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42 U.S.C. § 6631 — Establishment of Committee
Federal law — U.S. Code and appendices · legal_authorities
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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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
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262a
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262a
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289a
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Federal law — U.S. Code and appendices · legal_authorities
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
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 289a
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Federal law — U.S. Code and appendices · legal_authorities
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”).
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 6631
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