View all text of Subpart 1 [§ 287 - § 287a-4]

§ 287.
National Center for Advancing Translational Sciences
(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)
(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) 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)
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.

(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.)