42 USC 287 - General clinical research centers

Collapse to view only § 287a-4. General clinical research centers

§ 287. National Center for Advancing Translational Sciences
§ 287a. Cures Acceleration Network
§ 287a-1. Office of Rare Diseases
§ 287a-2. Rare disease regional centers of excellence
§§ 287a-3, 287a-3a. Transferred
§ 287a-4. General clinical research centers

§ 287. National Center for Advancing Translational Sciences

(a) PurposeThe 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) ExceptionThe 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 reportThe 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;

(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.)

§ 287a. Cures Acceleration Network

(a) DefinitionsIn this section:

(1) Biological product

(2) Drug; device

(3) High need cureThe term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,1

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

biological product (as that term is defined by section 262(i) 2

2 See References in Text note below.

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

(b) Establishment of the Cures Acceleration NetworkSubject 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.

(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

(2) Membership

(A) In general

(i) Appointment

(ii) Chairperson and Vice Chairperson

(B) Terms

(i) In general

(ii) Consecutive appointments; maximum terms

(i) In general

(ii) ExpertiseThe 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,(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.

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

(3) Ex-officio members

(A) AppointmentIn 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

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

(A) Responsibilities of the Board

(i) In generalThe 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

(B) Responsibilities of the Director of the Center

(5) Meetings

(A) In general

(B) Quorum; requirements; limitations

(i) Quorum

(ii) Chairperson or Vice Chairperson

(iii) Diverse representation

(6) Compensation and travel expenses

(A) Compensation

(B) Travel expenses

(e) Grant program

(1) Supporting innovationTo 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 entitiesTo 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

(3) Awards

(A) The cures acceleration partnership awards

(i) Initial award amount

(ii) Funding in subsequent fiscal years

(iii) Matching funds

(B) The cures acceleration grant awards

(i) Initial award amount

(ii) Funding in subsequent fiscal years

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

(5) Audits

(6) Closeout procedures

(7) Review

(f) Competitive basis of awards

(g) Authorization of appropriations

(1) In general

(2) Limitation on use of funds otherwise appropriated

(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.)

§ 287a–1. Office of Rare Diseases

(a) Establishment

(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

(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.)

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

(a) Cooperative agreements and grants

(1) In general

(2) Policies

(b) Coordination with other institutes

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

(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.)

§§ 287a–3, 287a–3a. Transferred

§ 287a–4. General clinical research centers

(a) Grants

(b) Activities

(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.)