Sec. 495.
(a) 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).
(b) (1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which
conducts biomedical and behavioral research with funds provided under this Act (including the National Institutes of
Health and the national research institutes) to assure compliance with
the guidelines established under subsection (a).
(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 semiannually to evaluate
compliance with applicable guidelines established under subsection (a)
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) 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 violation. Reports filed under subparagraph
(C) shall include any minority views filed by members of the committee.
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1/ Public Law 99-158, November 20, 1985.
NIST Administrative Manual 14.02 Appendix B
Animal Care and Use
(c) 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 the date of enactment
this section--
(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) and has an animal care committee
which meets the requirements of subsection (b); 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, United States Code, regulations
under this subsection shall be promulgated in accordance with the notice
and comment requirements of such section.
(d) 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 title do not meet applicable guidelines established
under subsection (a);
(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) No guideline or regulation promulgated under subsection (a) or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential.