PRIA, Government Policy, Made Personal

Summary

Allows the Director of the Office of Rare Diseases, working with other NIH institute leaders, to award grants or cooperative agreements to public or private nonprofit groups to help start, improve, and run regional centers that do clinical research, training, and demonstrations of how to diagnose, prevent, control, and treat rare diseases. Awards must follow NIH rules. The Director must coordinate with other NIH parts and the FDA. Federal funds can pay staff, basic operations (including patient care needed for research), training and public information, and clinical studies. Support can last up to 5 years and can be renewed in extra 5‑year periods after a scientific peer review recommends extension.

Title 42, §287a–2

The Public Health and Welfare, Source: USLM XML via OLRC

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

(b)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)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)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.

Notes & Related Subsidiaries

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 AmendmentAmendment 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–2 Rare Disease Regional Centers of Excellence