Public Health Service Act

Attachment A1
Legislative Authority: Public Health Service Act, 42 U.S.C. 241

TITLE III – GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
PART A – RESEARCH AND INVESTIGATION
IN GENERAL
Sec. 301 [Sec. 241] (a) 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) (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) 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.