research institutes) to assure compliance with the guideHnes estab-
Hshed 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 violations.
Reports filed under subparagraph (C) shall include any 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 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 of 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
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 877
"(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.