I 
114TH CONGRESS 
2D SESSION 
H. R. 4669 
To support the establishment of a Standards Coordinating Body in 
Regenerative Medicine and Advanced Therapies. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 2, 2016 
Mr. FOSTER introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To support the establishment of a Standards Coordinating 
Body in Regenerative Medicine and Advanced Therapies. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Advancing Standards 
in Regenerative Medicine Act’’. 
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SEC. 2. SUPPORT FOR THE ESTABLISHMENT OF A STAND-
ARDS COORDINATING BODY IN REGENERA-
TIVE MEDICINE AND ADVANCED THERAPIES. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506F the following: 
‘‘SEC. 506G. COORDINATING BODY IN REGENERATIVE MEDI-
CINE AND ADVANCED THERAPIES. 
‘‘(a) IN GENERAL.—The Secretary, in consultation 
with stakeholders, including regenerative medicine product 
manufacturers and clinical trial sponsors, contract manu-
facturers, academic institutions, standard setting organi-
zations, the National Institute of Standards and Tech-
nology, and other relevant Federal agencies, as appro-
priate, shall facilitate establishment of a public-private 
Standards Coordinating Body in Regenerative Medicine 
and Advanced Therapies. 
‘‘(b) FUNCTION
OF
STANDARDS
COORDINATING 
BODY.—Upon establishment of the Standards Coordi-
nating Body in Regenerative Medicine and Advanced 
Therapies under subsection (a), the Secretary shall— 
‘‘(1) identify opportunities for the development 
of laboratory regulatory science research and docu-
mentary standards that the Secretary determines 
would support the development, evaluation, and re-
view of regenerative medicine products; and 
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‘‘(2) work with such Standards Coordinating 
Body, as appropriate, in the development of stand-
ards described in paragraph (1). 
‘‘(c) GUIDANCE.—The Secretary shall issue guidance, 
as appropriate, on how standards may be used in regu-
latory review for regenerative medicine and advanced 
therapies. 
‘‘(d) DEFINITION.—For purposes of this section, the 
term ‘regenerative medicine and advanced therapies’ in-
cludes cell therapy, gene therapy, gene-modified cell ther-
apy, therapeutic tissue engineering products, and human 
cell and tissue products, and combination products using 
any such therapies or products. 
‘‘(e) NO ADDITIONAL FUNDS.—The Secretary shall 
carry out this section using funds otherwise made avail-
able to the Food and Drug Administration. No additional 
funds are authorized to be appropriated to carry out this 
section.’’. 
Æ 
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