42 U.S.C. § 289e — Use of appropriations

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. Page 807 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 289g Such appropriations may be expended by con- tract if deemed necessary, without regard to section 6101 of title 41. (b)(1) None of the amounts appropriated under this chapter for the purposes of this subchapter may be obligated for the construction of facili- ties (including the acquisition of land) unless a provision of this subchapter establishes express authority for such purpose and unless the Act making appropriations under such provision specifies that the amounts appropriated are available for such purpose. (2) Any grants, cooperative agreements, or contracts authorized in this subchapter for the construction of facilities may be awarded only on a competitive basis. (July 1, 1944, ch. 373, title IV, § 496, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 101–190, § 8, Nov. 29, 1989, 103 Stat. 1695; Pub. L. 103–43, title XX, § 2008(b)(15), June 10, 1993, 107 Stat. 211.) Editorial Notes CODIFICATION In subsec. (a), ‘‘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 Con- tracts. AMENDMENTS 1993—Subsec. (a). Pub. L. 103–43 substituted ‘‘Appro- priations to carry out the purposes of this subchapter’’ for ‘‘Such appropriations’’. 1989—Subsec. (a). Pub. L. 101–190 designated existing provisions as subsec. (a), struck out first sentence which read as follows: ‘‘Appropriations to carry out the purposes of this subchapter shall be available for the acquisition of land or the erection of buildings only if so specified.’’, and added subsec. (b). Statutory Notes and Related Subsidiaries CONSTRUCTION OF BIOMEDICAL FACILITIES FOR DEVEL- OPMENT AND BREEDING OF SPECIALIZED STRAINS OF MICE Pub. L. 101–190, §§ 1–7, Nov. 29, 1989, 103 Stat. 1691–1695, as amended by Pub. L. 101–374, § 4(a), (c)(1), Aug. 15, 1990, 104 Stat. 458, 459, authorized a reservation of funds for making a grant to construct facilities for develop- ment and breeding of specialized strains of mice for use in biomedical research, provided for a competitive grant award process, required applicant for the grant to agree to a twenty-year transferable obligation, re- stricted grant applicant to public or nonprofit private status, with assurances of sufficient financial re- sources, set forth other grant requirements, and speci- fied consequences of failure to comply with agreements and violation of the twenty-year obligation. § 289f. Gifts and donations; memorials The Secretary may, in accordance with sec- tion 238 of this title, accept conditional gifts for the National Institutes of Health or a national research institute or for the acquisition of grounds or for the erection, equipment, or main- tenance of facilities for the National Institutes of Health or a national research institute. Dona- tions of $50,000 or over for the National Insti- tutes of Health or a national research institute for carrying out the purposes of this subchapter may be acknowledged by the establishment within the National Institutes of Health or a na- tional research institute of suitable memorials to the donors. (July 1, 1944, ch. 373, title IV, § 497, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 877; amended Pub. L. 99–660, title III, § 311(b)(1), Nov. 14, 1986, 100 Stat. 3779; Pub. L. 100–607, title II, § 204(3), Nov. 4, 1988, 102 Stat. 3079; Pub. L. 100–690, title II, § 2620(b)(2), Nov. 18, 1988, 102 Stat. 4244; Pub. L. 101–381, title I, § 102(5), Aug. 18, 1990, 104 Stat. 586; Pub. L. 103–43, title XX, § 2010(b)(6), June 10, 1993, 107 Stat. 214.) Editorial Notes AMENDMENTS 1993—Pub. L. 103–43 substituted ‘‘section 238’’ for ‘‘section 300aaa’’. 1990—Pub. L. 101–381 made technical amendment to reference to section 300aaa of this title to reflect re- numbering of corresponding section of original act. 1988—Pub. L. 100–690 made technical amendment to reference to section 300aaa of this title to reflect re- numbering of corresponding section of original act. Pub. L. 100–607 substituted ‘‘300aaa’’ for ‘‘300cc’’. 1986—Pub. L. 99–660 substituted ‘‘section 300cc of this title’’ for ‘‘section 300aa of this title’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–690 effective immediately after enactment of Pub. L. 100–607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100–690, set out as a note under section 242m of this title. EFFECTIVE DATE OF 1986 AMENDMENT Amendment by Pub. L. 99–660 effective Dec. 22, 1987, see section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title. § 289g. Fetal research (a) Conduct or support by Secretary; restrictions The Secretary may not conduct or support any research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimen- tation— (1) may enhance the well-being or meet the health needs of the fetus or enhance the prob- ability of its survival to viability; or (2) will pose no added risk of suffering, in- jury, or death to the fetus and the purpose of the research or experimentation is the devel- opment of important biomedical knowledge which cannot be obtained by other means. (b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same In administering the regulations for the pro- tection of human research subjects which— (1) apply to research conducted or supported by the Secretary; (2) involve living human fetuses in utero; and (3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations; or any successor to such regulations, the Sec- retary shall require that the risk standard (pub-