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42 U.S.C. § 287a–2Rare disease regional centers of excellence

submitted 82 years ago by Pub. L. 107-280 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 337 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Office of Rare Diseases can fund regional centers to research and treat rare diseases. These grants pay for staffing, training, and clinical research, and can run up to five years, renewable. The Director must coordinate this work with other NIH institutes and the FDA.

(a) Cooperative agreements and grants. (1) The Director of the Office of Rare Diseases, working with the directors of other relevant NIH institutes and centers, may make cooperative agreements with, or grants to, public or private nonprofit entities. This money pays all or part of the cost to plan, start, strengthen, and run regional centers of excellence that do clinical research on, train people in, and demonstrate ways to diagnose, prevent, control, and treat rare diseases. (2) These agreements and grants must follow policies NIH's Director sets. (b) Coordination with other institutes. The Director must coordinate this work with similar work done by other NIH research institutes, centers, and agencies, and by the FDA, wherever their responsibilities also touch rare diseases. (c) Uses for federal payments. Money paid under a cooperative agreement or grant here can cover: (1) staffing, administrative, and other basic running costs, including the patient-care costs research requires; (2) clinical training — including training allied health professionals, continuing education for health professionals, and public information programs about rare diseases; and (3) clinical research and demonstration programs. (d) Period of support. A center can be supported for up to 5 years at a time. The Director can extend that support for more 5-year periods, if an appropriate technical and scientific peer-review group has reviewed the center's work and recommends extending it.
the actual law source: uscode.house.gov ↗public domain
(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.

Source credit: (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.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 107-280 · 116 Stat. 1990
  • 2007Amended · Pub. L. 109-482 · 120 Stat. 3687
  • 2011Amended · Pub. L. 112-74 · 125 Stat. 1089

A history note hasn’t been published yet. The record shows enactment by Pub. L. 107-280 on 1944-07-01.

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