Authorizing Legislation

ATTACHMENT 2

Section 301 of the Public Health Service Act [42 U.S.C. 241]

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.