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42 U.S.C. § 289d — Animals in research

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 289d — Animals in research

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Stable record: federal_law:legal_authorities:record_usc_c4265e0fa484023b60f8f404
Source file: Laws/federal/codes/united-states-code/title-42/section-289d-animals-in-research--5c37195994.md
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Source location: Title 42, Chapter 6A, § 289d; chapter-6a-public-health-service.md

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**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim), 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.

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 283e — Plan for use of animals in research

**(a) Preparation** The Director of NIH, after consultation with the committee established under subsection (e), shall prepare a plan— (1) for the National Institutes of Health to conduct or support research into— (A) methods of biomedical research and experimentation that do not require the use of animals; (B) methods of such research and experimentation that reduce the number of animals used in such research; (C) methods of such research and experimentation that produce less pain and distress in such animals; and (D) methods of such research and experimentation that involve the use of marine life (other than marine mammals); (2) for establishing the validity and reliability of the methods described in paragraph (1); (3) for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and (4) for training scientists in the use of such methods that have been found to be valid and reliable. **(b) Submission to Congressional committees** Not later than October 1, 1993, the Director of NIH shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, the plan required in subsection (a) and shall begin implementation of the plan. **(c) Periodic review and revision** The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a). A description of any revision made in the plan shall be included in the first biennial report under [section 283 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section283&num=0&edition=prelim) that is submitted after the revision is made. **(d) Dissemination of information** The Director of

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 283e

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 553 — Rule making

**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved— (1) a military or foreign affairs function of the United States; or (2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. **(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include— (1) a statement of the time, place, and nature of public rule making proceedings; (2) reference to the legal authority under which the rule is proposed; (3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and (4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov). Except when notice or hearing is required by statute, this subsection does not apply— (A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or (B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. **(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm

Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 553

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 300c–12 — Sudden infant death syndrome research

From the sums appropriated to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Secretary shall assure that there are applied to research of the type described in subparagraphs (A) and (B) of subsection (b)(1) 11 See References in Text note below. of this section such amounts each year as will be adequate, given the leads and findings then available from such research, in order to make maximum feasible progress toward identification of infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 300c–12

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 289d — Animals in research

Page 805 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289d section in the case of proposals for contracts for such research; (3) may provide administrative supplemental increases in existing grants and contracts to support new research relevant to such disease or disorder; and (4) shall disseminate, to health professionals and the public, information on the cause, pre- vention, and treatment of such disease or dis- order that has been developed in research as- sisted under this section. The amount of an increase in a grant or con- tract provided under paragraph (3) may not ex- ceed one-half the original amount of the grant or contract. (July 1, 1944, ch. 373, title IV, § 494, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875; amended Pub. L. 102–531, title III, § 312(d)(9), Oct. 27, 1992, 106 Stat. 3504; Pub. L. 109–482, title I, § 104(b)(1)(P), Jan. 15, 2007, 120 Stat. 3693.) Editorial Notes CODIFICATION In par. (2), ‘‘section 6101 of title 41’’ substituted for ‘‘section 3709 of the Revised Statutes (41 U.S.C. 5)’’ on authority of Pub. L. 111–350, § 6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts. AMENDMENTS 2007—Pub. L. 109–482 struck out subsec. (a) designa- tion before ‘‘If the Secretary’’ and subsec. (b) which read as follows: ‘‘Not later than 90 days after the end of a fiscal year, the Secretary shall report to the Com- mittee on Energy and Commerce of the House of Rep- resentatives and the Committee on Labor and Human Resources of the Senate on actions taken under sub- section (a) of this section in such fiscal year.’’ 1992—Subsec. (a). Pub. L. 102–531 substituted ‘‘Centers for Disease Control and Prevention’’ for ‘‘Centers for Disease Control’’. Statutory Notes and Related Subsidiaries EFFECT

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 289d

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