
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC289d]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 289d. Animals in research


(a) Establishment of guidelines

    The Secretary, acting through the Director of NIH, shall establish 
guidelines for the following:
        (1) The proper care of animals to be used in biomedical and 
    behavioral research.
        (2) The proper treatment of animals while being used in such 
    research. Guidelines under this paragraph shall require--
            (A) the appropriate use of tranquilizers, analgesics, 
        anesthetics, paralytics, and euthanasia for animals in such 
        research; and
            (B) appropriate pre-surgical and post-surgical veterinary 
        medical and nursing care for animals in such research.

    Such guidelines shall not be construed to prescribe methods of 
    research.
        (3) The organization and operation of animal care committees in 
    accordance with subsection (b) of this section.

(b) Animal care committees; establishment; membership; functions

    (1) Guidelines of the Secretary under subsection (a)(3) of this 
section shall require animal care committees at each entity which 
conducts biomedical and behavioral research with funds provided under 
this chapter (including the National Institutes of Health and the 
national research institutes) to assure compliance with the guidelines 
established under subsection (a) of this section.
    (2) Each animal care committee shall be appointed by the chief 
executive officer of the entity for which the committee is established, 
shall be composed of not fewer than three members, and shall include at 
least one individual who has no association with such entity and at 
least one doctor of veterinary medicine.
    (3) Each animal care committee of a research entity shall--
        (A) review the care and treatment of animals in all animal study 
    areas and facilities of the research entity at least semi-annually 
    to evaluate compliance with applicable guidelines established under 
    subsection (a) of this section for appropriate animal care and 
    treatment;
        (B) keep appropriate records of reviews conducted under 
    subparagraph (A); and
        (C) for each review conducted under subparagraph (A), file with 
    the Director of NIH at least annually (i) a certification that the 
    review has been conducted, and (ii) reports of any violations of 
    guidelines established under subsection (a) of this section or 
    assurances required under paragraph (1) which were observed in such 
    review and which have continued after notice by the committee to the 
    research entity involved of the violations.

Reports filed under subparagraph (C) shall include any minority views 
filed by members of the committee.

(c) Assurances required in application or contract proposal; reasons for 
        use of animals; notice and comment requirements for promulgation 
        of regulations

    The Director of NIH shall require each applicant for a grant, 
contract, or cooperative agreement involving research on animals which 
is administered by the National Institutes of Health or any national 
research institute to include in its application or contract proposal, 
submitted after the expiration of the twelve-month period beginning on 
November 20, 1985--
        (1) assurances satisfactory to the Director of NIH that--
            (A) the applicant meets the requirements of the guidelines 
        established under paragraphs (1) and (2) of subsection (a) of 
        this section and has an animal care committee which meets the 
        requirements of subsection (b) of this section; and
            (B) scientists, animal technicians, and other personnel 
        involved with animal care, treatment, and use by the applicant 
        have available to them instruction or training in the humane 
        practice of animal maintenance and experimentation, and the 
        concept, availability, and use of research or testing methods 
        that limit the use of animals or limit animal distress; and

        (2) a statement of the reasons for the use of animals in the 
    research to be conducted with funds provided under such grant or 
    contract.

Notwithstanding subsection (a)(2) of section 553 of title 5, regulations 
under this subsection shall be promulgated in accordance with the notice 
and comment requirements of such section.

(d) Failure to meet guidelines; suspension or revocation of grant or 
        contract

    If the Director of NIH determines that--
        (1) the conditions of animal care, treatment, or use in an 
    entity which is receiving a grant, contract, or cooperative 
    agreement involving research on animals under this subchapter do not 
    meet applicable guidelines established under subsection (a) of this 
    section;
        (2) the entity has been notified by the Director of NIH of such 
    determination and has been given a reasonable opportunity to take 
    corrective action; and
        (3) no action has been taken by the entity to correct such 
    conditions;

the Director of NIH shall suspend or revoke such grant or contract under 
such conditions as the Director determines appropriate.

(e) Disclosure of trade secrets or privileged or confidential 
        information

    No guideline or regulation promulgated under subsection (a) or (c) 
of this section may require a research entity to disclose publicly trade 
secrets or commercial or financial information which is privileged or 
confidential.

(July 1, 1944, ch. 373, title IV, Sec. 495, as added Pub. L. 99-158, 
Sec. 2, Nov. 20, 1985, 99 Stat. 875.)


Prohibition on Funding of Projects Involving Use of Chimpanzees Obtained 
                              From the Wild

    Pub. L. 102-394, title II, Sec. 213, Oct. 6, 1992, 106 Stat. 1812, 
provided that: ``No funds appropriated under this Act or subsequent 
Departments of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Acts shall be used by the National 
Institutes of Health, or any other Federal agency, or recipient of 
Federal funds on any project that entails the capture or procurement of 
chimpanzees obtained from the wild. For purposes of this section, the 
term `recipient of Federal funds' includes private citizens, 
corporations, or other research institutions located outside of the 
United States that are recipients of Federal funds.''
    Similar provisions were contained in the following prior 
appropriation acts:
    Pub. L. 102-170, title II, Sec. 213, Nov. 26, 1991, 105 Stat. 1127.
    Pub. L. 101-517, title II, Sec. 211, Nov. 5, 1990, 104 Stat. 2209.
    Pub. L. 101-166, title II, Sec. 214, Nov. 21, 1989, 103 Stat. 1178.


                   Plan for Research Involving Animals

    Section 4 of Pub. L. 99-158 directed Director of National Institutes 
of Health to establish, not later than Oct. 1, 1986, a plan for research 
into methods of biomedical research and experimentation which reduces 
the use of animals in research or which produce less pain and distress 
in animals to develop methods found to be valid and reliable, to train 
scientists in use of such methods, to disseminate information on such 
methods and to establish an Interagency Coordinating Committee to assist 
in development of the plan, prior to repeal by Pub. L. 103-43, title II, 
Sec. 205(b), June 10, 1993, 107 Stat. 148. See section 283e of this 
title.
