I 

108TH CONGRESS 

2D SESSION H. R. 4779 

To amend the Public Health Service Act to provide for clinical research 

support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 8, 2004 

Mr. WELDON of Florida (for himself and Mr. DOYLE) 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 

clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Clinical Research Act 

5 of 2004’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 
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1 (1) Strong academic health centers are essential 

2 to a vigorous clinical research enterprise. 

3 (2) Breakthroughs in basic biomedical sciences 

4 over the past 5 decades have provided an unprece5 dented supply of information for improving human 

6 health and preventing disease. 

7 (3) Translating the information gained through 

8 these basic discoveries into knowledge that will im9 pact clinical practice and ultimately human health 

10 requires strong clinical research institutions. 

11 (4) Without a sound infrastructure to accom12 plish this translation in a systematic and coherent 

13 way, the sum of data and information produced by 

14 the basic science enterprise will not result in tangible 

15 public benefit. 

16 (5) The clinical research environment is in17 creasingly encumbered by facility decay, incompat18 ible databases, shortage of qualified investigators, 

19 rising costs, inadequate funding, and mounting un20 reimbursed regulatory burdens such as human sub21 ject research protections and additional record-keep22 ing requirements under the Health Insurance Port23 ability and Accountability Act of 1996. 

24 SEC. 3. DEFINITIONS. 

25 In this Act: 
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1 (1) The term ‘‘Director’’ means the Director of 

2 the National Institutes of Health. 

3 (2) The term ‘‘eligible academic health center’’ 

4 means— 

5 (A) an academic institution that receives 

6 an annual average of not less than $20,000,000 

7 in grant funds from the Department of De8 fense, the Department of Veterans Affairs, and 

9 the Department of Health and Human Services 

10 for basic, applied, or clinical biomedical or be11 havioral research in the fields of dentistry, med12 icine, and nursing; or 

13 (B) a consortium of such academic institu14 tions. 

15 (3) The term ‘‘Secretary’’ means the Secretary 

16 of Health and Human Services. 

17 SEC. 4. CLINICAL RESEARCH SUPPORT GRANTS. 

18 (a) AUTHORIZATION.—For the purposes described in 

19 subsection (b), the Director shall make a clinical research 

20 support grant in the amount determined under subsection 

21 (c) to each eligible academic health center that submits 

22 an application in accordance with this section. 

23 (b) PURPOSE.—A funding agreement for a grant 

24 under this section is that the eligible academic health cen-
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1 ter involved will use the grant only for the following pur2 poses: 

3 (1) To defray the costs of unfunded Federal re4 quirements for the protection of human research 

5 subjects, including the costs of complying with the 

6 Health Insurance Portability and Accountability Act 

7 of 1996 (Pub. Law 104–191) and maintaining insti8 tutional review boards. 

9 (2) To support activities leading to innovative 

10 ways to meet the requirements described in para11 graph (1) in an efficient and cost effective manner. 

12 (c) ALLOCATION.—Of the amount appropriated to 

13 carry out this section for a fiscal year, the Director shall 

14 allocate such appropriated amount among the eligible aca15 demic health centers receiving a grant under this section 

16 in an amount that bears the same relation to such appro17 priated amount as the investment in clinical research of 

18 the grantee involved bears to the total investment in clin19 ical research of all grantees under this section. 

20 (d) APPLICATIONS.—To seek a grant under this sec21 tion, an eligible academic health center shall submit an 

22 application to the Director in such manner, at such time, 

23 and containing such information and assurances as the 

24 Director may require. 
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1 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

2 out this section, there is authorized to be appropriated 

3 $40,000,000 for each of the fiscal years 2005 through 

4 2009. 

5 SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS. 

6 (a) AUTHORIZATION.—The Director may make clin7 ical research infrastructure grants on a competitive basis 

8 to eligible academic health centers. 

9 (b) USE OF FUNDS.—The Director may not make a 

10 grant to an eligible academic health center under this sec11 tion unless the center agrees to use the grant only for the 

12 following: 

13 (1) Infrastructure that is necessary to facilitate 

14 the transfer of new understandings of disease mech15 anisms gained in the laboratory into the develop16 ment of new methodologies for diagnosis, therapy, 

17 and prevention. 

18 (2) The initial testing of human subjects. 

19 (3) Addressing the many obstacles impeding the 

20 expeditious application of new science, such as— 

21 (A) a lack of up-to-date information tech22 nology systems; 

23 (B) incompatible databases; 
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1 (C) the need for training and mentoring 

2 required for increasing the supply of qualified 

3 clinical investigators; and 

4 (D) a shortage of willing participants. 

5 (c) APPLICATIONS.—To seek a grant under this sec6 tion, an eligible academic health center shall submit an 

7 application to the Director in such manner, at such time, 

8 and containing such information and assurances as the 

9 Director may require. 

10 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

11 out this section, there is authorized to be appropriated 

12 $125,000,000 for each of fiscal years 2005 through 2009. 

13 SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN 

14 CLINICAL RESEARCH. 

15 (a) GRANTS.—The Secretary may make grants to not 

16 more than 5 eligible academic health centers to form part17 nerships between the center involved and health care pro18 viders for carrying out clinical human subject research for 

19 the purpose of demonstrating how academic research cen20 ters may collaborate with the practicing health care com21 munity in such research. 

22 (b) MAXIMUM AMOUNT.—The Secretary may not 

23 make a grant to any eligible academic health center under 

24 this section in an amount that is greater than $5,000,000. 
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1 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated to carry out this section 

3 $25,000,000 for the period of fiscal years 2005 through 

4 2009. 

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