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42 U.S.C. § 287 — National Center for Advancing Translational Sciences
Federal law — U.S. Code and appendices · legal_authorities
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim)) 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) th
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Stable record: federal_law:legal_authorities:record_usc_a65ed8fac4027a46cf2ee0aa
Source file: Laws/federal/codes/united-states-code/title-42/section-287-national-center-for-advancing-translational-sciences--728ae68a6d.md
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Source location: Title 42, Chapter 6A, § 287; chapter-6a-public-health-service.md
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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 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim)) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Requirements for grants** In determining whether to award a grant to an applicant under the Shared Instrumentation Grant Program, the Director of NIH, acting through the Office of the Director of NIH, shall consider—
(1) the extent to which an award for the specific instrument involved would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited;
(2) with respect to the instrument involved, the availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation;
(3) the adequacy of the organizational plan for the use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any;
(4) the applicant’s commitment for continued support of the utilization and maintenance of the instrument; and
(5) the extent to which the specified instrument will be shared and the benefit of the proposed instrument to the overall research community to be served.
**(b) Peer review** In awarding grants under the program described in subsection (a), the Director of NIH, acting through the Office of the Director of NIH, shall comply with the peer review requirements in [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim).
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 283n
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Request by sponsor; preconditions; “rare disease or condition” defined**
(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—
(A) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim),
the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 11 See References in Text note below. respecting the designation of the drug.
(2) For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,0
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bb
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
When used in this chapter—
**(a)** The term “Service” means the Public Health Service;
**(b)** The term “Surgeon General” means the Surgeon General of the Public Health Service;
**(c)** Unless the context otherwise requires, the term “Secretary” means the Secretary of Health and Human Services.
**(d)** The term “regulations”, except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary;
**(e)** The term “executive department” means any executive department, agency, or independent establishment of the United States or any corporation wholly owned by the United States;
**(f)** Except as provided in sections 246(g)(4)(B),11 See References in Text note below. 247c(c)(1),1 254d(h)(3),1 263c(5),1 264(d), 292a(9),1 300a(c), 300f(13), and 300n(1) 1 of this title, the term “State” includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
**(g)** The term “possession” includes, among other possessions, Puerto Rico and the Virgin Islands;
**(h)** Repealed. Pub. L. 97–35, title IX, § 986(a), Aug. 13, 1981, 95 Stat. 603.
**(i)** The term “vessel” includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphibious contrivances;
**(j)** The term “habit-forming narcotic drug” or “narcotic” means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 202
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Federal law — U.S. Code and appendices · legal_authorities
Page 777
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 287
Editorial Notes
AMENDMENTS
1999—Subsec. (d). Pub. L. 106–129 substituted ‘‘Direc-
tor of the Agency for Healthcare Research and Qual-
ity’’ for ‘‘Administrator for Health Care Policy and Re-
search’’.
Statutory Notes and Related Subsidiaries
CONSTRUCTION
Pub. L. 103–43, § 1422(b), June 10, 1993, 107 Stat. 172,
provided that: ‘‘The amendments made by section 3 of
Public Law 102–410 (106 Stat. 2094) [amending section
299a–1 of this title], by section 1421 of this Act [enact-
ing this section], and by subsection (a) of this section
[amending section 299a–1 of this title] may not be con-
strued as terminating the information center on health
care technologies and health care technology assess-
ment established under section 904 of the Public Health
Service Act [42 U.S.C. 299a–2], as in effect on the day
before the date of the enactment of Public Law 102–410
[Oct. 13, 1992]. Such center shall be considered to be the
center established in section 478A of the Public Health
Service Act [42 U.S.C. 286d], as added by section 1421 of
this Act, and shall be subject to the provisions of such
section 478A.’’
PART E—OTHER AGENCIES OF NIH
SUBPART 1—NATIONAL CENTER FOR ADVANCING
TRANSLATIONAL SCIENCES
Editorial Notes
CODIFICATION
Pub. L. 112–74, div. F, title II, § 221(a)(1)(A), Dec. 23,
2011,
125
Stat.
1086,
substituted
‘‘advancing
translational sciences’’ for ‘‘research resources’’ in sub-
part heading.
§ 287.
National
Center
for
Advancing
Translational Sciences
(a) Purpose
The purpose of the National Center for Ad-
vancing Translational Sciences (in this subpart
referred to as the ‘‘Center’’) is to advance
translational sciences, including by—
(1) coordinating and developing resources
that leve
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 287
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.