42 USC CHAPTER 6A, SUBCHAPTER III, Part E: Other Agencies of NIH
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42 USC CHAPTER 6A, SUBCHAPTER III, Part E: Other Agencies of NIH
From Title 42—THE PUBLIC HEALTH AND WELFARECHAPTER 6A—PUBLIC HEALTH SERVICESUBCHAPTER III—NATIONAL RESEARCH INSTITUTES

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 subpart heading.

§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

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.)


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.

§287a. Cures Acceleration Network

(a) Definitions

In this section:

(1) Biological product

The term "biological product" has the meaning given such term in section 262 of this title.

(2) Drug; device

The terms "drug" and "device" have the meanings given such terms in section 321 of title 21.

(3) High need cure

The term "high need cure" means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center—

(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and

(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.

(4) Medical product

The term "medical product" means a drug, device, biological product, or product that is a combination of drugs, devices, and biological products.

(b) Establishment of the Cures Acceleration Network

Subject to the appropriation of funds as described in subsection (g), there is established within the Center a program to be known as the Cures Acceleration Network (referred to in this section as "CAN"), which shall—

(1) be under the direction of the Director of the Center, taking into account the recommendations of a CAN Review Board (referred to in this section as the "Board"), described in subsection (d); and

(2) award grants and contracts to eligible entities, as described in subsection (e), to accelerate the development of high need cures, including through the development of medical products and behavioral therapies.

(c) Functions

The functions of the CAN are to—

(1) conduct and support revolutionary advances in basic research, translating scientific discoveries from bench to bedside;

(2) award grants and contracts to eligible entities to accelerate the development of high need cures;

(3) provide the resources necessary for government agencies, independent investigators, research organizations, biotechnology companies, academic research institutions, and other entities to develop high need cures;

(4) reduce the barriers between laboratory discoveries and clinical trials for new therapies; and

(5) facilitate review in the Food and Drug Administration for the high need cures funded by the CAN, through activities that may include—

(A) the facilitation of regular and ongoing communication with the Food and Drug Administration regarding the status of activities conducted under this section;

(B) ensuring that such activities are coordinated with the approval requirements of the Food and Drug Administration, with the goal of expediting the development and approval of countermeasures and products; and

(C) connecting interested persons with additional technical assistance made available under section 360bbb–4 of title 21.

(d) CAN Board

(1) Establishment

There is established a Cures Acceleration Network Review Board (referred to in this section as the "Board"), which shall advise the Director of the Center on the conduct of the activities of the Cures Acceleration Network.

(2) Membership

(A) In general

(i) Appointment

The Board shall be comprised of 24 members who are appointed by the Secretary and who serve at the pleasure of the Secretary.

(ii) Chairperson and Vice Chairperson

The Secretary shall designate, from among the 24 members appointed under clause (i), one Chairperson of the Board (referred to in this section as the "Chairperson") and one Vice Chairperson.

(B) Terms

(i) In general

Each member shall be appointed to serve a 4-year term, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term.

(ii) Consecutive appointments; maximum terms

A member may be appointed to serve not more than 3 terms on the Board, and may not serve more than 2 such terms consecutively.

(C) Qualifications

(i) In general

The Secretary shall appoint individuals to the Board based solely upon the individual's established record of distinguished service in one of the areas of expertise described in clause (ii). Each individual appointed to the Board shall be of distinguished achievement and have a broad range of disciplinary interests.

(ii) Expertise

The Secretary shall select individuals based upon the following requirements:

(I) For each of the fields of—

(aa) basic research;

(bb) medicine;

(cc) biopharmaceuticals;

(dd) discovery and delivery of medical products;

(ee) bioinformatics and gene therapy;

(ff) medical instrumentation; and

(gg) regulatory review and approval of medical products,


the Secretary shall select at least 1 individual who is eminent in such fields.

(II) At least 4 individuals shall be recognized leaders in professional venture capital or private equity organizations and have demonstrated experience in private equity investing.

(III) At least 8 individuals shall represent disease advocacy organizations.

(3) Ex-officio members

(A) Appointment

In addition to the 24 Board members described in paragraph (2), the Secretary shall appoint as ex-officio members of the Board—

(i) a representative of the National Institutes of Health, recommended by the Secretary of the Department of Health and Human Services;

(ii) a representative of the Office of the Assistant Secretary of Defense for Health Affairs, recommended by the Secretary of Defense;

(iii) a representative of the Office of the Under Secretary for Health for the Veterans Health Administration, recommended by the Secretary of Veterans Affairs;

(iv) a representative of the National Science Foundation, recommended by the Chair of the National Science Board; and

(v) a representative of the Food and Drug Administration, recommended by the Commissioner of Food and Drugs.

(B) Terms

Each ex-officio member shall serve a 3-year term on the Board, except that the Chairperson may adjust the terms of the initial ex-officio members in order to provide for a staggered term of appointment for all such members.

(4) Responsibilities of the Board and the Director of the Center

(A) Responsibilities of the Board

(i) In general

The Board shall advise, and provide recommendations to, the Director of the Center with respect to—

(I) policies, programs, and procedures for carrying out the duties of the Director of the Center under this section; and

(II) significant barriers to successful translation of basic science into clinical application (including issues under the purview of other agencies and departments).

(ii) Report

In the case that the Board identifies a significant barrier, as described in clause (i)(II), the Board shall submit to the Secretary a report regarding such barrier.

(B) Responsibilities of the Director of the Center

With respect to each recommendation provided by the Board under subparagraph (A)(i), the Director of the Center shall respond in writing to the Board, indicating whether such Director will implement such recommendation. In the case that the Director of the Center indicates a recommendation of the Board will not be implemented, such Director shall provide an explanation of the reasons for not implementing such recommendation.

(5) Meetings

(A) In general

The Board shall meet 4 times per calendar year, at the call of the Chairperson.

(B) Quorum; requirements; limitations

(i) Quorum

A quorum shall consist of a total of 13 members of the Board, excluding ex-officio members, with diverse representation as described in clause (iii).

(ii) Chairperson or Vice Chairperson

Each meeting of the Board shall be attended by either the Chairperson or the Vice Chairperson.

(iii) Diverse representation

At each meeting of the Board, there shall be not less than one scientist, one representative of a disease advocacy organization, and one representative of a professional venture capital or private equity organization.

(6) Compensation and travel expenses

(A) Compensation

Members shall receive compensation at a rate to be fixed by the Chairperson but not to exceed a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5 for each day (including travel time) during which the member is engaged in the performance of the duties of the Board. All members of the Board who are officers or employees of the United States shall serve without compensation in addition to that received for their services as officers or employees of the United States.

(B) Travel expenses

Members of the Board shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for persons employed intermittently by the Federal Government under section 5703(b) 3 of title 5, while away from their homes or regular places of business in the performance of services for the Board.

(e) Grant program

(1) Supporting innovation

To carry out the purposes described in this section, the Director of the Center shall award contracts, grants, or cooperative agreements to the entities described in paragraph (2), to—

(A) promote innovation in technologies supporting the advanced research and development and production of high need cures, including through the development of medical products and behavioral therapies.

(B) accelerate the development of high need cures, including through the development of medical products, behavioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or

(C) help the award recipient establish protocols that comply with Food and Drug Administration standards and otherwise permit the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.

(2) Eligible entities

To receive assistance under paragraph (1), an entity shall—

(A) be a public or private entity, which may include a private or public research institution, an institution of higher education, a medical center, a biotechnology company, a pharmaceutical company, a disease advocacy organization, a patient advocacy organization, or an academic research institution;

(B) submit an application containing—

(i) a detailed description of the project for which the entity seeks such grant or contract;

(ii) a timetable for such project;

(iii) an assurance that the entity will submit—

(I) interim reports describing the entity's—

(aa) progress in carrying out the project; and

(bb) compliance with all provisions of this section and conditions of receipt of such grant or contract; and


(II) a final report at the conclusion of the grant period, describing the outcomes of the project; and


(iv) a description of the protocols the entity will follow to comply with Food and Drug Administration standards and regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product; and


(C) provide such additional information as the Director of the Center may require.

(3) Awards

(A) The cures acceleration partnership awards

(i) Initial award amount

Each award under this subparagraph shall be not more than $15,000,000 per project for the first fiscal year for which the project is funded, which shall be payable in one payment.

(ii) Funding in subsequent fiscal years

An eligible entity receiving an award under clause (i) may apply for additional funding for such project by submitting to the Director of the Center the information required under subparagraphs (B) and (C) of paragraph (2). The Director may fund a project of such eligible entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award under clause (i).

(iii) Matching funds

As a condition for receiving an award under this subsection, an eligible entity shall contribute to the project non-Federal funds in the amount of $1 for every $3 awarded under clauses (i) and (ii), except that the Director of the Center may waive or modify such matching requirement in any case where the Director determines that the goals and objectives of this section cannot adequately be carried out unless such requirement is waived.

(B) The cures acceleration grant awards

(i) Initial award amount

Each award under this subparagraph shall be not more than $15,000,000 per project for the first fiscal year for which the project is funded, which shall be payable in one payment.

(ii) Funding in subsequent fiscal years

An eligible entity receiving an award under clause (i) may apply for additional funding for such project by submitting to the Board the information required under subparagraphs (B) and (C) of paragraph (2). The Director of the Center may fund a project of such eligible entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award under clause (i).

(C) The cures acceleration flexible research awards

If the Director of the Center determines that the goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative agreement, the Director of the Center shall have flexible research authority to use other transactions to fund projects in accordance with the terms and conditions of this section. Awards made under such flexible research authority for a fiscal year shall not exceed 20 percent of the total funds appropriated under subsection (g)(1) for such fiscal year.

(4) Suspension of awards for defaults, noncompliance with provisions and plans, and diversion of funds; repayment of funds

The Director of the Center may suspend the award to any entity upon noncompliance by such entity with provisions and plans under this section or diversion of funds.

(5) Audits

The Director of the Center may enter into agreements with other entities to conduct periodic audits of the projects funded by grants or contracts awarded under this subsection.

(6) Closeout procedures

At the end of a grant or contract period, a recipient shall follow the closeout procedures under section 74.71 of title 45, Code of Federal Regulations (or any successor regulation).

(7) Review

A determination by the Director of the Center as to whether a drug, device, or biological product is a high need cure (for purposes of subsection (a)(3)) shall not be subject to judicial review.

(f) Competitive basis of awards

Any grant, cooperative agreement, or contract awarded under this section shall be awarded on a competitive basis.

(g) Authorization of appropriations

(1) In general

For purposes of carrying out this section, there are authorized to be appropriated $500,000,000 for fiscal year 2010, and such sums as may be necessary for subsequent fiscal years. Funds appropriated under this section shall be available until expended.

(2) Limitation on use of funds otherwise appropriated

No funds appropriated under this chapter, other than funds appropriated under paragraph (1), may be allocated to the Cures Acceleration Network.

(July 1, 1944, ch. 373, title IV, §480, formerly §402C, as added Pub. L. 111–148, title X, §10409(d), Mar. 23, 2010, 124 Stat. 978; renumbered §480 and amended Pub. L. 112–74, div. F, title II, §221(c)(1), Dec. 23, 2011, 125 Stat. 1089.)


Editorial Notes

References in Text

Section 262(i) of this title, referred to in subsec. (a)(3), was in the original "section 262(i)", and was translated as meaning section 351(i) of act July 1, 1944, ch. 373, to reflect the probable intent of Congress.

Codification

Section was formerly classified to section 282d of this title.

Prior Provisions

A prior section 287a, July 1, 1944, ch. 373, title IV, §480, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 864; amended Pub. L. 101–381, title I, §102(3), Aug. 18, 1990, 104 Stat. 586; Pub. L. 102–405, title III, §302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L. 103–43, title XV, §1501(2)(C), (D), title XX, §§2008(b)(12), 2010(b)(4), June 10, 1993, 107 Stat. 172, 173, 211, 214, related to the advisory council for the National Center for Research Resources, prior to repeal by Pub. L. 112–74, div. F, title II, §221(a)(1)(B), Dec. 23, 2011, 125 Stat. 1086.

Amendments

2011—Pub. L. 112–74, §221(c)(1)(C), substituted "Director of the Center" for "Director of NIH" wherever appearing.

Subsec. (b). Pub. L. 112–74, §221(c)(1)(B), substituted "within the Center" for "within the Office of the Director of NIH" in introductory provisions.

Subsec. (d)(4). Pub. L. 112–74, §221(c)(1)(D), substituted "Director of the Center" for "Director of NIH" in heading.

Subsec. (d)(4)(B). Pub. L. 112–74, §221(c)(1)(D), substituted "Director of the Center" for "Director of NIH" in heading.

1 So in original. A closing parenthesis probably should precede the comma.

2 See References in Text note below.

3 So in original. Section 5703 of title 5 does not contain a subsec. (b).

§287a–1. Office of Rare Diseases

(a) Establishment

There is established within the Center an office to be known as the Office of Rare Diseases (in this section referred to as the "Office"), which shall be headed by a Director (in this section referred to as the "Director"), appointed by the Director of the Center.

(b) Duties

(1) In general

The Director of the Office shall carry out the following:

(A) The Director shall recommend an agenda for conducting and supporting research on rare diseases through the national research institutes and centers. The agenda shall provide for a broad range of research and education activities, including scientific workshops and symposia to identify research opportunities for rare diseases.

(B) The Director shall, with respect to rare diseases, promote coordination and cooperation among the national research institutes and centers and entities whose research is supported by such institutes.

(C) The Director, in collaboration with the directors of the other relevant institutes and centers of the National Institutes of Health, may enter into cooperative agreements with and make grants for regional centers of excellence on rare diseases in accordance with section 287a–2 of this title.

(D) The Director shall promote the sufficient allocation of the resources of the National Institutes of Health for conducting and supporting research on rare diseases.

(E) The Director shall promote and encourage the establishment of a centralized clearinghouse for rare and genetic disease information that will provide understandable information about these diseases to the public, medical professionals, patients and families.

(2) Principal advisor regarding orphan diseases

With respect to rare diseases, the Director shall serve as the principal advisor to the Director of NIH and shall provide advice to other relevant agencies. The Director shall provide liaison with national and international patient, health and scientific organizations concerned with rare diseases.

(c) Definition

For purposes of this section, the term "rare disease" means any disease or condition that affects less than 200,000 persons in the United States.

(July 1, 1944, ch. 373, title IV, §481, formerly §404F, as added Pub. L. 107–280, §3, Nov. 6, 2002, 116 Stat. 1989; amended Pub. L. 109–482, title I, §§103(b)(5), 104(b)(1)(B), Jan. 15, 2007, 120 Stat. 3687, 3693; renumbered §481 and amended Pub. L. 112–74, div. F, title II, §221(c)(2)(A), Dec. 23, 2011, 125 Stat. 1089.)


Editorial Notes

Codification

Section was formerly classified to section 283h of this title.

Prior Provisions

A prior section 287a–1, act July 1, 1944, ch. 373, title IV, §481, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 866; amended Pub. L. 103–43, title XV, §1501(2)(C), (D), June 10, 1993, 107 Stat. 172, 173, required biennial reports regarding the activities and policies of the National Center for Research Resources, prior to repeal by Pub. L. 112–74, div. F, title II, §221(a)(1)(B), Dec. 23, 2011, 125 Stat. 1086.

Amendments

2011—Subsec. (a). Pub. L. 112–74, §221(c)(2)(A)(ii), substituted "within the Center" for "within the Office of the Director of NIH" and "Director of the Center" for "Director of NIH".

Subsec. (b)(1)(C). Pub. L. 112–74, §221(c)(2)(A)(iii), substituted "287a–2" for "283i".

2007—Subsec. (b)(1)(F), (G). Pub. L. 109–482, §104(b)(1)(B), struck out subpars. (F) and (G) which read as follows:

"(F) The Director shall biennially prepare a report that describes the research and education activities on rare diseases being conducted or supported through the national research institutes and centers, and that identifies particular projects or types of projects that should in the future be conducted or supported by the national research institutes and centers or other entities in the field of research on rare diseases.

"(G) The Director shall prepare the NIH Director's annual report to Congress on rare disease research conducted by or supported through the national research institutes and centers."

Subsec. (d). Pub. L. 109–482, §103(b)(5), struck out heading and text of subsec. (d). Text read as follows: "For the purpose of carrying out this section, there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $4,000,000 for each of the fiscal years 2003 through 2006."


Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

Findings and Purposes

Pub. L. 107–280, §2, Nov. 6, 2002, 116 Stat. 1988, provided that:

"(a) Findings.—Congress makes the following findings:

"(1) Rare diseases and disorders are those which affect small patient populations, typically populations smaller than 200,000 individuals in the United States. Such diseases and conditions include Huntington's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), Tourette syndrome, Crohn's disease, cystic fibrosis, cystinosis, and Duchenne muscular dystrophy.

"(2) For many years, the 25,000,000 Americans suffering from the over 6,000 rare diseases and disorders were denied access to effective medicines because prescription drug manufacturers could rarely make a profit from marketing drugs for such small groups of patients. The prescription drug industry did not adequately fund research into such treatments. Despite the urgent health need for these medicines, they came to be known as 'orphan drugs' because no companies would commercialize them.

"(3) During the 1970s, an organization called the National Organization for Rare Disorders (NORD) was founded to provide services and to lobby on behalf of patients with rare diseases and disorders. NORD was instrumental in pressing Congress for legislation to encourage the development of orphan drugs.

"(4) The Orphan Drug Act [Pub. L. 97–414, see Short Title of 1983 Amendments note set out under section 301 of Title 21, Food and Drugs] created financial incentives for the research and production of such orphan drugs. New Federal programs at the National Institutes of Health and the Food and Drug Administration encouraged clinical research and commercial product development for products that target rare diseases. An Orphan Products Board was established to promote the development of drugs and devices for rare diseases or disorders.

"(5) Before 1983, some 38 orphan drugs had been developed. Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more than 220 new orphan drugs have been approved and marketed in the United States and more than 800 additional drugs are in the research pipeline.

"(6) Despite the tremendous success of the Orphan Drug Act, rare diseases and disorders deserve greater emphasis in the national biomedical research enterprise. The Office of Rare Diseases at the National Institutes of Health was created in 1993, but lacks a statutory authorization.

"(7) The National Institutes of Health has received a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research.

"(8) Notwithstanding such increases, funding for rare diseases and disorders at the National Institutes of Health has not increased appreciably.

"(9) To redress this oversight, the Department of Health and Human Services has proposed the establishment of a network of regional centers of excellence for research on rare diseases.

"(b) Purposes.—The purposes of this Act [see Short Title of 2002 Amendments note set out under section 201 of this title] are to—

"(1) amend the Public Health Service Act [42 U.S.C. 201 et seq.] to establish an Office of Rare Diseases at the National Institutes of Health; and

"(2) increase the national investment in the development of diagnostics and treatments for patients with rare diseases and disorders."

§287a–2. Rare disease regional centers of excellence

(a) Cooperative agreements and grants

(1) In general

The Director of the Office of Rare Diseases (in this section referred to as the "Director"), in collaboration with the directors of the other relevant institutes and centers of the National Institutes of Health, may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for regional centers of excellence for clinical research into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for rare diseases.

(2) Policies

A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH.

(b) Coordination with other institutes

The Director shall coordinate the activities under this section with similar activities conducted by other national research institutes, centers and agencies of the National Institutes of Health and by the Food and Drug Administration to the extent that such institutes, centers and agencies have responsibilities that are related to rare diseases.

(c) Uses for Federal payments under cooperative agreements or grants

Federal payments made under a cooperative agreement or grant under subsection (a) may be used for—

(1) staffing, administrative, and other basic operating costs, including such patient care costs as are required for research;

(2) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public with respect to rare diseases; and

(3) clinical research and demonstration programs.

(d) Period of support; additional periods

Support of a center under subsection (a) may be for a period of not to exceed 5 years. Such period may be extended by the Director for additional periods of not more than 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(July 1, 1944, ch. 373, title IV, §481A, formerly §404G, as added Pub. L. 107–280, §4, Nov. 6, 2002, 116 Stat. 1990; amended Pub. L. 109–482, title I, §103(b)(6), Jan. 15, 2007, 120 Stat. 3687; renumbered §481A, Pub. L. 112–74, div. F, title II, §221(c)(3), Dec. 23, 2011, 125 Stat. 1089.)


Editorial Notes

Codification

Section was formerly classified to section 283i of this title.

Prior Provisions

A prior section 481A of act July 1, 1944, was renumbered section 404I, and is classified to section 283k of this title.

Amendments

2007—Subsec. (e). Pub. L. 109–482 struck out heading and text of subsec. (e). Text read as follows: "For the purpose of carrying out this section, there are authorized to be appropriated such sums as already have been appropriated for fiscal year 2002, and $20,000,000 for each of the fiscal years 2003 through 2006."


Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

§§287a–3, 287a–3a. Transferred


Editorial Notes

Codification

Section 287a–3, act July 1, 1944, ch. 373, title IV, §481B, as added Pub. L. 103–43, title XV, §1503, June 10, 1993, 107 Stat. 178; amended Pub. L. 105–392, title IV, §411, Nov. 13, 1998, 112 Stat. 3590; Pub. L. 106–505, title III, §304, Nov. 13, 2000, 114 Stat. 2335; Pub. L. 109–482, title I, §103(b)(41), Jan. 15, 2007, 120 Stat. 3688, which related to construction of regional centers for research on primates, was renumbered section 404J of act July 1, 1944, by Pub. L. 112–74, div. F, title II, §221(b)(2)(A), Dec. 23, 2011, 125 Stat. 1088, and transferred to section 283l of this title.

Section 287a–3a, July 1, 1944, ch. 373, title IV, §481C, as added Pub. L. 106–551, §2, Dec. 20, 2000, 114 Stat. 2752; amended Pub. L. 110–170, §2(a), Dec. 26, 2007, 121 Stat. 2465, which related to sanctuary system for surplus chimpanzees, was renumbered section 404K of act July 1, 1944, by Pub. L. 112–74, div. F, title II, §221(b)(3)(A), Dec. 23, 2011, 125 Stat. 1088, and transferred to section 283m of this title.

A prior section 481C of act July 1, 1944, was renumbered section 481B of act July 1, 1944, and is classified to section 287a–4 of this title.

§287a–4. General clinical research centers

(a) Grants

The Director of the Center shall award grants for the establishment of general clinical research centers to provide the infrastructure for clinical research including clinical research training and career enhancement. Such centers shall support clinical studies and career development in all settings of the hospital or academic medical center involved.

(b) Activities

In carrying out subsection (a), the Director of National Institutes of Health shall expand the activities of the general clinical research centers through the increased use of telecommunications and telemedicine initiatives.

(July 1, 1944, ch. 373, title IV, §481B, formerly §481C, as added Pub. L. 106–505, title II, §204(a), Nov. 13, 2000, 114 Stat. 2327; amended Pub. L. 109–482, title I, §103(b)(42), Jan. 15, 2007, 120 Stat. 3688; renumbered §481D, Pub. L. 110–170, §2(b), Dec. 26, 2007, 121 Stat. 2466; renumbered §481B and amended Pub. L. 112–74, div. F, title II, §221(c)(4), Dec. 23, 2011, 125 Stat. 1089.)


Editorial Notes

Prior Provisions

A prior section 481B of act July 1, 1944, was renumbered section 404J, and is classified to section 283l of this title.

Amendments

2011—Subsec. (a). Pub. L. 112–74, §221(c)(4)(B), substituted "Director of the Center" for "Director of the National Center for Research Resources".

2007—Subsec. (c). Pub. L. 109–482 struck out heading and text of subsec. (c). Text read as follows: "For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each fiscal year."


Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

subpart 2—john e. fogarty international center for advanced study in health sciences

§287b. General purpose

The general purpose of the John E. Fogarty International Center for Advanced Study in the Health Sciences is to—

(1) facilitate the assembly of scientists and others in the biomedical, behavioral, and related fields for discussion, study, and research relating to the development of health science internationally;

(2) provide research programs, conferences, and seminars to further international cooperation and collaboration in the life sciences;

(3) provide postdoctorate fellowships for research training in the United States and abroad and promote exchanges of senior scientists between the United States and other countries;

(4) coordinate the activities of the National Institutes of Health concerned with the health sciences internationally; and

(5) receive foreign visitors to the National Institutes of Health.

(July 1, 1944, ch. 373, title IV, §482, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 866.)

subpart 3—national center for human genome research


Editorial Notes

Codification

Subpart 3 of part E of title IV of act July 1, 1944, comprising this subpart, was renumbered subpart 19 of part C of title IV by Pub. L. 109–482, title I, §101(c)(1)–(3), Jan. 15, 2007, 120 Stat. 3681, and is classified to subpart 19 (§285s) of part C of this subchapter.

§287c. Transferred


Editorial Notes

Codification

Section, act July 1, 1944, ch. 373, title IV, §485B, as added Pub. L. 103–43, title XV, §1521(2), June 10, 1993, 107 Stat. 180, which set out the purpose of the National Center for Human Genome Research, was renumbered section 464z–1 of act July 1, 1944, by Pub. L. 109–482, title I, §101(c)(4)(A), Jan. 15, 2007, 120 Stat. 3681, and transferred to section 285s of this title.

Prior Provisions

Another prior section 287c, act July 1, 1944, ch. 373, title IV, §483, as added Nov. 20, 1985, Pub. L. 99–158, §2, 99 Stat. 867, and amended, which related to purpose of National Center for Nursing Research, was renumbered section 464V of act July 1, 1944, by Pub. L. 103–43, title XV, §1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q of this title.

A prior section 287c–1, act July 1, 1944, ch. 373, title IV, §484, as added Nov. 20, 1985, Pub. L. 99–158, §2, 99 Stat. 867, and amended, which related to specific authorities of the Director of the Center, was renumbered section 464W of act July 1, 1944, by Pub. L. 103–43, title XV, §1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q–1 of this title.

A prior section 287c–2, act July 1, 1944, ch. 373, title IV, §485, as added Nov. 20, 1985, Pub. L. 99–158, §2, 99 Stat. 867, and amended, which related to the advisory council for the Center, was renumbered section 464X of act July 1, 1944, by Pub. L. 103–43, title XV, §1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q–2 of this title.

A prior section 287c–3, act July 1, 1944, ch. 373, title IV, §486, as added Nov. 20, 1985, Pub. L. 99–158, §2, 99 Stat. 869, and amended, which related to biennial report of activities of the Center, was renumbered section 464Y of act July 1, 1944, by Pub. L. 103–43, title XV, §1511(b)(2), June 10, 1993, 107 Stat. 179, and transferred to section 285q–3 of this title. Section 285q–3 was subsequently repealed by Pub. L. 114–255, div. A, title II, §2042(h)(1), Dec. 13, 2016, 130 Stat. 1073.

subpart 4—office of dietary supplements

§287c–11. Dietary supplements

(a) Establishment

The Secretary shall establish an Office of Dietary Supplements within the National Institutes of Health.

(b) Purpose

The purposes of the Office are—

(1) to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care; and

(2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions.

(c) Duties

The Director of the Office of Dietary Supplements shall—

(1) conduct and coordinate scientific research within the National Institutes of Health relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism;

(2) collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign sources or the Office of Alternative Medicine; 1

(3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs on issues relating to dietary supplements including—

(A) dietary intake regulations;

(B) the safety of dietary supplements;

(C) claims characterizing the relationship between—

(i) dietary supplements; and

(ii)(I) prevention of disease or other health-related conditions; and

(II) maintenance of health; and


(D) scientific issues arising in connection with the labeling and composition of dietary supplements;


(4) compile a database of scientific research on dietary supplements and individual nutrients; and

(5) coordinate funding relating to dietary supplements for the National Institutes of Health.

(d) "Dietary supplement" defined

As used in this section, the term "dietary supplement" has the meaning given the term in section 321(ff) of title 21.

(July 1, 1944, ch. 373, title IV, §485C, as added Pub. L. 103–417, §13(a), Oct. 25, 1994, 108 Stat. 4334; amended Pub. L. 109–482, title I, §103(b)(43), Jan. 15, 2007, 120 Stat. 3688.)


Editorial Notes

References in Text

The Office of Alternative Medicine, referred to in subsec. (c)(2), probably should be a reference to the National Center for Complementary and Integrative Health. Establishment of the Office of Alternative Medicine was repealed and authority for the National Center for Complementary and Alternative Medicine was enacted by Pub. L. 105–277, div. A, §101(f) [title VI, §601], Oct. 21, 1998, 112 Stat. 2681–337, 2681-387. The National Center for Complementary and Alternative Medicine was renamed the National Center for Complementary and Integrative Health by Pub. L. 113–235, div. G, title II, §224(1), Dec. 16, 2014, 128 Stat. 2490. See section 287c–21 of this title and Prior Provisions note under section 283g of this title.

Amendments

2007—Subsec. (e). Pub. L. 109–482 struck out heading and text of subsec. (e). Text read as follows: "There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 1994 and such sums as may be necessary for each subsequent fiscal year."


Statutory Notes and Related Subsidiaries

Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

1 See References in Text note below.

subpart 5—national center for complementary and integrative health


Editorial Notes

Codification

Pub. L. 113–235, div. G, title II, §224(1), Dec. 16, 2014, 128 Stat. 2490, substituted "national center for complementary and integrative health" for "national center for complementary and alternative medicine" in subpart heading.

§287c–21. Purpose of Center

(a) In general

The general purposes of the National Center for Complementary and Integrative Health (in this subpart referred to as the "Center") are the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating, and validating complementary and integrative health, diagnostic and prevention modalities, disciplines and systems. The Center shall be headed by a director, who shall be appointed by the Secretary. The Director of the Center shall report directly to the Director of NIH.

(b) Advisory council

The Secretary shall establish an advisory council for the Center in accordance with section 284a of this title, except that at least half of the members of the advisory council who are not ex officio members shall include practitioners licensed in one or more of the major systems with which the Center is concerned, and at least 3 individuals representing the interests of individual consumers of complementary and integrative health.

(c) Integration of new and non-traditional approaches

In carrying out subsection (a), the Director of the Center shall, as appropriate, study the integration of new and non-traditional approaches to health care treatment and consumption, including but not limited to non-traditional treatment, diagnostic and prevention systems, modalities, and disciplines.

(d) Appropriate scientific expertise and coordination with institutes and Federal agencies

The Director of the Center, after consultation with the advisory council for the Center and the division of research grants, shall ensure that scientists with appropriate expertise in research on complementary and integrative health are incorporated into the review, oversight, and management processes of all research projects and other activities funded by the Center. In carrying out this subsection, the Director of the Center, as necessary, may establish review groups with appropriate scientific expertise. The Director of the Center shall coordinate efforts with other Institutes and Federal agencies to ensure appropriate scientific input and management.

(e) Evaluation of various disciplines and systems

In carrying out subsection (a), the Director of the Center shall identify and evaluate complementary and integrative health, diagnostic and prevention modalities in each of the disciplines and systems with which the Center is concerned, including each discipline and system in which accreditation, national certification, or a State license is available.

(f) Ensuring high quality, rigorous scientific review

In order to ensure high quality, rigorous scientific review of complementary and alternative, diagnostic and prevention modalities, disciplines and systems, the Director of the Center shall conduct or support the following activities:

(1) Outcomes research and investigations.

(2) Epidemiological studies.

(3) Health services research.

(4) Basic science research.

(5) Clinical trials.

(6) Other appropriate research and investigational activities.


The Director of NIH, in coordination with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time liaisons with the Center in facilitating appropriate coordination and scientific input.

(g) Data system; information clearinghouse

(1) Data system

The Director of the Center shall establish a bibliographic system for the collection, storage, and retrieval of worldwide research relating to complementary and integrative health, diagnostic and prevention modalities, disciplines and systems. Such a system shall be regularly updated and publicly accessible.

(2) Clearinghouse

The Director of the Center shall establish an information clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of integrative health treatment, diagnostic and prevention practices by health professionals, patients, industry, and the public.

(h) Research centers

The Director of the Center, after consultation with the advisory council for the Center, shall provide support for the development and operation of multipurpose centers to conduct research and other activities described in subsection (a) with respect to complementary and integrative health, diagnostic and prevention modalities, disciplines and systems. The provision of support for the development and operation of such centers shall include accredited complementary and integrative health research and education facilities.

(i) Availability of resources

After consultation with the Director of the Center, the Director of NIH shall ensure that resources of the National Institutes of Health, including laboratory and clinical facilities, fellowships (including research training fellowship and junior and senior clinical fellowships), and other resources are sufficiently available to enable the Center to appropriately and effectively carry out its duties as described in subsection (a). The Director of NIH, in coordination with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time liaisons with the Center in facilitating appropriate coordination and scientific input.

(j) Availability of appropriations

Amounts appropriated to carry out this section for fiscal year 1999 are available for obligation through September 30, 2001. Amounts appropriated to carry out this section for fiscal year 2000 are available for obligation through September 30, 2001.

(July 1, 1944, ch. 373, title IV, §485D, as added Pub. L. 105–277, div. A, §101(f) [title VI, §601(2)], Oct. 21, 1998, 112 Stat. 2681–337, 2681-387; amended Pub. L. 113–235, div. G, title II, §224, Dec. 16, 2014, 128 Stat. 2490.)


Editorial Notes

Amendments

2014—Subsec. (a). Pub. L. 113–235, §224(1), (3), substituted "National Center for Complementary and Integrative Health" for "National Center for Complementary and Alternative Medicine" and "complementary and integrative health" for "complementary and alternative treatment".

Subsec. (b). Pub. L. 113–235, §224(2), substituted "integrative health" for "alternative medicine".

Subsec. (c). Pub. L. 113–235, §224(5), added subsec. (c) and struck out former subsec. (c). Prior to amendment, text read as follows: "In carrying out subsection (a) of this section, the Director of the Center shall, as appropriate, study the integration of alternative treatment, diagnostic and prevention systems, modalities, and disciplines with the practice of conventional medicine as a complement to such medicine and into health care delivery systems in the United States."

Subsec. (d). Pub. L. 113–235, §224(2), substituted "integrative health" for "alternative medicine".

Subsec. (e). Pub. L. 113–235, §224(3), substituted "complementary and integrative health" for "alternative and complementary medical treatment".

Subsec. (g)(1). Pub. L. 113–235, §224(3), substituted "complementary and integrative health" for "complementary and alternative treatment".

Subsec. (g)(2). Pub. L. 113–235, §224(4), substituted "integrative health treatment" for "alternative medical treatment".

Subsec. (h). Pub. L. 113–235, §224(2), (3), substituted "complementary and integrative health," for "complementary and alternative treatment," and "integrative health research" for "alternative medicine research".


Statutory Notes and Related Subsidiaries

Termination of Advisory Councils

Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 1001(2) and 1013 of Title 5, Government Organization and Employees.

Pub. L. 93–641, §6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.


Executive Documents

Executive Order No. 13147

Ex. Ord. No. 13147, Mar. 7, 2000, 65 F.R. 13233, as amended by Ex. Ord. No. 13167, Sept. 15, 2000, 65 F.R. 54079 [57079], 65 F.R. 57436, which established White House Commission on Complementary and Alternative Medicine Policy, was revoked by Ex. Ord. No. 13316, §3(i), Sept. 17, 2003, 68 F.R. 55256, eff. Sept. 30, 2003.

subpart 6—transferred


Editorial Notes

Codification

Subpart 6 of part E of title IV of act July 1, 1944, comprising this subpart, was renumbered subpart 20 of part C of title IV by Pub. L. 111–148, title X, §10334(c)(1)(A)–(C), Mar. 23, 2010, 124 Stat. 973, and is classified to subpart 20 (§285t et seq.) of part C of this subchapter.

§§287c–31 to 287c–34. Transferred


Editorial Notes

Codification

Section 287c–31, act July 1, 1944, ch. 373, title IV, §485E, as added Pub. L. 106–525, title I, §101(a), Nov. 22, 2000, 114 Stat. 2497; amended Pub. L. 109–482, title I, §§103(b)(44), 104(b)(1)(N), Jan. 15, 2007, 120 Stat. 3688, 3693, which set out the purpose of the National Center on Minority Health and Health Disparities, was renumbered section 464z–3 of act July 1, 1944, and transferred to section 285t of this title.

Section 287c–32, act July 1, 1944, ch. 373, title IV, §485F, as added Pub. L. 106–525, title I, §102, Nov. 22, 2000, 114 Stat. 2501; amended Pub. L. 109–482, title I, §103(b)(45), Jan. 15, 2007, 120 Stat. 3688, which related to centers of excellence for research education and training, was renumbered section 464z–4 of act July 1, 1944, and transferred to section 285t–1 of this title.

Section 287c–33, act July 1, 1944, ch. 373, title IV, §485G, as added Pub. L. 106–525, title I, §103, Nov. 22, 2000, 114 Stat. 2503; amended Pub. L. 109–482, title I, §103(b)(46), Jan. 15, 2007, 120 Stat. 3688, which related to loan repayment program for minority health disparities research, was renumbered section 464z–5 of act July 1, 1944, and transferred to section 285t–2 of this title, prior to repeal by Pub. L. 114–255, div. A, title II, §2022(c)(1), Dec. 13, 2016, 130 Stat. 1054.

Section 287c–34, act July 1, 1944, ch. 373, title IV, §485H, as added Pub. L. 106–525, title I, §104, Nov. 22, 2000, 114 Stat. 2503; amended Pub. L. 109–482, title I, §104(b)(1)(O), Jan. 15, 2007, 120 Stat. 3693, which related to administrative support and support services, was renumbered section 464z–6 of act July 1, 1944, and transferred to section 285t–3 of this title.