Download:
pdf |
pdfAttachment 1
Section 301 of the Public Health Service Act (42 U.S.C. 241) as the authorizing law
Link below describes the different sections:
https://www.govinfo.gov/content/pkg/USCODE-2013-title42/html/USCODE-2013-title42-chap6A.htm
TITLE 42 > CHAPTER 6A > SUBCHAPTER II > Part A > § 241 § 241. Research and investigations generally
(a) 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— (1) collect and make available
through publications and other appropriate means, information as to, and the practical application of,
such research and other activities; (2) make available research facilities of the Service to appropriate
public authorities, and to health officials and scientists engaged in special study; (3) 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; (4) 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; (5) for purposes of study, admit and treat at institutions, hospitals, and stations
of the Service, persons not otherwise eligible for such treatment; (6) 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; (7) 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 2353 and 2354 of title 10, except that determination, approval, and certification required
thereby shall be by the Secretary of Health and Human Services; and (8) 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. 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. (b) Testing for carcinogenicity, teratogenicity,
mutagenicity, and other harmful biological effects; consultation (1) 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. (2) (A) 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. (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 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. (4) The Secretary shall publish a biennial report which contains— (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 and Human Services for the Secretary, or (II) 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. (5)
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. (c) 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. (d)
Protection of privacy of individuals who are research subjects 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.
File Type | application/pdf |
Author | Bozikis, Michele |
File Modified | 2020-07-16 |
File Created | 2020-07-16 |