H.R. 1108 (109th): Liver Research Enhancement Act of 2005

109th Congress, 2005–2006. Text as of Mar 03, 2005 (Introduced).

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I

109th CONGRESS

1st Session

H. R. 1108

IN THE HOUSE OF REPRESENTATIVES

March 3, 2005

(for himself, Mr. King of New York, Mr. Towns, Mr. McDermott, Mrs. Christensen, Mr. McGovern, Mr. Abercrombie, and Mr. Capuano) 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.

Short title

This Act may be cited as the Liver Research Enhancement Act of 2005.

2.

Findings

The Congress finds as follows:

(1)

An estimated 25,000,000 people in the United States are affected by a liver or liver-related disease.

(2)

In excess of $8,800,000,000 is spent annually to provide medical care for people in the United States with liver disease.

(3)

There are over 4,000,000 people in the United States who are or have been infected with hepatitis C, 3,000,000 of whom are chronically infected.

(4)

Due to limited research, current treatments for hepatitis C are effective in fewer than 50 percent of the cases.

(5)

A vaccine has not been developed for hepatitis C.

(6)

There are 8,000 to 10,000 deaths each year due to hepatitis C, and the annual death total is projected to increase to 30,000 each year absent increased public health and research interventions.

(7)

Chronic infection with hepatitis B or C is associated with an increased incidence of primary liver cancer, once a rare malignancy in the United States, but now the fastest growing cancer.

(8)

There are 1,250,000 people in the United States who have been infected with hepatitis B.

(9)

Up to 15 percent of Asian and Pacific-Islander Americans are chronically infected with hepatitis B.

(10)

Fifteen out of every 100,000 people in the United States are affected by a chronic, life-threatening disease known as primary biliary cirrhosis (PBC), and 95 percent of those affected are women.

(11)

There is an emerging obesity-related chronic liver disease, nonalcoholic fatty liver disease (NAFLD), which may affect as many as 1 in every 4 adults over the age of 18.

(12)

There are 15,000 children hospitalized in the United States each year due to liver disease.

(13)

The only option for many individuals with liver disease is a liver transplant.

(14)

There are over 17,600 people in the United States on the waiting list for a liver transplant, but because of the limited supply of livers available for transplantation only approximately 5,100 transplants are performed each year.

(15)

There are 1,400 people in the United States who die each year waiting for a liver transplant, and that number is expected to increase.

(16)

To address the public health threat posed by liver disease, there is a need for the establishment of a National Center on Liver Disease Research to provide dedicated scientific leadership, to create a research action plan, and to ensure the funding of the scientific opportunities identified by the plan.

3.

National Center on Liver Disease Research

Subpart 3 of part C of title IV of the Public Health Service Act (42 U.S.C. 285c, et seq.) is amended by adding at the end the following:

434B.

National Center on Liver Disease Research

(a)

Establishment

There is established the National Center on Liver Disease Research (hereafter in this section referred to as the Center) in the National Institute of Diabetes and Digestive and Kidney Diseases.

(b)

Director

The Center shall be headed by a Director, who shall be appointed by the Director of the Institute, in consultation with the Director of NIH, from among individuals with the highest scientific credentials. The Director of the Center shall report directly to the Director of the Institute.

(c)

Duties

To ensure the development of increased understanding of and better treatments and cures for liver diseases through a dedicated scientific leadership and an adequate allocation of resources, the Director shall—

(1)

assist the Liver Disease Research Advisory Board to develop the Liver Disease Research Action Plan; and

(2)

encourage and coordinate the implementation of the Plan by the national research institutes, including by issuing research solicitations and by using all other available mechanisms.

(d)

Liver Disease Research Advisory Board

(1)

Establishment

Not later than 90 days after the date of the enactment of the Liver Research Enhancement Act of 2005, the Director of NIH shall establish a board to be known as the Liver Disease Research Advisory Board (hereafter in this section referred to as the Advisory Board).

(2)

Duties

The Advisory Board shall advise and assist the Director of the Center concerning matters relating to liver disease research, including by developing and revising the Liver Disease Research Action Plan in accordance with subsection (e).

(3)

Voting members

The Advisory Board shall be composed of 18 voting members appointed by the Director of NIH, in consultation with the Director of the Institute, of whom 12 shall be eminent scientists and 6 shall be lay persons. The Director of NIH, in consultation with the Director of the Institute, shall select 1 of the members to serve as the Chair of the Advisory Board.

(4)

Ex officio members

The Director of NIH shall appoint each director of a national research institute that funds liver disease research to serve as a nonvoting, ex officio member of the Advisory Board. The Director of NIH shall invite 1 representative of the Centers for Disease Prevention and Control, 1 representative of the Food and Drug Administration, and 1 representative of the Department of Veterans Affairs to serve as such a member. Each ex officio member of the Advisory Board may appoint an individual to serve as that member’s representative on the Advisory Board.

(e)

Liver Disease Research Action Plan

(1)

Development

Not later than 15 months after the date of the enactment of the Liver Research Enhancement Act of 2005, the Advisory Board shall develop (with appropriate support from the Director and staff of the Center) a comprehensive plan for the conduct and support of liver disease research to be known as the Liver Disease Research Action Plan. The Advisory Board shall submit the Plan to the Director of NIH and the head of each institute or center within the National Institutes of Health that funds liver disease research.

(2)

Content

The Liver Disease Research Action Plan shall identify scientific opportunities and priorities of liver disease research necessary to increase understanding of and to prevent, cure, and develop better treatment protocols for liver diseases.

(3)

Revision

The Advisory Board shall revise every 3 years the Liver Disease Research Action Plan, but shall meet annually to review progress and to amend the Plan as may be appropriate because of new scientific discoveries.

(f)

Allocation of funds

Subject to the availability of appropriations, the Director of each institute or center within the National Institutes of Health shall allocate to liver disease research through peer-reviewed methods, the amounts necessary to fund existing scientific research opportunities and, subject to completion and subsequent updates of the Liver Disease Research Action Plan, amounts adequate to carry out the recommendations of the Plan.

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