PRIA, Government Policy, Made Personal

Summary

The Director of NIH must create rules for how animals are cared for and treated in biomedical and behavioral research. The rules must require proper use of drugs like tranquilizers, painkillers, anesthetics, paralytics, and humane killing when needed. They must also require proper veterinary care before and after surgery. The rules cannot tell scientists how to do their experiments. Every institution that gets NIH research money must have an animal care committee to make sure the rules are followed. Each committee must be appointed by the institution’s chief executive, have no fewer than three members, include at least one person not connected to the institution, and include at least one veterinarian. Committees must review animal care at least twice a year, keep records, and send the NIH Director an annual certification plus reports of any ongoing violations (including any minority views). For grant or contract applications submitted after the 12-month period beginning on November 20, 1985, applicants must promise they meet the rules, have a committee, train staff in humane animal care and alternatives, and explain why animals are needed. Rules under that part must be made with the notice-and-comment process in section 553 of title 5. If an institution is out of compliance, is told about it, is given a fair chance to fix it, and does not fix it, the NIH Director may suspend or cancel the grant or contract. Rules cannot force public disclosure of trade secrets or confidential commercial or financial information.

Title 42, §289d

The Public Health and Welfare, Source: USLM XML via OLRC

(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).

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

(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 chapter (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 semi-annually 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)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) 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, 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);

(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) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Prohibition on Funding of Projects Involving Use of Chimpanzees Obtained From the Wild Pub. L. 102–394, title II, § 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, § 213, Nov. 26, 1991, 105 Stat. 1127. Pub. L. 101–517, title II, § 211, Nov. 5, 1990, 104 Stat. 2209. Pub. L. 101–166, title II, § 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, § 205(b), June 10, 1993, 107 Stat. 148. See section 283e of this title.

§289d Animals in Research

Summary

Title 42, §289d

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Citations & Metadata