42 U.S.C. § 287 — Untitled legal text

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’’. Page 778 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 287a 1 So in original. A closing parenthesis probably should precede the comma. 2 See References in Text note below. Subsec. (c). Pub. L. 114–255, § 2042(e), substituted ‘‘Bi- ennial’’ for ‘‘Annual’’ in heading and ‘‘a report on a bi- ennial basis’’ for ‘‘an annual report’’ in introductory provisions. Subsec. (c)(6), (7). Pub. L. 114–255, § 2037(b)(1), added pars. (6) and (7). Subsecs. (d), (e). Pub. L. 114–255, § 2037(b)(2), added subsecs. (d) and (e). 2011—Pub. L. 112–74 amended section generally. Prior to amendment, text read as follows: ‘‘The general pur- pose of the National Center for Research Resources (in this subpart referred to as the ‘Center’) is to strengthen and enhance the research environments of entities en- gaged in health-related research by developing and sup- porting essential research resources.’’ 1993—Pub. L. 103–43 substituted ‘‘the National Center for Research Resources (in this subpart referred to as the ‘Center’)’’ for ‘‘the Division of Research Re- sources’’. Statutory Notes and Related Subsidiaries SHARED INSTRUMENTATION GRANT PROGRAM Pub. L. 106–505, title III, § 305, Nov. 13, 2000, 114 Stat. 2335, which was formerly set out as a note under this section, was renumbered section 404L of act July 1, 1944, ch. 373, the Public Health Service Act, by Pub. L. 112–74, div. F, title II, § 221(b)(4)(A), Dec. 23, 2011, 125 Stat. 1088, and is classified to section 283n of this title. § 287a. Cures Acceleration Network (a) Definitions In this section: (1) Biological product The term ‘‘biological product’’ has the meaning given such term in section 262 of this title. (2) Drug; device The terms ‘‘drug’’ and ‘‘device’’ have the meanings given such terms in section 321 of title 21. (3) High need cure The term ‘‘high need cure’’ means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center— (A) is a priority to diagnose, mitigate, pre- vent, or treat harm from any disease or con- dition; and (B) for which the incentives of the com- mercial market are unlikely to result in its adequate or timely development. (4) Medical product The term ‘‘medical product’’ means a drug, device, biological product, or product that is a combination of drugs, devices, and biological products. (b) Establishment of the Cures Acceleration Net- work Subject to the appropriation of funds as de- scribed in subsection (g), there is established within the Center a program to be known as the Cures Acceleration Network (referred to in this section as ‘‘CAN’’), which shall— (1) be under the direction of the Director of the Center, taking into account the rec- ommendations of a CAN Review Board (re- ferred to in this section as the ‘‘Board’’), de- scribed in subsection (d); and (2) award grants and contracts to eligible en- tities, as described in subsection (e), to accel- erate the development of high need cures, in- cluding through the development of medical products and behavioral therapies. (c) Functions The functions of the CAN are to— (1) conduct and support revolutionary ad- vances in basic research, translating scientific discoveries from bench to bedside; (2) award grants and contracts to eligible en- tities to accelerate the development of high need cures; (3) provide the resources necessary for gov- ernment agencies, independent investigators, research organizations, biotechnology compa- nies, academic research institutions, and other entities to develop high need cures; (4) reduce the barriers between laboratory discoveries and clinical trials for new thera- pies; and (5) facilitate review in the Food and Drug Administration for the high need cures funded by the CAN, through activities that may in- clude— (A) the facilitation of regular and ongoing communication with the Food and Drug Ad- ministration regarding the status of activi- ties conducted under this section; (B) ensuring that such activities are co- ordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and ap- proval of countermeasures and products; and (C) connecting interested persons with ad- ditional technical assistance made available under section 360bbb–4 of title 21. (d) CAN Board (1) Establishment There is established a Cures Acceleration Network Review Board (referred to in this sec- tion as the ‘‘Board’’), which shall advise the Director of the Center on the conduct of the activities of the Cures Acceleration Network. (2) Membership (A) In general (i) Appointment The Board shall be comprised of 24 mem- bers who are appointed by the Secretary and who serve at the pleasure of the Sec- retary. (ii) Chairperson and Vice Chairperson The Secretary shall designate, from among the 24 members appointed under clause (i), one Chairperson of the Board (referred to in this section as the ‘‘Chair- person’’) and one Vice Chairperson. (B) Terms (i) In general Each member shall be appointed to serve a 4-year term, except that any member ap-