I 
111TH CONGRESS 
2D SESSION 
H. R. 6173 
To provide for a Federal initiative to support regenerative medicine through 
increased funding for research and commercial development of regenera-
tive medicine products and development of a regulatory environment 
that enables rapid approval of safe and effective products, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 22, 2010 
Mr. CASTLE (for himself and Ms. DEGETTE) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To provide for a Federal initiative to support regenerative 
medicine through increased funding for research and 
commercial development of regenerative medicine prod-
ucts and development of a regulatory environment that 
enables rapid approval of safe and effective products, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Regenerative Medicine Promotion Act of 2010’’. 
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(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Findings. 
Sec. 3. Report on ongoing Federal programs and activities regarding regenera-
tive medicine. 
Sec. 4. Establishment of Regenerative Medicine Coordinating Council. 
Sec. 5. Grants for basic or preclinical research into regenerative medicine. 
Sec. 6. Grants for development of drugs, biological products, medical devices, 
and biomaterials for use in regenerative medicine. 
Sec. 7. Supporting innovation in regenerative medicine through Cures Accelera-
tion Network. 
Sec. 8. Funding for Food and Drug Administration Research. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Regenerative medicine has the potential to 
treat many chronic diseases and promote economic 
growth in the United States. 
(2) Regenerative medicine has the potential to 
provide cures, treatments and diagnostics for a 
range of diseases and disabilities including diabetes, 
spinal cord injury, heart disease, stroke, and various 
forms of cancer. 
(3) The Department of Defense has stated that 
regenerative medicine has the potential to treat 
many battlefield injuries such as burns, that it has 
the potential to heal wounds without scarring, and 
that it has the potential to be used for craniofacial 
reconstruction, limb reconstruction, regeneration, 
and transplantation. 
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(4) The Department of Health and Human 
Services and the Multi-Agency Tissue Engineering 
Science Interagency Working Group have endorsed a 
national initiative to support research and product 
development in regenerative medicine. 
(5) The Department of Health and Human 
Services has said the potential benefits of regenera-
tive medicine in improved health care and economic 
savings are enormous. States that have invested in 
regenerative medicine have experienced economic 
growth and see future growth potential, including an 
increase in biotech employment, payroll increases, 
and proportional impacts on tax receipts. 
SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 
ACTIVITIES 
REGARDING 
REGENERATIVE 
MEDICINE. 
Not later than 90 days after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall provide for the completion, and submission 
to the Congress, of a report identifying all ongoing Federal 
programs and activities regarding regenerative medicine. 
SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE CO-
ORDINATING COUNCIL. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services shall establish, in the Office of the Sec-
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retary, a Regenerative Medicine Coordinating Council (in 
this section referred to as the ‘‘Council’’). 
(b) COMPOSITION.—The Council shall be composed 
of the following: 
(1) The Secretary of Commerce. 
(2) The Secretary of Defense. 
(3) The Secretary of Health and Human Serv-
ices. 
(4) The Secretary of the Treasury. 
(5) The Secretary of Veterans Affairs. 
(6) The Administrator of the Agency for 
Healthcare Research and Quality. 
(7) The Administrator of the Centers for Medi-
care & Medicaid Services. 
(8) The Commissioner of Food and Drugs. 
(9) The Director of the National Institutes of 
Health. 
(10) The Director of the National Institutes of 
Standards and Technology. 
(11) Such other members as may be appointed 
by the Secretary. 
(c) CHAIR.—The Secretary of Health and Human 
Services shall be the Chair of the Council. 
(d) MEMBERS APPOINTED
BY SECRETARY.—The 
members of the Council appointed by the Secretary under 
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subsection (b)(11) shall include insurers, persons from 
academic institutions, patient advocates, persons with ex-
pertise in drug discovery, persons with expertise in drug 
development, persons with expertise in basic research, per-
sons with expertise in translational research, persons with 
expertise in medical device development, persons with ex-
pertise in biomaterials, and person with expertise in clin-
ical research. 
(e) FUNCTIONS.—The Council shall— 
(1) consult with and provide information to the 
Secretary of Health and Human Services for pur-
poses of preparing the report required by section 3; 
(2) prepare, and keep up-to-date, a national 
strategy for the promotion of research into regenera-
tive medicine and the development of drugs, biologi-
cal products, medical devices, and biomaterials for 
use in regenerative medicine; 
(3) prepare a plan specifying priorities for re-
search into regenerative medicine; 
(4) not later than 120 days after the date of 
the enactment of this Act, establish priorities for the 
award of grants under sections 5 and 6 (relating to 
grants for basic or preclinical research into regen-
erative medicine and for development of drugs, bio-
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logical products, medical devices, and biomaterials 
for use in regenerative medicine, respectively); 
(5) identify sources of funding for research into 
regenerative medicine; 
(6) identify areas where such funding is inad-
equate; 
(7) make recommendations regarding Federal 
regulatory, reimbursement, and other policies that 
will support development and marketing of regenera-
tive medicine products; 
(8) develop consensus standards regarding sci-
entific issues critical to regulatory approval of regen-
erative medicine products; and 
(9) determine the need for establishing centers 
of excellence or consortia to further advance regen-
erative medicine. 
(f) TRANSPARENCY; REPORTING REQUIREMENTS.— 
(1) TRANSPARENCY.—The Council shall adopt 
procedures to ensure the receipt of public input, 
such as holding public stakeholder meetings or cre-
ating advisory boards. 
(2) ANNUAL REPORTS.—The Council shall sub-
mit an annual report on its activities to the Con-
gress, the Director of the National Institutes of 
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