< Back to H.R. 3577 (103rd Congress, 1993–1994)

Text of the Center for Rare Disease Research Act of 1993

This bill was introduced on November 19, 1993, in a previous session of Congress, but was not enacted. The text of the bill below is as of Nov 19, 1993 (Introduced).

Source: GPO

HR 3577 IH

103d CONGRESS

1st Session

H. R. 3577

To establish a Center for Rare Disease Research in the National Institutes of Health, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

November 19, 1993

Mr. WASHINGTON (for himself, Mr. FRANKS of Connecticut, and Mr. TOWNS) introduced the following bill; which was referred to the Committee on Energy and Commerce


A BILL

To establish a Center for Rare Disease Research in the National Institutes of Health, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ‘Center for Rare Disease Research Act of 1993’.

SEC. 2. ESTABLISHMENT OF CENTER FOR RARE DISEASE RESEARCH.

    Part E of title IV of the Public Health Service Act (42 U.S.C. 287 et seq.) is amended by adding at the end thereof the following new subpart:

‘Subpart 4--Center for Rare Disease Research

‘SEC. 485C. ESTABLISHMENT.

    ‘(a) IN GENERAL- There shall be established in the Office of the Director of the National Institutes of Health a Center for Rare Disease Research (hereafter referred to in this section as the ‘Center’). The Director of the National Institutes of Health shall appoint an individual with expertise in rare diseases to serve as the Director of the Center (hereafter referred to in this section as the ‘Director’).

    ‘(b) PURPOSE- The general purpose of the Center is to promote and coordinate the conduct of research on rare diseases and to establish and manage a rare disease research clinical database. In carrying out the purpose of the Center, the Director shall--

      ‘(1) conduct and support research and research training;

      ‘(2) award grants and contracts;

      ‘(3) identify projects of research on rare diseases that should be conducted or supported by the National Institutes of Health;

      ‘(4) disseminate information among the institutes and the public on rare diseases;

      ‘(5) develop and maintain a central database on current clinical research projects for rare diseases;

      ‘(6) encourage the participation of a diversity of individuals in the conduct of rare disease research; and

      ‘(7) coordinate the conduct of rare disease research among all institutes and other Federal agencies.

    ‘(c) STRATEGIC RESEARCH PLAN- The Director shall develop a comprehensive plan for the conduct and support of research on rare diseases. The plan shall--

      ‘(1) identify current research activities conducted or supported by the Federal Government and private entities, opportunities and needs for additional research and priorities for such research;

      ‘(2) make recommendations for the improved coordination of research conducted by the Federal Government among its agencies and private entities;

      ‘(3) give emphasis to areas with respect to which little research has been conducted;

      ‘(4) examine the extent of research on gene therapy and genetic transfers and develop a plan to enhance the extent of research on gene therapy, particularly for rare diseases;

      ‘(5) determine the need for registries of research subjects and epidemiological studies of rare disease populations;

      ‘(6) identify the obstacles to the development of treatments for rare diseases; and

      ‘(7) examine training and education requirements for physicians treating rare diseases.

    ‘(d) COORDINATING COMMITTEE-

      ‘(1) ESTABLISHMENT- The Secretary shall establish a Coordinating Committee on Rare Disease Research (hereafter referred to as the ‘Coordinating Committee’) to be composed of--

        ‘(A) the Directors of the agencies and institutes of the National Institutes of Health;

        ‘(B) the Director of the Center who shall serve as the chairperson of the Coordinating Committee;

        ‘(C) the Administrator of the Veterans Administration;

        ‘(D) the Secretary of Defense;

        ‘(E) the Administrator of the Food and Drug Administration;

        ‘(F) the Administrator of the Health Care Financing Administration; and

        ‘(G) the Director of the Center for Disease Control and Prevention.

      ‘(2) DUTIES- The Coordinating Committee shall--

        ‘(A) identify needs for research on rare diseases;

        ‘(B) estimate the funds needed during each fiscal year to adequately fund research on rare diseases;

        ‘(C) encourage the agencies and Institutes of the National Institutes of Health to support and conduct research on rare diseases;

        ‘(D) coordinate research on rare diseases in the Federal Government in an effort to avoid duplication and enhance research in areas traditionally not funded;

        ‘(E) ensure that a diversity of individuals are able to participate as research subjects in projects conducting research on rare diseases; and

        ‘(F) biennially prepare and submit to the Secretary and the Congress a report concerning the activities of the Coordinating Committee.

    ‘(e) NATIONAL ADVISORY BOARD ON RARE DISEASE RESEARCH-

      ‘(1) ESTABLISHMENT- The Director shall establish an advisory board to be known as the Advisory Board on Rare Disease Research (hereafter referred to in this section as the ‘Board’).

      ‘(2) DUTIES- The Board shall review and assess Federal research needs, priorities, activities, funding and findings regarding rare diseases and shall advise the Director on the development and implementation of the research plan required under subsection (c).

      ‘(3) COMPOSITION- The Board shall be composed of 15 individuals to be appointed by the Director of the National Institutes of Health, of which eight individuals shall be representatives of health and scientific disciplines with respect to rare diseases and seven individuals shall be representing the interest of individuals with rare diseases. Such individuals shall not be officers or employees of the Federal Government.

      ‘(4) EX OFFICIO MEMBERS- The members of the Coordinating Committee shall serve as ex officio members of the Board.

      ‘(5) CHAIRPERSON- The members of the Board shall annually select an individual to serve as the chairperson of the Board.

    ‘(f) NATIONAL RARE DISEASE CLINICAL AND INFORMATIONAL DATABASE-

      ‘(1) ESTABLISHMENT- The Director shall establish a database that--

        ‘(A) identifies the extent, location, and sponsor of current research conducted on rare diseases;

        ‘(B) connects researchers of rare diseases with patients needed as subjects for clinical trials;

        ‘(C) provides physicians and individuals with information concerning the location and sponsors of clinical trials on rare diseases; and

        ‘(D) connects patients with support groups in rare diseases.

      ‘(2) AVAILABILITY- The Director shall ensure that information in the database is available to the general public.

    ‘(g) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated to carry out this section, $10,000,000 for each of the fiscal years 1994 through 1996.

    ‘(h) DEFINITION- As used in this section, the term ‘rare disease’ means any disease or condition that affects fewer than 200,000 individuals in the United States.’.