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 EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title. § 289c–1. Collaborative use of certain health serv- ices research funds The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental health be used collaboratively, as appro- priate, and in consultation with the Agency for Healthcare Research and Quality. (July 1, 1944, ch. 373, title IV, § 494A, as added Pub. L. 102–321, title I, § 125, July 10, 1992, 106 Stat. 366; amended Pub. L. 103–43, title XX, § 2016(c), June 10, 1993, 107 Stat. 218; Pub. L. 104–66, title I, § 1062(b), Dec. 21, 1995, 109 Stat. 720; Pub. L. 105–362, title VI, § 601(a)(1)(F), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.) Editorial Notes REFERENCES IN TEXT Subparts 14, 15 and 16 of part C, referred to in text, are classified to sections 285n et seq., 285o et seq., and 285p et seq., respectively, of this title. AMENDMENTS 1999—Pub. L. 106–129, which directed the substitution of ‘‘Agency for Healthcare Research and Quality’’ for ‘‘Agency for Health Care Policy and Research’’, was ex- ecuted by making the substitution for ‘‘Agency for Health Care Policy Research’’, to reflect the probable intent of Congress. 1998—Pub. L. 105–362 struck out heading and designa- tion of subsec. (a) and heading and text of subsec. (b). Text of subsec. (b) read as follows: ‘‘Not later than De- cember 30, 1993, and each December 30 thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representa- tives and the Committee on Labor and Human Re- sources of the Senate, a report concerning the activi- ties carried out with the amounts referred to in sub- section (a) of this section.’’ 1995—Subsec. (b). Pub. L. 104–66 substituted ‘‘Decem- ber 30, 1993, and each December 30 thereafter’’ for ‘‘Sep- tember 30, 1993, and annually thereafter’’. 1993—Subsec. (b). Pub. L. 103–43 substituted ‘‘Sep- tember 30, 1993’’ for ‘‘May 3, 1993’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Oct. 1, 1992, with provision for pro- grams providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as an Effective Date of 1992 Amendment note under section 236 of this title. § 289d. Animals in research (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 eu- thanasia for animals in such research; and (B) appropriate pre-surgical and post-sur- gical veterinary medical and nursing care for animals in such research. Such guidelines shall not be construed to pre- scribe methods of research. (3) The organization and operation of animal care committees in accordance with sub- section (b). (b) Animal care committees; establishment; mem- bership; functions (1) Guidelines of the Secretary under sub- section (a)(3) shall require animal care commit- tees at each entity which conducts biomedical and behavioral research with funds provided under this chapter (including the National Insti- tutes of Health and the national research insti- tutes) to assure compliance with the guidelines established under subsection (a). (2) Each animal care committee shall be ap- pointed by the chief executive officer of the en- tity for which the committee is established, shall be composed of not fewer than three mem- bers, 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 ani- mals in all animal study areas and facilities of Page 806 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289e the research entity at least semi-annually to evaluate compliance with applicable guide- lines established under subsection (a) for ap- propriate animal care and treatment; (B) keep appropriate records of reviews con- ducted under subparagraph (A); and (C) for each review conducted under subpara- graph (A), file with the Director of NIH at least annually (i) a certification that the re- view 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 re- view and which have continued after notice by the committee to the research entity involved of the violations. Reports filed under subparagraph (C) shall in- clude any minority views filed by members of the committee. (c) Assurances required in application or con- tract proposal; reasons for use of animals; notice and comment requirements for pro- mulgation of regulations The Director of NIH shall require each appli- cant for a grant, contract, or cooperative agree- ment involving research on animals which is ad- ministered 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 para- graphs (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, avail- ability, and use of research or testing meth- ods 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 rev- ocation 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 Direc- tor of NIH of such determination and has been given a reasonable opportunity to take correc- tive 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 enti- ty to disclose publicly trade secrets or commer- cial or financial information which is privileged or confidential. (July 1, 1944, ch. 373, title IV, § 495, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 875.) 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 In- stitutes of Health, or any other Federal agency, or re- cipient 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 ‘recipi- ent of Federal funds’ includes private citizens, corpora- tions, 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 Na- tional Institutes of Health to establish, not later than Oct. 1, 1986, a plan for research into methods of bio- medical 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. § 289e. Use of appropriations (a) Appropriations to carry out the purposes of this subchapter, unless otherwise expressly pro- vided, may be expended in the District of Colum- bia for— (1) personal services; (2) stenographic recording and translating services; (3) travel expenses (including the expenses of attendance at meetings when specifically au- thorized by the Secretary); (4) rental; (5) supplies and equipment; (6) purchase and exchange of medical books, books of reference, directories, periodicals, newspapers, and press clippings; (7) purchase, operation, and maintenance of passenger motor vehicles; (8) printing and binding (in addition to that otherwise provided by law); and (9) all other necessary expenses in carrying out this subchapter.