[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1203 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                S. 1203

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                July 1 (legislative day, June 30), 1993

 Mr. Hatfield introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 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. 486A. 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.''.

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