42 USC 287 - National Center for Advancing Translational Sciences

U.S Code last checked for updates: May 03, 2024

§ 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)

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

(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

(e)

Rule of construction

(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.)

cite as: 42 USC 287