if applicable. Consistent with subsection (f), a depository institution that redeems a payment stablecoin issued by a depository institution in receivership shall be considered to have a valid claim, with corresponding priority under this subsection, on a payment stablecoin issued by the institution in receivership. (i) Incidental activities A depository institution may conduct all incidental activities relating to the issuance and redemption of payment stablecoins, which shall include the following: (1) Management of required payment stablecoin assets in accordance with subsection (b). (2) Making a market in payment stablecoins. (3) Custodial services. (4) Settlement and clearing. (5) Post-trade services. (6) All other activities consistent with a safe and sound operation, as determined by the appropriate Federal banking agency or State bank supervisor. (j) Applicability of Gramm-Leach-Bliley data privacy provisions Title V of the Gramm-Leach-Bliley Act ( 12 U.S.C. 6801 et seq. ) shall apply to the payment stablecoin activities of a depository institution under this section. (k) Rules (1) In general The appropriate Federal banking agencies, in consultation with State bank supervisors, shall adopt rules to implement this section, including— (A) capital treatment for depository institutions described in subsection (m)(1) in accordance with paragraph (2); (B) liquidity, leverage, and interest rate risk; (C) third-party service provider activities— (i) including custodial wallet providers; and (ii) not including licensing or capital requirements for third-party service providers; (D) management practices with respect to required payment stablecoin assets; (E) appropriate operational, compliance, and information technology risk management; (F) tailored recovery and resolution standards relating to payment stablecoins; and (G) any other material topic. (2) Significant differences In accordance with section 5169(c)(3)(A) of the Revised Statutes, in determining capital and leverage requirements applicable to a depository institution that has no material assets other than required payment stablecoin assets under this section— (A) the depository institution shall not be subject to section 171 of the Financial Stability Act of 2010 ( 12 U.S.C. 5371 ); and (B) the appropriate Federal banking agencies shall take into account the significant differences between the risks of the assets of the institution and those of depository institutions with assets that consist primarily of commercial or consumer loans. (l) Non-Depository institution payment stablecoin issuers Nothing in this section shall be construed to prohibit an entity operating under a State or Federal charter or license that is not a depository institution from issuing and redeeming a payment stablecoin and conducting all activities related to the management of such payment stablecoin consistent with a safe and sound operation, as determined by the appropriate regulator of the entity. The entity shall— (1) be subject to the requirements of subsections (b) and (c); and (2) redeem an outstanding payment stablecoin at par in the coins, currency, or other instruments that are legal tender, as defined in section 5103, or the similar laws of the jurisdiction of the unit of account in which the payment stablecoin is denominated or to which the value of the payment stablecoin is pegged. (m) Definitions In this section: (1) Depository institution The term depository institution has the meaning given the term in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1) ) and includes— (A) an insured depository institution; or (B) a depository institution operating under subsection (c) of section 5169 of the Revised Statutes ( 12 U.S.C. 27 ), or a substantially similar State law, which is exclusively engaged in issuing payment stablecoins, providing safekeeping, trust or custodial services, or activities incidental to the foregoing. (2) Payment stablecoin The term payment stablecoin has the meaning given the term in section 9801 of title 31, United States Code. (3) Segregated balance account The term segregated balance account includes an account of a depository institution with a Federal Reserve bank or a foreign central bank to which only required payment stablecoin assets are credited. . 602. Sanctions compliance responsibilities of payment stablecoin issuers Not later than 120 days after the date of the enactment of this Act, the Secretary of the Treasury shall adopt final guidance clarifying the sanctions compliance responsibilities and liability of an issuer of a payment stablecoin with respect to downstream transactions relating to the stablecoin that take place after the stablecoin is first provided to a customer of the issuer. 603. Use of the official digital currency of the People’s Republic of China on Government devices (a) Definitions In this section— (1) the term digital yuan means the official central bank digital currency of the People’s Republic of China; (2) the term executive agency has the meaning given that term in section 133 of title 41, United States Code; and (3) the term information technology has the meaning given that term in section 11101 of title 40, United States Code. (b) Use of digital yuan Not later than 60 days after the date of enactment of this Act, the Director of the Office of Management and Budget, in consultation with the Administrator of General Services, the Director of the Cybersecurity and Infrastructure Security Agency, the Director of National Intelligence, and the Secretary of Defense, and consistent with the information security requirements under subchapter II of chapter 35 of title 44, United States Code, shall develop standards and guidelines for executive agencies which require adequate security measures for use of the digital yuan on Government information technology devices. 604. Certificate of authority to commence banking Section 5169 of the Revised Statutes ( 12 U.S.C. 27 ) is amended— (1) in subsection (a), in the third sentence, by striking to those of a trust company and activities related thereto. and inserting the following: to— (1) those of a trust company and fiduciary activities related thereto; or (2) those of a depository institution required to maintain assets valued at not less than 100 percent of the deposits of the institution, for the purposes of issuing a payment stablecoin (as defined in section 9801 of title 31, United States Code) and activities related thereto consistent with subsection (c) of this section and without the requirement to maintain deposit insurance under the Federal Deposit Insurance Act ( 12 U.S.C. 1811 et seq. ). ; and (2) by adding at the end the following: (c) (1) Notwithstanding any other provision of law, a National Bank Association described in subsection (a) may not engage in maturity transformation or facilitate consumer lending through third parties. (2) Restrictions on affiliate transactions applicable for insured depository institutions shall apply to such depository institutions. (3) The Comptroller of the Currency, in close consultation with the Board of Governors of the Federal Reserve System and State bank supervisors, shall develop the following: (A) A simplified capital framework based on the following: (i) Payment system risk. (ii) The greater of— (I) all projected costs of receivership; or (II) 3 years of projected operating expenses. (B) Appropriate standards for the depository institution to develop a community contribution plan, which may include consumer education, financial literacy, charitable donations, volunteerism, job training and internships or similar involvement. (C) A tailored recovery and resolution plan that would permit the orderly resumption of a safe and sound operation or the orderly wind-down of operations relating to a payment stablecoin in the event of distress. (D) Tailored holding company supervision, as specified by section 15 of the Bank Holding Company Act of 1956. (4) In designing the simplified capital framework required by paragraph (3)(A), the Comptroller of the Currency— (A) shall not subject depository institutions to the standards of section 171 of the Financial Stability Act of 2010 ( 12 U.S.C. 5371 ); and (B) shall take into account the significant differences between the risks of the assets of the institution and those of depository institutions with assets that consist primarily of commercial or consumer loans. (d) The Comptroller of the Currency may promulgate rules to carry out this section. . 605. Holding company supervision of covered depository institutions The Bank Holding Company Act of 1956 ( 12 U.S.C. 1841 et seq. ) is amended— (1) in section 2(c) ( 12 U.S.C. 1841(c) ), by striking paragraph (2) and by inserting the following: (2) Exceptions The term bank does not include a covered depository institution subject to tailored holding company supervision under section 15. ; and (2) by adding at the end the following: 15. Tailored holding company supervision for covered depository institutions (a) Definitions In this section: (1) Appropriate banking supervisor The term appropriate banking supervisor means the Comptroller of the Currency, a State bank supervisor, in the case of a State member bank, the Board, or in the case of an insured bank, the Federal Deposit Insurance Corporation, as applicable. (2) Controlling interest The term controlling interest means a circumstance when a person, directly or indirectly, or acting through or in concert with 1 or more persons— (A) owns, controls, or has the power to vote 25 percent or more of any class of voting securities of a covered depository institution; (B) controls in any manner the election of a majority of the directors of the covered depository institution; or (C) has the power to exercise a controlling influence over the management or policies of the covered depository institution. (3) Covered depository institution The term covered depository institution means a depository institution operating under subsection (c) of section 5169 of the Revised Statutes ( 12 U.S.C. 27 ), or a substantially similar State law, other than a bank, as defined in section 2 of the Bank Holding Company Act of 1956 ( 12 U.S.C. 1841 ), or an insured depository institution, as defined in section 3 of the Federal Deposit Insurance Act ( 12 U.S.C. 1813 ), which is exclusively engaged in issuing payment stablecoins, providing safekeeping, trust or custodial services, or activities incidental to the foregoing. (b) Controlling interest A person with a controlling interest in a covered depository institution shall— (1) submit annual audited financial statements and other information as otherwise reasonably required by the appropriate banking supervisor; and (2) provide a description of all affiliated or parent entities and their relationships with the institution, including annual updates. (c) Tax allocation agreement The appropriate banking supervisor may require a legal entity with a controlling interest in a covered depository institution to execute a tax allocation agreement with the institution that— (1) expressly states that an agency relationship exists between the person and the institution with respect to tax assets generated by the institution, and that the assets are held in trust by the person for the benefit of the institution and will be promptly remitted to the institution; and (2) may provide that the amount and timing of any payments or refunds to the institution by the person should be no less favorable than if the institution were a separate taxpayer. (d) Prohibition on controlling interests A person that is a commercial firm, as defined in section 602 of the Bank and Savings Association Holding Company and Depository Institution Regulatory Improvements Act of 2010 ( 12 U.S.C. 1815 note), may not obtain a controlling interest in a covered depository institution. (e) Public interest If the appropriate banking supervisor finds that it is in the public interest and has reasonable cause to believe it is necessary to protect the customers of a covered depository institution, the supervisor may— (1) conduct an examination of a legal entity with a controlling interest in a covered depository institution or otherwise require information from the person; and (2) require a person with a controlling interest in a covered depository institution to divest or sever their relationship with the institution, if necessary to maintain safety and soundness. . 606. Implementation rules to preserve adequate competition in payment stablecoins (a) In general The application of a non-depository trust company or the holder of a State license that only persons engaged in digital asset activities may obtain, which was chartered or issued under the laws of a State or the National Bank Act before the date of enactment of this Act, to receive a charter as a depository institution and to operate under subsection (c) of section 5169 of the Revised Statutes ( 12 U.S.C. 27 ), as added by section 604 of this Act, shall be decided upon by the Comptroller of the Currency before an application for a charter to operate under that section from another entity that is filed on or after the date of enactment of this Act. (b) Application The application of a covered depository institution, as defined in section 15(a) of the Bank Holding Company Act of 1956 ( 12 U.S.C. 1853(a) ), chartered before the date of enactment of this Act to become a State member bank in the Federal Reserve System or for access to Federal Reserve services under section 11A of the Federal Reserve Act ( 12 U.S.C. 248a ) shall be decided upon by the Board of Governors of the Federal Reserve System, or a Federal Reserve bank, as applicable, before any application to become a State member bank or for Federal Reserve services from any other entity which seeks to operate as a covered depository institution and which is filed on or after the date of enactment of this Act. (c) Decision The applications described in subsections (a) and (b) of this section shall be decided upon by the appropriate Federal banking agency (as defined in section 3 of the Federal Deposit Insurance Act ( 12 U.S.C. 1813 )) or Federal Reserve bank, as applicable, before an insured depository institution in operation before the enactment date of this Act may issue a payment stablecoin in accordance with section 722A of the Gramm-Leach-Bliley Act, as added by section 601 of this Act. 607. Financial Crimes Enforcement Network Innovation Laboratory Section 310 of title 31, United States Code, is amended by adding at the end the following: (m) Innovation laboratory (1) In general There is established within the Financial Crimes Enforcement Network an Innovation Laboratory to promote regulatory dialogue, data sharing between the Financial Crimes Enforcement Network and financial companies, and an assessment of potential changes in law, rules, or policies to facilitate the appropriate supervision of financial technology and the laws under the jurisdiction of the agency. (2) Chief innovation officer The innovation officer appointed under section 6208 of the Anti-Money Laundering Act of 2020 ( 31 U.S.C. 5311 note) by the Director of the Financial Crimes Enforcement Network shall manage the Innovation Laboratory. (3) Duties The Innovation Laboratory, as appropriate, shall study changes in financial technology and make recommendations to Congress, the Secretary, and the Director for appropriate changes in laws, rules, or policies that can more effectively facilitate the supervision of financial technology with respect to the laws under the jurisdiction of the Financial Crimes Enforcement Network, including digital assets, distributed ledger technology and decentralized finance. (4) Pilot projects The Innovation Laboratory, as appropriate, shall conduct pilot projects with financial companies to more effectively facilitate the supervision of financial technology, consistent with applicable law. . VII Responsible banking innovation 701. Study on use of distributed ledger technology for reduction of risk in depository institutions Not later than 180 days after the date of enactment of this Act, the Board of Governors of the Federal Reserve System shall complete a study and submit to the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives a report regarding the manner in which distributed ledger technology may reduce risk for depository institutions, as defined in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1) ), including settlement risk, operational risk and capital requirements. 702. Eligibility for Federal Reserve services to depository institutions (a) Findings Congress finds the following: (1) Final settlement of transactions in central bank money reduces risk in the financial system, including through the reduction of counterparty exposure. (2) Digital assets settle with finality in seconds or minutes, whereas traditional financial transactions may take days to settle. (3) This mismatch in the settlement window of digital assets and traditional financial assets creates risk in the economy that may be reduced through the ability of depository institutions to simultaneously conduct digital asset transactions and settle, with finality, the United States dollar component of these transactions. (4) The Federal Reserve Act specifies that a depository institution, as defined in section 19(b)(1) of that Act ( 12 U.S.C. 461(b)(1) ), upon receiving a charter from the Office of the Comptroller of the Currency, National Credit Union Administration or State bank supervisor, is required to be made available services from Federal Reserve banks under section 11A of the Federal Reserve Act ( 12 U.S.C. 248a ), including currency and coin services, wire transfer services, automated clearinghouse services and settlement services. (5) Numerous Federal courts have found that the provision of services to depository institutions under section 11A of the Federal Reserve Act ( 12 U.S.C. 248a ) is a ministerial duty imposed by Congress with respect to all depository institutions. (6) The Board of Governors of the Federal Reserve System has long interpreted the Federal Reserve Act to mean that the Federal Reserve banks must provide services to all depository institutions, noting that it has a duty to ensure the provision of payment services to all depository institutions on an equitable basis, and to do so in an atmosphere of competitive fairness . (7) The Federal Reserve banks have, on occasion, provided services to non-depository, non-insured institutions without appropriate statutory authority. (8) Certain novel legal positions that conflict with or frustrate these precedents are not in the best traditions of the Federal Reserve Act, our dual banking system, and the imperatives of Congress. (9) The statutory independence of the Board of Governors and the Federal Reserve banks under the Constitution of the United States is properly rooted in absolute fidelity to the laws enacted by Congress. (10) It is appropriate for Congress to reaffirm its existing statutory intent to ensure that all depository institutions may access services under the Federal Reserve Act on an equitable basis, and to do so in an atmosphere of competitive fairness . (b) Pricing of services Section 11A of the Federal Reserve Act ( 12 U.S.C. 248a ) is amended by adding at the end the following: (f) A Federal Reserve bank shall provide a segregated balance account to a depository institution upon the request of any institution that receives services under this section. . (c) Deposits; exchange and collection; member and nonmember banks or other depository institutions; charges Section 13 of the Federal Reserve Act ( 12 U.S.C. 342 ) is amended to read as follows: Any Federal Reserve bank shall receive from any of its member banks or other depository institutions, and from the United States, deposits of current funds in lawful money, national-bank notes, Federal reserve notes, or checks, and drafts, payable upon presentation or other items, and also, for collection, maturing notes and bills; or, solely for purposes of exchange or of collection, shall receive from other Federal Reserve banks deposits of current funds in lawful money, national-bank notes, or checks upon other Federal Reserve banks, and checks and drafts, payable upon presentation within its district or other items, and maturing notes and bills payable within its district; or, solely for the purposes of exchange or of collection, shall receive from any nonmember bank or trust company or other depository institution deposits of current funds in lawful money, national-bank notes, Federal reserve notes, checks and drafts payable upon presentation or other items, or maturing notes and bills: Provided, Such nonmember bank or trust company or other depository institutions maintains with the Federal Reserve bank of its district a balance in such amount as the Board determines taking into account items in transit, services provided by the Federal Reserve bank, and other factors as the Board may deem appropriate: Provided further, That nothing in this or any other section of this Act shall be construed as prohibiting a member or nonmember bank or other depository institution from making reasonable charges, to be determined and regulated by the Board of Governors, but in no case to exceed 10 cents per $100 or fraction thereof, based on the total of checks and drafts presented at any one time, for collection or payment of checks and drafts and remission therefor by exchange or otherwise; but no such charges shall be made against the Federal Reserve banks. . 703. Routing transit number issuance Not later than 2 years after the date of enactment of this Act, the Board of Governors of the Federal Reserve System shall assume responsibility for issuing routing transit numbers to depository institutions for all purposes relating to the clearing of transactions and the services required to be made available to all depository institutions under section 11A of the Federal Reserve Act ( 12 U.S.C. 248a ). 704. Clarifying application review times with respect to the Federal banking agencies Section 343 of the Riegle Community Development and Regulatory Improvement Act of 1994 ( 12 U.S.C. 4807 ) is amended by striking subsection (a) and inserting the following: (a) Final action (1) Definition In this subsection, the term completed application — (A) means the information requested by the Federal banking agency at the outset of an application through application forms or similar means; and (B) does not include supplemental information requested by the agency after filing of an application. (2) Action Each Federal banking agency, including Federal Reserve banks, shall take final action on any application to the agency before the end of the 1-year period beginning on the date on which a completed application is received by the agency. (b) Report Each Federal banking agency, including the Federal Reserve banks, shall annually report to Congress a list of the applications that have been pending for 9 months or longer since the date of the initial application filed by an applicant. Such list— (1) shall disclose the reason why the application has not yet been approved or denied by the Federal banking agency; and (2) shall not contain confidential supervisory information. . 705. Examination standards for digital asset activities (a) In general Not later than 18 months after the date of enactment of this Act, the Federal Financial Institutions Examination Council, in consultation with the Financial Crimes Enforcement Network, shall publish final guidance and examiner handbooks for depository institutions, as defined in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1) ), on the following topics related to digital assets: (1) Anti-money laundering, customer identification, beneficial ownership, and sanctions compliance, including with respect to payment stablecoin activities and subsidiary value (as defined in section 9802(c) of title 31, United States Code). (2) Custody. (3) Fiduciary and capital markets activities. (4) Information technology standards. (5) Payment system risk. (6) Consumer protection. (b) Final guidance Not later than 18 months after the date of enactment of this Act, Securities and Exchange Commission and Commodity Futures Trading Commission, in consultation with the Financial Crimes Enforcement Network, shall publish final guidance and examiner handbooks relating to digital asset intermediaries regarding the topics described in paragraphs (1) and (4) of subsection (a). 706. Asset custody for depository institutions and certain other entities (a) Findings Congress finds the following: (1) The laws surrounding custody of financial assets is largely customary, uncodified, and poorly understood. (2) Lack of uniformity amongst various jurisdictions’ laws relating to custody has largely not been addressed by regulators, can contribute to risk, and is producing uncertainty for innovators. (3) Codifying basic principles around custody of financial assets will reduce systemic risk, clearly define the rights and duties of both custodian and customer, and contribute to a more uniform and effective banking system. (b) Definition In this section, the term custody means the safekeeping, servicing and management of customer financial assets, including currency, securities and commodities, on an off-balance sheet basis. (c) Custody (1) In general Except as provided in paragraph (2), custody of financial assets is accomplished by a bailment and established by a written customer agreement. Custody shall not be a fiduciary or trust activity unless the custodian is providing substantial discretionary services with respect to an account, including through investment advice or investment discretion, and the custodian owes a customer a higher standard of care or duty with respect to the customer of that account. (2) Exception A custodian and customer may establish a legal relationship other than a bailment pursuant to a written customer agreement. (d) Proper documentation A custodial account shall be properly documented in a customer agreement, with a clearly defined legal relationship between the custodian and customer. Custodial assets shall be properly identified and segregated from the assets of the custodian, with proper documentation of asset segregation. (e) Not assets or liabilities Assets properly held in a custodial account under this section are not assets or liabilities of the custodian and shall be maintained on an off-balance sheet basis, including for the purpose of accounting treatment for the custodian and the customers of the custodian, notwithstanding the form in which the assets are maintained. (f) Applicability This section shall apply to depository institutions, as defined in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1) ), and non-depository trust companies chartered under section 5169 of the Revised Statutes ( 12 U.S.C. 27 ). 707. Reputation risk; requirements for account termination requests and orders (a) Reputation risk An appropriate Federal banking agency may not formally or informally request or order a depository institution to terminate a specific customer account or group of customer accounts unless the agency has a valid reason for such request or order, consistent with subsections (b) and (c). (b) No restriction An appropriate Federal banking agency shall not restrict or discourage a depository institution from entering into or maintaining a banking relationship with a specific customer or group of customers based on reputation risk, including through the examinations and ratings of the depository institution. (c) Treatment of national security threats If an appropriate Federal banking agency believes a specific customer or group of customers is, or acting as a conduit for, an entity which— (1) poses a threat to national security; (2) is involved in terrorist financing; (3) is an agency of the Government of Iran, North Korea, Syria, or any country listed from time to time on the State Sponsors of Terrorism list; (4) is located in, or is subject to the jurisdiction of, any country specified in paragraph (3); or (5) does business with any entity described in paragraph (3) or (4), unless the appropriate Federal banking agency determines that the customer or group of customers has used due diligence to avoid doing business with that entity, such belief shall satisfy the requirement under subsection (a). (d) Notice requirement (1) In general If an appropriate Federal banking agency formally requests or orders a depository institution to terminate a specific customer account or a group of customer accounts, the agency shall— (A) provide such request or order to the institution in writing; and (B) accompany such request or order with a written justification for why such termination is needed, including any specific laws or rules the agency believes are being violated by the customer or group of customers. (2) Justification requirement Consistent with subsection (b), the justification described in paragraph (1)(B) may not be based on reputation risk to the depository institution. (e) Customer notice (1) Notice required Except as provided under paragraph (2) or as otherwise prohibited from being disclosed by law, if an appropriate Federal banking agency orders a depository institution to terminate a specific customer account or a group of customer accounts, the depository institution shall inform the specific customer or group of customers of the justification for the customer’s account termination described under subsection (b). (2) Notice prohibited (A) Notice prohibited in cases of national security If an appropriate Federal banking agency requests or orders a depository institution to terminate a specific customer account or a group of customer accounts based on a belief that the customer or customers pose a threat to national security, or are otherwise described under subsection (a)(2), neither the depository institution nor the appropriate Federal banking agency may inform the customer or customers of the justification for the customer’s account termination. (B) Notice prohibited in other cases If an appropriate Federal banking agency determines that the notice required under paragraph (1) may interfere with an authorized criminal investigation, neither the depository institution nor the appropriate Federal banking agency may inform the specific customer or group of customers of the justification for the customer’s account termination. (f) Reporting requirement Each appropriate Federal banking agency shall issue an annual report to Congress stating— (1) the aggregate number of specific customer accounts that the agency requested or ordered a depository institution to terminate during the previous year; and (2) the legal authority on which the agency relied in making such requests and orders and the frequency on which the agency relied on each such authority. (g) Definitions In this section: (1) Appropriate federal banking agency The term appropriate Federal banking agency means— (A) the appropriate Federal banking agency, as defined in section 3 of the Federal Deposit Insurance Act ( 12 U.S.C. 1813 ); and (B) the National Credit Union Administration, in the case of an insured credit union. (2) Depository institution The term depository institution has the meaning given the term in section 19(b)(1) of the Federal Reserve Act ( 12 U.S.C. 461(b)(1)(A) ). 708. Conforming amendments (a) Federal deposit insurance act Section 12 of the Federal Deposit Insurance Act ( 12 U.S.C. 1822 ) is amended by adding at the end the following: (g) Appointment of receiver (1) Definition In this subsection, the term covered depository institution has the meaning given the term in section 15(a) of the Bank Holding Company Act of 1956. (2) Appointment The Corporation may be appointed as receiver of a covered depository institution, as defined in section 15(a) of the Bank Holding Company Act of 1956. (3) Premiums A covered depository institution may not be charged deposit insurance premiums for the purpose of this subsection, but the Corporation may use the capital of the covered depository institution to fund the costs of the receivership. (4) Rules The Corporation may promulgate rules to carry out this subsection, which shall— (A) be substantially consistent with the rules for receivership of an insured depository institution; and (B) account for the limited activities, capital, and the required tailored recovery and resolution plan of the covered depository institution. . (b) Federal Reserve Act The Federal Reserve Act ( 12 U.S.C. 221 et seq. ) is amended— (1) in section 19(b)(1)(A) ( 12 U.S.C. 461(b)(1)(A) )— (A) in clause (vi), by striking and at the end; (B) in clause (vii), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following: (viii) a covered depository institution, as defined in section 15(a) of the Bank Holding Company Act of 1956. ; and (2) in the first undesignated paragraph of section 9 ( 12 U.S.C. 321 ), in the first sentence, by inserting , covered depository institutions, as defined in section 15(a) of the Bank Holding Company Act of 1956 ( 12 U.S.C. 1853(a) ), after Plan banks . VIII Responsible interagency coordination 801. Timeline for interpretive guidance issued by Federal financial agencies (a) In general Title 31, United States Code, is amended by adding after chapter 98, as added by section 101(a) of this Act, the following: 99 Responsible interagency coordination Sec. 9901. Timeline for interpretive guidance issues by Federal financial agencies. 9902. Interstate sandbox activities. 9901. Timeline for interpretive guidance issues by Federal financial agencies (a) In general In this section: (1) Federal financial regulator The term Federal financial regulator means— (A) Board of Governors of the Federal Reserve System and the Federal Reserve banks; (B) Commodity Futures Trading Commission; (C) Department of the Treasury; (D) Federal Deposit Insurance Corporation; (E) Federal Housing Finance Agency; (F) National Credit Union Administration; (G) Office of the Comptroller of the Currency; (H) Consumer Financial Protection Bureau; and (I) Securities and Exchange Commission. (2) Requesting person The term requesting person — (A) means any entity that is required to be chartered, licensed, supervised or registered by that agency; and (B) includes State agencies and self-regulatory organizations. (b) Response Not later than 180 days after filing a written request for individualized interpretive guidance with respect to the application of a statute, rule or policy under the jurisdiction of a Federal financial regulator, the agency shall provide a final, complete and written response to the requesting person. This subsection shall not apply to requests for guidance that the Federal financial regulator determine lack substance. (c) Other matters With respect to matters delegated or otherwise under the jurisdiction of self-regulatory organizations, including national securities exchanges, boards of trade, and similar entities, the self-regulatory organization shall be subject to the same requirements as a Federal financial regulator under this section. . 802. Interstate sandbox activities (a) In general Chapter 99 of title 31, United States Code, as added by section 701 of this Act, is amended by adding at the end the following: 9902. Interstate sandbox activities (a) Definitions In this section: (1) Federal financial regulator The term Federal financial regulator means the Federal agency described in section 9901(a)(1) that would typically exercise jurisdiction over the product or service made available in the State financial regulatory sandbox, or the Department of the Treasury, in the case of a matter only within the jurisdiction of a State. (2) Financial company The term financial company means a business entity primarily engaged in activities that are financial in nature, as described in section 4(k)(4) of the Bank Holding Company Act of 1956 ( 12 U.S.C. 1843(k)(4) ). (3) Host State The term host State means a State in which a financial company is not operating in the State financial regulatory sandbox of that State. (4) Innovative The term innovative means new or emerging technology, or new uses of existing technology, that— (A) provides a financial product, service, business model, or delivery mechanism to the public; and (B) has no substantially comparable, widely available analogue in common use in the United States. (5) State financial regulator The term State financial regulator includes State agencies that regulate, supervise, or license banks, trust companies, credit unions, consumer credit, consumer protection, money transmission, securities, commodities, and similar areas. (6) State financial regulatory sandbox The term State financial regulator sandbox means a program created under State law that allows a financial company to make an innovative financial product or service available to customers within that State during a defined period in order to permit regulatory dialogue, data sharing amongst regulators and financial companies, and to promote an assessment of potential changes in law, rule, or policy to facilitate the appropriate supervision of financial technology. (b) Business conducted Upon joint approval under subsection (d), a financial company in good standing in a State financial regulatory sandbox and operating for not less than 6 months in that sandbox program, may do business across State lines under the standards of this section. If approved, the State financial regulator and the Federal financial regulator may agree upon reasonable adjustments to the number of customers that may be served, increased bonding or collateral requirements, and similar conditions which may be appropriate for conducting business nationally. (c) State sandbox requirements A State financial regulatory sandbox shall contain the following components for financial companies to be eligible to do business across State lines under this section: (1) A limited sandbox period of not more than 24 months. (2) Consumer protection requirements, which may include disclosures, bonding, insurance requirements, and financial literacy programs for specified consumers. (3) Authority to conduct examinations of the financial company. (4) A background investigation of the financial company and its officers, directors, members, managers and key employees, prior to commencing business. (d) Decision Upon submission of an application by a financial company to conduct business across State lines under subsection (b), the State financial regulator and Federal financial regulator shall jointly issue a decision within 120 days with respect to that application, irrespective of any supplemental information with respect to the application that may be requested after initial filing. The Federal financial regulator shall have the authority to conduct a joint examination of any financial company doing business under this section. (e) Factors The State financial regulator and Federal financial regulator shall consider the following factors in rendering a decision on the application: (1) Whether the product or service offered may be offered in a safe and sound manner across State lines. (2) Whether the management and capital of the financial company is commensurate with the scale of the company. (3) Risk management plans of the financial company. (4) Conduct of the financial company to date in the State regulatory sandbox, and any past regulatory actions, including actions against officers, directors, members, managers and key employees. (5) Plans for consumer education and financial literacy, including partnerships with local educational institutions and community colleges to provide financial literacy classes or resources. (6) Other factors determined by the State and Federal financial regulators to be material. (f) Election A host State may elect not to permit financial companies operating under this section to do business in their State through issuance of an executive order by the Governor of that State. (g) Innovative A product or service made available under this section through a State financial regulatory sandbox shall be innovative. (h) Rules of construction This section shall not be construed to extend to permit— (1) a financial company to engage in any activities for which a charter, license, registration or for which permission would be required under Federal or State law but for the innovative financial product or service being offered by the company, except to the extent the financial company would be required to obtain a charter, license or other authorization required in a host State; (2) failure to comply with any applicable portion of State law required by the State financial regulatory sandbox, or failure to comply with any applicable portion of Federal law, unless authorized on a limited basis by the Federal financial regulator to achieve the purposes of this section and the State financial regulatory sandbox; or (3) lending activities in excess of the maximum statutory rate of interest permissible in a State. . (b) Technical and conforming amendment The table of contents for subtitle VI of title 31, United States Code, as amended by section 101(b) of this Act, is amended by adding at the end the following: 99. Responsible interagency coordination 9901 . 803. State money transmission coordination relating to digital assets (a) In general In order to increase uniformity, reduce regulatory burden, and enhance consumer protection, the States, through the Conference of State Bank Supervisors and the Money Transmission Regulators Association, shall, not later than 2 years after the date of enactment of this Act, ensure uniform treatment of digital assets for the purposes of State money transmission laws on the following matters: (1) Whether digital assets are subject to money transmission licensing requirements, as appropriate, which shall include the exchange of digital assets for legal tender. (2) Treatment of payment stablecoins. (3) Non-applicability to persons or software that engage in validation of transactions, non-custodial wallet providers, or software or hardware development. (4) Tangible net worth and permissible investment requirements. (5) Disclosures, reporting, and recordkeeping. (6) Common examination and examiner training standards, including common customer identification, anti-money laundering, and sanctions best practices developed in consultation with the Financial Crimes Enforcement Network and the Office of Foreign Assets Control. (b) Regulations If the Director of the Bureau of Consumer Financial Protection determines that a State does not have the requirements of subsection (a) in effect by law (including regulations) that are substantively consistent with the requirements of the several States on the date that is 2 years after the date of enactment of this section, the Director shall adopt rules applicable to that State that achieve the purposes of subsection (a) and that are consistent with the standards adopted in the States that have the requirements of subsection (a) in effect. The Director may extend the deadline under this section for not more than 1 year if a State has shown a good faith effort towards implementation. The Director may promulgate regulations to monitor State compliance with this subsection. 804. Information sharing among Federal and State financial regulators Subtitle C of title VII of the Gramm-Leach-Bliley Act ( Public Law 106–102 ; 113 Stat. 1470), as amended by section 601 of this Act, is amended by adding at the end the following: 722B. Information sharing among Federal and State financial regulators (a) Confidentiality Notwithstanding any other provision of law, any requirement under Federal or State law regarding the privacy or confidentiality of any information or materials exchanged among financial regulators and any privilege arising under Federal or State law (including the rules of any Federal or State court) with respect to such information or material, shall continue to apply to such information or material after the information or material has been disclosed to any State or Federal financial regulator. (b) Non-Applicability of certain requirements Information or material that is subject to privilege or confidentiality under subsection (a) shall not be subject to— (1) disclosure under any Federal or State law governing the disclosure to the public of information held by an officer or an agency of the Federal Government or the respective State; or (2) subpoena or discovery, or admission into evidence, in any private civil action or administrative process, unless with respect to any privilege held by the Nationwide Mortgage Licensing System and Registry or the Director with respect to such information or material, the person to whom such information or material pertains waives that privilege, in whole or in part, based on the discretion of such person. (c) Coordination with other law Any State or Federal law, including any State open records law, relating to the disclosure of confidential supervisory information or any information or material described in subsection (a) that is inconsistent with subsection (a) shall be superseded by the requirements of such provision to the extent the State or Federal law provides less confidentiality or a weaker privilege. (d) Conference of State Bank Supervisors The Conference of State Bank Supervisors shall be considered the agent of the State financial regulators for the purposes of sharing information under this provision. (e) Definition In this section, the term financial regulator means— (1) the Board of Governors of the Federal Reserve System and the Federal Reserve banks; (2) the Commodity Futures Trading Commission; (3) the Department of the Treasury, including the Financial Crimes Enforcement Network and the Office of Foreign Assets Control; (4) the Federal Deposit Insurance Corporation; (5) the Federal Housing Finance Agency; (6) the National Credit Union Administration; (7) the Office of the Comptroller of the Currency; (8) the Bureau of Consumer Financial Protection; (9) the Securities and Exchange Commission; and (10) State agencies that regulate, supervise, or license banks, trust companies, credit unions, consumer credit, consumer protection, money transmission, securities, commodities, and similar areas. . 805. Analysis of decentralized finance markets and technologies Not later than 1 year after the date of enactment of this Act, the Secretary of the Treasury, in consultation with the Commodity Futures Trading Commission, Securities and Exchange Commission, and private sector developers and participants in decentralized protocols, digital assets, and digital asset exchanges, shall— (1) analyze the market position of decentralized finance technologies with respect to digital assets; and (2) submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Financial Services and the Committee on Agriculture of the House of Representatives a report on— (A) current development and use of decentralized finance protocols in the United States and other countries; (B) opportunities, benefits, and challenges relating to decentralized finance protocols and self-custody of digital assets; (C) a comparison of operational friction, fees, liquidity and trading opportunities in decentralized finance protocols, digital asset markets, and traditional markets; (D) transparency, prevention of manipulation, and customer protection; (E) cybersecurity and resiliency; and (F) ensuring the accuracy of information regarding the underlying smart contracts of a decentralized finance protocol and the transactions facilitated by such contracts, as the information appears on a website or other similar means relating to the protocol. 806. Analysis of energy consumption in digital asset markets (a) In general Each year, the Federal Energy Regulatory Commission, in consultation with the Commodity Futures Trading Commission and Securities and Exchange Commission, shall analyze the following topics with respect to digital asset markets: (1) Energy consumption for mining and staking of digital asset transactions. (2) The effect of energy consumption described in paragraph (1) on national, regional, and local energy prices. (3) The effects of mining and staking of digital asset transactions on baseload power levels. (4) The use of renewable energy sources, including use of nonrenewable sources that would otherwise be wasted, and a comparison of digital asset market energy consumption with the financial services industry and economy as a whole. (5) The sources and reliability of the data used under this subsection. (6) A process for regulated entities to make information publicly available regarding energy consumption, including sources of energy and amount, and, if appropriate, recommendations to Congress to establish such a process. (b) Report Not later than December 31 of each year, the Federal Energy Regulatory Commission shall submit to the Committee on Energy and Natural Resources and the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce and the Committee on Natural Resources of the House of Representatives a report containing the analysis required by subsection (a). 807. Analysis of self-regulation and registered digital asset associations (a) In general Not later than 180 days after the date of enactment of this Act, the Commodity Futures Trading Commission and Securities and Exchange Commission, in consultation with digital asset intermediaries, as defined in section 9801 of title 31, United States Code, as added by section 101 of this Act, and standard-setting associations representing the digital asset industry, shall conduct a study and submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Financial Services and the Committee on Agriculture of the House of Representatives a report setting forth principles for self-regulation for digital asset markets and a proposal for the establishment of registered digital asset associations for digital asset markets based on delegated authority from the Commodity Futures Trading Commission and Securities and Exchange Commission to facilitate innovative, efficient, and orderly markets for digital assets in accordance with this Act, and the amendments made by this Act, including— (1) standard setting, corporate transparency requirements, and rulemaking relating to digital asset market conduct; (2) regular consultation between the Commodity Futures Trading Commission and Securities and Exchange Commission with respect to rules governing digital asset market conduct and the governance of registered digital asset associations; (3) appropriate investigatory and disciplinary powers of registered digital asset associations and registered digital asset exchanges, respectively; (4) the authority of digital asset intermediaries to conduct activities relating to traditional assets; (5) consumer education and financial literacy; (6) professional accreditation and education; (7) market surveillance and oversight, including use of technology to facilitate shared trade practices and market surveillance; (8) risk-based examination authority; (9) dispute resolution and arbitration; (10) membership of registered digital asset association members in other self-regulatory organizations and mutual recognition and acceptance of rules and examination reports amongst self-regulatory organizations; (11) voluntary and compulsory membership structures; (12) the initial determination of the legal classification of a digital asset by a registered digital asset association, subject to oversight by the Commodity Futures Trading Commission and Securities and Exchange Commission; and (13) the funding of registered digital asset associations based on fees. (b) Interim rule Not later than August 1, 2022, the Commodity Futures Trading Commission and Securities and Exchange Commission shall jointly adopt an interim final rule specifying the scope of the study under subsection (a), including topics of discussion and questions for digital asset intermediaries and associations representing the digital asset industry, and setting forth not fewer than 3 public meetings for staff of the Commodity Futures Trading Commission and the Securities and Exchange Commission to receive public comment. The interim final rule shall establish a comment period of not less than 120 days prior to publication of the report under subsection (a) and contain draft legislative text for the creation of registered digital asset associations by Congress. 808. Cybersecurity standards for digital asset intermediaries (a) Definition In this section, the term digital asset intermediary has the meaning given the term in section 9801 of title 31, United States Code, as added by section 101 of this Act. (b) Requirement Not later than 18 months after the date of enactment of this Act, the Commodity Futures Trading Commission and the Securities and Exchange Commission, in consultation with the Secretary of the Treasury and the Director of the National Institute of Standards and Technology, shall develop comprehensive, principles-based guidance relating to cybersecurity for digital asset intermediaries that account for, with respect to such a digital asset intermediary— (1) the internal governance, and organizational culture, of the cybersecurity program of the digital asset intermediary; (2) security operations of the digital asset intermediary, including threat identification, incident response, and mitigation; (3) risk identification and measurement by the digital asset intermediary; (4) the mitigation of risk by the digital asset intermediary, including policies of the digital asset intermediary, controls implemented by the digital asset intermediary, change management with respect to the digital asset intermediary, and the supply chain integrity of the digital asset intermediary; (5) assurance provided by, and testing conducted by, the digital asset intermediary, including penetration testing and independent audits so conducted; and (6) the potential for digital asset intermediaries to be used to facilitate illicit activities, including sanctions avoidance. 809. Advisory Committee on Financial Innovation (a) Establishment There is established the Advisory Committee on Financial Innovation (in this section referred to as the Committee ). (b) Membership (1) Composition The Committee shall be composed of 10 members, as follows: (A) 2 members appointed by the President from the financial technology industry. (B) 4 members appointed by the President with specializations in consumer protection, consumer education, financial literacy, or financial inclusion. (C) A commissioner from the Securities and Exchange Commission, as designated by the Chair of the Commission. (D) A commissioner from the Commodity Futures Trading Commission, as designated by the Chair of the Commission. (E) A member of the Board of Governors of the Federal Reserve System, as designated by the Chair of the Board. (F) A State financial regulator, as jointly designated by the National Association of State Securities Administrators and the Conference of State Bank Supervisors. (2) Political affiliation Not more than 4 of the members of the Committee shall be from the same political party. (3) Appointment date The appointments of the members of the Committee shall be made not later than 60 days after the date of enactment of this Act. (4) Period of appointment; vacancies (A) In general A member of the Committee shall be appointed for a term of 4 years. (B) Vacancies A vacancy in the Committee— (i) shall not affect the powers of the Committee; and (ii) shall be filled in the same manner as the original appointment. (5) Meetings (A) Initial meeting Not later than 60 days after the date on which all members of the Committee have been appointed, the Committee shall hold its first meeting. (B) Frequency The Committee shall meet at the call of the Chair. (C) Quorum A majority of the members of the Committee shall constitute a quorum, but a lesser number of members may hold hearings. (6) Chairperson The members described in subparagraphs (C) and (D) of paragraph (1) shall alternate, on a yearly basis, as Chairperson of the Committee, with the member described in such subparagraph (D) serving as the Chair for the 1-year period following establishment of the Committee. (c) Duties (1) Matters studied The matters studied by the Committee shall include— (A) digital assets; (B) consumer education and financial literacy; (C) market structure in the securities and commodities markets; (D) banking, payments and settlement; (E) consumer credit; (F) financial inclusion, including reducing the cost of financial services for all people of the United States and promoting access to those services; (G) efficiency in the financial system; (H) reduction of systemic risk; (I) competition in financial services; and (J) the State-Federal partnership in financial services regulation. (2) Report On an annual basis, or as otherwise determined necessary by the Chair of the Committee, the Committee shall report to the President and to Congress on, and provide recommendations for legislation, regulation, and supervision relating to innovation in, the matters studied under paragraph (1). (d) Powers (1) Hearings The Committee shall hold not less than 2 hearings per calendar year to hear from interested parties and to discuss the work of the Committee. (2) Information from Federal agencies (A) In general The Committee may secure directly from a Federal department or agency such information as the Committee considers necessary to carry out this section. (B) Furnishing information On request of the Chair of the Committee, the head of the department or agency shall furnish the information to the Committee. (3) Postal services The Committee may use the United States mails in the same manner and under the same conditions as other departments and agencies of the Federal Government. (e) Compensation (1) In general All members of the Committee shall serve without compensation in addition to that received for their services as officers or employees of the United States, and all other members of the Committee shall serve without compensation. (2) Travel expenses Each member of the Committee may be allowed travel expenses, including per diem in lieu of subsistence, in accordance with sections 5702 and 5703 of title 5, United States Code, while away from their homes or regular places of business in performance of services for the Council. (f) Staff (1) In general The Chair of the Committee may, without regard to the civil service laws (including regulations), appoint and terminate an executive director and such other additional personnel as may be necessary to enable the Committee to perform its duties, except that the employment of an executive director shall be subject to confirmation by the Committee. (2) Compensation The Chair of the Committee may fix the compensation of the executive director and other personnel without regard to chapter 51 and subchapter III of chapter 53 of title 5, United States Code, relating to classification of positions and General Schedule pay rates, except that the rate of pay for the executive director and other personnel may not exceed the rate payable for level V of the Executive Schedule under section 5316 of that title. (g) Detail of government employees A Federal Government employee may be detailed to the Committee without reimbursement, and such detail shall be without interruption or loss of civil service status or privilege. (h) Procurement of temporary and intermittent services The Chair of the Committee may procure temporary and intermittent services under section 3109(b) of title 5, United States Code, at rates for individuals that do not exceed the daily equivalent of the annual rate of basic pay prescribed for level V of the Executive Schedule under section 5316 of that title. (i) Termination Section 14 of the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the Committee. (j) Authorization of appropriations There is authorized to be appropriated to the Committee to carry out this section $2,000,000 for fiscal year 2023, to remain available through fiscal year 2024. | https://www.govinfo.gov/content/pkg/BILLS-117s4356is/xml/BILLS-117s4356is.xml |
117-s-4357 | II 117th CONGRESS 2d Session S. 4357 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Ms. Cantwell (for herself and Mr. Wicker ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To reauthorize the Maritime Administration, and for other purposes.
1. Short title (a) Short title This Act may be cited as the Maritime Administration Authorization Act for Fiscal Year 2023 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Authorization of appropriations for the Maritime Administration. TITLE I—General provisions Sec. 101. Study to inform a national maritime strategy. Sec. 102. National maritime strategy. Sec. 103. Modification of cargo preference 3-year eligibility rule. TITLE II—Maritime infrastructure Sec. 201. Marine highways. Sec. 202. GAO review of efforts to support and grow the United States Merchant Fleet. Sec. 203. GAO review of Federal efforts to enhance port infrastructure resiliency and disaster preparedness. Sec. 204. Study on foreign investment in shipping. Sec. 205. Report regarding alternate marine fuel bunkering facilities at ports. TITLE III—Maritime workforce Sec. 301. Sense of Congress on Merchant Marine. Sec. 302. Ensuring diverse mariner recruitment. Sec. 303. Low emissions vessels training. Sec. 304. Improving Protections for Midshipmen Act. Sec. 305. Board of Visitors. Sec. 306. Maritime Technical Advancement Act. Sec. 307. Study on CIP program at the USMMA. Sec. 308. Implementation of recommendations from the National Academy of Public Administration. Sec. 309. Service Academy faculty parity. Sec. 310. Updated Requirements for Fishing Crew Agreements. TITLE IV—Technology innovation and resilience Sec. 401. Maritime Environmental and Technical Assistance Program. Sec. 402. Quieting Federal non-combative vessels. Sec. 403. Study on stormwater impacts on salmon. 2. Authorization of appropriations for the Maritime Administration (a) Maritime administration There are authorized to be appropriated to the Department of Transportation for fiscal year 2023, for programs associated with maintaining the United States Merchant Marine, the following amounts: (1) For expenses necessary to support the United States Merchant Marine Academy, $112,848,000, of which— (A) $87,848,000 shall be for Academy operations; (B) $22,000,000 shall be for facilities maintenance and repair and equipment; and (C) $3,000,000 shall be for training, staffing, retention, recruiting, and contract management for United States Merchant Marine Academy capital improvement projects. (2) For expenses necessary to support the State maritime academies, $80,700,000, of which— (A) $2,400,000 shall be for the Student Incentive Program; (B) $6,000,000 shall be for direct payments for State maritime academies; (C) $6,800,000 shall be for training ship fuel assistance; (D) $8,080,000 shall be for offsetting the costs of training ship sharing; and (E) $30,500,000 shall be for maintenance and repair of State maritime academy training vessels. (3) For expenses necessary to support the National Security Multi-Mission Vessel Program and to meet requirements for shore-side infrastructure improvements, $75,000,000. (4) For expenses necessary to support Maritime Administration operations and programs, $101,250,000, of which— (A) $15,000,000 shall be for the Maritime Environmental and Technical Assistance program authorized under section 50307 of title 46, United States Code; (B) $14,819,000 shall be for the Marine Highways Program, including to make grants as authorized under section 55601 of title 46, United States Code; and (C) $67,433,000 shall be for headquarters operations expenses. (5) For expenses necessary for the disposal of obsolete vessels in the National Defense Reserve Fleet of the Maritime Administration, $6,000,000. (6) For expenses necessary to maintain and preserve a fleet of merchant vessels documented under chapter 121 of title 46, United States Code, to serve the national security needs of the United States, as authorized under chapter 531 of title 46, United States Code, $318,000,000. (7) For expenses necessary for the loan guarantee program authorized under chapter 537 of title 46, United States Code, $33,000,000, of which— (A) $30,000,000 may be for the cost (as defined in section 502(5) of the Federal Credit Reform Act of 1990 ( 2 U.S.C. 661a(5) )) of loan guarantees under the program; and (B) $3,000,000, may be used for administrative expenses relating to loan guarantee commitments under the program. (8) For expenses necessary to provide assistance to small shipyards and for maritime training programs authorized under section 54101 of title 46, United States Code, $40,000,000. (9) For expenses necessary to implement the Port Infrastructure Development Program, as authorized under section 54301 of title 46, United States Code, $750,000,000, to remain available until expended, except that no such funds authorized under this Act for this program may be used to provide a grant to purchase fully automated cargo handling equipment that is remotely operated or remotely monitored with or without the exercise of human intervention or control, if the Secretary of Transportation determines such equipment would result in a net loss of jobs within a port or port terminal. If such a determination is made, the data and analysis for such determination shall be reported to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives not later than 3 days after the date of the determination. (b) Availability of amounts Amounts appropriated— (1) pursuant to the authority provided in paragraphs (1)(A), (2)(A), and (4)(A) of subsection (a) shall remain available through September 30, 2023; and (2) pursuant to the authority provided in paragraphs (1)(B), (1)(C), (2)(B), (2)(C), (2)(D), (2)(E), (3), (4)(B), (4)(C), (5), (6), (7)(A), (7)(B), (8), and (9) of subsection (a) shall remain available without fiscal year limitation. (c) Tanker security fleet Section 53411 of title 46, United States Code, is amended by striking $60,000,000 and inserting $120,000,000 . I General provisions 101. Study to inform a national maritime strategy (a) In general The Secretary of Transportation and the Secretary of the department in which the Coast Guard is operating shall enter into an agreement with a federally funded research and development center under which such federally funded research and development center shall conduct a study of the key elements and objectives needed for a national maritime strategy. The strategy shall address national objectives, as described in section 50101 of title 46, United States Code, to ensure— (1) a capable, commercially viable, militarily useful fleet of merchant vessels documented under chapter 121 of title 46, United States Code; (2) a robust United States mariner workforce, as described in section 50101 of title 46, United States Code; (3) strong United States domestic shipbuilding infrastructure, and related shipbuilding trades amongst skilled workers in the United States; and (4) that the Navy Fleet Auxiliary Force, the National Defense Reserve Fleet, the Military Sealift Command, the Maritime Security Program under chapter 531 of title 46, United States Code, the Tanker Security Program under chapter 534 of title 46, United States Code, and the Cable Security Program under chapter 532 of title 46, United States Code, currently meet the economic and national security needs of the United States and would reliably continue to meet those needs under future economic or national security emergencies. (b) Input In carrying out the study, the federally funded research and development center shall solicit input from— (1) relevant Federal departments and agencies; (2) nongovernmental organizations; (3) United States companies; (4) maritime labor organizations; (5) commercial industries that depend on United States mariners; (6) domestic shipyards regarding shipbuilding and repair capacity, and the associated skilled workforce, such as the workforce required for transportation, offshore wind, fishing, and aquaculture; (7) providers of maritime workforce training; and (8) any other relevant organizations. (c) Elements of the Study The study conducted under subsection (a) shall include consultation with the Department of Transportation, the Department of Defense, the Department of Homeland Security, the National Oceanic and Atmospheric Administration, and other relevant Federal agencies, in the identification and evaluation of— (1) incentives needed to continue to meet the shipbuilding and ship maintenance needs of the United States for commercial and national security purposes, including through a review of— (A) the loans and guarantees program carried out under chapter 537 of title 46, United States Code, and how the development of new offshore commercial industries, such as wind, could be supported through modification of such program or other Federal programs, and thus also support the United States sealift in the future; (B) the barriers to participation in the loans and guarantees program carried out under chapter 537 of title 46, United States Code, and how the program may be improved to facilitate additional shipbuilding activities in the United States; and (C) the needed resources, human and financial, for such incentives; (2) incentives needed to maintain a commercially viable United States-documented fleet, which shall include— (A) an examination of how the preferences under section 2631 of title 10, United States Code, and chapter 553 of title 46, United States Code, the Maritime Security Program under chapter 531 of title 46, United States Code, the Tanker Security Program under chapter 534 of title 46, United States Code, and the Cable Security Program under chapter 532 of title 46, United States Code, should be used to further maintain and grow a United States-documented fleet and the identification of other incentives that could be used that may not be authorized at the time of the study; and (B) estimates of the needed human and financial resources for such incentives; (3) the availability of United States mariners, and future needs, including— (A) the number of mariners needed for the United States commercial and national security needs over the next 30 years; (B) the policies and programs (at the time of the study) to recruit, train, and retain United States mariners to support the United States maritime workforce needs during peace time and at war; (C) how those programs could be improved to grow the number of maritime workers trained each year, including potential collaboration between the uniformed services, the United States Merchant Marine Academy, State maritime academies, maritime labor training centers, and the Centers of Excellence for Domestic Maritime Workforce Training under section 51706 of title 46, United States Code, could be used most effectively; and (D) estimates of the necessary resources, human and financial, to implement such programs in each relevant Federal agency over the next 30 years; and (4) the interaction among the elements described under paragraphs (1) through (3). (d) Public availability The study conducted under subsection (a) shall be made publicly available on a website of the Department of Transportation. 102. National maritime strategy (a) In general Not later than 60 days after the date of the enactment of this Act, the Secretary of Transportation, in consultation with the Secretary of the department in which the Coast Guard is operating, and every 5 years thereafter, shall submit to the Committee on Transportation and Infrastructure of the House of Representatives and the Committee on Commerce, Science, and Transportation of the Senate a national maritime strategy. (b) Contents The strategy required under subsection (a) shall— (1) identify— (A) international policies and Federal regulations and policies that reduce the competitiveness of United States-documented vessels with foreign vessels in domestic and international transportation markets; and (B) the impact of reduced cargo flow due to reductions in the number of members of the United States Armed Forces stationed or deployed outside of the United States; and (2) include recommendations to— (A) make United States-documented vessels more competitive in shipping routes between United States and foreign ports; (B) increase the use of United States-documented vessels to carry cargo imported to and exported from the United States; (C) ensure compliance by Federal agencies with chapter 553 of title 46, United States Code; (D) increase the use of short sea transportation routes, including routes designated under section 55601(c) of title 46, United States Code, to enhance intermodal freight movements; (E) enhance United States shipbuilding capability; (F) invest in, and identify gaps in, infrastructure needed to facilitate the movement of goods at ports and throughout the transportation system, including innovative physical and information technologies; (G) enhance workforce training and recruitment for the maritime workforce, including training on innovative physical and information technologies; (H) increase the resilience of ports and the marine transportation system; and (I) increase the carriage of government-impelled cargo on United States-documented vessels pursuant to chapter 553 of title 46, United States Code, section 2631 of title 10, United States Code, or otherwise. (c) Update Not later than 6 months after the date of receipt of the study conducted under section 101, the Secretary of Transportation, in consultation with the Secretary of the department in which the Coast Guard is operating and the Secretary of Defense, shall— (1) update the national maritime strategy required by section 603 of the Howard Coble Coast Guard and Maritime Transportation Act of 2014 ( Public Law 113–281 ); (2) submit a report to Congress containing the updated national maritime strategy; and (3) make the updated national maritime strategy publicly available on the website of the Department of Transportation. (d) Implementation plan Not later than 6 months after completion of the updated national maritime strategy under subsection (c), and after the completion of each strategy thereafter, the Secretary of Transportation, in consultation with the Secretary of the department in which the Coast Guard is operating and the Secretary of Defense, shall publish on a publicly available website an implementation plan for the most recent national maritime strategy. 103. Modification of cargo preference 3-year eligibility rule Section 55305 of title 46, United States Code, is amended— (1) by striking subsection (a); (2) by redesignating— (A) subsection (b) as subsection (a); and (B) subsections (c), (d), and (e), as subsections (d), (e), and (f), respectively; (3) in subsection (a), as redesignated by paragraph (1), by striking privately-owned commercial vessels of the United States, and inserting privately-owned commercial vessels of the United States, as provided under subsection (b), ; and (4) by inserting after subsection (a), as redesignated by paragraph (1), the following: (b) Eligible vessels To be eligible to carry cargo as provided under subsection (a), a privately-owned commercial vessel shall be documented under the laws of the United States— (1) for not less than 3 years; or (2) for less than 3 years if the vessel owner signs an agreement with the Secretary providing that— (A) the vessel shall remain documented under the laws of the United States for not less than 3 years; and (B) the vessel owner shall, upon request of the Secretary, agree to enroll the vessel in an emergency preparedness agreement or voluntary agreement authorized under section 708 of the Defense Production Act of 1950 ( 50 U.S.C. 4558 ) and shall remain so enrolled until the vessel ceases to be documented under the laws of the United States. (c) Violation of agreement A vessel under an agreement executed pursuant to subsection (b)(2) may be seized by and forfeited to the United States if, in violation of that agreement— (1) the vessel owner places the vessel under foreign registry; or (2) a person operates the vessel under the authority of a foreign country. . II Maritime infrastructure 201. Marine highways (a) Short title This section may be cited as the Marine Highway Promotion Act . (b) Findings Congress finds the following: (1) Our Nation's waterways are an integral part of the transportation network of the United States. (2) Using the Nation's coastal, inland, and other waterways can support commercial transportation, and alleviates surface transportation congestion and burdensome road and bridge repair costs. (3) Marine highways are serviced by documented United States Flag vessels and manned by United States citizens, providing added resources for national security and to aid in times of crisis. (4) According to the United States Army Corps of Engineers, inland navigation is a key element of economics development and is essential in maintaining economic competitiveness and national security. (c) United States marine highway program (1) In general Section 55601 of title 46, United States Code, is amended to read as follows: 55601. United States Marine Highway Program (a) Program (1) Establishment The Maritime Administrator shall establish a Marine Highway Program to be known as the United States Marine Highway Program . Under such program, the Maritime Administrator shall— (A) designate marine highway routes as extensions of the surface transportation system under subsection (b); and (B) subject to the availability of appropriations, make grants or enter into contracts or cooperative agreements under subsection (c). (2) Program activities In carrying out the Marine Highway Program established under paragraph (1), the Maritime Administrator may— (A) coordinate with ports, State departments of transportation, localities, other public agencies, and the private sector on the development of landside facilities and infrastructure to support marine highway transportation; (B) develop performance measures for such Marine Highway Program; (C) collect and disseminate data for the designation and delineation of marine highway routes under subsection (b); and (D) conduct research on solutions to impediments to marine highway services eligible for assistance under subsection (c)(1). (b) Designation of marine highway routes (1) Authority The Maritime Administrator may designate or modify a marine highway route as an extension of the surface transportation system if— (A) such a designation or modification is requested by— (i) the government of a State or territory; (ii) a metropolitan planning organization; (iii) a port authority; (iv) a non-Federal navigation district; or (v) a Tribal government; and (B) the Maritime Administrator determines such marine highway route satisfies at least one covered function under subsection (d). (2) Determination Not later than 180 days after the date on which the Maritime Administrator receives a request for designation or modification of a marine highway route under paragraph (1), the Maritime Administrator shall make a determination of whether to make the requested designation or modification. (3) Notification Not later than 14 days after the date on which the Maritime Administrator makes the determination whether to make the requested designation or modification, the Maritime Administrator shall send the requester a notification of the determination. (4) Map (A) In General Not later than 120 days after the date of enactment of the Marine Highway Promotion Act, and thereafter each time a marine highway route is designated or modified, the Administrator shall make publicly available a map showing the location of marine highway routes, including such routes along the coasts, in the inland waterways, and at sea. (B) Coordination The Administrator shall coordinate with the National Oceanic and Atmospheric Administration to incorporate the map into the Marine Cadastre. (c) Assistance for marine highway services (1) In general The Maritime Administrator may make grants to, or enter into contracts or cooperative agreements with an eligible entity to implement a marine highway service or component of a marine highway service, if the Administrator determines the service— (A) satisfies at least one covered function under subsection (d); (B) uses vessels documented under chapter 121 of this title; and (C) (i) implements strategies developed under section 55603; or (ii) develops, expands, or promotes— (I) marine highway transportation services; or (II) shipper utilization of marine highway transportation. (2) Eligible entity In this subsection, the term eligible entity means— (A) a State, a political subdivision of a State, or a local government; (B) a United States metropolitan planning organization; (C) a United States port authority; (D) a Tribal government in the United States; or (E) a United States private sector operator of marine highway services or private sector owners of facilities with an endorsement letter from the marine highway route sponsor described in subsection (b)(1)(A). (3) Application (A) In General To be eligible to receive a grant or enter into a contract or cooperative agreement under this subsection to implement a marine highway service, an eligible entity shall submit an application in such form and manner, at such time, and containing such information as the Maritime Administrator may require, including— (i) a comprehensive description of— (I) the regions to be served by the marine highway service; (II) the marine highway route that the service will use, which may include connection to existing or planned transportation infrastructure and intermodal facilities, key navigational factors such as available draft, channel width, bridge air draft, or lock clearance, and any foreseeable impacts on navigation or commerce, and a map of the proposed route; (III) the marine highway service supporters, which may include business affiliations, private sector stakeholders, State departments of transportation, metropolitan planning organizations, municipalities, or other governmental entities (including Tribal governments), as applicable; (IV) the estimated volume of passengers, if applicable, or cargo using the service, and predicted changes in such volume during the 5-year period following the date of the application; (V) the need for the service; (VI) the definition of the success goal for the service, such as volumes of cargo or passengers moved, or contribution to environmental mitigation, safety, reduced vehicle miles traveled, or reduced maintenance and repair costs; (VII) the methodology for implementing the service, including a description of the proposed operational framework of the service including the origin, destination, and any intermediate stops on the route, transit times, vessel types, and service frequency; and (VIII) any existing programs or arrangements that can be used to supplement or leverage assistance under the program; and (ii) a demonstration, to the satisfaction of the Maritime Administrator, that— (I) the marine highway service is financially viable; (II) the funds or other assistance provided under this subsection will be spent or used efficiently and effectively; and (III) a market exists for the services of the proposed marine highway service, as evidenced by contracts or written statements of intent from potential customers. (B) Pre-proposal Prior to accepting a full application under subparagraph (A), the Maritime Administrator may require that an eligible entity first submit a pre-proposal that contains a brief description of the items under subparagraph (A). (C) Pre-proposal feedback Not later than 30 days after receiving a pre-proposal, the Maritime Administrator shall provide feedback to the eligible entity that submitted the pre-proposal to encourage or discourage the eligible entity from submitting a full application. An eligible entity may still submit a full application even if that eligible entity is not encouraged to do so after submitting a pre-proposal. (4) Timing of grant notice The Maritime Administrator shall post a Notice of Funding Opportunity regarding grants, contracts, or cooperative agreements under this subsection not more than 60 days after the date of enactment of the appropriations Act for the fiscal year concerned. (5) Grant application feedback Following the award of grants for a particular fiscal year, the Maritime Administrator may provide feedback to applicants to help applicants improve future applications if the feedback is requested by that applicant. (6) Timing of grants The Maritime Administrator shall award grants, contracts, or cooperative agreements under this subsection not later than 270 days after the date of the enactment of the appropriations Act for the fiscal year concerned. (7) Non-Federal share (A) In general An applicant shall provide not less than 20 percent of the costs from non-Federal sources, except as provided in subparagraph (B). (B) Tribal and Rural areas The Maritime Administrator may increase the Federal share of service costs above 80 percent for a service located in a Tribal or rural area. (C) Tribal Government The Maritime Administrator may increase the Federal share of service costs above 80 percent for a service benefitting a Tribal Government. (D) Preference In awarding grants, or entering in contracts or cooperative agreements under this subsection, the Maritime Administrator shall give a preference to marine highway services that present the most financially viable transportation services and require the lowest percentage Federal share of the costs. (8) Reuse of unexpended grant funds Notwithstanding paragraph (6), amounts awarded under this subsection that are not expended by the recipient within 3 years after obligation of funds or that are returned under paragraph (10)(C) shall remain available to the Maritime Administrator to make grants and enter into contracts and cooperative agreements under this subsection. (9) Administrative costs Not more than 3 percent of the total amount made available to carry out this subsection for any fiscal year may be used for the necessary administrative costs associated with grants, contracts, and cooperative agreements made under this subsection. (10) Procedural safeguards The Maritime Administrator, in consultation with the Office of the Inspector General, shall issue guidelines to establish appropriate accounting, reporting, and review procedures to ensure that— (A) amounts made available to carry out this subsection are used for the purposes for which they were made available; (B) recipients of funds under this subsection (including through grants, contracts, or cooperative agreements) have properly accounted for all expenditures of such funds; and (C) any such funds that are not obligated or expended for the purposes for which they were made available are returned to the Administrator. (11) Conditions on provision of funds The Maritime Administrator may not award funds an applicant under this subsection unless the Maritime Administrator determines that— (A) sufficient funding is available to meet the non-Federal share requirement of paragraph (7); (B) the marine highway service for which such funds are provided will be completed without unreasonable delay; and (C) the recipient of such funds has authority to implement the proposed marine highway service. (d) Covered functions A covered function under this subsection is one of the following: (1) Promotion of marine highway transportation. (2) Provision of a coordinated and capable alternative to landside transportation. (3) Mitigation or relief of landside congestion. (e) Prohibited uses Funds awarded under this section may not be used to— (1) raise sunken vessels, construct buildings or other physical facilities, or acquire land unless such activities are necessary for the establishment or operation of a marine highway service implemented using grant funds provided, or pursuant to a contract or cooperative entered into under, subsection (c); or (2) improve port or land-based infrastructure outside the United States. (f) Geographic distribution In making grants, contracts, and cooperative agreements under this section the Maritime Administrator shall take such measures so as to ensure an equitable geographic distribution of funds. (g) Audits and examinations All recipients (including recipients of grants, contracts, and cooperative agreements) under this section shall maintain such records as the Maritime Administrator may require and make such records available for review and audit by the Maritime Administrator. . (2) Rules (A) Final rule Not later than 1 year after the date of enactment of this Act, the Secretary of Transportation shall prescribe such final rules as are necessary to carry out the amendments made by this subsection. (B) Interim rules The Secretary of Transportation may prescribe temporary interim rules necessary to carry out the amendments made by this subsection. For this purpose, the Maritime Administrator, in prescribing rules under this subparagraph, is excepted from compliance with the notice and comment requirements of section 553 of title 5, United States Code, prior to the effective date of the interim rules. All interim rules prescribed under the authority of this subparagraph shall request comment and remain in effect until such time as the interim rules are superseded by a final rule, following notice and comment. (C) Savings clause The requirements under section 55601 of title 46, United States Code, as amended by this subsection, shall take effect only after the interim rule described in subparagraph (B) is promulgated by the Secretary. (d) Multistate, State, and regional transportation planning Chapter 556 of title 46, United States Code, is amended by inserting after section 55602 the following: 55603. Multistate, State, and regional transportation planning (a) In general The Maritime Administrator, in consultation with the heads of other appropriate Federal departments and agencies, State and local governments, and appropriate private sector entities, may develop strategies to encourage the use of marine highway transportation for the transportation of passengers and cargo. (b) Strategies If the Maritime Administrator develops the strategies described in subsection (a), the Maritime Administrator may— (1) assess the extent to which States and local governments include marine highway transportation and other marine transportation solutions in transportation planning; (2) encourage State departments of transportation to develop strategies, where appropriate, to incorporate marine highway transportation, ferries, and other marine transportation solutions for regional and interstate transport of freight and passengers in transportation planning; and (3) encourage groups of States and multistate transportation entities to determine how marine highway transportation can address congestion, bottlenecks, and other interstate transportation challenges. . (e) Research on marine highway transportation Section 55604 of title 46, United States Code, is amended— (1) by redesignating paragraphs (1) through (3) as paragraphs (4) through (6), respectively; and (2) by inserting before paragraph (4), as redesignated by paragraph (1), the following new paragraphs: (1) the economic importance of marine highway transportation to the United States economy; (2) the importance of marine highway transportation to rural areas; (3) pairs of United States regions and territories, and within-region areas, that do not yet have marine highway services underway, but that could benefit from the establishment of marine highway services; . (f) Definitions Section 55605 of title 46, United States Code, is amended to read as follows: 55605. Definitions In this chapter— (1) the term marine highway transportation means the carriage by a documented vessel of cargo— (A) that is— (i) contained in intermodal cargo containers and loaded by crane on the vessel; (ii) loaded on the vessel by means of wheeled technology; (iii) shipped in discrete units or packages that are handled individually, palletized, or unitized for purposes of transportation; or (iv) freight vehicles carried aboard commuter ferry boats; and (B) that is— (i) loaded at a port in the United States and unloaded either at another port in the United States or at a port in Canada or Mexico; or (ii) loaded at a port in Canada or Mexico and unloaded at a port in the United States; (2) the term marine highway service means a planned or contemplated new service, or expansion of an existing service, on a marine highway route, that seeks to provide new modal choices to shippers, offer more desirable services, reduce transportation costs, or provide public benefits; (3) the term marine highway route means a route on commercially navigable coastal, inland, or intracoastal waters of the United States, including connections between the United States and a port in Canada or Mexico, that is designated under section 55601(b); and (4) the term “Tribal Government” means the recognized governing body of any Indian or Alaska Native Tribe, band, nation, pueblo, village, community, component band, or component reservation, individually identified (including parenthetically) in the list published most recently as of the date of enactment of Marine Highway Promotion Act pursuant to section 104 of the Federally Recognized Indian Tribe List Act of 1994 ( 25 U.S.C. 5131 ). . (g) Clerical amendments The analysis for chapter 556 of title 46, United States Code, is amended— (1) by striking the item relating to section 55601 and inserting the following: 55601. United States Marine Highway Program. ; (2) by inserting after the item relating to section 55602 the following: 55603. Multistate, State, and regional transportation planning. ; and (3) by striking the item relating to section 55605 and inserting the following: 55605. Definitions. . 202. GAO review of efforts to support and grow the United States Merchant Fleet Not later than 18 months after the date of enactment of this section, the Comptroller General of the United States shall transmit a report to the Committee on Commerce of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives that examines United States Government efforts to promote the growth and modernization of the United States maritime industry, and the vessels of the United States, as defined in section 116 of title 46, United States Code, including the overall efficacy of United States Government financial support and policies, including the Capital Construction Fund, Construction Reserve Fund, and other eligible loan, grant, or other programs. 203. GAO review of Federal efforts to enhance port infrastructure resiliency and disaster preparedness Not later than 18 months after the date of enactment of this section, the Comptroller General of the United States shall transmit a report to the Committee on Commerce of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives that examines Federal efforts to assist ports in enhancing the resiliency of their key intermodal connectors to weather-related disasters. The report shall include consideration of the following: (1) Actions being undertaken at various ports to better identify critical land-side connectors that may be vulnerable to disruption in the event of a natural disaster, including how to communicate such information during a disaster when communications systems may be compromised, and the level of Federal involvement in such efforts. (2) The extent to which the Department of Transportation and other Federal agencies are working in line with recent recommendations from key resiliency reports, including the National Academies of Science study on strengthening supply chain resilience, to establish a framework for ports to follow to increase resiliency to major weather-related disruptions before they happen. (3) The extent to which the Department of Transportation or other Federal agencies have provided funds to ports for resiliency-related projects. (4) The extent to which Federal agencies have a coordinated approach to helping ports and the multiple State, local, and private stakeholders involved, to improve resiliency prior to weather-related disasters. 204. Study on foreign investment in shipping (a) Assessment The Under Secretary of Commerce for International Trade (referred to in this section as the Under Secretary ) in coordination with Maritime Administration, the United States Transportation Command, and the Federal Maritime Commission shall conduct an assessment of subsidies, indirect state support, or other financial infrastructure or benefits provided by foreign states that control more than 1 percent of the world merchant fleet to entities or individuals building, owning, chartering, operating, or financing vessels not documented under the laws of the United States that are engaged in foreign commerce. (b) Report Not later than 1 year after the date of enactment of this section, the Under Secretary shall submit to Congress a report on the assessment conducted under subsection (a), including— (1) the amount, in United States dollars, of such support provided by a foreign state described in subsection (a) to— (A) the shipping industry of each country as a whole; (B) the shipping industry as a percent of gross domestic product of each country; and (C) each ship on average, by ship type for cargo, tanker, and bulk; (2) the amount, in United States dollars, of such support provided by a foreign state described in subsection (a) to the shipping industry of another foreign state, including favorable financial arrangements for ship construction; (3) a description of the shipping industry activities of state-owned enterprises of a foreign state described in subsection (a); (4) a description of the type of support provided by a foreign state described in subsection (a), including tax relief, direct payment, indirect support of state-controlled financial entities, or other such support, as determined by the Under Secretary; and (5) a description of how the subsidies provided by a foreign state described in subsection (a) may be disadvantaging the competitiveness of vessels documented under the laws of the United States that are engaged in foreign commerce and the national security of the United States. (c) Definitions In this section: (1) Foreign commerce The term foreign commerce means— (A) commerce or trade between the United States, its territories or possessions, or the District of Columbia, and a foreign country; (B) commerce or trade between foreign countries; or (C) commerce or trade within a foreign country. (2) Foreign state The term foreign state has the meaning given the term in section 1603(a) of title 28, United States Code. (3) Shipping industry The term shipping industry means the construction, ownership, chartering, operation, or financing of vessels engaged in foreign commerce. 205. Report regarding alternate marine fuel bunkering facilities at ports (a) In general Not later than 1 year after the date of enactment of this Act, the Maritime Administrator shall report on the necessary port-related infrastructure needed to support bunkering facilities for liquefied natural gas, hydrogen, ammonia, or other new marine fuels under development. The Maritime Administrator shall publish the report on a publicly available website. (b) Contents The report described in subsection (a) shall include— (1) information about the existing United States infrastructure, in particular the storage facilities, bunkering vessels, and transfer systems to support bunkering facilities for liquefied natural gas, hydrogen, ammonia, or other new marine fuels under development; (2) a review of the needed upgrades to United States infrastructure, including storage facilities, bunkering vessels, and transfer systems, to support bunkering facilities for liquefied natural gas, hydrogen, ammonia, or other new marine fuels under development; (3) an assessment of the estimated government investment in this infrastructure and the duration of that investment; and (4) in consultation with relevant Federal agencies, information on the relevant Federal agencies that would oversee the permitting and construction of bunkering facilities for liquefied natural gas, hydrogen, ammonia, or other new marine fuels, as well as the Federal funding grants or formula programs that could be used for such marine fuels. III Maritime workforce 301. Sense of Congress on Merchant Marine It is the sense of Congress that the United States Merchant Marine is a critical part of the national infrastructure of the United States, and the men and women of the United States Merchant Marine are essential workers. 302. Ensuring diverse mariner recruitment Not later than 6 months after the date of enactment of this section, the Secretary of Transportation shall develop and deliver to Congress a strategy to assist State maritime academies and the United States Merchant Marine Academy to improve the representation of women and underrepresented communities in the next generation of the mariner workforce, including each of the following: (1) Black and African American. (2) Hispanic and Latino. (3) Asian. (4) American Indian, Alaska Native, and Native Hawaiian. (5) Pacific Islander. 303. Low emissions vessels training (a) Development of strategy The Secretary of Transportation, in consultation with the United States Merchant Marine Academy, State maritime academies, and civilian nautical schools and the Secretary of the department in which Coast Guard is operating, shall develop a strategy to ensure there is an adequate supply of trained United States citizen mariners sufficient to meet the operational requirements of low and zero emission vessels. (b) Report Not later than 6 months after the date the Secretary of Transportation determines that there is commercially viable technology for low and zero emission vessels, the Secretary of Transportation shall— (1) submit a report on the strategy developed under subsection (a) and plans for its implementation to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives; and (2) make such report publicly available. 304. Improving Protections for Midshipmen Act (a) Short title This section may be cited as the Improving Protections for Midshipmen Act . (b) Suspension or revocation of merchant mariner credentials for perpetrators of sexual harassment or sexual assault (1) In general Chapter 77 of title 46, United States Code, is amended by inserting after section 7704 the following: 7704a. Sexual harassment or sexual assault as grounds for suspension or revocation (a) Sexual harassment If it is shown at a hearing under this chapter that a holder of a license, certificate of registry, or merchant mariner’s document issued under this part, within 10 years before the beginning of the suspension and revocation proceedings, is the subject of a substantiated claim of sexual harassment, then the license, certificate of registry, or merchant mariner’s document shall be suspended or revoked. (b) Sexual assault If it is shown at a hearing under this chapter that a holder of a license, certificate of registry, or merchant mariner’s document issued under this part, within 20 years before the beginning of the suspension and revocation proceedings, is the subject of a substantiated claim of sexual assault, then the license, certificate of registry, or merchant mariner’s document shall be revoked. (c) Substantiated claim (1) In general The term substantiated claim means— (A) a legal proceeding or agency action in any administrative proceeding that determines the individual committed sexual harassment or sexual assault in violation of any Federal, State, local, or Tribal law or regulation and for which all appeals have been exhausted, as applicable; or (B) a determination after an investigation by the Coast Guard that it is more likely than not the individual committed sexual harassment or sexual assault as defined in subsection (d), if the determination affords appropriate due process rights to the subject of the investigation. (2) Investigation by the coast guard An investigation by the Coast Guard under paragraph (1)(B) shall include evaluation of the following materials that shall be provided to the Coast Guard: (A) Any inquiry or determination made by the employer of the individual as to whether the individual committed sexual harassment or sexual assault. (B) Upon request from the Coast Guard, any investigative materials, documents, records, or files in the possession of an employer or former employer of the individual that are related to the claim of sexual harassment or sexual assault by the individual. (3) Additional review A license, certificate of registry, or merchant mariner’s document shall not be suspended or revoked under subsection (a) or (b) unless the substantiated claim is reviewed and affirmed, in accordance with the applicable definition in subsection (d), by an administrative law judge at the same suspension or revocation hearing under this chapter described in subsection (a) or (b), as applicable. (d) Definitions (1) Sexual harassment The term sexual harassment means any of the following: (A) Conduct that— (i) involves unwelcome sexual advances, requests for sexual favors, or deliberate or repeated offensive comments or gestures of a sexual nature, when— (I) submission to such conduct is made either explicitly or implicitly a term or condition of a person’s job, pay, or career; (II) submission to or rejection of such conduct by a person is used as a basis for career or employment decisions affecting that person; (III) such conduct has the purpose or effect of unreasonably interfering with an individual’s work performance or creates an intimidating, hostile, or offensive working environment; or (IV) conduct may have been by a person’s supervisor, a supervisor in another area, a co-worker, or another credentialed mariner; and (ii) is so severe or pervasive that a reasonable person would perceive, and the victim does perceive, the environment as hostile or offensive. (B) Any use or condonation, by any person in a supervisory or command position, of any form of sexual behavior to control, influence, or affect the career, pay, or job of a subordinate. (C) Any deliberate or repeated unwelcome verbal comment or gesture of a sexual nature by any fellow employee of the complainant. (2) Sexual assault The term sexual assault means any form of abuse or contact as defined in chapter 109A of title 18. (e) Regulations The Secretary of the department in which the Coast Guard is operating may issue further regulations as necessary to update the definitions in this section, consistent with descriptions of sexual harassment and sexual assault addressed in titles 10 and title 18 to implement this section. . (c) Clerical amendment The chapter analysis of chapter 77 of title 46, United States Code, is amended by inserting after the item relating to section 7704 the following: 7704a. Sexual harassment or sexual assault as grounds for suspension or revocation. . (d) Supporting the united states merchant marine academy (1) In general Chapter 513 of title 46, United States Code, is amended by adding at the end the following: 51325. Sexual assault and sexual harassment prevention information management system (a) Information management system (1) In general Not later than January 1, 2023, the Maritime Administrator shall establish an information management system to track and maintain, in such a manner that patterns can be reasonably identified, information regarding claims and incidents involving cadets that are reportable pursuant to subsection (d) of section 51318 of this chapter. (2) Information maintained in the system Information maintained in the system shall include the following information, to the extent that information is available: (A) The overall number of sexual assault or sexual harassment incidents per fiscal year. (B) The location of each such incident, including vessel name and the name of the company operating the vessel, if applicable. (C) The names and ranks of the individuals involved in each such incident. (D) The general nature of each such incident, to include copies of any associated reports completed on the incidents. (E) The type of inquiry made into each such incident. (F) A determination as to whether each such incident is substantiated. (G) Any informal and formal accountability measures taken for misconduct related to the incident, including decisions on whether to prosecute the case. (3) Past information included The information management system under this section shall include the relevant data listed in this subsection related to sexual assault and sexual harassment that the Maritime Administrator possesses, and shall not be limited to data collected after January 1, 2023. (4) Privacy protections The Maritime Administrator and the Department of Transportation Chief Information Officer shall coordinate to ensure that the information management system under this section shall be established and maintained in a secure fashion to ensure the protection of the privacy of any individuals whose information is entered in such system. (5) Cybersecurity audit Ninety days after the implementation of the information management system, the Office of Inspector General of the Department of Transportation shall commence an audit of the cybersecurity of the system and shall submit a report containing the results of that audit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives. (6) Correcting records In establishing the information management system, the Maritime Administrator shall create a process to ensure that if any incident report results in a final agency action or final judgement that acquits an individual of wrongdoing, all personally identifiable information about the acquitted individual is removed from that incident report in the system. (b) Sea year program The Maritime Administrator shall provide for the establishment of in-person and virtual confidential exit interviews, to be conducted by personnel who are not involved in the assignment of the midshipmen to a Sea Year vessel, for midshipmen from the Academy upon completion of Sea Year and following completion by the midshipmen of the survey under section 51322(d). (c) Data-Informed decisionmaking The data maintained in the data management system under subsection (a) and through the exit interviews under subsection (b) shall be affirmatively referenced and used to inform the creation of new policy or regulation, or changes to any existing policy or regulation, in the areas of sexual harassment, dating violence, domestic violence, sexual assault, and stalking. 51326. Student advisory board at the United States Merchant Marine Academy (a) In general The Maritime Administrator shall establish at the United States Merchant Marine Academy an advisory board to be known as the Advisory Board to the Secretary of Transportation (referred to in this section as the Advisory Board ). (b) Membership The Advisory Board shall be composed of not fewer than 12 midshipmen of the Merchant Marine Academy who are enrolled at the Merchant Marine Academy at the time of the appointment, including not fewer than 3 cadets from each class. (c) Appointment; term Midshipmen shall serve on the Advisory Board pursuant to appointment by the Maritime Administrator. Appointments shall be made not later than 60 days after the date of the swearing in of a new class of midshipmen at the Academy. The term of membership of a midshipmen on the Advisory Board shall be 1 academic year. (d) Reappointment The Maritime Administrator may reappoint not more than 6 cadets from the previous term to serve on the Advisory Board for an additional academic year if the Maritime Administrator determines such reappointment to be in the best interests of the Merchant Marine Academy. (e) Meetings The Advisory Board shall meet with the Secretary of Transportation not less than once each academic year to discuss the activities of the Advisory Board. The Advisory Board shall meet in person with the Maritime Administrator not less than 2 times each academic year to discuss the activities of the Advisory Board. (f) Duties The Advisory Board shall— (1) identify health and wellbeing, diversity, and sexual assault and harassment challenges and other topics considered important by the Advisory Board facing midshipmen at the Merchant Marine Academy, off campus, and while aboard ships during Sea Year or other training opportunities; (2) discuss and propose possible solutions, including improvements to culture and leadership development at the Merchant Marine Academy; and (3) periodically review the efficacy of the program in section 51325(b), as appropriate, and provide recommendations to the Maritime Administrator for improvement. (g) Working groups The Advisory Board may establish one or more working groups to assist the Advisory Board in carrying out its duties, including working groups composed in part of midshipmen at the Merchant Marine Academy who are not current members of the Advisory Board. (h) Reports and briefings The Advisory Board shall regularly provide the Secretary of Transportation and the Maritime Administrator reports and briefings on the results of its duties, including recommendations for actions to be taken in light of such results. Such reports and briefings may be provided in writing, in person, or both. 51327. Sexual Assault Advisory Council (a) Establishment The Secretary of Transportation shall establish a Sexual Assault Advisory Council (in this section referred to as the Council ). (b) Membership (1) In general The Council shall be composed of not fewer than 8 and not more than 14 individuals selected by the Secretary of Transportation who are alumni that have graduated within the last 4 years or current midshipmen of the United States Merchant Marine Academy (including midshipmen or alumni who were victims of sexual assault and midshipmen or alumni who were not victims of sexual assault) and governmental and nongovernmental experts and professionals in the sexual assault field. (2) Experts included The Council shall include— (A) not less than 1 member who is licensed in the field of mental health and has prior experience working as a counselor or therapist providing mental health care to survivors of sexual assault in a victim services agency or organization; and (B) not less than 1 member who has prior experience developing or implementing sexual assault or sexual harassment prevention and response policies in an academic setting. (3) Rules regarding membership No employee of the Department of Transportation shall be a member of the Council. The number of governmental experts appointed to the Council shall not exceed the number of nongovernmental experts. (c) Duties; authorized activities (1) In general The Council shall meet not less often than semiannually to— (A) review— (i) the policies on sexual harassment, dating violence, domestic violence, sexual assault, and stalking under section 51318 of this title; (ii) the trends and patterns of data contained in the system described under section 51325 of this title; and (iii) related matters the Council views as appropriate; and (B) develop recommendations designed to ensure that such policies and such matters conform, to the extent practicable, to best practices in the field of sexual assault and sexual harassment response and prevention. (2) Authorized activities To carry out this subsection, the Council may— (A) conduct case reviews, as appropriate and only with the consent of the victim of sexual assault or harassment; (B) interview current and former midshipmen of the United States Merchant Marine Academy (to the extent that such midshipmen provide the Department of Transportation express consent to be interviewed by the Council); and (C) review— (i) exit interviews under section 51325(b) and surveys under section 51322(d); (ii) data collected from restricted reporting; and (iii) any other information necessary to conduct such case reviews. (3) Personally identifiable information In carrying out this subsection, the Council shall comply with the obligations of the Department of Transportation to protect personally identifiable information. (d) Reports On an annual basis for each of the 5 years after the date of enactment of this section, and at the discretion of the Council thereafter, the Council shall submit, to the President and the Committee on Commerce, Science, and Transportation and the Committee on Appropriations of the Senate and the Committee on Transportation and Infrastructure and the Committee on Appropriations of the House of Representatives, a report on the Council’s findings based on the reviews conducted pursuant to subsection (c) and related recommendations. (e) Employee status Members of the Council shall not be considered employees of the United States Government for any purpose and shall not receive compensation other than reimbursement of travel expenses and per diem allowance in accordance with section 5703 of title 5. (f) Nonapplicability of FACA The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the Council. 51328. Student support The Maritime Administrator shall— (1) require a biannual survey of midshipmen, faculty, and staff of the Academy assessing the inclusiveness of the environment of the Academy; and (2) require an annual survey of faculty and staff of the Academy assessing the inclusiveness of the environment of the Sea Year program. . (e) Report to Congress Not later than 30 days after the date of enactment of this section, the Maritime Administrator shall provide Congress with a briefing on the resources necessary to properly implement section 51328 of title 46, United States Code, as added by this section. (f) Conforming amendments The chapter analysis for chapter 513 of title 46, United States Code, is amended by adding at the end the following: 51325. Sexual assault and sexual harassment prevention information management system. 51326. Student advisory board at the United States Merchant Marine Academy. 51327. Sexual Assault Advisory Council. 51328. Student support. . (g) United states merchant marine academy student support plan (1) Student support plan Not later than January 1, 2023, the Maritime Administrator shall issue a Student Support Plan for the United States Merchant Marine Academy, in consultation with relevant mental health professionals in the Federal Government or experienced with the maritime industry or related industries. Such plan shall— (A) address the mental health resources available to midshipmen, both on-campus and during Sea Year; (B) establish a tracking system for suicidal ideations and suicide attempts of midshipmen; (C) create an option for midshipmen to obtain assistance from a professional care provider virtually; and (D) require an annual survey of faculty and staff assessing the adequacy of mental health resources for midshipmen of the Academy, both on campus and during Sea Year. (2) Report to congress Not later than 30 days after the date of enactment of this section, the Maritime Administrator shall provide Congress with a report on the resources necessary to properly implement this subsection. (h) Special victims advisor Section 51319 of title 46, United States Code, is amended— (1) by redesignating subsection (c) as subsection (d); (2) by inserting after subsection (b) the following: (c) Special victims advisor (1) In general The Secretary shall designate an attorney (to be known as the Special Victims Advisor ) for the purpose of providing legal assistance to any cadet of the Academy who is the victim of an alleged sex-related offense regarding administrative and criminal proceedings related to such offense, regardless of whether the report of that offense is restricted or unrestricted. (2) Special victims advisory The Secretary shall ensure that the attorney designated as the Special Victims Advisor has knowledge of the Uniform Code of Military Justice, as well as criminal and civil law. (3) Privileged communications Any communications between a victim of an alleged sex-related offense and the Special Victim Advisor, when acting in their capacity as such, shall have the same protection that applicable law provides for confidential attorney-client communications. ; and (3) by adding at the end the following: (e) Unfilled vacancies The Administrator of the Maritime Administration may appoint qualified candidates to positions under subsections (a) and (d) of this section without regard to sections 3309 through 3319 of title 5. . (i) Catch a serial offender assessment (1) Assessment Not later than one year after the date of enactment of this section, the Commandant of the Coast Guard, in coordination with the Maritime Administrator, shall conduct an assessment of the feasibility and process necessary, and appropriate responsible entities to establish a program for the United States Merchant Marine Academy and United States Merchant Marine modeled on the Catch a Serial Offender program of the Department of Defense using the information management system required under subsection (a) of section 51325 of title 46, United States Code, and the exit interviews under subsection (b) of such section. (2) Legislative change proposals If, as a result of the assessment required by paragraph (1), the Commandant or the Administrator determines that additional authority is necessary to implement the program described in paragraph (1), the Commandant or the Administrator, as applicable, shall provide appropriate legislative change proposals to Congress. (j) Shipboard training Section 51322(a) of title 46, United States Code, is amended by adding at the end the following: (3) Training (A) In general As part of training that shall be provided not less than semiannually to all midshipmen of the Academy, pursuant to section 51318, the Maritime Administrator shall develop and implement comprehensive in-person sexual assault risk-reduction and response training that, to the extent practicable, conforms to best practices in the sexual assault prevention and response field and includes appropriate scenario-based training. (B) Development and consultation with experts In developing the sexual assault risk-reduction and response training under subparagraph (A), the Maritime Administrator shall consult with and incorporate, as appropriate, the recommendations and views of experts in the sexual assault field. . 305. Board of Visitors Section 51312 of title 46, United States Code, is amended— (1) in subsection (b)— (A) in paragraph (2)— (i) by redesignating subparagraph (C) as subparagraph (D); (ii) in subparagraph (D), as redesignated by clause (i), by striking flag-rank who and inserting flag-rank ; (iii) in subparagraph (B), by striking and after the semicolon; and (iv) by inserting after subparagraph (B) the following: (C) at least 1 shall be a representative of a maritime labor organization; and ; and (B) in paragraph (3), by adding at the end the following: (C) Replacement If a member of the Board is replaced, not later than 60 days after the date of the replacement, the Designated Federal Officer selected under subsection (g)(2) shall notify that member. ; (2) in subsection (d)— (A) in paragraph (1), by inserting and 2 additional meetings, which may be held in person or virtually after Academy ; and (B) by adding at the end the following: (3) Scheduling; notification When scheduling a meeting, the Designated Federal Officer shall coordinate, to the greatest extent practicable, with the members of the Board to determine the date and time of the meeting. Members of the Board shall be notified of the date of each meeting not less than 30 days prior to the meeting date. ; (3) in subsection (e), by adding at the end the following: (4) Staff One of more staff of each member of the Board may accompany them on Academy visits. (5) Scheduling; notification When scheduling a visit to the Academy, the Designated Federal Officer shall coordinate, to the greatest extent practicable, with the members of the Board to determine the date and time of the visit. Members of the Board shall be notified of the date of each visit not less than 30 days prior to the visit date. ; and (4) in subsection (h)— (A) by inserting and ranking member after chairman each place the term appears; and (B) by adding at the end the following: Such staff may attend meetings and may visit the Academy. . 306. Maritime Technical Advancement Act (a) Short title This section may be cited as the Maritime Technological Advancement Act of 2022 . (b) Centers of excellence for domestic maritime workforce Section 51706 of title 46, United States Code, is amended— (1) in subsection (a), by striking of Transportation ; (2) in subsection (b), in the subsection heading, by striking Assistance and inserting Cooperative agreements ; (3) by redesignating subsection (c) as subsection (d); (4) in subsection (d), as redesignated by paragraph (2), by adding at the end the following: (3) Secretary The term Secretary means the Secretary of Transportation. ; and (5) by inserting after subsection (b) the following: (c) Grant program (1) Definitions In this subsection: (A) Administrator The term Administrator means the Administrator of the Maritime Administration. (B) Eligible institution The term eligible institution means an institution that has a demonstrated record of success in training and is— (i) a postsecondary educational institution (as defined in section 3 of the Carl D. Perkins Career and Technical Education Act of 2006 ( 20 U.S.C. 2302 )) that offers a 2-year program of study or a 1-year program of training; (ii) a postsecondary vocational institution (as defined under section 102(c) of the Higher Education Act of 1965 ( 20 U.S.C. 1002(c) )); (iii) a public or private nonprofit entity that offers 1 or more other structured experiential learning training programs for American workers in the United States maritime industry, including a program that is offered by a labor organization or conducted in partnership with a nonprofit organization or 1 or more employers in the maritime industry; or (iv) an entity sponsoring a registered apprenticeship program. (C) Registered apprenticeship program The term registered apprenticeship program means an apprenticeship program registered with the Office of Apprenticeship of the Employment and Training Administration of the Department of Labor or a State apprenticeship agency recognized by the Office of Apprenticeship pursuant to the Act of August 16, 1937 (commonly known as the National Apprenticeship Act ; 50 Stat. 664, chapter 663; 29 U.S.C. 50 et seq. ). (D) United States maritime industry The term United States maritime industry means all segments of the maritime-related transportation system of the United States, both in domestic and foreign trade, and in coastal, offshore, and inland waters, as well as non-commercial maritime activities, such as pleasure boating and marine sciences (including all scientific research vessels), and all of the industries that support or depend upon such uses, including vessel construction and repair, vessel operations, ship logistics supply, berthing, port operations, port intermodal operations, marine terminal operations, vessel design, marine brokerage, marine insurance, marine financing, chartering, maritime-oriented supply chain operations, offshore industry, offshore wind, and maritime-oriented research and development. (2) Grant authorization (A) In general Not later than 1 year after the date of enactment of the Maritime Technological Advancement Act of 2022 , the Administrator may award maritime career training grants to eligible institutions for the purpose of developing, offering, or improving educational or career training programs for American workers related to the maritime workforce. (B) Guidelines Not later than 1 year after the date of enactment of the Maritime Technological Advancement Act of 2022 , the Administrator shall— (i) promulgate guidelines for the submission of grant proposals under this subsection; and (ii) publish and maintain such guidelines on the website of the Maritime Administration. (3) Limitations The Administrator may not award a grant under this subsection in an amount that is more than $12,000,000. (4) Required information (A) In general An eligible institution that desires to receive a grant under this subsection shall submit to the Administrator a grant proposal that includes a detailed description of— (i) the specific project for which the grant proposal is submitted, including the manner in which the grant will be used to develop, offer, or improve an educational or career training program that is suited to maritime industry workers; (ii) the extent to which the project for which the grant proposal is submitted will meet the educational or career training needs of maritime workers in the community served by the eligible institution, particularly any individuals with a barrier to employment; (iii) the extent to which the project for which the grant proposal is submitted fits within any overall strategic plan developed by an eligible community; and (iv) any previous experience of the eligible institution in providing maritime educational or career training programs. (B) Community outreach required In order to be considered by the Administrator, a grant proposal submitted by an eligible institution under this subsection shall— (i) demonstrate that the eligible institution— (I) reached out to employers to identify— (aa) any shortcomings in existing maritime educational and career training opportunities available to workers in the community; and (bb) any future employment opportunities within the community and the educational and career training skills required for workers to meet the future maritime employment demand; and (II) reached out to other similarly situated institutions in an effort to benefit from any best practices that may be shared with respect to providing maritime educational or career training programs to workers eligible for training; and (ii) include a detailed description of— (I) the extent and outcome of the outreach conducted under clause (i); (II) the extent to which the project for which the grant proposal is submitted will contribute to meeting any shortcomings identified under clause (i)(I)(aa) or any maritime educational or career training needs identified under clause (i)(I)(bb); and (III) the extent to which employers, including small- and medium-sized firms within the community, have demonstrated a commitment to employing workers who would benefit from the project for which the grant proposal is submitted. (5) Criteria for award of grants (A) In general Subject to the appropriation of funds, the Administrator shall award a grant under this subsection based on— (i) a determination of the merits of the grant proposal submitted by the eligible institution to develop, offer, or improve maritime educational or career training programs to be made available to workers; (ii) an evaluation of the likely employment opportunities available to workers who complete a maritime educational or career training program that the eligible institution proposes to develop, offer, or improve; (iii) an evaluation of prior demand for training programs by workers in the community served by the eligible institution, as well as the availability and capacity of existing maritime training programs to meet future demand for training programs; (iv) any prior designation of an institution as a Center of Excellence for Domestic Maritime Workforce Training and Education; and (v) an evaluation of the previous experience of the eligible institution in providing maritime educational or career training programs. (B) Matching requirements A grant awarded under this subsection may not be used to satisfy any private matching requirement under any other provision of law. (6) Competitive awards (A) In general The Administrator shall award grants under this subsection to eligible institutions on a competitive basis in accordance with guidelines and requirements established by the Administrator under paragraph (2)(B). (B) Timing of grant notice The Administrator shall post a Notice of Funding Opportunity regarding grants awarded under this subsection not more than 90 days after the date of enactment of the appropriations Act for the fiscal year concerned. (C) Timing of grants The Administrator shall award grants under this subsection not later than 270 days after the date of the enactment of the appropriations Act for the fiscal year concerned. (D) Application of requirements The requirements under subparagraphs (B) and (C) shall not apply until the guidelines required under paragraph (2)(B) have been promulgated. (E) Reuse of unexpended grant funds Notwithstanding subparagraph (C), amounts awarded as a grant under this subsection that are not expended by the grantee shall remain available to the Administrator for use for grants under this subsection. (F) Administrative costs Not more than 3 percent of amounts made available to carry out this subsection may be used for the necessary costs of grant administration. (7) Eligible uses of grant funds An eligible institution receiving a grant under this subsection— (A) shall carry out activities that are identified as priorities for the purpose of developing, offering, or improving educational or career training programs for the United States maritime industry workforce; (B) shall provide training to upgrade the skills of the United States maritime industry workforce, including training to acquire covered requirements as well as technical skills training for jobs in the United States maritime industry; and (C) may use the grant funds to— (i) admit additional students to maritime training programs; (ii) develop, establish, and annually update viable training capacity, courses, and mechanisms to rapidly upgrade skills and perform assessments of merchant mariners during time of war or a national emergency, and to increase credentials for domestic or defense needs where training can decrease the gap in the numbers of qualified mariners for sealift; (iii) provide services to upgrade the skills of United States offshore wind marine service workers who transport, install, operate, or maintain offshore wind components and turbines, including training, curriculum and career pathway development, on-the-job training, safety and health training, and classroom training; (iv) expand existing or create new maritime training programs, including through partnerships and memoranda of understanding with— (I) 4-year institutions of higher education; (II) labor organizations; (III) registered apprenticeship programs with the United States maritime industry; or (IV) an entity described in subclause (I) through (III) that has a memorandum of understanding with 1 or more employers in the maritime industry; (v) create new maritime career pathways; (vi) expand existing or create new training programs for transitioning military veterans to careers in the United States maritime industry; (vii) expand existing or create new training programs that address the needs of individuals with a barrier to employment, as determined by the Secretary in consultation with the Secretary of Labor, in the United States maritime industry; (viii) purchase, construct, develop, expand, or improve training facilities, buildings, and equipment to deliver maritime training programs; (ix) recruit and train additional faculty to expand the maritime training programs offered by the institution; (x) provide financial assistance through scholarships or tuition waivers, not to exceed the applicable tuition expenses associated with the covered programs; (xi) promote the use of distance learning that enables students to take courses through the use of teleconferencing, the Internet, and other media technology; (xii) assist in providing services to address maritime workforce recruitment and training of youth residing in targeted high-poverty areas within empowerment zones and enterprise communities; (xiii) implement partnerships with national and regional organizations with special expertise in developing, organizing, and administering maritime workforce recruitment and training services; (xiv) carry out customized training in conjunction with— (I) an existing registered apprenticeship program or a pre-apprenticeship program that articulates to a registered apprenticeship program; (II) a paid internship; or (III) a joint labor-management partnership; (xv) design, develop, and test an array of approaches to providing recruitment, training, or retention services, to enhance diversity, equity and inclusion in the United States maritime industry workforce; (xvi) in conjunction with employers, organized labor, other groups (such as community coalitions), and Federal, State, or local agencies, design, develop, and test various training approaches in order to determine effective practices; or (xvii) assist in the development and replication of effective service delivery strategies for the United States maritime industry as a whole. (8) Public report Not later than December 15 in each of the calendar years 2023 through 2025, the Administrator shall make available on a publicly available website a report and provide a briefing to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives— (A) describing each grant awarded under this subsection during the preceding fiscal year; (B) assessing the impact of each award of a grant under this subsection in a fiscal year preceding the fiscal year referred to in subparagraph (A) on workers receiving training; and (C) the performance of the grant awarded with respect to the indicators of performance under section 116(b)(2)(A)(i) of the Workforce Innovation and Opportunity Act ( 29 U.S.C. 3141(b)(2)(A)(i) ). (9) Authorization of appropriations There is authorized to be appropriated to carry out this subsection $60,000,000 for each of the fiscal years 2023 through 2027. . 307. Study on CIP program at the USMMA (a) Findings Congress finds the following: (1) The United States Merchant Marine Academy campus is nearly 80 years old and many of the buildings have fallen into a serious state of disrepair. (2) Except for renovations to student barracks in the early 2000s, all of the buildings on campus have exceeded their useful life and need to be replaced or undergo major renovations. (3) According to the Maritime Administration, since 2011, $234,000,000 has been invested in capital improvements on the campus, but partly due to poor planning and cost overruns, maintenance and building replacement backlogs continue. (b) Study The Comptroller General shall conduct a study of the United States Merchant Marine Academy Capital Improvement Program. The study shall include an evaluation of— (1) the actions the United States Merchant Marine Academy has taken to bring the buildings, infrastructure, and other facilities on campus up to standards and the further actions that are required to do so; (2) how the approach that the United States Merchant Marine Academy uses to manage its capital assets meets leading practices; (3) how cost estimates prepared for capital asset projects meet cost estimating leading practices; (4) whether the United States Merchant Marine Academy has adequate staff who are trained to identify needed capital projects, estimate the cost of those projects, perform building maintenance, and manage capital improvement projects; and (5) how the United States Merchant Marine Academy identifies and prioritizes capital construction needs, and how that priority relates to the safety, education, and wellbeing of midshipmen. (c) Report Not later than 18 months after the date of enactment of this section, the Comptroller General shall prepare and submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report containing the results of the study under this section. 308. Implementation of recommendations from the National Academy of Public Administration (a) Inspector General audit The Inspector General of the Department of Transportation shall— (1) not later than 180 days after the date of enactment of this section, initiate an audit of the Maritime Administration’s actions to address only recommendations 4.1 through 4.3, 4.7 through 4.11, 5.1 through 5.4, 5.6, 5.7, 5.11, 5.14, 5.15, 5.16, 6.1 through 6.4, 6.6, and 6.7, identified by a National Academy of Public Administration panel in the November 2021 report entitled Organizational Assessment of the United States Merchant Marine Academy: A Path Forward ; and (2) release publicly, and submit to the appropriate committees of Congress, a report containing the results of the audit described in paragraph (1) once the audit is completed. (b) Agreement for study by national academy of public administration (1) In general Not later than 30 days after the date of enactment of this Act, the Secretary of Transportation shall enter into an agreement with the National Academy of Public Administration (referred to in this section as the Academy ) to provide support for— (A) prioritizing and addressing the recommendations described in subsection (a)(1), and establishing a process for prioritizing other recommendations in the future; (B) development of long-term processes and a timeframe for long-term process improvements, as well as corrective actions and best practice criteria that can be implemented in the medium- and near-term; (C) establishment of a clear assignment of responsibility for implementation of each recommendation described in subsection (a)(1), and a strategy for assigning other recommendations in the future; and (D) a performance measurement system, including data collection and tracking and evaluating progress toward goals. (2) Report of progress Not later than 1 year after the date of the agreement described in paragraph (1), the Academy shall prepare and submit a report of progress to the Maritime Administrator and the appropriate committees of Congress. (c) Prioritization and implementation plan (1) In general Not later than 1 year after the date of enactment of this Act, the Maritime Administrator shall provide a prioritization and implementation plan to assess, prioritize, and address the recommendations identified by the National Academy of Public Administration panel in the November 2021 report entitled Organizational Assessment of the United States Merchant Marine Academy: A Path Forward that are relevant to the Maritime Administration and not listed in subsection (a)(1). The prioritization and implementation plan shall— (A) make use of the strategies, processes, and systems described in subsection (b)(1); (B) include estimated timelines and cost estimates for implementation of priority goals; (C) include summaries of stakeholder and interagency engagement used to assess goals and timelines; and (D) be released publicly and submitted to the appropriate committees of Congress. (2) Audit and report The Inspector General of the Department of Transportation shall— (A) not later than 180 days after the date of publication of the prioritization and implementation plan described in paragraph (1), initiate an audit of the Maritime Administration’s actions to address the prioritization and implementation plan; (B) not later than 2 years after the date of publication of the prioritization and implementation plan, and every 3 years thereafter, initiate an audit of the Maritime Administration’s progress on the plan; and (C) release publicly and submit to the appropriate committees of Congress a report containing the results of the audit once the audit is completed. (d) Agreement for plan on capital improvements Not later than 90 days after the date of enactment of this Act, the Maritime Administration shall enter into an agreement with a Federal construction agent to create a plan to execute capital improvements at the United States Merchant Marine Academy. (e) Appropriate committees of Congress defined In this section, the term appropriate committees of Congress means the Committee on Commerce, Science, and Transportation of the Senate, the Committee on Transportation and Infrastructure of the House of Representatives, the Appropriations Subcommittees on Transportation, Housing and Urban Development, and Related Agencies of the Senate and the House of Representatives, and the Committees on Armed Services of the Senate and the House of Representatives. 309. Service Academy faculty parity Section 105 of title 17, United States Code, is amended— (1) in the heading of subsection (b), by deleting Certain of Works and inserting Certain Works ; (2) in the first subsection (c), by deleting The Secretary of Defense may and inserting The Secretary of Defense (or, with respect to the United States Merchant Marine Academy, the Secretary of Transportation, or, with respect to the United States Coast Guard Academy, the Secretary of Homeland Security) may ; (3) by redesignating the second subsection (c) as subsection (d); and (4) in subsection (d), as redesignated by paragraph (3), by adding at the end the following: (M) United States Merchant Marine Academy. . 310. Updated Requirements for Fishing Crew Agreements Section 10601(b) of title 46, United States Code, is amended— (1) in paragraph (2), by striking and after the semicolon; (2) by redesignating paragraph (3) as paragraph (4); and (3) by inserting after paragraph (2) the following: (3) if the vessel is a catcher processor with more than 25 crew, require that the crewmember be served not less than 3 meals a day that total not less than 3,100 calories, including adequate water and minerals in accordance with the Untied States Recommended Daily Allowances; and . IV Technology innovation and resilience 401. Maritime Environmental and Technical Assistance Program Section 50307 of title 46, United States Code, is amended— (1) by striking the subsection (a) enumerator and all that follows through Transportation and inserting the following: (a) Emerging Marine Technologies and Practices (1) In General The Secretary of Transportation ; (2) in subsection (b)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively and adjusting the margins accordingly; and (ii) in clause (iv), as redesignated by clause (i), by striking propeller cavitation and inserting incidental vessel-generated underwater noise, such as noise from propeller cavitation or hydrodynamic flow ; and (B) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively and adjusting the margins accordingly; (3) in subsection (c), by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively and adjusting the margins accordingly; (4) in subsection (e), by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively and adjusting the margins accordingly; (5) by redesignating subsections (b) through (d) as paragraphs (2) through (4), respectively and adjusting the margins accordingly; (6) by redesignating subsection (e) as subsection (b); (7) by striking subsection (f); (8) in subsection (a)— (A) in paragraph (1), as designated under paragraph (1) of this section— (i) by inserting or support after engage in ; and (ii) by striking the use of public and all that follows through the end of the sentence and inserting eligible entities. ; (B) in paragraph (2), as redesignated under paragraph (5) of this section— (i) by striking this section and inserting this subsection ; and (ii) by striking or improve and inserting improve, or support efforts related to, ; (C) in paragraph (3), as redesignated by paragraph (5) of this section, by striking under subsection (b)(2) may include and inserting with other Federal agencies or with State, local, or Tribal governments, as appropriate, under paragraph (2)(B) may include ; (D) in paragraph (4), as redesignated by paragraph (5) of this section— (i) by striking academic, public, private, and nongovernmental entities and facilities and inserting eligible entities; and (ii) by striking subsection (a) and inserting this subsection ; and (E) by adding at the end the following: (5) Grants Subject to the availability of appropriations, the Maritime Administrator, may establish and carry out a competitive grant program to award grants to eligible entities for projects in the United States consistent with the goals of this subsection to study, evaluate, test, demonstrate, or apply technologies and practices to improve environmental performance. ; (9) in subsection (b), as redesignated by paragraph (6) of this section, by striking subsection (b)(1) and inserting this section ; and (10) by adding at the end the following: (c) Vessels Activities carried out under a grant or cooperative agreement made under this section may be conducted on public vessels under the control of the Maritime Administration, upon approval of the Maritime Administrator. (d) Eligible entity defined In this section, the term eligible entity means— (1) a private entity, including a nonprofit organization; (2) a State, regional, local, or Tribal government or entity, including special districts; (3) an institution of higher education as defined under section 102 of the Higher Education Act of 1965 ( 20 U.S.C. 1002 ); and (4) a partnership or collaboration of entities described in paragraphs (1) through (3). (e) Center for Maritime Innovation (1) In general Not later than 1 year after the date of enactment of the Maritime Administration Authorization Act for Fiscal Year 2023 , the Secretary of Transportation shall, through a cooperative agreement, establish a United States Center for Maritime Innovation (referred to in this subsection as the Center ) to support the study, research, development, assessment, and deployment of emerging marine technologies and practices related to the maritime transportation system. (2) Selection The Center shall be— (A) selected through a competitive process; (B) a nonprofit organization based in the United States with technical expertise in emerging marine technologies and practices related to the maritime transportation system; and (C) located in close proximity to eligible entities with expertise in United States emerging marine technologies and practices, including the use of alternative fuels and the development of both vessel and shoreside infrastructure. (3) Coordination The Secretary of Transportation shall coordinate with other agencies critical for science, research, and regulation of emerging marine technologies for the maritime sector, including the Department of Energy, the Environmental Protection Agency, and the Coast Guard, when establishing the Center. (4) Functions The Center shall— (A) support eligible entities regarding the development and use of clean energy and necessary infrastructure to support the deployment of clean energy on vessels of the United States; (B) monitor and assess, on an ongoing basis, the current state of knowledge regarding emerging marine technologies in the United States; (C) identify any significant gaps in emerging marine technologies research specific to the United States maritime industry, and seek to fill those gaps; (D) conduct research, development, testing, and evaluation for equipment, technologies, and techniques to address the components under subsection (a)(2); (E) provide— (i) guidance on best available technologies; (ii) technical analysis; (iii) assistance with understanding complex regulatory requirements; and (iv) documentation of best practices in the maritime industry, including training and informational webinars on solutions for the maritime industry; and (F) work with academic and private sector response training centers to develop maritime strategies applicable to various segments of the United States maritime industry, including the inland, deep water, and coastal fleets. . 402. Quieting Federal non-combative vessels (a) In general The Secretary of Defense, in consultation with the Administrator of the National Oceanic and Atmospheric Administration, the Administrator of the Maritime Administration, and the Secretary of the department in which the Coast Guard is operating, shall, not later than 18 months after the date of enactment of this section, submit a report to the committees identified under subsection (b) and publish an unclassified report— (1) identifying existing, at the time of submission, non-classified naval technologies that reduce underwater noise; and (2) evaluating the effectiveness and feasibility of incorporating such technologies in the design, procurement, and construction of non-combatant vessels of the United States. (b) Committees The report under subsection (a) shall be submitted the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives. (c) Authorization of appropriations There is authorized to be appropriated to the Secretary of Defense for carrying out this section, $100,000 for fiscal year 2022, to remain available until expended. 403. Study on stormwater impacts on salmon (a) In general Not later than 90 days after the date of enactment of this section, the Administrator of the National Oceanic and Atmospheric Administration, in concert with the Secretary of Transportation and the Administrator of the Environmental Protection Agency, shall commence a study that— (1) examines the existing science on tire-related chemicals in stormwater runoff at ports and associated transportation infrastructure and the impacts of such chemicals on Pacific salmon and steelhead; (2) examines the challenges of studying tire-related chemicals in stormwater runoff at ports and associated transportation infrastructure and the impacts of such chemicals on Pacific salmon and steelhead; (3) provides recommendations for improving monitoring of stormwater and research related to run-off for tire-related chemicals and the impacts of such chemicals on Pacific salmon and steelhead at ports and associated transportation infrastructure near ports; and (4) provides recommendations based on the best available science on relevant management approaches at ports and associated transportation infrastructure under their respective jurisdictions. (b) Submission of study Not later than 18 months after commencing the study under subsection (a), the Administrator of the National Oceanic and Atmospheric Administration, in concert with the Secretary of Transportation and the Administrator of the Environmental Protection Agency, shall— (1) submit the study to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives, including detailing any findings from the study; and (2) make such study publicly available. | https://www.govinfo.gov/content/pkg/BILLS-117s4357is/xml/BILLS-117s4357is.xml |
117-s-4358 | II 117th CONGRESS 2d Session S. 4358 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Ms. Murkowski (for herself, Mrs. Feinstein , Ms. Hassan , and Mr. Sullivan ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs, and to provide community-based coalition enhancement grants to mitigate the effects of drug misuse.
1. Short title This Act may be cited as the Bruce's Law . 2. Awareness campaigns (a) Opioid program Section 102 of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended— (1) in the section heading, by inserting relating to opioids after campaigns ; and (2) in subsection (c)— (A) in paragraph (1), by inserting and after the semicolon; (B) in paragraph (2)(B), by striking ; and and inserting a period; and (C) by striking paragraph (3). (b) Additional campaign Title I of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended by inserting after section 102 the following: 102A. Awareness campaign related to lethality of fentanyl and fentanyl-contaminated drugs (a) In general The Secretary of Health and Human Services, in coordination with the heads of other Federal departments and agencies, shall, as appropriate, through a public awareness campaign, advance the education and awareness of the public (including school-aged children, youth, parents, first responders, and providers) and other appropriate entities regarding the risk of counterfeit drugs being contaminated with fentanyl and the dangers of fentanyl lethality. (b) Topics The education and awareness campaigns under subsection (a) shall address— (1) the dangers of using drugs which may be contaminated with fentanyl; (2) the prevention of drug abuse, including through safe disposal of prescription medications and other safety precautions; and (3) the detection of early warning signs of addiction in school-aged children and youth. (c) Other requirements The education and awareness campaigns under subsection (a) shall, as appropriate, take into account any association between prescription drug misuse, heroin use, and drugs contaminated by fentanyl. (d) Drug defined In this section, the term drug means an illicit drug, such as marijuana, hashish, cocaine (including crack cocaine), inhalants, hallucinogens, heroin, a synthetic opioid, methamphetamine or other stimulant, a counterfeit prescription drug, or a prescription drug that is sold illegally. (e) Authorization of appropriations There are authorized to be appropriated for fiscal years 2023 through 2027 such sums as may be necessary to carry out this section. . 3. Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs Title I of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ), as amended by section 2(b), is further amended by inserting after section 102A the following: 102B. Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs (a) Establishment The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall establish the Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs (referred to in this section as the Work Group ). (b) Membership; consultation (1) Composition Not later than 120 days after the date of enactment of Bruce's Law , the heads of the Office of National Drug Control Policy, the Substance Abuse and Mental Health Services Administration, the Administration for Children and Families, the Centers for Disease Control and Prevention, the Department of Justice, the Drug Enforcement Administration, the Department of State, the Department of Education, and other Federal agencies (as determined by the Secretary) shall designate representatives of the respective agency or office to the Work Group. (2) Consultation The Work Group shall consult with— (A) experts at the State, Tribal, and local levels with relevant backgrounds in reducing, preventing, and responding to drug overdose by fentanyl contamination of illegal drugs; (B) family members of adults who have overdosed by fentanyl-contaminated illegal drugs; (C) family members of school-aged children and youth who have overdosed by fentanyl-contaminated illegal drugs; (D) researchers and other experts in the design and implementation of effective drug-related messaging and prevention campaigns; and (E) technology companies. (c) Duties The Work Group shall— (1) examine all Federal efforts directed towards reducing and preventing drug overdose by fentanyl-contaminated illegal drugs; (2) identify strategies, resources, and supports to improve State, Tribal, and local responses to overdose by fentanyl-contaminated illegal drugs; (3) make recommendations to Congress for improving Federal programs and efforts and coordination across such programs and efforts to reduce and prevent drug overdose by fentanyl-contaminated illegal drugs; and (4) make recommendations for educating youth on the dangers of drugs contaminated by fentanyl. (d) Annual report to Secretary The Work Group shall annually prepare and submit to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Education and Labor of the House of Representatives, a report on the activities carried out by the Work Group under subsection (c), including recommendations to reduce and prevent drug overdose by fentanyl contamination of illegal drugs, in all populations, and specifically among youth at risk for substance misuse. . 4. Community-based coalition enhancement grants to address local drug crises Section 103(i) of the Comprehensive Addiction and Recovery Act of 2016 ( 21 U.S.C. 1536(i) ) is amended by striking 2017 through 2021 and inserting 2023 through 2027 . 5. Community-based coalition enhancement grants to educate youth on the risks of drugs contaminated with fentanyl or other synthetic opioids Title I of the Comprehensive Addiction and Recovery Act of 2016 ( Public Law 114–198 ) is amended by inserting after section 103 the following: 103A. Community-based coalition enhancement grants to educate youth on the risks of drugs contaminated with fentanyl or other synthetic opioids (a) Program authorized The Director of the Office of National Drug Control Policy (referred to in this section as the Director ), in coordination with the Director of the Centers for Disease Control and Prevention, may make grants to eligible entities to implement education of the public on the dangers of contamination of drugs with fentanyl or other synthetic opioids. (b) Application (1) In general An eligible entity seeking a grant under this section shall submit an application to the Director at such time, in such manner, and accompanied by such information as the Director may require. (2) Criteria As part of an application for a grant under this section, the Director shall require an eligible entity to submit a detailed, comprehensive, multisector plan for addressing the implementation of an evidence-based public education campaign on the dangers of drugs contaminated with fentanyl or other synthetic opioids, with a specific consideration given to education focused on youth at increased risk for developing a substance use disorder. (3) Eligible entities For purposes of this section, the term eligible entity means an entity that— (A) has documented, using local data, rates of drug overdose related to fentanyl or other synthetic opioids at levels that are significant, as determined by the Director; and (B) has received a grant under the Drug-Free Communities Act of 1997. (c) Use of funds An eligible entity shall use a grant received under this section— (1) for programs designed to implement comprehensive community-wide prevention strategies to address the dangers of drugs contaminated with fentanyl or other synthetic opioids, in the area served by the eligible entity, in accordance with the plan submitted under subsection (b)(2); (2) to obtain specialized training and technical assistance from the organization funded under section 4 of Public Law 107–82 ( 21 U.S.C. 1521 note); and (3) for programs designed to implement comprehensive community-wide strategies to address the dangers of drugs contaminated with fentanyl or other synthetic opioids in the community. (d) Supplement not supplant An eligible entity shall use Federal funds received under this section only to supplement the funds that would, in the absence of those Federal funds, be made available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds. (e) Evaluation A grant under this section shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a grant under the Drug-Free Communities Act of 1997, and may also include an evaluation of the effectiveness at reducing the use of illicit fentanyl or other synthetic opioids. (f) Limitation on administrative expenses Not more than 12 percent of the amounts made available to carry out this section for a fiscal year may be used to pay for administrative expenses. (g) Delegation authority The Director may enter into an interagency agreement with the Director of the Centers for Disease Control and Prevention to delegate authority for the execution of grants and for such other activities, as the Director determines necessary to carry out this section. (h) Definition In this section, the term drug means an illicit drug, such as marijuana, hashish, cocaine (including crack cocaine), inhalants, hallucinogens, heroin, a synthetic opioid, methamphetamine or other stimulant, a counterfeit prescription drug, or a prescription drug that is sold illegally. (i) Authorization of Appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2023 through 2027. . | https://www.govinfo.gov/content/pkg/BILLS-117s4358is/xml/BILLS-117s4358is.xml |
117-s-4359 | II 117th CONGRESS 2d Session S. 4359 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Ossoff (for himself, Mr. Blunt , Mr. Warnock , Mr. Tester , Mr. Moran , Mr. Schumer , Mr. McConnell , and Mr. Portman ) introduced the following bill; which was read twice and referred to the Committee on Veterans' Affairs A BILL To designate the regional office of the Department of Veterans Affairs in metropolitan Atlanta as the Senator Johnny Isakson Department of Veterans Affairs Atlanta Regional Office , and for other purposes.
1. Short title This Act may be cited as the Senator Johnny Isakson VA Regional Office Act of 2022 . 2. Findings Congress finds the following: (1) John Hardy Isakson, known as Johnny , was born December 28, 1944, in Atlanta, Georgia, to Julia Isakson and Edwin Andrew Isakson. (2) Johnny Isakson graduated from the University of Georgia in 1966 with a Bachelor’s Degree in Business Administration. (3) In 1966, Johnny Isakson enlisted in the Georgia Air National Guard, serving until 1972 and attaining the rank of Staff Sergeant. (4) Johnny Isakson gained success in private business, serving for 22 years as a real estate executive and growing his business into one of the largest of its kind in both Georgia and in the United States. (5) Johnny Isakson was elected to the Georgia General Assembly in 1976, serving in the State House of Representatives until 1990. (6) Johnny Isakson was elected to the Georgia State Senate in 1992, serving until 1996. (7) In 1996, Governor Zell Miller appointed Johnny Isakson to be Chairman of the Georgia State Board of Education. (8) Johnny Isakson was elected to represent the 6th District of Georgia in the United States House of Representatives in 1999, and served until 2005. (9) During his time in the House of Representatives, Johnny Isakson, as a member of the Committee on Education and Labor of the House of Representatives, worked to improve American education, and was a key advocate for the bipartisan education reforms that became the No Child Left Behind Act of 2001 ( Public Law 107–110 ). (10) Johnny Isakson was elected to the United States Senate in 2004, serving until December 31, 2019. (11) During his time in the Senate, Johnny Isakson was an exemplar of courtesy, dignity, and kindness, beloved and respected by colleagues regardless of party. (12) Johnny Isakson, during the 111th Congress, demonstrated a bipartisan yearning for peace, and crossed party lines to support the ratification of the 2010 Strategic Arms Reduction Treaty between the United States and the Russian Federation, also known as New START. (13) During the 114th, 115th, and 116th Congresses, Johnny Isakson served as Chairman of the Committee on Veterans’ Affairs of the Senate, a position with which he tirelessly championed reform to improve the benefits and quality of service for our nation’s military veterans. (14) During the 114th, 115th, and 116th Congresses, Johnny Isakson served as Chairman of the Select Committee on Ethics of the Senate. (15) The late Congressman John Lewis once described Johnny Isakson as A man who has strong belief but also willing to work with others to get things done. . (16) On December 19, 2021, Johnny Isakson passed away, but his legacy of character and goodwill will endure as an example to all who serve, or will serve, in the United States Senate. 3. Senator Johnny Isakson Department of Veterans Affairs Atlanta Regional Office (a) Designation The Department of Veterans Affairs Atlanta Regional Office in Georgia shall, after the date of the enactment of this Act, be known and designated as the Senator Johnny Isakson Department of Veterans Affairs Atlanta Regional Office or the Isakson VA Atlanta Regional Office . (b) Reference Any reference in a law, regulation, map, document, paper, or other record of the United States to the Regional Office referred to in subsection (a) shall be deemed to be a reference to the Senator Johnny Isakson Department of Veterans Affairs Atlanta Regional Office. | https://www.govinfo.gov/content/pkg/BILLS-117s4359is/xml/BILLS-117s4359is.xml |
117-s-4360 | II 117th CONGRESS 2d Session S. 4360 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Ossoff (for himself and Mr. Rubio ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To amend title 37, United States Code, to extend the authority to temporarily adjust the basic allowance for housing in certain areas.
1. Short title This Act may be cited as the Military Housing Affordability Act of 2022 . 2. Findings Congress makes the following findings: (1) In April 2022, the median price for existing home sales increased 14.8 percent from the previous year and 2021 saw year-over-year median price increases as high as 23.6 percent, according to data from the National Association of Realtors. (2) The Military Times, in July 2021, reported, A number of service members [are] being forced to pay hundreds of dollars more in rent per month than their housing allowance covers. . (3) In September 2021, the Department of Defense exercised its authority to temporarily adjust basic allowance for housing rates in 56 housing markets for members of the uniformed services who incurred increased housing costs above their current basic allowance for housing rate, in order to help ease the financial burden of rising housing costs facing Service members moving to new duty stations or signing new leases . (4) In November 2021, the Secretary of Defense approved a temporary basic allowance for housing increase for members in locations where rental prices rose at least 10 percent in 2021. (5) The Secretary of Defense’s authority to temporarily adjust basic allowance for housing rates in a military housing area, if the actual costs of adequate housing for civilians in that military housing area differs from the basic allowance for housing rate by more than 20 percent, is set to expire on September 30, 2022. 3. Extension of authority to temporarily adjust basic allowance for housing in certain areas Section 403(b) of title 37, United States Code, is amended by striking 2022 both places it appears and inserting 2024 . | https://www.govinfo.gov/content/pkg/BILLS-117s4360is/xml/BILLS-117s4360is.xml |
117-s-4361 | II 117th CONGRESS 2d Session S. 4361 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Luján introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require reports to Congress on reporting and disclosure requirements related to retirement plans, and for other purposes.
1. Short title This Act may be cited as the Savvy Saver Act . 2. Defined contribution plan fee disclosure improvements Not later than 3 years after the date of enactment of this Act, the Secretary of Labor shall— (1) review section 2550.404a–5 of title 29, Code of Federal Regulations; (2) study, through a public request for information or otherwise, how the content and design of the disclosures described in such section may be improved to enhance participants’ understanding of fees and expenses related to a defined contribution plan (as defined in section 3 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1002 )) as well as the cumulative effect of fees and expenses on retirement savings over time; and (3) submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Education and Labor of the House of Representatives on the findings of the study described in paragraph (2), including beneficial education for consumers on financial literacy concepts as related to retirement plan fees, and recommendations for legislative changes needed to address such findings. 3. Review and report to Congress relating to reporting and disclosure requirements (a) Study As soon as practicable after the date of enactment of this Act, the Secretary of Labor, the Secretary of the Treasury, and the Director of the Pension Benefit Guaranty Corporation shall review the reporting and disclosure requirements as applicable to each such agency head, of— (1) the Employee Retirement Income Security Act of 1974 applicable to pension plans (as defined in section 3(2) of such Act ( 29 U.S.C. 1002(2) ); and (2) the Internal Revenue Code of 1986 applicable to qualified retirement plans (as defined in section 4974(c) of such Code, without regard to paragraphs (4) and (5) of such section). (b) Report (1) In general Not later than 3 years after the date of enactment of this Act, the Secretary of Labor, the Secretary of the Treasury, and the Director of the Pension Benefit Guaranty Corporation, jointly, and after consultation with a balanced group of participant and employer representatives, shall with respect to plans referenced in subsection (a) report on the effectiveness of the applicable reporting and disclosure requirements and make such recommendations as may be appropriate to the Committee on Education and Labor and the Committee on Ways and Means of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate to consolidate, simplify, standardize, and improve such requirements so as to simplify reporting for such plans and ensure that plans can furnish and participants and beneficiaries timely receive and better understand the information they need to monitor their plans, plan for retirement, and obtain the benefits they have earned. (2) Analysis of effectiveness To assess the effectiveness of the applicable reporting and disclosure requirements, the report shall include an analysis, based on plan data, of how participants and beneficiaries are providing preferred contact information, the methods by which plan sponsors and plans are furnishing disclosures, and the rate at which participants and beneficiaries (grouped by key demographics) are receiving, accessing, understanding, and retaining disclosures. (3) Collection of information The agencies shall conduct appropriate surveys and data collection to obtain any needed information. | https://www.govinfo.gov/content/pkg/BILLS-117s4361is/xml/BILLS-117s4361is.xml |
117-s-4362 | II 117th CONGRESS 2d Session S. 4362 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Casey introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend the Juvenile Justice and Delinquency Prevention Act of 1974 to eliminate the use of valid court orders to secure lockup of status offenders, and for other purposes.
1. Short title This Act may be cited as the Prohibiting Detention of Youth Status Offenders Act of 2022 . 2. Findings Congress finds the following: (1) Under the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11101 et seq. ), Congress recognized the need to set clear standards and protect juveniles across the United States by, among other things, providing that States should not place youth in secure detention for status offenses, which are offenses that would not be criminal offenses if committed by an adult. (2) In 1980, Congress amended the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11101 et seq. ) to create an exception that permits judges to place a youth in secure detention if the youth violates a valid court order (referred to in this section as the VCO exception ). The VCO exception has led to thousands of youth being placed in secure detention for noncriminal status offenses. (3) Placing a child charged with a noncriminal status offense in secure confinement with children who have been accused of serious criminal offenses can expose the child to negative influences and behaviors that could contribute to that child returning into the status offense system or the delinquency system. (4) The 5 most common juvenile status offense include skipping school, drinking while underage, running away from home, violating curfew, and acting out. (5) In 2019— (A) 11 percent of formally processed juvenile court cases were for a status offense; and (B) although most petitioned status offense cases involved white youth (61 percent), Black youth and American Indian and Alaska Native youth were overrepresented among petitioned status offenses cases relative to their population size. (6) Girls are more often sent to the justice system for less serious offenses, such as status offenses, than boys. In 2013, the female share of formally processed status offense cases (43 percent) was greater than the share of female delinquency cases (27 percent). (7) Girls often engage in status offense behaviors in response to abuse or trauma and may, for example, run away to escape abuse at home or in a foster care placement. (8) Anyone under the age of majority, which, in most States, is the age of 18, is subject to status offense charges, but teenagers between the ages of 14 and 17 comprise most status offense cases. (9) Most youth who engage in status and other minor offenses never progress to more serious behavior and will age out of the behavior without court intervention. (10) Since 1980, more than half of States have recognized the dangers of placing youth in secure detention for noncriminal status offenses and have stopped using the VCO exception. (11) While the number of status offenses petitioned in courts decreased by 53 percent between 2005 and 2019, during 2019, there were still approximately 4,200 instances of a youth being detained in response to a status offense. (12) Congress recognized the need to reform the VCO exception under the Juvenile Justice Reform Act of 2018 (115–385; 132 Stat. 5123), which, among other things, limited the time that a juvenile could be detained under a VCO exception to not more than 7 days. (13) Congress must now act to eliminate the VCO exception and fully return to the original intent of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11101 et seq. ), which originally provided that no youth should be held in secure detention for a noncriminal status offense. 3. Deinstitutionalization of status offenders Section 223 of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11133 ) is amended— (1) in subsection (a)— (A) in paragraph (11)(A)(i)(III), by inserting a runaway before held ; and (B) in paragraph (23)— (i) in subparagraph (C)(iii)— (I) in subclause (I)(dd), by striking 7 and inserting 3 ; and (II) in subclause (II), by striking and at the end; (ii) in subparagraph (D)— (I) by striking 7 and inserting 3 ; and (II) by adding and at the end; and (iii) by inserting after subparagraph (D) the following: (E) the juvenile may only be held in a secure detention facility or secure correctional facility if the detention— (i) is pursuant to a court order described in subparagraph (C)(iii) and the other conditions set forth in subparagraph (C) are satisfied; and (ii) occurs only 1 time in any 6-month period; ; and (2) by adding at the end the following: (h) Additional requirement (1) In general Except as provided in paragraph (2), not later than 1 year after the date of enactment of this subsection, no State receiving a formula grant under this part may use a valid court order described in subsection (a)(23)(C)(iii) to place a juvenile status offender in a secure detention facility or secure correctional facility. (2) Extension A State that can demonstrate hardship, as determined by the Administrator, may submit to the Administrator an application for a single 1-year extension of the 1-year period described in paragraph (1) to comply with paragraph (1), which shall describe— (A) the measurable progress and good effort in the State to reduce the number of juvenile status offenders who are placed in a secure detention facility or correctional facility pursuant to a court order described in subsection (a)(23)(C)(iii); and (B) a plan to comply with the requirement described in paragraph (1) not later than 1 year after the date the extension is granted. . | https://www.govinfo.gov/content/pkg/BILLS-117s4362is/xml/BILLS-117s4362is.xml |
117-s-4363 | II 117th CONGRESS 2d Session S. 4363 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Thune (for himself and Ms. Duckworth ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To require commissary and exchange stores in the United States that offer gasoline for commercial sale to offer the sale of at least one fuel that contains not less than 13 percent ethanol.
1. Short title This Act may be cited as the Armed Forces Fuel Choice Act of 2022 . 2. Fuel choice at commissary and exchange stores (a) In general Except as provided by subsection (b), each commissary or exchange store located on a military installation in the United States or any territory or possession of the United States that offers gasoline for commercial sale shall offer the sale of at least one fuel that contains not less than 13 percent ethanol not later than January 1, 2024. (b) Exception for gas stations requiring new storage tanks A commissary or exchange store described in subsection (a) that requires the replacement of an underground storage tank to offer for sale fuel described in that subsection shall offer the sale of at least one such fuel not later than January 1, 2025. | https://www.govinfo.gov/content/pkg/BILLS-117s4363is/xml/BILLS-117s4363is.xml |
117-s-4364 | II 117th CONGRESS 2d Session S. 4364 IN THE SENATE OF THE UNITED STATES June 8 (legislative day, June 7), 2022 Mr. Scott of Florida introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To prohibit contracting with persons that have business operations with the Government of the Russian Federation or the Russian energy sector, and for other purposes.
1. Short title This Act may be cited as the Keeping Russia’s Energy and Military Liable for Invading its Neighbors Act or the KREMLIN Act . 2. Prohibition on contracting with persons that have business operations with the Government of the Russian Federation or the Russian energy sector (a) Prohibition Except as provided under subsection (b), the head of an executive agency may not enter into a contract for the procurement of goods or services with any person that has business operations with— (1) an authority of the Government of the Russian Federation; or (2) a fossil fuel company that operates in the Russian Federation, except if the fossil fuel company transports oil or gas— (A) through the Russian Federation for sale outside of the Russian Federation; and (B) that was extracted from a country other than the Russian Federation with respect to the energy sector of which the President has not imposed sanctions as of the date on which the contract is awarded. (b) Exceptions (1) Humanitarian assistance, disaster relief, and national security (A) In general The prohibition under subsection (a) does not apply to a contract that the head of an executive agency and the Secretary of State jointly determine— (i) is necessary for purposes of providing humanitarian assistance to the people of the Russian Federation; (ii) is necessary for purposes of providing disaster relief and other urgent life-saving measures; or (iii) is vital to the national security interests of the United States. (B) Notification requirement The head of an executive agency shall notify the appropriate congressional committees of any contract entered into on the basis of an exception under subparagraph (A). (2) Office of Foreign Assets Control licenses The prohibition under subsection (a) does not apply to a person that has a valid license to operate in the Russian Federation issued by the Office of Foreign Assets Control of the Department of the Treasury or is otherwise authorized to operate notwithstanding the imposition of sanctions with respect to the Russian Federation. (3) American diplomatic mission in Russia The prohibition under subsection (a) does not apply to contracts related to the operation and maintenance of the consular offices and diplomatic posts of the United States Government in the Russian Federation. (c) Applicability This section shall take effect on the date of the enactment of this Act and apply with respect to any contract entered into on or after such date. (d) Sunset This section shall terminate on the date on which the President submits to the appropriate congressional committees a certification in writing that contains a determination of the President that the Russian Federation— (1) has reached an agreement relating to the withdrawal of Russian forces from Ukraine and cessation of military hostilities in Ukraine that is accepted by the free and independent Government of Ukraine; (2) poses no immediate military threat of aggression to any member of the North Atlantic Treaty Organization; and (3) recognizes the right of the people of Ukraine to independently and freely choose their own government. (e) Definitions In this section: (1) Agency or instrumentality of the Government of the Russian Federation The term agency or instrumentality of the Government of the Russian Federation means an agency or instrumentality of a foreign state as defined in section 1603(b) of title 28, United States Code, with each reference in such section to a foreign state deemed to be a reference to the Russian Federation . (2) Appropriate congressional committees The term appropriate congressional committees means— (A) the Committee on Armed Services, the Committee on Foreign Relations, and the Committee on Homeland Security and Governmental Affairs of the Senate; and (B) the Committee on Armed Services, the Committee on Foreign Affairs, and the Committee on Oversight and Reform of the House of Representatives. (3) Business operations The term business operations means the act of engaging in commerce in any form, including acquiring, developing, maintaining, owning, selling, possessing, leasing, or operating equipment, facilities, personnel, products, services, personal property, real property, or any other apparatus of business or commerce. (4) Executive agency The term executive agency has the meaning given the term in section 133 of title 41, United States Code. (5) Fossil fuel company The term fossil fuel company means a person that— (A) carries out oil, gas, or coal exploration, development, or production activities; (B) processes or refines oil, gas, or coal; or (C) transports, or constructs facilities for the transportation of, oil, gas, or coal. (6) Government of the Russian Federation The term Government of the Russian Federation includes the government of any political subdivision of the Russian Federation and any agency or instrumentality of the Government of the Russian Federation. (7) Person The term person means— (A) a natural person, corporation, company, business association, partnership, society, trust, or any other nongovernmental entity, organization, or group; (B) a governmental entity or instrumentality of a government, including a multilateral development institution (as defined in section 1701(c)(3) of the International Financial Institutions Act ( 22 U.S.C. 262r(c)(3) )); and (C) a successor, subunit, parent entity, or subsidiary of, or an entity under common ownership or control with, an entity described in subparagraph (A) or (B). | https://www.govinfo.gov/content/pkg/BILLS-117s4364is/xml/BILLS-117s4364is.xml |
117-s-4365 | II 117th CONGRESS 2d Session S. 4365 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Sanders (for himself, Ms. Warren , Mr. Whitehouse , Mr. Merkley , Mr. Van Hollen , Mr. Padilla , Mrs. Gillibrand , and Mr. Booker ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To enhance Social Security benefits and ensure the long-term solvency of the Social Security program.
1. Short title; table of contents (a) Short title This Act may be cited as the Social Security Expansion Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Across-the-board benefit increase. Sec. 3. Computation of cost-of-living increases. Sec. 4. Increase in minimum benefit for lifetime low earners based on years in the workforce. Sec. 5. Extended benefit eligibility for children who are full-time students. Sec. 6. Payroll tax on remuneration up to contribution and benefit base and more than $250,000. Sec. 7. Tax on net earnings from self-employment up to contribution and benefit base and more than $250,000. Sec. 8. Tax on investment gain. Sec. 9. Social Security Trust Fund established. 2. Across-the-board benefit increase (a) Increase of first bend point percentage Section 215(a)(1)(A)(i) of the Social Security Act ( 42 U.S.C. 415(a)(1)(A)(i) ) is amended by striking 90 percent and inserting 95 percent . (b) Adjustment to Bend point amount (1) In general Section 215(a)(1)(B) of the Social Security Act ( 42 U.S.C. 415(a)(1)(B) ) is amended— (A) by redesignating clause (iii) as clause (iv); and (B) by inserting after clause (ii) the following new clause: (iii) For an individual who is eligible for an old-age or disability insurance benefit (or who dies before becoming eligible for such a benefit) in any calendar year after 2022, the amount determined for the individual under clause (ii) of this subparagraph for purposes of subparagraph (A)(i)(I) shall be increased by 22 percent. . (2) Conforming amendment Clause (iv) of section 215(a)(1)(B) of the Social Security Act ( 42 U.S.C. 415(a)(1)(B) ), as redesignated by subsection (b), is amended by inserting (after the application of clause (iii), when applicable) after clause (ii) . (c) Effective date (1) In general The amendments made by this section shall take effect on January 1, 2023, and shall apply with respect to monthly insurance benefits payable under title II of the Social Security Act ( 42 U.S.C. 401 et seq. ) for months in calendar years beginning on or after such date. (2) Recomputation of primary insurance amounts (A) In general Notwithstanding section 215(f) of the Social Security Act ( 42 U.S.C. 415(f) ), the Commissioner of Social Security shall recompute primary insurance amounts to the extent necessary to carry out the amendments to this section. (B) Rule of application In recomputing the primary insurance amount of an individual who initially became eligible for old-age or disability insurance benefits before January 1, 2023, the Commissioner of Social Security shall apply the increase described in clause (iii) of section 215(a)(1)(B) of the Social Security Act (as added by subsection (b)(1)(B)) to the amount determined under clause (ii) of such section 215(a)(1)(B) for the calendar year in which the individual initially became eligible for such benefits. 3. Computation of cost-of-living increases (a) In general Section 215(i)(1) of the Social Security Act ( 42 U.S.C. 415(i)(1) ) is amended by adding at the end the following new subparagraph: (H) the term Consumer Price Index means the Consumer Price Index for Elderly Consumers (CPI–E, as published by the Bureau of Labor Statistics of the Department of Labor). . (b) Application to pre-1979 law (1) In general Section 215(i)(1) of the Social Security Act as in effect in December 1978, and as applied in certain cases under the provisions of such Act as in effect after December 1978, is amended by adding at the end the following new subparagraph: (D) the term Consumer Price Index means the Consumer Price Index for Elderly Consumers (CPI–E, as published by the Bureau of Labor Statistics of the Department of Labor). . (2) Conforming change Section 215(i)(4) of the Social Security Act ( 42 U.S.C. 415(i)(4) ) is amended— (A) by striking and by section 9001 and inserting , section 9001 ; and (B) by inserting and section 3 of the Social Security Expansion Act , after 1986, . (c) No effect on adjustments under other laws Section 215(i) of the Social Security Act ( 42 U.S.C. 415(i) ) is amended by adding at the end the following: (6) Any provision of law (other than in this title, title VIII, or title XVI) which provides for adjustment of an amount based on a change in benefit amounts resulting from a determination made under this subsection shall be applied and administered without regard to the amendments made by section 3 of the Social Security Expansion Act , and, for purposes of making such an adjustment under such a provision, this subsection as in effect on the day before the date of enactment of such Act shall continue to apply. . (d) Publication of Consumer Price Index for Elderly Consumers The Bureau of Labor Statistics of the Department of Labor shall prepare and publish the index authorized by section 191 of the Older Americans Amendments Act of 1987 ( 29 U.S.C. 2 note) for each calendar month, beginning with July of the calendar year following the calendar year in which this Act is enacted, and such index shall be known as the Consumer Price Index for Elderly Consumers . (e) Effective date The amendments made by subsection (a) shall apply to determinations made with respect to cost-of-living computation quarters (as defined in section 215(i)(1)(B) of the Social Security Act ( 42 U.S.C. 415(i)(1)(B) )) ending on or after September 30 of the second calendar year following the calendar year in which this Act is enacted. 4. Increase in minimum benefit for lifetime low earners based on years in the workforce (a) In general Section 215(a)(1) of the Social Security Act ( 42 U.S.C. 415(a)(1) ) is amended— (1) by redesignating subparagraph (D) as subparagraph (E); and (2) by inserting after subparagraph (C) the following new subparagraph: (D) (i) Effective with respect to the benefits of individuals who become eligible for old-age insurance benefits or disability insurance benefits (or die before becoming so eligible) after 2022, no primary insurance amount computed under subparagraph (A) may be less than the greater of— (I) the minimum monthly amount computed under subparagraph (C); or (II) in the case of an individual who has more than 10 years of work (as defined in clause (iv)(I)), the alternative minimum amount determined under clause (ii). (ii) (I) The alternative minimum amount determined under this clause is the applicable percentage of 1/12 of the annual dollar amount determined under clause (iii) for the year in which the amount is determined. (II) For purposes of subclause (I), the applicable percentage is the percentage specified in connection with the number of years of work, as set forth in the following table: If the number of years The applicable of work is: percentage is: 11 6.25 percent 12 12.50 percent 13 18.75 percent 14 25.00 percent 15 31.25 percent 16 37.50 percent 17 43.75 percent 18 50.00 percent 19 56.25 percent 20 62.50 percent 21 68.75 percent 22 75.00 percent 23 81.25 percent 24 87.50 percent 25 93.75 percent 26 100.00 percent 27 106.25 percent 28 112.50 percent 29 118.75 percent 30 or more 125.00 percent. (iii) The annual dollar amount determined under this clause is— (I) for calendar year 2023, the poverty guideline for 2022; and (II) for any calendar year after 2023, the annual dollar amount for 2022 multiplied by the ratio of— (aa) the national average wage index (as defined in section 209(k)(1)) for the second calendar year preceding the calendar year for which the determination is made, to (bb) the national average wage index (as so defined) for 2021. (iv) For purposes of this subparagraph— (I) the term year of work means, with respect to an individual, a year to which 4 quarters of coverage have been credited based on such individual’s wages and self-employment income; and (II) the term poverty guideline for 2022 means the annual poverty guideline for 2022 (as updated annually in the Federal Register by the Department of Health and Human Services under the authority of section 673(2) of the Omnibus Budget Reconciliation Act of 1981) as applicable to a single individual. . (b) Recomputation Notwithstanding section 215(f)(1) of the Social Security Act, the Commissioner of Social Security shall recompute primary insurance amounts originally computed for months prior to November 2018 to the extent necessary to carry out the amendments made by this section. (c) Conforming amendment Section 209(k)(1) of such Act ( 42 U.S.C. 409(k)(1) ) is amended by inserting 215(a)(1)(E), after 215(a)(1)(D), . 5. Extended benefit eligibility for children who are full-time students (a) In general (1) In general Section 202(d) of the Social Security Act ( 42 U.S.C. 402(d) ) is amended— (A) in paragraph (1)— (i) in subparagraph (B)— (I) by striking or (ii) and inserting (ii) ; and (II) by inserting or (iii) was the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual and was a full-time student at an educational institution and had not attained the age of 22, after 22, ; (ii) in subparagraph (E)— (I) by striking and (ii) and inserting (ii) ; and (II) by inserting and (iii) is not a full-time student at an educational institution during any part of such month (in the case of a child who is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual) before the comma at the end; (iii) in subparagraph (F), by striking clauses (i) and (ii) and inserting the following: (i) in the case of a child who is the child of an individual entitled to old-age insurance benefits— (I) the first month during no part of which the child is a full-time elementary or secondary school student, or (II) the month in which the child attains the age of 19, and (ii) in the case of a child who is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual— (I) the first month during no part of which the child is a full-time student at an educational institution, or (II) the month in which the child attains the age of 22, ; and (iv) in subparagraph (G), by striking clauses (ii) and (iii) and inserting the following: (ii) in the case of a child who is the child of an individual entitled to old-age insurance benefits— (I) the first month during no part of which the child is a full-time elementary or secondary school student, or (II) the month in which the child attains the age of 19, and (iii) in the case of a child who is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual— (I) the first month during no part of which the child is a full-time student at an educational institution, or (II) the month in which the child attains the age of 22, ; (B) in paragraph (6)— (i) in subparagraph (A)— (I) by striking or (ii) and inserting (ii) ; and (II) by inserting or (iii) is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual and is a full-time student at an educational institution and has not attained the age of 22, after 22, ; and (ii) by striking subparagraphs (D) and (E) and inserting the following: (D) the earlier of— (i) in the case of a child who is the child of an individual entitled to old-age insurance benefits— (I) the first month during no part of which the child is a full-time elementary or secondary school student; or (II) the month in which the child attains the age of 19; and (ii) in the case of a child who is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual— (I) the first month during no part of which the child is a full-time student at an educational institution; or (II) the month in which the child attains the age of 22; but only if the child is not under a disability (as so defined) in such earlier month; or (E) if the child was under a disability (as so defined), the termination month (as defined in paragraph (1)(G)(i)), subject to section 223(e), or (if later) the earlier of— (i) in the case of a child who is the child of an individual entitled to old-age insurance benefits— (I) the first month during no part of which the child is a full-time elementary or secondary school student; or (II) the month in which the child attains the age of 19; and (ii) in the case of a child who is the child of an individual entitled to disability insurance benefits or of an individual who dies a fully or currently insured individual— (I) the first month during no part of which the child is a full-time student at an educational institution; or (II) the month in which the child attains the age of 22. ; and (C) in paragraph (7), by adding at the end the following new paragraphs: (E) The term full-time student at an educational institution means an individual who is in full-time attendance as a student at an elementary school (but only in the case of an individual who has not attained the age of 19) or a secondary school or an institution described in section 102 of the Higher Education Act of 1965 ( 20 U.S.C. 1002 ), as determined by the Commissioner of Social Security (in accordance with regulations prescribed by the Commissioner) in the light of the standards and practices of the schools and institutions involved, except that no individual shall be considered a full-time student at an educational institution if the individual is paid by his employer while attending a school or institution at the request, or pursuant to a requirement, of his employer. An individual shall not be considered a full-time student at an educational institution for the purpose of this section while that individual is confined in a jail, prison, or other penal institution or correctional facility, pursuant to the individual's conviction of an offense (committed after the effective date of this sentence) which constituted a felony under applicable law. An individual who is determined to be a full-time student at an educational institution shall be deemed to be such a student throughout the month with respect to which such determination is made. (F) Except to the extent provided in such regulations, an individual shall be deemed to be a full-time student at a school or educational institution during any period of nonattendance at a school or institution at which he has been in full-time attendance if (i) such period is 4 calendar months or less, and (ii) the individual shows to the satisfaction of the Commissioner of Social Security that the individual intends to continue to be in full-time attendance at a secondary school or institution described in section 102 of the Higher Education Act of 1965 ( 20 U.S.C. 1002 ) immediately following such period. An individual who does not meet the requirement of clause (ii) with respect to such period of nonattendance shall be deemed to have met such requirement (as of the beginning of such period) if he is in full-time attendance at such a school or institution immediately following such period. (G) A child who attains age 22 at a time when the child is a full-time student of an educational institution (as defined in subparagraph (E) and without application of subparagraph (F)) but has not (at such time) completed the requirements for, or received, a diploma or equivalent certificate from a secondary school (as defined in subparagraph (C)(i)) or, if such child is a student at an educational institution described in section 102 of the Higher Education Act of 1965, a diploma, degree, or equivalent degree from such an institution, shall be deemed (for purposes of determining whether the child's entitlement to benefits under this subsection has terminated under paragraph (1)(F) and for purposes of determining his initial entitlement to such benefits under clause (iii) of paragraph (1)(B)) not to have attained such age until the first day of the first month following the end of the quarter or semester in which he is enrolled at such time (or, if the secondary school or educational institution in which he is enrolled is not operated on a quarter or semester system, until the first day of the first month following the completion of the course in which the child is so enrolled or until the first day of the third month beginning after such time, whichever first occurs). . (2) Effective date The amendments made by this subsection shall apply to child's insurance benefits that are payable for months beginning on or after January 1, 2023. (b) Railroad Retirement Act (1) Section 2(d) of the Railroad Retirement Act of 1974 (45 U.S.C. 232(2)(d)) is amended— (A) in clause (iii) of paragraph (1), by striking will be less than nineteen years of age and a full-time elementary or secondary school student and inserting will be less than 22 years of age and a full-time student at an educational institution (as defined in section 202(d)(7)(E) of the Social Security Act) ; and (B) in paragraph (4)— (i) by striking (defining the terms full-time elementary or secondary school student and elementary or secondary school ) ; (ii) by striking nineteen and inserting 22 ; (iii) by striking full-time elementary or secondary school student and inserting full-time student at an educational institution ; (iv) by striking subparagraph (A) of paragraph (7) of section 202(d) of the Social Security Act and without the application of subparagraph (B) and inserting subparagraph (E) of section 202(d)(7) of the Social Security Act, without regard to subparagraph (F) of such section ; (v) by striking a diploma or equivalent certificate from a secondary school (as defined in section 202(d)(7)(c)(i) of the Social Security Act) and inserting a diploma, degree, or equivalent certificate from a secondary school or educational institution described in section 202(d)(7)(E) of the Social Security Act ; and (vi) by striking elementary or secondary school in which he is enrolled and inserting school or institution in which the child is enrolled . (2) Section 5(c)(7) of the Railroad Retirement Act of 1974 ( 45 U.S.C. 235(c)(7) ) is amended— (A) by striking full-time elementary or secondary school student and inserting full-time student at an educational institution ; and (B) by striking 19 and inserting 22 . (3) The amendments made by this subsection shall apply to benefits under the Railroad Retirement Act of 1974 that are payable for months beginning on or after January 1, 2023. 6. Payroll tax on remuneration up to contribution and benefit base and more than $250,000 (a) In general Paragraph (1) of section 3121(a) of the Internal Revenue Code of 1986 is amended by inserting after such calendar year. the following: The preceding sentence shall apply only to calendar years for which the contribution and benefit base (as so determined) is less than $250,000, and, for such calendar years, only to so much of the remuneration paid to such employee by such employer with respect to employment as does not exceed $250,000. . (b) Conforming amendment Paragraph (1) of section 3121(a) of the Internal Revenue Code of 1986 is amended by striking Act) to and inserting Act), or in excess of $250,000, to . (c) Effective date The amendments made by this section shall apply to remuneration paid on or after January 1 of the first calendar year that begins after the date of enactment of this Act. 7. Tax on net earnings from self-employment up to contribution and benefit base and more than $250,000 (a) In general Paragraph (1) of section 1402(b) of the Internal Revenue Code of 1986 is amended to read as follows: (1) in the case of the tax imposed by section 1401(a), the excess of— (A) that part of the net earnings from self-employment which is in excess of— (i) an amount equal to the contribution and benefit base (as determined under section 230 of the Social Security Act) which is effective for the calendar year in which such taxable year begins, minus (ii) the amount of the wages paid to such individual during such taxable years, over (B) the sum of— (i) the excess of— (I) the net earning from self-employment reduced by the excess (if any) of subparagraph (A)(i) over subparagraph (A)(ii), over (II) $250,000, reduced by such contribution and benefit base, plus (ii) the amount of the wages paid to such individual during such taxable year in excess of such contribution and benefit base and not in excess of $250,000; or . (b) Phaseout Subsection (b) of section 1402 of the Internal Revenue Code of 1986 is amended by adding at the end the following: Paragraph (1) shall apply only to taxable years beginning in calendar years for which the contribution and benefit base (as determined under section 230 of the Social Security Act) is less than $250,000. . (c) Effective date The amendments made by this section shall apply to net earnings from self-employment derived, and remuneration paid, on or after January 1 of the first calendar year that begins after the date of enactment of this Act. 8. Tax on investment gain (a) Increase in tax (1) In general Subsection (a) of section 1411 of the Internal Revenue Code of 1986 is amended by striking 3.8 percent each place it appears and inserting 16.2 percent . (2) Conforming amendment The heading for chapter 2A of the Internal Revenue Code of 1986 is amended by striking Unearned income medicare contribution and inserting Additional tax on unearned income in lieu of Social Security and Medicare taxes . (b) Inclusion of active trade or business income (1) In general Section 1411(c)(1)(A) of the Internal Revenue Code of 1986 is amended— (A) in clause (i), by striking , other than such income which is derived in the ordinary course of a trade or business not described in paragraph (2) , (B) in clause (ii), by striking described in paragraph (2) and inserting (determined under rules similar to the rules of paragraphs (5) and (6) of section 469(c)) , and (C) in clause (iii), by striking other than property held in a trade or business not described in paragraph (2) . (2) Denial of deduction for net operating losses Section 1411(c)(1)(B) of such Code is amended by inserting (other than the deduction for net operating losses provided in section 172) after net gain . (3) Conforming amendments (A) Section 1411(c) of such Code is amended by striking paragraphs (2), (3), and (4) and by redesignating paragraphs (5) and (6) as paragraphs (2) and (3), respectively. (B) Section 1411(c)(3) of such Code, as redesignated by subparagraph (A), is amended to read as follows: (3) Special rule Net investment income shall not include— (A) any item taken into account in determining self-employment income for such taxable year on which a tax is imposed by section 1401, or (B) any item taken into account in determining wages received with respect to employment for such taxable year on which a tax is imposed by section 3101. . (c) Effective date The amendments made by this section shall apply to taxable years beginning after the date of enactment of this Act. 9. Social Security Trust Fund established (a) In general Section 201(a) of the Social Security Act ( 42 U.S.C. 401(a) ) is amended to read as follows: (a) There is hereby created on the books of the Treasury of the United States a trust fund to be known as the Social Security Trust Fund . The Social Security Trust Fund shall consist of the securities held by the Secretary of the Treasury for the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and the amount standing to the credit of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund on the books of the Treasury on January 1 of the first calendar year beginning after the date of the enactment of section 9 of the Social Security Expansion Act , which securities and amount the Secretary of the Treasury is authorized and directed to transfer to the Social Security Trust Fund, and, in addition, such gifts and bequests as may be made as provided in subsection (i)(1), and such amounts as may be appropriated to, or deposited in, the Social Security Trust Fund as hereinafter provided. There is hereby appropriated to the Social Security Trust Fund for the first fiscal year that begins after the date of the enactment of section 9 of the Social Security Expansion Act , and for each fiscal year thereafter, out of any moneys in the Treasury not otherwise appropriated, amounts equivalent to 100 percent of— (1) the taxes imposed by chapter 21 (other than sections 3101(b) and 3111(b)) of the Internal Revenue Code of 1986 with respect to wages (as defined in section 3121 of such Code) reported to the Secretary of the Treasury pursuant to subtitle F of the Internal Revenue Code of 1986, as determined by the Secretary of the Treasury by applying the applicable rates of tax under such chapter (other than sections 3101(b) and 3111(b)) to such wages, which wages shall be certified by the Commissioner of Social Security on the basis of the records of wages established and maintained by such Commissioner in accordance with such reports; (2) the taxes imposed by chapter 2 (other than section 1401(b)) of the Internal Revenue Code of 1986 with respect to self-employment income (as defined in section 1402 of such Code) reported to the Secretary of the Treasury on tax returns under subtitle F of such Code, as determined by the Secretary of the Treasury by applying the applicable rate of tax under such chapter (other than section 1401(b)) to such self-employment income, which self-employment income shall be certified by the Commissioner of Social Security on the basis of the records of self-employment income established and maintained by the Commissioner of Social Security in accordance with such returns; and (3) 62 percent of the taxes imposed under section 1411 of the Internal Revenue Code of 1986. The amounts appropriated by paragraphs (1), (2), and (3) shall be transferred from time to time from the general fund in the Treasury to the Social Security Trust Fund, such amounts to be determined on the basis of estimates by the Secretary of the Treasury of the taxes, specified in paragraphs (1), (2), and (3), paid to or deposited into the Treasury; and proper adjustments shall be made in amounts subsequently transferred to the extent prior estimates were in excess of or were less than the taxes specified in such paragraphs. All amounts transferred to the Social Security Trust Fund under the preceding sentence shall be invested by the Managing Trustee in the same manner and to the same extent as the other assets of the Trust Fund. Notwithstanding the preceding sentence, in any case in which the Secretary of the Treasury determines that the assets of the Trust Fund would otherwise be inadequate to meet the Trust Fund's obligations for any month, the Secretary of the Treasury shall transfer to the Trust Fund on the first day of such month the total amount which would have been transferred to the Trust Fund under this section as in effect on October 1, 1990; and the Trust Fund shall pay interest to the general fund on the amount so transferred on the first day of any month at a rate (calculated on a daily basis, and applied against the difference between the amount so transferred on such first day and the amount which would have been transferred to the Trust Fund up to that day under the procedures in effect on January 1, 1983) equal to the rate earned by the investments of the Trust Fund in the same month under subsection (d). . (b) Required actuarial analysis Section 201(c) of the Social Security Act is amended by striking the fourth sentence in the matter following paragraph (5) and inserting the following: Such report shall also include actuarial analysis of the benefit cost with respect to disabled beneficiaries and their auxiliaries, to retired beneficiaries and their auxiliaries, and to survivor beneficiaries. . (c) Board of Trustees (1) Board of Trustees of Social Security Trust Fund Section 201(c) of the Social Security Act, as amended by subsection (b) of this section, is further amended in the matter preceding paragraph (1) by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund (hereinafter in this title called the Trust Funds ) and inserting the Social Security Trust Fund (in this title referred to as the Trust Fund ) . (2) Continuity of Board of Trustees The Board of Trustees of the Social Security Trust Fund created by the amendment made by subsection (a) shall be a continuous body with the Board of Trustees of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund in operation prior to the effective date of such amendment. Individuals serving as members of the Board of Trustees of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund as of the effective date of such amendment shall serve the remainder of their term as members of the Board of Trustees of the Social Security Trust Fund. (d) Conforming amendments related to Social Security Trust Fund (1) Amendment to section heading The section heading for section 201 of the Social Security Act is amended to read as follows: Social Security Trust Fund . (2) Board of Trustees Section 201(c) of such Act, as amended by subsections (b) and (c)(1), is further amended— (A) in the matter preceding paragraph (1), by striking Board of Trustees of the Trust Funds and inserting Board of Trustees of the Trust Fund ; (B) in paragraph (1), by striking Trust Funds and inserting Trust Fund ; (C) in paragraph (2)— (i) by striking Trust Funds and inserting Trust Fund ; and (ii) by striking their and inserting its ; (D) in paragraph (3), by striking either of the Trust Funds and inserting the Trust Fund ; (E) in paragraph (5)— (i) by striking managing the Trust Funds and inserting managing the Trust Fund ; and (ii) by striking Trust Funds are and inserting Trust Fund is ; (F) in the matter following paragraph (5), by striking Trust Funds each place it appears and inserting Trust Fund ; and (G) in the second sentence in the matter following paragraph (5), by striking whether the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, individually and collectively, are and inserting whether the Social Security Trust Fund is . (3) Investments Section 201 of such Act is amended in subsections (d) and (e) by striking Trust Funds each place it appears and inserting Trust Fund . (4) Crediting of interest and proceeds to Trust Funds Section 201(f) of such Act is amended— (A) by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund shall be credited to and form a part of the Federal Old-Age and Survivors Insurance Trust Fund and the Disability Insurance Trust Fund, respectively and inserting the Social Security Trust Fund shall be credited to and form a part of the Social Security Trust Fund ; (B) by striking either of the Trust Funds and inserting the Trust Fund ; and (C) by striking such Trust Fund and inserting the Trust Fund . (5) Administrative costs Section 201(g) of such Act is amended— (A) in paragraph (1)— (i) in subparagraph (A), by striking Of the amounts authorized to be made available out of the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund under the preceding sentence and all that follows through ( Public Law 103–296 ). ; and (ii) in subparagraph (B)(i)— (I) by striking subclauses (II) and (III) and inserting the following: (II) the portion of such costs which should have been borne by the Social Security Trust Fund, ; and (II) by redesignating subclauses (IV) and (V) as subclauses (III) and (IV); (B) in paragraph (2)— (i) by striking Trust Funds and inserting Trust Fund ; and (ii) by striking the last sentence; and (C) in paragraph (4), by striking Trust Funds each place it appears and inserting Trust Fund . (6) Benefit payments Section 201(h) of such Act is amended to read as follows: (h) All benefit payments required to be made under this title shall be made only from the Social Security Trust Fund. . (7) Gifts Section 201(i) of such Act is amended— (A) in paragraph (1), by striking the Federal Old-Age and Survivors Insurance Trust Fund, the Federal Disability Insurance Trust Fund and inserting the Social Security Trust Fund ; and (B) in paragraph (2)(B), by striking the Federal Old-Age and Survivors Insurance Trust Fund and inserting the Social Security Trust Fund . (8) Travel expenses Section 201(j) of such Act is amended by striking the Federal Old-Age and Survivors Insurance Trust Fund, or the Federal Disability Insurance Trust Fund (as determined appropriate by the Commissioner of Social Security) and inserting the Social Security Trust Fund . (9) Demonstration projects Section 201(k) of such Act is amended by striking the Federal Disability Insurance Trust Fund and the Federal Old-Age and Survivors Insurance Trust Fund, as determined appropriate by the Commissioner of Social Security and inserting the Social Security Trust Fund . (10) Benefit checks Section 201(m) of such Act is amended— (A) in paragraph (2), by striking each of the Trust Funds and inserting the Social Security Trust Fund ; (B) in paragraph (3), by striking one of the Trust Funds and inserting the Trust Fund ; and (C) by striking such Trust Fund each place it appears and inserting the Trust Fund . (11) Conforming repeals (A) In general Section 201 of such Act is amended by striking subsections (b), (l), and (n). (B) Redesignations Section 201 of such Act is further amended— (i) by redesignating subsections (c) through (j) as subsections (b) through (i), respectively; (ii) by redesignating subsection (k) as subsection (j); and (iii) by redesignating subsection (m) as subsection (k). (C) References to redesignated sections (i) Section 201(a) of such Act, as amended by subsection (a) of this section, is further amended— (I) by striking subsection (i)(1) and inserting subsection (h)(1) ; and (II) by striking subsection (d) and inserting subsection (c) . (ii) Section 1131(b)(1) of such Act is amended by striking section 201(g)(1) and inserting section 201(f)(1) . (e) Other conforming amendments to Social Security Act (1) Title II Title II of the Social Security Act ( 42 U.S.C. 401 et seq. ) is amended— (A) in section 202(x)(3)(B)(iii), by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, as appropriate, and inserting the Social Security Trust Fund ; (B) in section 206(d)(5), by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, as appropriate and inserting the Social Security Trust Fund ; (C) in section 206(e)(3)(B), by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting the Social Security Trust Fund ; (D) in section 208(b)(5)(A), by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund, as appropriate and inserting the Social Security Trust Fund ; (E) in section 215(i)(1)(F)— (i) in clause (i)— (I) by striking the combined balance in the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting the balance in the Social Security Trust Fund ; and (II) by striking and reduced by the outstanding amount of any loan (including interest thereon) theretofore made to either such Fund from the Federal Hospital Insurance Trust Fund under section 201(l) ; and (ii) in clause (ii)— (I) by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting the Social Security Trust Fund ; and (II) by striking (other than payments and all that follows through from that Account ; (F) in section 217(g)(2), by inserting after the first sentence the following: For purposes of any such revision of the amount determined under paragraph (1) that occurs in a year after 2015, any reference in such paragraph to the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund shall be deemed to be a reference to the Social Security Trust Fund. ; (G) in section 221(e)— (i) by striking Trust Funds each place it appears and inserting Trust Fund ; and (ii) by striking the last sentence; (H) in section 221(f), by striking Trust Funds and inserting Trust Fund ; (I) in section 222(d)— (i) in the section heading, by striking Trust Funds and inserting Trust Fund ; (ii) in paragraph (1), by striking to the end that savings will accrue to the Trust Funds as a result of rehabilitating such individuals, there are authorized to be transferred from the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting to the end that savings will accrue to the Trust Fund as a result of rehabilitating such individuals, there are authorized to be transferred from the Social Security Trust Fund ; and (iii) by amending paragraph (4) to read as follows: (4) The Commissioner of Social Security shall determine according to such methods and procedures as the Commissioner may deem appropriate the total amount to be reimbursed for the cost of services under this subsection. ; (J) in section 228(g)— (i) in the section heading, by striking Federal Old-Age and Survivors Insurance Trust Fund and inserting Social Security Trust Fund ; and (ii) in the matter preceding paragraph (1), by striking Federal Old-Age and Survivors Insurance Trust Fund and inserting Social Security Trust Fund ; (K) in section 231(c), by striking Trust Funds each place it appears and inserting Trust Fund ; and (L) in section 234(a)(1), by striking Trust Funds and inserting Trust Fund . (2) Title VII Title VII of the Social Security Act ( 42 U.S.C. 901 et seq. ) is amended— (A) in section 703(j), by striking Federal Disability Insurance Trust Fund, the Federal Old-Age and Survivors Insurance Trust Fund, and inserting Social Security Trust Fund ; (B) in section 708(c), by striking the OASDI trust fund ratio under section 201(l), after computing ; (C) in section 709— (i) in subsection (a), by striking Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; and (ii) in subsection (b)— (I) in paragraph (1), by striking section 201(l) or ; and (II) in paragraph (2), by striking Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; and (D) in section 710— (i) in subsection (a), by striking Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; and (ii) in subsection (b)— (I) by striking any Trust Fund specified in subsection (a) and inserting the Social Security Trust Fund ; and (II) by striking payments from any such Trust Fund and inserting payments from the Social Security Trust Fund . (3) Title XI Title XI of the Social Security Act ( 42 U.S.C. 1301 et seq. ) is amended— (A) in section 1106(b), by striking the Federal Old-Age and Survivors Insurance Trust Fund, the Federal Disability Insurance Trust Fund and inserting the Social Security Trust Fund ; (B) in section 1129(e)(2)(A), by striking the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund, as determined appropriate by the Secretary and inserting the Social Security Trust Fund ; (C) in sections 1131(b)(2) and 1140(c)(2), by striking the Federal Old-Age and Survivors Insurance Trust Fund and inserting the Social Security Trust Fund ; (D) in section 1145(c)— (i) by striking paragraphs (1) and (2) and inserting the following: (1) the Social Security Trust Fund; ; and (ii) by redesignating paragraphs (3) and (4) as paragraphs (2) and (3), respectively; and (E) in section 1148(j)(1)(A)— (i) in the first sentence, by striking the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting the Social Security Trust Fund ; and (ii) by striking the second sentence. (4) Title XVIII Title XVIII of the Social Security Act ( 42 U.S.C. 1395 ) is amended— (A) in section 1817(g), by striking Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; (B) in section 1840(a)(2), by striking Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; and (C) in section 1841(f), by striking Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund . (f) Conforming amendments outside of Social Security Act (1) Budget (A) Off-budget exemption Section 405(a) of the Congressional Budget Act of 1974 ( 2 U.S.C. 655(a) ) is amended by striking Federal Old-Age and Survivors Insurance and Federal Disability Insurance Trust Funds and inserting Social Security Trust Fund . (B) Sequestration exemption Section 255(g)(1)(A) of the Balanced Budget and Emergency Deficit Control Act of 1985 ( 2 U.S.C. 905(g)(1)(A) ) is amended by striking Payments to Social Security Trust Funds and inserting Payments to the Social Security Trust Fund . (2) Tax (A) Taxable wages Section 3121(l)(4) of the Internal Revenue Code of 1986 is amended by striking Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund . (B) Overpayments (i) Section 6402(d)(3)(C) of the Internal Revenue Code of 1986 is amended by striking Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund, whichever is certified to the Secretary as appropriate by the Commissioner of Social Security and inserting Social Security Trust Fund . (ii) Subsection (f)(2)(B) of section 3720A of title 31, United States Code, is amended by striking Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund, whichever is certified to the Secretary of the Treasury as appropriate by the Commissioner of Social Security and inserting Social Security Trust Fund . (3) False claims penalties Subsection (g)(2) of section 3806 of title 31, United States Code, is amended— (A) in subparagraph (B)— (i) by striking Secretary of Health and Human Services and inserting Commissioner of Social Security ; and (ii) by striking Federal Old-Age and Survivors Insurance Trust Fund and inserting Social Security Trust Fund ; and (B) in subparagraph (C)— (i) by striking Secretary of Health and Human Services and inserting Commissioner of Social Security ; and (ii) by striking Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund . (4) Railroad Retirement Board Section 7 of the Railroad Retirement Act of 1974 ( 45 U.S.C. 231f ) is amended— (A) in subsection (b)(2), by striking Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund and inserting Social Security Trust Fund ; (B) in subsection (c)(2)— (i) by striking Secretary of Health, Education, and Welfare each time it appears and inserting Commissioner of Social Security ; and (ii) by striking Federal Old-Age and Survivors Insurance Trust Fund, the Federal Disability Insurance Trust Fund, each time it appears and inserting Social Security Trust Fund ; and (C) in subsection (c)(4), by striking Federal Old-Age and Survivors Insurance Trust Fund, the Federal Disability Insurance Trust Fund, and inserting Social Security Trust Fund . (g) Rule of construction Effective beginning on January 1 of the first calendar year beginning after the date of the enactment of this section, any reference in law to the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund is deemed to be a reference to the Social Security Trust Fund. (h) Effective date The amendments made by this section shall take effect on January 1 of the first calendar year beginning after the date of the enactment of this section. | https://www.govinfo.gov/content/pkg/BILLS-117s4365is/xml/BILLS-117s4365is.xml |
117-s-4366 | II 117th CONGRESS 2d Session S. 4366 IN THE SENATE OF THE UNITED STATES June 9, 2022 Ms. Ernst (for herself, Ms. Rosen , Mr. Lankford , and Mr. Booker ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To require the Secretary of Defense to seek to cooperate with allies and partners in the Middle East to identify an architecture and develop an acquisition approach for certain countries in the Middle East to implement an integrated air and missile defense capability to protect the people, infrastructure, and territory of such countries from cruise and ballistic missiles, manned and unmanned aerial systems, and rocket attacks from Iran, and for other purposes.
1. Short title This Act may be cited as the Deterring Enemy Forces and Enabling National Defenses Act of 2022 or the DEFEND Act of 2022 . 2. Middle East integrated air and missile defense (a) In general The Secretary of Defense shall seek to cooperate with allies and partners in the Middle East to identify an architecture and develop an acquisition approach for the countries specified in subsection (b) to implement an integrated air and missile defense capability to protect the people, infrastructure, and territory of such countries from cruise and ballistic missiles, manned and unmanned aerial systems, and rocket attacks from Iran and groups linked to Iran. (b) Countries specified The countries specified in this subsection are as follows: (1) Countries of the Gulf Cooperation Council. (2) Iraq. (3) Israel. (4) Jordan. (5) Egypt. (6) Such other regional allies or partners of the United States as the Secretary may identify. (c) Strategy (1) In general Not later than 180 days after the date of the enactment of this Act, the Secretary shall submit to the congressional defense committees a strategy on cooperation with allies and partners in the Middle East to identify an architecture and develop an acquisition approach for the countries specified in subsection (b) to implement an integrated air and missile defense capability to protect the people, infrastructure, and territory of such countries from cruise and ballistic missiles, manned and unmanned aerial systems, and rocket attacks from Iran and groups linked to Iran. (2) Contents The strategy submitted under paragraph (1) shall include the following: (A) An assessment of the threat of ballistic and cruise missiles, manned and unnamed aerial systems, and rocket attacks from Iran and groups linked to Iran to the countries specified in subsection (b). (B) A description of current efforts to coordinate indicators and warnings from such attacks with the countries specified in subsection (b). (C) A description of current systems to defend against attacks in coordination with the countries specified in subsection (b). (D) An explanation of how an integrated air and missile defense architecture would improve collective security in the region covered by the countries specified in subsection (b). (E) A description of efforts to engage specified foreign partners in establishing such an architecture. (F) An identification of elements of the integrated air and missile defense architecture that— (i) can be acquired and operated by specified foreign partners; and (ii) can only be provided and operated by members of the Armed Forces. (G) An identification of any challenges in establishing an integrated air and missile defense architecture with specified foreign partners. (H) An assessment of progress, and key challenges, in the implementation of the strategy using such metrics identified under paragraph (4). (I) Recommendations for improvements in the implementation of the strategy based on the metrics identified under paragraph (4). (J) Such other matters as the Secretary considers relevant. (3) Protection of sensitive information Any activity carried out under paragraph (1) shall be conducted in a manner that appropriately protects sensitive information and the national security interests of the United States. (4) Metrics The Secretary shall identify metrics to assess progress in the implementation of the strategy required in paragraph (1). (5) Format The strategy submitted under paragraph (1) shall be submitted in unclassified form, but may include a classified annex. (d) Feasibility study (1) In general Not later than 180 days after the date of the enactment of this act, the Secretary of Defense shall— (A) complete a study on the feasibility and advisability of establishing a fund for an integrated air and missile defense system to counter the threats from cruise and ballistic missiles, manned and unmanned aerial systems, and rocket attacks for the countries specified in subsection (b) from Iran and groups linked with Iran; and (B) submit to the congressional defense committees the findings of the Secretary with respect to the study completed under subparagraph (A). (2) Assessment of contributions The study completed under paragraph (1)(A) shall include an assessment of funds that could be contributed by allies of the United States and countries that are partners with the United States. (e) Congressional defense committees defined In this section, the term congressional defense committees has the meaning given such term in section 101(a) of title 10, United States Code. | https://www.govinfo.gov/content/pkg/BILLS-117s4366is/xml/BILLS-117s4366is.xml |
117-s-4367 | II 117th CONGRESS 2d Session S. 4367 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Cornyn (for himself, Ms. Sinema , Mr. Tillis , Mr. Rubio , Mr. Ossoff , Ms. Ernst , and Mrs. Feinstein ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To improve certain sexual assault and domestic violence prevention policies.
1. Short title This Act may be cited as the Protecting our Servicemembers through Proven Methods Act of 2022 . 2. Annual primary prevention research agenda Section 549A(c) of the National Defense Authorization Act for Fiscal Year 2022 ( Public Law 117–81 ) is amended— (1) by redesignating paragraphs (2), (3), and (4) as paragraphs (5), (6), and (7), respectively; (2) by inserting after paragraph (1) the following new paragraphs: (2) include a focus on whether and to what extent sub-populations of the military community may be targeted for sexual assault, sexual harassment, or domestic violence more than others; (3) seek to identify factors that influence the prevention, perpetration, and victimization of sexual assault, sexual harassment, and domestic violence; (4) seek to improve the collection and dissemination of data on hazing and bullying related to sexual assault, sexual harassment, and domestic violence; ; and (3) in paragraph (6), as redesignated by paragraph (1) of this section, by amending the text to read as follows: (6) incorporate collaboration with other Federal departments and agencies, including the Department of Health and Human Services and the Centers for Disease Control and Prevention, State governments, academia, industry, federally funded research and development centers, nonprofit organizations, and other organizations outside of the Department of Defense, including civilian institutions that conduct similar data-driven studies, collection, and analysis; and . 3. Primary prevention workforce Section 549B of the National Defense Authorization Act for Fiscal Year 2022 ( Public Law 117–81 ) is amended— (1) in subsection (c), by adding at the end the following new paragraph: (3) Comptroller general report Not later than one year after the date of the enactment of this paragraph, the Comptroller General of the United States shall submit to the congressional defense committees a report comparing the sexual harassment and prevention training of the Department of Defense with similar programs at other Federal departments and agencies and including data collected by colleges and universities and other relevant outside entities. ; and (2) by adding at the end the following new subsection: (e) Incorporation of research and findings The Primary Prevention Workforce established under subsection (a) shall, on a regular basis, incorporate findings and conclusions from the primary prevention research agenda established under section 549A, as appropriate, into the work of the workforce. . | https://www.govinfo.gov/content/pkg/BILLS-117s4367is/xml/BILLS-117s4367is.xml |
117-s-4368 | II 117th CONGRESS 2d Session S. 4368 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Bennet (for himself, Mr. Sasse , and Mr. Warner ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To establish the Office of Global Competition Analysis, and for other purposes.
1. Short title This Act may be cited as the American Technology Leadership Act of 2022 . 2. Office of Global Competition Analysis (a) Definitions In this section: (1) Executive agency The term Executive agency has the meaning given such term in section 105 of title 5, United States Code. (2) Office The term Office means the Office of Global Competition Analysis established under subsection (b). (b) Establishment (1) In general The President shall establish an office on analysis of global competition. (2) Purposes The purposes of the Office are as follows: (A) To carry out a program of analysis on United States leadership in technology and innovation sectors critical to national security and economic prosperity relative to other countries, particularly those countries that are strategic competitors of the United States. (B) To support policy development and decisionmaking to ensure United States leadership in technology and innovation sectors critical to national security and economic prosperity. (3) Designation The Office shall be known as the Office of Global Competition Analysis . (c) Activities In accordance with the priorities determined under subsection (d), the Office shall— (1) acquire and prepare data relating to the purposes of the Office under subsection (b), including data relating to critical technologies, innovation, and production capacity in the United States and other countries, consistent with applicable provisions of law; (2) conduct long- and short-term analysis regarding— (A) United States policies that enable technological competitiveness relative to those of other countries, particularly with respect to countries that are strategic competitors of the United States; (B) United States science and technology ecosystem elements relative to those of other countries, particularly with respect to countries that are strategic competitors of the United States; (C) United States competitiveness in technology and innovation sectors critical to national security and economic prosperity relative to other countries, including the availability of United States technology in such sectors abroad, particularly with respect to countries that are strategic competitors of the United States; (D) trends and trajectories, including rate of change in technologies, related to technology and innovation sectors critical to national security and economic prosperity; (E) threats to United States national security interests as a result of any foreign country's dependence on technologies of strategic competitors of the United States; and (F) threats to United States interests based on dependencies on foreign technologies critical to national security and economic prosperity; and (3) engage with private sector entities on matters relating to analysis under paragraph (2). (d) Determination of priorities On a periodic basis, the Director of the Office of Science and Technology Policy, the National Economic Council, and the National Security Council, in coordination with such heads of such Executive agencies as the Director and the Councils jointly consider appropriate, shall jointly determine the priorities of the Office with respect to subsection (b)(2)(A). (e) Administration To carry out the purposes set forth under subsection (b)(2), the Office shall enter into an agreement with a public-private or a federally funded research and development center, a university affiliated research center, or consortium of federally funded research and development centers, and university affiliated research centers. (f) Access to, use, and handling of information (1) Federal information In carrying out the activities under subsection (c), the Office shall have access to all information, data, or reports of any Executive agency that the Office determines necessary to carry out this section— (A) upon written request; (B) subject to limitations under applicable provisions of law; and (C) consistent with the protection of sources and methods, law enforcement strictures, protection of proprietary information of businesses, and protection of personally identifiable information. (2) Commercial information The Office may obtain commercially available information that may not be publicly available. (3) Use of information The Office may use information obtained under this subsection for purposes set forth under subsection (b)(2). (4) Handling of information The Office shall handle information obtained under this subsection subject to all restrictions required by the source of the information. (g) Additional support A head of an Executive agency may provide to the Office such support, in the form of financial assistance and personnel, as the head considers appropriate to assist the Office in carrying out any activity under subsection (c), consistent with the priorities determined under subsection (d). (h) Annual report Not less frequently than once each year, the Office shall submit to Congress a report on the activities of the Office under this section. (i) Authorization of appropriations There is authorized to be appropriated to carry out this section $20,000,000 for fiscal year 2023. | https://www.govinfo.gov/content/pkg/BILLS-117s4368is/xml/BILLS-117s4368is.xml |
117-s-4369 | II 117th CONGRESS 2d Session S. 4369 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Marshall (for himself, Mr. Barrasso , Mrs. Blackburn , Mr. Braun , Mr. Daines , Mr. Grassley , Mr. Johnson , Mr. Moran , Mr. Scott of Florida , Mr. Scott of South Carolina , Mr. Tillis , Mr. Wicker , Mr. Young , and Mr. Kennedy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To allow States and local educational agencies to use any remaining COVID–19 elementary and secondary school emergency relief funds for school security measures.
1. Short title This Act may be cited as the Safe Schools Act . 2. Additional funds for school security (a) In general Notwithstanding any other provision of an ESSERF program or any other law, a State or local educational agency that has received funds under an ESSERF program may, in lieu of the original requested or authorized use for such funds, use a portion of, or all, of the unexpended funds to carry out 1 or more school security measures. (b) No Federal interference The Secretary of Education shall not— (1) prevent or discourage any State or local educational agency from using any ESSERF program funds for school security measures; (2) require the use of funds under subsection (a) to be in response to, or in any way connected with, the coronavirus; or (3) enforce any requirement of an ESSERF program if such requirement would prevent a State or local educational agency from carrying out a school security measure authorized under subsection (a). (c) Definitions In this section: (1) ESSERF program The term ESSERF program means a program carried out under— (A) section 18003 of the CARES Act ( 20 U.S.C. 3401 note; Public Law 116–136 ); (B) section 313 of division M of the Consolidated Appropriations Act, 2021 ( Public Law 116–260 ; 134 Stat. 1929); or (C) section 2001 of the American Rescue Plan Act of 2021 ( Public Law 117–2 ; 135 Stat. 19). (2) School security measure The term school security measure means any of the following: (A) An evidence-based strategy or program to prevent violence, which may include the use of appropriate technologies, including the placement and use of metal detectors and other deterrent measures and emergency notification and response technologies. (B) Training to prevent student violence against others and self, including training for local law enforcement officers, school personnel, and students. (C) The development and operation of an anonymous reporting system for threats of school violence, including a mobile telephone application, hotline, or internet website. (D) The development and operation of— (i) a school threat assessment and intervention team that may include coordination with law enforcement agencies and school personnel; and (ii) specialized training for school officials in responding to mental health crises. (E) Coordination with local law enforcement agencies. (F) A security assessment. (G) Security training of personnel and students. (H) Acquisition and installation of technology for expedited notification of local law enforcement during an emergency. (I) Reinforcing or replacing classroom doors, locks, or window panels. (J) Constructing fencing, bollards, planters, curbs, walls, or any other entry control measure to create a single point of entry to the campus. (K) Clearing exterior spaces of foliage or structures to eliminate spaces that could conceal illicit activity, provide access to the building above the first floor, or otherwise aid an intruder. (L) Installing a system to monitor entryways, hallways, stairwells, and utility rooms, such as physical inspection, a buzz-in system, or surveillance cameras. (M) Hiring and paying the salaries of qualified individuals, such as retired law enforcement officers or military veterans, to serve as armed school resource officers. | https://www.govinfo.gov/content/pkg/BILLS-117s4369is/xml/BILLS-117s4369is.xml |
117-s-4370 | II 117th CONGRESS 2d Session S. 4370 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Inhofe (for himself, Mr. Tillis , Mr. Wicker , Mr. Crapo , Mr. Risch , Mr. Kennedy , Mr. Cruz , Mr. Grassley , Mr. Hagerty , Ms. Lummis , Mr. Braun , Mr. Cassidy , Mr. Hawley , Mr. Cramer , Mrs. Hyde-Smith , Mr. Marshall , Mr. Rounds , Mr. Daines , Mr. Rubio , and Mr. Barrasso ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend the Immigration and Nationality Act to provide for extensions of detention of certain aliens ordered removed, and for other purposes.
1. Short title This Act may be cited as the Keep Our Communities Safe Act of 2022 . 2. Sense of Congress It is the sense of Congress that— (1) rights guaranteed by the United States Constitution should be upheld and protected; (2) Congress intends to uphold the constitutional principle of due process; and (3) due process of law is a right afforded to every person in the United States. 3. Detention of dangerous aliens during removal proceedings Section 236 of the Immigration and Nationality Act ( 8 U.S.C. 1226 ) is amended— (1) by striking Attorney General each place such term appears and inserting Secretary of Homeland Security ; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting or the Attorney General before the em dash; (B) in paragraph (1), by striking and at the end; and (C) in paragraph (2)(B), by striking conditional parole; but and inserting recognizance; and ; (3) in subsection (b)— (A) in the subsection heading, by striking parole and inserting recognizance ; and (B) by striking parole and inserting recognizance ; (4) in subsection (c)(1), by striking the undesignated matter following subparagraph (D) and inserting the following: any time after the alien is released, without regard to whether an alien is released related to any activity, offense, or conviction described in this paragraph; to whether the alien is released on parole, supervised release, or probation; or to whether the alien may be arrested or imprisoned again for the same offense. If the activity described in this paragraph does not result in the alien being taken into custody by any person other than the Secretary, when the alien is brought to the attention of the Secretary or when the Secretary determines it is practical to take such alien into custody, the Secretary shall take such alien into custody. ; (5) in subsection (e), by striking Attorney General’s and inserting Secretary of Homeland Security’s ; and (6) by adding at the end the following: (f) Length of detention Notwithstanding any other provision under this section, an alien may be detained under this section for any period, without limitation, except as provided in subsection (h), until the alien is subject to a final order of removal. The length of detention under this section shall not affect a detention under section 241. (g) Administrative review (1) Limitation The Attorney General’s review of the Secretary of Homeland Security’s custody determinations under subsection (a) shall be limited to whether the alien may be detained, released on bond (of at least $1,500 with security approved by the Secretary), or released with no bond. Any review involving an alien described in paragraph (2)(D) shall be limited to a determination of whether the alien is properly included in such category. (2) Classes of aliens The Attorney General shall review the Secretary’s custody determinations for— (A) aliens in exclusion proceedings; (B) aliens described in sections 212(a)(3) and 237(a)(4); (C) aliens described in subsection (c); and (D) aliens in deportation proceedings subject to section 242(a)(2) (as in effect between April 24, 1996, and April 1, 1997). (h) Release on bond (1) In general An alien detained under subsection (a) may seek release on bond. No bond may be granted under this subsection unless the alien establishes, by clear and convincing evidence, that the alien is not a flight risk or a risk to another person or the community. (2) Certain aliens ineligible No alien detained under subsection (c) may seek release on bond under this subsection. . 4. Aliens ordered removed Section 241(a) of the Immigration and Nationality Act ( 8 U.S.C. 1231(a) ) is amended— (1) by striking Attorney General each place such term appears (except for the first place it appears in paragraph (4)(B)(i)) and inserting Secretary of Homeland Security ; (2) in paragraph (1)— (A) by amending subparagraphs (B) and (C) to read as follows: (B) Beginning of period The removal period begins on the latest of— (i) the date on which the order of removal becomes administratively final; (ii) the date on which the alien is taken into such custody if the alien is not in the custody of the Secretary on the date on which the order of removal becomes administratively final; and (iii) the date on which the alien is taken into the custody of the Secretary after the alien is released from detention or confinement if the alien is detained or confined (except for an immigration process) on the date on which the order of removal becomes administratively final. (C) Suspension of period (i) Extension The removal period shall be extended beyond 90 days and the Secretary may, in the Secretary’s sole discretion, keep the alien in detention during such extended period, if— (I) the alien fails or refuses to make all reasonable efforts to comply with the removal order, or to fully cooperate with the Secretary’s efforts to establish the alien’s identity and carry out the removal order, including making timely application in good faith for travel or other documents necessary to the alien's departure or conspires or acts to prevent the alien's removal that is subject to an order of removal; (II) a court, the Board of Immigration Appeals, or an immigration judge orders a stay of removal of an alien who is subject to an administratively final order of removal; (III) the Secretary transfers custody of the alien pursuant to law to another Federal agency or a State or local government agency in connection with the official duties of such agency; or (IV) a court or the Board of Immigration Appeals orders a remand to an immigration judge or the Board of Immigration Appeals, during the time period when the case is pending a decision on remand (with the removal period beginning anew on the date that the alien is ordered removed on remand). (ii) Renewal If the removal period has been extended under clause (i), a new removal period shall be deemed to have begun on the date on which— (I) the alien makes all reasonable efforts to comply with the removal order, or to fully cooperate with the Secretary’s efforts to establish the alien’s identity and carry out the removal order; (II) the stay of removal is no longer in effect; or (III) the alien is returned to the custody of the Secretary. (iii) Mandatory detention for certain aliens The Secretary shall keep an alien described in subparagraphs (A) through (D) of section 236(c)(1) in detention during the extended period described in clause (i). (iv) Sole form of relief An alien may only seek relief from detention under this subparagraph by filing an application for a writ of habeas corpus in accordance with chapter 153 of title 28, United States Code. No alien whose period of detention is extended under this subparagraph shall have the right to seek release on bond. ; (3) in paragraph (3)— (A) in the matter preceding subparagraph (A), by inserting or is not detained pursuant to paragraph (6) after the removal period ; and (B) by amending subparagraph (D) to read as follows: (D) to obey reasonable restrictions on the alien’s conduct or activities that the Secretary prescribes for the alien— (i) to prevent the alien from absconding; (ii) for the protection of the community; or (iii) for other purposes related to the enforcement of Federal immigration laws. ; (4) in paragraph (4)(A), by striking paragraph (2) and inserting subparagraph (B) ; and (5) by amending paragraph (6) to read as follows: (6) Additional rules for detention or release of certain aliens (A) Detention review process for cooperative aliens established (i) In general The Secretary of Homeland Security shall establish an administrative review process to determine whether an alien who is not otherwise subject to mandatory detention, who has made all reasonable efforts to comply with a removal order and to cooperate fully with the Secretary’s efforts to establish the alien’s identity and carry out the removal order, including making timely application in good faith for travel or other documents necessary to the alien’s departure, and who has not conspired or acted to prevent removal should be detained or released on conditions. (ii) Determination The Secretary of Homeland Security shall make a determination whether to release an alien after the removal period in accordance with subparagraph (B), which— (I) shall include consideration of any evidence submitted by the alien; and (II) may include consideration of any other evidence, including— (aa) any information or assistance provided by the Secretary of State or other Federal official; and (bb) any other information available to the Secretary of Homeland Security pertaining to the ability to remove the alien. (B) Authority to detain beyond removal period (i) In general The Secretary of Homeland Security may continue to detain an alien for 90 days beyond the removal period (including any extension of the removal period under paragraph (1)(C)). An alien whose detention is extended under this subparagraph shall not have the right to seek release on bond. (ii) Specific circumstances The Secretary of Homeland Security may continue to detain an alien beyond the 90 days authorized under clause (i)— (I) until the alien is removed, if the Secretary determines that there is a significant likelihood that the alien— (aa) will be removed in the reasonably foreseeable future; (bb) would be removed in the reasonably foreseeable future; or (cc) would have been removed if the alien had not— (AA) failed or refused to make all reasonable efforts to comply with the removal order; (BB) failed or refused to cooperate fully with the Secretary’s efforts to establish the alien’s identity and carry out the removal order, including making timely application in good faith for travel or other documents necessary to the alien’s departure; or (CC) conspired or acted to prevent removal; (II) until the alien is removed, if the Secretary of Homeland Security certifies in writing— (aa) in consultation with the Secretary of Health and Human Services, that the alien has a highly contagious disease that poses a threat to public safety; (bb) after receipt of a written recommendation from the Secretary of State, that release of the alien is likely to have serious adverse foreign policy consequences for the United States; (cc) based on information available to the Secretary of Homeland Security (including classified, sensitive, or national security information, and without regard to the grounds upon which the alien was ordered removed), that there is reason to believe that the release of the alien would threaten the national security of the United States; or (dd) that the release of the alien will threaten the safety of the community or any person, conditions of release cannot reasonably be expected to ensure the safety of the community or of any person; (AA) the alien has been convicted of 1 or more aggravated felonies (as defined in section 101(a)(43)(A)) or of 1 or more crimes identified by the Secretary of Homeland Security by regulation, or of 1 or more attempts or conspiracies to commit any such aggravated felonies or such identified crimes, if the aggregate term of imprisonment for such attempts or conspiracies is at least 5 years; or (BB) the alien has committed 1 or more crimes of violence (as defined in section 16 of title 18, United States Code, but not including a purely political offense) and, because of a mental condition or personality disorder and behavior associated with that condition or disorder, the alien is likely to engage in acts of violence in the future; or (III) pending a certification under subclause (II), if the Secretary of Homeland Security has initiated the administrative review process not later than 30 days after the expiration of the removal period (including any extension of the removal period under paragraph (1)(C)). (iii) No right to bond hearing An alien whose detention is extended under this subparagraph shall not have a right to seek release on bond, including by reason of a certification under clause (ii)(II). (C) Renewal and delegation of certification (i) Renewal The Secretary of Homeland Security may renew a certification under subparagraph (B)(ii)(II) every 6 months after providing an opportunity for the alien to request reconsideration of the certification and to submit documents or other evidence in support of that request. If the Secretary does not renew a certification, the Secretary may not continue to detain the alien under subparagraph (B)(ii)(II). (ii) Delegation Notwithstanding section 103, the Secretary of Homeland Security may not delegate the authority to make or renew a certification described in item (bb), (cc), or (dd) of subparagraph (B)(ii)(II) below the level of the Assistant Secretary for Immigration and Customs Enforcement. (iii) Hearing The Secretary of Homeland Security may request that the Attorney General or the Attorney General’s designee provide for a hearing to make the determination described in subparagraph (B)(ii)(II)(dd)(BB). (D) Release on conditions If it is determined that an alien should be released from detention by a Federal court, the Board of Immigration Appeals, or if an immigration judge orders a stay of removal, the Secretary of Homeland Security may impose conditions on release as provided under paragraph (3). (E) Redetention (i) In general The Secretary of Homeland Security, without any limitations other than those specified in this section, may detain any alien subject to a final removal order who is released from custody if— (I) removal becomes likely in the reasonably foreseeable future; (II) the alien fails to comply with the conditions of release or to continue to satisfy the conditions described in subparagraph (A); or (III) upon reconsideration, the Secretary determines that the alien can be detained under subparagraph (B). (ii) Applicability This section shall apply to any alien returned to custody pursuant to this subparagraph as if the removal period terminated on the day of the redetention. (F) Review of determinations by secretary A determination by the Secretary under this paragraph shall not be subject to review by any other agency. . 5. Crime of violence defined Section 16(b) of title 18, United States Code, is amended— (1) by striking by its nature, involves and inserting based on the facts of the offense, involved ; and (2) by striking may be used and inserting may have been used . 6. Severability If any of the provisions of this Act, any amendment made by this Act, or the application of any such provision to any person or circumstance, is held to be invalid for any reason, the remainder of this Act, the amendments made by this Act, and the application of the provisions and amendments made by this Act to any other person or circumstance shall not be affected by such holding. 7. Effective dates (a) Apprehension and detention of aliens The amendments made by section 3 shall take effect on the date of the enactment of this Act. Section 236 of the Immigration and Nationality Act, as amended by section 3, shall apply to any alien in detention under the provisions of such section on or after such date of enactment. (b) Aliens ordered removed The amendments made by section 4 shall take effect on the date of the enactment of this Act. Section 241 of the Immigration and Nationality Act, as amended by section 4, shall apply to— (1) all aliens subject to a final administrative removal, deportation, or exclusion order that was issued before, on, or after the date of the enactment of this Act; and (2) acts and conditions occurring or existing before, on, or after such date of enactment. | https://www.govinfo.gov/content/pkg/BILLS-117s4370is/xml/BILLS-117s4370is.xml |
117-s-4371 | II 117th CONGRESS 2d Session S. 4371 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Padilla (for himself and Mrs. Feinstein ) introduced the following bill; which was read twice and referred to the Committee on Energy and Natural Resources A BILL To establish the César E. Chávez and the Farmworker Movement National Historical Park in the States of California and Arizona, and for other purposes.
1. Short title This Act may be cited as the César E. Chávez and the Farmworker Movement National Historical Park Act . 2. Findings and purpose (a) Findings Congress finds that— (1) the César E. Chávez National Monument was established by Presidential Proclamation 8884 ( 54 U.S.C. 320301 note) for the purposes of protecting and interpreting the nationally significant resources associated with the property in Keene, California, known as Nuestra Señora Reina de la Paz ; (2) Nuestra Señora Reina de la Paz— (A) served as the national headquarters of the United Farm Workers; and (B) was the home and workplace of César E. Chávez, the family of César E. Chávez, union members, and supporters of César E. Chávez; (3) while the César E. Chávez National Monument marks the extraordinary achievements and contributions to the history of the United States by César E. Chávez and the farmworker movement, there are other significant sites in the States of California and Arizona that are important to the story of the farmworker movement; and (4) in the study conducted by the National Park Service entitled Cesar Chavez Special Resource Study and Environmental Assessment and submitted to Congress on October 24, 2013, the National Park Service— (A) (i) found that several sites associated with César E. Chávez and the farmworker movement— (I) are suitable for inclusion in the National Park System; and (II) depict a distinct and important aspect of the history of the United States not otherwise adequately represented at existing units of the National Park System; and (ii) recommended that Congress establish a national historical park to honor the role that César E. Chávez played in lifting up the lives of farmworkers; and (B) (i) found that the route of the 1966 march from Delano to Sacramento, California— (I) is eligible for National Historic Landmark status; and (II) meets the criteria for designation as a national historic trail; and (ii) recommended that the National Park Service work with partner organizations and agencies to provide for interpretation programs along the route of the 1966 march from Delano to Sacramento, California. (b) Purpose The purpose of this Act is to establish the César E. Chávez and the Farmworker Movement National Historical Park— (1) to help preserve, protect, and interpret the nationally significant resources associated with César E. Chávez and the farmworker movement; (2) to interpret and provide for a broader understanding of the extraordinary achievements and contributions to the history of the United States made by César E. Chávez and the farmworker movement; and (3) to support and enhance the network of sites and resources associated with César E. Chávez and the farmworker movement. 3. Definitions In this Act: (1) Historical park The term historical park means the César E. Chávez and the Farmworker Movement National Historical Park established by section 4(a). (2) Map The term map means the map entitled César Chávez National Historical Park Proposed Boundary , numbered 502/179857, and dated March 2022. (3) Secretary The term Secretary means the Secretary of the Interior. (4) State The term State means each of— (A) the State of California; and (B) the State of Arizona. (5) Study The term Study means the study conducted by the National Park Service entitled Cesar Chavez Special Resource Study and Environmental Assessment and submitted to Congress on October 24, 2013. 4. César E. Chávez and the Farmworker Movement National Historical Park (a) Establishment There is established in the States a unit of the National Park System, to be known as the César E. Chávez and the Farmworker Movement National Historical Park . (b) Boundary The boundary of the historical park shall include the following areas, as generally depicted on the map: (1) The Forty Acres in Delano, California. (2) César E. Chávez National Monument, which includes Nuestra Señora Reina de la Paz, in Keene, California. (3) Santa Rita Center in Phoenix, Arizona. (c) Additional site On written agreement by the Secretary and the owner of the property indicating support for the inclusion, the Secretary may include within the boundary of the historical park McDonnell Hall in San Jose, California, as generally depicted on the map. (d) Availability of map The map shall be available for public inspection in the appropriate offices of the National Park Service. (e) Land acquisition The Secretary may acquire land and interests in land that are within the boundary of the historical park by— (1) donation; (2) purchase with donated or appropriated funds; or (3) exchange. (f) César E. Chávez National Monument Notwithstanding the inclusion of the César E. Chávez National Monument within the boundaries of the historical park, the César E. Chávez National Monument shall continue to be administered as a distinct and identifiable unit of the National Park System in accordance with Presidential Proclamation 8884 ( 54 U.S.C. 320301 note). (g) Administration (1) In general The Secretary shall administer the historical park in accordance with— (A) this section; and (B) the laws generally applicable to units of the National Park System, including— (i) section 100101(a), chapter 1003, and sections 100751(a), 100752, 100753, and 102101 of title 54, United States Code; and (ii) chapter 3201 of title 54, United States Code. (2) Interpretation The Secretary may provide technical assistance and public interpretation of historic sites, museums, and resources on land not administered by the Secretary relating to the life of César E. Chávez and the history of the farmworker movement. (3) Cooperative agreements The Secretary may enter into cooperative agreements with the States, local governments, public and private organizations, and individuals to provide for the preservation, development, interpretation, and use of the historical park. (h) General management plan (1) In general Not later than 3 years after the date on which funds are made available to carry out this section, the Secretary shall prepare a general management plan for the historical park in accordance with section 100502 of title 54, United States Code. (2) Additional sites (A) In general The general management plan shall include a determination of whether there are— (i) sites located in the Coachella Valley in the State of California that were reviewed in the Study that should be added to the historical park; (ii) additional representative sites in the States that were reviewed in the Study that should be added to the historical park; or (iii) sites outside of the States in the United States that relate to the farmworker movement that should be linked to, and interpreted at, the historical park. (B) Inclusion On a determination by the Secretary under subparagraph (A) that an additional site is appropriate for inclusion in the historical park, the Secretary may, with the consent of the owner of the applicable site, incorporate the applicable site into the historical park by publishing notice in the Federal Register of the inclusion of the site in the historical park. (3) Consultation The general management plan under paragraph (1) shall be prepared in consultation with— (A) any owner of land that is included within the boundaries of the historical park; and (B) appropriate Federal and State agencies, public and private organizations, and individuals, including— (i) the National Chávez Center; and (ii) the César Chávez Foundation. 5. Farmworker Peregrinación National Historic Trail Section 5(a) of the National Trails System Act ( 16 U.S.C. 1244(a) ) is amended by adding at the end the following: (31) Farmworker Peregrinación national historic trail (A) In general The Farmworker Peregrinación National Historic Trail (referred to in this paragraph as the trail ), a route of approximately 300 miles taken by farmworkers between Delano and Sacramento, California, in 1966, as generally depicted as Alternative C in the study conducted by the National Park Service entitled Cesar Chavez Special Resource Study and Environmental Assessment and submitted to Congress on October 24, 2013. (B) Map A map describing the trail shall be on file and available for public inspection in the appropriate offices of the National Park Service. (C) Administration The trail shall be administered by the Secretary of the Interior, in consultation with— (i) other Federal, State, Tribal, regional, and local agencies; and (ii) the private sector. (D) Land acquisition The United States shall not acquire for the trail any land or interest in land outside the exterior boundary of any federally managed area without the consent of the owner of the land or interest in land. (E) Cooperative agreements The Secretary of the Interior may enter into cooperative agreements with interested entities to provide for the preservation, development, interpretation, and use of the trail. . | https://www.govinfo.gov/content/pkg/BILLS-117s4371is/xml/BILLS-117s4371is.xml |
117-s-4372 | II 117th CONGRESS 2d Session S. 4372 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Thune (for himself and Ms. Sinema ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To require the Administrator of the Federal Aviation Administration to carry out a pilot program on developing and testing dynamic management of special activity airspace, and for other purposes.
1. Short title This Act may be cited as the Dynamic Airspace Pilot Program Act of 2022 . 2. Development and testing of dynamic scheduling and management of special activity airspace (a) Sense of Congress on special activity airspace scheduling and management It is the sense of Congress that— (1) where it does not conflict with safety, dynamic scheduling and management of special activity airspace (also referred to as dynamic airspace ) is expected to optimize the use of the national airspace system for all stakeholders; and (2) the Administrator of the Federal Aviation Administration and the Secretary of Defense should take such actions as may be necessary to support ongoing efforts to develop dynamic scheduling and management of special activity airspace, including— (A) the continuation of formal partnerships between the Federal Aviation Administration and the Department of Defense that focus on special activity airspace, future airspace needs, and joint solutions; and (B) maturing research within their federally funded research and development centers, Federal partner agencies, and the aviation community. (b) Pilot program (1) Pilot program required Not later than 90 days after the date of the enactment of this Act, the Administrator of the Federal Aviation Administration, in coordination with the Secretary of Defense, shall establish a pilot program on developing and testing dynamic management of special activity airspace in order to accommodate emerging military training requirements through flexible scheduling, along with increasing access to special activity airspace used by the Department of Defense for test and training. (2) Testing of special activity airspace scheduling and management Under the pilot program established under paragraph (1), the Administrator and the Secretary shall jointly test not fewer than three areas of episodic or permanent special activity airspace designated by the Federal Aviation Administration for use by the Department of Defense, of which— (A) at least one shall be over coastal waters of the United States; (B) at least two shall be over land of the United States; (C) access to airspace available for test and training is increased to accommodate dynamic scheduling of airspace to more efficiently and realistically provide test and training capabilities to Department of Defense aircrews; and (D) any increase in access to airspace made available for test and training shall not conflict with the safe management of the national airspace system or the safety of all stakeholders of the national airspace system. (c) Report by the Administrator (1) In general Not less than two years after the date of the establishment of the pilot program under subsection (b)(1), the Administrator shall submit to the appropriate committees of Congress a report on the interim findings of the Administrator with respect to the pilot program. (2) Elements The report submitted under paragraph (1) shall include the following: (A) An analysis of how the pilot program established under subsection (b)(1) affected access to special activity airspace by nonmilitary users of the national airspace system. (B) An analysis of whether the dynamic management of special activity airspace conducted for the pilot program established under subsection (b)(1) contributed to more efficient use of the national airspace system by all stakeholders. (d) Report by the secretary Not less than two years after the date of the establishment of the pilot program under subsection (b)(1), the Secretary shall submit to the appropriate committees of Congress a report on the interim findings of the Secretary with respect to the pilot program. Such report shall include an analysis of how the pilot program affected military test and training. (e) Definitions In this section: (1) The term appropriate committees of Congress means— (A) the Committee on Commerce, Science, and Transportation, the Committee on Armed Services, and the Committee on Appropriations of the Senate; and (B) the Committee on Transportation and Infrastructure, the Committee on Science, Space, and Technology, the Committee on Armed Services, and the Committee on Appropriations of the House of Representatives. (2) The term special activity airspace means the following airspace with defined dimensions within the National Airspace System wherein limitations may be imposed upon aircraft operations: (A) Restricted areas. (B) Military operations areas. (C) Air Traffic Control assigned airspace. (D) Warning areas. | https://www.govinfo.gov/content/pkg/BILLS-117s4372is/xml/BILLS-117s4372is.xml |
117-s-4373 | II 117th CONGRESS 2d Session S. 4373 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Leahy (for himself and Mr. Lee ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend title 18, United States Code, to modify delayed notice requirements, and for other purposes.
1. Short title This Act may be cited as the NDO Fairness Act . 2. Delay of notification Section 2705(a) of title 18, United States Code, is amended to read as follows: (a) Delay of notification (1) Application A governmental entity that is seeking a warrant, order, or subpoena under section 2703 may include in the application (or motion in the case of an administrative subpoena authorized by a Federal or State statute or a Federal or State grand jury or trial subpoena) a request to a court of competent jurisdiction for an order delaying the notification under section 2703 for a period of not more than 60 days. (2) Determination The court may not grant a request for delayed notification to a customer or subscriber made under paragraph (1), or an extension of such delayed notification requested by the governmental entity pursuant to paragraph (3), unless the court issues a written determination, based on specific and articulable facts, and including written findings of fact and conclusions of law, that it is substantially likely that the notification of the customer or subscriber of the existence of the warrant, order, or subpoena will result in— (A) endangering the life or physical safety of an individual; (B) flight from prosecution; (C) destruction of or tampering with evidence; (D) intimidation of potential witnesses; or (E) otherwise seriously jeopardizing an investigation or unduly delaying a trial. (3) Extension The governmental entity may request one or more extensions of the delay of notification granted under paragraph (2) for a period of not more than 60 days for each such extension. The court may only grant such an extension if the court makes a written determination required under paragraph (2) and the extension is in accordance with the requirements of such paragraph. (4) Expiration of delay of notification Upon expiration of the period of delay of notification and all extensions thereof under paragraphs (2) and (3) of this subsection, the governmental entity shall deliver to the customer or subscriber by at least 2 methods, which shall be personal service, registered or first-class mail, electronic mail, or other means approved by the court, as reasonably calculated to reach the customer or subscriber within 72 hours of the expiration of the delay— (A) a copy of the warrant, order, or subpoena; and (B) notice that informs such customer or subscriber— (i) of the nature of the inquiry made by the governmental entity, with reasonable specificity; (ii) that information maintained for such customer or subscriber by the provider of electronic communications service or remote computing service to which the warrant, order, or subpoena under section 2703 was directed, was supplied to or requested by the governmental entity; (iii) that notification of such customer or subscriber was delayed by court order; (iv) the identity of the court that issued such order; (v) the provision of law under which the order delaying notification was authorized; and (vi) that the governmental entity will, upon request by the customer or subscriber made within 180 days after receiving notification under this paragraph, provide the customer or subscriber with a copy of the information that was disclosed in response to the warrant, order, or subpoena, or in the event that no information was disclosed, a written certification that no information was disclosed. (5) Copy of information disclosed Upon expiration of the period of delay of notification under paragraph (2) or (3) of this subsection, and at the request of the customer or subscriber made within 180 days of receiving notification under paragraph (4), the governmental entity shall promptly provide the customer or subscriber— (A) with a description of the information disclosed and a copy of the information that was disclosed in response to the warrant, order, or subpoena; or (B) in the event that no information was disclosed, with a written certification that no information was disclosed. . 3. Preclusion of notice Section 2705(b) of title 18, United States Code, is amended to read as follows: (b) Preclusion of Notice (1) Application A governmental entity that is seeking a warrant, order, or subpoena under section 2703, when it is not required to notify the customer or subscriber, or to the extent that it may delay such notice pursuant to subsection (a), may apply to a court for an order, subject to paragraph (6), directing a provider of electronic communications service or remote computing service to which a warrant, order, or subpoena under section 2703 is directed not to notify any other person of the existence of the warrant, order, or subpoena for a period of not more than either 60 days or the period of delay of notice provided under subsection (a), if any. (2) Determination The court may not grant a request for an order made under paragraph (1), or an extension of such order requested by the governmental entity pursuant to paragraph (3), unless— (A) the court issues a written determination, based on specific and articulable facts, and including written findings of fact and conclusions of law, that it is substantially likely that not granting the request will result in— (i) endangering the life or physical safety of an individual; (ii) flight from prosecution; (iii) destruction of or tampering with evidence; (iv) intimidation of potential witnesses; or (v) otherwise seriously jeopardizing an investigation or unduly delaying a trial; and (B) the order is narrowly tailored and there is no less restrictive alternative, including notification to an individual or organization within or providing legal representation to the customer or subscriber, to avoid an adverse result as described in clauses (i) through (v) of subparagraph (A). (3) Extension A governmental entity may request one or more extensions of an order granted under paragraph (2) of not more than 60 days for each such extension. The court may only grant such an extension if the court makes a written determination required under paragraph (2)(A) and the extension is in accordance with the requirements of (2)(B). (4) Notification of changed circumstances If the need for the order issued under paragraph (2) changes materially, the governmental entity that requested the order shall notify the court within 72 hours of the changed circumstances, and the court shall reassess the order and modify or vacate as appropriate. (5) Opportunity to be heard (A) In general Upon an application, petition, or motion by a provider of electronic communications service or remote computing service or person acting on behalf of the provider to which an order under paragraph (2) (or an extension under paragraph (3)) has been issued, the court may modify or vacate the order if— (i) the order does not meet requirements provided in paragraph (2); or (ii) compliance with the order is unreasonable or otherwise unlawful. (B) Stay of disclosure of customer or subscriber communications or records A provider's obligation to disclose the information requested in the warrant, order, or subpoena to which the order in paragraph (1) applies is stayed upon the filing of the application, petition, or motion under this paragraph pending resolution of the application, petition, or motion, unless the court with jurisdiction over the challenge determines based on a showing by the governmental entity that the stay should be lifted in whole or in part prior to resolution. (C) Finality of order The decision of the court resolving an application, petition, or motion under this paragraph shall constitute a final, appealable order. (6) Exception A provider of electronic communications service or remote computing service to which an order under paragraph (2) applies, or an officer, employee, or agent thereof, may disclose information otherwise subject to any applicable nondisclosure requirement to— (A) those persons to whom disclosure is necessary in order to comply with the warrant, order, or subpoena; (B) an attorney in order to obtain legal advice or assistance regarding the warrant, order, or subpoena; and (C) any person the court determines can be notified of the warrant, order, or subpoena. (7) Scope of nondisclosure Any person to whom disclosure is made under paragraph (6) (other than the governmental entity) shall be subject to the nondisclosure requirements applicable to the person to whom the order is issued. Any recipient authorized under this subsection to disclose to a person information otherwise subject to a nondisclosure requirement shall notify the person of the applicable nondisclosure requirement. (8) Supporting documentation Upon serving a provider of electronic communications service or remote computing service with an order granted under paragraph (2), or an extension of such order granted under paragraph (3), the governmental entity shall include a copy of the warrant, order, or subpoena to which the nondisclosure order applies. (9) Expiration of order precluding notice Upon expiration of an order issued under paragraph (2) or, if an extension has been granted under paragraph (3), expiration of the extension, the governmental entity shall deliver to the customer or subscriber, by at least 2 methods, which shall be personal service, registered or first-class mail, electronic mail, or other means approved by the court as reasonably calculated to reach the customer or subscriber within 72 hours of the expiration of the order— (A) a copy of the warrant, order, or subpoena; and (B) notice that informs the customer or subscriber— (i) of the nature of the law enforcement inquiry with reasonable specificity; (ii) that information maintained for such customer or subscriber by the provider of electronic communications service or remote computing service to which the warrant, order, or subpoena under section 2703, was directed was supplied to or requested by the government entity; (iii) that notification of such customer or subscriber was precluded by court order; (iv) of the identity of the court authorizing the preclusion of notice; (v) of the provision of this chapter under which the preclusion of notice was authorized; and (vi) that the government will, upon request by the customer or subscriber made within 180 days after receiving notification under this paragraph, provide the customer or subscriber with a copy of the information that was disclosed in response to the warrant, order or subpoena, or in the event that no information was disclosed, a written certification that no information was disclosed. (10) Copy of information disclosed Upon expiration of the order precluding notice issued under paragraph (2) or (3) of this subsection, and at the request of the customer or subscriber made within 180 days of receiving notification under paragraph (9), the governmental entity shall promptly provide the customer or subscriber— (A) with a copy of the information that was disclosed in response to the warrant, order or subpoena; or (B) in the event that no information was disclosed, a written certification that no information was disclosed. . 4. Additional provisions regarding delayed notice Section 2705 of title 18, United States Code, is amended by adding at the end the following: (c) Annual report On an annual basis, the Attorney General shall provide to the Committee on the Judiciary of the House of Representatives and the Committee on the Judiciary of the Senate, in a manner consistent with protection of national security, a report setting forth with respect to the preceding calendar year, for each Federal judicial district— (1) the number of customers or subscribers with respect to whom, in that calendar year, a warrant, subpoena, or court order was issued pursuant to section 2703; (2) the aggregate number of applications requesting delay of notification pursuant to subsections (a)(1) and (b)(1); (3) the aggregate number of orders under this section either granting, extending, or denying a request for delay of notification; (4) the aggregate number of orders under this section affecting a member of the news media, including any conduct related to activities protected under the First Amendment; and (5) the aggregate number of arrests, trials, and convictions, resulting from investigations in which orders under this section were obtained, including the offenses for which individuals were arrested, tried, or convicted. The Attorney General shall include in the report under this subsection a description of the process and the information used to determine the numbers for each of paragraphs (1) through (5). . | https://www.govinfo.gov/content/pkg/BILLS-117s4373is/xml/BILLS-117s4373is.xml |
117-s-4374 | II 117th CONGRESS 2d Session S. 4374 IN THE SENATE OF THE UNITED STATES June 9, 2022 Ms. Warren introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To prevent price gouging at the Department of Defense.
1. Short title This Act may be cited as the Stop Price Gouging the Military Act . 2. Strengthening Truth in Negotiations Act provisions (a) Required cost or pricing data and certification Section 3702(a)(1) of title 10, United States Code, is amended by striking only expected to receive one bid shall be required and replacing with only expected to have one offeror, or for which award of a cost-reimbursement contract is contemplated regardless of the number of offers received, shall be required . (b) Exceptions Section 3703(a) of title 10, United States Code, is amended— (1) in paragraph (1)(A), by striking adequate competition and all that follows through bids and inserting adequate price competition, except for the award of a cost-reimbursement contract, that results in at least two responsive and viable competing offerors ; and (2) in paragraph (2), by inserting based on adequate price competition that results in at least two responsive and responsible offers after commercial service . (c) Conforming amendment related to civilian contracts Section 3503(a)(2) of title 41, United States Code is by inserting after commercial service the following: based on adequate price competition that results in at least two responsive and responsible offers . 3. Revision of definition of term commercial item for purposes of Federal procurement statutes providing procedures for procurement of commercial items (a) Elimination of of a type criterion Section 103 of title 41, United States Code, is amended by striking of a type each place it appears. (b) Elimination of items and services merely offered for sale, lease, or license (1) Items Section 103(1)(B) of title 41, United States Code, is amended by striking , or offered for sale, lease, or license, . (2) Services Section 103a(2) of title 41, United States Code, is amended by striking offered and . 4. Progress payment incentive pilot (a) Pilot program The Secretary of Defense, acting through the Under Secretary of Defense for Acquisition and Sustainment, shall establish and implement a pilot program, to be known as the Progress Payment Incentive Pilot Program , to make accelerated progress payments contingent upon responsiveness to Department of Defense goals for effectiveness, efficiency, and increasing small business contract opportunities. (b) Purpose The purpose of the pilot program is to reward Department of Defense contractors who meet contract delivery dates, respond to Department solicitations for required certified cost or pricing data, meet small business contracting goals, and provide subcontracting opportunities for AbilityOne contracts. (c) Progress payments (1) Limitations for large contractors Except as provided under paragraph (2), under the pilot program, the Department of Defense may not award to large business contractors progress payments in excess of 50 percent. (2) Exceptions The Department of Defense may increase the rate of progress payments, up to a total of 95 percent, by the following percentages: (A) 10 percent if the relevant division of the contractor met contract delivery dates for contract end items and contract data requirement lists or performance milestone schedule, as the case may be, at least 95 percent of the time during the preceding Government fiscal year. (B) 10 percent if the division does not have open level III or IV corrective action requests. (C) 7.5 percent if all applicable contractor business systems are acceptable, without significant deficiencies. (D) 10 percent if at least 95 percent of the time during the preceding Government fiscal year, when responding to solicitations that required submission of certified cost or pricing data, the division met the due date in the request for proposal. (E) 5 percent if the contractor discloses first tier subcontractor data, the prime contractor’s beneficial owners, and total compensation for recipient executives. (F) 5 percent if the contractor has met its small business subcontracting goals during the preceding Government fiscal year. (G) 3 percent if the contractor has provided subcontracting opportunities for the blind and severely disabled. (d) Definitions In this section: (1) Beneficial owners The term beneficial owner has the meaning given the term in section 847 of the National Defense Authorization Act for Fiscal Year 2020 ( Public Law 116–92 ; 133 Stat. 1505; 10 U.S.C. 2509 note). (2) Compensation for recipient executives The term compensation for recipient executives refers to the names and total compensation of the five most highly compensated officers of the entity pursuant to section 2(b)(1) of the Federal Funding Accountability and Transparency Act of 2006 ( Public Law 109–282 ; 31 U.S.C. 6101 note). (3) First tier subcontractor The term first tier subcontractor means a subcontractor who has a subcontract directly with the prime contractor. (4) Large defense contractor The term large defense contractor means a contractor (other than an institute of higher education or a federally funded research and development center) that received more than $10,000,000 in annual revenue from the Department of Defense contracts or licenses in any of the previous three years. (5) Progress payments The term progress payments means payments provided for under section 3804 of title 10, United States Code. 5. Disclosure by large defense contractors (a) Annual reporting Not later than 60 days after the date of the enactment of this Act, the Secretary of Defense shall amend the Department of Defense Supplement to the Federal Acquisition Regulation to provide that large defense contractors shall be required to annually report to the Under Secretary of Defense for Acquisition and Sustainment the following information with regard to the covered year, as compared with the year preceding that covered year: (1) The percentage change in the volume of goods or services sold and the percentage change in the average sales price of those goods or services, which shall be broken down by material product categories, when relevant, and presented in a tabular format. (2) The gross margins of the large defense contractor, which shall be broken down by material product categories, when relevant, and presented in a tabular format. (3) Presented in tabular format, the share of the increase in revenue of the large defense contractor that is attributable to— (A) a change in the cost of goods or services sold by the large defense contractor; and (B) a change in the volume of goods or services sold by the large defense contractor. (4) The percentage change in the costs of the large defense contractor, which shall be broken down by category and presented in tabular format. (5) In dollars, the change in the costs of the large defense contractor, which shall be presented in tabular format. (6) A detailed narrative disclosure of the pricing strategy of the large defense contractor, which shall include— (A) an explanation for any increase in the gross margins of material product categories, including— (i) all material causes for such an increase; (ii) an explanation of how each such material cause affected such an increase; and (iii) a description of the relative importance of each such material cause with respect to such an increase; (B) an explanation for the decisions made by the large defense contractor with respect to the prices of goods and services sold by the large defense contractor; (C) if the large defense contractor increased prices at a rate that was greater than the rate at which the costs incurred by the large defense contractor increased, the rationale and objectives for increasing prices in such a manner; and (D) a description of conditions under which the large defense contractor plans to modify pricing after the date on which the large defense contractor submits the report. (b) Publication The Under Secretary of Defense for Acquisition and Sustainment shall annually publish on a publicly available internet website the previous year’s reports received under subsection (a). (c) Penalties A knowing failure to disclose or update information in accordance with subsection (a) may result in— (1) entry of the violation in the database for Federal agency contract and grant officers and suspension and debarment officials defined in section 2313 of title 41, United States Code; (2) imprisonment for not more than 5 years or a fine under title 18, United States Code, or both; (3) a civil fine of not more than $200,000, depending on the extent and gravity of the violation; (4) liability pursuant to section 3729 of title 31, United States Code; or (5) suspension or debarment. (d) Large defense contractor defined In this section, the term large defense contractor means a contractor (other than an institute of higher education or a federally funded research and development center) that— (1) received more than $10,000,000 in annual revenue from the Department of Defense contracts or licenses in any of the previous three years; and (2) earned more than 20 percent of its total annual revenue from Department of Defense contracts or licenses in any of the previous three fiscal years. | https://www.govinfo.gov/content/pkg/BILLS-117s4374is/xml/BILLS-117s4374is.xml |
117-s-4375 | II 117th CONGRESS 2d Session S. 4375 IN THE SENATE OF THE UNITED STATES June 9, 2022 Ms. Murkowski (for herself and Mr. Sullivan ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To amend titles 10 and 37, United States Code, to establish special pay and allowances for members of the Armed Forces assigned to cold weather operations, and for other purposes.
1. Short title This Act may be cited as the Don Young Arctic Warrior Act . 2. Special pay and allowances for certain members of the Armed Forces assigned to cold weather operations (a) Special pay (1) Establishment Subchapter II of chapter 5 of title 37, United States Code, is amended by inserting after section 336 the following new section: 337. Special pay: members of the Armed Forces assigned to cold weather operations (a) Special pay authorized The Secretary concerned shall pay monthly special pay (to be known as arctic pay ) to a member of the Armed Forces— (1) assigned to perform cold weather operations; or (2) required to maintain proficiency through frequent operations in cold weather. (b) Amount of pay Special pay under this section shall equal $300 per month. (c) Relationship to other pay or allowances Special pay under this section is in addition to any other pay or allowance to which a member is entitled. (d) Sunset No special pay may be paid under this section after December 31, 2023. . (2) Clerical amendment The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 336 the following: 337. Special pay: members of the armed forces assigned to cold weather operations. . (3) Regulations The Secretary of Defense shall prescribe regulations for the payment of arctic pay under section 337 of such title, as added by paragraph (1). (b) Allowance for broadband (1) Establishment Chapter 7 of title 37, United States Code, is amended by inserting after section 425 the following new section: 426. Allowance for broadband for certain members of the Armed Forces assigned to permanent duty stations in Alaska (a) Allowance authorized The Secretary concerned shall pay, to a member of the Armed Forces in the grade of E–5 or below who is assigned to a permanent duty station in Alaska, a monthly allowance for broadband. (b) Amount The monthly allowance to a member under this section shall be— (1) $125 during calendar year 2023; and (2) in subsequent calendar years, an amount determined by the Secretary of Defense based on the difference between the average costs of unlimited broadband plans in Alaska and in the continental United States. (c) Sunset No allowance may be paid under this section after December 31, 2028. . (2) Clerical amendment The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 425 the following: 426. Allowance for broadband for certain members of the Armed Forces assigned to permanent duty stations in Alaska. . (3) Effective date Section 426 of such title, as added by paragraph (1), shall take effect on the day the Secretary of Defense prescribes regulations under paragraph (4). (4) Regulations Not later than 180 days after the date of the enactment of this Act, the Secretary of Defense shall prescribe regulations to carry out section 426 of such title, as added by paragraph (1). (5) Report Not later than December 31, 2027, the Secretary of Defense shall submit to the Committees on Armed Services of the Senate and the House of Representatives a report containing— (A) the evaluation of the Secretary of the allowance under section 426 of such title, as added by paragraph (1); and (B) any recommendation of the Secretary regarding whether such allowance should be amended, extended, or made permanent. (c) Travel and transportation allowance (1) Entitlement Not later than 90 days after the date of the enactment of this Act, the Secretary of Defense shall prescribe regulations and guidance that entitle a member of the Armed Forces in the grade of E–5 or below who is assigned to a permanent duty station in Alaska to a one-time allowance for air travel for the member and dependents of such member. (2) Amounts (A) Travel to permanent residence If the air travel for which an allowance under paragraph (1) is paid to a member is to the permanent residence of the member, the amount of the allowance shall equal the total costs of such air travel. (B) Travel to other destinations If the air travel for which an allowance under paragraph (1) is paid to a member is to a destination in the United States other than the permanent residence of the member, the amount of the allowance shall be equal to the lesser of the following: (i) The rate for such air travel under the City Pair Program of the General Services Administration (or successor program) in effect at the time of such air travel. (ii) The actual costs of such air travel. (3) Timing Air travel for which an allowance under paragraph (1) is paid to a member may not commence later than 30 months after the member is assigned to a permanent duty station in Alaska. (4) Additional authorization The Secretary concerned (as defined in section 101 of title 37, United States Code) may authorize an additional allowance for a member who has used the allowance to which such member is entitled under paragraph (1). 3. Pilot program on car sharing on remote military installations (a) Establishment Not later than 180 days after the date of the enactment of this Act, the Secretary of Defense shall seek to carry out a pilot program to allow car sharing at military installations in Alaska. (b) Program elements To carry out a pilot program under this section, the Secretary shall take steps including the following: (1) Seek to enter into an agreement with an entity that— (A) provides car sharing services; and (B) is capable of serving all military installations in Alaska. (2) Provide to members assigned to such installations the resources the Secretary determines necessary to participate in such pilot program. (3) Promote such pilot program to such members. (c) Implementation plan Not later than 90 days after the date the Secretary enters into an agreement under subsection (b)(1), the Secretary shall submit to the congressional defense committees a plan to carry out the pilot program. (d) Duration A pilot program under this section shall terminate two years after the Secretary commences such pilot program. (e) Report Upon the termination of a pilot program under this section, the Secretary of Defense shall submit to the congressional defense committees a report containing the following information: (1) The number of individuals who used car sharing services offered pursuant to the pilot program. (2) The cost to the United States of the pilot program. (3) An analysis of the effect of the pilot program on mental health and community connectedness of members described in subsection (b)(2). (4) Other information the Secretary determines appropriate. (f) Definitions In this section: (1) Congressional defense committees The term congressional defense committees has the meaning given that term in section 101(a) of title 10, United States Code. (2) Military installation The term military installation has the meaning given that term in section 2801 of title 10, United States Code. 4. Clarification regarding licensure requirements for provision of non-medical counseling services by certain health-care professionals Section 1094 of title 10, United States Code is amended— (1) in subsection (d)(1), by inserting , including by providing non-medical counseling services in connection with such practice, after the health profession or professions of the health-care professional ; and (2) in subsection (e), by adding at the end the following new paragraph: (3) The term non-medical counseling — (A) means short-term, non-therapeutic counseling that is not an appropriate substitute for individuals in need of clinical therapy; and (B) includes counseling that is supportive in nature and addresses issues such as general conditions of living, life skills, improving relationships at home and at work, stress management, adjustment issues (such as those related to returning from a deployment), marital problems, parenting, and grief and loss. . 5. Improvements relating to behavioral health care available under military health system (a) Expansion of certain behavioral health programs at the Uniformed Services University of the Health Sciences (1) Establishment of graduate programs The Secretary of Defense shall establish graduate degree-granting programs in counseling and social work at the Uniformed Services University of the Health Sciences. (2) Expansion of clinical psychology graduate program The Secretary of Defense shall take such steps as may be necessary to expand the clinical psychology graduate program of the Uniformed Services University of the Health Sciences. (3) Post-award employment obligation (A) Agreement with Secretary Subject to subparagraph (B), as a condition of enrolling in a degree-granting program in clinical psychology, social work, or counseling at the Uniformed Services University of the Health Sciences, a civilian student shall enter into an agreement with the Secretary of Defense pursuant to which the student agrees that, if the student does not become a member of a uniformed service upon graduating such program, the student shall work on a full-time basis as a covered civilian behavioral health provider for a period that is at least equivalent to the period during which the student was enrolled in such program. (B) Other terms and conditions An agreement entered into pursuant to subparagraph (A) may include such other terms and conditions as the Secretary of Defense may determine necessary to protect the interests of the United States or otherwise appropriate for purposes of this section, including terms and conditions providing for limited exceptions from the employment obligation specified in such subparagraph. (C) Repayment (i) In general A civilian graduate who does not complete the employment obligation required under the agreement entered into pursuant to subparagraph (A) shall repay to the Secretary of Defense a prorated portion of the cost of attendance in the program described in such subparagraph that are paid by the Secretary on behalf of the civilian graduate. (ii) Determination of amount The amount of any repayment required under clause (i) shall be determined by the Secretary. (D) Applicability This paragraph shall apply to civilian students who enroll in the first year of a degree-granting program in clinical psychology, social work, or counseling at the Uniformed Services University of the Health Sciences on or after the date of the enactment of this Act. (4) Implementation plan (A) In general Not later than one year after the date of the enactment of this Act, the Secretary shall submit to the congressional defense committees a plan for the implementation of this subsection. (B) Elements The plan required by subparagraph (A) shall include— (i) a determination as to the resources for personnel and facilities required for the implementation of this subsection; (ii) estimated timelines for such implementation; and (iii) a projection of the number of graduates from the programs specified in paragraph (1) upon the completion of such implementation. (b) Scholarship-for-Service program for civilian behavioral health providers (1) In general Beginning not later than two years after the date of the enactment of this Act, the Secretary of Defense shall carry out a program under which— (A) the Secretary may provide— (i) direct grants to cover tuition, fees, living expenses, and any other cost of attendance at an institution of higher education to an individual enrolled in a program of study leading to a graduate degree in clinical psychology, social work, counseling, or a related field (as determined by the Secretary); and (ii) student loan repayment assistance to a credentialed behavioral health provider who has a graduate degree in clinical psychology, social work, counseling, or a related field (as determined by the Secretary); and (B) in exchange for such assistance, the recipient shall commit to work as a covered civilian behavioral health provider in accordance with paragraph (2). (2) Post-award employment obligations (A) In general Subject to subparagraph (B), as a condition of receiving assistance under paragraph (1), the recipient of such assistance shall enter into an agreement with the Secretary of Defense pursuant to which the recipient agrees to work on a full-time basis as a covered civilian behavioral health provider for a period that is at least equivalent to the period during which the recipient received assistance under such paragraph. (B) Other terms and conditions An agreement entered into pursuant to subparagraph (A) may include such other terms and conditions as the Secretary of Defense may determine necessary to protect the interests of the United States or otherwise appropriate for purposes of this section, including terms and conditions providing for limited exceptions from the post-award employment obligation specified in such subparagraph. (3) Repayment (A) In general An individual who receives assistance under paragraph (1) and does not complete the employment obligation required under the agreement entered into pursuant to paragraph (2) shall repay to the Secretary of Defense a prorated portion of the financial assistance received by the individual under paragraph (1). (B) Determination of amount The amount of any repayment required under subparagraph (A) shall be determined by the Secretary. (4) Implementation plan Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a plan for the implementation of this subsection. (c) Internship programs for civilian behavioral health (1) Establishment of programs The Secretary of Defense shall establish paid pre-doctoral and post-doctoral internship programs for the purpose of training clinical psychologists to work as covered civilian behavioral health providers. (2) Employment obligation (A) In general Subject to subparagraph (B), as a condition of participating in an internship program under paragraph (1), an individual shall enter into an agreement with the Secretary of Defense pursuant to which the individual agrees to work on a full-time basis as a covered civilian behavioral health provider for a period that is at least equivalent to the period of participation by the individual in such internship program. (B) Other terms and conditions An agreement entered into pursuant to subparagraph (A) may include such other terms and conditions as the Secretary of Defense may determine necessary to protect the interests of the United States or otherwise appropriate for purposes of this section, including terms and conditions providing for limited exceptions from the employment obligation specified in such subparagraph. (3) Repayment (A) In general An individual who participates in an internship program under paragraph (1) and does not complete the employment obligation required under the agreement entered into pursuant to paragraph (2) shall repay to the Secretary of Defense a prorated portion of the cost of administering such program with respect to such individual and of any payment received by the individual under such program. (B) Determination of amount The amount of any repayment required under subparagraph (A) shall be determined by the Secretary. (4) Implementation plan Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a plan for the implementation of this subsection. (d) Retention bonuses for certain behavioral health providers (1) Retention bonus From amounts available in the Department of Defense Civilian Workforce Incentive Fund established under section 9902(a)(3) of title 5, United States Code, the Secretary of Defense may pay an incentive payment of not more than $50,000 annually per employee to employees described in paragraph (2) for the purposes of retaining such employees. (2) Eligible recipients of bonus Employees described in this paragraph are covered civilian behavioral health providers in the following professions: (A) Clinical psychologists. (B) Social workers. (C) Counselors. (e) Report on behavioral health workforce (1) In general Not later than 90 days after the date of the enactment of this Act, the Secretary of Defense shall conduct an analysis of the behavioral health workforce under the direct care component of the TRICARE program and submit to the congressional defense committees a report containing the results of such analysis. (2) Elements The report required under paragraph (1) shall include, with respect to the workforce specified in such paragraph, the following: (A) The number of positions authorized for military behavioral health providers within such workforce, and the number of such positions filled, disaggregated by the professions described in paragraph (3). (B) The number of positions authorized for civilian behavioral health providers within such workforce, and the number of such positions filled, disaggregated by the professions described in paragraph (3). (C) For each military department, the ratio of military behavioral health providers assigned to military medical treatment facilities compared to civilian behavioral health providers so assigned, disaggregated by the professions described in paragraph (3). (D) For each military department, the number of military behavioral health providers authorized to be embedded within an operational unit, and the number of such positions filled, disaggregated by the professions described in paragraph (3). (E) Data on the historical demand for behavioral health services by members of the Armed Forces. (F) An estimate of the number of health care providers necessary to meet the demand by such members for behavioral health services under the direct care component of the TRICARE program, disaggregated by provider type. (G) An identification of any shortfall between the estimated number under subparagraph (F) and the total number of positions for behavioral health providers filled within such workforce. (H) Such other information as the Secretary may determine appropriate. (3) Provider types The professions described in this paragraph are as follows: (A) Clinical psychologists. (B) Social workers. (C) Counselors. (D) Such other professions as the Secretary may determine appropriate. (f) Plan To address shortfalls in behavioral health workforce (1) In general Not later than 180 days after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a plan to address any shortfall of the behavioral health workforce identified under subsection (e)(2)(G). (2) Elements The plan required by paragraph (1) shall— (A) address, with respect to any shortfall of military behavioral health providers (addressed separately with respect to such providers assigned to military medical treatment facilities and such providers assigned to be embedded within operational units)— (i) recruitment; (ii) accession; (iii) retention; (iv) special pay and other aspects of compensation; (v) workload; (vi) the role of the Uniformed Services University of the Health Sciences and the Armed Forces Health Professions Scholarship Program under chapter 105 of title 10, United States Code; (vii) any additional authorities or resources necessary for the Secretary to increase the number of such providers; and (viii) such other considerations as the Secretary may consider appropriate; (B) address, with respect to any shortfall of civilian behavioral health providers— (i) recruitment; (ii) hiring; (iii) retention; (iv) pay and benefits; (v) workload; (vi) educational scholarship programs; (vii) any additional authorities or resources necessary for the Secretary to increase the number of such providers; and (viii) such other considerations as the Secretary may consider appropriate; (C) recommend whether the number of military behavioral health providers in each military department should be increased, and if so, by how many; (D) include a plan to expand access to behavioral health services under the military health system through the use of telehealth; (E) include a plan by each military department to allocate additional uniformed mental health providers in military medical treatment facilities at remote installations; and (F) assess the feasibility of hiring civilian mental health providers at remote installations to augment the provision of mental health care services by uniformed mental health providers. (g) Definitions In this section: (1) Armed Forces; congressional defense committees The terms Armed Forces and congressional defense committees have the meanings given those terms in section 101 of title 10, United States Code. (2) Behavioral health The term behavioral health includes psychiatry, clinical psychology, social work, counseling, and related fields. (3) Civilian behavioral health provider The term civilian behavioral health provider means a behavioral health provider who is a civilian employee of the Department of Defense. (4) Cost of attendance The term cost of attendance has the meaning given that term in section 472 of the Higher Education Act of 1965 ( 20 U.S.C. 1087ll ). (5) Covered civilian behavioral health provider The term covered civilian behavioral health provider means a civilian behavioral health provider whose employment by the Secretary of Defense involves the provision of behavioral health services at a military medical treatment facility. (6) Institution of higher education The term institution of higher education has the meaning given that term in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ). (7) Military behavioral health provider The term military behavioral health provider means a behavioral health provider who is a member of the Armed Forces. (8) TRICARE program The term TRICARE program has the meaning given that term in section 1072(7) of title 10, United States Code. (9) Uniformed Services University of the Health Sciences The term Uniformed Services University of the Health Sciences means the university established under section 2112 of title 10, United States Code. 6. Pilot program on safe storage of personally owned firearms (a) Establishment The Secretary of Defense shall establish a pilot program to promote the safe storage of personally owned firearms. (b) Voluntary participation Participation by members of the Armed Forces in the pilot program under subsection (a) shall be on a voluntary basis. (c) Elements Under the pilot program under subsection (a), the Secretary of Defense shall furnish to members of the Armed Forces who are participating in the pilot program at military installations selected under subsection (e) locking devices and firearm safes for the purpose of securing personally owned firearms when not in use (including by directly providing, subsidizing, or otherwise making available such devices or safes). (d) Plan Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall submit to the congressional defense committees a plan for the implementation of the pilot program under subsection (a). (e) Selection of installations Not later than two years after the date of the enactment of this Act, the Secretary of Defense shall select not fewer than five military installations at which to carry out the pilot program under subsection (a). (f) Duration The duration of the pilot program under subsection (a) shall be for a period of six years. (g) Report Upon the termination of the pilot program under subsection (a), the Secretary of Defense shall submit to the congressional defense committees a report containing the following information: (1) The number and type of locking devices and firearm safes furnished to members of the Armed Forces under the pilot program. (2) The cost of carrying out the pilot program. (3) An analysis of the effect of the pilot program on suicide prevention. (4) Such other information as the Secretary may determine appropriate, which shall exclude any personally identifiable information about participants in the pilot program. (h) Definitions In this section, the terms Armed Forces and congressional defense committees have the meanings given those terms in section 101 of title 10, United States Code. | https://www.govinfo.gov/content/pkg/BILLS-117s4375is/xml/BILLS-117s4375is.xml |
117-s-4376 | II 117th CONGRESS 2d Session S. 4376 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Cotton (for himself, Mr. Cassidy , Mr. Hawley , Mr. Young , Mr. Tillis , Mrs. Blackburn , Mr. Daines , Mr. Kennedy , and Mr. Thune ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To amend title 18, United States Code, relating to sentencing of armed career criminals.
1. Short title This Act may be cited as the Stop Gun Criminals Act . 2. Amendments to the Armed Career Criminal Act Section 924 of title 18, United States Code, is amended— (1) in subsection (a)(2)— (A) by striking violates subsection and inserting the following: violates— (A) subsection ; (B) in subparagraph (A), as so designated, by striking (g) ; (C) by striking the period at the end and inserting ; or ' and (D) by adding at the end the following: (B) section 922(g) shall be— (i) fined as provided in this title; and (ii) except as provided in subsection (e) of this section, imprisoned not less than 5 years and not more than 10 years. ; (2) in subsection (c)(1)(A)— (A) in clause (i), by striking 5 years and inserting 7 years ; (B) in clause (ii), by striking 7 years and inserting 10 years ; and (C) in clause (iii), by striking 10 years and inserting 15 years ; and (3) by striking subsection (e) and inserting the following: (e) (1) Whoever knowingly violates section 922(g) and has 3 or more previous serious felony convictions for offenses committed on occasions different from one another shall be fined under this title and imprisoned not less than 15 years and not more than 30 years, and, notwithstanding any other provision of law, the court shall not suspend the sentence of, or grant a probationary sentence to, such person with respect to the conviction under section 922(g). (2) In this subsection— (A) the term offense punishable by imprisonment for a statutory maximum term of not less than 10 years includes an offense (without regard to the application of any sentencing guideline, statutory criterion, or judgment that may provide for a shorter period of imprisonment within the statutory sentencing range) for which the statute provides for a range in the period of imprisonment that may be imposed at sentencing the maximum term of which is not less than 10 years; and (B) the term serious felony conviction means— (i) any conviction by a court referred to in section 922(g)(1) for an offense that, at the time of sentencing, was an offense punishable by imprisonment for a statutory maximum term of not less than 10 years; or (ii) any group of convictions for which a court referred to in section 922(g)(1) imposed in the same proceeding or in consolidated proceedings a total term of imprisonment of not less than 10 years, regardless of how many years of that total term the defendant served in custody. . 3. Applicability (a) In general The amendments made by this Act relating to offenses committed by an individual who has 3 or more previous serious felony convictions (as defined in subsection (e) of section 924 of title 18, United States Code, as amended by this Act) shall apply to any offense committed after the date of enactment of this Act by an individual who, on the date on which the offense is committed, has 3 or more previous serious felony convictions. (b) Rule of construction This Act and the amendments made by this Act shall not be construed to create any right to challenge a sentence imposed under subsection (e) of section 924 of title 18, United States Code. | https://www.govinfo.gov/content/pkg/BILLS-117s4376is/xml/BILLS-117s4376is.xml |
117-s-4377 | II 117th CONGRESS 2d Session S. 4377 IN THE SENATE OF THE UNITED STATES June 9, 2022 Mr. Cornyn (for himself and Mr. Luján ) introduced the following bill; which was read twice and referred to the Committee on Energy and Natural Resources A BILL To designate the El Paso Community Healing Garden National Memorial, and for other purposes.
1. Designation of El Paso Community Healing Garden National Memorial (a) Designation The Healing Garden located at 6900 Delta Drive, El Paso, Texas, is designated as the El Paso Community Healing Garden National Memorial . (b) Effect of designation The national memorial designated by this section is not a unit of the National Park System and the designation of the El Paso Community Healing Garden National Memorial shall not require or authorize Federal funds to be expended for any purpose related to that national memorial. | https://www.govinfo.gov/content/pkg/BILLS-117s4377is/xml/BILLS-117s4377is.xml |
117-s-4378 | II 117th CONGRESS 2d Session S. 4378 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Marshall introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To reauthorize a provision of the Federal Food, Drug, and Cosmetic Act pertaining to drugs containing single enantiomers.
1. Short title This Act may be cited as the Hatch-Waxman Improvement Act of 2022 . 2. Reauthorization of provision pertaining to drugs containing single enantiomers Section 505(u) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(u) ) is amended— (1) in paragraph (1)(A)(ii)(II), by adding (other than bioavailability studies) after any clinical investigations ; and (2) in paragraph (4), by striking October 1, 2022 and inserting October 1, 2027 . | https://www.govinfo.gov/content/pkg/BILLS-117s4378is/xml/BILLS-117s4378is.xml |
117-s-4379 | II 117th CONGRESS 2d Session S. 4379 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Peters (for himself and Mrs. Blackburn ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To include State active duty in the calculation of creditable service for members of the National Guard under certain circumstances.
1. Short title This Act may be cited as the No Guardsman Left Behind Act of 2022 . 2. Inclusion of State active duty in calculation of creditable service for members of National Guard Section 12732 of title 10, United States Code, is amended— (1) in subsection (b)(4), by striking Service and inserting Except as provided in subsection (c), service ; and (2) by adding at the end the following new subsection: (c) Special rule for State active duty (1) In general Subject to regulations prescribed by the Secretary of Defense, in the case of a member of the National Guard who serves on State active duty during a one-year period during which the member would, but for this subsection, be credited with fewer than 50 points under subsection (a), such service may be counted under subsection (a). (2) Computation Subject to paragraph (3), a member of the National Guard described in paragraph (1) shall be credited with 1 point for each day of State active duty during a one-year period described in that paragraph. (3) Limitation A member of the National Guard described in paragraph (1) may be credited in a one-year period under this subsection not more than the lesser of— (A) the number of points required for the member to be credited with 50 points under this section for that one-year period; or (B) 15 points. (4) State active duty defined In this subsection, the term State active duty means full-time service at the order of the Governor of a State or the Commonwealth of Puerto Rico, Guam, or the Virgin Islands, or the commanding general of the District of Columbia National Guard, pursuant to the law of the State, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, or the District of Columbia, as the case may be. . | https://www.govinfo.gov/content/pkg/BILLS-117s4379is/xml/BILLS-117s4379is.xml |
117-s-4380 | II 117th CONGRESS 2d Session S. 4380 IN THE SENATE OF THE UNITED STATES June 13, 2022 Ms. Warren (for herself, Ms. Hirono , Mr. Durbin , Mr. Markey , Mr. Whitehouse , and Mr. King ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To transition the nontactical vehicle fleet of the Department of Defense to electric or other zero emission vehicles, and for other purposes.
1. Short title This Act may be cited as the Military Vehicle Fleet Electrification Act . 2. Procurement of electric or zero emission vehicles for the Department of Defense (a) Procurement requirement (1) In general Section 2922g of title 10, United States Code, is amended to read as follows: 2922g. Procurement of electric or zero emission vehicles (a) Requirement To procure electric or zero emission vehicles Not less than 75 percent of the total number of covered nontactical vehicles purchased or leased by or for the use of the Department of Defense shall— (1) be electric or zero emission vehicles; and (2) use a charging connector type (or other means to transmit electricity to the vehicle) that meets applicable industry accepted standards for interoperability and safety. (b) Relation to other vehicle technologies that reduce consumption of fossil fuels The head of the department or agency of the Federal Government concerned may authorize the purchase or lease of covered nontactical vehicles that use a technology other than electric or zero emission technology only if the head of such department or agency determines, on a case by case basis, that— (1) the technology used in the vehicles to be purchased or leased reduces the consumption of fossil fuels compared to any vehicles being replaced by the newly purchased or leased vehicles (regardless of the engine technology used in the vehicles being replaced); (2) the purchase or lease of such vehicles is consistent with the energy performance goals and master plan of the Department of Defense required by subsections (c) and (d) of section 2911 of this title; (3) the purchase or lease of such vehicles will not result in a total number of non-electric or non-zero emission vehicles in excess of the threshold specified in subsection (a); and (4) the purchase or lease of electric or zero emission vehicles is impracticable under the circumstances. (c) Domestic sourcing requirements (1) In general The following provisions of law shall apply to the purchase or lease of covered nontactical vehicles under this section: (A) Chapter 83 of title 41 (commonly referred to as the Buy American Act ). (B) Section 4862 of this title (commonly referred to as the Berry Amendment ). (C) Section 4863 of this title (commonly referred to as the Specialty Metal Clause ). (2) Domestic sourcing of batteries Any vehicle battery included in a covered nontactical vehicle shall be sourced from a manufacturer— (A) within the national technology and industrial base; or (B) from a qualifying country (as defined in section 225.003 of title 48, Code of Federal Regulations, or successor regulations). (3) Applicability to leased vehicles The requirements of paragraphs (1) and (2) shall apply to leased vehicles in the same manner that such requirements apply to purchased vehicles. (4) Prohibition on waiver No provision of a memorandum of understanding or related agreement referred to in section 4851 of this title (commonly referred to as a Reciprocal Defense Procurement Agreement ) may waive or supercede the requirements of paragraphs (1) and (2). (d) Prohibition on sourcing from non-Allied foreign nations A covered nontactical vehicle that is an electric or zero emission vehicle purchased or leased by or for the use of the Department of Defense may not— (1) include an automotive item, including a vehicle battery, battery pack, or battery cell, sourced from a covered nation; or (2) be sourced, including final assembly, from— (A) a covered nation; (B) a country that is not part of the national technology and industrial base; or (C) a country that does not have a memorandum of understanding or related agreement referred to in section 4851 of this title with the United States (commonly referred to as a reciprocal defense procurement agreement ). (e) Definitions In this section: (1) Covered nation The term covered nation has the meaning given that term in section 4872(d) of this title. (2) Covered nontactical vehicle The term covered nontactical vehicle means any vehicle— (A) that is not a tactical vehicle designed for use in combat; and (B) that is purchased or leased by the Department of Defense, or by another department or agency of the Federal Government for the use of the Department of Defense, pursuant to a contract entered into, renewed, modified, or amended on or after October 1, 2022. (3) National technology and industrial base The term national technology and industrial base has the meaning given that term in section 4801 of this title. . (2) Clerical amendment The table of sections at the beginning of subchapter II of chapter 173 of title 10, United States Code, is amended by striking the item relating to section 2922g and inserting the following new item: 2922g. Procurement of electric or zero emission vehicles. . (b) Effective date The amendments made by subsection (a) shall take effect on October 1, 2022. 3. Electric vehicle charging stations at military installations (a) Charging stations at commissary stores and military exchanges (1) In general Subchapter I of chapter 147 of title 10, United States Code, is amended by adding at the end the following new section: 2486. Electric vehicle charging stations at commissary stores and military exchanges (a) Authority The Secretary of Defense may furnish electric vehicle charging stations at a commissary store or MWR retail facility for commercial use by individuals authorized to access such facilities. (b) Rates and procedures If the Secretary of Defense furnishes electric vehicle charging stations pursuant to subsection (a)— (1) the Secretary shall establish rates and procedures that the Secretary determines appropriate for the purchase of electric power from the charging stations; and (2) such charging stations may be installed and operated by a contractor on a for-profit basis. (c) Interoperability Any vehicle charging station provided under this section shall use a charging connector type (or other means to transmit electricity to the vehicle) that— (1) meets applicable industry accepted standards for interoperability and safety; and (2) is compatible with— (A) electric vehicles commonly available for purchase by a member of the general public; and (B) covered nontactical vehicles (as defined in section 2922g(e) of this title) for which charging is required. (d) MWR retail facility defined In this section, the term MWR retail facility has the meaning given the term MWR retail facilities in section 1063(e) of this title. . (2) Clerical amendment The table of sections at the beginning of such subchapter is amended by adding at the end the following new item: 2486. Electric vehicle charging stations at commissary stores and military exchanges. . (b) Additional requirements and authorities (1) In general Subchapter II of chapter 173 of title 10, United States Code, is amended by adding at the end the following new section: 2922j. Requirements and authorities relating to electric vehicle charging stations (a) Use of qualified electricians Any electrical work (including installation, maintenance, repair, rehabilitation, or replacement) required for an electric vehicle charging station located at a military installation shall be carried out by a qualified electrician who— (1) is licensed to perform such work in the State in which the work is performed; (2) is paid wages not less than those prevailing for similar work in the locality, as determined by the Secretary of Labor under subchapter IV of chapter 31 of title 40 (commonly referred to as the Davis-Bacon Act ); and (3) holds a valid certification from the nongovernmental Electric Vehicle Infrastructure Training Program. (b) Authority To carry out unspecified minor military construction projects The Secretary of Defense may use the authority provided under section 2805 of this title for the installation, maintenance, repair, rehabilitation, or replacement of an electric vehicle charging station on a military installation. (c) Definitions In this section: (1) The term military installation has the meaning given that term in section 2801 of this title. (2) The term State means any of the several States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the United States Virgin Islands, and the Commonwealth of the Northern Mariana Islands. . (2) Clerical amendment The table of sections at the beginning of such subchapter is amended by adding at the end the following new item: 2922j. Requirements and authorities relating to electric vehicle charging stations. . | https://www.govinfo.gov/content/pkg/BILLS-117s4380is/xml/BILLS-117s4380is.xml |
117-s-4381 | II 117th CONGRESS 2d Session S. 4381 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Warner (for himself and Mr. Scott of South Carolina ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend titles XVIII and XIX of the Social Security Act with respect to nursing facility requirements, and for other purposes.
1. Short title This Act may be cited as the Ensuring Seniors’ Access to Quality Care Act . 2. Training and competency evaluation programs (a) Medicare Section 1819(f)(2) of the Social Security Act ( 42 U.S.C. 1395i–3(f)(2) ) is amended— (1) in subparagraph (A)(iv)(I), by striking (unless the facility is described in subparagraph (B)(iii)(I)) ; (2) in subparagraph (B)— (A) in clause (i)— (i) by striking (subject to clause (iii)) ; and (ii) by inserting and after the semicolon; (B) in clause (ii), by striking ; and and inserting a period; and (C) by striking clause (iii); (3) by striking A State may not delegate (through subcontract or otherwise) its responsibility under clause (iii)(II) to the skilled nursing facility. ; (4) by striking subparagraphs (C) and (D); and (5) by adding at the end the following: (C) Disapproval of nurse aide training and competency evaluation programs and nurse aide competency evaluation programs (i) In general With respect to a State, the Secretary shall, in consultation with such State, disapprove, for a period not to exceed 2 years, a nurse aide training and competency evaluation program or a nurse aide competency evaluation program offered by or in a skilled nursing facility if such facility— (I) has been assessed a civil monetary penalty under subsection (h)(2)(B)(ii) or section 1919(h)(2)(A)(ii) of not less than $10,697 for providing substandard quality of care; and (II) has not, in the determination of the Secretary, corrected the deficiencies in quality of care for which such civil monetary penalty was assessed. (ii) Rescission of disapproval The Secretary shall rescind a disapproval under clause (i) upon demonstration by a skilled nursing facility that— (I) all deficiencies for which the civil monetary penalty described in clause (i)(I) was assessed have been remedied; (II) the facility has not received deficiencies related to direct patient harm for substandard quality of care deficiencies in the prior 2 years; and (III) the Secretary certifies that the civil monetary penalty assessed under clause (i)(I) did not result in immediate jeopardy for direct patient harm or injury related to an abuse or neglect deficiency. For purposes of rescinding disapproval under this clause, the Secretary may require additional oversight of the skilled nursing facility for a period not to exceed the period of disapproval imposed under clause (i) with respect to such facility. . (b) Medicaid Section 1919(f)(2) of the Social Security Act ( 42 U.S.C. 1396r(f)(2) ) is amended— (1) in subparagraph (A)(iv)(I), by striking (unless the facility is described in subparagraph (B)(iii)(I)) ; (2) in subparagraph (B)— (A) in clause (i), by inserting and after the semicolon; (B) in clause (ii), by striking ; and and inserting a period; (C) by striking clause (iii); and (D) by striking A State may not delegate (through subcontract or otherwise) its responsibility under clause (iii)(II) to the nursing facility. ; (3) by striking subparagraphs (C) and (D); and (4) by adding at the end the following: (C) Disapproval of nurse aide training and competency evaluation programs and nurse aide competency evaluation programs (i) In general With respect to a State, the Secretary shall, in consultation with such State, disapprove, for a period not to exceed 2 years, a nurse aide training and competency evaluation program or a nurse aide competency evaluation program offered by or in a nursing facility if such facility— (I) has been assessed a civil monetary penalty under section 1819(h)(2)(B)(ii) or subsection (h)(2)(A)(ii) of not less than $10,697 for providing substandard quality of care; and (II) has not, in the determination of the Secretary, corrected the deficiencies in quality of care for which such civil monetary penalty was assessed. (ii) Rescission of disapproval The Secretary shall rescind a disapproval under clause (i) upon demonstration by a nursing facility that— (I) all deficiencies for which the civil monetary penalty described in clause (i)(I) was assessed have been remedied; (II) the facility has not received deficiencies related to direct patient harm for substandard quality of care deficiencies in the prior 2 years; and (III) the Secretary certifies that the civil monetary penalty assessed under clause (i)(I) did not result in immediate jeopardy for direct patient harm or injury related to an abuse or neglect deficiency. For purposes of rescinding disapproval under this clause, the Secretary may require additional oversight of the nursing facility for a period not to exceed the period of disapproval imposed under clause (i) with respect to such facility. . (c) Regulations Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations as necessary to implement the amendments made by this section. (d) Applicability (1) In general (A) Timing of determinations The amendments made by subsections (a)(4) and (b)(4) of this section shall apply only to a civil monetary penalty if the relevant covered determination was made on or after the date of enactment of this Act. (B) Covered determination defined The term covered determination means, with respect to a skilled nursing facility or a nursing facility in a State, a determination by the State or the Secretary of Health and Human Services that the facility has provided a substandard quality of care for which a civil monetary penalty described in section 1819(f)(2)(C)(i)(I) or 1919(f)(2)(C)(i)(I) of the Social Security Act (as such sections have been amended by this Act) may be assessed. (2) Previously prohibited programs (A) Waiver With respect to a skilled nursing facility or a nursing facility subject, on the day before the date of enactment of this Act, to a prohibition under item (a) of either section 1819(f)(2)(B)(iii)(I) or section 1919(f)(2)(B)(iii)(I) of the Social Security Act (as in effect on the day before such date of enactment), such prohibition shall no longer apply to the facility on or after such date of enactment. (B) Survey or civil monetary penalty With respect to a skilled nursing facility or a nursing facility subject, on the day before the date of enactment of this Act, to a prohibition under item (b) or (c) of either section 1819(f)(2)(B)(iii)(I) or section 1919(f)(2)(B)(iii)(I) of the Social Security Act (as in effect on the day before such date of enactment), such prohibition shall no longer apply to the facility on or after such date of enactment upon a determination by the Secretary of Health and Human Services that the facility has corrected the issue that resulted in such prohibition. 3. Permitting Medicare and Medicaid providers to access the National Practitioner Data Bank to conduct employee background checks Section 1921(b)(6) of the Social Security Act ( 42 U.S.C. 1396r–2(b)(6) ) is amended— (1) by striking and other health care entities (as defined in section 431 of the Health Care Quality Improvement Act of 1986) and inserting , other health care entities (as defined in section 431 of the Health Care Quality Improvement Act of 1986), providers of services (as defined in section 1861(u)), suppliers (as defined in section 1861(d)), and providers of items or services under a State plan under this title (or a waiver of such a plan) ; and (2) by striking such hospitals or other health care entities and inserting such hospitals, health care entities, providers, or suppliers . | https://www.govinfo.gov/content/pkg/BILLS-117s4381is/xml/BILLS-117s4381is.xml |
117-s-4382 | II 117th CONGRESS 2d Session S. 4382 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Padilla (for himself, Mrs. Feinstein , and Mr. Romney ) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs A BILL To require the Secretary of the Treasury to mint coins in commemoration of the 2028 Olympic and Paralympic Games in Los Angeles, California.
1. Short title This Act may be cited as the LA28 Olympic and Paralympic Games Commemorative Coin Act . 2. Findings Congress finds the following: (1) The 2028 Olympic and Paralympic Games, officially known as the Games of the XXXIV Olympiad or LA28 , will be held in Los Angeles, California. (2) This will be the first time the Olympic and Paralympic Games have been held in the United States in 26 years. (3) The United States has hosted the modern Olympic Games 9 times, with the 2028 Games becoming the third time Los Angeles will host the summer Olympic Games. (4) The Paralympic Games will celebrate its 80th anniversary in 2028, with Los Angeles hosting the Paralympic Games for the first time. (5) Unlike some other countries, Olympic Games in the United States are privately funded. The LA28 Games maintain this model with its revenue generated by corporate partners, broadcast rights, licensing, hospitality and ticket sales. (6) With Los Angeles hosting the Paralympic Games for the first time in 2028, the 2028 Olympic and Paralympic Games Commemorative Coin Program has the opportunity to increase awareness and create more inclusivity for people with disabilities with the creation of a single, unifying coin to commemorate the Games. 3. Coin specifications (a) Denominations The Secretary of the Treasury (in this Act referred to as the Secretary ) shall mint and issue the following coins in commemoration of the 2028 Olympic and Paralympic Games in Los Angeles, California: (1) $5 Gold coins Not more than 100,000 $5 coins, each of which shall— (A) weigh 8.359 grams; (B) have a diameter of 0.850 inches; and (C) contain not less than 90 percent gold. (2) $1 silver coins Not more than 500,000 $1 coins, each of which shall— (A) weigh 26.73 grams; (B) have a diameter of 1.500 inches; and (C) contain not less than 90 percent silver. (3) Half dollar clad coins Not more than 300,000 half-dollar coins, each of which shall— (A) weigh 11.34 grams; (B) have a diameter of 1.205 inches; and (C) be minted to the specifications for half-dollar coins contained in section 5112(b) of title 31, United States Code. (4) Proof silver $1 coins Not more than 100,000 proof silver $1 coins, each of which shall— (A) weigh 5 ounces; (B) have a diameter of 3 inches; and (C) contain .999 fine silver. (b) Legal tender The coins minted under this Act shall be legal tender, as provided in section 5103 of title 31, United States Code. (c) Numismatic items For purposes of section 5134 of title 31, United States Code, all coins minted under this Act shall be considered to be numismatic items. (d) Mintage limit exception If the Secretary determines, based on independent, market based research conducted by the U.S. Olympic and Paralympic Committee, that the mintage levels described under this subsection are not adequate to meet public demand, the Secretary may increase the mintage levels as the Secretary determines is necessary to meet public demand. 4. Designs of coins (a) Design requirements (1) In general The designs of the coins minted under this Act shall be emblematic of the participation of United States athletes in the LA28 Games. (2) Designation and inscriptions On each coin minted under this Act there shall be— (A) a designation of the value of the coin; (B) an inscription of the year 2028 ; and (C) inscriptions of the words Liberty, In God We Trust, United States of America, and E Pluribus Unum . (3) Selection of designs The designs for the coins minted under this Act shall be— (A) selected by the Secretary after consultation with— (i) the United States Olympic and Paralympic Properties; and (ii) the Commission of Fine Arts; and (B) reviewed by the Citizens Coinage Advisory Committee. 5. Issuance of coins (a) Quality of coins The Secretary may issue coins minted under this Act in uncirculated and proof qualities. (b) Period of issuance The Secretary may issue coins minted under this Act only during the 1-year period beginning on January 1, 2028. 6. Sale of coins (a) Sale price The coins issued under this Act shall be sold by the Secretary at a price equal to the sum of— (1) the face value of the coins; (2) the surcharge provided in section 7(a) with respect to such coins; and (3) the cost of designing and issuing such coins (including labor, materials, dies, use of machinery, overhead expenses, and marketing, and shipping). (b) Bulk sales The Secretary shall make bulk sales of the coins issued under this Act at a reasonable discount. (c) Prepaid orders (1) In general The Secretary shall accept prepaid orders for the coins minted under this Act before the issuance of such coins. (2) Discount Sales with respect to prepaid orders under paragraph (1) shall be at a reasonable discount. 7. Surcharges (a) In general All sales of coins issued under this Act shall include a surcharge of— (1) $35 per coin for the $5 coin; (2) $10 per coin for the $1 coin described under section 3(a)(2); (3) $5 per coin for the half-dollar coin; and (4) $50 per coin for the $1 proof silver coin. (b) Distribution Subject to section 5134(f) of title 31, United States Code, all surcharges received by the Secretary from the sale of coins issued under this Act shall be promptly paid by the Secretary to the United States Olympic and Paralympic Properties for the objects and purposes related to the hosting of the 2028 Olympic and Paralympic Games and to aid in the execution of its legacy programs, including the promotion of youth sports in the United States. (c) Audits The United States Olympic and Paralympic Properties shall be subject to the audit requirements of section 5134(f)(2) of title 31, United States Code, with regard to the amounts received under subsection (b). (d) Limitation Notwithstanding subsection (a), no surcharge may be included with respect to the issuance under this Act of any coin during a calendar year if, as of the time of such issuance, the issuance of such coin would result in the number of commemorative coin programs issued during such year to exceed the annual 2 commemorative coin programs issuance limitation under section 5112(m)(1) of title 31, United States Code (as in effect on the date of the enactment of this Act). The Secretary may issue guidance to carry out this subsection. 8. Marketing and financial assurances (a) In general The Secretary shall take such actions as may be necessary to ensure that— (1) minting and issuing coins under this Act result in no net cost to the Federal Government; and (2) no funds, including applicable surcharges, shall be disburses to any recipient designated in section 7(b) until the total cost of designing and issuing all of the coins authorized by this Act, including labor, materials, dies, use of machinery, overhead expenses, marketing and shipping, is recovered by the United States Treasury, consistent with sections 5112(m) and 5134(f) of title 31, United States Code. (b) Marketing and educational program The Secretary is encouraged to develop and execute a marketing and educational program, including appropriate cooperative marketing opportunities with the United States Olympic and Paralympic Properties and its licensees, to promote and sell the coins authorized under this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4382is/xml/BILLS-117s4382is.xml |
117-s-4383 | II 117th CONGRESS 2d Session S. 4383 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Padilla (for himself and Mrs. Feinstein ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To provide assistance for surface transportation projects relating to international Olympic, Paralympic, and Special Olympics events.
1. Short title This Act may be cited as the Transportation Assistance for Olympic Cities Act of 2022 . 2. Transportation assistance for Olympic, Paralympic, and Special Olympics cities (a) Purpose The purpose of this section is to prioritize and support State and local efforts on surface transportation issues necessary to obtain the national recognition and economic benefits of participation in the international Olympic, Paralympic, and Special Olympics movement by hosting international Olympic, Paralympic, and Special Olympics events in the United States. (b) Definitions In this section: (1) Covered event (A) In general The term covered event means an international Olympic, Paralympic, or Special Olympics event held at a site that has been selected to hold such event. (B) Exclusion The term covered event does not include activities relating to preparing or submitting a bid to be selected to hold an international Olympic, Paralympic, or Special Olympics event. (2) Secretary The term Secretary means the Secretary of Transportation. (c) Priority for transportation projects relating to Olympic, Paralympic, and Special Olympics events (1) In general Notwithstanding any other provision of law, in providing grants for surface transportation projects described in paragraph (2), the Secretary may give priority to a surface transportation project relating to a covered event. (2) Grants described A grant referred to in paragraph (1) is a discretionary grant for a surface transportation project— (A) under title 23 or 49, United States Code, beginning on the date of enactment of this Act; or (B) otherwise administered by the Secretary for surface transportation projects. (d) Transportation planning activities The Secretary shall take all reasonable efforts to provide assistance to a covered event, including— (1) by providing assistance for planning activities of States and metropolitan planning organizations under sections 134 and 135 of title 23, United States Code, for surface transportation projects relating to a covered event; (2) by developing intermodal transportation plans in coordination with States and local transportation agencies; (3) by expediting review and comment of any required submissions to the Secretary relating to a covered event; and (4) by providing technical assistance. (e) Transportation projects relating to Olympic, Paralympic, and Special Olympics events (1) In general The Secretary may provide assistance, including planning, capital, and operating assistance, to a State or unit of local government in carrying out surface transportation projects relating to a covered event. (2) Use of funds Notwithstanding any other provision of law, any funding provided in accordance with this section may be used for any temporary facility, equipment, operations, and maintenance that meets the extraordinary surface transportation needs associated with hosting a covered event. (f) Funding (1) In general There are authorized to be appropriated to carry out this section such sums as are necessary for each of fiscal years 2022 through 2034. (2) Supplement, not supplant Any amounts provided to a State or unit of local government in accordance with this section shall be in addition to any Federal funds otherwise available to the State or unit of local government for the surface transportation project. (g) Sunset The authority provided by this section shall terminate on September 30, 2034. | https://www.govinfo.gov/content/pkg/BILLS-117s4383is/xml/BILLS-117s4383is.xml |
117-s-4384 | II 117th CONGRESS 2d Session S. 4384 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Coons (for himself, Mr. Cornyn , Mr. King , Mr. Inhofe , Mr. Kelly , and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To authorize the Secretary of Education to make grants to support educational programs in civics and history, and for other purposes.
1. Short title This Act may be cited as the Civics Secures Democracy Act . 2. Purposes; Rule of Construction (a) Purposes The purposes of this Act are— (1) to support local educational agencies, elementary schools, and secondary schools in selecting and making available to all students innovative, engaging curricula and programs in civics and history that prepare them to understand American Government and engage in American democratic practices as citizens and residents of the United States; (2) to provide resources to institutions of higher education for the purposes of offering effective professional development opportunities to enable and encourage teachers to deliver instruction that engages students in learning civics and history; (3) to provide resources to nonprofit organizations that have developed, or are developing, programs in civics education that incorporate practices that are proven to be effective in engaging students, and to assist in making such curricula and programs more widely available to schools and students, particularly in rural and inner-city urban areas that have traditionally been underserved by civics learning programs; (4) to provide resources to continue and expand research into practices, methods, and approaches that are effective in instructing elementary and secondary school students in civics and history; (5) to diversify the civics, history, and government education workforce by offering targeted incentives and honoring those who commit to the profession; (6) to encourage participation in the National Assessment of Educational Progress assessments in civics and history in grades 4, 8, and 12, using a methodology sufficient to provide accurate State-level data on student proficiency in civics and history, disaggregated so as to have statistical significance for every State; (7) to reauthorize and modernize the existing Federal civics education grant program for institutions of higher education, including by strengthening academic independence and supporting partnerships between academic centers and local educational agencies; and (8) to strengthen and make independently sustainable the Harry S. Truman Scholarship Foundation Trust Fund and the James Madison Memorial Fellowship Trust Fund, which respectively support exceptional Americans who aspire to careers in public service and as secondary school history, government, and civics educators. (b) Rule of construction Nothing in this Act shall be construed to authorize the Secretary of Education to prescribe a civics and history curriculum. I Grant Program 101. Definitions In this Act: (1) The term civics , when used with respect to an educational program, means a program that addresses the following: (A) Acquisition of civic knowledge, including an understanding of the history, heritage, civic life, and civic institutions of the United States. (B) Acquisition of civic skills, such as the ability to analyze text and determine the reliability of sources and an understanding of the ways in which civic institutions operate and how individuals may be involved in civic life. (C) Acquisition of civic dispositions, values such as appreciation for free speech, civil discourse, tolerance and inclusion, and understanding perspectives that differ from one’s own as well as a disposition to be civically engaged. (D) Development of civic behaviors, including civic habits and practices such as voting, serving on juries, engagement in deliberative discussions, volunteering, and attending public meetings. (2) The term eligible entity means— (A) with respect to grant program under section 103, a State; (B) with respect to the grant program under section 104, a qualified nonprofit organization; (C) with respect to the grant program under section 105, an institution of higher education; and (D) with respect to the grant program under section 106, a qualified researcher. (3) The term evidence-based practices means practices proven to contribute to the effectiveness of educational programs in civics, including— (A) innovative and engaging classroom instruction in civics, Government, and history; (B) philanthropic and community service linked to classroom learning; (C) learning through participation in models and simulations of democratic processes; (D) meaningful participation in school governance; and (E) instruction in media literacy through the study of common informal fallacies in logic. (4) The term institution of higher education has the meaning given that term in section 101 of the Higher Education Act of 1965 ( 20 U.S.C. 1001 ). (5) The term National Assessment of Educational Progress means the National Assessment of Educational Progress carried out under section 303(b) of the National Assessment of Educational Progress Authorization Act ( 20 U.S.C. 9622(b) ). (6) The term qualified nonprofit organization means an organization that— (A) is described in section 501(c)(3) of the Internal Revenue Code of 1986 and which is exempt from taxation under section 501(a) of such Code; and (B) has experience developing curricula, instructional models, and other educational programs for students in elementary schools and secondary schools. (7) The term qualified researcher means— (A) a nonprofit organization that has ability and capacity to carry out scientifically valid research; or (B) an individual affiliated with such an organization. (8) The terms elementary school , local educational agency , secondary school , Secretary , and State have the meanings given those terms in section 8101 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7801 ). 102. General provisions (a) In general The Secretary of Education is authorized to carry out the civics education grant programs described in sections 103 through 106. (b) Application To be considered for a grant under this Act, an eligible entity shall submit to the Secretary of Education an application at such time, in such manner, and containing such information as the Secretary may require. (c) Grant duration Each grant under this Act shall be awarded for a period of not less than 3 years. (d) Priority Except as otherwise provided in this Act, the Secretary shall prioritize the award of grants to eligible entities that demonstrate the greatest potential to— (1) improve knowledge among students traditionally underserved by comprehensive civics education and American history programs; (2) close gaps in civic knowledge and achievement among traditionally underserved students; (3) improve performance on the National Assessment of Educational Progress assessments in civics and history among students in grades 4, 8, and 12; and (4) provide cost-effective, scalable delivery of programs and services. 103. Grants to States (a) Program authorized The Secretary of Education is authorized to make grants to each State that has an approved application and meets the program requirements to enable those States to support educational programs in civics and history in accordance with this section. (b) Grant amount The amount of each grant to a State under this section shall be proportional to the amount received by all local educational agencies in the State under part A of title I of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 6311 et seq. ) for the previous fiscal year relative to the total such amount received by all local educational agencies in every State that receives a grant under this section. (c) State reservation A State that receives a grant under this section may reserve not more than 5 percent of the amount of the grant for— (1) administrative costs of carrying out the State’s responsibilities under this section; and (2) monitoring and evaluating programs and activities supported with the grant. (d) Subgrants to local educational agencies A State that receives a grant under this section shall use not less than 95 percent of the amount of the grant to make subgrants, on a competitive or formula basis, to local educational agencies within the State to assist such agencies in carrying out programs to improve the achievement of elementary and secondary school students in the fields of civics and history. (e) Supplement not supplant A State shall use a grant under this section only to supplement the level of Federal, State, and local public funds that would, in absence of such grant, be made available for the activities supported by the grant, and not to supplant such funds. (f) Contents of application As part of the application required under section 102(b), a State shall include a plan describing how the State intends to use the grant under this section. Each State plan shall include, at a minimum, the following: (1) An explanation of how the State will use the grant to supplement, and not supplant, other public funds provided for educational programs in civics and history. (2) Plans to address civics and history achievement gaps among traditionally underserved students. (3) Plans to improve civics and history achievement among traditionally underserved students. (4) Plans for making subgrants to local educational agencies as required under subsection (d), including— (A) details of how the State intends to distribute funding to local educational agencies, whether by competition or through a formula-based system; (B) how the State’s approach to distributing funds to local educational agencies will take into account requirements of paragraphs (1) through (3); (C) criteria by which local educational agencies’ applications for funding will be evaluated, including how such applications will take into account the requirements of paragraphs (1) through (3); (D) how the State will ensure that local educational agencies will use grant funds to supplement, and not supplant, other public funding for educational programs in civics and history; and (E) how the State will evaluate and hold local educational agencies accountable for improved student knowledge and achievement in civics and history. (5) An assurance that the State will participate in the National Assessment of Educational Progress assessments in civics and history in grades 4, 8, and 12. (6) In the case of a State applying to renew a grant previously received under this section, an evaluation of the effectiveness of the activities carried out using the previous grant, which shall be based on the results of the most recent National Assessment of Educational Progress assessment in civics and history, to the extent the results of such assessment are available at the time of the State’s application. 104. Grants to nonprofit organizations (a) Program authorized The Secretary of Education is authorized to make grants to qualified nonprofit organizations, on a competitive basis, to assist such organizations in developing or expanding access to civics curricula, instructional models, and other educational programs to enhance student knowledge in civics and history in elementary schools and secondary schools. (b) Contents of application As part of the application required under section 102(b), a qualified nonprofit organization shall include a proposal that demonstrates how the activities proposed to be carried out with the grant under this section will enhance student knowledge in civics and history in elementary schools and secondary schools. (c) Priority of awards In awarding grants under this section, the Secretary shall give priority to qualified nonprofit organizations that propose to use the grant to develop or expand access to curricula, instructional models, and other educational programs that— (1) address the learning needs of traditionally underserved students; and (2) incorporate evidence-based practices to enhance student knowledge in civics and history. 105. Grants to institutions of higher education (a) Program authorized The Secretary of Education is authorized to make grants to institutions of higher education, on a competitive basis, to assist such institutions in developing and implementing programs to train elementary and secondary school teachers in methods for instructing students in civics and history. (b) Contents of application As part of the application required under section 102(b), an institution of higher education shall include a proposal demonstrating that the institution— (1) has the ability to train elementary and secondary school teachers to provide comprehensive civics education; (2) is familiar with research on practices that are proven to contribute to effective instruction in civics and history and will incorporate such research into the training provided to teachers using the grant; and (3) will use the grant to make training in civics education available to elementary and secondary school teachers in the State or geographic region served by the institution. (c) Priority of awards In awarding grants under this section, the Secretary shall give priority to institutions of higher education that propose to use the grant to carry out training programs for teachers that— (1) address the specific needs of teachers working with traditionally underserved students; and (2) incorporate evidence-based practices for improving the ability of teachers to provide effective instruction in civics and history. (d) Reservation of funds From the amounts made available to carry out this section, 35 percent shall be reserved to award grants, on a competitive basis, to institutions of higher education that are eligible to receive funds under— (1) part A or part B of title III of the Higher Education Act of 1965 ( 20 U.S.C. 1057 et seq. , 1060 et seq.); (2) part A or part B of title V of such Act ( 20 U.S.C. 1101 et seq. , 1102 et seq.); or (3) subpart 4 of part A of title VII of such Act ( 20 U.S.C. 1136a et seq. ). 106. Research grants (a) Program authorized The Secretary of Education is authorized to make grants, on a competitive basis, to qualified researchers to research and evaluate— (1) elementary and secondary school students’ knowledge of civics and history; and (2) effective instructional practices and educator professional development in the fields of civics and history. (b) Contents of application As part of the application required under section 102(b), a qualified researcher shall include a description of the project to be funded with the grant under this section. The description of the project shall include a separate section that describes how the project may directly or indirectly affect civics education generally, which may include effects such as— (1) achieving the full participation of women, persons with disabilities, and underrepresented minorities in civics and history education; or (2) increasing student knowledge in civics and history. (c) Priority of awards In awarding grants under this section, the Secretary shall give priority to qualified researchers who propose to carry out activities that will benefit traditionally underserved communities. II Amendments to other laws 201. Prince Hall Civics Fellowship Program The James Madison Memorial Fellowship Act ( 20 U.S.C. 4501 et seq. ) is amended— (1) in section 802, by inserting , and to establish the Prince Hall Civics Fellowship Program which is designed to diversify the civics and history education workforce after development ; (2) in section 807— (A) by striking this title and inserting section 804 each place the term appears; and (B) by striking this Act and inserting section 804 each place the term appears; and (3) by inserting after section 810 the following new section: 810A. Prince Hall Civics Fellowship Program (a) In general Notwithstanding sections 804 through 810— (1) the Foundation is authorized to award scholarships under an additional fellowship program to be administered by the James Madison Fellowship Program, which shall be known as the Prince Hall Civics Fellowship Program ; and (2) the terms and conditions under this section shall apply with respect to the Prince Hall Civics Fellowship Program. (b) Purpose The purpose of the Prince Hall Civics Fellowship Program is to diversify the civics and history education workforce. (c) Applications In order to be eligible to receive a scholarship under the Prince Hall Civics Fellowship Program, an individual shall submit an application to the Foundation, containing an assurance that the applicant meets the following requirements: (1) The applicant holds a valid teaching credential in the applicant's home State and a baccalaureate degree or higher degree in the subject of humanities, political science, government, or American history, or a dual degree in one of those subjects and education. (2) The applicant will commit to 5 years of teaching in kindergarten through grade 12 and will provide verification for each year of employment. (d) Selection The Foundation shall, either directly or by contract, provide for the conduct of a nationwide competition for the purpose of selecting recipients of fellowships under the Prince Hall Civics Fellowship Program (referred to as fellows ). The Foundation shall adopt selection procedures which shall assure that— (1) the number of recipients selected from each State is in proportion to each State’s share of funding under part A of title I of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 6311 et seq. ); and (2) in selecting fellows, priority is given to individuals— (A) who are teaching in communities to which the individual has ties at the time of the individual's application for the fellowship; (B) who are from populations underrepresented in the civics and history education workforce; or (C) based on merit. (e) Amount of fellowship Each fellow shall receive a stipend of $5,000 for each year, not to exceed a total of 5 years, that the fellow is employed as a teacher in kindergarten through grade 12 and submits employment verification to the Foundation in the manner prescribed by the Foundation. . 202. National Assessment of Educational Progress Section 303(b) of the Education Sciences Reform Act of 2002 ( 20 U.S.C. 9622(b) ) is amended— (1) in paragraph (2)— (A) by redesignating subparagraphs (D) through (H) as subparagraphs (E) through (I) respectively; (B) by inserting after subparagraph (C) the following: (D) conduct a national assessment, using a methodology sufficient to provide accurate, disaggregated, statistically significant State-level data on student proficiency for every State, on student academic achievement in public and private elementary schools and secondary schools at least once every 2 years, in grades 4, 8, and 12 in civics and history; ; and (C) in subparagraph (E), as so redesignated, by striking history, geography, civics and inserting geography ; and (2) in paragraph (3)(A)— (A) in clause (i), by striking (2)(E) and inserting (2)(F) ; (B) by redesignating clauses (iii) and (iv) as clauses (iv) and (v), respectively; (C) by inserting after clause (ii) the following: (iii) shall conduct biennial State academic assessments of student achievement in civics and history in grades 4, 8, and 12, as described in paragraph (2)(D); ; and (D) in clause (iv), as so redesignated, by striking (2)(D) and inserting (2)(E) . 203. USA Civics Act Section 805 of the Higher Education Act of 1965 ( 20 U.S.C. 1161e ) is amended— (1) in the section heading, by striking history for freedom and inserting civics and history education program ; (2) in subsection (a)— (A) by striking subsection (f) and inserting subsection (g) ; (B) by striking the Secretary is authorized to award three-year grants, on a competitive basis, and inserting the Secretary is authorized to award grants, at the Secretary's discretion but not less frequently than once every 3 years and on a competitive basis, ; (C) by striking paragraph (1) and inserting the following: (1) American political thought and history; ; and (D) by striking paragraph (3) and inserting the following: (3) the history, achievements, and impact of American representative democracy and constitutional democracies globally. ; (3) in subsection (b)— (A) in paragraph (1), by striking as defined in section 101. and inserting , or a partnership that includes an institution of higher education and one or more nonprofit organizations, whose missions and demonstrated expertise are consistent with the purpose of this section. ; (B) in paragraph (2), by striking that emerged and all that follows through the period at the end and inserting founded on the principles of representative democracy, constitutional government, individual rights, market economics, religious freedom and religious tolerance, and freedom of thought and inquiry. ; and (C) by striking paragraph (3) and inserting the following: (3) American political thought and history The term American political thought and history means— (A) the significant constitutional, political, intellectual, economic, social, and foreign policy trends and issues that have shaped the course of American history; and (B) the key episodes, turning points, texts, and figures involved in the constitutional, political, intellectual, diplomatic, social, and economic history of the United States. ; (4) in subsection (c)(2)— (A) in subparagraph (A), by striking traditional and all that follows through the semicolon and inserting American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; ; and (B) in subparagraph (B), by inserting , which may include the creation or use of open educational resources after subsection (e)(1)(B) ; (5) in subsection (d)— (A) by striking paragraph (1) and inserting the following: (1) increase access to quality programming that expands knowledge of American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; ; and (B) in paragraph (2), by striking traditional American history, free institutions, or Western civilization and inserting American political thought and history, free institutions, the impact of American representative democracy and constitutional democracies globally, or the means of participation in political and civic life. ; (6) by striking subsection (e) and inserting the following: (e) Use of funds (1) Required use of funds Funds provided under this section shall be used— (A) for collaboration with local educational agencies for the purpose of providing elementary school and secondary school teachers an opportunity to enhance their knowledge of American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; and (B) to carry out one or more of the following: (i) Establishing or strengthening academic programs or centers focused on American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally, which may include— (I) design and implementation of programs of study, courses, lecture series, seminars, and symposia; (II) development, publication, and dissemination of instructional materials; (III) research; (IV) support for faculty teaching in undergraduate and, if applicable, graduate programs; or (V) support for graduate and postgraduate fellowships, if applicable. (ii) For teacher preparation initiatives that stress content mastery regarding American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally. (iii) To conduct outreach activities to ensure that information about the activities funded under this section is widely disseminated— (I) to undergraduate students (including students enrolled in teacher education programs, if applicable); (II) to graduate students (including students enrolled in teacher education programs, if applicable); (III) to faculty; (IV) to local educational agencies; and (V) within the local community. (2) Allowable uses of funds Funds provided under this section may be used to support— (A) collaboration with entities such as— (i) nonprofit organizations whose missions and demonstrated expertise are consistent with the purpose of this section, for assistance in carrying out activities described under subsection (a); and (ii) Federal or State humanities programs, which may include those funded by the National Endowment for the Humanities; and (B) the creation and use of open educational resources on American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally. ; (7) by redesignating subsection (f) as subsection (g); (8) in subsection (g), as redesignated by paragraph (7), by striking 2009 and inserting 2022 ; and (9) by inserting after subsection (e) the following: (f) Rule of construction Nothing in this section shall be construed to authorize the Secretary to prescribe an American political thought and history curriculum. . 204. Sustaining the Truman Foundation Section 10(b) of Public Law 93–642 ( 20 U.S.C. 2001 et seq. ) is amended to read as follows: (b) (1) It shall be the duty of the Secretary of the Treasury to invest in full the amounts appropriated to the fund. (2) Investments of amounts appropriated to the fund shall be made in public debt securities of the United States with maturities suitable to the fund. For such purpose, such obligations may be acquired— (A) on original issue at the issue price; or (B) by purchase of outstanding obligations at the market price. (3) The purposes for which obligations of the United States may be issued under chapter 31 of title 31, United States Code, are hereby extended to authorize the issuance at par of special obligations exclusively to the fund. Such special obligations shall bear interest at a rate equal to the average rate of interest, computed as to the end of the calendar month next preceding the date of such issue, borne by all marketable interest-bearing obligations of the United States then forming a part of the public debt, except that where such average rate is not a multiple of 1/8 of 1 percent, the rate of interest of such special obligations shall be the multiple of 1⁄8 of 1 percent next lower than such average rate. Such special obligations shall be issued only if the Secretary determines that the purchases of other interest-bearing obligations of the United States, or of obligations guaranteed as to both principal and interest by the United States or original issue or at the market price, is not in the public interest. . 205. Sustaining the Madison Foundation Subsection (b) of section 811 of the James Madison Memorial Fellowship Act ( 20 U.S.C. 4510 ) is amended to read as follows: (b) (1) It shall be the duty of the Secretary of the Treasury to invest in full the amounts appropriated to the fund. (2) Subject to paragraph (3), investments of amounts appropriated to the fund shall be made in public debt securities of the United States with maturities suitable to the fund. For such purpose, such obligations may be acquired (A) on original issue at the issue price, or (B) by purchase of outstanding obligations at the market price. The purposes for which obligations of the United States may be issued under chapter 31 of title 31, United States Code, are hereby extended to authorize the issuance at par of special obligations exclusively to the fund. Such special obligations shall bear interest at a rate equal to the average rate of interest, computed as to the end of the calendar month next preceding the date of such issue, borne by all marketable interest-bearing obligations of the United States then forming a part of the public debt, except that where such average rate is not a multiple of 1/8 of 1 percent, the rate of interest of such special obligations shall be the multiple of 1/8 of 1 percent next lower than such average rate. Such special obligations shall be issued only if the Secretary determines that the purchases of other interest-bearing obligations of the United States, or of obligations guaranteed as to both principal and interest by the United States or original issue or at the market price, is not in the public interest. (3) (A) Notwithstanding paragraph (2), upon receiving a determination of the Board described in subparagraph (B), the Secretary shall invest up to 40 percent of the fund’s assets in securities other than public debt securities of the United States, provided that the securities are traded in established United States markets. (B) A determination described in this subparagraph is a determination by the Board that investments as described in subparagraph (A) are necessary to enable the Foundation to carry out the purposes of this title without any diminution of the number of fellowships provided under section 804. (C) Nothing in this paragraph shall be construed to limit the authority of the Board to increase the number of fellowships provided under section 804, or to increase the amount of the fellowship authorized by section 809, as the Board considers appropriate and is otherwise consistent with the requirements of this title. . 206. The CIVICS Act Section 2233(b) of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 6663(b) ) is amended by striking paragraphs (1) and (2) and inserting the following: (1) shall— (A) show potential to improve the quality of student achievement in, and teaching of, American history, civics and government, or geography, in elementary schools and secondary schools; (B) demonstrate innovation, scalability, accountability, and a focus on underserved populations; and (C) include programs that educate students about the history and principles of the Constitution of the United States, including the Bill of Rights; and (2) may include hands-on civic engagement activities for teachers and students. . III Civics Secures Democracy Fund 301. Civics Secures Democracy Fund (a) Definitions In this section: (1) The term Civics Secures Democracy Fund means the Civics Secures Democracy Fund established under subsection (b). (2) The term COVID relief funds means amounts made available under— (A) the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 ( Public Law 116–123 ; 134 Stat 146); (B) the Families First Coronavirus Response Act ( Public Law 116–127 ; 134 Stat. 178); (C) the CARES Act ( Public Law 116–136 ; 134 Stat. 281); (D) the Paycheck Protection Program and Health Care Enhancement Act ( Public Law 116–139 ; 134 Stat. 620); (E) division N of the Consolidated Appropriations Act, 2021 ( Public Law 116–260 ); or (F) the American Rescue Plan Act of 2021 13 ( Public Law 117–2 ). (3) The term Secretary means the Secretary of Education. (b) Civics Secures Democracy Fund There is established in the Treasury a fund to be known as the Civics Secures Democracy Fund . Amounts deposited into the Civics Secures Democracy Fund pursuant to subsection (c) shall be available to the Secretary, without fiscal year limitation or need for subsequent appropriation, and shall be used as follows: (1) For fiscal year 2022 and for each of the 5 succeeding fiscal years— (A) $585,000,000 from the Civics Secures Democracy Fund shall be made available to carry out section 103; (B) $200,000,000 from the Civics Secures Democracy Fund shall be made available to carry out section 104; and (C) $50,000,000 from the Civics Secures Democracy Fund shall be made available to carry out section 106. (2) For fiscal year 2022 and for each of the 5 succeeding fiscal years, $150,000,000 shall be made available from the Civics Secures Democracy Fund to carry out section 105 of this Act and section 805 of the Higher Education Act of 1965 ( 20 U.S.C. 1161e ). (3) For fiscal year 2022 and for each of the 5 succeeding fiscal years, $15,000,000 shall be made available from the Civics Secures Democracy Fund to carry out section 810A of the James Madison Memorial Fellowship Act (20 18 U.S.C. 4501 et seq. ), as added by section 201 of this Act. (4) $300,000,000 from the Civics Secures Democracy Fund shall be made available for a one-time payment for the Harry S. Truman Scholarship Foundation Trust Fund, established by section 10 of Public Law 93–642 ( 20 U.S.C. 2009 ). (5) $20,000,000 from the Civics Secures Democracy Fund shall be made available for a one-time payment for the James Madison Memorial Fellowship Trust Fund, established by section 811 of the James Madison Memorial Fellowship Act ( 20 U.S.C. 4510 ). (6) For fiscal years beginning after fiscal year 2027— (A) amounts appropriated for any such fiscal year for deposit into the Civics Secures Democracy Fund shall be used to carry out the provisions of law specified in paragraphs (1) through (3); and (B) the amount allocated from the Fund to carry out each such provision for a fiscal year shall be determined by the Secretary. (c) Identification and use of excess funds (1) Identification of sufficient sums Not later than 30 days after the date of enactment of this Act, the Secretary, in consultation with the Secretary of the Treasury and Director of the Office of Management and Budget, shall identify unobligated COVID relief funds for programs that have expired that are appropriate for transfer to the Civics Secures Democracy Fund— (A) in the amount equal to $6,320,000,000; or (B) if unobligated funds in that amount are not available and appropriate for transfer, a lesser amount not to exceed $6,320,000,000. (2) Transfer Effective on the date that is 30 days after the date of enactment of this Act— (A) the unobligated COVID relief funds identified in accordance with paragraph (1) shall be transferred to and merged with the Civics Secures Democracy Fund; and (B) the provisions of law specified in subparagraphs (A) through (F) of subsection (a)(2) shall no longer apply to such funds. (3) Conditional authorization of appropriations In the event the amount transferred to the Civics Secures Democracy Fund pursuant to paragraph (2) is less than $6,320,000,000, there is appropriated to the Fund an amount equal to the difference between— (A) the amount transferred to the Fund pursuant to such paragraph; and (B) $6,320,000,000. | https://www.govinfo.gov/content/pkg/BILLS-117s4384is/xml/BILLS-117s4384is.xml |
117-s-4385 | II 117th CONGRESS 2d Session S. 4385 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Braun introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to allow waivers of annual establishment registration fees for small businesses, and for other purposes.
1. Short title This Act may be cited as the Small Business Establishment Registration Waiver Act . 2. Waiver of annual establishment registration fees for small businesses Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended— (1) in subsection (a)(3)(B)— (A) by striking No fee and inserting the following: (i) In general No fee ; and (B) by adding at the end the following: (ii) Small businesses fee waiver (I) Definition of small business For the purposes of this clause, the term small business means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. (II) Waiver The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined on the basis of criteria established by the Secretary. (III) Firms submitting tax returns to the united states internal revenue service The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates. (IV) Firms not submitting tax returns to the united states internal revenue service In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment's firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates. (V) Request for waiver An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable. ; (2) in subsection (d)(2)(B)(iii), by inserting , if extant, after national taxing authority ; and (3) in subsection (e)(2)(B)(iii), by inserting , if extant, after national taxing authority . | https://www.govinfo.gov/content/pkg/BILLS-117s4385is/xml/BILLS-117s4385is.xml |
117-s-4386 | II 117th CONGRESS 2d Session S. 4386 IN THE SENATE OF THE UNITED STATES June 13, 2022 Mr. Braun (for himself and Mr. Hickenlooper ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
1. Predetermined change control plans for devices (a) In general Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by inserting after section 515B ( 21 U.S.C. 360e–3 ) the following: 515C. Predetermined change control plans for devices (a) Approved devices (1) In general Notwithstanding section 515(d)(5)(A), a supplemental application shall not be required for a change to a device approved under section 515, if such change is consistent with a predetermined change control plan that is approved pursuant to paragraph (2). (2) Predetermined change control plan The Secretary may approve a predetermined change control plan submitted in an application, including a supplemental application, under section 515 that describes planned changes that may be made to the device (and that would otherwise require a supplemental application under section 515), if the device remains safe and effective without any change. (3) Scope The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (b) Cleared devices (1) In general Notwithstanding section 510(k), a premarket notification shall not be required for a change to a device cleared under section 510(k), if such change is consistent with an established predetermined change control plan granted pursuant to paragraph (2). (2) Predetermined change control plan The Secretary may clear a predetermined change control plan submitted in a notification submitted under section 510(k) that describes planned changes that may be made to the device (and that would otherwise require a new notification), if— (A) the device remains safe and effective without any such change; and (B) the device would remain substantially equivalent to the predicate. (3) Scope The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. (c) Predicate devices In making a determination of substantial equivalence pursuant to section 513(i), the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device. . (b) Conforming amendments (1) Cleared devices Section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(l)(1) ) is amended, in the first sentence, by inserting , or with respect to a change that is consistent with a predetermined change control plan cleared under section 515C before the period at the end. (2) Approved devices Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e(d)(5)(A)(i) ) is amended by striking A supplemental and inserting Unless the change is consistent with a predetermined change control plan approved under section 515C, a supplemental . (3) Documentation of rationale for significant decisions Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360g–1(a)(1) ) is amended to read as follows: (1) In general The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 510(k), a petition for classification under section 513(f), an application under section 515, or an application for an exemption under section 520(g), including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion. . | https://www.govinfo.gov/content/pkg/BILLS-117s4386is/xml/BILLS-117s4386is.xml |
117-s-4387 | II 117th CONGRESS 2d Session S. 4387 IN THE SENATE OF THE UNITED STATES June 13, 2022 Ms. Duckworth introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To provide for the procurement of parts for commercially derived aircraft.
1. Short title This Act may be cited as the Improving Military Aviation Readiness Act of 2022 . 2. Procurement of parts for commercially derived aircraft The Secretary of the Air Force and the Secretary of the Navy shall— (1) include FAA-certified airworthy used, overhauled, reconditioned, and remanufactured commercial common/dual use parts, except for life limited parts, in supply chain solutions to provide for replacement or increased inventories for all Department of Defense commercial derivative aircraft and engines and aircraft that are based on commercial design; and (2) ensure that the acquisition of all follow-on used, overhauled, reconditioned, and remanufactured commercial common/dual use parts under paragraph (1) is conducted on a competitive basis, based on price and quality, and procured only from suppliers who provide FAA-certified parts that possess a FAA Authorized Release Certificate, FAA Form 8130–3 Airworthy Approval Tag from certificated repair stations pursuant to part 145 of title 14, Code of Federal Regulations. | https://www.govinfo.gov/content/pkg/BILLS-117s4387is/xml/BILLS-117s4387is.xml |
117-s-4388 | II 117th CONGRESS 2d Session S. 4388 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Ossoff (for himself and Mr. Cramer ) introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To amend title 10, United States Code, to waive cost-sharing under the TRICARE program for three mental health outpatient visits per year, and for other purposes.
1. Short title This Act may be cited as the Military Families Mental Health Services Act . 2. Waiver of cost-sharing for three mental health outpatient visits under the TRICARE program (a) TRICARE Select Section 1075(c) of title 10, United States Code, is amended by adding at the end the following new paragraph: (4) Consistent with other provisions of this chapter and under requirements to be prescribed by the Secretary, the Secretary may waive cost-sharing requirements for the first three outpatient mental health visits of a beneficiary each year. . (b) TRICARE Prime Section 1075a(a) of such title is amended by adding at the end the following new paragraph: (4) Consistent with other provisions of this chapter and under requirements to be prescribed by the Secretary, the Secretary may waive cost-sharing requirements for the first three outpatient mental health visits of a beneficiary each year. . | https://www.govinfo.gov/content/pkg/BILLS-117s4388is/xml/BILLS-117s4388is.xml |
117-s-4389 | II 117th CONGRESS 2d Session S. 4389 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Scott of South Carolina (for himself and Ms. Rosen ) introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To provide for the abolition of certain United Nations groups, and for other purposes.
1. Short title This Act may be cited as the COI Elimination Act . 2. Abolition and restriction (a) Statement of policy It is the policy of the United States— (1) to seek the abolition of the United Nations Independent International Commission of Inquiry on the Occupied Palestinian Territory, including East Jerusalem, and in Israel; and (2) to combat systemic anti-Israel bias at the United Nations Human Rights Council and other international fora. (b) Abolition of certain United Nations groups Section 721(b) of the Admiral James W. Nance and Meg Donovan Foreign Relations Authorization Act, Fiscal Years 2000 and 2001, enacted by reference pursuant to section 1000(a)(7) of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2000 ( Public Law 106–113 ) ( 22 U.S.C. 287 note) is amended by striking ; and the Division on Public Information on the Question of Palestine and inserting ; the Division on Public Information on the Question of Palestine; and the United Nations Independent International Commission of Inquiry on the Occupied Palestinian Territory, including East Jerusalem, and in Israel . (c) Withholding of funds Section 114 of the Department of State Authorization Act, Fiscal Years 1984 and 1985 ( Public Law 98–164 ; 22 U.S.C. 287e note) is amended— (1) in subsection (a)— (A) in paragraph (6), by striking and after the semicolon; (B) in paragraph (7), by striking the period and inserting ; and ; and (C) by adding at the end the following new paragraph: (8) 25 percent of the amount budgeted for the United Nations Independent International Commission of Inquiry on the Occupied Palestinian Territory, including East Jerusalem, and in Israel, unless the Secretary of State submits to Congress a certification that the United Nations Independent International Commission of Inquiry on the Occupied Palestinian Territory, including East Jerusalem, and in Israel has been abolished. ; and (2) by adding at the end the following: (e) If the Secretary of State submits to Congress a certification under paragraph (8) of subsection (a), the United States shall, subject to available appropriations, provide to the United Nations an amount equal to the total amount of funds withheld in accordance with such paragraph during the current and any prior year. . | https://www.govinfo.gov/content/pkg/BILLS-117s4389is/xml/BILLS-117s4389is.xml |
117-s-4390 | II 117th CONGRESS 2d Session S. 4390 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Hickenlooper introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require summary approval information with respect to certain approved drugs and biological products.
1. Short title This Act may be cited as the Accelerated Approval Transparency Act . 2. Summary approval information With respect to each new drug application for a new molecular entity approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or biological product licensed under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) pursuant to accelerated approval under section 506(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c) ), the Secretary of Health and Human Services shall provide for the drug or biologic action package a summary of the basis for approval, including, as relates to such new molecular entity, whether an advisory committee meeting was held and a rationale for a determination by the Secretary that a surrogate endpoint is reasonably likely to predict clinical benefit. | https://www.govinfo.gov/content/pkg/BILLS-117s4390is/xml/BILLS-117s4390is.xml |
117-s-4391 | II 117th CONGRESS 2d Session S. 4391 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Cassidy introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish rules for export certification of devices manufactured outside of the United States.
1. Short title This Act may be cited as the Correcting a Lack of Efficient, Adequate, and Reasonable Documentation Act or the CLEAR Documentation Act . 2. Certification of imported devices Section 801(e)(4)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384(e)(4) ) is amended by striking clause (iii) and inserting the following: (F) (i) The Secretary shall issue a certification under subparagraph (A) for a device manufactured by an establishment located outside of the United States that is registered under section 510(i), if the device— (I) is listed pursuant to section 510(j); (II) has been approved under section 515 or cleared under section 510(k), or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510; (III) is imported or offered for import into the United States; and (IV) otherwise meets the requirements of this Act. (ii) (I) A certification for a device described in clause (i)— (aa) shall be subject to the fee described in subparagraph (B); and (bb) notwithstanding subparagraph (C), shall address and include the same material information as a Certificate to Foreign Government, and shall have a document title that includes the words Certificate to Foreign Government . (iii) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph. . | https://www.govinfo.gov/content/pkg/BILLS-117s4391is/xml/BILLS-117s4391is.xml |
117-s-4392 | II 117th CONGRESS 2d Session S. 4392 IN THE SENATE OF THE UNITED STATES June 14, 2022 Ms. Duckworth introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To require the Secretary of Defense to carry out a pilot program on the use of sustainable aviation fuel by the Department of Defense.
1. Short title This Act may be cited as the Reduce Our Military’s Reliance on Foreign Fuel Act . 2. Pilot program on use of sustainable aviation fuel (a) Pilot program required (1) In general The Secretary of Defense shall conduct a pilot program on the use of sustainable aviation fuel by the Department of Defense. (2) Design of program The pilot program shall be designed to— (A) identify any logistical challenges with respect to the use of sustainable aviation fuel by the Department; (B) promote understanding of the technical and performance characteristics of sustainable aviation fuel when used in a military setting; and (C) engage nearby commercial airports to explore opportunities and challenges to partner on increased use of sustainable aviation fuel. (b) Selection of facilities (1) Selection (A) In general Not later than one year after the date of the enactment of this Act, the Secretary of Defense shall select not fewer than two geographically diverse facilities of the Department at which to carry out the pilot program. (B) Onsite refinery Not fewer than one facility selected under subparagraph (A) shall be a facility with an onsite refinery that is located in proximity to not fewer than one major commercial airport that is also actively seeking to increase the use of sustainable aviation fuel. (2) Notice to Congress Upon the selection of each facility under paragraph (1), the Secretary shall submit to the Committees on Armed Services of the Senate and the House of Representatives notice of the selection, including an identification of the facility selected. (c) Use of sustainable aviation fuel (1) Plans For each facility selected under subsection (b), not later than one year after the selection of the facility, the Secretary shall— (A) develop a plan on how to implement, by September 30, 2028, a target of exclusively using at the facility aviation fuel that is blended to contain not less than 10 percent sustainable aviation fuel; (B) submit the plan developed under subparagraph (A) to the Committees on Armed Services of the Senate and the House of Representatives; and (C) provide to the Committees on Armed Services of the Senate and the House of Representatives a briefing on such plan that includes, at a minimum— (i) a description of any operational, infrastructure, or logistical requirements and recommendations for the blending and use of sustainable aviation fuel; and (ii) a description of any stakeholder engagement in the development of the plan, including any consultations with nearby commercial airport owners or operators. (2) Implementation of plans For each facility selected under subsection (b), during the period beginning on a date that is not later than September 30, 2028, and for five years thereafter, the Secretary shall require, in accordance with the respective plan developed under paragraph (1), the exclusive use at the facility of aviation fuel that is blended to contain not less than 10 percent sustainable aviation fuel. (d) Criteria for sustainable aviation fuel Sustainable aviation fuel used under the pilot program shall meet the following criteria: (1) Such fuel shall be produced in the United States from domestic feedstock sources. (2) Such fuel shall constitute drop-in fuel that meets all specifications and performance requirements of the Department of Defense and the Armed Forces. (e) Waiver The Secretary may waive the use of sustainable aviation fuel at a facility under the pilot program if the Secretary— (1) determines such use is not feasible due to a lack of domestic availability of sustainable aviation fuel or a national security contingency; and (2) submits to the congressional defense committees notice of such waiver and the reasons for such waiver. (f) Final report (1) In general At the conclusion of the pilot program, the Assistant Secretary of Defense for Energy, Installations, and Environment shall submit to the Committees on Armed Services of the Senate and the House of Representatives a final report on the pilot program. (2) Elements The report required by paragraph (1) shall include each of the following: (A) An assessment of the effect of using sustainable aviation fuel on the overall fuel costs of blended fuel. (B) A description of any operational, infrastructure, or logistical requirements and recommendations for the blending and use of sustainable aviation fuel, with a focus on scaling up adoption of such fuel throughout the Armed Forces. (C) Recommendations with respect to how military installations can leverage proximity to commercial airports and other jet fuel consumers to increase the rate of use of sustainable aviation fuel, for both military and non-military use, including potential collaboration on innovative financing or purchasing and shared supply chain infrastructure. (D) A description of the effects on performance and operation of aircraft using sustainable aviation fuel, including— (i) if used, considerations of various blending ratios and their associated benefits; (ii) efficiency and distance improvements of flights using sustainable aviation fuel; (iii) weight savings on large transportation aircraft and other types of aircraft with using blended fuel with higher concentrations of sustainable aviation fuel; (iv) maintenance benefits of using sustainable aviation fuel, including engine longevity; (v) the effect of the use of sustainable aviation fuel on emissions and air quality; (vi) the effect of the use of sustainable aviation fuel on the environment and on surrounding communities, including environmental justice factors that are created by the demand for and use of sustainable aviation fuel by the Department of Defense; and (vii) benefits with respect to job creation in the sustainable aviation fuel production and supply chain. (g) Sustainable aviation fuel defined In this section, the term sustainable aviation fuel means liquid fuel that— (1) consists of synthesized hydrocarbon; (2) meets the requirements of ASTM International Standard D7566 (or successor standard); (3) is derived from biomass (as such term is defined in section 45K(c)(3) of the Internal Revenue Code of 1986), waste streams, renewable energy sources, or gaseous carbon oxides; and (4) is not derived from palm fatty acid distillates. | https://www.govinfo.gov/content/pkg/BILLS-117s4392is/xml/BILLS-117s4392is.xml |
117-s-4393 | II 117th CONGRESS 2d Session S. 4393 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Grassley (for himself, Mr. Barrasso , Mr. Daines , Mr. Lankford , Mr. Young , and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to modify the maximum capital gains tax rate, to modify the tax on net investment income, and for other purposes.
1. Short title This Act may be cited as the Middle-Class Savings and Investment Act . 2. Modification of capital gain rates (a) Expansion of zero percent rate (1) In general Section 1(h)(1)(B)(i) of the Internal Revenue Code of 1986 is amended by striking which would (without regard to this paragraph) be taxed at a rate below 25 percent and inserting below the maximum zero rate amount . (2) Maximum zero rate amount Section 1(h) of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph: (12) Maximum zero rate amount (A) In general The maximum zero rate amount shall be— (i) in the case of a joint return or surviving spouse, $165,000, (ii) in the case of any other individual (other than an estate or trust), an amount equal to ½ of the amount in effect for the taxable year under clause (i), and (iii) in the case of an estate or trust, $2,600. (B) Inflation adjustment In the case of any taxable year beginning after 2021, each of the dollar amounts in subparagraph (A) shall be increased by an amount equal to— (i) such dollar amount, multiplied by (ii) the cost-of-living adjustment determined under subsection (f)(3) for the calendar year in which the taxable year begins, determined by substituting calendar year 2017 for calendar year 2016 in subparagraph (A)(ii) thereof. If any increase under this subparagraph is not a multiple of $50, such increase shall be rounded to the next lowest multiple of $50. . (3) Conforming amendments Paragraph (5) of section 1(j) of such Code is amended— (A) in subparagraph (A), by striking shall be applied and all that follows through by substituting below the maximum 15-percent rate amount and inserting shall be applied by substituting below the maximum 15-percent rate amount , (B) in subparagraph (B)— (i) by striking all that preceding clause (ii), (ii) by redesignating clause (ii) as subparagraph (B), (iii) by redesignating subclauses (I) through (IV) of subparagraph (B) (as so redesignated) as clauses (i) through (iv), respectively, and (iv) by moving subparagraph (B) and each of clauses (i) through (iv) (as so redesignated) 2 ems to the left, and (C) in subparagraph (C), by striking clauses (i) and (ii) of . (b) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2021. 3. Partial exclusion of certain interest received by individuals (a) In general Part III of subchapter B of chapter 1 of the Internal Revenue Code of 1986 (relating to amounts specifically excluded from gross income) is amended by inserting after section 115 the following new section: 116. Partial exclusion of certain interest received by individuals (a) Exclusion from gross income Gross income does not include the sum of the amounts received during the taxable year by an individual as qualified interest. (b) Limitations The aggregate amount excluded under subsection (a) for any taxable year shall not exceed $300 ($600 in the case of a joint return). (c) Qualified interest For purposes of this section— (1) In general The term qualified interest means any interest other than interest excluded from gross income under any other provision of this chapter. (2) Special rules for dividends received from certain money market mutual funds (A) In general The term qualified interest shall include qualified interest-related dividends. (i) In general Except as provided in clause (ii), a qualified interest-related dividend is any dividend or part thereof (other than a capital gain dividend or exempt interest dividend)— (I) paid by a regulated investment company regulated as a money market fund under section 270.2a–7 of title 17, Code of Federal Regulations, and (II) reported by the company as a qualified interest-related dividend in written statements furnished to its shareholders. (ii) Excess reported amounts If the aggregate reported amount with respect to the company for any taxable year exceeds the applicable qualified interest of the company for such taxable year, a qualified interest-related dividend is the excess of— (I) the reported qualified interest-related dividend amount, over (II) the excess reported amount which is allocable to such reported qualified interest-related dividend amount. (iii) Allocation of excess reported amount (I) In general Except as provided in subclause (II), the excess reported amount (if any) which is allocable to the reported qualified interest-related dividend amount is that portion of the excess reported amount which bears the same ratio to the excess reported amount as the reported qualified interest-related dividend amount bears to the aggregate reported amount. (II) Special rule for noncalendar year taxpayers In the case of any taxable year which does not begin and end in the same calendar year, if the post-December reported amount equals or exceeds the excess reported amount for such taxable year, subclause (I) shall be applied by substituting post-December reported amount for aggregate reported amount and no excess reported amount shall be allocated to any dividend paid on or before December 31 of such taxable year. (iv) Definitions For purposes of this subparagraph— (I) Reported qualified interest-related dividend amount The term reported qualified interest-related dividend amount means the amount reported to its shareholders under clause (i) as a qualified interest-related dividend. (II) Excess reported amount The term excess reported amount means the excess of the aggregate reported amount over the applicable qualified interest of the company for the taxable year. (III) Aggregate reported amount The term aggregate reported amount means the aggregate amount of dividends reported by the company under clause (i) as qualified interest-related dividends for the taxable year (including qualified interest-related dividends paid after the close of the taxable year described in section 855). (IV) Post-December reported amount The term post-December reported amount means the aggregate reported amount determined by taking into account only dividends paid after December 31 of the taxable year. (V) Applicable qualified interest The term applicable qualified interest means interest described in paragraph (1). (d) Nonresident aliens ineligible for exclusion Subsection (a) shall not apply to any nonresident alien individual. (e) Regulations The Secretary may prescribe such regulations as are appropriate (including regulations requiring reporting) to apply this section in the case of interest received— (1) from partnerships and S corporations, and (2) from a trade or business of the taxpayer. . (b) Conforming amendments (1) The table of sections for part III of subchapter B of chapter 1 of such Code is amended by inserting after the item relating to section 115 the following new item: Sec. 116. Partial exclusion of certain interest received by individuals. . (2) Paragraph (2) of section 265(a) of such Code is amended by inserting before the period at the end the following: , or to purchase or carry obligations or shares, or to make deposits, to the extent the interest thereon is excludable from gross income under section 116 . (3) Subsection (c) of section 584 of such Code is amended by adding at the end the following: The proportionate share of each participant in the amount of qualified interest (as defined in section 116) received by the common trust fund shall be considered for purposes of such section as having been received by such participant. . (4) Subsection (a) of section 643 of such Code is amended by redesignating paragraph (7) as paragraph (8) and by inserting after paragraph (6) the following new paragraph: (7) Qualified interest There shall be included the amount of any qualified interest (as defined in section 116) excluded from gross income pursuant to section 116 (reduced by amounts which would be deductible in respect of disbursements allocable to such income but for the provisions of section 265). . (c) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2021. 4. Modification of threshold amount under net investment income tax (a) In general Section 1411(b) of the Internal Revenue Code of 1986 is amended to read as follows: (b) Threshold amount For purposes of this chapter— (1) In general The term threshold amount means— (A) in the case of a taxpayer making a joint return under section 6013 or a surviving spouse (as defined in section 2(a)), $400,000, and (B) in any other case, ½ of the dollar amount determined under paragraph (1). (2) Inflation adjustment In the case of any taxable year beginning in a calendar year after 2022, the dollar amount in paragraph (1)(A) shall be increased by an amount equal to— (A) such dollar amount, multiplied by (B) the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which the taxable year begins, determined by substituting calendar year 2021 for calendar year 2016 in subparagraph (A)(ii) thereof. Any increase determined under the preceding sentence shall be rounded to the nearest multiple of $1,000. . (b) Effective date The amendment made by this section shall apply to taxable years beginning after December 31, 2021. 5. Enhancement of Saver’s Credit (a) Maximum contribution amount Section 25B(a) of the Internal Revenue Code of 1986 is amended by striking $2,000 and inserting $2,500 . (b) Modification of credit rate (1) 50 percent credit rate Section 25B(a) of the Internal Revenue Code of 1986 is amended by striking the applicable percentage and inserting 50 percent . (2) Adjusted gross income phaseouts Section 25B(b) of such Code is amended to read as follows: (b) Limitation For purposes of this section— (1) In general The amount of credit allowable under subsection (a) (determined without regard to this subsection) shall be reduced (but not below zero) by an amount which bears the same ratio to the credit otherwise so allowable as— (A) the excess (if any) of— (i) adjusted gross income of the taxpayer, over (ii) the threshold amount, bears to (B) the phaseout amount. (2) Threshold amount The term threshold amount means— (A) in the case of a joint return or a surviving spouse (as defined in section 2(a)), $45,000, (B) in the case of a head of household, 75 percent of the amount in effect for the taxable year under subparagraph (A), and (C) in the case of any other individual, 50 percent of the amount in effect for the taxable year under subparagraph (A). (3) Phaseout amount The term phaseout amount means— (A) in the case of a joint return or a surviving spouse (as defined in 2(a)), $40,000, (B) in the case of a head of household (as defined in section 2(b)), 75 percent of the amount in effect for the taxable year under subparagraph (A), and (C) in the case of any other individual, 50 percent of the amount in effect for the taxable year under subparagraph (A). (4) Inflation adjustment (A) In general In the case of any taxable year beginning in a calendar year after 2022, the $45,000 dollar amount in paragraph (2) and the $40,000 in paragraph (3) shall each be increased by an amount equal to— (i) such dollar amount, multiplied by (ii) the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which the taxable year begins, determined by substituting calendar year 2021 for calendar year 2016 in subparagraph (A)(ii) thereof. (B) Rounding Any increase determined under subparagraph (A) that is not a multiple of $500 shall be rounded to the nearest multiple of $500. . (c) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2021. 6. Extension of limitation on deduction for state and local taxes (a) In general Section 164(b)(6) of the Internal Revenue Code of 1986 is amended— (1) by striking January 1, 2026 and inserting January 1, 2029 , and (2) by striking 2025 in the heading thereof and inserting 2028 . (b) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2022. | https://www.govinfo.gov/content/pkg/BILLS-117s4393is/xml/BILLS-117s4393is.xml |
117-s-4394 | II 117th CONGRESS 2d Session S. 4394 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Rubio (for himself and Mr. Scott of Florida ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To modify the minimum required weight of orange juice soluble solids.
1. Short title This Act may be cited as the Defending Domestic Orange Juice Production Act . 2. Revision of pasteurized orange juice standards (a) In general Effective on the date of enactment of this Act, the standard of identity for pasteurized orange juice , established in section 146.140 of title 21, Code of Federal Regulations, shall be deemed to require finished pasteurized orange juice to contain not less than 10.0 percent by weight of orange juice soluble solids, exclusive of the solids of any added optional sweetening ingredients. (b) Regulation authority Nothing in this section shall be construed to limit the authority of the Secretary of Health and Human Services to promulgate regulations to amend the standard of identity for pasteurized orange juice. | https://www.govinfo.gov/content/pkg/BILLS-117s4394is/xml/BILLS-117s4394is.xml |
117-s-4395 | II 117th CONGRESS 2d Session S. 4395 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Scott of Florida (for himself and Mr. Luján ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.
1. Short title This Act may be cited as the Ryan White PrEP Availability Act . 2. Services for individuals at risk of acquiring HIV Title XXVI of the Public Health Service Act ( 42 U.S.C. 300ff–11 et seq. ) is amended by adding at the end the following: H Services for individuals at risk of acquiring HIV 2696. Individuals at risk of acquiring HIV (a) In general Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV— (1) drugs and biological products for pre-exposure prophylaxis (PrEP) prescribed by a professional who is authorized under State or other applicable law to write prescriptions, consistent with Federal guidelines issued by the Centers for Disease Control and Prevention; (2) medical, laboratory, and counseling services related to such drugs and biological products; and (3) referrals and linkages to appropriate services for the prevention of HIV, as prescribed to eligible individuals who are at risk of acquiring HIV. (b) Voluntary program Nothing in this section shall be construed to permit any eligible area, State, or public or private nonprofit entity to allocate any grant funds received under this title for the purposes described in paragraph (1) or (2) of subsection (a). . | https://www.govinfo.gov/content/pkg/BILLS-117s4395is/xml/BILLS-117s4395is.xml |
117-s-4396 | II 117th CONGRESS 2d Session S. 4396 IN THE SENATE OF THE UNITED STATES June 14, 2022 Ms. Duckworth introduced the following bill; which was read twice and referred to the Committee on Armed Services A BILL To require the Secretary of Defense to conduct a study on providing benefits under TRICARE Reserve Select and the TRICARE dental program to members of the Selected Reserve and their dependents.
1. Short title This Act may be cited as the Access to Healthcare for Reservists Act . 2. Study on providing benefits under TRICARE Reserve Select and TRICARE dental program to members of the Selected Reserve and their dependents (a) Study The Secretary of Defense shall conduct a study on the feasibility, potential cost effects to the budget of the Department of Defense, changes in out-of-pocket costs to beneficiaries, and effects on other Federal programs of expanding eligibility for TRICARE Reserve Select and the TRICARE dental program to include all members of the Selected Reserve of the Ready Reserve of a reserve component of the Armed Forces, their dependents, and their non-dependent children under the age of 26. (b) Specifications In conducting the study under subsection (a), the Secretary shall include an assessment of the following: (1) Cost-shifting to the Department of Defense to support the expansion of TRICARE Reserve Select and the TRICARE dental program from— (A) health benefit plans under chapter 89 of title 5, United States Code; (B) employer-sponsored health insurance; (C) private health insurance; (D) insurance under a State health care exchange; and (E) the Medicaid program under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq. ). (2) New costs for the Department of Defense to enroll in TRICARE Reserve Select and the TRICARE dental program members of the Selected Reserve of the Ready Reserve of a reserve component of the Armed Forces who were previously uninsured. (3) The resources needed to implement TRICARE Reserve Select and the TRICARE dental program for all such members, their dependents, and their non-dependent children under the age of 26. (4) Anticipated cost-savings or cost-avoidance of the expansion of TRICARE Reserve Select and the TRICARE dental program with regard to increased training days performed in support of mass medical events during battle assemblies of the reserve components, including an assessment of the impact of such expansion on— (A) medical readiness; (B) overall deployability rates; (C) deployability timelines; (D) fallout rates at mobilization sites; (E) cross-leveling of members of the reserve components to backfill medical fallouts at mobilization sites; and (F) any other readiness metrics affected by such expansion. (5) Any impact of such expansion on recruitment and retention of members of the Ready Reserve of the reserve components of the Armed Forces. (6) Any changes to out-of-pocket costs for such members and their dependents resulting from such expansion. (7) Anticipated cost-savings or cost-avoidance in contracts that implement the Reserve Health Readiness Program of the Department of Defense. (c) Determination of cost effects In studying the potential cost effects to the budget of the Department of Defense under subsection (a), the Secretary of Defense shall study the cost effects for the following scenarios of expanded eligibility for TRICARE Reserve Select and the TRICARE dental program: (1) Premium free for members of the Selected Reserve of the Ready Reserve of a reserve component of the Armed Forces, their dependents, and their non-dependent children under the age of 26. (2) Premium free for such members and subsidized premiums for such dependents and non-dependent children. (3) Subsidized premiums for such members, dependents, and non-dependent children. (d) Use of a federally funded research and development center The Secretary shall contract with a federally funded research and development center that is qualified and appropriate to conduct the study required under subsection (a). (e) Briefing; report (1) Briefing Not later than one year after the date of the enactment of this Act, the Secretary shall provide to the Committee on Armed Services of the Senate and the Committee on Armed Services of the House of Representatives a briefing on the methodology and approach of the study required under subsection (a). (2) Report Not later than two years after the date of the enactment of this Act, the Secretary shall submit to the Committee on Armed Services of the Senate and the Committee on Armed Services of the House of Representatives a report on the results of the study required under subsection (a). (f) Definitions In this section: (1) TRICARE dental program The term TRICARE dental program means dental benefits under section 1076a of title 10, United States Code. (2) TRICARE Reserve Select The term TRICARE Reserve Select means health benefits under section 1076d of such title. | https://www.govinfo.gov/content/pkg/BILLS-117s4396is/xml/BILLS-117s4396is.xml |
117-s-4397 | II 117th CONGRESS 2d Session S. 4397 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Lankford introduced the following bill; which was read twice and referred to the Committee on Foreign Relations A BILL To authorize the Secretary of Defense to build capacity for counter-unmanned aircraft systems operations.
1. Short title This Act may be cited as the Strengthening Counter-Unmanned Aircraft Systems Operations (C-UAS) Partnerships Act . 2. Authority to build capacity for counter-unmanned aircraft systems operations (a) Sense of Congress It is the sense of Congress that military education and training (as defined in section 644 of the Foreign Assistance Act of 1961 ( 22 U.S.C. 2403 )) has an important role in training foreign partners on counter-unmanned aircraft systems operations. (b) Additional authority Section 333(a) of title 10, United States Code, is amended by adding at the end the following new paragraph: (10) Counter-unmanned aircraft systems operations. . | https://www.govinfo.gov/content/pkg/BILLS-117s4397is/xml/BILLS-117s4397is.xml |
117-s-4398 | II 117th CONGRESS 2d Session S. 4398 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Whitehouse (for himself, Ms. Warren , Mr. Markey , Mr. Brown , Mr. Sanders , and Ms. Klobuchar ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To allow Juvenile Justice and Delinquency Prevention Program assistance be used to reduce racial and ethnic disparities, and for other purposes.
1. Short title This Act may be cited as the Reducing Racial and Ethnic Disparities in the Juvenile Justice System Act of 2022 . 2. Findings Congress finds the following: (1) Black, Indigenous, Hispanic, and other youth of color are overrepresented in the juvenile justice system and receive harsher consequences than White youth. (2) Reducing reliance on incarceration and providing evidence-based, trauma-informed, and linguistically and culturally responsive support and services to youth who come in contact with the juvenile justice system is a key goal of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11101 et seq. ). (3) Addressing racial and ethnic disparities in the juvenile justice system requires accurate data regarding youth of color who come into contact with the juvenile justice system, including data that can be disaggregated by race, and ethnicity. (4) Youth of color and their families with lived experience interacting with the juvenile justice system can provide important insight, analysis, and solutions regarding how to recognize and address racial disparities in the juvenile justice system. 3. Definition of racial and ethnic disparity (a) In general Section 103 of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11103 ) is amended by striking paragraph (41) and inserting the following: (41) the term racial and ethnic disparity means— (A) that Black, Indigenous, Hispanic, and other youth of color are involved at a decision point in the juvenile justice system at disproportionately higher rates than White youth at that decision point; (B) that the percentage of Black, Indigenous, Hispanic, and other youth of color at any decision point is higher than the percentage of youth of color in the general population; (C) that Black, Indigenous, Hispanic, and other youth of color experience more severe outcomes at any decision point than similarly situated White youth; or (D) that Black, Indigenous, Hispanic, and other youth of color are detained and removed from their homes when less restrictive alternatives would be more effective; . (b) Technical and conforming amendment Section 251(a)(1)(B)(viii) of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11161(a)(1)(B)(viii) ) is amended by striking members of minority groups and inserting Black, Indigenous, Hispanic, and other youth of color . 4. Juvenile Justice and Delinquency Prevention Program State plans (a) In general Section 223(a) of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11133(a) ) is amended— (1) in paragraph (3)(A)(v), by striking of someone and inserting of a youth representative of the population in detention and secure confinement ; (2) in paragraph (7)(B)— (A) in clause (viii), by striking and at the end; (B) by redesignating clause (ix) as clause (x); and (C) by inserting after clause (viii) the following: (ix) a plan to implement systems for identifying and recording youth data disaggregated by race and ethnicity; and ; (3) in paragraph (9)— (A) in subparagraph (V), by striking and at the end; (B) in subparagraph (W), by adding and at the end; and (C) by inserting after subparagraph (W) the following: (X) programs seeking to reduce racial and ethnic disparities at any decision point, such as at the point of arrest, referral to court, diversion, secure detention, judicial waiver to adult criminal court, case petitioning, delinquency finding or adjudication, probation, or residential placement, including secure confinement, including prevention, diversion, and community supervision, and other programs that provide linguistically and culturally responsive support and services to youth; ; (4) in paragraph (15)— (A) in subparagraph (A), by inserting and youth representative of the population in detention and secure confinement who have been or are currently under the jurisdiction of the juvenile justice system or, if not feasible and in appropriate circumstances, parents or guardians of a Black, Indigenous, Hispanic, or other youth of color who has been or is currently under the jurisdiction of the juvenile justice system after educational system ; (B) in subparagraph (B) by striking and at the end; (C) in subparagraph (C), by adding and at the end; and (D) by adding at the end the following: (D) reporting on measurable progress on the work plan described in subparagraph (C) for the prior year; ; and (5) in paragraph (22)— (A) in subparagraph (B), by striking and at the end; (B) in subparagraph (C), adding and at the end; and (C) by adding at the end the following: (D) promote opportunity for community-based providers serving youth in communities with higher than average racial and ethnic disparities at any decision point in the juvenile justice system in the State, compared with other communities in the same State; . (b) Guidance for collection of data Section 223 of the Juvenile Justice and Delinquency Prevention Act of 1974 ( 34 U.S.C. 11133 ) is amended by adding at the end the following: (h) Guidance for collection of data Not later than 1 year after the date of enactment of the Reducing Racial and Ethnic Disparities in the Juvenile Justice System Act of 2022 , the Administrator shall, in consultation with the United States Commission on Civil Rights and the Director of the Census Bureau, develop guidance for States with respect to a uniform standard for the collection and reporting of disaggregated and cross-referenced data on race and ethnicity under this section to assist States in implementing subsection (a)(15). . | https://www.govinfo.gov/content/pkg/BILLS-117s4398is/xml/BILLS-117s4398is.xml |
117-s-4399 | II 117th CONGRESS 2d Session S. 4399 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Brown (for himself, Ms. Collins , Mr. Manchin , and Mr. Scott of Florida ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To require the purchase of domestically made flags of the United States of America for use by the Federal Government.
1. Short title This Act may be cited as the All-American Flag Act . 2. Requirement for agencies to buy domestically made United States flags (a) Requirement for agencies To buy domestically made United States flags (1) In general Chapter 63 of title 41, United States Code, is amended by adding at the end the following new section: 6310. Requirement for agencies to buy domestically made United States flags (a) Requirement Except as provided in subsections (b) through (d), funds appropriated or otherwise available to an agency may not be used for the procurement of any flag of the United States, unless such flag has been 100 percent manufactured in the United States from articles, materials, or supplies that have been grown or 100 percent produced or manufactured in the United States. (b) Availability exception Subsection (a) does not apply to the extent that the head of the agency concerned determines that satisfactory quality and sufficient quantity of a flag described in such subsection cannot be procured as and when needed at United States market prices. (c) Exception for certain procurements Subsection (a) does not apply to the following: (1) Procurements by vessels in foreign waters. (2) Procurements for resale purposes in any military commissary, military exchange, or nonappropriated fund instrumentality operated by an agency. (3) Procurements for amounts less than the simplified acquisition threshold. (d) Presidential waiver (1) In general The President may waive the requirement in subsection (a) if the President determines a waiver is necessary to comply with any trade agreement to which the United States is a party. (2) Notice of waiver Not later than 30 days after granting a waiver under paragraph (1), the President shall publish a notice of the waiver in the Federal Register. (e) Definitions In this section: (1) Agency The term agency has the meaning given the term executive agency in section 102 of title 40. (2) Simplified acquisition threshold The term simplified acquisition threshold has the meaning given that term in section 134. . (2) Clerical amendment The table of sections at the beginning of such chapter is amended by adding at the end the following new item: 6310. Requirement for agencies to buy domestically made United States flags. . (b) Applicability Section 6310 of title 41, United States Code, as added by subsection (a)(1), shall apply with respect to any contract entered into on or after the date that is 180 days after the date of the enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4399is/xml/BILLS-117s4399is.xml |
117-s-4400 | II 117th CONGRESS 2d Session S. 4400 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Burr (for himself and Mr. Casey ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to allow for special rollovers to Roth IRAs from long-term qualified tuition programs.
1. Short title This Act may be cited as the College Savings Recovery Act. 2. Special rollover to Roth IRA from long-term qualified tuition program (a) In general Paragraph (3) of section 529(c) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph: (E) Special rollover to Roth IRA from long-term qualified tuition program For purposes of this section— (i) In general In the case of a distribution from a qualified tuition program which has been maintained by an account owner in one or more qualified tuition programs for the 10-year period ending on the date of such distribution— (I) subparagraph (A) shall not apply to any portion of such distribution which is paid in a direct trustee-to-trustee transfer to a Roth IRA maintained for the benefit of such account owner or the designated beneficiary under such qualified tuition program, and (II) such portion shall be treated as a rollover contribution for purposes of section 408A(e). (ii) Limitation Clause (i) shall only apply to so much of any distribution as does not exceed the lesser of— (I) the amount applicable to the account owner or the designated beneficiary, as the case may be, under section 408A(c)(2) for the taxable year (reduced by the amount of aggregate contributions made during the taxable year before the date of such distribution to all individual retirement plans maintained for the benefit of the account owner or designated beneficiary, as the case may be), or (II) the aggregate amount contributed to the program (and earnings attributable thereto) before the 5-year period ending on the date of the distribution. (iii) Account owner For purposes of this subparagraph, the term account owner means the individual who established the qualified tuition program account under applicable State law. . (b) Qualified rollover contribution Paragraph (1) of section 408A(e) of such Code is amended— (1) by striking the period at the end of subparagraph (B) and inserting , and , (2) by inserting after subparagraph (B) the following new subparagraph: (C) from a qualified tuition program to the extent provided in section 529(c)(3)(E). , and (3) by adding at the end the following new sentence: Under regulations established by the Secretary, the earnings and contributions of any qualified tuition program from which a qualified rollover contribution is made under subparagraph (C) shall be treated in the same manner as the earnings and contributions of a Roth IRA from which a qualified rollover contribution is made under subparagraph (A). . (c) Reporting Section 529(d) of such Code is amended— (1) by striking Each officer and inserting the following: (1) In general Each officer , (2) by striking by this subsection and inserting by this paragraph , and (3) by adding at the end the following new paragraph: (2) Rollover distributions In the case of any distribution described in subsection (c)(3)(A), the officer or employee having control of the qualified tuition program (or their designee) shall provide a report to the trustee of the Roth IRA to which the distribution is made. Such report shall be filed at such time and in such manner as the Secretary may require and shall include information with respect to the contributions, distributions, and earnings of the qualified tuition program as of the date of the distribution described in subsection (c)(3)(A), together with such other matters as the Secretary may require. . (d) Effective date The amendments made by this section shall apply with respect to distributions after December 31, 2022. | https://www.govinfo.gov/content/pkg/BILLS-117s4400is/xml/BILLS-117s4400is.xml |
117-s-4401 | II 117th CONGRESS 2d Session S. 4401 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Rubio (for himself and Mr. Cotton ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To modify the Freedom of Information Act, and for other purposes.
1. Short title This Act may be cited as the First Opportunity for Information to Americans Act or the FOIA Fix Act . 2. FOIA requests Section 552 of title 5, United States Code, is amended— (1) in subsection (a)— (A) in paragraph (3)(A), by inserting or paragraph (9) after subparagraph (E) ; and (B) by adding at the end the following: (9) (A) Except as provided in subparagraph (D), an agency may not make any record available under this subsection to any requester that— (i) is an individual who is not a citizen of the United States or an alien lawfully admitted for permanent residence; (ii) is an entity that does not have a principal place of business or headquarters located in a State, the District of Columbia, or any territory or possession of the United States; or (iii) is an entity that is a subsidiary of an entity with a principal place of business or headquarters located in— (I) the People’s Republic of China; (II) the Russian Federation; (III) the Democratic People’s Republic of Korea; (IV) the Islamic Republic of Iran; (V) the Republic of Cuba; (VI) the Syrian Arab Republic; or (VII) the regime of Nicolás Maduro in Venezuela. (B) Knowingly assisting, conspiring, or abetting a request for information under this section on behalf of an individual or entity that is prohibited from receiving the information under subparagraph (A) is punishable by a fine of up $10,000 per violation and not more than 1 year in prison. (C) Each agency shall promulgate regulations as necessary to carry out subparagraph (A). (D) Subparagraph (A) shall not apply to a requester that is seeking official copies of the immigration court proceedings of the requester. (10) Notwithstanding any other provision of this section, an agency may determine the manner in which a request is fulfilled under this subsection if the agency has a reasonable belief that fulfilling the request in the manner requested by the requester— (A) is likely to result in the exposure of material or information that is not responsive to the request, including any data describing the structure, data elements, interrelationships, or other characteristics of electronic records otherwise responsive to the request; or (B) poses a material security risk to the agency or another entity in the Federal Government. ; and (2) in subsection (b)— (A) in paragraph (8), by striking or at the end; and (B) in paragraph (9), by striking the period at the end and inserting ; or ; and (C) by adding at the end the following: (10) records or information, such as blueprints, schematics, formulae, technical expertise, or other similar information that is susceptible to reverse engineering— (A) the disclosure of which is likely to damage the interests of the United States; (B) that is materially related to the study of an emerging or foundational technology identified by the Department of Commerce; and (C) for which the interest of the public in disclosure does not outweigh the interests described in subparagraph (A). . | https://www.govinfo.gov/content/pkg/BILLS-117s4401is/xml/BILLS-117s4401is.xml |
117-s-4402 | II 117th CONGRESS 2d Session S. 4402 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Booker introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To direct the Attorney General to establish a grant program to establish, implement, and administer the violent incident clearance and technology investigative method, and for other purposes.
1. Short title This Act may be cited as the Violent Incident Clearance and Technological Investigative Methods Act of 2022 or the VICTIM Act of 2022 . 2. Findings Congress finds the following: (1) Research indicates that law enforcement agencies can increase clearance rates by improving— (A) investigative processes; (B) detective capacities; and (C) organizational oversight and supervision of investigations. (2) When a law enforcement agency expends additional investigative effort, the law enforcement agency improves its success in gaining cooperation of key witnesses and increases the amount of forensic evidence collected. (3) Effective investigation of shootings can prevent subsequent related violence by— (A) deterring retaliation; and (B) providing interventions to individuals who may continue to commit crimes or become victims of retaliatory violence. (4) Law enforcement agencies that demonstrate higher rates of clearance for homicides and non-fatal shootings— (A) have more structured oversight and formal interactions between investigative units and agency leadership; (B) are more likely to have investigative units that have collaborative relationships and robust information sharing with other units of the law enforcement agency; (C) have investigative units that have specific goals and performance metrics for both the unit and for investigators within the unit; (D) have investigators who more frequently respond to the initial crime scene shortly after crimes have been reported to collect evidence and interview witnesses; (E) have investigators who either have specialized experience before joining investigative units or are trained in investigations once they join those units; (F) often have standard operating procedures for investigations that establish policies and evidence-based best practices for conducting and completing homicide investigations; and (G) have better relationships with the communities they serve, even if no specific community-oriented campaign or initiative exists between investigative units and community groups. (5) Criminal justice agencies should collaborate with each other and share best practices for solving homicides and non-fatal shootings. (6) A comprehensive community engagement strategy concerning gun violence is essential to improving clearance rates for homicides and non-fatal shootings. 3. Grant program with respect to violent incident clearance and technological investigative methods (a) Definitions In this section: (1) Clearance by arrest The term clearance by arrest , with respect to an offense reported to a law enforcement agency, means the law enforcement agency— (A) has— (i) arrested not less than 1 person for the offense; (ii) charged the person described in subparagraph (A) with the commission of the offense; and (iii) referred the person described in subparagraph (A) for prosecution for the offense; or (B) has cited an individual under the age of 18 to appear in juvenile court or before another juvenile authority with respect to the offense, regardless of whether a physical arrest occurred. (2) Clearance by exception The term clearance by exception , with respect to an offense reported to a law enforcement agency, means the law enforcement agency— (A) has identified not less than 1 person suspected of the offense; and (B) with respect to the suspect described in subparagraph (A), has— (i) gathered enough evidence to— (I) support an arrest of the suspect; (II) make a charge against the suspect; and (III) refer the suspect for prosecution; (ii) identified the exact location of the suspect so that the suspect could be taken into custody immediately; and (iii) encountered a circumstance outside the control of the law enforcement agency that prohibits the agency from arresting the suspect, charging the suspect, or referring the suspect for prosecution, including— (I) the death of the suspect; (II) the refusal of the victim to cooperate with the prosecution after the suspect has been identified; or (III) the denial of extradition because the suspect committed an offense in another jurisdiction and is being prosecuted for that offense. (3) Clearance rate The term clearance rate , with respect to a law enforcement agency, means— (A) the number of offenses cleared by the law enforcement agency, including through clearance by arrest and clearance by exception, divided by (B) the total number of offenses reported to the law enforcement agency. (4) Eligible entity The term eligible entity means a State, Tribal, or local law enforcement agency or prosecuting office, or a group of Tribal law enforcement agencies or Tribal prosecuting offices. (5) Grant recipient The term grant recipient means a recipient of a grant under the Program. (6) Law enforcement agency The term law enforcement agency means a public agency charged with policing functions, including any component bureau of the agency (such as a governmental victim services program or village public safety officer program), including an agency composed of officers or persons referred to in subparagraph (B) or (C) of section 2(10) of the Indian Law Enforcement Reform Act ( 25 U.S.C. 2801(10) ). (7) Program The term Program means the grant program established under subsection (b)(1). (b) Grant program (1) In general Not later than 180 days after the date of enactment of this Act, the Attorney General shall establish a grant program within the Office of Justice Programs under which the Attorney General awards grants to eligible entities to establish, implement, and administer violent incident clearance and technological investigative methods. (2) Applications An eligible entity seeking a grant under the Program shall submit to the Attorney General an application at such time, in such manner, and containing or accompanied by— (A) such information as the Attorney General may reasonably require; and (B) a description of each eligible project under paragraph (4) that the grant will fund. (3) Selection of grant recipients The Attorney General, in selecting a recipient of a grant under the Program, shall consider the specific plan and activities proposed by the applicant to improve clearance rates for homicides and non-fatal shootings. (4) Eligible projects A grant recipient shall use the grant for activities with the specific objective of improving clearance rates for homicides and non-fatal shootings, including— (A) ensuring the retention of detectives who are assigned to investigate homicides and non-fatal shootings as of the date of receipt of the grant; (B) hiring and training additional detectives who will be dedicated to investigating homicides and non-fatal shootings; (C) developing policies, procedures, and training to improve the ability of detectives to effectively investigate and solve homicides and non-fatal shootings, including implementing best practices relating to— (i) improving internal agency cooperation, organizational oversight and accountability, and supervision of investigations; (ii) developing specific goals and performance metrics for both investigators and investigative units; (iii) establishing or improving relationships with the communities the agency serves; and (iv) collaboration with and among other law enforcement agencies and criminal justice organizations; (D) training personnel to address the needs of victims and family members of victims of homicides and non-fatal shootings or collaborating with trained victim advocates and specialists to better meet the needs of victims; (E) acquiring, upgrading, or replacing investigative, evidence processing, or forensic testing technology or equipment; (F) development and implementation of policies that safeguard civil rights and civil liberties during the collection, processing, and forensic testing of evidence; (G) hiring or training personnel for collection, processing, and forensic testing of evidence; (H) hiring and training of personnel to analyze violent crime and the temporal and geographic trends among homicides and shootings; (I) retaining experts to conduct a detailed analysis of homicides and shootings using Gun Violence Problem Analysis (commonly known as GVPA ) or a similar research methodology; (J) ensuring victims have appropriate access to emergency food, housing, clothing, travel, and transportation; (K) developing competitive and evidence-based programs to improve homicide and non-fatal shooting clearance rates; (L) developing best practices for improving access to and acceptance of victim services, including victim services that promote medical and psychological wellness, ongoing counseling, legal advice, and financial compensation; (M) training investigators and detectives in trauma-informed interview techniques; (N) establishing programs to support officers who experience stress or trauma as a result of responding to or investigating shootings or other violent crime incidents; or (O) ensuring language and disability access supports are provided to victims and their families so that victims can exercise their rights and participate in the criminal justice process. (c) Federal share (1) In general The Federal share of the cost of a project assisted with a grant under the Program shall not exceed— (A) 100 percent if the grant is awarded on or before December 31, 2032; or (B) subject to paragraph (2), 50 percent if the grant is awarded after December 31, 2032. (2) Waiver With respect to a grant awarded under the Program after December 31, 2032, the Attorney General may determine that the Federal share of the cost of a project assisted with the grant shall not exceed 100 percent. (d) Report by grant recipient Not later than 1 year after receiving a grant under the Program, and each year thereafter, a grant recipient shall submit to the Attorney General a report on the activities carried out using the grant, including, if applicable— (1) the number of homicide and non-fatal shooting detectives hired by the grant recipient; (2) the number of evidence processing personnel hired by the grant recipient; (3) a description of any training that is— (A) provided to existing (as of the date on which the grant was awarded) or newly hired homicide and non-fatal shooting detectives; and (B) designed to assist in the solving of crimes and improve clearance rates; (4) any new evidence processing technology or equipment purchased or any upgrades made to existing (as of the date on which the grant was awarded) evidence technology or equipment, and the associated cost; (5) any assessments of evidence processing technology or equipment purchased with the grant to determine whether the technology or equipment satisfies the objectives of the use of the technology or equipment in increasing clearance rates, and any policies in place to govern the use of the technology or equipment; (6) the internal policies and oversight used to ensure that any technology purchased through the grant for the purposes of improving clearance rates does not violate the civil rights and civil liberties of individuals; (7) data regarding clearance rates for homicides and non-fatal shootings, including the rate of clearances by arrest and clearances by exception, and crime trends from within each jurisdiction in which the grant recipient carried out activities supported by the grant; (8) whether the grant recipient has provided grant funds to any victim services organizations, and if so, which organizations; (9) the demographic information for victims of homicides and non-fatal shootings, and the length and outcomes of each investigation, including whether the investigation was cleared by arrest or exception; (10) the demographic information for each victim or family member of a victim who received victim-related services provided by the grant recipient; and (11) identification of the services most used by victims and their families and identification of additional services needed. (e) National institute of justice evaluation and report to congress (1) Evaluation Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter, the Director of the National Institute of Justice shall conduct an evaluation of— (A) the practices deployed by grant recipients to identify policies and procedures that have successfully improved clearance rates for homicides and non-fatal shootings; and (B) the efficacy of any services provided to victims and family members of victims of homicides and non-fatal shootings. (2) Report to Congress Not later than 30 days after completion of an evaluation by the National Institute of Justice under paragraph (1), the Attorney General shall submit to Congress a report including— (A) the results of the evaluation; and (B) information reported by each grant recipient under subsection (d). (f) Authorization of appropriations (1) In general There are authorized to be appropriated to carry out this section $100,000,000 for each of fiscal years 2023 through 2032. (2) Percent for certain eligible entities The Attorney General shall use 10 percent of the amount made available under paragraph (1) for a fiscal year to award grants under the Program to Tribal law enforcement agencies or prosecuting offices, or groups of such agencies or offices. | https://www.govinfo.gov/content/pkg/BILLS-117s4402is/xml/BILLS-117s4402is.xml |
117-s-4403 | II 117th CONGRESS 2d Session S. 4403 IN THE SENATE OF THE UNITED STATES June 14, 2022 Mr. Cornyn (for himself, Mr. Coons , and Mr. Kennedy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Higher Education Act of 1965 to provide for a civics and history education program.
1. Short title This Act may be cited as the USA Civics Act of 2022 . 2. USA Civics Act Section 805 of the Higher Education Act of 1965 ( 20 U.S.C. 1161e ) is amended— (1) in the section heading, by striking history for freedom and inserting civics and history education program ; (2) in subsection (a)— (A) by striking subsection (f) and inserting subsection (g) ; (B) by striking the Secretary is authorized to award three-year grants, on a competitive basis, and inserting the Secretary is authorized to award grants, at the Secretary's discretion but not less frequently than once every 3 years and on a competitive basis, ; (C) by striking paragraph (1) and inserting the following: (1) American political thought and history; ; and (D) by striking paragraph (3) and inserting the following: (3) the history, achievements, and impact of American representative democracy and constitutional democracies globally. ; (3) in subsection (b)— (A) in paragraph (1), by striking as defined in section 101. and inserting , or a partnership that includes an institution of higher education and one or more nonprofit organizations, whose missions and demonstrated expertise are consistent with the purpose of this section. ; (B) in paragraph (2), by striking that emerged and all that follows through the period at the end and inserting founded on the principles of representative democracy, constitutional government, individual rights, market economics, religious freedom and religious tolerance, and freedom of thought and inquiry. ; and (C) by striking paragraph (3) and inserting the following: (3) American political thought and history The term American political thought and history means— (A) the significant constitutional, political, intellectual, economic, social, and foreign policy trends and issues that have shaped the course of American history; and (B) the key episodes, turning points, texts, and figures involved in the constitutional, political, intellectual, diplomatic, social, and economic history of the United States. ; (4) in subsection (c)(2)— (A) in subparagraph (A), by striking traditional and all that follows through the semicolon and inserting American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; ; and (B) in subparagraph (B), by inserting , which may include the creation or use of open educational resources after subsection (e)(1)(B) ; (5) in subsection (d)— (A) by striking paragraph (1) and inserting the following: (1) increase access to quality programming that expands knowledge of American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; ; and (B) in paragraph (2), by striking traditional American history, free institutions, or Western civilization and inserting American political thought and history, free institutions, the impact of American representative democracy and constitutional democracies globally, or the means of participation in political and civic life. ; (6) by striking subsection (e) and inserting the following: (e) Use of funds (1) Required use of funds Funds provided under this section shall be used— (A) for collaboration with local educational agencies for the purpose of providing elementary school and secondary school teachers an opportunity to enhance their knowledge of American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally; and (B) to carry out one or more of the following: (i) Establishing or strengthening academic programs or centers focused on American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally, which may include— (I) design and implementation of programs of study, courses, lecture series, seminars, and symposia; (II) development, publication, and dissemination of instructional materials; (III) research; (IV) support for faculty teaching in undergraduate and, if applicable, graduate programs; or (V) support for graduate and postgraduate fellowships, if applicable. (ii) For teacher preparation initiatives that stress content mastery regarding American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally. (iii) To conduct outreach activities to ensure that information about the activities funded under this section is widely disseminated— (I) to undergraduate students (including students enrolled in teacher education programs, if applicable); (II) to graduate students (including students enrolled in teacher education programs, if applicable); (III) to faculty; (IV) to local educational agencies; and (V) within the local community. (2) Allowable uses of funds Funds provided under this section may be used to support— (A) collaboration with entities such as— (i) nonprofit organizations whose missions and demonstrated expertise are consistent with the purpose of this section, for assistance in carrying out activities described under subsection (a); and (ii) Federal or State humanities programs, which may include those funded by the National Endowment for the Humanities; and (B) the creation and use of open educational resources on American political thought and history, free institutions, or the impact of American representative democracy and constitutional democracies globally. ; (7) by redesignating subsection (f) as subsection (g); (8) in subsection (g), as redesignated by paragraph (7), by striking 2009 and inserting 2022 ; and (9) by inserting after subsection (e) the following: (f) Rule of construction Nothing in this section shall be construed to authorize the Secretary to prescribe an American political thought and history curriculum. . | https://www.govinfo.gov/content/pkg/BILLS-117s4403is/xml/BILLS-117s4403is.xml |
117-s-4404 | II 117th CONGRESS 2d Session S. 4404 IN THE SENATE OF THE UNITED STATES June 14, 2022 Ms. Ernst (for herself, Mr. Manchin , Mr. Daines , Mrs. Blackburn , Mr. Scott of Florida , Mr. King , and Mr. Peters ) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs A BILL To authorize certain actions to address domestic industrial base shortfalls, and for other purposes.
1. Short title This Act may be cited as the Homeland Acceleration of Recovering Deposits and Renewing Onshore Critical Keystones Act of 2022 or the HARD ROCK Act of 2022 . 2. Authority to acquire materials for National Defense Stockpile to address shortfalls (a) Modification of acquisition authority Section 5 of the Strategic and Critical Materials Stock Piling Act ( 50 U.S.C. 98d ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) in the first sentence, by inserting under the authority of paragraph (3) or after Except for acquisitions made ; and (ii) in the second sentence, by striking for such acquisition and inserting for any acquisition of materials under this Act ; (B) in paragraph (2), by striking any such transaction and inserting any transaction ; and (C) by adding at the end the following: (3) Using funds available in the National Defense Stockpile Transaction Fund established under section 9, the National Defense Stockpile Manager may acquire materials determined to be strategic and critical under section 3(a) without regard to the requirement of the first sentence of paragraph (1) if the Stockpile Manager determines there is a shortfall of such materials in the stockpile. ; and (2) in subsection (c), by striking to carry out the purposes for which appropriated for a period of two fiscal years, if so provided in the appropriations Acts and inserting until expended, unless otherwise provided in appropriations Acts . (b) Clarification that stockpile may not be used for budgetary purposes Section 2(c) of the Strategic and Critical Materials Stock Piling Act ( 50 U.S.C. 98(c) ) is amended by striking is not to be used and inserting shall not be used . (c) Annual briefings Section 11 of the Strategic and Critical Materials Stock Piling Act ( 50 U.S.C. 98h–2 ) is amended by adding at the end the following: (c) (1) Not later than 30 days after submitting a report required by subsection (a), the National Defense Stockpile Manager shall brief the committees specified in paragraph (2) on the state of the stockpile and the acquisitions intended to be made within the next fiscal year. (2) The committees specified in this paragraph are— (A) the Committee on Armed Services, the Committee on Foreign Relations, the Committee on Energy and Natural Resources, the Committee on Commerce, Science, and Transportation, and the Select Committee on Intelligence of the Senate; and (B) the Committee on Armed Services, the Committee on Foreign Affairs, the Committee on Natural Resources, the Committee on Energy and Commerce, and the Permanent Select Committee on Intelligence of the House of Representatives. . 3. Increased threshold for actions to remedy certain domestic industrial base shortfalls Section 303(a)(6) of the Defense Production Act of 1950 ( 50 U.S.C. 4533(a)(6) ) is amended— (1) in subparagraph (B)— (A) by striking If the taking and inserting the following: (i) In general If the taking ; (B) by striking $50,000,000 and inserting the amount specified in clause (ii) ; and (C) by adding at the end the following: (ii) Amount specified The amount specified in this clause is— (I) except as provided in subclause (II), $50,000,000; and (II) in the case of a domestic industrial base shortfall relating to an industrial resource described in clause (iii), $350,000,000. (iii) Industrial resources described An industrial resource described in this clause is any of the following: (I) A material determined to be a strategic and critical material under section 3(a) of the Strategic and Critical Materials Stock Piling Act ( 50 U.S.C. 98b(a) ) with respect to which the National Defense Stockpile has a shortfall of more than $100,000,000, as demonstrated by the most recent report required by section 11 of that Act ( 50 U.S.C. 98h–2 ). (II) Any industrial resource necessary for the production, separation, or processing of a critical mineral (as defined in section 7002(a) of the Energy Act of 2020 ( 30 U.S.C. 1606(a) )). ; and (2) by amending subparagraph (C) to read as follows: (C) Limitation If entering into an obligation under this section to correct an industrial resource shortfall would cause the aggregate outstanding amount of all such obligations for such industrial resource shortfall to exceed $50,000,000, no such obligation may be entered until the President provides a briefing to Congress on the nature of the shortfall and the action or actions necessary to mitigate the shortfall. . 4. Report on modifications to national technology and industrial base (a) In general Not later than December 1, 2023, the Secretary of Defense shall submit to the congressional defense committees a report on the benefits and risks of potential legislative proposals to increase the availability of strategic and critical materials that are, as of the date of the enactment of this Act, sourced primarily from the People’s Republic of China or the Russian Federation. (b) Elements The report required by subsection (a) shall include an assessment of the following: (1) The implications of modifying the term domestic source for purposes of the Defense Production Act of 1950 ( 50 U.S.C. 4501 et seq. ) to domestic and allied source and including business concerns in Canada, the United Kingdom, and Australia in the definition of that term. (2) The benefits of facilitating more effective integration of the national technology and industrial base with the technology and industrial bases of countries that are allies or partners of the United States with respect to technology transfer, socioeconomic procurement requirements, and export controls. (c) Definitions In this section: (1) Congressional defense committees The term congressional defense committees has the meaning given that term in section 101(a) of title 10, United States Code. (2) National technology and industrial base The term national technology and industrial base has the meaning given that term in section 4801 of title 10, United States Code. (3) Strategic and critical materials The term strategic and critical materials has the meaning given that term in section 12 of the Strategic and Critical Materials Stock Piling Act ( 50 U.S.C. 98h–3 ). | https://www.govinfo.gov/content/pkg/BILLS-117s4404is/xml/BILLS-117s4404is.xml |
117-s-4405 | II 117th CONGRESS 2d Session S. 4405 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Kennedy introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To establish a joint task force to improve the collection of restitution and improve oversight of the Bureau of Prisons Inmate Trust Fund Accounts for the purpose of deterring illicit financial activity, money laundering, and for other purposes.
1. Short title This Act may be cited as the Inmate Financial Accountability Task Force Act . 2. Task force (a) In general The Attorney General (in consultation with the Director of the Bureau of Prisons and the Director of the Executive Office for United States Attorneys), the Director of the Administrative Office of the United States Courts, the Secretary of Health and Human Services (in consultation with the Commissioner of the Office of Child Support Enforcement), the Secretary of the Treasury, and the Director of the United States Marshals Service shall establish a joint task force (referred to in this Act as the Inmate Financial Accountability Task Force ) to develop— (1) a strategic plan to improve the criminal and civil debt collection process and establish an effective coordination mechanism among each entity involved in that process; and (2) a strategic plan to improve oversight of Bureau of Prisons Inmate Trust Fund Accounts for detecting and deterring illicit financial activity and money laundering. (b) Required review of procedures Not later than 180 days after the date of enactment of this Act, the Inmate Financial Accountability Task Force shall— (1) review the long-standing problems in the collection of outstanding criminal and civil debt, including fragmented processes and lack of coordination; (2) review and enhance training and examination procedures to improve the capabilities of criminal and civil debt reporting and collection by Federal agencies; (3) recommend the proper accounting, reporting, collecting, and management of criminal and civil debt eligible for referral to the Secretary of the Treasury for collection actions; (4) review and enhance training and examination procedures to improve the capabilities of anti-money laundering processes to detect financial transactions relating to Bureau of Prisons Inmate Trust Fund Accounts; (5) review and enhance procedures for referring potential cases relating to money laundering and illicit financial activity to the appropriate law enforcement agency; and (6) determine, as appropriate, whether requirements for the Bureau of Prisons are sufficient to detect and deter money laundering relating to Bureau of Prisons Inmate Trust Fund Accounts. (c) Reports (1) Criminal and civil debt collection report Not later than 1 year after the date of enactment of this Act, the Inmate Financial Accountability Task Force shall submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on the Judiciary of the Senate and the Committee on Financial Services and the Committee on the Judiciary of the House of Representatives , a report containing— (A) an analysis of criminal and civil debt collection efforts of the Federal Government; (B) appropriate legislative, administrative, and other recommendations to strengthen criminal and civil debt collection processes; and (C) recommendations, including— (i) feedback from stakeholders, including financial institutions and advocacy groups for victims of crime, on policy proposals derived from the analysis conducted by the Inmate Financial Accountability Task Force that would enhance the efforts and programs of Federal and State agencies to improve criminal and civil debt reporting and collection, including any recommended changes to internal policies, procedures, and controls; (ii) any recommended changes to expand information sharing relating to criminal and civil debt reporting and collection between financial institutions, appropriate law enforcement agencies, appropriate State agencies, and appropriate Federal agencies; (iii) any recommended changes to enhance the efforts and programs of Federal and State agencies to improve criminal and civil debt reporting and collection and expand information sharing of the Bureau of Prisons Inmate Trust Fund Accounts with appropriate law enforcement agencies; and (iv) any recommended changes, if necessary, to existing statutes to more effectively report and collect criminal and civil debt. (2) Anti-money laundering report Not later than 1 year after the date of enactment of this Act, the Inmate Financial Accountability Task Force shall submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on the Judiciary of the Senate , the Committee on Financial Services and the Committee on the Judiciary of the House of Representatives , a report containing— (A) an analysis of anti-money laundering efforts of the Federal Government and Federal financial institutions relating to Bureau of Prisons Inmate Trust Fund Accounts; (B) appropriate legislative, administrative, and other recommendations to improve anti-money laundering efforts relating to Bureau of Prisons Inmate Trust Fund Accounts; and (C) recommendations, including— (i) feedback from Federal agencies on best practices under successful programs related to anti-money laundering efforts in place that may be suitable for broader adoption by the Director of the Bureau of Prisons; (ii) feedback from stakeholders, including law enforcement agencies and financial institutions, on policy proposals derived from the analysis conducted by the Inmate Financial Accountability Task Force that would enhance anti-money laundering efforts and oversight of Bureau of Prisons Inmate Trust Fund Accounts, including any recommended changes to internal policies, procedures, and controls to improve anti-money laundering efforts; (iii) any recommended changes to training programs at the Bureau of Prisons to better equip employees to deter and detect money laundering relating to Bureau of Prisons Inmate Trust Fund Accounts; and (iv) recommended changes, if necessary, to existing statutes to more effectively detect and deter money laundering relating to Bureau of Prisons Inmate Trust Fund Accounts. (d) Limitation Nothing in this Act shall be construed to grant rulemaking authority to the Inmate Financial Accountability Task Force. (e) Bureau of Prisons Inmate Trust Fund Accounts In this Act, the term Bureau of Prisons Inmate Trust Fund Accounts refers to— (1) funds of Federal prisoners held in trust by the Bureau of Prisons; and (2) commissary funds of Federal prisoners. | https://www.govinfo.gov/content/pkg/BILLS-117s4405is/xml/BILLS-117s4405is.xml |
117-s-4406 | II 117th CONGRESS 2d Session S. 4406 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Scott of South Carolina (for himself and Mr. Brown ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend the Internal Revenue Code of 1986 to provide incentives for the use of automatic portability arrangements under defined contribution plans, and for other purposes.
1. Short title This Act may be cited as the Advancing Auto-Portability Act of 2022 . 2. Findings Congress finds as follows: (1) Up to $105,000,000,000 of retirement savings leaves the defined contribution pension plan system annually because employees cash out their savings after a job change. (2) Federal law should encourage the private sector to reduce such cash-outs by developing automated solutions to improve defined contribution plan portability. 3. Prohibited transaction exemption (a) In general Section 4975(d) of the Internal Revenue Code of 1986 is amended— (1) by striking or at the end of paragraph (22)(I), (2) by striking the period at the end of paragraph (23) and inserting , or , and (3) by adding at the end the following new paragraph: (24) any transaction described in subparagraph (D) or (E) of subsection (c)(1) which consists of the receipt of fees by an automatic portability provider in connection with such provider’s exercise of discretion with respect to an automatic portability transaction. . (b) Definitions Section 4975(f) of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph: (12) Rules relating to automatic portability transactions (A) In general For purposes of subsection (d)(24)— (i) Automatic portability transaction An automatic portability transaction is a transfer of assets made— (I) from an individual retirement plan which is established on behalf of an individual and to which amounts were transferred under section 401(a)(31)(B)(i), (II) to an employer-sponsored retirement plan described in clause (iii), (iv), (v), or (vi) of section 402(c)(8)(B) (other than a defined benefit plan) in which such individual is an active participant, and (III) after such individual has been given advance notice of the transfer and has not affirmatively opted out of such transfer. (ii) Automatic portability provider An automatic portability provider is a person that executes transfers described in clause (i). (B) Conditions for automatic portability transactions Subsection (d)(24) shall not apply to an automatic portability transaction unless the following requirements are satisfied: (i) Acknowledgment of fiduciary status An automatic portability provider shall acknowledge in writing, at such time and format as specified by the Secretary, that the provider is a fiduciary with respect to the individual on whose behalf the individual retirement plan described in subparagraph (A)(i)(I) is established. (ii) Fees The fees and compensation received by the automatic portability provider in connection with the automatic portability transaction shall not exceed reasonable compensation and must be approved in writing by the plan fiduciary for the plan described in subparagraph (A)(i)(II). (iii) Data usage The automatic portability provider shall not market or sell data relating to the individual retirement plan described in subparagraph (A)(i)(I). (iv) Open participation The automatic portability provider shall offer automatic portability transactions on the same terms to any plan described in subparagraph (A)(i)(II) regardless of whether the provider provides other services for such plan. (v) Pre-transaction notice At least 30 days in advance of an automatic portability transaction, the automatic portability provider shall provide notice to the individual on whose behalf the individual retirement plan described in subparagraph (A)(i)(I) is established which includes— (I) a description of the automatic portability transaction and the fees which will be charged in connection with the transaction, (II) a description of the individual’s right to affirmatively elect not to participate in the transaction, the procedures for such an election, and a telephone number at which the individual can contact the automatic portability provider, and (III) such other disclosures as the Secretary may require by regulation. (vi) Post-transaction notice Not later than 3 business days after an automatic portability transaction, the automatic portability provider shall provide notice to the individual on whose behalf the individual retirement plan described in subparagraph (A)(i)(I) is established of— (I) the actions taken by the automatic portability provider with respect to the individual’s account, (II) all relevant information regarding the location and amount of any transferred assets, (III) a statement of fees charged against the account by the automatic portability provider or its affiliates in connection with the transfer, (IV) a telephone number at which the individual can contact the automatic portability provider, and (V) such other disclosures as the Secretary may require by regulation. (vii) Notice requirements The notices required under clauses (v) and (vi) shall be written in a manner calculated to be understood by the average intended recipient and shall not include materially misleading statements. (viii) Timeliness of execution After liquidating the assets of an individual retirement plan described in subparagraph (A)(i)(I) to cash, an automatic portability provider shall transfer the account balance of such plan as soon as practicable to the plan described in subparagraph (A)(i)(II). (ix) Record retention and audits (I) In general An automatic portability provider shall, for 6 years, maintain the records sufficient to demonstrate the terms of this subparagraph have been met. (II) Audits An automatic portability provider shall conduct an annual audit of automatic portability transactions occurring during the calendar year to demonstrate compliance with this subparagraph, and shall submit such audit annually to the Secretary, in such form and manner as specified by the Secretary. . (c) Effective date The amendments made by this section shall apply to transactions occurring after December 31, 2023. 4. Employer automatic portability arrangement tax credit (a) In general Subpart D of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: 45U. Employer automatic portability arrangement credit (a) In general For purposes of section 38, in the case of an eligible employer, the automatic portability arrangement credit determined under this section for the adoption year is an amount equal to $500. (b) Eligible employer For purposes of this section, the term eligible employer has the meaning given the term by section 408(p)(2)(C)(i) (without regard to subclause (II) thereof). (c) Adoption year For purposes of this section— (1) In general The term adoption year means the taxable year during which the eligible employer adopts an automatic portability arrangement as part of an eligible plan maintained by the employer. (2) Automatic portability arrangement (A) In general The term automatic portability arrangement means an arrangement providing for automatic portability transactions. (B) Automatic portability transaction The term automatic portability transaction means a transaction in which amounts distributed pursuant to section 401(a)(31)(B)(i) from a plan to an individual retirement plan established on behalf of an individual are subsequently transferred to an eligible plan in which such individual is an active participant, after such individual has been given advance notice of the transfer and has not affirmatively opted out of such transfer. (3) Eligible plan The term eligible plan means a qualified employer plan as defined in section 4972(d)(1), other than a defined benefit plan. . (b) Credit To be part of general business credit Subsection (b) of section 38 of the Internal Revenue Code of 1986 is amended by striking plus at the end of paragraph (32), by striking the period at the end of paragraph (33) and inserting , plus , and by adding at the end the following new paragraph: (34) in the case of an eligible employer (as defined in section 45U(b)), the automatic portability arrangement credit determined under section 45U(a). . (c) Clerical amendment The table of sections for subpart D of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item: Sec. 45U. Employer automatic portability arrangement credit. . (d) Effective date The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act. | https://www.govinfo.gov/content/pkg/BILLS-117s4406is/xml/BILLS-117s4406is.xml |
117-s-4407 | II 117th CONGRESS 2d Session S. 4407 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Rubio (for himself and Mr. Scott of Florida ) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban Affairs A BILL To amend the Energy Policy and Conservation Act to prohibit exports of crude and refined oil and certain petroleum products to the People’s Republic of China.
1. Short title This Act may be cited as the China Oil Export Prohibition Act of 2022 . 2. Prohibition on export of crude and refined oil and certain petroleum products to the People’s Republic of China (a) In general The Energy Policy and Conservation Act ( 42 U.S.C. 6201 et seq. ) is amended by inserting after section 101 the following: 102. Prohibition on export of certain petroleum products to the People’s Republic of China (a) In general Notwithstanding any other provision of law, no petroleum product described in subsection (b) that is produced in the United States may be exported from the United States to the People’s Republic of China. (b) Petroleum product described A petroleum product referred to in subsection (a) is— (1) crude oil; (2) refined oil or a refined oil product; (3) residual fuel oil; or (4) any other petroleum product (other than natural gas or any natural gas liquid product). (c) Applicability (1) Petroleum products in transport Subsection (a) shall not apply to any petroleum product described in subsection (b) that is in the process of being transported from the United States to the People’s Republic of China as of the date on which the prohibition under that subsection takes effect pursuant to subsection (d). (2) Natural gas Subsection (a) does not apply to natural gas or any natural gas liquid product. (d) Effective date The prohibition described in subsection (a) shall take effect on the date that is 10 days after the date of enactment of the China Oil Export Prohibition Act of 2022 . . (b) Clerical amendment The table of contents for the Energy Policy and Conservation Act ( Public Law 94–163 ; 89 Stat. 871; 114 Stat. 2034) is amended by inserting after the item relating to section 101 the following: Sec. 102. Prohibition on export of certain petroleum products to the People’s Republic of China. . (c) Conforming amendment Section 101(b) of division O of the Consolidated Appropriations Act, 2016 ( 42 U.S.C. 6212a(b) ) is amended by inserting and section 102 of the Energy Policy and Conservation Act after subsections (c) and (d) . | https://www.govinfo.gov/content/pkg/BILLS-117s4407is/xml/BILLS-117s4407is.xml |
117-s-4408 | II 117th CONGRESS 2d Session S. 4408 IN THE SENATE OF THE UNITED STATES June 15, 2022 Ms. Warren (for herself, Mr. Wyden , Mrs. Murray , Mr. Whitehouse , and Mr. Sanders ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To prohibit data brokers from selling and transferring certain sensitive data.
1. Short title This Act may be cited as the Health and Location Data Protection Act of 2022 . 2. Unfair and deceptive acts and practices relating to health and location data (a) In general It shall be unlawful for a data broker to sell, resell, license, trade, transfer, share, or otherwise provide or make available any of the following forms of data, whether declared or inferred, of an individual: (1) Location data. (2) Health data. (3) Other categories of data identified by the Commission that address or reveal a category of data described in paragraphs (1) and (2). (b) Exceptions (1) Actions that are HIPAA-compliant (A) In general Nothing in this Act shall be construed to prohibit any action taken with respect to the health information of an individual by a data broker that is a business associate or covered entity that is permissible under the Federal regulations concerning standards for privacy of individually identifiable health information promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note). (B) Application of terms In paragraph (1), the terms business associate , covered entity , and health information shall have the meaning given those terms in the Federal regulations specified in such paragraph. (2) Publication of newsworthy information of legitimate public concern Nothing in this Act shall be construed to prohibit the publication of newsworthy information of legitimate public concern. (3) Disclosure pursuant to valid authorization Nothing in this Act shall be construed to prohibit a disclosure of the data of an individual for which the individual provides valid authorization. For purposes of this paragraph, the term valid authorization has the meaning given such term in section 164.508 of title 45, Code of Federal Regulations (or a successor regulation), subject to such adaptations as the Commission shall deem necessary to apply such term to the disclosure of both location data and health data. (c) Effective date The prohibition under subsection (a) shall take effect on the earlier of— (1) the date the Commission issues the final rule under subsection (d); or (2) 180 days after the date of enactment of this Act. (d) Rulemaking (1) Final rule Pursuant to section 553 of title 5, United States Code, the Commission shall promulgate regulations to carry out the provisions of this Act. The Commission shall issue a final rule by not later than 180 days after the date of enactment of this Act. (2) Additional guidance Pursuant to section 553 of title 5, United States Code, the Commission may promulgate further regulations to carry out the provisions of this Act, including further guidance regarding the types of data described in subsection (a). 3. Enforcement (a) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of section 2 shall be treated as a violation of a rule defining an unfair or a deceptive act or practice under section 18(a)(1)(B) of the Federal Trade Commission Act ( 15 U.S.C. 57a(a)(1)(B) ). (2) Powers of Commission (A) In general Except as provided in subparagraphs (D) and (E), the Commission shall enforce section 2 in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq. ) were incorporated into and made a part of this Act. (B) Privileges and immunities Any person who violates section 2 shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act ( 15 U.S.C. 41 et seq. ). (C) Authority preserved Nothing in this Act shall be construed to limit the authority of the Federal Trade Commission under any other provision of law. (D) Nonprofit organizations Notwithstanding section 4 of the Federal Trade Commission Act ( 15 U.S.C. 44 ) or any jurisdictional limitation of the Commission, the Commission shall also enforce this Act, in the same manner provided in subparagraphs (A) and (B), with respect to organizations not organized to carry on business for their own profit or that of their members. (E) Independent litigation authority In any case in which the Commission has reason to believe that a data broker is violating or has violated section 2, the Commission may bring a civil action in an appropriate district court of the United States to— (i) enjoin any further such violation by such person; (ii) enforce compliance with this Act, including through deletion of the relevant information; (iii) obtain a permanent, temporary, or preliminary injunction; (iv) obtain civil penalties; (v) obtain damages (whether actual, punitive, or otherwise), restitution, disgorgement of unjust enrichment, or other compensation on behalf of aggrieved persons; or (vi) obtain any other appropriate equitable relief. (b) Enforcement by States (1) In general In any case in which the attorney general of a State has reason to believe that an interest of the residents of the State has been or is threatened or adversely affected by the engagement of any data broker subject to section 2 in a practice that violates such section, the attorney general of the State may, as parens patriae, bring a civil action on behalf of the residents of the State in an appropriate district court of the United States to— (A) enjoin any further such violation by such person; (B) enforce compliance with this Act, including through deletion of the relevant information; (C) obtain a permanent, temporary, or preliminary injunction; (D) obtain civil penalties; (E) obtain damages (whether actual, punitive, or otherwise), restitution, disgorgement of unjust enrichment, or other compensation on behalf of aggrieved persons; or (F) obtain any other appropriate equitable relief. (2) Notice Before filing an action under paragraph (1), the attorney general, official, or agency of the State involved shall provide to the Commission a written notice of such action and a copy of the complaint for such action. If the attorney general, official, or agency determines that it is not feasible to provide the notice described in this paragraph before the filing of the action, the attorney general, official, or agency shall provide written notice of the action and a copy of the complaint to the Commission immediately upon the filing of the action. (3) Limitation on State action while Federal action is pending If the Commission has instituted a civil action for a violation of section 2, no State attorney general, or official or agency of a State, may bring an action under this paragraph during the pendency of that action against any defendant named in the complaint of the Commission for any violation of section 2 alleged in the complaint. (4) Relationship with State-law claims If the attorney general of a State has authority to bring an action under State law directed at acts or practices that also violate section 2, the attorney general may assert the State-law claim and a claim under section 2 in the same civil action. (5) Investigatory powers Nothing in this subsection may be construed to prevent the attorney general of a State from exercising the powers conferred on the attorney general by the laws of the State to conduct investigations, to administer oaths or affirmations, or to compel the attendance of witnesses or the production of documentary or other evidence. (c) Private enforcement Any person whose interest has been or is threatened or adversely affected by the engagement of any data broker subject to section 2 in a practice that violates such section may bring a civil action in an appropriate district court of the United States to— (1) enjoin any further such violation by such person; (2) enforce compliance with this Act, including through deletion of the relevant information; (3) obtain a permanent, temporary, or preliminary injunction; (4) obtain damages (whether actual, punitive, or otherwise), restitution, or other compensation; (5) obtain reasonable attorney’s fees, including litigation expenses, and costs; or (6) obtain any other appropriate equitable relief. (d) Civil penalties In addition to any other penalties as may be prescribed by law, a violation of this Act shall carry a civil penalty not to exceed 15 percent of the revenues earned by the person’s ultimate parent entity during the preceding 12-month period. (e) Exclusive jurisdiction (1) District courts For any action brought under this Act, the following district courts shall have exclusive jurisdiction: (A) For actions brought by the Commission, the United States District Court for the District of Columbia. (B) For actions brought by a State attorney general, the district court of the United States for the judicial district in which the capital of the State is located. (C) For private actions brought by persons— (i) the United States District Court for the District of Columbia; or (ii) the district court of the United States for the judicial district in which the violation took place or in which any defendant resides or does business. (2) Court of appeals The United States Court of Appeals for the District of Columbia Circuit shall have exclusive jurisdiction of appeals from all decisions under paragraph (1). (f) Statute of limitations A proceeding for a violation of this Act may be commenced not later than 6 years after the date upon which the plaintiff obtains actual knowledge of the facts giving rise to such violation. (g) Preemption The provisions of this Act preempt only the provisions of State or local law that require disclosure prohibited by this Act. 4. Definitions In this Act: (1) Commission The term Commission means the Federal Trade Commission. (2) Data (A) In general Not later than 180 days after the date of enactment of this Act, the Commission shall adopt rules in accordance with section 553 of title 5, United States Code, to define the term data for the purpose of implementing and enforcing this Act. (B) Requirement The term data shall include information that is linked, or reasonably linkable, to— (i) specific individuals; or (ii) specific groups of individuals who share the same place of residence or internet protocol address. (3) Data broker The term data broker means a person that collects, buys, licenses, or infers data about individuals and then sells, licenses, or trades that data. (4) Health data The term health data means data that reveal or describe— (A) the search for, attempt to obtain, or receipt of any health services; (B) any past, present, or future disability, physical health condition, mental health condition, or health condition of an individual, including, but not limited to, pregnancy and miscarriage; or (C) any treatment or diagnosis of a disability or condition described in subparagraph (B). (5) Location data The term location data means data capable of determining the past or present physical location of an individual or an individual’s device. (6) State The term State means each of the several States, the District of Columbia, each commonwealth, territory, or possession of the United States, and each federally recognized Indian Tribe. (7) Ultimate parent entity The term ultimate parent entity has the meaning given the term in section 801.1 of title 16, Code of Federal Regulations (or any successor regulation). 5. Funding In addition to amounts otherwise available, there is appropriated to the Commission for fiscal year 2023, out of any money in the Treasury not otherwise appropriated, $1,000,000,000, to remain available until September 30, 2032, for carrying out the work of the Commission. | https://www.govinfo.gov/content/pkg/BILLS-117s4408is/xml/BILLS-117s4408is.xml |
117-s-4409 | II 117th CONGRESS 2d Session S. 4409 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Thune (for himself, Mr. McConnell , Mr. Barrasso , Mr. Blunt , Ms. Ernst , Mr. Scott of Florida , Mr. Daines , Mr. Cotton , Mr. Marshall , Mr. Cramer , Mr. Crapo , Ms. Lummis , Mr. Lankford , Mr. Rubio , Mrs. Blackburn , Mr. Boozman , Mr. Wicker , Mr. Hawley , Mr. Risch , Mrs. Capito , Mr. Braun , Mr. Tuberville , Mr. Moran , Mrs. Fischer , Mr. Scott of South Carolina , Mr. Grassley , and Mr. Sullivan ) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation A BILL To prohibit providers of email services from using filtering algorithms to flag emails from political campaigns that consumers have elected to receive as spam.
1. Short title This Act may be cited as the Political Bias In Algorithm Sorting Emails Act of 2022 or the Political BIAS Emails Act of 2022 . 2. Unfair and deceptive acts and practices relating to filtering political emails that a consumer has elected to receive (a) Conduct prohibited (1) In general It shall be unlawful for an operator of an email service to use a filtering algorithm to apply a label to an email sent to an email account from a political campaign unless the owner or user of the account took action to apply such a label. (2) Effective date The prohibition under subsection (1) shall take effect on the date that is 3 months after the date of enactment of this Act. (b) Quarterly transparency report (1) In general Beginning with the first year that begins on or after the date that is 120 days after the date of enactment of this Act, each operator of an email service shall be required to make publicly available, on a quarterly basis, a transparency report that meets the requirements of this subsection. (2) Content of report Each quarterly report by an operator of an email service required under this subsection shall include the following: (A) The total number of instances during the previous quarter in which emails from political campaigns were flagged as spam. (B) The number of instances during the previous quarter in which emails from political campaigns were flagged as spam by a filtering algorithm without direction from the email account owner or user. (C) The total number of instances during the previous quarter when emails from political campaigns of candidates belonging to the Republican Party were flagged as spam. (D) The percentage of emails during the previous quarter of the year flagged as spam from political campaigns of candidates belonging to the Republican Party. (E) The number of instances during the previous quarter in which emails from political campaigns of candidates belonging to the Republican Party were flagged as spam by a filtering algorithm without direction from the email account owner or user. (F) The percentage of emails during the previous quarter of the year flagged as spam by a filtering algorithm without direction from the email account owner or user for emails from political campaigns of candidates belonging to the Republican Party. (G) The total number of instances during the previous quarter when emails from political campaigns of candidates belonging to the Democratic Party were flagged as spam. (H) The percentage of emails during the previous quarter of the year flagged as spam from political campaigns of candidates belonging to the Democratic Party. (I) The number of instances during the previous quarter in which emails from political campaigns of candidates belonging to the Democratic Party were flagged as spam by a filtering algorithm without direction from the email account owner or user. (J) The percentage of emails during the previous quarter of the year flagged as spam by a filtering algorithm without direction from the email account owner or user for emails from political campaigns of candidates belonging to the Democratic Party. (K) A descriptive summary of the kinds of tools, practices, actions, and techniques used by an operator of an email service during the previous quarter in determining which emails from political campaigns to flag as spam. (3) Publication and format The operator of an email service shall publish each quarterly report required under this subsection with an open license, in a machine-readable and open format, and in a location that is easily accessible to consumers. (c) Disclosure for political campaigns (1) In General Beginning 3 months after the date of the enactment of this Act, each operator of an email service shall be required to disclose to a political campaign, upon the request of the campaign and subject to paragraph (3), a report that includes any of the information described in paragraph (2) that is requested by the campaign. (2) Content of the disclosure The information described in this paragraph is the following: (A) The number of instances during the previous quarter when emails from the political campaign requesting the information were flagged as spam. (B) The percentage of emails sent from the political campaign requesting the information that were flagged as spam during the previous quarter. (C) The number of instances during the previous calendar quarter when emails from the political campaign requesting the information were flagged as spam by a filtering algorithm. (D) The total number of emails sent from the political campaign requesting the information that reached the intended recipient's primary inbox. (E) The percentage of emails sent from the political campaign requesting the information that reached the intended recipient's primary inbox. (F) A descriptive summary as to why an email from the political campaign requesting the information did not reach the intended recipient's primary inbox. (3) Frequency of requests A political campaign may not request that an operator of an email service provide a report containing any of the information described in paragraph (2) more than— (A) once per week during election years; (B) twice per month during non-election years; and (C) once a week in the 12 months preceding the date of a special election in which a candidate associated with the political campaign is seeking election. (4) Best practices An operator of an email service shall provide to a political campaign, upon request, best practices on steps the political campaign should take to increase the number of emails from the political campaign that reach the intended recipient’s primary inbox. (5) Deadline for providing disclosure to political campaigns An operator of an email service that receives a request from a political campaign for a disclosure report described in paragraph (1) or best practices described in paragraph (4) shall provide such report or best practices to the political campaign not later than 4 days after the operator receives the request. (d) Enforcement by the Federal Trade Commission (1) Unfair or deceptive acts or practices A violation of subsection (a), (b), or (c) shall be treated as a violation of a rule defining an unfair or a deceptive act or practice under section 18(a)(1)(B) of the Federal Trade Commission Act ( 15 U.S.C. 57a(a)(1)(B) ). (2) Powers of Commission (A) In general The Federal Trade Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act ( 15 U.S.C. 41 et seq. ) were incorporated into and made a part of this section. (B) Privileges and immunities Any person who violates subsection (a) shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act ( 15 U.S.C. 41 et seq. ). (C) Authority preserved Nothing in this section shall be construed to limit the authority of the Federal Trade Commission under any other provision of law. 3. Definitions In this Act: (1) Filtering algorithm The term filtering algorithm means a computational process, including one derived from algorithmic decision making, machine learning, statistical analysis, or other data processing or artificial intelligence techniques, used by an email service to identify and filter emails sent to an email account. (2) Operator (A) In general The term operator means any person who operates an email service and includes any person that wholly owns a subsidiary entity that operates an email service. (B) Exclusions Such term shall not include any person who operates an email service if such service is wholly owned, controlled, and operated by a person that— (i) for the most recent 6-month period, did not employ more than 500 employees; and (ii) for the most recent 12-month period, averaged less than $5,000,000,000 in annual gross receipts. (3) Political campaign The term political campaign includes— (A) an individual who is a candidate (as such term is defined in section 301(2) of the Federal Election Campaign Act of 1971 ( 52 U.S.C. 30101(2) ); (B) an authorized committee (as such term is defined in section 301(6) of such Act); (C) a connected organization (as such term is defined in section 301(7) of such Act); (D) a national committee (as such term is defined in section 301(15) of such Act); (E) a State committee (as such term is defined in section 301(15) of such Act); and (F) a joint fundraising committee that includes any entity described in subparagraphs (A) through (E). | https://www.govinfo.gov/content/pkg/BILLS-117s4409is/xml/BILLS-117s4409is.xml |
117-s-4410 | II 117th CONGRESS 2d Session S. 4410 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Romney (for himself, Mr. Barrasso , and Mr. Hickenlooper ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Higher Education Act of 1965 to provide for comprehensive student achievement information.
1. Short title This Act may be cited as the Graduation Reporting for Accuracy and Decision-Making Act or the GRAD Act . 2. Consumer information about completion or graduation times (a) Transparency in college tuition for consumers Section 132(i)(1)(J) of the Higher Education Act of 1965 ( 20 U.S.C. 1015a(i)(1)(J) ) is amended to read as follows: (J) (i) For programs of study 4 years of length or longer— (I) the percentages of first-time, full-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (III) of clause (iii); (II) the percentages of first-time, part-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (III) of clause (iii); (III) the percentages of non-first time, full-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (III) of clause (iii); and (IV) the percentages of non-first-time, part-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (III) of clause (iii). (ii) For programs of study less than 4 years— (I) the percentages of first-time, full-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (IV) of clause (iii); (II) the percentages of first-time, part-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (IV) of clause (iii); (III) the percentages of non-first-time, full-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (IV) of clause (iii); and (IV) the percentages of non-first-time, part-time, degree- or certificate-seeking undergraduate students enrolled at the institution who obtain a degree or certificate within each of the times for completion or graduation described in subclauses (I) through (IV) of clause (iii). (iii) For purposes of this subparagraph, the times for completion or graduation are as follows: (I) The normal time for completion of, or graduation from, the student’s program. (II) 150 percent of the normal time for completion of, or graduation from, the student’s program. (III) 200 percent of the normal time for completion of, or graduation from, the student’s program. (IV) 300 percent of the normal time for completion of, or graduation from, the student’s program. (iv) In making publicly available the percentages described in this subparagraph, the Secretary shall display each percentage in a consistent manner and with equal visibility. . (b) Institutional and financial assistance information for students Section 485(a) of the Higher Education Act of 1965 ( 20 U.S.C. 1092(a) ) is amended— (1) in paragraph (1), by striking subparagraph (L) and inserting the following: (L) each completion or graduation rate for each type of student and program described in clauses (i) and (ii) of section 132(i)(1)(J); ; and (2) in paragraph (3), by striking within 150 percent of the normal time for completion of or graduation from the program and inserting within the time for completion or graduation described in section 132(i)(1)(J) applicable to such student and such program . | https://www.govinfo.gov/content/pkg/BILLS-117s4410is/xml/BILLS-117s4410is.xml |
117-s-4411 | II 117th CONGRESS 2d Session S. 4411 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Cruz (for himself and Mr. Cornyn ) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental Affairs A BILL To designate the facility of the United States Postal Service located at 5302 Galveston Road in Houston, Texas, as the Vanessa Guillén Post Office Building .
1. Vanessa Guillén Post Office Building (a) Designation The facility of the United States Postal Service located at 5302 Galveston Road in Houston, Texas, shall be known and designated as the Vanessa Guillén Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Vanessa Guillén Post Office Building . | https://www.govinfo.gov/content/pkg/BILLS-117s4411is/xml/BILLS-117s4411is.xml |
117-s-4412 | II 117th CONGRESS 2d Session S. 4412 IN THE SENATE OF THE UNITED STATES June 15, 2022 Ms. Sinema (for herself and Ms. Murkowski ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To authorize the Secretary of Health and Human Services to award grants to States, Indian Tribes, Tribal organizations, and urban Indian organizations to provide safety measures to social workers, health workers, and human services professionals performing services placing such individuals in high-risk and potentially dangerous situations, and for other purposes.
1. Short title This Act may be cited as the Protecting Social Workers and Health Professionals from Workplace Violence Act . 2. Workplace safety grant program (a) Grants authorized (1) In general The Secretary shall award grants to States, Indian Tribes, Tribal organizations, and urban Indian organizations to provide safety measures to social workers, health workers, and human services professionals (as designated by the Secretary), performing services placing such individuals in high-risk and potentially dangerous situations. (2) Consultation In awarding grants under this subsection, the Secretary may consult with the Secretary of Labor and the heads of other relevant Federal agencies. (b) Use of funds A grant awarded under subsection (a) may be used to provide or support the following safety measures: (1) (A) The procurement and installation of safety equipment, including communications or recording systems, such as cell phones, wearable tracking devices with GPS/Bluetooth locator, or panic buttons, such as the equipment used for supervised foster care visits and other client visits, to assist entities employing social workers, health workers, and human services professionals described in subsection (a) in ensuring staff safety. (B) Technical assistance and training for safety communications. (2) Training sessions and exercises for self-defense and crisis management, provided together with such organizations as local law enforcement. (3) Facility safety improvements, such as barrier protection and security cameras. (4) Training in cultural competency, including linguistic training, and training on strategies for de-escalating conflict situations. (5) Training to help social workers, health workers, and human services professionals work with clients who— (A) have serious mental and substance use disorders; or (B) have behavioral problems and need help coping. (6) Resources and materials to inform and educate staff on safety and awareness measures. (7) Support services, counseling, and additional resources for social workers, health workers, and human services professionals, who have experienced safety issues or trauma-related incidents in the workplace. (8) Installation of a local data incident tracking system to monitor, prevent, and mitigate violence against social workers, health workers, and human services professionals. (9) Other prevention and mitigation measures determined appropriate by the Secretary for safety training, resources, and support for social workers, health workers, and human services professionals. (c) Application (1) In general A State, Indian Tribe, Tribal organization, or urban Indian organization seeking a grant under subsection (a) shall submit an application to the Secretary at such time, in such manner, and accompanied by such additional information as the Secretary may require. (2) Contents Each application submitted pursuant to paragraph (1) shall— (A) describe the type of entities that will receive funding through the grant and type of work to be done by such entities; (B) describe the specific activities for which the grant is sought and include a program budget; and (C) contain an assurance that the applicant will evaluate the effectiveness of the safety measures provided through the grant. (d) Priority In awarding grants under subsection (a), the Secretary shall give priority to applicants that— (1) (A) demonstrate the greatest need based on documented incidents of violence against social workers, health workers, and human services professionals; and (B) seek to provide assistance to multiple entities employing social workers, health workers, and human services professionals performing services placing such individuals in high-risk and potentially dangerous situations; or (2) seek to enhance existing efforts by the applicant (existing on the date on which the applicant submits the application) to improve the safety of social workers, health workers, and human services professionals. (e) Quality assurance and cost effectiveness The Secretary shall establish guidelines for ensuring the quality and cost effectiveness of the safety measures funded under this section. (f) Technical assistance The Secretary shall provide technical assistance to recipients of a grant under this section with respect to planning, developing, implementing, reporting, and sustaining safety measures through the grant. (g) Report requirement Each State, Indian Tribe, Tribal organization, or urban Indian organization receiving a grant under this section shall submit to the Secretary, not later than 2 years after receiving such grant, a report that includes— (1) an assessment of the effectiveness of the activities funded in whole or in part with funds awarded through the grant; (2) the range and scope of training opportunities provided through training programs funded in whole or in part with such funds, including the numbers and percentages of social workers, health workers, and human services professionals, engaged in such training programs; and (3) the incidence of threats to social workers, health workers, and human services professionals, if any, and the strategies used to address their safety. (h) Definitions In this section: (1) The term health worker includes— (A) a Community Health Representative that has completed training under the Community Health Representative Program of the Indian Health Service under section 107 of the Indian Health Care Improvement Act ( 25 U.S.C. 1616 ); (B) a health aide or community health practitioner certified under the Community Health Aide Program of the Indian Health Service under section 119 of that Act ( 25 U.S.C. 1616l ); and (C) other behavioral health aides and mental health aides. (2) The terms Indian Tribe and Tribal organization have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). (3) The term Secretary means the Secretary of Health and Human Services. (4) The term social work means— (A) the applied science of helping individuals, groups, or communities to enhance or restore capacity for social and psychosocial functioning, and effecting societal changes favorable to such enhancement or restoration for all people; and (B) the professional application of social work values, principles, and techniques related to the activities described in subparagraph (A), including— (i) diagnosing mental and emotional disorders and providing counseling and psychotherapy services to individuals, families, or groups for such disorders; and (ii) helping individuals, families, or groups to obtain tangible services, including personal, protective, informational, advisory, community, housing, education, health, and mental health services in order to improve the overall well-being of individuals. (5) The term social worker means an individual, with a baccalaureate, master’s, or doctoral degree in social work from an institution of higher education, who uses knowledge and skills to provide social work services for individuals, families, groups, communities, organizations, or society in general. (6) The term urban Indian organization has the meaning given such term in section 4 of the Indian Health Care Improvement Act ( 25 U.S.C. 1603 ). (i) Authorization of appropriations To carry out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2023 through 2027. | https://www.govinfo.gov/content/pkg/BILLS-117s4412is/xml/BILLS-117s4412is.xml |
117-s-4413 | II 117th CONGRESS 2d Session S. 4413 IN THE SENATE OF THE UNITED STATES June 15, 2022 Mr. Ossoff introduced the following bill; which was read twice and referred to the Committee on Environment and Public Works A BILL To amend the Infrastructure Investment and Jobs Act to remove the exclusion of certain small business concerns from the disadvantaged business enterprise program, and for other purposes.
1. Disadvantaged business enterprises Section 11101(e)(2)(A) of the Infrastructure Investment and Jobs Act ( Public Law 117–58 ; 135 Stat. 449) is amended to read as follows: (A) Small business concern The term small business concern means a small business concern (as the term is used in section 3 of the Small Business Act ( 15 U.S.C. 632 )). . | https://www.govinfo.gov/content/pkg/BILLS-117s4413is/xml/BILLS-117s4413is.xml |
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