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(3) a description of the technological requirements to appropriately link and enhance existing networks and a description of the system design that will meet these requirements; (4) an enterprise architecture that— (A) is consistent with applicable laws and guidance with regard to planning, design, acquisition, operation, and management of information systems; (B) will be used to guide and define the development and implementation of the Network; and (C) addresses the existing and planned enterprise architectures of the departments and agencies participating in the Network; (5) a description of how privacy and civil liberties will be protected throughout the design and implementation of the Network;
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(6) objective, systemwide performance measures to enable the assessment of progress toward achieving full implementation of the Network; (7) a plan, including a time line, for the development and phased implementation of the Network; (8) total budget requirements to develop and implement the Network, including the estimated annual cost for each of the 5 years following the date of the enactment of this Act; and (9) proposals for any legislation that the Director of Management and Budget determines necessary to implement the Network.
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(g) Director of management and budget responsible for information sharing across the federal government
(1) Additional duties and responsibilities
(A) In general
The Director of Management and Budget, in consultation with the Executive Council, shall— (i) implement and manage the Network; (ii) develop and implement policies, procedures, guidelines, rules, and standards as appropriate to foster the development and proper operation of the Network; and (iii) assist, monitor, and assess the implementation of the Network by Federal departments and agencies to ensure adequate progress, technological consistency and policy compliance; and regularly report the findings to the President and to Congress.
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(B) Content of policies, procedures, guidelines, rules, and standards
The policies, procedures, guidelines, rules, and standards under subparagraph (A)(ii) shall— (i) take into account the varying missions and security requirements of agencies participating in the Network; (ii) address development, implementation, and oversight of technical standards and requirements; (iii) address and facilitate information sharing between and among departments and agencies of the intelligence community, the Department of Defense, the homeland security community and the law enforcement community; (iv) address and facilitate information sharing between Federal departments and agencies and State, tribal and local governments;
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(v) address and facilitate, as appropriate, information sharing between Federal departments and agencies and the private sector; (vi) address and facilitate, as appropriate, information sharing between Federal departments and agencies with foreign partners and allies; and (vii) ensure the protection of privacy and civil liberties.
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(2) Appointment of principal officer
Not later than 30 days after the date of the enactment of this Act, the Director of Management and Budget shall appoint, with approval of the President, a principal officer in the Office of Management and Budget whose primary responsibility shall be to carry out the day-to-day duties of the Director specified in this section. The officer shall report directly to the Director of Management and Budget, have the rank of a Deputy Director and shall be paid at the rate of pay payable for a position at level III of the Executive Schedule under section 5314 of title 5, United States Code.
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(h) Executive council on information sharing
(1) Establishment
There is established an Executive Council on Information Sharing that shall assist the Director of Management and Budget in the execution of the Director’s duties under this Act concerning information sharing. (2) Membership
The members of the Executive Council shall be— (A) the Director of Management and Budget, who shall serve as Chairman of the Executive Council; (B) the Secretary of Homeland Security or his designee; (C) the Secretary of Defense or his designee; (D) the Attorney General or his designee;
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(E) the Secretary of State or his designee; (F) the Director of the Federal Bureau of Investigation or his designee; (G) the National Intelligence Director or his designee; (H) such other Federal officials as the President shall designate; (I) representatives of State, tribal, and local governments, to be appointed by the President; and (J) individuals who are employed in private businesses or nonprofit organizations that own or operate critical infrastructure, to be appointed by the President.
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(3) Responsibilities
The Executive Council shall assist the Director of Management and Budget in— (A) implementing and managing the Network; (B) developing policies, procedures, guidelines, rules, and standards necessary to establish and implement the Network; (C) ensuring there is coordination among departments and agencies participating in the Network in the development and implementation of the Network; (D) reviewing, on an ongoing basis, policies, procedures, guidelines, rules, and standards related to the implementation of the Network; (E) establishing a dispute resolution process to resolve disagreements among departments and agencies about whether particular information should be shared and in what manner;
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and (F) considering such reports as are submitted by the Advisory Board on Information Sharing under subsection (i)(2). (4) Reports
Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the Director of Management and Budget, in the capacity of Chair of the Executive Council, shall submit a report to the President and to Congress that shall include— (A) a description of the activities and accomplishments of the Council in the preceding year; and (B) the number and dates of the meetings held by the Council and a list of attendees at each meeting.
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(5) Informing the public
The Executive Council shall— (A) make its reports to Congress available to the public to the greatest extent that is consistent with the protection of classified information and applicable law; and (B) otherwise inform the public of its activities, as appropriate and in a manner consistent with the protection of classified information and applicable law.
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(i) Reports
(1) In general
Not later than 1 year after the date of the enactment of this Act, and semiannually thereafter, the President through the Director of Management and Budget shall submit a report to Congress on the state of the Network and of information sharing across the Federal Government. (2) Content
Each report under this subsection shall include— (A) a progress report on the extent to which the Network has been implemented, including how the Network has fared on the government-wide and agency-specific performance measures and whether the performance goals set in the preceding year have been met;
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(B) objective systemwide performance goals for the following year; (C) an accounting of how much was spent on the Network in the preceding year; (D) actions taken to ensure that agencies procure new technology that is consistent with the Network and information on whether new systems and technology are consistent with the Network; (E) the extent to which, in appropriate circumstances, all terrorism watch lists are available for combined searching in real time through the Network and whether there are consistent standards for placing individuals on, and removing individuals from, the watch lists, including the availability of processes for correcting errors;
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(F) the extent to which unnecessary roadblocks, impediments, or disincentives to information sharing, including the inappropriate use of paper-only intelligence products and requirements for originator approval, have been eliminated; (G) the extent to which positive incentives for information sharing have been implemented; (H) the extent to which classified information is also made available through the Network, in whole or in part, in unclassified form; (I) the extent to which State, tribal, and local officials— (i) are participating in the Network; (ii) have systems which have become integrated into the Network;
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(iii) are providing as well as receiving information; and (iv) are using the Network to communicate with each other; (J) the extent to which— (i) private sector data, including information from owners and operators of critical infrastructure, is incorporated in the Network; and (ii) the private sector is both providing and receiving information; (K) where private sector data has been used by the Government or has been incorporated into the Network— (i) the measures taken to protect sensitive business information; and (ii) where the data involves information about individuals, the measures taken to ensure the accuracy of such data;
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(L) the measures taken by the Federal Government to ensure the accuracy of other information on the Network and, in particular, the accuracy of information about individuals; (M) an assessment of the Network s privacy and civil liberties protections, including actions taken in the preceding year to implement or enforce privacy and civil liberties protections and a report of complaints received about interference with an individual s privacy or civil liberties; and (N) an assessment of the security protections of the Network.
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(j) Agency responsibilities
The head of each department or agency possessing or using intelligence or homeland security information or otherwise participating in the Network shall— (1) ensure full department or agency compliance with information sharing policies, procedures, guidelines, rules, and standards established for the Network under subsections (c) and (g); (2) ensure the provision of adequate resources for systems and activities supporting operation of and participation in the Network; and (3) ensure full agency or department cooperation in the development of the Network and associated enterprise architecture to implement governmentwide information sharing, and in the management and acquisition of information technology consistent with applicable law.
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(k) Agency plans and reports
Each Federal department or agency that possesses or uses intelligence and homeland security information, operates a system in the Network or otherwise participates, or expects to participate, in the Network, shall submit to the Director of Management and Budget— (1) not later than 1 year after the date of the enactment of this Act, a report including— (A) a strategic plan for implementation of the Network’s requirements within the department or agency; (B) objective performance measures to assess the progress and adequacy of the department or agency’s information sharing efforts;
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and (C) budgetary requirements to integrate the agency into the Network, including projected annual expenditures for each of the following 5 years following the submission of the report; and (2) annually thereafter, reports including— (A) an assessment of the progress of the department or agency in complying with the Network’s requirements, including how well the agency has performed on the objective measures developed under paragraph (1)(B); (B) the agency’s expenditures to implement and comply with the Network’s requirements in the preceding year;
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and (C) the agency’s or department’s plans for further implementation of the Network in the year following the submission of the report.
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(l) Periodic assessments
(1) Comptroller general
(A) In general
Not later than 1 year after the date of the enactment of this Act, and periodically thereafter, the Comptroller General shall evaluate the implementation of the Network, both generally and, at the discretion of the Comptroller General, within specific departments and agencies, to determine the extent of compliance with the Network’s requirements and to assess the effectiveness of the Network in improving information sharing and collaboration and in protecting privacy and civil liberties, and shall report to Congress on the findings of the Comptroller General.
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(B) Information available to the Comptroller General
Upon request by the Comptroller General, information relevant to an evaluation under subsection (a) shall be made available to the Comptroller General under section 716 of title 31, United States Code.
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(C) Consultation with congressional committees
If a record is not made available to the Comptroller General within a reasonable time, before the Comptroller General files a report under section 716(b)(1) of title 31, United States Code, the Comptroller General shall consult with the Select Committee on Intelligence of the Senate, the Permanent Select Committee on Intelligence of the House of Representatives, the Committee on Governmental Affairs of the Senate, and the Committee on Government Reform of the House of Representatives concerning the Comptroller’s intent to file a report.
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(2) Inspectors general
The Inspector General in any Federal department or agency that possesses or uses intelligence or homeland security information or that otherwise participates in the Network shall, at the discretion of the Inspector General— (A) conduct audits or investigations to— (i) determine the compliance of that department or agency with the Network’s requirements; and (ii) assess the effectiveness of that department or agency in improving information sharing and collaboration and in protecting privacy and civil liberties; and (B) issue reports on such audits and investigations.
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(3) Chief privacy officers
The Chief Privacy Officers established under section 5092 in any Federal department or agency that possesses or uses intelligence or homeland security information or that otherwise participates in the Network shall, at the discretion of the Chief Privacy Officer— (A) conduct audits or investigations to ensure that the network, or the use of the network by that department or agency, does not erode privacy protections; and (B) issue reports on such audits and investigations.
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(m) Authorization of appropriations
There are authorized to be appropriated— (1) $50,000,000 to the Director of Management and Budget to carry out this section for fiscal year 2005; and (2) such sums as are necessary to carry out this section in each fiscal year thereafter, to be disbursed and allocated in accordance with the Network implementation plan required by subsection (f). (n) Section 1017
Section 1017 of this Act shall have no force or effect. 171.
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Critical infrastructure evaluation and prioritization program
(a) Program
Not later than 90 days after the date of the enactment of this Act, the Secretary of Homeland Security shall develop, in cooperation with other relevant Federal agencies, State and local governments, and the private sector, as appropriate, a prioritized list of national critical infrastructure and key assets, based on the degree to which destruction or significant disruption of such infrastructure or assets would result in— (1) substantial human casualties; (2) a substantial adverse impact on the national economy; or (3) a substantial adverse impact on national security.
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(b) Security plan
(1) Requirement
Not later than 180 days after the date of the enactment of this Act, the Secretary, in coordination with other relevant Federal agencies, State and local governments, and the private sector, as appropriate, shall— (A) review existing plans for securing the critical infrastructure and key assets included in the list under subsection (a); (B) recommend changes to existing plans and develop additional plans for securing such infrastructure and assets that the Secretary determines necessary; and (C) coordinate or contribute to protective efforts of other agencies as directed in Homeland Security Presidential Directive 7.
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(2) Contents of plans
Recommendations under paragraph (1) shall include— (A) recommendations on necessary protective measures to secure such infrastructure and assets, including suggested milestones and timeframes for implementation; and (B) to the extent practicable, performance measures to evaluate the benefits to national and economic security from the implementation of such protective measures.
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(c) Implementation report
(1) In general
Within one year after the date of the enactment of this Act, the Secretary shall submit a report to the appropriate congressional committees (as that term is defined in section 2 of the Homeland Security Act of 2002 ( 6 U.S.C. 101 )) on the implementation of subsection (b).
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Such report shall detail— (A) the Secretary’s review, development, and coordination of security plans under such subsection; and (B) the Secretary’s oversight of the execution and effectiveness of such security plans (2) Update
The Secretary shall provide an updated report under this subsection to the appropriate congressional committees one year after the submission of the report under paragraph (1). (d) Protection of information
Information that is generated, compiled, or disseminated by the Department of Homeland Security in carrying out this section— (1) is exempt from disclosure under section 552 of title 5, United States Code;
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and (2) shall not, if provided by the Department to a State or local government or government agency— (A) be made available pursuant to any State or local law requiring disclosure of information or records; (B) otherwise be disclosed or distributed to any person by such State or local government or government agency without the written consent of the Secretary; or (C) be used other than for the purpose of protecting critical infrastructure or protected systems, or in furtherance of an investigation or the prosecution of a criminal act. 172.
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Deadline for comprehensive national plan to secure critical infrastructure and key assets
Within one year after the date of the enactment of this Act, the Secretary of Homeland Security shall develop a comprehensive national plan for securing critical infrastructure and key assets and recommend protective measures for such infrastructures and assets, as required by paragraphs (5) and (6) of subsection 201(d) of the Homeland Security Act of 2002 ( 6 U.S.C. 121(d) ). 173.
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Regulatory authority
(a) In general
The Secretary of Homeland Security may promulgate such regulations as the Secretary determines to be necessary to enhance protection of critical infrastructure in accordance with the plans developed under the sections _171 and _172 of this Act and the requirements of paragraphs (5) and (6) of section 201(d) of the Homeland Security Act of 2002 ( 6 U.S.C. 121(d) ). (b) Conforming amendment
Section 877(a) of the Homeland Security Act of 2002 ( 6 U.S.C.
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457(a) ) is amended by inserting paragraphs (5) and (6) of section 201(d) and after Except as otherwise provided in. 174.
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Best practices
Within one year after the date of the enactment of this Act, the Secretary of Homeland Security shall— (1) develop, in collaboration with the heads of other appropriate Federal agencies and in consultation with the private sector, security-related best practices for each critical infrastructure sector identified by the President; (2) ensure the broad dissemination of such best practices to appropriate public and private sector entities and authorities; and (3) encourage the adoption of such best practices by such entities and authorities. 181.
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National biodefense strategy
(a) Strategy
(1) In general
Consistent with the provisions of section 505 of the Homeland Security Act of 2002 ( 6 U.S.C. 315 ) and subsections (a) and (b) of section 304 of such Act ( 6 U.S.C.
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184 ), the Secretary of Homeland Security, in consultation with the heads of other appropriate Federal agencies, shall develop a comprehensive national biodefense strategy (in this section referred to as the biodefense strategy ) for meeting the requirements, responsibilities, and authorities of the Homeland Security Act of 2002 ( 6 U.S.C. 101 et seq. ), including sections 201(d)(1), 302(2), and 502(3) of such Act, with respect to the biodefense mission of the Department.
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(2) Deadlines
The Secretary shall (A) develop the biodefense strategy not later than one year after the date of the enactment of this Act; and (B) regularly update such strategy as necessary, but not less than every four years. (b) Contents
The biodefense strategy shall set forth the following: (1) The objectives, missions, and priorities, including how such objectives, missions, and priorities were established and will be updated. (2) A description of the biological threats to and vulnerabilities of the Nation, including a prioritization of such threats in terms of risk.
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(3) A specification of each Federal agency with research and development responsibilities regarding such objectives, missions, and priorities, and a description of such responsibilities. (4) A specification of each Federal agency with other responsibilities regarding such objectives, missions, and priorities (including surveillance, threat and risk analysis, and incident response), and a description of such responsibilities. (5) The mechanisms by which coordination among the Federal agencies described in paragraphs (3) and (4) will be achieved.
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(6) The role of State and local governments and private sector institutions in the biodefense strategy, as identified by the Federal agencies described in paragraphs (3) and (4) with the responsibility and mission to coordinate and communicate with State and local governments and private sector institutions. (7) The mechanisms by which the Federal agencies referred to in paragraph (6) coordinate and communicate with State and local governments and private sector institutions. (8) Performance benchmarks to measure progress in achieving the objectives of the biodefense strategy, including a specification of expected timeframes for implementation.
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(c) Other agency responsibilities
The Secretary shall obtain the concurrence of the relevant Federal agency head with respect to such other agency’s responsibilities or activities covered by this section. (d) Submission
Upon its completion, the Secretary shall transmit a copy of the biodefense strategy to the Congress in an unclassified form with a classified annex as appropriate. 184. Short title
This subtitle may be cited as the Rapid Pathogen Identification to Delivery of Cures Act. 185.
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Findings and policy
(a) Findings
The Congress finds as follows: (1) The possibility exists today that terrorists or others who intend harm to United States forces deployed abroad or to the homeland will use techniques in biotechnology to enhance the transmissibility, stability, virulence, or host range of a biological agent, or to render existing diagnostic, therapeutic, and vaccine strategies or innate immune responses against a biological agent less effective. (2) This possibility will likely grow over time as such techniques develop, improve, and spread as an inevitable result of biotechnology innovation.
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(3) Natural processes can also lead to the emergence of previously unknown and harmful pathogens or render known pathogens resistant to existing diagnostic, therapeutic, or adaptive immune approaches. (4) Long delays in developing new and effective responses to pathogens are typical. The discovery, development, and approval process for new drugs and vaccines typically requires 10 to 20 years and costs an average of $800 million.
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These constraints reflect the long, costly research and development process, including the failure of most drug or vaccine candidates to demonstrate favorable characteristics in pre-clinical testing, as well as the expensive, time-consuming clinical trials required to prove the safety and effectiveness of new treatments. (5) Congress has already authorized the abridgement of the long testing and approval process required to ensure safety and efficacy under the emergency conditions of a severe outbreak of a harmful pathogen. However, it will likely still take years for even an experimental treatment or vaccine to become available.
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(6) There is no coordinated, focused research and development program or overall national strategy to achieve significant and dramatic reductions in the timeframe from the identification of a pathogen to the development and emergency approval for human use of reasonably safe and effective new biodefense medical countermeasures against a previously unknown or engineered pathogen or toxin.
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(7) Even utilizing existing technologies, there is no organized capability in the public or private sector to rapidly screen drug candidates for potential therapeutic activity against pathogens, develop and manufacture drug, biological, or medical device products, or test already approved treatments for efficacy against a previously unknown or engineered biological threat that puts our deployed armed forces or the homeland at risk. (8) In the area of infectious disease in particular, private sector firms are abandoning all types of innovation and research and development in favor of investments in more profitable medical markets.
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(9) Tremendous potential exists for benefits to health by concerted, targeted public-private investment to dramatically reduce the timeframe for the development of new countermeasures. The pharmaceutical and biotechnology industries are fundamentally innovative and are quick to integrate new technologies. Useful and important discoveries and technological advances will be rapidly absorbed by the private sector, leading to faster delivery of new medicines and reductions in the costs of drug development.
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(b) Policy
The Congress hereby declares it to be the national policy of the United States to promote technological advancements that will dramatically reduce the timeframe for the development of new medical countermeasures to treat or prevent disease caused by infectious disease agents or toxins that, through natural processes or intentional introduction, may pose a significant risk to public health now or in the future. 186. Rapid biodefense countermeasures development national strategy
Title III of the Homeland Security Act of 2002 ( 6 U.S.C. 181 et seq. )
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( Public Law 107–296 ) is amended by inserting after section 304 the following section: 304A.
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Rapid biodefense countermeasures development national strategy
(a) National strategy for shortening the medical countermeasure development timeframe
Not later than 180 days after the date of the enactment of the Rapid Pathogen Identification to Delivery of Cures Act, the Secretaries of Homeland Security, Health and Human Services, and Defense shall submit to Congress a report setting forth a strategy to achieve dramatic reductions in the timeframe from pathogen identification to the development and emergency approval for human use of reasonably safe and effective priority countermeasure against a novel or unknown pathogen or toxin.
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(b) Elements
The report under subsection (a) shall include the following: (1) The identification of the technical impediments to reductions in the timeframe from pathogen identification to priority countermeasure development and approval under emergency conditions. (2) The identification of the research, development, and technology needs and clinical research needs to address these impediments. (3) The identification of existing research and development efforts in Federal agencies, academia and industry that are addressing the needs identified in subsection (c)(2).
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(4) The identification of facilities, programs and resources that can be utilized to address these research, development, and technology needs and clinical research needs among— (A) Federal agencies; (B) colleges and universities; (C) not-for-profit institutions; (D) industry, including information technology, software, robotics, pharmaceutical and biotechnology companies and their consortia; and (E) foreign research and technological institutions. (5) A proposal for the establishment of a coordinated and integrated federal program to address these research, development, and technology needs, including— (A) the application of Federal Government resources,
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including recommendations for the allocation and prioritization of Federal funds; (B) interagency management and coordination mechanisms; (C) the establishment of partnerships between private corporations and Federal agencies or Federally funded entities; (D) information and technology sharing and coordination mechanisms among public, private, academic, not-for-profit, and international institutions; (E) the use of incentives to promote private sector participation; and (F) the adjustment of Federal regulatory requirements to promote private sector innovation.
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(6) The identification of potential liability concerns stemming from distribution of rapidly-developed priority countermeasures under emergency conditions and a proposal for regulatory or legislative approaches to eliminating these concerns. (7) A proposal for managing the transfer of new technologies and associated intellectual property rights. (c) Considerations
In developing the national strategy under subsection (a), the Secretaries shall consider— (1) The research, development, and technology needs and clinical research needs of the entire pathogen identification to priority countermeasures discovery, development, production, and Approval process,
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including— (A) initial identification and characterization of a pathogen or toxin, including the identification of any genetic or other manipulations; (B) priority countermeasures discovery; (C) pre-clinical testing and evaluation of priority countermeasures; (D) safety and efficacy animal testing, including the needs for approval under emergency conditions and accelerated approval of new priority countermeasure under the final rule New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible published in the Federal Register on May 31,
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2002 (67 Fed. Reg. 37988); (E) safety and efficacy human testing, including mechanisms for the conduct of clinical trials under emergency conditions; (F) research-scale and full production-scale manufacturing, including biologics manufacturing sciences; and (G) the approval of priority countermeasure under emergency conditions; (2) the potential importance of advanced technologies such as automation, computer modeling and simulation, bioinformatics, pharmacogenomics, and bioengineering techniques for manufacturing; (3) the availability of sufficient manufacturing capacity for priority countermeasures production to meet potential public demand under emergency conditions;
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and (4) the current state of national and international collaborative research networks and applications to facilitate and encourage the rapid and coordinated development and sharing of laboratory and clinical research planning and results.
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(d) Authority to contract
The Secretary of Homeland Security, after consultation with the Secretaries of Health and Human Services and Defense and the working group established under section 319F(a) of the Public Health Service Act, may contract with any one or more for-profit or non-profit firm or institution to conduct the necessary research and analysis needed to complete any one or more of the elements described in subsection (b) of the report required in this section, provided the considerations described in subsection (c) are met.
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(e) Definitions
In this section: (1) The term emergency conditions refers to a declaration of emergency under section 564 of the Federal Food, Drug, and Cosmetic Act. (2) The term pathogen identification means the point in time in which a specific agent that can be reasonably assumed to be the cause of (or has the potential to be the cause of) an infectious disease or toxin-induced syndrome has been identified and partially or wholly characterized scientifically. (3) The term priority countermeasure has the same meaning given such term in section 319F(h) of the Public Health Service Act.
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(f) Authorization of Appropriations
For the purpose of carrying out this section, there is authorized to be appropriated $10,000,000 for fiscal year 2005.. 304A.
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Rapid biodefense countermeasures development national strategy
(a) National strategy for shortening the medical countermeasure development timeframe
Not later than 180 days after the date of the enactment of the Rapid Pathogen Identification to Delivery of Cures Act, the Secretaries of Homeland Security, Health and Human Services, and Defense shall submit to Congress a report setting forth a strategy to achieve dramatic reductions in the timeframe from pathogen identification to the development and emergency approval for human use of reasonably safe and effective priority countermeasure against a novel or unknown pathogen or toxin.
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(b) Elements
The report under subsection (a) shall include the following: (1) The identification of the technical impediments to reductions in the timeframe from pathogen identification to priority countermeasure development and approval under emergency conditions. (2) The identification of the research, development, and technology needs and clinical research needs to address these impediments. (3) The identification of existing research and development efforts in Federal agencies, academia and industry that are addressing the needs identified in subsection (c)(2).
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(4) The identification of facilities, programs and resources that can be utilized to address these research, development, and technology needs and clinical research needs among— (A) Federal agencies; (B) colleges and universities; (C) not-for-profit institutions; (D) industry, including information technology, software, robotics, pharmaceutical and biotechnology companies and their consortia; and (E) foreign research and technological institutions. (5) A proposal for the establishment of a coordinated and integrated federal program to address these research, development, and technology needs, including— (A) the application of Federal Government resources,
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including recommendations for the allocation and prioritization of Federal funds; (B) interagency management and coordination mechanisms; (C) the establishment of partnerships between private corporations and Federal agencies or Federally funded entities; (D) information and technology sharing and coordination mechanisms among public, private, academic, not-for-profit, and international institutions; (E) the use of incentives to promote private sector participation; and (F) the adjustment of Federal regulatory requirements to promote private sector innovation.
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(6) The identification of potential liability concerns stemming from distribution of rapidly-developed priority countermeasures under emergency conditions and a proposal for regulatory or legislative approaches to eliminating these concerns. (7) A proposal for managing the transfer of new technologies and associated intellectual property rights. (c) Considerations
In developing the national strategy under subsection (a), the Secretaries shall consider— (1) The research, development, and technology needs and clinical research needs of the entire pathogen identification to priority countermeasures discovery, development, production, and Approval process,
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including— (A) initial identification and characterization of a pathogen or toxin, including the identification of any genetic or other manipulations; (B) priority countermeasures discovery; (C) pre-clinical testing and evaluation of priority countermeasures; (D) safety and efficacy animal testing, including the needs for approval under emergency conditions and accelerated approval of new priority countermeasure under the final rule New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible published in the Federal Register on May 31,
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2002 (67 Fed. Reg. 37988); (E) safety and efficacy human testing, including mechanisms for the conduct of clinical trials under emergency conditions; (F) research-scale and full production-scale manufacturing, including biologics manufacturing sciences; and (G) the approval of priority countermeasure under emergency conditions; (2) the potential importance of advanced technologies such as automation, computer modeling and simulation, bioinformatics, pharmacogenomics, and bioengineering techniques for manufacturing; (3) the availability of sufficient manufacturing capacity for priority countermeasures production to meet potential public demand under emergency conditions;
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and (4) the current state of national and international collaborative research networks and applications to facilitate and encourage the rapid and coordinated development and sharing of laboratory and clinical research planning and results.
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(d) Authority to contract
The Secretary of Homeland Security, after consultation with the Secretaries of Health and Human Services and Defense and the working group established under section 319F(a) of the Public Health Service Act, may contract with any one or more for-profit or non-profit firm or institution to conduct the necessary research and analysis needed to complete any one or more of the elements described in subsection (b) of the report required in this section, provided the considerations described in subsection (c) are met.
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(e) Definitions
In this section: (1) The term emergency conditions refers to a declaration of emergency under section 564 of the Federal Food, Drug, and Cosmetic Act. (2) The term pathogen identification means the point in time in which a specific agent that can be reasonably assumed to be the cause of (or has the potential to be the cause of) an infectious disease or toxin-induced syndrome has been identified and partially or wholly characterized scientifically. (3) The term priority countermeasure has the same meaning given such term in section 319F(h) of the Public Health Service Act.
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(f) Authorization of Appropriations
For the purpose of carrying out this section, there is authorized to be appropriated $10,000,000 for fiscal year 2005. 187. Clinical research under emergency conditions
(a) In general
Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall establish a system for the rapid establishment of clinical research programs to examine the safety and efficacy of new or existing treatments for novel, unknown, or bioengineered pathogens or toxins.
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The Secretary shall also provide the means for rapid dissemination of results and recommendations to clinicians nationwide. (b) Emergency fund
A fund is authorized to be established for use, at the discretion of the Secretary, solely for the support of clinical research as described in subsection (a). 188. Interagency working group
Section 319F(a) of the Public Health Service Act, as amended by Public Law 107–188 , is amended— (1) by inserting the Secretary of Homeland Security, after in coordination with the ;
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(2) by redesignating subparagraphs (D) through (L) as subparagraphs (E) through (M), respectively; and (3) by inserting after subparagraph (C) the following subparagraph: (D) development of a national strategy to achieve dramatic reductions in the timeframe from the identification of a pathogen to the development and approval for human use under emergency conditions of priority countermeasures against a novel, unknown, or engineered pathogen or toxin; 189.
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Developing the capability for rapid biodefense countermeasure development
(a) Research
Section 319F(h)(1) of the Public Health Service Act, as amended by Public Law 107–188 , is amended (1) in subparagraph (C), by striking and after the semicolon; (2) by redesignating subparagraph (D) as subparagraph (E); and (3) by inserting after subparagraph (C) the following subparagraph: (D) the development of a capability to rapidly identify, develop, produce, and approve for human use under emergency conditions priority countermeasures against a novel, unknown,
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or engineered pathogen or toxin; and. (b) Research and development at the Department of Defense
Section 1601(a) of the National Defense Authorization Act for Fiscal Year 2004 ( Public Law 108–136 ) is amended by adding at the end the following: The program shall also include research, development, and procurement to provide the Federal Government with the capability to rapidly identify, develop, produce, and approve for human use under emergency conditions priority countermeasures against a novel, unknown, or engineered pathogen or toxin, and for which no existing countermeasure has been determined to be safe or efficacious.
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(c) Research and development at the Department of Homeland Security
Title III of the Homeland Security Act of 2002, as amended by section 186 of this Act, is amended by inserting after section 304A the following section: 304B.
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Developing the capability for rapid biodefense countermeasure development
The Secretary, in collaboration with the Secretaries of Defense and Health and Human Services, shall carry out a program for research, development, and procurement to provide the Federal Government with the capability to rapidly identify, develop, produce, and approve for human use under emergency conditions priority countermeasures against a novel, unknown, or engineered pathogen or toxin, and for which no existing countermeasure has been determined to be safe or efficacious.. 304B.
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Developing the capability for rapid biodefense countermeasure development
The Secretary, in collaboration with the Secretaries of Defense and Health and Human Services, shall carry out a program for research, development, and procurement to provide the Federal Government with the capability to rapidly identify, develop, produce, and approve for human use under emergency conditions priority countermeasures against a novel, unknown, or engineered pathogen or toxin, and for which no existing countermeasure has been determined to be safe or efficacious. 191. Short title
This title may be cited as the Chemical Security Improvement Act of 2004. 192.
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Definitions
In this title: (1) Alternative approaches
The term alternative approach means an approach that significantly reduces or eliminates the threat or consequences of a terrorist release from a chemical source, including an approach that— (A) uses smaller quantities, nonhazardous forms, or less hazardous forms of dangerous substances; (B) replaces a dangerous substance with a nonhazardous or less hazardous substance; or (C) uses nonhazardous or less hazardous conditions or processes.
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(2) Chemical source
The term chemical source means a non-Federal facility listed by the Secretary under section 193(e) as a chemical source. (3) Dangerous substance
The term dangerous substance means a substance present at a chemical source that— (A) can cause death, injury, or serious adverse effects to human health or the environment; or (B) could harm critical infrastructure or national security. (4) Department
The term Department means the Department of Homeland Security.
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(5) Environment
The term environment means— (A) the navigable waters, the waters of the contiguous zone, and the ocean waters of which the natural resources are under the exclusive management authority of the United States; and (B) any other surface water, ground water, drinking water supply, land surface or subsurface strata, or ambient air within the United States or under the jurisdiction of the United States.
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(6) Full consideration
The term full consideration includes an analysis of— (A) alternative approaches, including the benefits and risks of such approaches; (B) the potential of the alternative approaches to prevent or reduce the threat or consequences of a terrorist release; (C) the cost and technical feasibility of alternative approaches; and (D) the effect of alternative approaches on product quality, product cost, and employee safety. (7) Owner or operator
The term owner or operator means any person who owns, leases, operates, controls, or supervises a chemical source.
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(8) Release
The term release means any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment (including the abandonment or discarding of barrels, containers, and other closed receptacles containing any hazardous substance or pollutant or contaminant), but excludes— (A) any release which results in exposure to persons solely within a workplace, with respect to a claim which such persons may assert against the employer of such persons; (B) emissions from the engine exhaust of a motor vehicle, rolling stock, aircraft, vessel,
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or pipeline pumping station engine; or (C) the normal application of fertilizer. (9) Secretary
The term Secretary means the Secretary of Homeland Security. (10) Security measure
(A) In general
The term security measure means an action carried out to ensure or enhance the security of a chemical source. (B) Inclusions
The term security measure , with respect to a chemical source, includes measures such as— (i) employee training and background checks; (ii) the limitation and prevention of access to controls of the chemical source; (iii) the protection of the perimeter of the chemical source,
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including the deployment of armed physical security personnel; (iv) the installation and operation of intrusion detection sensors; (v) the implementation of measures to increase computer or computer network security; (vi) the installation of measures to protect against long-range weapons; (vii) the installation of measures and controls to protect against or reduce the consequences of a terrorist attack; and (viii) the implementation of any other security-related measures or the conduct of any similar security-related activity, as determined by the Secretary.
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(11) Terrorism
The term terrorism has the meaning given to that term in section 2 of the Homeland Security Act of 2002 ( 6 U.S.C. 101 ). (12) Terrorist release
The term terrorist release means— (A) a release from a chemical source into the environment of a dangerous substance that is caused by an act of terrorism; and (B) the theft of a dangerous substance by a person for off-site release in furtherance of an act of terrorism. 193.
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Vulnerability assessments and site security plans
(a) Requirement
(1) In general
Not later than 1 year after the date of the enactment of this subtitle, the Secretary shall promulgate regulations that— (A) require the owner or operator of each chemical source— (i) to conduct an assessment of the vulnerability of the chemical source to a terrorist release; and (ii) to prepare and implement a site security plan that addresses the results of the vulnerability assessment; and (B) establish procedures, protocols, and standards for vulnerability assessments and site security plans.
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(2) Contents of vulnerability assessment
A vulnerability assessment required under the regulations promulgated under paragraph (1) or any assessment determined substantially equivalent by the Secretary under subsection (c) shall include the identification and evaluation of— (A) critical assets and infrastructures; (B) hazards that may result from a terrorist release; and (C) weaknesses in— (i) physical security; (ii) structural integrity of containment, processing, and other critical infrastructure; (iii) protection systems; (iv) procedural and employment policies; (v) communication systems; (vi) transportation infrastructure in the proximity of the chemical source;
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(vii) utilities; (viii) contingency response; and (ix) other areas as determined by the Secretary. (3) Contents of site security plan
A site security plan required under the regulations promulgated under paragraph (1) or any plan submitted to the Secretary under subsection (c)— (A) shall include security measures to significantly reduce the vulnerability of the chemical source covered by the plan to a terrorist release; (B) shall describe, at a minimum, particular equipment, plans, and procedures that could be implemented or used by or at the chemical source in the event of a terrorist release;
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(C) shall include full consideration and, where practicable in the judgment of the owner or operator of the chemical source, implementation of options to reduce the threat of a terrorist release through the use of alternative approaches; and (D) shall be developed in consultation with local law enforcement and first responders. (4) Security exercises
Not later than 1 year after the date of the enactment of this subtitle, the Secretary shall promulgate regulations establishing procedures, protocols, and standards for the conduct of security exercises,
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including— (A) the performance of force-on-force exercises that— (i) involve physical security personnel employed by the owner or operator of the chemical source to act as the force designated to defend the facility; (ii) involve personnel designated by the Secretary to act as the force designated to simulate a terrorist attempt to attack the chemical source to cause a terrorist release; (iii) are designed, overseen, and evaluated by the Department; and (iv) are conducted at least once every 3 years; and (B) the performance of all other such exercises at periodic intervals necessary to ensure the optimal performance of security measures.
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(5) Guidance to small entities
Not later than 1 year after the date of the enactment of this Act, the Secretary shall publish guidance to assist small entities in complying with paragraphs (2) and (3). (6) Threat information
To the maximum extent practicable under applicable authority and in the interests of national security, the Secretary shall provide to an owner or operator of a chemical source required to prepare a vulnerability assessment and site security plan threat information that is relevant to the chemical source.
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(7) Coordinated assessments and plans
The regulations promulgated under paragraph (1) shall permit the development and implementation of coordinated vulnerability assessments and site security plans in any case in which more than 1 chemical source is operating at a single location or at contiguous locations, including cases in which a chemical source is under the control of more than 1 owner or operator.
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(b) Certification and submission
(1) In general
Except as provided in subsection (c), each owner or operator of a chemical source shall certify in writing to the Secretary that the owner or operator has completed a vulnerability assessment and has developed and implemented (or is implementing) a site security plan in accordance with this title, including— (A) regulations promulgated under subsection (a)(1); and (B) any existing vulnerability assessment or security plan endorsed by the Secretary under subsection (c)(1).
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(2) Submission
(A) In general
Not later than 18 months after the date of the promulgation of regulations under subsection (a)(1), an owner or operator of a chemical source shall provide to the Secretary copies of the vulnerability assessment and site security plan of the chemical source for review.
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(B) Certification
(i) In general
Not later than 2 years after the date on which the Secretary receives copies of the vulnerability assessment and site security plan of a chemical source under subparagraph (A), the Secretary shall determine whether the chemical source is in compliance with the requirements of this title, including— (I) paragraph (1); (II) regulations promulgated under subsections (a)(1) and (a)(3); and (III) any existing vulnerability assessment or site security plan endorsed by the Secretary under subsection (c)(1).
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(ii) Certificate
If the Secretary determines that the chemical source is in compliance with the requirements of this title, the Secretary shall provide to the chemical source and make available for public inspection a certificate of approval that contains the following statement (in which statement the bracketed space shall be the name of the chemical source): [____] is in compliance with the Chemical Security Improvement Act of 2004.. (iii) Determination of noncompliance
If the Secretary determines under clause (i) that a chemical source is not in compliance with the requirements of this title, the Secretary shall exercise the authority provided in section 195.
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(iv) Report to congress
Not later than 1 year after the promulgation of regulations in subsection (a)(1) and for every year afterwards, the Secretary shall submit to the Congress a report outlining the number of facilities that have provided vulnerability assessments and site security plans to the Secretary, what portion of these submissions have been reviewed by the Secretary, and what portion of these submissions are in compliance with clause (i).
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(3) Oversight
(A) In general
The Secretary shall, at such times and places as the Secretary determines to be appropriate, conduct or require the conduct of vulnerability assessments and other activities (including qualified third-party audits) to ensure and evaluate compliance with this title (including regulations promulgated under subsection (a)(1) and (c)(1)). (B) Right of entry
In carrying out this title, the Secretary (or a designee), on presentation of credentials, shall have a right of entry to, on, or through any premises of an owner or operator of a chemical source.
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