42 U.S.C. § 285k — National Institute of General Medical

Page 744 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 285j–1 Editorial Notes AMENDMENTS 1989—Pub. L. 101–93 substituted ‘‘disease and’’ for ‘‘disease and and’’. 1988—Pub. L. 100–553 and Pub. L. 100–607 made iden- tical amendments, substituting ‘‘Neurological Dis- orders’’ for ‘‘Neurological and Communicative Dis- orders’’ and ‘‘and disorder and stroke’’ for ‘‘disorder, stroke, and disorders of human communication’’. Pub. L. 100–690 amended this section to read as if the amend- ments by Pub. L. 100–607 had not been enacted. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1988 AMENDMENT For effective date of amendment by Pub. L. 100–690, see section 2613(b)(1) of Pub. L. 100–690, set out as an Ef- fect of Enactment of Similar Provisions note under sec- tion 285m of this title. § 285j–1. Spinal cord regeneration research The Director of the Institute shall conduct and support research into spinal cord regenera- tion. (July 1, 1944, ch. 373, title IV, § 458, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857.) Statutory Notes and Related Subsidiaries INTERAGENCY COMMITTEE ON SPINAL CORD INJURY Pub. L. 99–158, § 7, Nov. 20, 1985, 99 Stat. 881, provided that: ‘‘(a) ESTABLISHMENT.—Within 90 days after the date of enactment of this Act [Nov. 20, 1985], the Secretary of Health and Human Services shall establish in the Na- tional Institute of Neurological and Communicative Diseases and Stroke an Interagency Committee on Spi- nal Cord Injury (hereafter in this section referred to as the ‘Interagency Committee’). The Interagency Com- mittee shall plan, develop, coordinate, and implement comprehensive Federal initiatives in research on spinal cord injury and regeneration. ‘‘(b) COMMITTEE COMPOSITION AND MEETINGS.—(1) The Interagency Committee shall consist of representatives from— ‘‘(A) the National Institute on Neurological and Communicative Disorders and Stroke; ‘‘(B) the Department of Defense; ‘‘(C) the Department of Education; ‘‘(D) the Veterans’ Administration; ‘‘(E) the Office of Science and Technology Policy; and ‘‘(F) the National Science Foundation; designated by the heads of such entities. ‘‘(2) The Interagency Committee shall meet at least four times. The Secretary of Health and Human Serv- ices shall select the Chairman of the Interagency Com- mittee from the members of the Interagency Com- mittee. ‘‘(c) REPORT.—Within the 18 months after the date of enactment of this Act [Nov. 20, 1985], the Interagency Committee shall prepare and transmit to the Congress a report concerning its activities under this section. The report shall include a description of research projects on spinal cord injury and regeneration con- ducted or supported by Federal agencies during such 18- month period, the nature and purpose of each such project, the amounts expended for each such project, and an identification of the entity which conducted the research under each such project. ‘‘(d) TERMINATION.—The Interagency Committee shall terminate 90 days after the date on which the Inter- agency Committee transmits the report required by subsection (c) to the Congress.’’ § 285j–2. Bioengineering research The Director of the Institute shall make grants or enter into contracts for research on the means to overcome paralysis of the extrem- ities through electrical stimulation and the use of computers. (July 1, 1944, ch. 373, title IV, § 459, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857.) § 285j–3. Research on multiple sclerosis The Director of the Institute shall conduct and support research on multiple sclerosis, espe- cially research on effects of genetics and hor- monal changes on the progress of the disease. (July 1, 1944, ch. 373, title IV, § 460, as added Pub. L. 103–43, title XII, § 1201, June 10, 1993, 107 Stat. 169.) SUBPART 11—NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES § 285k. National Institute of General Medical Sciences (a) General purpose The general purpose of the National Institute of General Medical Sciences is the conduct and support of research, training, and, as appro- priate, health information dissemination, and other programs with respect to general or basic medical sciences and related natural or behav- ioral sciences which have significance for two or more other national research institutes or are outside the general area of responsibility of any other national research institute. (b) Institutional development award program (1)(A) In the case of entities described in sub- paragraph (B), the Director of NIH, acting through the Director of the National Institute of General Medical Sciences, shall establish a pro- gram to enhance the competitiveness of such en- tities in obtaining funds from the national re- search institutes for conducting biomedical and behavioral research. (B) The entities referred to in subparagraph (A) are entities that conduct biomedical and be- havioral research and are located in a State in which the aggregate success rate for applica- tions to the national research institutes for as- sistance for such research by the entities in the State has historically constituted a low success rate of obtaining such funds, relative to such ag- gregate rate for such entities in other States. (C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in carrying out the program established under such subparagraph, may— (i) provide technical assistance to the enti- ties involved, including technical assistance in the preparation of applications for obtaining funds from the national research institutes; (ii) assist the entities in developing a plan for biomedical or behavioral research pro- posals; and (iii) assist the entities in implementing such plan. (2) The Director of NIH shall establish a pro- gram of supporting projects of biomedical or be- havioral research whose principal researchers are individuals who have not previously served as the principal researchers of such projects sup- ported by the Director. Page 745 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 285l–3 (July 1, 1944, ch. 373, title IV, § 461, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended Pub. L. 112–74, div. F, title II, § 221(b)(5), Dec. 23, 2011, 125 Stat. 1088.) Editorial Notes CODIFICATION Section 282(g) of this title, which was transferred and redesignated as subsec. (b) of this section by Pub. L. 112–74, div. F, title II, § 221(b)(5)(B), Dec. 23, 2011, 125 Stat. 1088, was based on act July 1, 1944, ch. 373, title IV, § 402(g), as added Pub. L. 103–43, title II, § 202, June 10, 1993, 107 Stat. 144. AMENDMENTS 2011—Pub. L. 112–74, § 221(b)(5)(A), substituted ‘‘Na- tional Institute of General Medical Sciences’’ for ‘‘Pur- pose of Institute’’ in section catchline, designated ex- isting provisions as subsec. (a), and inserted subsec. heading. Subsec. (b). Pub. L. 112–74, § 221(b)(5)(C)(i), (ii), in- serted heading and realigned margins. Pub. L. 112–74, § 221(b)(5)(B), transferred subsec. (g) of section 282 of this title and redesignated it as subsec. (b) of this section. See Codification note above. Subsec. (b)(1)(A). Pub. L. 112–74, § 221(b)(5)(C)(iii), sub- stituted ‘‘acting through the Director of the National Institute of General Medical Sciences’’ for ‘‘acting through the Director of the National Center for Re- search Resources’’. SUBPART 12—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES § 285l. Purpose of Institute The general purpose of the National Institute of Environmental Health Sciences (in this sub- part referred to as the ‘‘Institute’’) is the con- duct and support of research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly. (July 1, 1944, ch. 373, title IV, § 463, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 857; amended Pub. L. 103–43, title XIII, § 1301(b), June 10, 1993, 107 Stat. 170.) Editorial Notes AMENDMENTS 1993—Pub. L. 103–43 inserted ‘‘(in this subpart referred to as the ‘Institute’)’’ after ‘‘Sciences’’. § 285l–1. Applied Toxicological Research and Testing Program (a) There is established within the Institute a program for conducting applied research and testing regarding toxicology, which program shall be known as the Applied Toxicological Re- search and Testing Program. (b) In carrying out the program established under subsection (a), the Director of the Insti- tute shall, with respect to toxicology, carry out activities— (1) to expand knowledge of the health effects of environmental agents; (2) to broaden the spectrum of toxicology in- formation that is obtained on selected chemi- cals; (3) to develop and validate assays and proto- cols, including alternative methods that can reduce or eliminate the use of animals in acute or chronic safety testing; (4) to establish criteria for the validation and regulatory acceptance of alternative test- ing and to recommend a process through which scientifically validated alternative methods can be accepted for regulatory use; (5) to communicate the results of research to government agencies, to medical, scientific, and regulatory communities, and to the pub- lic; and (6) to integrate related activities of the De- partment of Health and Human Services. (July 1, 1944, ch. 373, title IV, § 463A, as added Pub. L. 103–43, title XIII, § 1301(a), June 10, 1993, 107 Stat. 169.) § 285l–2. Definitions In sections 285l–2 to 285l–5 of this title: (1) Alternative test method The term ‘‘alternative test method’’ means a test method that— (A) includes any new or revised test meth- od; and (B)(i) reduces the number of animals re- quired; (ii) refines procedures to lessen or elimi- nate pain or distress to animals, or enhances animal well-being; or (iii) replaces animals with non-animal sys- tems or one animal species with a phylogenetically lower animal species, such as replacing a mammal with an inverte- brate. (2) ICCVAM test recommendation The term ‘‘ICCVAM test recommendation’’ means a summary report prepared by the ICCVAM characterizing the results of a sci- entific expert peer review of a test method. (Pub. L. 106–545, § 2, Dec. 19, 2000, 114 Stat. 2721.) Editorial Notes CODIFICATION Section was enacted as part of the ICCVAM Author- ization Act of 2000, and not as part of the Public Health Service Act which comprises this chapter. § 285l–3. Interagency Coordinating Committee on the Validation of Alternative Methods (a) In general With respect to the interagency coordinating committee that is known as the Interagency Co- ordinating Committee on the Validation of Al- ternative Methods (referred to in sections 285l–2 to 285l–5 of this title as ‘‘ICCVAM’’) and that was established by the Director of the National Institute of Environmental Health Sciences for purposes of section 285l–1(b) of this title, the Di- rector of the Institute shall designate such com- mittee as a permanent interagency coordinating committee of the Institute under the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Meth- ods. Sections 285l–2 to 285l–5 of this title may not be construed as affecting the authorities of such Director regarding ICCVAM that were in effect on the day before December 19, 2000, except to the extent inconsistent with sections 285l–2 to 285l–5 of this title.