I 

109TH CONGRESS 

1ST SESSION H. R. 3168 

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. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. CENTERS FOR CLINICAL DISCOVERY. 

4 Part B of title IX of the Public Health Service Act 

5 (42 U.S.C. 299b et seq.) is amended by adding at the end 

6 the following section: 
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1 ‘‘SEC. 918. CENTERS FOR CLINICAL DISCOVERY. 

2 ‘‘(a) IN GENERAL.—The Director shall make grants 

3 on a competitive basis for research centers to accelerate 

4 next-generation approaches to the development of new 

5 therapies and diagnostics by bringing together patients, 

6 researchers with specialized expertise, and sophisticated 

7 technologies and basing such development on individual 

8 genotypes and individual variations in cell and molecular 

9 physiology. Each such center shall be known as a Center 

10 for Clinical Discovery. 

11 ‘‘(b) REQUIREMENTS.—The Director may make a 

12 grant under subsection (a) only if, with respect to the re13 search center involved, the following conditions are met: 

14 ‘‘(1) The application for the grant meets the re15 quirements of section 922 for approval (relating to 

16 technical and scientific peer review). 

17 ‘‘(2) Such center is a collaboration between an 

18 academic medical center and one or more nongovern19 mental entities engaged in the development of thera20 pies and diagnostics, activities supporting such de21 velopment, and health research. 

22 ‘‘(3) At least one the of the nongovernmental 

23 entities referred to in paragraph (2) has significant 

24 current experience in— 

25 ‘‘(A) studies in pharmacogenetics, 

26 proteomics, metabonomics, biostatistics, clinical 
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1 chemistry, genomics, advanced imaging tech2 nology, and health registries; and 

3 ‘‘(B) other longitudinal studies in which 

4 clinical and other patient data are collected to 

5 assist in research and development of new 

6 therapies and diagnostics. 

7 ‘‘(4) The professionals serving the center in8 clude leaders in the fields of health research, health 

9 policy, and health-outcomes research. 

10 ‘‘(5) The center is located at an academic med11 ical center. 

12 ‘‘(c) INITIAL GRANT.—Not later than June 30, 2006, 

13 the Director shall award one grant under subsection (a), 

14 subject to amounts made available in appropriations Acts. 

15 The Director shall consider the research center involved 

16 as a demonstration project for purposes of such sub17 section. The Director shall evaluate the project through 

18 a process, and on the basis of criteria, established by the 

19 Director. 

20 ‘‘(d) ADDITIONAL GRANTS.—If the research center 

21 operated pursuant to subsection (c) meets the criteria of 

22 the Director for continued support under subsection (a), 

23 the Director shall make grants under such subsection for 

24 additional centers and shall ensure, subject to amounts 
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1 made available in appropriations Acts, that not fewer than 

2 four research centers are operated under such subsection. 

3 ‘‘(e) AMOUNT OF GRANT.—The amount of a grant 

4 under subsection (a) to any center for a fiscal year shall 

5 not exceed $5,000,000. 

6 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

7 purpose of carrying out this section, there are authorized 

8 to be appropriated $5,000,000 for fiscal year 2006, and 

9 $25,000,000 for each of the fiscal years 2007 through 

10 2011.’’. 

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