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108th CONGRESS
2d Session
S. 2924
To amend the Public Health Service Act to provide for clinical research
support grants, clinical research infrastructure grants, and a
demonstration program on partnerships in clinical research, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 7, 2004
Mr. Santorum introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for clinical research
support grants, clinical research infrastructure grants, and a
demonstration program on partnerships in clinical research, 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 ``Clinical Research Act of 2004''.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Strong academic health centers are essential to a
vigorous clinical research enterprise.
(2) Breakthroughs in basic biomedical sciences over the
past 5 decades have provided an unprecedented supply of
information for improving human health and preventing disease.
(3) Translating the information gained through these basic
discoveries into knowledge that will impact clinical practice
and ultimately human health requires strong clinical research
institutions.
(4) Without a sound infrastructure to accomplish this
translation in a systematic and coherent way, the sum of data
and information produced by the basic science enterprise will
not result in tangible public benefit.
(5) The clinical research environment is increasingly
encumbered by facility decay, incompatible databases, shortage
of qualified investigators, rising costs, inadequate funding,
and mounting unreimbursed regulatory burdens such as human
subject research protections and additional record-keeping
requirements under the Health Insurance Portability and
Accountability Act of 1996.
SEC. 3. DEFINITIONS.
In this Act:
(1) Director.--The term ``Director'' means the Director of
the National Institutes of Health.
(2) Eligible academic health center.--The term ``eligible
academic health center'' means--
(A) an academic institution that receives an annual
average of not less than $20,000,000 in grant funds
from the Department of Defense, the Department of
Veterans Affairs, and the Department of Health and
Human Services for basic, applied, or clinical
biomedical or behavioral research in the fields of
dentistry, medicine, and nursing; or
(B) a consortium of such academic institutions.
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 4. CLINICAL RESEARCH SUPPORT GRANTS.
(a) Authorization.--For the purposes described in subsection (b),
the Director shall award a clinical research support grant in the
amount determined under subsection (c) to each eligible academic health
center that submits an application in accordance with this section.
(b) Purpose.--A funding agreement for a grant under this section is
that the eligible academic health center involved will use the grant
only for the following purposes:
(1) To defray the costs of unfunded Federal requirements
for the protection of human research subjects, including the
costs of complying with the Health Insurance Portability and
Accountability Act of 1996 (Pub. Law 104-191) and maintaining
institutional review boards.
(2) To support activities leading to innovative ways to
meet the requirements described in paragraph (1) in an
efficient and cost effective manner.
(c) Allocation.--Of the amount appropriated to carry out this
section for a fiscal year, the Director shall allocate such
appropriated amount among the eligible academic health centers
receiving a grant under this section in an amount that bears the same
relation to such appropriated amount as the investment in clinical
research of the grantee involved bears to the total investment in
clinical research of all grantees under this section.
(d) Applications.--To be eligible for a grant under this section,
an eligible academic health center shall submit an application to the
Director in such manner, at such time, and containing such information
and assurances as the Director may require.
(e) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $40,000,000 for each of the
fiscal years 2005 through 2009.
SEC. 5. CLINICAL RESEARCH INFRASTRUCTURE GRANTS.
(a) Authorization.--The Director may award clinical research
infrastructure grants on a competitive basis to eligible academic
health centers.
(b) Use of Funds.--The Director may not award a grant to an
eligible academic health center under this section unless the center
agrees to use the grant only for the following:
(1) Infrastructure that is necessary to facilitate the
transfer of new understandings of disease mechanisms gained in
the laboratory into the development of new methodologies for
diagnosis, therapy, and prevention.
(2) The initial testing of human subjects.
(3) Addressing the many obstacles impeding the expeditious
application of new science, such as--
(A) a lack of up-to-date information technology
systems;
(B) incompatible databases;
(C) the need for training and mentoring required
for increasing the supply of qualified clinical
investigators; and
(D) a shortage of willing participants.
(c) Applications.--To be eligible for a grant under this section,
an eligible academic health center shall submit an application to the
Director in such manner, at such time, and containing such information
and assurances as the Director may require.
(d) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $125,000,000 for each of fiscal
years 2005 through 2009.
SEC. 6. DEMONSTRATION PROGRAM ON PARTNERSHIPS IN CLINICAL RESEARCH.
(a) Grants.--The Secretary may award grants to not more than 5
eligible academic health centers to form partnerships between the
center involved and health care providers for carrying out clinical
human subject research for the purpose of demonstrating how academic
research centers may collaborate with the practicing health care
community in such research.
(b) Maximum Amount.--The Secretary may not award a grant to any
eligible academic health center under this section in an amount that is
greater than $5,000,000.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $25,000,000 for the period of
fiscal years 2005 through 2009.
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