§287 — Title 42 The Public Health and Welfare | U.S. Code

Summary

Creates the National Center for Advancing Translational Sciences to help turn basic research into real medical treatments. The Center must build and share resources and work with others so efforts add up instead of duplicating or competing with industry. It can provide infrastructure for all clinical trial stages, but may only fund trials through the end of phase IIB unless the trial is for a rare disease treatment. For rare disease phase III support, the Center must give at least 120 days public notice, receive no credible written plans from another organization to continue the work beyond phase IIB, and make sure federal liability does not exceed the award amount. Every two years the Center must publish a report listing molecules studied, clinical trial work, methods and tools in development, partnerships (with reasons, status, funding, and what was moved to industry), related outside research, new tools since the last report, and tools used by the FDA for reviews. The first report after December 13, 2016 must list all methods and tools developed by Center-funded research. The Center may not disclose trade secrets or other confidential information protected under 5 U.S.C. 552(b)(4) or 18 U.S.C. 1905.

Title 42, §287

The Public Health and Welfare — Source: USLM XML via OLRC

(a)The purpose of the National Center for Advancing 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 cooperatively to foster synergy in ways that do not create duplication, redundancy, and competition with industry activities.

(b)(1)The Center may develop and provide infrastructure and resources for all phases of clinical trials research. Except as provided in paragraph (2), the Center may support clinical trials only through the end of phase IIB.

(2)The Center may support clinical trial activities through the end of phase III for a treatment for a rare disease or condition (as defined in section 360bb of title 21) so long as—

(A)the Center gives public notice for a period of at least 120 days of the Center’s intention to support the clinical trial activities in phase III;

(B)no public or private organization provides credible written intent to the Center that the organization has timely plans to further the clinical trial activities or conduct clinical trials of a similar nature beyond 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 support.

(c)The Center shall publish a report on a biennial basis that, with respect to all research supported 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 transferred to industry pursuant to each partnership;

(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)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 supported by the Center.

(e)Nothing in this section shall be construed as authorizing the Secretary to disclose any information 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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2016—Subsec. (b)(1). Pub. L. 114–255, § 2037(a)(1), substituted “phase IIB” for “phase IIA”. Subsec. (b)(2). Pub. L. 114–255, § 2037(a)(2)(A), substituted “phase III” for “phase IIB” in introductory provisions. Subsec. (b)(2)(A). Pub. L. 114–255, § 2037(a)(2)(B), substituted “phase III” for “phase IIB”. Subsec. (b)(2)(B). Pub. L. 114–255, § 2037(a)(2)(C), substituted “phase IIB” for “phase IIA”. Subsec. (b)(2)(C). Pub. L. 114–255, § 2037(a)(2)(D), substituted “phase III” for “phase IIB”. Subsec. (c). Pub. L. 114–255, § 2042(e), substituted “Biennial” for “Annual” in heading and “a report on a biennial 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 purpose 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 engaged in health-related research by developing and supporting 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 Resources”.

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.

§287 National Center for Advancing Translational Sciences