I 

111TH CONGRESS 

1ST SESSION H. R. 1128 

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

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 23, 2009 

Mr. LYNCH (for himself and Mr. KING of New York) 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 of 2009’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) An estimated 30,000,000 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 $15,000,000,000 is spent annu2 ally to provide medical care for people in the United 

3 States with hepatitis C. This cost is projected to 

4 grow substantially over the next decade without a 

5 vaccine, cure, or the discovery of better treatments. 

6 (3) There are over 5,000,000 people in the 

7 United States who are or have been infected with 

8 hepatitis C, 3,200,000 of whom are chronically in9 fected. 

10 (4) Due to limited research, current treatments 

11 for hepatitis B and C are effective in approximately 

12 50 percent of the cases. 

13 (5) A vaccine has not been developed for hepa14 titis C. 

15 (6) There are 10,000 to 12,000 deaths each 

16 year due to hepatitis C, and the annual death total 

17 is projected to triple absent increased public health 

18 and research interventions. 

19 (7) Hepatitis C is the leading cause of death 

20 among people co-infected with HIV. 

21 (8) Chronic hepatitis B and C affect over 6 mil22 lion Americans with nearly half of those individuals 

23 unaware of their infection. 

24 (9) Chronic infection with hepatitis B or C is 

25 associated with an increased incidence of primary 


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1 liver cancer in the United States, the fastest growing 

2 cancer in incidence, despite a decline in most other 

3 types of cancers. 

4 (10) There are 1,400,000 people in the United 

5 States who have been infected with hepatitis B, and 

6 1 out of 4 individuals with chronic hepatitis B will 

7 die prematurely from end-stage liver disease or liver 

8 cancer. 

9 (11) One out of 10 Asian and Pacific-Islander 

10 Americans are chronically infected with hepatitis B, 

11 and the Centers for Disease Control and Prevention 

12 has reported a reduction in long-term protection 

13 from the current hepatitis B vaccines. 

14 (12) It is estimated that as many as 20 percent 

15 of Americans have fatty liver disease which can lead 

16 to cirrhosis and liver failure. 

17 (13) There are 15,000 children hospitalized in 

18 the United States each year due to liver disease. 

19 (14) The only option for many individuals with 

20 advanced or chronic liver disease is a liver trans21 plant. 

22 (15) Approximately 17,000 people in the United 

23 States are on the waiting list for a liver transplant, 

24 but because of the limited supply of livers available 


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1 for transplantation, only approximately 6,000 liver 

2 transplants are performed each year. 

3 (16) There are 1,300 people in the United 

4 States who die each year waiting for a liver trans5 plant. 

6 (17) To address the public health threat posed 

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

8 of a National Center on Liver Disease Research to 

9 provide dedicated scientific leadership, to create a 

10 research action plan, to ensure the funding of the 

11 scientific opportunities identified by the plan, and 

12 the coordination of efforts across the institutes and 

13 centers of the National Institutes of Health. 

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

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

16 Service Act (42 U.S.C. 285c, et seq.) is amended by add17 ing at the end the following: 

18 ‘‘NATIONAL CENTER ON LIVER DISEASE RESEARCH

19 ‘‘SEC. 434B. (a) ESTABLISHMENT.—There is estab20 lished the National Center on Liver Disease Research 

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

22 the National Institute of Diabetes and Digestive and Kid23 ney Diseases. 

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

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

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


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1 among individuals with the highest scientific credentials. 

2 The Director of the Center shall report directly to the Di3 rector of the Institute. 

4 ‘‘(c) DUTIES.—To ensure the development of in5 creased understanding of and better treatments and cures 

6 for liver disease through a dedicated scientific leadership 

7 and an adequate allocation of resources, the Director 

8 shall— 

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

10 Board to develop the Liver Disease Research Action 

11 Plan; and 

12 ‘‘(2) encourage and coordinate the implementa13 tion of the Plan by the national research institutes, 

14 including by issuing research solicitations and by 

15 using all other available mechanisms. 

16 ‘‘(d) LIVER DISEASE RESEARCH ADVISORY

17 BOARD.— 

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

19 after the date of the enactment of the Liver Re20 search Enhancement Act of 2009, the Director of 

21 NIH shall establish a board to be known as the 

22 Liver Disease Research Advisory Board (hereafter in 

23 this section referred to as the ‘Advisory Board’). 

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

25 and assist the Director of the Center concerning 


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1 matters relating to liver disease research, including 

2 by developing and revising the Liver Disease Re3 search Action Plan in accordance with subsection 

4 (e). 

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

6 shall be composed of 18 voting members appointed 

7 by the Director of NIH, in consultation with the Di8 rector of the Institute, of whom 12 shall be eminent 

9 scientists and 6 shall be lay persons. The Director 

10 of NIH, in consultation with the Director of the In11 stitute, shall select 1 of the members to serve as the 

12 Chair of the Advisory Board. 

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

14 NIH shall appoint each director of a national re15 search institute that funds liver disease research to 

16 serve as a nonvoting, ex officio member of the Advi17 sory Board. The Director of NIH shall invite 1 rep18 resentative of the Food and Drug Administration, 

19 and 1 representative of the Department of Veterans 

20 Affairs, to serve as a nonvoting, ex officio member 

21 of the Advisory Board. Each ex officio member of 

22 the Advisory Board may appoint an individual to 

23 serve as that member’s representative on the Advi24 sory Board. 

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


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

2 months after the date of the enactment of the Liver 

3 Research Enhancement Act of 2009, the Advisory 

4 Board shall develop (with appropriate support from 

5 the Director and staff of the Center) a comprehen6 sive plan for the conduct and support of liver disease 

7 research to be known as the Liver Disease Research 

8 Action Plan. The Advisory Board shall submit the 

9 Plan to the Director of NIH and the head of each 

10 institute or center within the National Institutes of 

11 Health that funds liver disease research. 

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

13 Action Plan shall identify scientific opportunities 

14 and priorities of liver disease research necessary to 

15 increase understanding of and to prevent, cure, and 

16 develop better treatment protocols for liver diseases. 

17 ‘‘(3) REVISION.—The Advisory Board shall re18 vise the Liver Disease Research Action Plan every 3 

19 years, but shall meet annually to review progress 

20 and to amend the Plan as may be appropriate be21 cause of new scientific discoveries. 

22 ‘‘(f) ALLOCATION OF FUNDS.—Subject to the avail23 ability of appropriations, the Director of each institute or 

24 center within the National Institutes of Health shall allo25 cate to liver disease research through peer-reviewed methVerDate Nov 24 2008 23:58 Feb 24, 2009 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1128.IH H1128

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1 ods, the amounts necessary to fund existing scientific re2 search opportunities and, subject to completion and subse3 quent updates of the Liver Disease Research Action Plan, 

4 amounts adequate to carry out the recommendations of 

5 the Plan.’’. 

Æ 


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