Authorizing Legislation

ATTACHMENT A
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.