Health Research Extension Act of 1985
The Health Research Extension Act of 1985 (HREA) provides the legislative mandate for the PHS Policy. It was signed into law by the 99th U.S. Congress with the purpose to “amend the Public Health Service Act to revise and extend the authorities under that Act relating to the National Institutes of Health and National Research Institutes, and for other purposes.” (Pub. L. 99-158) Among other things, it instructs the Secretary of the U.S. Department of Health and Human Services (through the NIH Director) to establish a plan for the care and use of animals in biomedical and behavioral research relating to the NIH. This requirement is met in the 1986 edition of the PHS Policy and subsequent revisions.
Scroll down to the blue title banner to view an excerpt of the HREA. This excerpt can also be found in the PHS Policy, and the complete legal text is available online from the U.S. Government Printing Office. The Public Health Service Act (PHSA), as amended, contains language added by the HREA in 42 U.S. Code Subchapter III.
Excerpt From the 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:
"(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and
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.
"(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 sub-paragraph (A); and
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
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
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."
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