[Congressional Bills 103th Congress]
[From the U.S. Government Printing 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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