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42 U.S.C. § 6631 — Establishment of Committee

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 6631 — Establishment of Committee

Page 6871 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 6631 pathogens of pandemic potential, takes into consideration the benefits of such research, and supports the mitigation of related risks. (2) Requirements The policy established pursuant to para- graph (1) shall include— (A) a clear scope to support the consistent identification of research proposals subject to such policy by relevant Federal depart- ments and agencies; (B) a framework for such reviews that ac- counts for safety, security, and ethical con- siderations related to the creation, transfer, or use of enhanced pathogens of pandemic potential; (C) measures to enhance the transparency and public availability of information re- lated to such research activities in a manner that does not compromise national security, the safety and security of such research ac- tivities, or any identifiable, sensitive infor- mation of relevant individuals; and (D) consistent procedures across relevant Federal department and agencies to ensure that— (i) proposed research that has been de- termined to have scientific and technical merit and may be subject to such policy is identified and referred for review; (ii) subjected research activities con- ducted under an award, including activi- ties undertaken by any subrecipients of such award, are monitored regularly throughout the project period to ensure compliance with such policy and the terms and conditions of such award; and (iii) in the event that federally-funded research activities not subject to such pol- icy produce unanticipated results related to the creation, transfer, or use of en- hanced pathogens of pandemic potential, such research activities are identified and appropriately reviewed under such policy. (3) Clarification Reviews requi

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Source file: Laws/federal/codes/united-states-code-2024/title-42/section-6631-establishment-of-committee--1370501bdc.md
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Page 6871 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 6631 pathogens of pandemic potential, takes into consideration the benefits of such research, and supports the mitigation of related risks. (2) Requirements The policy established pursuant to para- graph (1) shall include— (A) a clear scope to support the consistent identification of research proposals subject to such policy by relevant Federal depart- ments and agencies; (B) a framework for such reviews that ac- counts for safety, security, and ethical con- siderations related to the creation, transfer, or use of enhanced pathogens of pandemic potential; (C) measures to enhance the transparency and public availability of information re- lated to such research activities in a manner that does not compromise national security, the safety and security of such research ac- tivities, or any identifiable, sensitive infor- mation of relevant individuals; and (D) consistent procedures across relevant Federal department and agencies to ensure that— (i) proposed research that has been de- termined to have scientific and technical merit and may be subject to such policy is identified and referred for review; (ii) subjected research activities con- ducted under an award, including activi- ties undertaken by any subrecipients of such award, are monitored regularly throughout the project period to ensure compliance with such policy and the terms and conditions of such award; and (iii) in the event that federally-funded research activities not subject to such pol- icy produce unanticipated results related to the creation, transfer, or use of en- hanced pathogens of pandemic potential, such research activities are identified and appropriately reviewed under such policy. (3) Clarification Reviews required pursuant to this section shall be in addition to any applicable require- ments for research project applications re- quired under the Public Health Service Act [42 U.S.C. 201 et seq.], including reviews required under section 492 of such Act (42 U.S.C. 289a), as applicable, or other applicable laws. (b) Implementation (1) In general The Director shall direct all heads of rel- evant Federal departments and agencies to up- date, modernize, or promulgate applicable im- plementing guidance to implement the re- quirements of this section. (2) Updates Consistent with the requirements under sub- section (a)(1)(B), the Director shall require all heads of relevant Federal departments and agencies to update such policies consistent with any changes to the policy established pursuant to subsection (a)(1). (c) Limitations on countries of concern con- ducting certain research (1) In general Beginning not later than 60 days after De- cember 29, 2022, the Secretary of Health and Human Services shall not fund research con- ducted by a foreign entity at a facility located in a country of concern, in the estimation of the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Secretary of Health and Human Services, involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)). (2) Conditions for lifting or suspending prohi- bition The Secretary of Health and Human Serv- ices may lift or suspend the prohibition of funding under paragraph (1)— (A) only after the review required under subsection (a)(1)(A)(i) is complete; and (B) only if the Secretary notifies Congress not less than 15 days before such prohibition is lifted or suspended. (Pub. L. 117–328, div. FF, title II, § 2315, Dec. 29, 2022, 136 Stat. 5763.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (a)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables. CODIFICATION Section was enacted as part of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act, also known as the PREVENT Pandemics Act, and also as part of the Health Extend- ers, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, and not as part of the National Science and Technology Policy, Organization, and Priorities Act of 1976 which comprises this chapter. SUBCHAPTER III—PRESIDENT’S COM- MITTEE ON SCIENCE AND TECHNOLOGY § 6631. Establishment of Committee The President shall establish within the Exec- utive Office of the President a President’s Com- mittee on Science and Technology (hereinafter referred to as the ‘‘Committee’’). (Pub. L. 94–282, title III, § 301, May 11, 1976, 90 Stat. 468.) Executive Documents ABOLITION OF PRESIDENT’S COMMITTEE ON SCIENCE AND TECHNOLOGY; TRANSFER OF FUNCTIONS The President’s Committee on Science and Tech- nology, established pursuant to this subchapter, was abolished and its functions transferred to the Presi- dent, by Reorg. Plan No. 1 of 1977, § 5A, 42 F.R. 56101, 91 Stat. 1634, set out in the Appendix to Title 5, Govern- ment Organization and Employees, effective Feb. 26, Page 6872 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 6632 1 See References in Text note below. 1978, as provided by section 1(b) of Ex. Ord. No. 12039, Feb. 24, 1978, 43 F.R. 8095, set out under section 6601 of this title. § 6632. Membership of Committee (a) Composition; appointment The Committee shall consist of— (1) the Director of the Office of Science and Technology Policy established under sub- chapter II of this chapter; and (2) not less than eight nor more than four- teen other members appointed by the Presi- dent not more than sixty days after the Direc- tor has assumed office (as provided in section 6612 of this title). (b) Qualifications Members of the Committee appointed by the President pursuant to subsection (a)(2) of this section shall— (1) be qualified and distinguished in one or more of the following areas: science, engineer- ing, technology, information dissemination, education, management, labor, or public af- fairs; (2) be capable of critically assessing the poli- cies, priorities, programs, and activities of the Nation, with respect to the findings, policies, and purposes set forth in subchapter I; and (3) shall collectively constitute a balanced composition with respect to (A) fields of science and engineering, (B) academic, indus- trial, and government experience, and (C) busi- ness, labor, consumer, and public interest points of view. (c) Chairman; Vice Chairman The President shall appoint one member of the Committee to serve as Chairman and another member to serve as Vice Chairman for such peri- ods as the President may determine. (d) Compensation Each member of the Committee who is not an officer of the Federal Government shall, while serving on business of the Committee, be enti- tled to receive compensation at a rate not to ex- ceed the daily rate prescribed for GS–18 of the General Schedule under section 5332 of title 5, including traveltime, and while so serving away from his home or regular place of business he may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as the expenses authorized by section 5703(b) 1 of title 5 for persons in Government service em- ployed intermittently. (Pub. L. 94–282, title III, § 302, May 11, 1976, 90 Stat. 468.) Editorial Notes REFERENCES IN TEXT Section 5703 of title 5, referred to in subsec. (d), was amended generally by Pub. L. 94–22, § 4, May 19, 1975, 89 Stat. 95, and, as so amended, does not contain a subsec. (b). Statutory Notes and Related Subsidiaries REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organi- zation and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5. Executive Documents ABOLITION OF PRESIDENT’S COMMITTEE ON SCIENCE AND TECHNOLOGY; TRANSFER OF FUNCTIONS See note set out under section 6631 of this title. § 6633. Federal science, engineering, and tech- nology survey; reports (a) The Committee shall survey, examine, and analyze the overall context of the Federal science, engineering, and technology effort in- cluding missions, goals, personnel, funding, or- ganization, facilities, and activities in general, taking adequate account of the interests of indi- viduals and groups that may be affected by Fed- eral scientific, engineering, and technical pro- grams, including, as appropriate, consultation with such individuals and groups. In carrying out its functions under this section, the Com- mittee shall, among other things, consider needs for— (1) organizational reform, including institu- tional realinement designed to place Federal agencies whose missions are primarily or sole- ly devoted to scientific and technological re- search and development, and those agencies primarily or solely concerned with fuels, en- ergy, and materials, within a single cabinet- level department; (2) improvements in existing systems for handling scientific and technical information on a Government-wide basis, including consid- eration of the appropriate role to be played by the private sector in the dissemination of such information; (3) improved technology assessment in the executive branch of the Federal Government; (4) improved methods for effecting tech- nology innovation, transfer, and use; (5) stimulating more effective Federal-State and Federal-industry liaison and cooperation in science and technology, including the for- mation of Federal-State mechanisms for the mutual pursuit of this goal; (6) reduction and simplification of Federal regulations and administrative practices and procedures which may have the effect of re- tarding technological innovation or opportuni- ties for its utilization; (7) a broader base for support of basic re- search; (8) ways of strengthening the Nation’s aca- demic institutions’ capabilities for research and education in science and technology; (9) ways and means of effectively integrating scientific and technological factors into our national and international policies; (10) technology designed to meet community and individual needs; (11) maintenance of adequate scientific and technological manpower with regard to both quality and quantity; (12) improved systems for planning and anal- ysis of the Federal science and technology pro- grams; and

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Definitions

Page 35 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 201 1 See References in Text note below. Sec. 300jj–34. Competitive grants to States and Indian tribes for the development of loan pro- grams to facilitate the widespread adoption of certified EHR technology. 300jj–35. Demonstration program to integrate in- formation technology into clinical education. 300jj–36. Information technology professionals in health care. 300jj–37. General grant and loan provisions. 300jj–38. Authorization for appropriations. PART C—OTHER PROVISIONS 300jj–51. Health information technology enroll- ment standards and protocols. 300jj–52. Information blocking. SUBCHAPTER XXIX—DATA COLLECTION, ANALYSIS, AND QUALITY 300kk. Data collection, analysis, and quality. SUBCHAPTER XXX—COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS 300ll to 300ll–9. Repealed. SUBCHAPTER XXXI—WORLD TRADE CENTER HEALTH PROGRAM PART A—ESTABLISHMENT OF PROGRAM; ADVISORY COMMITTEE 300mm. Establishment of World Trade Center Health Program. 300mm–1. WTC Health Program Scientific/Tech- nical Advisory Committee; WTC Health Program Steering Committees. 300mm–2. Education and outreach. 300mm–3. Uniform data collection and analysis. 300mm–4. Clinical Centers of Excellence and Data Centers. 300mm–5. Definitions. PART B—PROGRAM OF MONITORING, INITIAL HEALTH EVALUATIONS, AND TREATMENT SUBPART 1—WTC RESPONDERS 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services. 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions. 300mm–23. National arrangement for benefits for el- igible individuals outside New York. SUBPART 2—WTC SURVIVORS 300mm–31. Identification and initial health evalua- tion of screening-eligible and

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262a — Enhanced control of dangerous biological agents and toxins

**(a) Regulatory control of certain biological agents and toxins** (1) **List of biological agents and toxins** (A) *In general* — The Secretary shall by regulation establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety. (B) *Criteria* — In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall— (i) consider— (I) the effect on human health of exposure to the agent or toxin; (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; (III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate; and (ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups, including groups with pediatric expertise. (2) **Biennial review** — The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph. **(b) Regulation of transfers of listed agents and toxins** The Secretary shall by regulation provide for— (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure— (A) proper training, including with respect to notification requirements under this section, of— (i) individuals who are involved in the handling and use of

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262a — Enhanced control of dangerous biological

Page 468 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 262a ployees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, set out as a note under section 202 of this title. References to Secretary and Department of Health, Education, and Welfare substituted for references to Federal Security Administrator and Federal Security Agency, respectively, pursuant to Reorg. Plan No. 1 of 1953, § 5, set out as a note under section 3501 of this title, which transferred all functions of Federal Secu- rity Administrator to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agen- cy to Department of Health, Education, and Welfare. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953. § 262a. Enhanced control of dangerous biological agents and toxins (a) Regulatory control of certain biological agents and toxins (1) List of biological agents and toxins (A) In general The Secretary shall by regulation estab- lish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety. (B) Criteria In determining whether to include an agent or toxin on the list under subpara- graph (A), the Secretary shall— (i) consider— (I) the effect on human health of expo- sure to the agent or toxin; (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to hu- mans; (III) the availability and effectiveness of pharmacotherapies and immuniza- tions to treat and prevent any illness re- sulting from infecti

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 289a — Peer review requirements

**(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations** (1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of— (A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and (B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health. (2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted— (A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and (B) to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985, and shall authorize such review to be conducted by groups appointed under sections 282(b)(16) and 284(c)(3) of this title. **(b) Periodic review of research at National Institutes of Health** The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that— (1) the reviewing entity be provided a written description of the research to be reviewed, and (2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity, and shall authorize such review to be conducted by groups appointed under sections

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 289a — Peer review requirements

Page 797 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289a 1 See References in Text note below. ‘‘(c) REGULATIONS.—Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regula- tions related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.’’ STUDY CONCERNING RESEARCH INVOLVING CHILDREN Pub. L. 107–109, § 12, Jan. 4, 2002, 115 Stat. 1416, pro- vided that: ‘‘(a) CONTRACT WITH INSTITUTE OF MEDICINE.—The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine for— ‘‘(1) the conduct, in accordance with subsection (b), of a review of— ‘‘(A) Federal regulations in effect on the date of the enactment of this Act [Jan. 4, 2002] relating to research involving children; ‘‘(B) federally prepared or supported reports relat- ing to research involving children; and ‘‘(C) federally supported evidence-based research involving children; and ‘‘(2) the submission to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, not later than two years after the date of enactment of this Act, of a report concerning the review conducted under paragraph (1) that in- cludes recommendations on best practices relating to research involving children. ‘‘(b) AREAS OF REVIEW.—In conducting the review under subsection (a)(1), the Institute of Medicine shall consider the following: ‘‘(1) The written and oral process of obtaining and defining ‘assent

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 6631 — Establishment of Committee

The President shall establish within the Executive Office of the President a President’s Committee on Science and Technology (hereinafter referred to as the “Committee”).

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