42 U.S.C. § 286d — National Information Center

Page 776 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 286b–8 editing, and publication of reviews, abstracts, indices, handbooks, bibliographies, and related matter pertaining to scientific works and sci- entific developments. (b) Grants under subsection (a) in support of any single periodical publication may not be made for more than three years, except in those cases in which the Secretary determines that further support is necessary to carry out the purposes of subsection (a). (July 1, 1944, ch. 373, title IV, § 476, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 863.) § 286b–8. Grant payments, records, and audit (a) Payments under grants made under sec- tions 286b–3, 286b–4, 286b–5, 286b–6, and 286b–7 of this title may be made in advance or by way of reimbursement and in such installments as the Secretary shall prescribe by regulation after consultation with the Board. (b)(1) Each recipient of a grant under this sub- part shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit. (2) The Secretary and the Comptroller General of the United States, or any of their duly au- thorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to any grant re- ceived under this subpart. (July 1, 1944, ch. 373, title IV, § 477, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 863.) SUBPART 3—NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION § 286c. Purpose, establishment, functions, and funding of National Center for Biotechnology Information (a) Establishment In order to focus and expand the collection, storage, retrieval, and dissemination of the re- sults of biotechnology research by information systems, and to support and enhance the devel- opment of new information technologies to aid in the understanding of the molecular processes that control health and disease, there is estab- lished the National Center for Biotechnology In- formation (hereinafter in this section referred to as the ‘‘Center’’) in the National Library of Med- icine. (b) Functions The Secretary, through the Center and subject to section 286(d) of this title, shall— (1) design, develop, implement, and manage automated systems for the collection, storage, retrieval, analysis, and dissemination of knowledge concerning human molecular biol- ogy, biochemistry, and genetics; (2) perform research into advanced methods of computer-based information processing ca- pable of representing and analyzing the vast number of biologically important molecules and compounds; (3) enable persons engaged in biotechnology research and medical care to use systems de- veloped under paragraph (1) and methods de- scribed in paragraph (2); and (4) coordinate, as much as is practicable, ef- forts to gather biotechnology information on an international basis. (July 1, 1944, ch. 373, title IV, § 478, as added Pub. L. 100–607, title I, § 105, Nov. 4, 1988, 102 Stat. 3052; amended Pub. L. 103–43, title XIV, § 1402(b), June 10, 1993, 107 Stat. 171.) Editorial Notes AMENDMENTS 1993—Subsec. (c). Pub. L. 103–43 struck out subsec. (c) which read as follows: ‘‘For the purpose of performing the duties specified in subsection (b) of this section, there are authorized to be appropriated $8,000,000 for fiscal year 1989 and such sums as may be necessary for fiscal year 1990. Funds appropriated under this sub- section shall remain available until expended.’’ SUBPART 4—NATIONAL INFORMATION CENTER ON HEALTH SERVICES RESEARCH AND HEALTH CARE TECHNOLOGY § 286d. National Information Center (a) Establishment There is established within the Library an en- tity to be known as the National Information Center on Health Services Research and Health Care Technology (in this section referred to as the ‘‘Center’’). (b) Purpose The purpose of the Center is the collection, storage, analysis, retrieval, and dissemination of information on health services research, clin- ical practice guidelines, and on health care tech- nology, including the assessment of such tech- nology. Such purpose includes developing and maintaining data bases and developing and im- plementing methods of carrying out such pur- pose. (c) Electronic, convenient format; criteria for in- clusion The Director of the Center shall ensure that information under subsection (b) concerning clinical practice guidelines is collected and maintained electronically and in a convenient format. Such Director shall develop and publish criteria for the inclusion of practice guidelines and technology assessments in the information center database. (d) Coordination with Director of the Agency for Healthcare Research and Quality The Secretary, acting through the Center, shall coordinate the activities carried out under this section through the Center with related ac- tivities of the Director of the Agency for Healthcare Research and Quality. (July 1, 1944, ch. 373, title IV, § 478A, as added Pub. L. 103–43, title XIV, § 1421, June 10, 1993, 107 Stat. 171; amended Pub. L. 106–129, § 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.) Page 777 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287 Editorial Notes AMENDMENTS 1999—Subsec. (d). Pub. L. 106–129 substituted ‘‘Direc- tor of the Agency for Healthcare Research and Qual- ity’’ for ‘‘Administrator for Health Care Policy and Re- search’’. Statutory Notes and Related Subsidiaries CONSTRUCTION Pub. L. 103–43, § 1422(b), June 10, 1993, 107 Stat. 172, provided that: ‘‘The amendments made by section 3 of Public Law 102–410 (106 Stat. 2094) [amending section 299a–1 of this title], by section 1421 of this Act [enact- ing this section], and by subsection (a) of this section [amending section 299a–1 of this title] may not be con- strued as terminating the information center on health care technologies and health care technology assess- ment established under section 904 of the Public Health Service Act [42 U.S.C. 299a–2], as in effect on the day before the date of the enactment of Public Law 102–410 [Oct. 13, 1992]. Such center shall be considered to be the center established in section 478A of the Public Health Service Act [42 U.S.C. 286d], as added by section 1421 of this Act, and shall be subject to the provisions of such section 478A.’’ PART E—OTHER AGENCIES OF NIH SUBPART 1—NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES Editorial Notes CODIFICATION Pub. L. 112–74, div. F, title II, § 221(a)(1)(A), Dec. 23, 2011, 125 Stat. 1086, substituted ‘‘advancing translational sciences’’ for ‘‘research resources’’ in sub- part heading. § 287. National Center for Advancing Translational Sciences (a) Purpose The purpose of the National Center for Ad- vancing Translational Sciences (in this subpart referred to as the ‘‘Center’’) is to advance translational sciences, including by— (1) coordinating and developing resources that leverage basic research in support of translational science; and (2) developing partnerships and working co- operatively to foster synergy in ways that do not create duplication, redundancy, and com- petition with industry activities. (b) Clinical trial activities (1) In general The Center may develop and provide infra- structure and resources for all phases of clin- ical trials research. Except as provided in paragraph (2), the Center may support clinical trials only through the end of phase IIB. (2) Exception The Center may support clinical trial activi- ties through the end of phase III for a treat- ment for a rare disease or condition (as de- fined in section 360bb of title 21) so long as— (A) the Center gives public notice for a pe- riod of at least 120 days of the Center’s in- tention to support the clinical trial activi- ties in phase III; (B) no public or private organization pro- vides credible written intent to the Center that the organization has timely plans to further the clinical trial activities or con- duct clinical trials of a similar nature be- yond phase IIB; and (C) the Center ensures that support of the clinical trial activities in phase III will not increase the Federal Government’s liability beyond the award value of the Center’s sup- port. (c) Biennial report The Center shall publish a report on a biennial basis that, with respect to all research sup- ported by the Center, includes a complete list of— (1) the molecules being studied; (2) clinical trial activities being conducted; (3) the methods and tools in development; (4) ongoing partnerships, including— (A) the rationale for each partnership; (B) the status of each partnership; (C) the funding provided by the Center to other entities pursuant to each partnership, and (D) the activities which have been trans- ferred to industry pursuant to each partner- ship; (5) known research activity of other entities that is or will expand upon research activity of the Center; (6) the methods and tools, if any, that have been developed since the last biennial report was prepared; and (7) the methods and tools, if any, that have been developed and are being utilized by the Food and Drug Administration to support medical product reviews. (d) Inclusion of list The first biennial report submitted under this section after December 13, 2016, shall include a complete list of all of the methods and tools, if any, which have been developed by research sup- ported by the Center. (e) Rule of construction Nothing in this section shall be construed as authorizing the Secretary to disclose any infor- mation that is a trade secret, or other privileged or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18. (July 1, 1944, ch. 373, title IV, § 479, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 864; amended Pub. L. 103–43, title XV, § 1501(2)(B), June 10, 1993, 107 Stat. 172; Pub. L. 112–74, div. F, title II, § 221(a)(1)(C), Dec. 23, 2011, 125 Stat. 1086; Pub. L. 114–255, div. A, title II, §§ 2037, 2042(e), Dec. 13, 2016, 130 Stat. 1063, 1073.) Editorial Notes AMENDMENTS 2016—Subsec. (b)(1). Pub. L. 114–255, § 2037(a)(1), sub- stituted ‘‘phase IIB’’ for ‘‘phase IIA’’. Subsec. (b)(2). Pub. L. 114–255, § 2037(a)(2)(A), sub- stituted ‘‘phase III’’ for ‘‘phase IIB’’ in introductory provisions. Subsec. (b)(2)(A). Pub. L. 114–255, § 2037(a)(2)(B), sub- stituted ‘‘phase III’’ for ‘‘phase IIB’’. Subsec. (b)(2)(B). Pub. L. 114–255, § 2037(a)(2)(C), sub- stituted ‘‘phase IIB’’ for ‘‘phase IIA’’. Subsec. (b)(2)(C). Pub. L. 114–255, § 2037(a)(2)(D), sub- stituted ‘‘phase III’’ for ‘‘phase IIB’’.