H. R. 4013—3
‘‘(D) The Director shall promote the sufficient allocation
of the resources of the National Institutes of Health for
conducting and supporting research on rare diseases.
‘‘(E) The Director shall promote and encourage the
establishment of a centralized clearinghouse for rare and
genetic disease information that will provide understand-
able information about these diseases to the public, medical
professionals, patients and families.
‘‘(F) The Director shall biennially prepare a report
that describes the research and education activities on
rare diseases being conducted or supported through the
national research institutes and centers, and that identifies
particular projects or types of projects that should in the
future be conducted or supported by the national research
institutes and centers or other entities in the field of
research on rare diseases.
‘‘(G) The Director shall prepare the NIH Director’s
annual report to Congress on rare disease research con-
ducted by or supported through the national research
institutes and centers.
‘‘(2) PRINCIPAL
ADVISOR
REGARDING
ORPHAN
DISEASES.—
With respect to rare diseases, the Director shall serve as the
principal advisor to the Director of NIH and shall provide
advice to other relevant agencies. The Director shall provide
liaison with national and international patient, health and
scientific organizations concerned with rare diseases.
‘‘(c) DEFINITION.—For purposes of this section, the term ‘rare
disease’ means any disease or condition that affects less than
200,000 persons in the United States.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as already have been appropriated for fiscal year 2002,
and $4,000,000 for each of the fiscal years 2003 through 2006.’’.
SEC. 4. RARE DISEASE REGIONAL CENTERS OF EXCELLENCE.
Title IV of the Public Health Service Act (42 U.S.C. 281 et
seq.), as amended by section 3, is further amended by inserting
after section 404F the following:
‘‘RARE DISEASE REGIONAL CENTERS OF EXCELLENCE
‘‘SEC. 404G. (a) COOPERATIVE AGREEMENTS AND GRANTS.—
‘‘(1) IN GENERAL.—The Director of the Office of Rare Dis-
eases (in this section referred to as the ‘Director’), in collabora-
tion with the directors of the other relevant institutes and
centers of the National Institutes of Health, may enter into
cooperative agreements with and make grants to public or
private nonprofit entities to pay all or part of the cost of
planning, establishing, or strengthening, and providing basic
operating support for regional centers of excellence for clinical
research into, training in, and demonstration of diagnostic,
prevention, control, and treatment methods for rare diseases.
‘‘(2) POLICIES.—A cooperative agreement or grant under
paragraph (1) shall be entered into in accordance with policies
established by the Director of NIH.
‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The Director
shall coordinate the activities under this section with similar activi-
ties conducted by other national research institutes, centers and
H. R. 4013—4
agencies of the National Institutes of Health and by the Food
and Drug Administration to the extent that such institutes, centers
and agencies have responsibilities that are related to rare diseases.
‘‘(c) USES FOR FEDERAL PAYMENTS UNDER COOPERATIVE AGREE-
MENTS OR GRANTS.—Federal payments made under a cooperative
agreement or grant under subsection (a) may be used for—
‘‘(1) staffing, administrative, and other basic operating
costs, including such patient care costs as are required for
research;
‘‘(2) clinical training, including training for allied health
professionals, continuing education for health professionals and
allied health professions personnel, and information programs
for the public with respect to rare diseases; and
‘‘(3) clinical research and demonstration programs.
‘‘(d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—Support of a
center under subsection (a) may be for a period of not to exceed
5 years. Such period may be extended by the Director for additional
periods of not more than 5 years if the operations of such center
have been reviewed by an appropriate technical and scientific peer
review group established by the Director and if such group has
recommended to the Director that such period should be extended.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as already have been appropriated for fiscal year 2002,
and $20,000,000 for each of the fiscal years 2003 through 2006.’’.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.