I 

108TH CONGRESS 

1ST SESSION H. R. 371

To establish the National Center on Liver Disease Research, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 27, 2003

Mr. LYNCH (for himself, Mr. QUINN, Mr. FROST, Mr. FRANK of Massachusetts, Mrs. CHRISTENSEN, and Ms. KAPTUR) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL

To establish the National Center on Liver Disease 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 ‘‘Liver Research En5 hancement Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) An estimated 25,000,000 people in the 

9 United States are affected by a liver or liver-related 

10 disease. 
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1 (2) In excess of $5,500,000,000 is spent annu2 ally to provide medical care for people in the United 

3 States with liver disease. 

4 (3) There are over 4,000,000 people in the 

5 United States who are or have been infected with 

6 hepatitis C, 2,700,000 of whom are chronically in7 fected. 

8 (4) Due to limited research, current treatments 

9 for hepatitis C are effective in fewer than 50 percent 

10 of the cases. 

11 (5) A vaccine has not been developed for hepa12 titis C. 

13 (6) There are 8,000 to 10,000 deaths each year 

14 due to hepatitis C, and the annual death total is 

15 projected to increase to 30,000 each year absent in16 creased public health and research interventions. 

17 (7) Chronic infection with hepatitis B or C is 

18 associated with an increased incidence of primary 

19 liver cancer, once a rare malignancy in the United 

20 States. 

21 (8) There are 1,250,000 people in the United 

22 States who have been infected with hepatitis B. 

23 (9) Up to 15 percent of Asian and Pacific-Is24 lander Americans are chronically infected with hepa25 titis B. 
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1 (10) Fifteen out of every 100,000 people in the 

2 United States are affected by a chronic, life-threat3 ening disease known as primary biliary cirrhosis 

4 (PBC), and 95 percent of those affected are women. 

5 (11) There is an emerging obesity-related 

6 chronic liver disease, nonalcoholic fatty liver disease 

7 (NAFLD), which may affect as many as 1 in every 

8 4 adults over the age of 18. 

9 (12) There are 15,000 children hospitalized in 

10 the United States each year due to liver disease. 

11 (13) The only option for many individuals with 

12 liver disease is a liver transplant. 

13 (14) There are over 17,500 people in the 

14 United States on the waiting list for a liver trans15 plant, but because of the limited supply of livers 

16 available for transplantation only approximately 

17 5,100 transplants are performed each year. 

18 (15) There are 1,300 people in the United 

19 States who die each year waiting for a liver trans20 plant, and that number is expected to increase. 

21 (16) To address the public health threat posed 

22 by liver disease, there is a need for the establishment 

23 of a National Center on Liver Disease Research to 

24 provide dedicated scientific leadership, to create a 
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1 research action plan, and to ensure the funding of 

2 the scientific opportunities identified by the plan. 

3 SEC. 3. NATIONAL CENTER ON LIVER DISEASE RESEARCH. 

4 Subpart 3 of part C of title IV of the Public Health 

5 Service Act (42 U.S.C. 285c, et seq.) is amended by add6 ing at the end the following: 

7 ‘‘NATIONAL CENTER ON LIVER DISEASE RESEARCH

8 ‘‘SEC. 434B. (a) ESTABLISHMENT.—There is estab9 lished the National Center on Liver Disease Research 

10 (hereafter in this section referred to as the ‘Center’) in 

11 the National Institute of Diabetes and Digestive and Kid12 ney Diseases. 

13 ‘‘(b) DIRECTOR.—The Center shall be headed by a 

14 Director, who shall be appointed by the Director of the 

15 Institute, in consultation with the Director of NIH, from 

16 among individuals with the highest scientific credentials. 

17 The Director of the Center shall report directly to the Di18 rector of the Institute. 

19 ‘‘(c) DUTIES.—To ensure the development of in20 creased understanding of and better treatments and cures 

21 for liver diseases through a dedicated scientific leadership 

22 and an adequate allocation of resources, the Director 

23 shall—

24 ‘‘(1) assist the Liver Disease Research Advisory 

25 Board to develop the Liver Disease Research Action 

26 Plan; and 
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1 ‘‘(2) encourage and coordinate the implementa2 tion of the Plan by the national research institutes, 

3 including by issuing research solicitations and by 

4 using all other available mechanisms. 

5 ‘‘(d) LIVER DISEASE RESEARCH ADVISORY

6 BOARD.—

7 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

8 after the date of the enactment of this Act, the Di9 rector of NIH shall establish a board to be known 

10 as the Liver Disease Research Advisory Board (here11 after in this section referred to as the ‘‘Advisory 

12 Board’’). 

13 ‘‘(2) DUTIES.—The Advisory Board shall advise 

14 and assist the Director of the Center concerning 

15 matters relating to liver disease research, including 

16 by developing and revising the Liver Disease Re17 search Action Plan in accordance with subsection 

18 (e). 

19 ‘‘(3) VOTING MEMBERS.—The Advisory Board 

20 shall be composed of 18 voting members appointed 

21 by the Director of NIH, in consultation with the Di22 rector of the Institute, of whom 12 shall be eminent 

23 scientists and 6 shall be lay persons. The Director 

24 of NIH, in consultation with the Director of the In-
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1 stitute, shall select 1 of the members to serve as the 

2 Chair of the Advisory Board. 

3 ‘‘(4) EX OFFICIO MEMBERS.—The Director of 

4 NIH shall appoint each director of a national re5 search institute that funds liver disease research to 

6 serve as a nonvoting, ex officio member of the Advi7 sory Board. The Director of NIH shall invite 1 rep8 resentative of the Centers for Disease Prevention 

9 and Control, 1 representative of the Food and Drug 

10 Administration, and 1 representative of the Depart11 ment of Veterans Affairs to serve as such a member. 

12 Each ex officio member of the Advisory Board may 

13 appoint an individual to serve as that member’s rep14 resentative on the Advisory Board. 

15 ‘‘(e) LIVER DISEASE RESEARCH ACTION PLAN.—

16 ‘‘(1) DEVELOPMENT.—Not later than 15 

17 months after the date of the enactment of this Act, 

18 the Advisory Board shall develop (with appropriate 

19 support from the Director and staff of the Center) 

20 a comprehensive plan for the conduct and support of 

21 liver disease research to be known as the Liver Dis22 ease Research Action Plan. The Advisory Board 

23 shall submit the Plan to the Director of NIH and 

24 the head of each institute or center within the Na-
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1 tional Institutes of Health that funds liver disease 

2 research. 

3 ‘‘(2) CONTENT.—The Liver Disease Research 

4 Action Plan shall identify scientific opportunities 

5 and priorities of liver disease research necessary to 

6 increase understanding of and to prevent, cure, and 

7 develop better treatment protocols for liver diseases. 

8 ‘‘(3) REVISION.—The Advisory Board shall re9 vise every 3 years the Liver Disease Research Action 

10 Plan, but shall meet annually to review progress and 

11 to amend the Plan as may be appropriate because 

12 of new scientific discoveries. 

13 ‘‘(f) ALLOCATION OF FUNDS.—Subject to the avail14 ability of appropriations, the Director of each institute or 

15 center within the National Institutes of Health shall allo16 cate to liver disease research through peer-reviewed meth17 ods, the amounts necessary to fund existing scientific re18 search opportunities and, subject to completion and subse19 quent updates of the Liver Disease Research Action Plan, 

20 amounts adequate to carry out the recommendations of 

21 the Plan.’’.

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