I 
112TH CONGRESS 
1ST SESSION H. R. 1862 
To launch a national strategy to support regenerative medicine through fund-
ing for research and commercial development of regenerative 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 
MAY 12, 2011 
Mr. BILBRAY (for himself, Ms. DEGETTE, Mr. DENT, Mr. GERLACH, Mr. 
HOLT, Ms. FUDGE, Mr. BUTTERFIELD, and Mr. LANGEVIN) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To launch a national strategy to support regenerative medi-
cine through funding for research and commercial devel-
opment of regenerative medicine products and develop-
ment 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 2011’’. 
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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, promote economic 
growth, and reduce health care spending in the 
United States. 
(2) Regenerative medicine products have al-
ready successfully treated numerous health condi-
tions, and have the potential to provide cures, treat-
ments, and diagnostics for a range of diseases and 
disabilities including diabetes, spinal cord injury, 
heart disease, stroke, and various forms of cancer. 
(3) A United States national strategy on regen-
erative medicine is critical to ensure that this tech-
nology fulfills its potential to cure and treat diseases 
and disabilities, reduce overall health spending, and 
promote economic growth. 
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(4) 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 traumatic 
brain injury and other forms of trauma, craniofacial 
reconstruction, limb reconstruction, regeneration, 
and transplantation. 
(5) 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. 
(6) 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. 
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SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 
ACTIVITIES 
REGARDING 
REGENERATIVE 
MEDICINE. 
Not later than 180 days after the date of the enact-
ment of this Act, the Comptroller General of the United 
States 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, within six months of the 
enactment of this Act, in the Office of the Secretary, a 
Regenerative Medicine Coordinating Council (in this sec-
tion 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. 
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(1) consult with, and provide information to, 
the Secretary of Health and Human Services for 
purposes of implementing any recommendations in 
the report required by section 3; 
(2) prepare, and keep up-to-date, a national 
strategy to support research into regenerative medi-
cine and the development of drugs, biological prod-
ucts, medical devices, and biomaterials for use in re-
generative medicine; 
(3) prepare a plan specifying priorities for re-
search into regenerative medicine; 
(4) not later than 1 year 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-
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, tax, and other policies 
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that will support development and marketing of re-
generative medicine products; 
(8) facilitate development of consensus stand-
ards regarding scientific issues critical to regulatory 
approval of regenerative 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 
Health, and the Commissioner of Food and Drugs. 
Each such report shall— 
(A) provide details on progress in meeting 
goals identified by the Council for regenerative 
medicine; 
(B) 
make 
recommendations 
regarding 
funding, regulatory, or other policies to achieve 
regenerative medicine goals identified by the 
Council; 
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(C) identify all regenerative medicine prod-
ucts currently on the market and those in devel-
opment; 
(D) identify regenerative medicine research 
and technological advances and discoveries that 
occurred in the previous year; and 
(E) assess the impact of regenerative medi-
cine on the Nation’s economy, including with 
respect to— 
(i) the number of people employed in 
companies or research institutions working 
in regenerative medicine; 
(ii) the number of companies pursuing 
regenerative medicine products; 
(iii) increases in tax revenues; and 
(iv) the impact on national health 
spending. 
SEC. 5. GRANTS FOR BASIC OR PRECLINICAL RESEARCH 
INTO REGENERATIVE MEDICINE. 
(a) GRANTS
FOR
BASIC
OR
PRECLINICAL
RE-
SEARCH.—The Secretary may make grants to eligible enti-
ties for the purpose of funding basic or preclinical research 
into regenerative medicine. 
(b) CONDITIONS.—The Secretary may make a grant 
under this section for research only if— 
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(1) the research is carried out directly by the 
grant recipient; 
(2) the research is partly funded by one or 
more private entities; and 
(3) the amount of the grant does not exceed the 
total amount provided for the research by private 
entities (other than the grant recipient itself). 
(c) TERMS AND CONDITIONS.—A grant under this 
section may be made on such terms and conditions as the 
Secretary determines appropriate. 
(d) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall take into consideration the prior-
ities established by the Regenerative Medicine Coordi-
nating Council under section 4(e). 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘eligible entity’’ means a non-
profit entity or an institution of higher education. 
(2) The term ‘‘institution of higher education’’ 
has the meaning given that term in section 101 of 
the Higher Education Act of 1965 (20 U.S.C. 
1001). 
(3) The term ‘‘nonprofit entity’’ means an enti-
ty that— 
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(A) is described in section 501(c)(3) of the 
Internal Revenue Code of 1986 (26 U.S.C. 
501(c)(3)); and 
(B) is exempt from tax under section 
501(a) of the Internal Revenue Code of 1986 
(26 U.S.C. 501(a)). 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Director of the National Institutes of Health. 
SEC. 6. GRANTS FOR DEVELOPMENT OF DRUGS, BIOLOGI-
CAL PRODUCTS, MEDICAL DEVICES, AND BIO-
MATERIALS 
FOR 
USE 
IN 
REGENERATIVE 
MEDICINE. 
(a) GRANTS FOR DRUG DEVELOPMENT.—The Sec-
retary may make grants to eligible entities for the purpose 
of funding projects that have as their aim— 
(1) the research and development of drugs, bio-
logical products, medical devices, and biomaterials 
for use in regenerative medicine; and 
(2) the making of an investigational new drug 
application with respect to such drugs or biological 
products, or the making of an investigational device 
exemption application with respect to such devices, 
by not later than the end of the 4-year period begin-
ning on the date on which such grant is made. 
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(b) TERMS AND CONDITIONS.—A grant under this 
section may be made on such terms and conditions as the 
Secretary determines appropriate. 
(c) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall take into consideration the prior-
ities established by the Regenerative Medicine Coordi-
nating Council under section 4(e). 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘biological product’’ has the 
meaning given the term in section 351(i) of the Pub-
lic Health Service Act (42 U.S.C. 262(i)). 
(2) The terms ‘‘drug’’ and ‘‘medical device’’ 
have the meanings given to the terms ‘‘drug’’ and 
‘‘device’’, respectively, in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
(3) The term ‘‘eligible entity’’ means a collabo-
rative partnership including— 
(A) a qualified nonprofit entity or an insti-
tution of higher education; and 
(B) a for-profit entity. 
(4) The term ‘‘institution of higher education’’ 
has the meaning given that term in section 101 of 
the Higher Education Act of 1965 (20 U.S.C. 
1001). 
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SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MED-
ICINE THROUGH CURES ACCELERATION NET-
WORK. 
Section 402C of the Public Health Service Act (42 
U.S.C. 282d) is amended— 
(1) in subsection (d), by adding at the end the 
following: 
‘‘(7) COLLABORATION.—With respect to activi-
ties of the Board relating to medical products and 
behavioral therapies for use in regenerative medi-
cine, the Board shall collaborate with the Regenera-
tive Medicine Coordinating Council.’’; and 
(2) in subsection (e)(3), by adding at the end 
the following: 
‘‘(D) THE CURES ACCELERATION AWARDS 
WITH RESPECT TO PRODUCTS AND THERAPIES 
FOR
USE
IN
REGENERATIVE
MEDICINE.—The 
Director of NIH may, without regard to sub-
paragraphs (A), (B), and (C), provide assist-
ance under paragraph (1) with respect to med-
ical products and behavioral therapies for use in 
regenerative medicine, including assistance— 
‘‘(i) to perform clinical trials under a 
protocol approved by the Commissioner of 
Food and Drugs or studies which use good 
manufacturing practice or good laboratory 
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practice procedures and the data from 
which are intended for inclusion in an in-
vestigational new drug application or an 
investigational device exemption applica-
tion; or 
‘‘(ii) to perform basic research or pre-
clinical studies in regenerative medicine the 
data from which are not intended for inclu-
sion in an investigational new drug appli-
cation or an investigational device exemp-
tion application.’’. 
SEC. 8. FUNDING FOR FOOD AND DRUG ADMINISTRATION 
RESEARCH. 
(a) GRANTS.—The Secretary may— 
(1) conduct, support, or collaborate in regu-
latory research for the purpose of assisting the Food 
and Drug Administration to perform its functions 
with respect to regenerative medicine; or 
(2) make grants to fund regulatory research for 
such purpose. 
(b) DEFINITIONS.—In this section: 
(1) The term ‘‘regulatory research’’ means re-
search regarding development, evaluation, and avail-
ability of new or improved tools, methods, standards, 
and applied science that support a better under-
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standing and improved evaluation of product safety, 
quality, effectiveness, and manufacturing throughout 
the product life cycle. 
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
Æ 
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