Title 42 — The Public Health and Welfare
Part A · Chapter 6A — Public Health Service
§ 241. Research and investigations generally
Statutory text
Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to—
collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities;
make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study;
make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research;
secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad;
for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise eligible for such treatment;
make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health and medical fields;
enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under sections 3861 and 4141 of title 10, except that determination, approval, and certification required thereby shall be by the Secretary of Health and Human Services; and
adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section.
Testing for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects; consultation
The Secretary shall conduct and may support through grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
The Secretary shall establish a comprehensive program of research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and contracts.
The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation.
The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the maintenance and promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health and Human Services and shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity.
The Secretary shall publish a biennial report which contains—
a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed;
information concerning the nature of such exposure and the estimated number of persons exposed to such substances;
a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and
a description of (i) each request received during the year involved—
from a Federal agency outside the Department of Health and Human Services for the Secretary, or
from an entity within the Department of Health and Human Services to any other entity within the Department,
to conduct research into, or testing for, the carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request.
The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.
Diseases not significantly occurring in United States
The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.
Protection of privacy of individuals who are research subjects
If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—
shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the Federal Government; and
may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded.
Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.
The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is—
required by Federal, State, or local laws, excluding instances described in subparagraph (D);
necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;
made with the consent of the individual to whom the information, document, or biospecimen pertains; or
made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.
Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii).
Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal process, and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding.
Identifiable, sensitive information collected by a person to whom a certificate has been issued under subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for perpetuity.
The Secretary shall take steps to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements of this subsection.
The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of this subsection.
Nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual’s participation in the research.
For purposes of this subsection, the term “identifiable, sensitive information” means information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and—
through which an individual is identified; or
for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
Preterm labor and delivery and infant mortality
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and coordinate the activities of the Centers for Disease Control and Prevention with respect to preterm labor and delivery, preventable maternal mortality and severe maternal morbidity, and infant mortality.
Exemption of certain biomedical information from disclosure
The Secretary may exempt from disclosure under section 552(b)(3) of title 5 biomedical information that is about an individual and that is gathered or used during the course of biomedical research if—
an individual is identified; or
there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, the request, and other available data sources could be used to deduce the identity of an individual.
Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination.
Each such determination and statement of basis shall be available to the public, upon request, through the Office of the Chief FOIA Officer of the Department of Health and Human Services.
Nothing in this subsection shall be construed to limit a research participant’s access to information about such participant collected during the participant’s participation in the research.
Inapplicability of Federal information policy
Subchapter I of chapter 35 of title 44 shall not apply to the voluntary collection of information during the conduct of research by the National Institutes of Health.
Availability of substances and living organisms for biomedical and behavioral research
The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
Where research substances and living organisms are made available under paragraph (1) through contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary.
Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts.
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Pub. L. 78–373 · 58 Stat. 682
Enacted · 42 U.S.C. § 241
July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691
Source evidence
Code source credit
July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691Public Law not identified
Changed · 42 U.S.C. § 241(d)
Subsec. (d). Act July 3, 1946, made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsec. (d). Act July 3, 1946, made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health.Public Law not identified
Changed · 42 U.S.C. § 241(g)
Subsec. (g). Act July 3, 1946, gave National Advisory Health Council the right to make recommendations to carry out purposes of this section
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsec. (g). Act July 3, 1946, gave National Advisory Health Council the right to make recommendations to carry out purposes of this section.Public Law not identified
Changed · 42 U.S.C. § 241(d)
Subsec. (d). Acts June 16, 1948, § 4(e), and June 24, 1948, § 4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsec. (d). Acts June 16, 1948, § 4(e), and June 24, 1948, § 4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.Public Law not identified
Changed · 42 U.S.C. § 241(d)
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects.Public Law not identified
Changed · 42 U.S.C. § 241(g)
Subsec. (g). Acts June 16, 1948, § 4(f), and June 24, 1948, § 4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsec. (g). Acts June 16, 1948, § 4(f), and June 24, 1948, § 4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.Public Law not identified
Added · 42 U.S.C. § 241(g); 42 U.S.C. § 241(h)
Subsecs. (g), (h). Act July 3, 1956, added subsec. (g)
Redesignated · 42 U.S.C. § 241(g); 42 U.S.C. § 241(h)
Subsecs. (g), (h). Act July 3, 1956, redesignated former subsec. (g) as (h)
Unresolved: No Public Law or Statutes at Large citation in the Code source.
Source evidence
Code amendment note
Subsecs. (g), (h). Act July 3, 1956, added subsec. (g) and redesignated former subsec. (g) as (h).Pub. L. 86–798 · 74 Stat. 1053
Changed · 42 U.S.C. § 241(d)
Pub. L. 86–798 authorized the Surgeon General, upon recommendation of the National Advisory Health Council, to make grants to public or non-profit universities, hospitals, laboratories, and other institutions to support research and research training programs, and to make available for such research and research training programs, up to 15 per centum of amounts provided for research grants through the appropriations for the National Institutes of Health
Source evidence
Code amendment note
Subsec. (d). Pub. L. 86–798 authorized the Surgeon General, upon recommendation of the National Advisory Health Council, to make grants to public or non-profit universities, hospitals, laboratories, and other institutions to support research and research training programs, and to make available for such research and research training programs, up to 15 per centum of amounts provided for research grants through the appropriations for the National Institutes of Health.Pub. L. 87–838 § 2 · 76 Stat. 1072
Inserted · 42 U.S.C. § 241(d)
Pub. L. 87–838 inserted “or research training” in two places
Source evidence
Code amendment note
Subsec. (d). Pub. L. 87–838 inserted “or research training” in two places.Enacted provision · exact public law section
Sec. 2. Section 301(d) of the Public Health Service Act is amended 62 Stat. 601. 42 USC 241. by striking out the words “research projects” wherever they appear therein and inserting in lieu thereof “research or research training projects”.Health Research Facilities Amendments of 1965
Pub. L. 89–115 § 3 · 79 Stat. 448
Added · 42 U.S.C. § 241(h); 42 U.S.C. § 241(i)
Pub. L. 89–115 added subsec. (h)
Redesignated · 42 U.S.C. § 241(h); 42 U.S.C. § 241(i)
Pub. L. 89–115 redesignated former subsec. (h) as (i)
Source evidence
Code amendment note
Subsecs. (h), (i). Pub. L. 89–115 added subsec. (h) and redesignated former subsec. (h) as (i).Enacted provision · exact public law section
Sec. 3. contract authority Section 301 of the Act is amended by striking out “and” at the end of subsection (g), by redesignating subsection (h) as subsection (i), and by inserting immediately before such subsection the following new subsection: “(h) Enter into contracts during the fiscal year ending June 30, 1966, and each of the two succeeding fiscal years, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under 70A Stat. 134. title 10, United States Code, sections 2353 and 2354, except that determination, approval, and certification required thereby shall be by the Secretary of Health, Education, and Welfare; and”.Partnership for Health Amendments of 1967
Pub. L. 90–174 § 9 · 81 Stat. 533
Substituted · 42 U.S.C. § 241(h)
Pub. L. 90–174 substituted “five” for “two” succeeding fiscal years
Source evidence
Code amendment note
Subsec. (h). Pub. L. 90–174 substituted “five” for “two” succeeding fiscal years.Enacted provision · exact public law section
Sec. 9. research contract authority Paragraph (h) of section 301 of the Public Health Service 79 Stat. 448. Act (42 U.S.C. 241) is amended by striking out “two succeeding fiscal years” and by inserting in lieu thereof “five succeeding fiscal years”.Comprehensive Drug Abuse Prevention and Control Act of 1970
Pub. L. 91–513 title I § 3(a) · 84 Stat. 1236
Added · 42 U.S.C. § 241(d)
Pub. L. 91–513 added subsec. (d). See 1988 Amendment note above
Source evidence
Code amendment note
Subsec. (d). Pub. L. 91–513 added subsec. (d). See 1988 Amendment note above.Enacted provision · exact public law section
(a) Section 303(a) of the Public Health Service Act (42 Research papulations, protection of identity. 70 Stat. 929. U.S.C. 242a (a)) is amended by adding after and below paragraph (2) the following: “The Secretary may authorize persons engaged in research on the use and effect, of drugs to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.”Pub. L. 91–515 title II § 292 · 84 Stat. 1297
Substituted · 42 U.S.C. § 241(h)
Pub. L. 91–515 substituted “eight” for “five” succeeding fiscal years
Source evidence
Code amendment note
Subsec. (h). Pub. L. 91–515 substituted “eight” for “five” succeeding fiscal years.Enacted provision · exact public law section
Sec. 292. Paragraph (h) of section 301 of the Public Health Service 79 Stat. 448; 81 Stat. 540. 42 USC 241. Act is amended by striking out “five succeeding fiscal years” and inserting in lieu thereof “eight succeeding fiscal years”.The National Cancer Act of 1971
Pub. L. 92–218 § 6(a)(2) · 85 Stat.
Substituted · 42 U.S.C. § 241(d); 42 U.S.C. § 241(i)
Pub. L. 92–218 substituted “National Cancer Advisory Board” for “National Advisory Cancer Council”
Source evidence
Code amendment note
Subsecs. (d), (i). Pub. L. 92–218 substituted “National Cancer Advisory Board” for “National Advisory Cancer Council”.Enacted provision · exact public law section
(2) Sections 301(d), 301 (i), 402, and 403(c) of such Act are each 42 USC 241. Ante, p. 784. amended by striking out “National Advisory Cancer Council” and inserting in lieu thereof “National Cancer Advisory Board”.National Heart, Blood Vessel, Lung, and Blood Act of 1972
Pub. L. 92–423 § 7(b) · 86 Stat. 679
Substituted · 42 U.S.C. § 241(d); 42 U.S.C. § 241(i)
Pub. L. 92–423 substituted “National Heart and Lung Advisory Council” for “National Advisory Heart Council”
Source evidence
Code amendment note
Subsecs. (d), (i). Pub. L. 92–423 substituted “National Heart and Lung Advisory Council” for “National Advisory Heart Council”.Enacted provision · exact public law section
(b) Sections 301(d) and 301 (i) of such Act are each amended by 58 Stat. 692; 62 Slat. 601; 79 Stat. 448. 42 USC 241. striking out “National Advisory Heart Council” and inserting in lieu thereof “National Heart and Lung Advisory Council”.Pub. L. 93–282 title I § 122(b) · 88 Stat. 125
Substituted · 42 U.S.C. § 241(d)
Pub. L. 93–282 substituted “mental health, including research on the use and effect of alcohol and other psychoactive drugs” for “the use and effect of drugs” in former concluding provisions of section 242a(a) of this title. See 1988 Amendment note above
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 93–282 substituted “mental health, including research on the use and effect of alcohol and other psychoactive drugs” for “the use and effect of drugs” in former concluding provisions of section 242a(a) of this title. See 1988 Amendment note above.Pub. L. 93–348 § 104(a)(1) · 88 Stat. 342
Redesignated · 42 U.S.C. § 241(c)
Pub. L. 93–348, § 104(a)(1), redesignated subsec. (d) as (c)
Substituted · 42 U.S.C. § 241(c)
Pub. L. 93–348, § 104(a)(1), substituted “research projects” for “research or research training projects” . Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may deem necessary to procure the assistance of the most brilliant and promising research fellows from the United States and abroad, was struck out
Substituted · 42 U.S.C. § 241(c)
Pub. L. 93–348, § 104(a)(1), substituted “general support of their research” for “general support of their research and research training programs” . Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may deem necessary to procure the assistance of the most brilliant and promising research fellows from the United States and abroad, was struck out
Substituted · 42 U.S.C. § 241(c)
Pub. L. 93–348, § 104(a)(1), substituted “research grants-in-aid” for “research and research training program grants-in-aid” . Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may deem necessary to procure the assistance of the most brilliant and promising research fellows from the United States and abroad, was struck out
Source evidence
Code amendment note
Subsec. (c). Pub. L. 93–348, § 104(a)(1), redesignated subsec. (d) as (c) and substituted “research projects” for “research or research training projects” in two places, “general support of their research” for “general support of their research and research training programs” and “research grants-in-aid” for “research and research training program grants-in-aid”. Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may deem necessary to procure the assistance of the most brilliant and promising research fellows from the United States and abroad, was struck out.Enacted provision · exact public law section
(1) Section 301 of the Public Health Service Act 42 USC 241. amended (A) by striking out paragraph (c); (B) by striking out in paragraph (d) “or research training” each place it occurs, “and research training programs”, and “and research training program”; and (C) by redesignating paragraphs (d), (e), (f), (g), (h), and (i) as paragraphs (c), (d), (e), (f), (g), and (h), respectively.Pub. L. 93–348 § 104(a)(1)(C) · 88 Stat. 342
Redesignated · 42 U.S.C. § 241(d)
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (e) as (d)
Source evidence
Code amendment note
Subsec. (d). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (e) as (d).Enacted provision · exact public law section
(1) Section 301 of the Public Health Service Act 42 USC 241. amended (A) by striking out paragraph (c); (B) by striking out in paragraph (d) “or research training” each place it occurs, “and research training programs”, and “and research training program”; and (C) by redesignating paragraphs (d), (e), (f), (g), (h), and (i) as paragraphs (c), (d), (e), (f), (g), and (h), respectively.Pub. L. 93–348 § 104(a)(1)(C) · 88 Stat. 342
Redesignated · 42 U.S.C. § 241(e); 42 U.S.C. § 241(f)
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (f) and (g) as (e) and (f), respectively. Former subsec. (e) redesignated (d)
Source evidence
Code amendment note
Subsecs. (e), (f). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (f) and (g) as (e) and (f), respectively. Former subsec. (e) redesignated (d).Enacted provision · exact public law section
(1) Section 301 of the Public Health Service Act 42 USC 241. amended (A) by striking out paragraph (c); (B) by striking out in paragraph (d) “or research training” each place it occurs, “and research training programs”, and “and research training program”; and (C) by redesignating paragraphs (d), (e), (f), (g), (h), and (i) as paragraphs (c), (d), (e), (f), (g), and (h), respectively.Pub. L. 93–348 § 104(a)(1)(C) · 88 Stat. 342
Redesignated · 42 U.S.C. § 241(g)
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).Enacted provision · exact public law section
(1) Section 301 of the Public Health Service Act 42 USC 241. amended (A) by striking out paragraph (c); (B) by striking out in paragraph (d) “or research training” each place it occurs, “and research training programs”, and “and research training program”; and (C) by redesignating paragraphs (d), (e), (f), (g), (h), and (i) as paragraphs (c), (d), (e), (f), (g), and (h), respectively.Pub. L. 93–348 § 104(a)(1)(C) · 88 Stat. 342
Redesignated · 42 U.S.C. § 241(h); 42 U.S.C. § 241(i)
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (h) and (i) as (g) and (h), respectively
Source evidence
Code amendment note
Subsecs. (h), (i). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (h) and (i) as (g) and (h), respectively.Enacted provision · exact public law section
(1) Section 301 of the Public Health Service Act 42 USC 241. amended (A) by striking out paragraph (c); (B) by striking out in paragraph (d) “or research training” each place it occurs, “and research training programs”, and “and research training program”; and (C) by redesignating paragraphs (d), (e), (f), (g), (h), and (i) as paragraphs (c), (d), (e), (f), (g), and (h), respectively.Pub. L. 93–352 title I § 111 · 88 Stat. 358
Redesignated · 42 U.S.C. § 241(g)
Pub. L. 93–352 struck out “during the fiscal year ending June 30, 1966, and each of the eight succeeding fiscal years” after “Enter into contracts”. Notwithstanding directory language that amendment be made to subsec. (h), the amendment was executed to subsec. (g) to reflect the probable intent of Congress and the intervening redesignation of subsec. (h) as (g) by Pub. L. 93–348
Source evidence
Code amendment note
Subsec. (g). Pub. L. 93–352 struck out “during the fiscal year ending June 30, 1966, and each of the eight succeeding fiscal years” after “Enter into contracts”. Notwithstanding directory language that amendment be made to subsec. (h), the amendment was executed to subsec. (g) to reflect the probable intent of Congress and the intervening redesignation of subsec. (h) as (g) by Pub. L. 93–348.Enacted provision · exact public law section
Sec. 111. Section 301(h) of the Public Health Service Act is 42 USC 241. amended by striking out “during the fiscal year ending June 30, 1966, and each of the eight succeeding fiscal years”.Health Research and Health Services Amendments of 1976
Pub. L. 94–278 title I § 111 · 90 Stat. 401
Substituted · 42 U.S.C. § 241(c); 42 U.S.C. § 241(h)
Pub. L. 94–278 substituted “heart, blood vessel, lung, and blood diseases and blood resources” for “heart diseases”
Substituted · 42 U.S.C. § 241(c); 42 U.S.C. § 241(h)
Pub. L. 94–278 substituted “National Heart, Lung and Blood Advisory Council” for “National Heart and Lung Advisory Council”
Source evidence
Code amendment note
Subsecs. (c), (h). Pub. L. 94–278 substituted “heart, blood vessel, lung, and blood diseases and blood resources” for “heart diseases” and “National Heart, Lung and Blood Advisory Council” for “National Heart and Lung Advisory Council”.Enacted provision · exact public law section
Sec. 111. (a) Section 301 is amended by striking out “heart diseases” 42 USC 241. in paragraphs (c) and (b) and inserting in lieu thereof “heart, blood vessel, lung, and blood diseases and blood resources”. (b) Section 301 is amended by striking out “National Heart and Lung Advisory Council” in paragraphs (c) and (h) and inserting in lieu thereof “National Heart, Lung, and Blood Advisory Council”.Pub. L. 95–622 title II · 92 Stat. 3412
Amended · 42 U.S.C. § 241
Pub. L. 95–622 designated existing provisions as subsec. (a)
Redesignated · 42 U.S.C. § 241
Pub. L. 95–622 redesignated former pars. (a) to (h) as (1) to (8), respectively
Substituted · 42 U.S.C. § 241
Pub. L. 95–622 substituted “Secretary” for “Surgeon General” wherever appearing
Inserted · 42 U.S.C. § 241
Pub. L. 95–622 inserted following par. (8) provisions relating to authority of Secretary to make available to individuals and entities substances and living organisms
Added · 42 U.S.C. § 241
Pub. L. 95–622 added subsec. (b)
Source evidence
Code amendment note
Pub. L. 95–622 designated existing provisions as subsec. (a), redesignated former pars. (a) to (h) as (1) to (8), respectively, substituted “Secretary” for “Surgeon General” wherever appearing, and inserted following par. (8) provisions relating to authority of Secretary to make available to individuals and entities substances and living organisms, and added subsec. (b).Enacted provision · exact public law
TITLE II— BIOMEDICAL RESEARCH EXTENSION AMENDMENTS Sec. 201. short title; reference to act (a) This title may be cited as the “Biomedical Research 42 USC 201 note. and Research Training Amendments of 1978”. (b) Whenever in this title (other than in sections 267 and 268) an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Public Health Service 42 USC 201 note. Act. Part A— Libraries of Medicine Sec. 211. extension of authorizations Section 390(c) is amended by striking out “and” after “1976,” and by inserting before the period the following: “, $15,000,000 for the fiscal year ending September 30, 1979, $16,500,000 for the fiscal year ending September 30, 1980, and $18,500,000 for the fiscal year ending September 30, 1981”. Sec. 212. board of regents’ appointments Section 383 is amended (1) by striking out “by the 42 USC 277. President, by and with the advice and consent of the Senate” in the first sentence of subsection (a) and inserting in lieu thereof “by the Secretary”, and (2) by striking out “by the President” in the first sentence of subsection (c) and inserting in lieu thereof “by the Secretary”. Part B— Programs of the National Heart, Lung, and Blood Institute Sec. 221. extension of authorizations (a) Section 414(b) is amended by striking out “and” after 42 USC 287c. “1977,” and by inserting before the period the following: “, $40,000,000 for the fiscal year ending September 30, 1979, and $45,000,000 for the fiscal year ending September 30, 1980”. (b) Section 419B is amended in the first sentence by striking out 42 USC 287i. “and” after “1977,” and by inserting before the period the following: “, $470,000,000 for the fiscal year ending September 30, 1979, and $515,000,000 for the fiscal year ending September 30, 1980”. Sec. 222. submission of reports (a) Section 413(b) (2) is amended by striking out “submit 42 USC 287b. to the President for transmittal to the Congress a report” and inserting in lieu thereof “submit a report to the Secretary, for simultaneous transmittal by the Secretary, not later than November 30 of each year, to the President and to the Congress,”. (b) Section 418(b) (2) is amended by inserting “by the Secretary” 42 USC 287g. after “transmittal”. Sec. 223. information programs (a) Section 412(5) is amended by striking out “make available” 42 USC 287a. and inserting in lieu thereof “make available on a timely basis”. (b) Section 413(d) is amended (1) by striking out “to provide” in 42 USC 287b. the second sentence and inserting in lieu thereof “to provide on a timely basis”, and (2) by striking out “diet” in the third sentence and inserting in lieu thereof “diet and nutrition, environmental pollutants”. Sec. 224. education and information programs of centers Section 415(a) (2) is amended by adding after subparagraph 42 USC 287d. (D) the following: “(E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and information programs for the public respecting the prevention and early diagnosis and treatment of such diseases.” Part C— Programs of the National Cancer Institute Subpart I— Extension of and Substantive Changes in Programs of the National Cancer Institute Sec. 231. extension of authorizations (a) Section 409(b) is amended by striking out “and” after “1977,” and by inserting before the period the following: “, $90,500,000 for the fiscal year ending September 30, 1979, and $103,000,000 for the fiscal year ending September 30, 1980”. (b) 42 USC 286g. Section 410C is amended by striking out “and” after “1977;” and by inserting before the period the following: “$924,500,000 for the fiscal year ending September 30, 1979; and $927,000,000 for the fiscal year ending September 30, 1980”. Sec. 232. national cancer advisory board (a) (1) (A) Subsection (a) of section 410B is amended by striking out “twenty-three” and inserting in lieu thereof “twenty-nine”. (B) Paragraph (1) of such subsection is amended by inserting after “Veterans’ Administration” the following: “, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission”. (2) The first sentence of such subsection following paragraph (2) is amended (A) by striking out “and not more” and inserting in lieu thereof “, not more”, and (B) by inserting before the period “, and not less than five of the appointed members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors)”. (3) The second sentence of such subsection following paragraph (2) is amended by inserting before the period a comma and the following: “and at least two of the physicians appointed to the Board shall be physicians primarily involved in treating individuals who have cancer”. (4) Such subsection is amended by adding at the end the following: “The ex officio members of the Board shall be nonvoting members. (5) Reports. Section 410B(g) is amended by striking out “a report to the President for transmittal to the Congress not later than January 31 of each year on the progress” and inserting in lieu thereof “a report to the Secretary, for simultaneous transmittal by the Secretary, not later than November 30 of each year, to the President and to the Congress, on the progress during the preceding fiscal year”. (b) 42 USC 286f note. The amendments made by subsection (a) of this section respecting the manner of appointing members of the National Cancer Advisory Board and the composition of such Board shall apply with respect to appointments made to the Board after the date of the enactment of this Act, and the President shall make appointments to such Board after such date in a manner which will bring about, at the earliest feasible time, the composition prescribed by such amendments. Sec. 233. submission of reports Section 410A(b) is amended (1) by striking out “end of 42 USC 286e. each calendar year” and inserting in lieu thereof “end of each fiscal year”, (2) by striking out “submit to the President for transmittal to the Congress” and inserting in lieu thereof “submit to the Secretary, for simultaneous transmittal by the Secretary, not later than November 30 of each year, to the President and to the Congress,”, and (3) by striking out “the preceding calendar year” and inserting in lieu thereof “the preceding fiscal year”. Sec. 234. functions of centers (a) Subsections (a) and (b) of section 408 are each 42 USC 286b. amended by striking out “clinical research, training, and demonstration of advanced diagnostic and treatment methods relating to cancer” and inserting in lieu thereof “basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods for cancer”. (b) Clause (3) of the second sentence of section 408(b) is amended by inserting after the comma the following: “continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer,”. Sec. 235. national cancer program (a) Paragraph (1) of subsection (b) of section 407 42 USC 286a. is amended by striking out “, plan and develop” and inserting in lieu thereof “(A.) plan and develop”, and by inserting before the period the following: and (B) implement an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens”. (b) Paragraph (7) of such subsection is amended to read as follows: “(7) Support appropriate programs of education (including continuing education) and training in fundamental sciences and clinical disciplines for investigators, physicians, and allied health professionals for participation in clinical programs relating to cancer, including the use of training stipends, fellowships, and career awards.” (c) The first sentence of subsection (c) (3) of such section is amended by striking out “twelve times” and inserting in lieu thereof “four times”. Sec. 236. cancer control programs (a) Subsection (a) of section 409 is amended to read as 42 USC 286c. follows: “(a) The Director of the National Cancer Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this subsection shall include— “(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting the detection, diagnosis, prevention, and treatment of cancer and rehabilitation and counseling respecting cancer to physicians and other health professionals who provide care to individuals who have cancer; “(2) the demonstration of and the education of health professionals in— “(A) effective methods for the early detection of cancer and the identification of individuals with a high risk of developing cancer, and “(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and “(3) the demonstration of new methods for the dissemination of information to the general public concerning the early detection and treatment of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer.”. Subpart II— Technical Revision of the Authority of the National Cancer Institute Sec. 241. technical revision (a) (1) Part A of title IV (as amended by subpart I of this part) is amended to read as follows: “Part A— National Cancer Institute “Sec. 400. “a division or the national institutes of health The National Cancer Institute (in this part referred to as the ‘Institute’) is a division of the National Institutes of Health. “Sec. 401. “cancer research and other activities (a) In carrying out the purposes of section 301 with respect to cancer, the Secretary, through the Institute and in cooperation with the National Cancer Advisory Board, shall— “(1) conduct, assist, and foster research, investigations, experiments, and studies relating to the cause, prevention, and methods of diagnosis and treatment of cancer ; “(2) promote the coordination of research conducted by the Institute and similar research conducted by other agencies and organizations and by individuals; “(3) provide clinical training and instruction in technical matters relating to the diagnosis and treatment of cancer; “(4) secure for the Institute consultation services and advice of cancer experts from the United States and abroad: “(5) cooperate with State health agencies in the prevention, control, and eradication of cancer; and “(6) procure, use, and lend radium as provided in subsection (b). “(b) In carrying out subsection (a), all appropriate provisions of section 301 shall be applicable to the authority of the Secretary, and the Secretary is authorized— “(1) to purchase radium, from time to time and without regard 41 USC 5. to section 3709 of the Revised Statutes, and to make such radium available for the purposes of this part, both to the Service and by loan to other agencies and institutions for such consideration and subject to such conditions as he may prescribe; and “(2) to provide the necessary facilities where training and instruction may be given in all technical matters relating to the diagnosis and treatement of cancer to persons found by the Secretary to have proper technical qualifications and designated by him for such training or instruction and to fix and pay them a per diem allowance during such training or instruction. “Sec. 402. “national cancer program The National Cancer Program shall consist of (1) an 42 USC 283. expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other research institutes and including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute. “Sec. 403. “cancer control programs The Director of the Institute shall establish and support 42 USC 284. demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include— “(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting the detection, diagnosis, prevention, and treatment of cancer and rehabilitation and counseling respecting cancer to physicians and other health professionals who provide care to individuals who have cancer; “(2) the demonstration of and the education of health professionals in— “(A) effective methods for the early detection of cancer and the identification of individuals with a high risk of developing cancer, and “(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and “(3) the demonstration of new methods for the dissemination of information to the general public concerning the early detection and treatment of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer. “Sec. 404. “duties and functions of the director (a) The Director of the Institute in carrying out the 42 USC 285. National Cancer Program shall— “(1) collect, analyze, and disseminate information (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer) useful in the prevention, diagnosis, and treatment of cancer, including the establishment of an international cancer research data bank to collect, catalog, store, and disseminate insofar as feasible the results of cancer research undertaken in any country for the use of any person involved in cancer research in any country; “(2) establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances tor research and set standards of safety and care for persons using such materials; “(3) support research in the cancer field outside the United States by highly qualified foreign nationals which research can be expected to inure to the benefit of the American people; support collaborative research involving American and foreign participants; and support the training of American scientists abroad and foreign scientists in the United States; “(4) support appropriate programs of education (including continuing education) and training in fundamental sciences and clinical disciplines for investigators, physicians, and allied health professionals for participation in clinical programs relating to cancer, including the use of training stipends, fellowships, and career awards; “(5) expeditiously utilize existing research facilities and personnel of the National Institutes of Health for accelerated exploration of opportunities in areas of special promise; “(6) encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research; “(7) provide and contract for a program to disseminate and interpret, on a current basis, for practitioners and other health professionals, scientists, and the general public scientific and other information respecting the cause, prevention, diagnosis, and treatment of cancer; “(8) Report to President and Congress. (A) prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel needed for the National Cancer Institute) for the National Cancer Program, after reasonable opportunity for comment (but without change) by the Secretary, the Director of the National Institutes of Health, and the National Cancer Advisory Board; and (B) receive from the President and the Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by the Institute; and “(9) Report to President and Congress. as soon as practicable after the end of each fiscal year, prepare in consultation with the National Cancer Advisory Board and submit to the Secretary, for simultaneous transmittal, not later than November 30 of each year, to the President and to the Congress, a report on the activities, progress, and accomplishments under the National Cancer Program during the preceding fiscal year, which shall include a report on the progress, activities, and accomplishments of, and expenditures for, the information services of the Program, and a plan for the Program during the next five years. “(b) Tile Director of the Institute (after consultation with the National Cancer Advisory Board) in carrying out his functions in administering the National Cancer Program and without regard to any other provision of this Act is authorized— “(1) to obtain (in accordance with section 3109 of title 5, United States Code and if authorized by the National Cancer Advisory Board, but without regard to the limitation in such section on the number of days or the period of such service) the services of not more than one hundred and fifty-one experts or consultants who have scientific or professional qualifications; “(2) to acquire, construct, improve, repair, operate, and maintain cancer centers, laboratories, research, and other necessary facilities and equipment, and related accommodations as may be necessary, and such other real or personal property (including patents) as the Director deems necessary; to acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; “(3) to appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments as he deems desirable to advise him with respect to his functions; “(4) to utilize, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor; “(5) to accept voluntary and uncompensated services; “(6) to accept unconditional gifts, or donations of services, money, or property, real, personal, or mixed, tangible or intangible; “(7) to enter into such contracts, leases, cooperative agreements, or other transactions, without regard to sections 3648 and 3709 of the Revised Statutes of the United States (31 U.S.C. 529, 41 U.S.C. 5), as may be necessary in the conduct of his functions, with any public agency, or with any person, firm, association, corporation, or educational institution; “(8) to take necessary action to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the other scientific, medical, and biomedical disciplines and organizations nationally and internationally; “(9) to award grants for new construction as well as alterations Grants. and renovations for improvement of basic research laboratory facilities, including those related to biohazard control, as deemed necessary for the National Cancer Program; and “(10) to call special meetings of the National Cancer Advisory Board at such times and in such places as the Director deems necessary in order to consult with, obtain advice from, or to secure the approval of projects, programs, or other actions to be undertaken without delay in order to gain maximum benefit from a new scientific or technical finding. “Sec. 405. “scientific review (a) The Director of the Institute shall, by regulation, 42 USC 286. provide for proper scientific review of all research grants and programs over which he has authority (1) by utilizing, to the maximum extent possible, appropriate peer review groups established within the National Institutes of Health and composed principally of non-Federal scientists and other experts in the scientific and disease fields, and (2) when appropriate, by establishing, with the approval of the National Cancer Advisory Board and the Director of the National Institutes of Health, other formal peer review groups as may be required. “(b) Grants. Under procedures approved by the Director of the National Institutes of Health, the Director of the National Cancer Institute may approve grants under this Act for cancer research or training— “(1) if the direct costs of such research and training do not exceed $35,000, but only after appropriate review for scientific merit, and “(2) if the direct costs of such research and training exceed $35,000, but only after appropriate review for scientific merit and recommendation for approval by the National Cancer 42 USC 286a. Advisory Board under section 407(b) (3). “Sec. 406. “national cancer research and demonstration centers (a) The Director of the Institute is authorized to provide for the establishment of new centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods for cancer. Such centers may be supported under subsection (b) or under any other applicable provision of law. “(b) Cooperative agreements. The Director of the Institute, under policies established by the Director of the National Institutes of Health and after consultation with the National Cancer Advisory Board, is authorized to enter into cooperative agreements with public or private nonprofit agencies or institutions to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for existing or new centers (including, but not limited to, centers established under subsection (a)) for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for cancer. Federal payments under this subsection in support of such cooperative agreements may be used for (1) construction (notwithstanding Post, p. 3432. any limitation under section 477), (2) staffing and other basic operating costs, including such patient care costs as are required for research, (3) clinical training (including clinical training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer, and (4) demonstration purposes. The aggregate of payments (other than payments for construction) made to any center in support of such an agreement for its costs (other than indirect costs) described in the first sentence may not exceed $5,000,000 in any fiscal year, except that if in any fiscal year there is an increase, as reflected in the Consumer Price Index published by the Bureau of Labor Statistics, in the cost of a center for which payments may be made under such an agreement, the aggregate of payments in such year for such center may exceed $5,000,000 to include such increase and any such increase in any preceding fiscal year for which payments were made to such center under such an agreement to the extent that such increase resulted in payments in excess of $5,000,000. As used in this section, the term ‘construction’ does not include the acquisition of land, and the term ‘training’ does not include research training for which fellowship support may be 42 USC 289l–1. provided under section 472. Support of a center under this section may be for a period of not to exceed three years and may be extended by the Director of the Institute for additional periods of not more than three years each, after review of the operations of such center by an appropriate scientific review group established by the Director or the Institute. “Sec. 407. “national cancer advisory board (a) (1) There is established in the Institute a National Establishment. 42 USC 286b. Cancer Advisory Board (hereinafter in this section referred to as the ‘Board’) to be composed of twenty-nine members as follows: “(A) The Secretary, the Director of the Office of Science and Technology Policy, the Director of the National Institutes of Health, the chief medical officer of the Veterans’ Administration, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission (or their designees), and a medical officer designated by the Secretary of Defense shall be ex officio members of the Board. “(B) Eighteen members appointed by the President. Not more than twelve of the appointed members of the Board shall be scientists or physicians, not more than eight of the appointed members shall be representatives from the general public, and not less than five of the appointed members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors). The scientists and physicians appointed to the Board shall be appointed from persons who are among the leading scientific or medical authorities outstanding in the study, diagnosis, or treatment of cancer or in fields related thereto, and at least two of the physicians appointed to the Board shall be physicians primarily involved in treating individuals who have cancer. Each appointed member of the Board shall be appointed from among persons who by virtue of their training, experience, and background are especially qualified to appraise the programs of the Institute. The ex officio members of the Board shall be non voting members. “(2) (A) Appointed members shall be appointed for six-year terms, except that of the members first appointed six shall be appointed for a term of two years, and six shall be appointed for a term of four years, as designated by the President at the time of appointment. “(B) Any member appointed to fill a vacancy occurring prior to expiration of the term for which his predecessor was appointed shall serve only for the remainder of such term. Appointed members shall be eligible for reappointment and may serve after the expiration of their terms until their successors have taken office. “(C) A vacancy in the Board shall not affect its activities, and twelve members thereof shall constitute a quorum. “(3) The President shall designate one of the appointed members to serve as Chairman for a term of two years. “(4) The Board shall meet at the call of the Director of the Institute or the Chairman, but not less often than four times a year and shall advise and assist the Director of the Institute with respect to the National Cancer Program. “(5) The Director of the Institute shall designate a member of the staff of the Institute to act as Executive Secretary of the Board. “(6) Hearings. The Board may hold such hearings, take such testimony, and sit and act at such times and places as the Board deems advisable to investigate programs and activities of the National Cancer Program. “(7) Reports. The Board shall submit a report to the Secretary for simultaneous transmittal by the Secretary, not later than November 30 of each year, to the President and the Congress, on the progress during the preceding fiscal year of the National Cancer Program toward the accomplishment of its objectives. “(8) Compensation. Members of the Board who are not officers or employees of the United States shall receive for each day they are engaged in the performance of the duties of the Board compensation at rates not to exceed the daily equivalent of the annual rate in effect for GS–18 of the 5 USC 5332 note. General Schedule, including traveltime; and all members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703, title 5, United States Code, for persons in the Government service employed intermittently. “(9) The Director of the Institute shall make available to the Board such staff, information, and other assistance as it may require to carry out its activities. “(b) The Board is authorized— “(1) to review research projects or programs conducted or Ante, p. 3424. authorized to be conducted under section 401 relating to the study of the cause, prevention, or methods of diagnosis and treatment of cancer, and recommend to the Secretary any such projects which it believes show promise of making valuable contributions to human knowledge with respect to the cause, prevention, or methods of diagnosis and treatment of cancer; “(2) to collect information as to studies which are being carried on in the United States or any other country as to the cause, prevention, and methods of diagnosis and treatment of cancer, by correspondence or by personal investigation of such studies, and with the approval of the Secretary make available such information through the appropriate publications for the benefit of health agencies and organizations (public or private), physicians, or any other scientists, and for the information of the general public; “(3) to review applications for grants for research projects relating to cancer and to recommend to the Director for approval Ante, p. 3427. under section 405(b) (2) those applications which show promise of making valuable contributions to human knowledge with respect to the cause or prevention of cancer or to methods of diagnosis or treatment of cancer; “(4) to recommend to the Secretary for acceptance conditional 42 USC 219. gifts pursuant to section 501 of this Act; and “(5) to make recommendations to the Secretary with respect to carrying out the provisions of this part. “Sec. 408. “president’s cancer panel (a) (1) There is established the President’s Cancer Panel (hereinafter in this section referred to as the ‘Panel’) which shall be composed of three persons appointed by the President, who by virtue of their training, experience, and background are exceptionally qual-ified to appraise the National Cancer Program. At least two of the members of the Panel shall be distinguished scientists or physicians. “(2) (A) Members of the Panel shall be appointed for three-year terms, except that (i) in the case of two of the members first appointed, one shall be appointed for a term of one year and one shall be appointed for a term of two years, as designated by the President at the time of appointment, and (ii) any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed only for the remainder of such term. “(B) The President shall designate one of the members to serve as Chairman for a term of one year. “(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during 5 USC 5332 note. which they are engaged in the actual performance of duties vested in the Panel, and shall be allowed travel expenses (including a per diem allowance) under section 5703(b) of title 5, United States Code. “(3) The Panel shall meet at the call of the Chairman, but not less Information available to public. often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the Chairman shall make such transcript available to the public. “(b) The Panel shall monitor the development and execution of the Report to President. National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President. The Panel shall submit to the President periodic progress reports on the Program and annually an evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct. “Sec. 409. “gifts The Secretary shall recommend acceptance of conditional 42 USC 286d. 42 USC 219. gifts pursuant to section 501 for study, investigation, or research into the cause, prevention, and methods of diagnosis and treatment of cancer, or for the acquisition of real property or the erection, equipment, or maintenance of premises, buildings, or equipment of the Institute, only after consultation with the National Cancer Advisory Board. Donations of $50,000 or over in aid of research under this part may be acknowledged by the establishment within the Institute of suitable memorials to the donors. “Sec. 410. “authorization of appropriations (a) For the purpose of carrying out this part (other than 42 USC 286e. section 403), there are authorized to be appropriated $400,000,000 for the fiscal year ending June 30, 1972; $500,000,000 for the fiscal year ending June 30, 1973; $600,000,000 for the fiscal year ending June 30, 1974; $750,000,000 for the fiscal year ending June 30, 1975; $830,000,000 for the fiscal year ending June 30, 1976; $985,000,000 for the fiscal year ending September 30, 1977; $923,590,000 for the fiscal year ending September 30, 1978; $924,500,000 for the fiscal year ending September 30, 1979; and $927,000,000 for the fiscal year ending September 30, 1980. “(b) There are authorized to be appropriated to carry out section 403 $20,000,000 for the fiscal year ending June 30, 1972; $30,000,000 for the fiscal year ending June 30, 1973; $40,000,000 for the fiscal year ending June 30, 1974; $53,500,000 for the fiscal year ending June 30, 1975; $68,500,000 for the fiscal year ending June 30, 1976; $88,500,000 for the fiscal year ending September 30, 1977; $84,560,000 for the fiscal year ending September 30, 1978; $90,500,000 for the fiscal year ending September 30, 1979; and $103,000,000 for the fiscal year ending September 30, 1980. “(c) Contract authority.Ante, p. 3425. The authority of the Secretary to enter into any contract for the conduct of a program under section 404 (a)(7) shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.”. (2) 42 USC 286b note. The change in the manner of appointing members of the National Cancer Advisory Board and in the composition of such Board prescribed by the amendment made by paragraph (1) shall apply with respect to appointments made to the Board after the date of the enactment of this Act, and the President shall make appointments to such Board after such date in a manner which will firing about, at the earliest feasible time, the composition prescribed by such amendment. (b) Part I of title IV is amended by adding at the end the following: “Sec. 477. “appropriations Appropriations to carry out the purposes of this title shall be available for the acquisition of land or the erection of buildings only if so specified, but in the absence of express limitation therein may be expended in the District of Columbia for personal services, stenographic recording and translating services, by contract if deemed 41 USC 5. necessary, without regard to section 3709 of the Revised Statutes; traveling expenses (including the expenses of attendance at meetings when specifically authorized by the Secretary); rental, supplies and equipment, purchase and exchange of medical books, books of reference, directories, periodicals, newspapers, and press clippings; purchase, operation, and maintenance of motor-propelled passenger-carrying vehicles; printing and binding (in addition to that otherwise provided by law); and for all other necessary expenses in carrying out the provisions of this title. “Sec. 478. “other authority This title shall not be construed as limiting (1) the functions or authority of the Secretary under any other title of this Act, or of any officer or agency of the United States, relating to the study of the prevention, diagnosis, and treatment of any disease or diseases for which a separate institute is established under this Act; or (2) the expenditure of money therefor.”. Sec. 242. conforming amendments (a) Section 415(b) (1) is amended by striking out “section 405” and inserting in lieu thereof “section 477”. (b) 42 USC 289l. Section 471 is amended by striking out “section 407(b) (9)” and inserting in lieu thereof “section 404 (a)(8)”. Part D— National Research Service Awards Sec. 251. extension of authorizations (a) Subsection (d) of section 472 is amended by striking 42 USC 289l–1. out “and” after “1977,” and by inserting before the period at the end of the first sentence the following: “, $197,500,000 for the fiscal year ending September 30, 1979, $210,000,000 for the fiscal year ending September 30, 1980, and $222,500,000 for the fiscal year ending September 30, 1981”. (b) Subsection (d) of such section is amended (1) by striking out “25 per centum” in the second sentence and inserting in lieu thereof “15 per centum”, and 12) by inserting before the period “and not less than 50 per centum shall be made available for grants under subsection (a)(1) (B) for National Research Service Awards”. (c) Subsection (d) of such section is amended by adding at the end thereof the following new sentence: “In any fiscal year not more than 4 per centum of the amount obligated to be expended under this section may be obligated for National Research Service Awards for periods of three months or less.”. Sec. 252. approval of awards Paragraph (2) of subsection (b) of such section is amended by striking out “The award of National Research Service Awards by the Secretary under subsection (a) and the making of grants for such Awards” and inserting in lieu thereof “The making of grants under subsection (a) (1) (B) for National Research Service Awards”. Sec. 253. period of awards Paragraph (4) of subsection (b) of such section is amended to read as follows: “(4) The period of any National Research Service Award made to any individual under subsection (a) may not exceed— “(A) five years in the aggregate for predoctoral training, and “(B) three years in the aggregate for postdoctoral training, unless the Secretary for good cause shown waives the application of such limit to such individual.” Sec. 254. adjustments in allowances The first sentence of subsection (b) (5) of such section is amended by inserting after “dependency allowances)” the following: “, adjusted periodically to reflect increases in the cost of living”. Sec. 255. service obligation (a) Subparagraph (B) of subsection (c) (1) of such section is amended (1) by inserting “or” in clause (i) after “Corps.”. (2) by striking out clause (ii), and (3) by redesignating clause (lii) as clause (ii). (b) (1) Paragraph (2) of subsection (c) of such section is amended to read as follows: “(2) For each month for which an individual receives a National Research Service Award which is made for a period in excess of three months, such individual shall— “(A) for one month engage in health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment, or, if so authorized, serve as a member of the National Health Service Corps, or “(B) if authorized under paragraph (1) (B) or (1)(C), for one month serve in the individual’s specialty or engage in a health-related activity.” (2) Paragraph (4) (A) of such subsection is amended by striking out and “ A = ϕ ( t − 1 / 2 s t ) ” inserting in lieu thereof “ A = ϕ ( t−s t ) ”. (3) Paragraph (5) (B) of such subsection amended by striking out “extreme hardship” and inserting in lieu thereof “substantial hardship”. (b) 42 USC 289l–1 note.42 USC 289l–1. The amendments made by subsection (a) shall apply only with respect to National Research Service Awards made under section 472 of the Public Health Service Act after the date of the enactment of this Act. Sec. 256. reports on studies Section 473(c) is amended by striking out “not later than September 30 of each year” and inserting in lieu thereof “at least once every two years”. Part E— Miscellaneous Amendments Sec. 261. substances and organisms for research Effective October 1, 1978, section 301 is amended by adding after and below paragraph (h) the following: “The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.” Sec. 262. expansion of research and testing authority Effective October 1, 1978, section 301 (as amended by section 261 of this title) is amended (1) by striking out “Surgeon General” each place it appears and inserting in lieu thereof “Secretary”, (2) by striking out “Collect” in paragraph (a) and inserting in lieu thereof “collect”, (3) by striking out “Make” in paragraphs (b), (c), and (f) and inserting in lieu thereof “make”, (4) by striking out “Secure” in paragraph (d) and inserting in lieu thereof “secure , (5) by striking out “For” in paragraph (e) and inserting in lieu thereof “for”, (6) by striking out “Enter” in paragraph (g) and inserting in lieu thereof “enter”, (7) by striking out ‘‘Adopt” m paragraph (h) and inserting in lieu thereof “adopt”, (8) by striking out “and” at the end of paragraph (f), (9) by redesignating paragraphs (a) through (h) as paragraphs (1) through (8), respectively, and (10) by inserting “(a)” after “301.” and by adding at the end the following: “(b) (1) The Secretary shall conduct and may support through Grants. grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. “(2) (A) The Secretary shall establish a comprehensive program of Low-level ionizing radiation. research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and contracts. “(B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation. “(3) The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the. maintenance and promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health. Education, and Welfare and shall consult with entities of the Federal Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity. “(4) The Secretary shall publish an annual report which contains— Annual report, publication. “(A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed; “(B) information concerning the nature of such exposure and the estimated number of persons exposed to such substances; “(C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and “(D) a description of (i) each request received during the year involved— “(I) from a Federal agency outside the Department of Health, Education, and Welfare for the Secretary, or “(II) from an entity within the Department of Health, Education, and Welfare to any other entity within the Department, to conduct research into, or testing for, the carcinogenicity of sub-stances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request. “(5) Contract authority. The authority of the Secretary to enter into any contract for authority. the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.”. Sec. 263. new arthritis centers Section 439 (g) is amended by striking out the last sentence. Sec. 264. peer review of research grants under the division of nursing Section 475(a) is amended (1) by inserting before “, shall by regulation” the following: “and the head of the Division of Nursing of the Health Resources Administration (or the successor to either such entity)”, (2) by inserting after “research” in paragraph (1) the following: “(including research under programs of such Division of Nursing)”, and (3) by striking out “or the” in paragraph (2) and inserting in lieu thereof “the” and by inserting before the period in that paragraph a comma and the following: “or the Division of Nursing of the Health Resources Administration (or the successor to either such entity)”. Sec. 265. experts and consultants for the institutes Title IV is amended by inserting after section 478 (as added by section 241(b) of this title) the following new section: “Sec. 479. “experts and consultants (a) The Director of the National Institutes of Health may obtain (in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the number of days or the period of service) the services of not more than two hundred experts or consultants who have scientific or professional qualifications, for the National Institutes of Health and for each of the research institutes (other than the National Cancer Institute and the National Heart, Lung, and Blood Institute). “(b)Compensation.42 USC 284, 287b. (1) Experts and consultants whose services are obtained under subsection (a) or under section 404(b) (1) or 413(c) (1) shall be paid or reimbursed for their expenses associated with traveling to and from their assignment location in accordance with sections 5724, 5724a(a) (1), 5724a(a) (3), and 5726(c) of title 5, United States Code. “(2) Expenses specified in paragraph (1) may not be allowed in connection with the assignment of an expert or consultant whose services are obtained under this subsection, unless and until the expert or consultant agrees in writing to complete the entire period of his assignment or 1 year, whichever is shorter, unless separated or reassigned for reasons beyond his control that are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for these expenses is recoverable from him as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subsection with respect to an expert or consultant on assignment with the Secretary.”. Sec. 266. public health service hospitals Section 321(a) is amended by striking out “, and tobacco”. 42 USC 248. Sec. 267. extension of deadline for final report of national commission on digestive diseases Section 301 (i) (1) of the Arthritis, Diabetes, and Digestive Disease Amendments of 1976 (Public Law 94–562) is amended by 42 USC 289a note. striking out “Within eighteen months following its initial meeting (as prescribed by subsection (d)),” and inserting in lieu thereof “Not later than February 1, 1979,”. Sec. 268. programs for families of alcoholics and alcohol abusers (a) Section 2(a) of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 is 42 USC 4541. amended— (1) by striking out “and” at the end of paragraph (5), (2) by redesignating paragraph (6) as paragraph (7), and (3) by inserting after paragraph (5) the following new paragraph: “(6) alcohol abuse and alcoholism have a substantial impact on the families of alcohol abusers and alcoholics; and”. (b) Section 303(a)(4)(B) of such Act is amended by inserting 42 USC 4573. “and for education, counseling, and treatment of the families of alcoholic abusers and alcoholics” after “under the age of eighteen”. (c) Section 501 (a) of such Act is amended— 42 USC 4585. (1) by striking out “of” each place it appears in paragraphs (1) through (4) and inserting “of” before “alcohol abuse and alcoholism”; (2) by striking out “and” at the end of paragraph (3) and inserting “and” after the comma at the end of paragraph (4); and (3) by inserting after paragraph (4) the following new paragraph: “(5) the impact on families,”. (d) Section 501(b)(5) of such Act is amended by inserting “or those of their families” after “individuals suffering from alcoholism or alcohol abuse”.Effective date note
Sections 261 and 262 of Pub. L. 95–622 provided that the amendments made by those sections are effective Oct. 1, 1978.Health Research Extension Act of 1985
Pub. L. 99–158 § 3(a)(5)(A) · 99 Stat. 820
Substituted · 42 U.S.C. § 241(a)(3)
Pub. L. 99–158, § 3(a)(5)(A), substituted “as are recommended by the advisory council to the entity of the Department supporting such projects or, in the case of mental health projects, by the National Advisory Mental Health Council; and make, upon recommendation of the advisory council to the appropriate entity of the Department or the National Advisory Mental Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research” for “as are recommended by the National Advisory Health Council, or, with respect to cancer, recommended by the National Cancer Advisory Board, or, with respect to mental health, recommended by the National Advisory Mental Health Council, or with respect to heart, blood vessel, lung, and blood diseases and blood resources, recommended by the National Heart, Lung, and Blood Advisory Council, or, with respect to dental diseases and conditions, recommended by the National Advisory Dental Research Council; and include in the grants for any such project grants of penicillin and other antibiotic compounds for use in such project; and make, upon recommendation of the National Advisory Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research: Provided, That such uniform percentage, not to exceed 15 per centum, as the Secretary may determine, of the amounts provided for grants for research projects for any fiscal year through the appropriations for the National Institutes of Health may be transferred from such appropriations to a separate account to be available for such research grants-in-aid for such fiscal year”
Source evidence
Code amendment note
Subsec. (a)(3). Pub. L. 99–158, § 3(a)(5)(A), substituted “as are recommended by the advisory council to the entity of the Department supporting such projects or, in the case of mental health projects, by the National Advisory Mental Health Council; and make, upon recommendation of the advisory council to the appropriate entity of the Department or the National Advisory Mental Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research” for “as are recommended by the National Advisory Health Council, or, with respect to cancer, recommended by the National Cancer Advisory Board, or, with respect to mental health, recommended by the National Advisory Mental Health Council, or with respect to heart, blood vessel, lung, and blood diseases and blood resources, recommended by the National Heart, Lung, and Blood Advisory Council, or, with respect to dental diseases and conditions, recommended by the National Advisory Dental Research Council; and include in the grants for any such project grants of penicillin and other antibiotic compounds for use in such project; and make, upon recommendation of the National Advisory Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research: Provided, That such uniform percentage, not to exceed 15 per centum, as the Secretary may determine, of the amounts provided for grants for research projects for any fiscal year through the appropriations for the National Institutes of Health may be transferred from such appropriations to a separate account to be available for such research grants-in-aid for such fiscal year”.Enacted provision · exact public law section
(A) in paragraph (3), by striking out “as are recommended” through “for such fiscal year” and inserting in lieu thereof “as are recommended by the advisory council to the entity of the Department supporting such projects or, in the case of mental health projects, by the National Advisory Mental Health Council; and make, upon recommendation of the advisory council to the appropriate entity of the Department or the National Advisory Mental Health Council, grants-in-aid to public or non-profit universities, hospitals, laboratories, and other institutions for the general support of their research”; andHealth Research Extension Act of 1985
Pub. L. 99–158 § 3(a)(5)(B) · 99 Stat. 820
Substituted · 42 U.S.C. § 241(a)(8)
Pub. L. 99–158, § 3(a)(5)(B), substituted “recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers” for “recommendation of the National Advisory Health Council, or, with respect to cancer, upon recommendation of the National Cancer Advisory Board, or, with respect to mental health, upon recommendation of the National Advisory Mental Health Council, or, with respect to heart, blood vessel, lung, and blood diseases and blood resources, upon recommendation of the National Heart, Lung and Blood Advisory Council, or, with respect to dental diseases and conditions, upon recommendations of the National Advisory Dental Research Council, such additional means as he deems”
Source evidence
Code amendment note
Subsec. (a)(8). Pub. L. 99–158, § 3(a)(5)(B), substituted “recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers” for “recommendation of the National Advisory Health Council, or, with respect to cancer, upon recommendation of the National Cancer Advisory Board, or, with respect to mental health, upon recommendation of the National Advisory Mental Health Council, or, with respect to heart, blood vessel, lung, and blood diseases and blood resources, upon recommendation of the National Heart, Lung and Blood Advisory Council, or, with respect to dental diseases and conditions, upon recommendations of the National Advisory Dental Research Council, such additional means as he deems”.Enacted provision · exact public law section
(B) in paragraph (8), by striking out “recommendations of the National Advisory Health Council” through “as he deems” and inserting in lieu thereof “recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers”.Anti-Drug Abuse Act of 1986
Pub. L. 99–570 title IV § 4021(b)(2) · 100 Stat. 3207
Struck · 42 U.S.C. § 241(a)(3)
Pub. L. 99–570 struck out “or, in the case of mental health projects, by the National Advisory Mental Health Council;” after “Department supporting such projects”
Struck · 42 U.S.C. § 241(a)(3)
Pub. L. 99–570 struck out “or the National Advisory Mental Health Council” after “appropriate entity of the Department”
Source evidence
Code amendment note
Subsec. (a)(3). Pub. L. 99–570 struck out “or, in the case of mental health projects, by the National Advisory Mental Health Council;” after “Department supporting such projects” and struck out “or the National Advisory Mental Health Council” after “appropriate entity of the Department”.Pub. L. 99–660 title I § 104 · 100 Stat. 3743
Added · 42 U.S.C. § 241(c)
Pub. L. 99–660 added subsec. (c)
Source evidence
Code amendment note
Subsec. (c). Pub. L. 99–660 added subsec. (c).Enacted provision · exact public law section
SEC. 104. TROPICAL DISEASES. Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following: “(c) The Secretary may conduct biomedical research, directly or Research and development. Grants. Contracts. through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.”.Health Omnibus Programs Extension of 1988
Pub. L. 100–607 title I § 163(1) · 102 Stat. 3048
Redesignated · 42 U.S.C. § 241(d)
Pub. L. 100–607 redesignated concluding provisions of subsec. (a) of section 242a of this title as subsec. (d) of this section
Substituted · 42 U.S.C. § 241(d)
Pub. L. 100–607 substituted “biomedical, behavioral, clinical, or other research (including research on mental health, including” for “research on mental health, including”
Substituted · 42 U.S.C. § 241(d)
Pub. L. 100–607 substituted “drugs)” for “drugs,”
Source evidence
Code amendment note
Subsec. (d). Pub. L. 100–607 redesignated concluding provisions of subsec. (a) of section 242a of this title as subsec. (d) of this section, substituted “biomedical, behavioral, clinical, or other research (including research on mental health, including” for “research on mental health, including”, and substituted “drugs)” for “drugs,”.National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 title XX § 2009 · 107 Stat. 122
Substituted · 42 U.S.C. § 241(b)(4)
Pub. L. 103–43 substituted “a biennial report” for “an annual report” in introductory provisions
Source evidence
Code amendment note
Subsec. (b)(4). Pub. L. 103–43 substituted “a biennial report” for “an annual report” in introductory provisions.Enacted provision · exact public law section
SEC. 2009. BIENNIAL REPORT ON CARCINOGENS. Section 301(b)(4) of the Public Health Service Act (42 U.S.C. 241(b)(4)) is amended by striking “an annual” and inserting “a biennial”.Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act
Pub. L. 109–450 § 3(a) · 120 Stat. 3341
Added · 42 U.S.C. § 241(e)
Pub. L. 109–450 added subsec. (e)
Source evidence
Code amendment note
Subsec. (e). Pub. L. 109–450 added subsec. (e).Enacted provision · exact public law section
(a) General Expansion of CDC Research.— Section 301 of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following: “(e) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand, intensify, and coordinate the activities of the Centers for Disease Control and Prevention with respect to preterm labor and delivery and infant mortality.” .21st Century Cures Act
Pub. L. 114–255 § 2043(1) · 130 Stat. 1033
Redesignated · 42 U.S.C. § 241(a)
Pub. L. 114–255, § 2043(1), redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h)
Source evidence
Code amendment note
Subsec. (a). Pub. L. 114–255, § 2043(1), redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h).Enacted provision · exact public law section
(1) in the flush matter at the end of subsection (a)— (A) by redesignating such matter as subsection (h)(1); and (B) by moving such matter so as to appear at the end of such section; and21st Century Cures Act
Pub. L. 114–255 § 2012(a) · 130 Stat. 1033
Amended · 42 U.S.C. § 241(d)
Pub. L. 114–255, § 2012(a), amended subsec. (d) generally. Prior to amendment, text read as follows: “The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.”
Source evidence
Code amendment note
Subsec. (d). Pub. L. 114–255, § 2012(a), amended subsec. (d) generally. Prior to amendment, text read as follows: “The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.”Enacted provision · exact public law section
(a) In General.— Subsection (d) of section 301 of the Public Health Service Act (42 U.S.C. 241) is amended to read as follows: “(d) (1) (A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable— “(i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the Federal Government; and “(ii) may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded. “(B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research. “(C) The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is— “(i) required by Federal, State, or local laws, excluding instances described in subparagraph (D); “(ii) necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual; “(iii) made with the consent of the individual to whom the information, document, or biospecimen pertains; or “(iv) made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research. “(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii). “(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal process, and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding. “(F) Identifiable, sensitive information collected by a person to whom a certificate has been issued under subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for perpetuity. “(G) The Secretary shall take steps to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements of this subsection. “(2) The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of this subsection. “(3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual’s participation in the research. “(4) For purposes of this subsection, the term ‘identifiable, sensitive information’ means information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and— “(A) through which an individual is identified; or “(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.” .21st Century Cures Act
Pub. L. 114–255 § 2013 · 130 Stat. 1033
Added · 42 U.S.C. § 241(f)
Pub. L. 114–255, § 2013, added subsec. (f)
Source evidence
Code amendment note
Subsec. (f). Pub. L. 114–255, § 2013, added subsec. (f).Enacted provision · exact public law section
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION. Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following: “(f) (1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical information that is about an individual and that is gathered or used during the course of biomedical research if— “(A) an individual is identified; or “(B) there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, the request, and other available data sources could be used to deduce the identity of an individual. “(2) (A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination. “(B) Each such determination and statement of basis shall be available to the public, upon request, through the Office of the Chief FOIA Officer of the Department of Health and Human Services. “(3) Nothing in this subsection shall be construed to limit a research participant’s access to information about such participant collected during the participant’s participation in the research.” .21st Century Cures Act
Pub. L. 114–255 § 2035 · 130 Stat. 1033
Added · 42 U.S.C. § 241(g)
Pub. L. 114–255, § 2035, added subsec. (g)
Source evidence
Code amendment note
Subsec. (g). Pub. L. 114–255, § 2035, added subsec. (g).Enacted provision · exact public law section
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS. Section 301 of the Public Health Service Act (42 U.S.C. 241), as amended by section 2013, is further amended by adding at the end the following: “(g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of information during the conduct of research by the National Institutes of Health.” .21st Century Cures Act
Pub. L. 114–255 § 2043 · 130 Stat. 1033
Redesignated · 42 U.S.C. § 241(h)
Pub. L. 114–255, § 2043, redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h)
Added · 42 U.S.C. § 241(h)
Pub. L. 114–255, § 2043, added pars. (2) and (3)
Source evidence
Code amendment note
Subsec. (h). Pub. L. 114–255, § 2043, redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h) and added pars. (2) and (3).Enacted provision · exact public law section
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING ORGANISMS. Section 301 of the Public Health Service Act (42 U.S.C. 241), as amended by section 2035, is further amended— (1) in the flush matter at the end of subsection (a)— (A) by redesignating such matter as subsection (h)(1); and (B) by moving such matter so as to appear at the end of such section; and (2) in subsection (h) (as so redesignated), by adding at the end the following: “(2) Where research substances and living organisms are made available under paragraph (1) through contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary. “(3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts.” .National Defense Authorization Act for Fiscal Year 2022
Pub. L. 117–81 div. A title XVII § 1702(j)(1)(A) · 135 Stat. 1541
Substituted · 42 U.S.C. § 241(a)(7)
Pub. L. 117–81 substituted “sections 3861 and 4141” for “sections 2353 and 2354”
Source evidence
Code amendment note
Subsec. (a)(7). Pub. L. 117–81 substituted “sections 3861 and 4141” for “sections 2353 and 2354”.Enacted provision · exact public law section
(A) in section 301(a)(7) (42 U.S.C. 241(a)(7)), by striking “sections 2353 and 2354” and inserting “sections 3861 and 4141”; andLegislative Branch Appropriations Act, 2022
Pub. L. 117–103 div. P title I § 141(a) · 136 Stat. 49
Inserted · 42 U.S.C. § 241(e)
Pub. L. 117–103 inserted “, preventable maternal mortality and severe maternal morbidity,” after “delivery”
Source evidence
Code amendment note
Subsec. (e). Pub. L. 117–103 inserted “, preventable maternal mortality and severe maternal morbidity,” after “delivery”.Enacted provision · exact public law section
(a) Revising Authorities of Librarian to Accept Gifts.— The first undesignated paragraph of section 4 of the Act entitled “An Act to create a Library of Congress Trust Fund Board, and for other purposes”, approved March 3, 1925 (2 U.S.C. 160), is amended— (1) in the first sentence— (A) by striking “and” before “(3) gifts or bequests of money for immediate disbursement”; and (B) by striking the period at the end and inserting the following: “; and (4) gifts or bequests of securities or other personal property.”; (2) in the second sentence, by inserting “of money” after “bequests”; (3) in the third sentence, by striking “enter them” and inserting “enter the gift, bequest, or proceeds”; and (4) by inserting after the second sentence the following new sentence: “In the case of a gift of securities, the Librarian shall sell the gift and provide the donor with such acknowledgment as needed for the donor to substantiate the gift.”.
32 of 52 references resolved to an enrolled provision · 13 partial · 7 unresolved
Editorial Notes
Amendments1946–2022 · 21 rounds
2022
Subsec. (e). Pub. L. 117–103 inserted “, preventable maternal mortality and severe maternal morbidity,” after “delivery”.
2021
Subsec. (a)(7). Pub. L. 117–81 substituted “sections 3861 and 4141” for “sections 2353 and 2354”.
2016
Subsec. (a). Pub. L. 114–255, § 2043(1), redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h).
Subsec. (d). Pub. L. 114–255, § 2012(a), amended subsec. (d) generally. Prior to amendment, text read as follows: “The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.”
Subsec. (f). Pub. L. 114–255, § 2013, added subsec. (f).
Subsec. (g). Pub. L. 114–255, § 2035, added subsec. (g).
Subsec. (h). Pub. L. 114–255, § 2043, redesignated concluding provisions of subsec. (a) as par. (1) of subsec. (h) and added pars. (2) and (3).
2006
Subsec. (e). Pub. L. 109–450 added subsec. (e).
1993
Subsec. (b)(4). Pub. L. 103–43 substituted “a biennial report” for “an annual report” in introductory provisions.
1988
Subsec. (d). Pub. L. 100–607 redesignated concluding provisions of subsec. (a) of section 242a of this title as subsec. (d) of this section, substituted “biomedical, behavioral, clinical, or other research (including research on mental health, including” for “research on mental health, including”, and substituted “drugs)” for “drugs,”.
1986
Subsec. (a)(3). Pub. L. 99–570 struck out “or, in the case of mental health projects, by the National Advisory Mental Health Council;” after “Department supporting such projects” and struck out “or the National Advisory Mental Health Council” after “appropriate entity of the Department”.
Subsec. (c). Pub. L. 99–660 added subsec. (c).
1985
Subsec. (a)(3). Pub. L. 99–158, § 3(a)(5)(A), substituted “as are recommended by the advisory council to the entity of the Department supporting such projects or, in the case of mental health projects, by the National Advisory Mental Health Council; and make, upon recommendation of the advisory council to the appropriate entity of the Department or the National Advisory Mental Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research” for “as are recommended by the National Advisory Health Council, or, with respect to cancer, recommended by the National Cancer Advisory Board, or, with respect to mental health, recommended by the National Advisory Mental Health Council, or with respect to heart, blood vessel, lung, and blood diseases and blood resources, recommended by the National Heart, Lung, and Blood Advisory Council, or, with respect to dental diseases and conditions, recommended by the National Advisory Dental Research Council; and include in the grants for any such project grants of penicillin and other antibiotic compounds for use in such project; and make, upon recommendation of the National Advisory Health Council, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research: Provided, That such uniform percentage, not to exceed 15 per centum, as the Secretary may determine, of the amounts provided for grants for research projects for any fiscal year through the appropriations for the National Institutes of Health may be transferred from such appropriations to a separate account to be available for such research grants-in-aid for such fiscal year”.
Subsec. (a)(8). Pub. L. 99–158, § 3(a)(5)(B), substituted “recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers” for “recommendation of the National Advisory Health Council, or, with respect to cancer, upon recommendation of the National Cancer Advisory Board, or, with respect to mental health, upon recommendation of the National Advisory Mental Health Council, or, with respect to heart, blood vessel, lung, and blood diseases and blood resources, upon recommendation of the National Heart, Lung and Blood Advisory Council, or, with respect to dental diseases and conditions, upon recommendations of the National Advisory Dental Research Council, such additional means as he deems”.
1978
Pub. L. 95–622 designated existing provisions as subsec. (a), redesignated former pars. (a) to (h) as (1) to (8), respectively, substituted “Secretary” for “Surgeon General” wherever appearing, and inserted following par. (8) provisions relating to authority of Secretary to make available to individuals and entities substances and living organisms, and added subsec. (b).
1976
Subsecs. (c), (h). Pub. L. 94–278 substituted “heart, blood vessel, lung, and blood diseases and blood resources” for “heart diseases” and “National Heart, Lung and Blood Advisory Council” for “National Heart and Lung Advisory Council”.
1974
Subsec. (c). Pub. L. 93–348, § 104(a)(1), redesignated subsec. (d) as (c) and substituted “research projects” for “research or research training projects” in two places, “general support of their research” for “general support of their research and research training programs” and “research grants-in-aid” for “research and research training program grants-in-aid”. Former subsec. (c), authorizing Surgeon General to establish and maintain research fellowships in the Public Health Service with such stipends and allowances, including traveling and subsistence expenses, as he may deem necessary to procure the assistance of the most brilliant and promising research fellows from the United States and abroad, was struck out.
Subsec. (d). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (e) as (d).
Pub. L. 93–282 substituted “mental health, including research on the use and effect of alcohol and other psychoactive drugs” for “the use and effect of drugs” in former concluding provisions of section 242a(a) of this title. See 1988 Amendment note above.
Subsecs. (e), (f). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (f) and (g) as (e) and (f), respectively. Former subsec. (e) redesignated (d).
Subsec. (g). Pub. L. 93–352 struck out “during the fiscal year ending , and each of the eight succeeding fiscal years” after “Enter into contracts”. Notwithstanding directory language that amendment be made to subsec. (h), the amendment was executed to subsec. (g) to reflect the probable intent of Congress and the intervening redesignation of subsec. (h) as (g) by Pub. L. 93–348.
Pub. L. 93–348, § 104(a)(1)(C), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).
Subsecs. (h), (i). Pub. L. 93–348, § 104(a)(1)(C), redesignated subsecs. (h) and (i) as (g) and (h), respectively.
1972
Subsecs. (d), (i). Pub. L. 92–423 substituted “National Heart and Lung Advisory Council” for “National Advisory Heart Council”.
1971
Subsecs. (d), (i). Pub. L. 92–218 substituted “National Cancer Advisory Board” for “National Advisory Cancer Council”.
1970
Subsec. (d). Pub. L. 91–513 added subsec. (d). See 1988 Amendment note above.
Subsec. (h). Pub. L. 91–515 substituted “eight” for “five” succeeding fiscal years.
1967
Subsec. (h). Pub. L. 90–174 substituted “five” for “two” succeeding fiscal years.
1965
Subsecs. (h), (i). Pub. L. 89–115 added subsec. (h) and redesignated former subsec. (h) as (i).
1962
Subsec. (d). Pub. L. 87–838 inserted “or research training” in two places.
1960
Subsec. (d). Pub. L. 86–798 authorized the Surgeon General, upon recommendation of the National Advisory Health Council, to make grants to public or non-profit universities, hospitals, laboratories, and other institutions to support research and research training programs, and to make available for such research and research training programs, up to 15 per centum of amounts provided for research grants through the appropriations for the National Institutes of Health.
1956
Subsecs. (g), (h). Act , added subsec. (g) and redesignated former subsec. (g) as (h).
1948
Subsec. (d). Acts , § 4(e), and , § 4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (d). Act , continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects.
Subsec. (g). Acts , § 4(f), and , § 4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
1946
Subsec. (d). Act , made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health.
Subsec. (g). Act , gave National Advisory Health Council the right to make recommendations to carry out purposes of this section.
Statutory Notes and Related Subsidiaries
Change of Name
“Secretary of Health and Human Services” substituted for “Secretary of Health, Education, and Welfare” in subsec. (a)(7), and “Department of Health and Human Services” substituted for “Department of Health, Education, and Welfare” in subsec. (b)(1), (3), and (4)(D)(I), (II), pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.
Effective Date of 1978 Amendment
Sections 261 and 262 of Pub. L. 95–622 provided that the amendments made by those sections are effective .
Effective Date of 1974 Amendment
Section 104(b) of Pub. L. 93–348 provided that: “The amendments made by subsection (a) [amending this section and sections 242a, 282, 286a, 286b, 287a, 287b, 287d, 288a, 289c, 289c–1, 289g, 289k, and heading preceding section 289l of this title] shall not apply with respect to commitments made before the date of the enactment of this Act [] by the Secretary of Health, Education, and Welfare for research training under the provisions of the Public Health Service Act amended or repealed by subsection (a).”
Effective Date of 1972 Amendment
Amendment by Pub. L. 92–423 effective 60 days after , or on such prior date after , as the President shall prescribe and publish in the Federal Register, see section 9 of Pub. L. 92–423, set out as a note under section 218 of this title.
Effective Date of 1971 Amendment
Amendment by Pub. L. 92–218 effective 60 days after , or on such prior date after , as the President shall prescribe and publish in the Federal Register, see section 7 of Pub. L. 92–218, set out as a note under section 218 of this title.
Applicability of 2016 Amendment
Pub. L. 114–255, div. A, title II, § 2012(b), , 130 Stat. 1050, provided that: “Beginning 180 days after the date of enactment of this Act [], all persons engaged in research and authorized by the Secretary of Health and Human Services to protect information under section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) prior to the date of enactment of this Act shall be subject to the requirements of such section (as amended by this Act).”
Prohibition Against Reinstating Interdisciplinary Review Process for Non-NIH-Funded Researchers
Pub. L. 117–215, title I, § 106, , 136 Stat. 2264, provided that:
“The Secretary of Health and Human Services may not—
“(1) reinstate the Public Health Service interdisciplinary review process described in the guidance entitled ‘Guidance on Procedures for the Provision of Marijuana for Medical Research’ (issued on ); or
“(2) require another review of scientific protocols that is applicable only to research on marijuana or its components.”
[For definition of “marijuana” as used in section 106 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out as a note under section 801 of Title 21, Food and Drugs.]
Director of Advanced Research Projects for Health
Pub. L. 117–328, div. H, title II, , 136 Stat. 4878, provided in part: “That the President shall appoint in the Department of Health and Human Services a director of advanced research projects for health (Director): Provided further, That funds may be used to make or rescind appointments of scientific, medical, and professional personnel without regard to any provision in title 5 governing appointments under the civil service laws: Provided further, That funds may be used to fix the compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code: Provided further, That the Director may use funds made available under this heading to make awards in the form of grants, contracts, cooperative agreements, and cash prizes, and enter into other transactions (as defined in section 319L(a)(3) of the PHS [Public Health Service] Act [42 U.S.C. 247d–7e(a)(3)]): Provided further, That activities supported with funds provided under this heading shall not be subject to the requirements of sections [sic] 406(a)(3)(A)(ii) or 492 of the PHS [Public Health Service] Act [42 U.S.C. 284a(a)(3)(A)(ii), 289a]: Provided further, That the Secretary [of Health and Human Services] may transfer the Advanced Research Projects Agency for Health, including the functions, personnel, missions, activities, authorities, and funds, within 30 days of enactment of this Act [] to any agency or office of the Department of Health and Human Services, including the National Institutes of Health: Provided further, That the Committees on Appropriations of the House of Representatives and the Senate shall be notified at least 15 days in advance of any transfer pursuant to the preceding proviso.”
[For transfer of all functions, personnel, missions, activities, authorities, and funds of the Advanced Research Projects Agency for Health to the Advanced Research Projects Agency–Health within the National Institutes of Health, see section 290c of this title.]
Similar provisions were contained in the following prior appropriation act:
Coordination of Data Surveys and Reports
Pub. L. 106–113, div. B, § 1000(a)(6) [title VII, § 703(e)], , 113 Stat. 1536, 1501A–402, provided that: “The Secretary of Health and Human Services, through the Assistant Secretary for Planning and Evaluation, shall establish a clearinghouse for the consolidation and coordination of all Federal databases and reports regarding children’s health.”
Female Genital Mutilation
Pub. L. 104–134, title I, § 101(d) [title V, § 520], , 110 Stat. 1321–211, 1321–250; renumbered title I, Pub. L. 104–140, § 1(a), , 110 Stat. 1327, provided that:
“(a) Congress finds that—
“(1) the practice of female genital mutilation is carried out by members of certain cultural and religious groups within the United States; and
“(2) the practice of female genital mutilation often results in the occurrence of physical and psychological health effects that harm the women involved.
“(b) The Secretary of Health and Human Services shall do the following:
“(1) Compile data on the number of females living in the United States who have been subjected to female genital mutilation (whether in the United States or in their countries of origin), including a specification of the number of girls under the age of 18 who have been subjected to such mutilation.
“(2) Identify communities in the United States that practice female genital mutilation, and design and carry out outreach activities to educate individuals in the communities on the physical and psychological health effects of such practice. Such outreach activities shall be designed and implemented in collaboration with representatives of the ethnic groups practicing such mutilation and with representatives of organizations with expertise in preventing such practice.
“(3) Develop recommendations for the education of students of schools of medicine and osteopathic medicine regarding female genital mutilation and complications arising from such mutilation. Such recommendations shall be disseminated to such schools.
“(c) For purposes of this section the term ‘female genital mutilation’ means the removal or infibulation (or both) of the whole or part of the clitoris, the labia minor, or the labia major.
“(d) The Secretary of Health and Human Services shall commence carrying out this section not later than 90 days after the date of enactment of this Act [].”
Sentinel Disease Concept Study
Pub. L. 103–43, title XIX, § 1910, , 107 Stat. 205, directed Secretary of Health and Human Services, in cooperation with Agency for Toxic Substances and Disease Registry and Centers for Disease Control and Prevention, to design and implement a pilot sentinel disease surveillance system for identifying relationship between occupation of household members and incidence of subsequent conditions or diseases in other members of household, and required Director of the National Institutes of Health to prepare and submit to Congress, not later than 4 years after , a report concerning this project.
Study of Thyroid Morbidity for Hanford, Washington
Pub. L. 100–607, title I, § 161, , 102 Stat. 3059, as amended by Pub. L. 102–531, title III, § 312(e)(1), , 106 Stat. 3506, directed Secretary of Health and Human Services, acting through Director of Centers for Disease Control and Prevention, to conduct a study of thyroid morbidity of the population, including Indian tribes and tribal organizations, in vicinity of Hanford, in State of Washington, authorized Director to contract out portions of study, and required Director, not later than 42 months after , to transmit a report, including such study, to Congress, chief executive officers of States of Oregon and Washington, and governing officials of Indian tribes in vicinity of Hanford, Washington.
National Commission on Sleep Disorders Research
Pub. L. 100–607,title I, § 162, , 102 Stat. 3060, directed Secretary of Health and Human Services, after consultation with Director of National Institutes of Health, to establish a National Commission on Sleep Disorders Research to conduct a comprehensive study of present state of knowledge of incidence, prevalence, morbidity, and mortality resulting from sleep disorders, and of social and economic impact of such disorders, evaluate public and private facilities and resources (including trained personnel and research activities) available for diagnosis, prevention, and treatment of, and research into, such disorders, and identify programs (including biological, physiological, behavioral, environmental, and social programs) by which improvement in management and research into sleep disorders could be accomplished and, not later than 18 months after initial meeting of Commission, to submit to appropriate Committees of Congress a final report, and provided for termination of the Commission 30 days after submission of final report.
Research With Respect to Health Resources and Services Administration
Pub. L. 100–607, title VI, § 632, , 102 Stat. 3147, provided that with respect to any program of research pursuant to this chapter, any such program carried out in fiscal year 1987 by an agency other than Health Resources and Services Administration (or appropriate to be carried out by such an agency) could not, for each of fiscal years 1989 through 1991, be carried out by such Administration.
Continuing Care for Psychiatric Patients in Former Clinical Research Center at National Institute on Drug Abuse
Pub. L. 99–117, § 10, , 99 Stat. 494, provided that: “In any fiscal year beginning after , from funds appropriated for carrying out section 301 of the Public Health Service Act [42 U.S.C. 241] with respect to mental health, the Secretary of Health and Human Services may provide, by contract or otherwise, for the continuing care of psychiatric patients who were under active and continuous treatment at the National Institute on Drug Abuse Clinical Research Center on the date such Clinical Research Center ceased operations.”
Analysis of Thyroid Cancer; Creation and Publication of Radioepidemiological Tables
Pub. L. 97–414, § 7, , 96 Stat. 2059, as amended by Pub. L. 109–482, title I, § 104(b)(3)(A), , 120 Stat. 3694, provided that:
“(a) In carrying out section 301 of the Public Health Service Act [42 U.S.C. 241], the Secretary of Health and Human Services shall—
“(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
“(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout; and
“(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests.
“(b) (1) Within one year after the date of enactment of this Act [], the Secretary of Health and Human Services shall devise and publish radioepidemiological tables that estimate the likelihood that persons who have or have had any of the radiation related cancers and who have received specific doses prior to the onset of such disease developed cancer as a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from 1 millirad to 1,000 rads in terms of sex, age at time of exposure, time from exposure to the onset of the cancer in question, and such other categories as the Secretary, after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation shall be calculated and displayed as a single percentage figure.
“(2) At the time the Secretary of Health and Human Services publishes the tables pursuant to paragraph (1), such Secretary shall also publish—
“(A) for the tables of each radiation related cancer, an evaluation which will assess the credibility, validity, and degree of certainty associated with such tables; and
“(B) a compilation of the formulas that yielded the probabilities of causation listed in such tables. Such formulas shall be published in such a manner and together with information necessary to determine the probability of causation of any individual who has or has had a radiation related cancer and has received any given dose.
“(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from the best available data that are most applicable to the United States, and shall be devised in accordance with the best available scientific procedures and expertise.”
Termination of Advisory Committees
Pub. L. 93–641, § 6, , 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after .
Executive Documents
Executive Order No. 13435
Ex. Ord. No. 13435, , 72 F.R. 34591, which directed research with stem cells not derived from the creation or destruction of a human embryo or fetus, was revoked by Ex. Ord. No. 13505, § 5(b), , 74 F.R. 10668, set out below.
Ex. Ord. No. 13505. Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
Ex. Ord. No. 13505, , 74 F.R. 10667, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. Research involving human embryonic stem cells and human non-embryonic stem cells has the potential to lead to better understanding and treatment of many disabling diseases and conditions. Advances over the past decade in this promising scientific field have been encouraging, leading to broad agreement in the scientific community that the research should be supported by Federal funds.
For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.
Sec. 2. Research. The Secretary of Health and Human Services (Secretary), through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.
Sec. 3. Guidance. Within 120 days from the date of this order, the Secretary, through the Director of NIH, shall review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH, shall review and update such guidance periodically, as appropriate.
Sec. 4. General Provisions. (a) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(b) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to an executive department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Sec. 5. Revocations. (a) The Presidential statement of , limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.
(b) Executive Order 13435 of , which supplements the , statement on human embryonic stem cell research, is revoked.
Barack Obama.
Guidelines for Human Stem Cell Research
Memorandum of President of the United States, , 74 F.R. 38885, provided:
Memorandum for the Heads of Executive Departments and Agencies
As outlined in Executive Order 13505 of , my Administration is committed to supporting and conducting ethically responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law. Pursuant to that order, the National Institutes of Health (NIH) published final “National Institutes of Health Guidelines for Human Stem Cell Research” (Guidelines), effective . These Guidelines apply to the expenditure of NIH funds for research using human embryonic stem cells and certain uses of human induced pluripotent stem cells. The Guidelines are based on the principles that responsible research with human embryonic stem cells has the potential to improve our understanding of human biology and aid in the discovery of new ways to prevent and treat illness, and that individuals donating embryos for research purposes should do so freely, with voluntary and informed consent. These Guidelines will ensure that NIH-funded research adheres to the highest ethical standards.
In order to ensure that all federally funded human stem cell research is conducted according to these same principles and to promote a uniform Federal policy across the executive branch, I hereby direct the heads of executive departments and agencies that support and conduct stem cell research to adopt these Guidelines, to the fullest extent practicable in light of legal authorities and obligations. I also direct those departments and agencies to submit to the Director of the Office of Management and Budget (OMB), within 90 days, proposed additions or revisions to any other guidance, policies, or procedures related to human stem cell research, consistent with Executive Order 13505 and this memorandum. The Director of the OMB shall, in coordination with the Director of NIH, review these proposals to ensure consistent implementation of Executive Order 13505 and this memorandum.
This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. Executive departments and agencies shall carry out the provisions of this memorandum to the extent permitted by law and consistent with their statutory and regulatory authorities and their enforcement mechanisms.
The Director of the OMB is hereby authorized and directed to publish this memorandum in the Federal Register.
Barack Obama.
Engaging in Public Health Research on the Causes and Prevention of Gun Violence
Memorandum of President of the United States, , 78 F.R. 4295, provided that:
Memorandum for the Secretary of Health and Human Services
In addition to being a law enforcement challenge, gun violence is also a serious public health issue that affects thousands of individuals, families, and communities across the Nation. Each year in the United States there are approximately 30,000 firearm-related deaths, and approximately 11,000 of those deaths result from homicides. Addressing this critical issue requires a comprehensive, multifaceted approach.
Recent research suggests that, in developing such an approach, a broader public health perspective is imperative. Significant strides can be made by assessing the causes of gun violence and the successful efforts in place for preventing the misuse of firearms. Taking these steps will improve our understanding of the gun violence epidemic and will aid in the continued development of gun violence prevention strategies.
Therefore, by the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby direct the following:
Section 1. Research. The Secretary of Health and Human Services (Secretary), through the Director of the Centers for Disease Control and Prevention and other scientific agencies within the Department of Health and Human Services, shall conduct or sponsor research into the causes of gun violence and the ways to prevent it. The Secretary shall begin by identifying the most pressing research questions with the greatest potential public health impact, and by assessing existing public health interventions being implemented across the Nation to prevent gun violence.
Sec. 2. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Sec. 3. Publication. You are hereby authorized and directed to publish this memorandum in the Federal Register.
Barack Obama.
Credits
1944–2022 · 29 acts
- 1944July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691
- 1946July 3, 1946, ch. 538, § 7(a), (b), 60 Stat. 423
- 1948June 16, 1948, ch. 481, § 4(e), (f), 62 Stat. 467
- 1948June 24, 1948, ch. 621, § 4(e), (f), 62 Stat. 601
- 1948June 25, 1948, ch. 654, § 1, 62 Stat. 1017
- 1956July 3, 1956, ch. 510, § 4, 70 Stat. 490
- 1960Pub. L. 86–798, , 74 Stat. 1053
- 1962Pub. L. 87–838, § 2, , 76 Stat. 1073
- 1965Pub. L. 89–115, § 3, , 79 Stat. 448
- 1967Pub. L. 90–174, § 9, , 81 Stat. 540
- 1970Pub. L. 91–513, title I, § 3(a), , 84 Stat. 1241
- 1970Pub. L. 91–515, title II, § 292, , 84 Stat. 1308
- 1971Pub. L. 92–218, § 6(a)(2), , 85 Stat. 785
- 1972Pub. L. 92–423, § 7(b), , 86 Stat. 687
- 1974Pub. L. 93–282, title I, § 122(b), , 88 Stat. 132
- 1974Pub. L. 93–348, title I, § 104(a)(1), , 88 Stat. 346
- 1974Pub. L. 93–352, title I, § 111, , 88 Stat. 360
- 1976Pub. L. 94–278, title I, § 111, , 90 Stat. 405
- 1978Pub. L. 95–622, title II, §§ 261, 262, , 92 Stat. 3434
- 1979Pub. L. 96–88, title V, § 509(b), , 93 Stat. 695
- 1985Pub. L. 99–158, § 3(a)(5), , 99 Stat. 879
- 1986Pub. L. 99–570, title IV, § 4021(b)(2), , 100 Stat. 3207–124
- 1986Pub. L. 99–660, title I, § 104, , 100 Stat. 3751
- 1988Pub. L. 100–607, title I, § 163(1), (2), , 102 Stat. 3062
- 1993Pub. L. 103–43, title XX, § 2009, , 107 Stat. 213
- 2006Pub. L. 109–450, § 3(a), , 120 Stat. 3341
- 2016Pub. L. 114–255, div. A, title II, §§ 2012(a), 2013, 2035, 2043, , 130 Stat. 1049, 1050, 1062, 1074
- 2021Pub. L. 117–81, div. A, title XVII, § 1702(j)(1)(A), , 135 Stat. 2159
- 2022Pub. L. 117–103, div. P, title I, § 141(a), , 136 Stat. 797.
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(July 1, 1944, ch. 373, title III, § 301, 58 Stat. 691; July 3, 1946, ch. 538, § 7(a), (b), 60 Stat. 423; June 16, 1948, ch. 481, § 4(e), (f), 62 Stat. 467; June 24, 1948, ch. 621, § 4(e), (f), 62 Stat. 601; June 25, 1948, ch. 654, § 1, 62 Stat. 1017; July 3, 1956, ch. 510, § 4, 70 Stat. 490; Pub. L. 86–798, , 74 Stat. 1053; Pub. L. 87–838, § 2, , 76 Stat. 1073; Pub. L. 89–115, § 3, , 79 Stat. 448; Pub. L. 90–174, § 9, , 81 Stat. 540; Pub. L. 91–513, title I, § 3(a), , 84 Stat. 1241; Pub. L. 91–515, title II, § 292, , 84 Stat. 1308; Pub. L. 92–218, § 6(a)(2), , 85 Stat. 785; Pub. L. 92–423, § 7(b), , 86 Stat. 687; Pub. L. 93–282, title I, § 122(b), , 88 Stat. 132; Pub. L. 93–348, title I, § 104(a)(1), , 88 Stat. 346; Pub. L. 93–352, title I, § 111, , 88 Stat. 360; Pub. L. 94–278, title I, § 111, , 90 Stat. 405; Pub. L. 95–622, title II, §§ 261, 262, , 92 Stat. 3434; Pub. L. 96–88, title V, § 509(b), , 93 Stat. 695; Pub. L. 99–158, § 3(a)(5), , 99 Stat. 879; Pub. L. 99–570, title IV, § 4021(b)(2), , 100 Stat. 3207–124; Pub. L. 99–660, title I, § 104, , 100 Stat. 3751; Pub. L. 100–607, title I, § 163(1), (2), , 102 Stat. 3062; Pub. L. 103–43, title XX, § 2009, , 107 Stat. 213; Pub. L. 109–450, § 3(a), , 120 Stat. 3341; Pub. L. 114–255, div. A, title II, §§ 2012(a), 2013, 2035, 2043, , 130 Stat. 1049, 1050, 1062, 1074; Pub. L. 117–81, div. A, title XVII, § 1702(j)(1)(A), , 135 Stat. 2159; Pub. L. 117–103, div. P, title I, § 141(a), , 136 Stat. 797.)