109 HR 3168 IH: To amend the Public Health Service Act to provide for Centers for Clinical Discovery through grants from the Director of the Agency for Healthcare Research and Quality. U.S. House of Representatives 2005-06-30 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 1st Session H. R. 3168 IN THE HOUSE OF REPRESENTATIVES June 30, 2005 Mr. Jones of North Carolina introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to provide for Centers for Clinical Discovery through grants from the Director of the Agency for Healthcare Research and Quality.

1.

Centers for clinical discovery

Part B of title IX of the Public Health Service Act (42 U.S.C. 299b et seq.) is amended by adding at the end the following section:

918.

Centers for Clinical Discovery

(a)

In general

The Director shall make grants on a competitive basis for research centers to accelerate next-generation approaches to the development of new therapies and diagnostics by bringing together patients, researchers with specialized expertise, and sophisticated technologies and basing such development on individual genotypes and individual variations in cell and molecular physiology. Each such center shall be known as a Center for Clinical Discovery. (b)

Requirements

The Director may make a grant under subsection (a) only if, with respect to the research center involved, the following conditions are met: (1)The application for the grant meets the requirements of section 922 for approval (relating to technical and scientific peer review). (2)Such center is a collaboration between an academic medical center and one or more nongovernmental entities engaged in the development of therapies and diagnostics, activities supporting such development, and health research. (3)At least one the of the nongovernmental entities referred to in paragraph (2) has significant current experience in— (A)studies in pharmacogenetics, proteomics, metabonomics, biostatistics, clinical chemistry, genomics, advanced imaging technology, and health registries; and (B)other longitudinal studies in which clinical and other patient data are collected to assist in research and development of new therapies and diagnostics. (4)The professionals serving the center include leaders in the fields of health research, health policy, and health-outcomes research. (5)The center is located at an academic medical center. (c)

Initial grant

Not later than June 30, 2006, the Director shall award one grant under subsection (a), subject to amounts made available in appropriations Acts. The Director shall consider the research center involved as a demonstration project for purposes of such subsection. The Director shall evaluate the project through a process, and on the basis of criteria, established by the Director. (d)

Additional grants

If the research center operated pursuant to subsection (c) meets the criteria of the Director for continued support under subsection (a), the Director shall make grants under such subsection for additional centers and shall ensure, subject to amounts made available in appropriations Acts, that not fewer than four research centers are operated under such subsection. (e)

Amount of grant

The amount of a grant under subsection (a) to any center for a fiscal year shall not exceed $5,000,000. (f)

Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2006, and $25,000,000 for each of the fiscal years 2007 through 2011.

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