42 USC § 287 - National Center for Advancing Translational Sciences | Title 42 - The Public Health and Welfare | U.S. Code

USCPrelim is a preliminary release and may be subject to further revision before it is released again as a final version.

Current through Pub. L. 113-99. (See Public Laws for the current Congress.)

(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 IIA.

(2) Exception

The Center may support clinical trial activities through the end of phase IIB 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 IIB;

(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 IIA; and

(C) the Center ensures that support of the clinical trial activities in phase IIB will not increase the Federal Government’s liability beyond the award value of the Center’s support.

(c) Annual report

The Center shall publish an annual report 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; and

(5) known research activity of other entities that is or will expand upon research activity of the Center.

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(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 IIA.

(2) Exception

The Center may support clinical trial activities through the end of phase IIB 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 IIB;

(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 IIA; and

(C) the Center ensures that support of the clinical trial activities in phase IIB will not increase the Federal Government’s liability beyond the award value of the Center’s support.

(c) Annual report

The Center shall publish an annual report 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; and

(5) known research activity of other entities that is or will expand upon research activity of the Center.

Source

(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.)

Amendments

2011—Pub. L. 112–74amended 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. 103–43substituted “the National Center for Research Resources (in this subpart referred to as the ‘Center’)” for “the Division of Research Resources”.

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.

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, May 21, 2013

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

How To Use

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The Session Year indicates which session of Congress was responsible for the changes classified. The Congress number forms the first part of the Public Law number; each Congress has two sessions.

Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

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The Statutes at Large references have been rendered in the format used as page numbers in the Public Law web pages to which we link, to facilitate copy-paste into browser "find on this (web) page" tools. We are still working on a more direct link facility.

For serious comparison work, we suggest copying all or a portion of the Public Law text into your favorite text editor, for convenient content traversal and window control.

Sections with change type "new" are a special case, still under development. All are now listed, at the title level only.

You will find that occassionally a specific update you notice in a Public Law listed in a classification table will already have made it into the Code. We assume this is an artifact of the LRC edit process. The LII does not edit the LRC content.

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General Reference

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You can look for information about what it is and is not, which titles are positive law, the schedule of Supplements, etc. Under download you can find the source data we use here (GPO locator files), as well as, PDF files that look just like the paper books (these may be rather large).

Refer to the Thomas site for changes that have not yet made it into the classification tables.

42 USC	Description of Change	Session Year	Public Law	Statutes at Large

42 USC § 287 - National Center for Advancing Translational Sciences

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