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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(5) The term ‘‘investigational new drug applica-
tion’’ means an investigational new drug application 
that is made to the Food and Drug Administration 
under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 505(i)). 
(6) The term ‘‘investigational device exemption 
application’’ means an application for an investiga-
tional device exemption that is made to the Food 
and Drug Administration under section 520(g) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(g)). 
(7) The term ‘‘qualified nonprofit entity’’ 
means an entity that— 
(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)). 
(8) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Director of the National Institutes of Health. 
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SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MED-
ICINE THROUGH CURES ACCELERATION NET-
WORK. 
Section 480 of the Public Health Service Act (42 
U.S.C. 287a) 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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