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PL 99-158
Health Research Extension Act of 1985

              HEALTH RESEARCH EXTENSION ACT OF 1985
              PUBLIC LAW 99-158, November 20, 1985

                      "ANIMALS IN RESEARCH"


   "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, paraltics, and euthanasia for animals in such
research; and
     "(B) appropriate presurgical 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
stud 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
sub-paragraph (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 an
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 violations.

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

   "(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 an 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."