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42 U.S.C. § 289dAnimals in research

submitted 82 years ago by Pub. L. 99-158 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 738 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must set guidelines for the humane care of research animals. Research institutions must form animal care committees to enforce these guidelines. Grant applicants must promise to follow the guidelines and explain why they used animals. The government can suspend funding if an institution won't fix violations.

(a) Establishing guidelines. The Secretary, acting through the Director of NIH, must create guidelines covering three things. First, the guidelines must cover the proper care of animals used in biomedical and behavioral research. Second, they must cover the proper treatment of animals during that research. These treatment guidelines must require the right use of tranquilizers, painkillers, anesthetics, paralyzing drugs, and euthanasia. They must also require proper veterinary and nursing care for animals before and after surgery. The guidelines cannot tell researchers what research methods to use — only how to treat the animals. Third, the guidelines must cover how animal care committees are organized and run, as described in subsection (b). (b) Animal care committees. Every entity that does biomedical or behavioral research with money from this chapter — including the National Institutes of Health and the national research institutes — must have an animal care committee. This committee makes sure the entity follows the guidelines from subsection (a). The entity's chief executive officer appoints the committee. It must have at least three members, including at least one person with no connection to the entity and at least one licensed veterinarian. The committee must review the entity's animal care and facilities at least twice a year to check for compliance. It must keep records of these reviews. At least once a year, it must file two things with the Director of NIH: a certification that the review happened, and any reports of guideline violations that the entity has not fixed after the committee warned it. These reports must include any dissenting views from committee members. (c) Assurances required in applications. Anyone applying for an NIH or national research institute grant, contract, or cooperative agreement involving animal research must include certain promises in their application. This requirement applies to applications submitted after the twelve months following November 20, 1985. The applicant must assure the Director of NIH that it meets the care and treatment guidelines and has an animal care committee that meets subsection (b)'s requirements. It must also assure that scientists, animal technicians, and other staff who work with the animals have access to training in humane animal care and in methods that limit animal use and animal distress. The applicant must also explain, in a statement, why the research needs to use animals. Any regulations written under this subsection must go through public notice and comment, even though a general rule in section 553(a)(2) of title 5 would normally allow the government to skip that step. (d) Failure to meet guidelines. The Director of NIH can suspend or revoke a grant or contract if three things are true: the entity's animal care doesn't meet the guidelines; the Director told the entity about the problem and gave it a fair chance to fix it; and the entity still didn't fix it. The Director decides the terms of the suspension or revocation. (e) Disclosure of trade secrets. No guideline made under subsection (a), and no regulation made under subsection (c), can force a research entity to publicly reveal its trade secrets or confidential commercial or financial information.
the actual law source: uscode.house.gov ↗public domain
(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.

Source credit: (July 1, 1944, ch. 373, title IV, § 495, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 99-158 · 99 Stat. 875

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-158 on 1944-07-01.

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