PRIA, Government Policy, Made Personal

Summary

Creates a National Center for Advancing Translational Sciences to move lab discoveries toward real treatments. The Center must build and share resources and work with partners so research is faster and not duplicated or competing with industry. It can support infrastructure for all clinical trial phases, but normally can fund trials only through the end of phase IIB. It can fund phase III for a rare-disease treatment (as defined in 21 U.S.C. 360bb) only if it posts public notice for at least 120 days, no public or private group tells the Center in writing that it will carry the trials beyond phase IIB in time, and the government’s liability won’t exceed the Center’s award. Every two years the Center must publish a full list of what it supports, including molecules studied, trials, methods and tools, partnerships (with reasons, status, funding, and what moved to industry), other groups’ related work, new tools since the last report, and tools the FDA uses. The first report after December 13, 2016 must list all methods and tools developed by Center-supported research. The law does not allow the Secretary to disclose trade secrets or other confidential information covered by section 552(b)(4) of title 5 or section 1905 of title 18.

Title 42, §287

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

(a)Purpose

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)Clinical trial activities

(1)In general

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)Exception

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)Biennial report

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)

(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)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 supported by the Center.

(e)Rule of construction

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