I 
114TH CONGRESS 
2D SESSION 
H. R. 4762 
To amend the Federal Food, Drug, and Cosmetic Act with respect to cellular 
therapies. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 16, 2016 
Mr. COFFMAN (for himself, Mr. TAKAI, and Mr. GRIFFITH) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to cellular 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 ‘‘Reliable and Effective 
Growth for Regenerative Health Options that Improve 
Wellness’’ or the ‘‘REGROW Act’’. 
SEC. 2. CELLULAR THERAPEUTICS. 
(a) CURRENT PATHWAYS.—Nothing in this Act, or 
the amendments made by this Act, shall be applied or in-
terpreted as restricting or otherwise modifying any path-
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way to market which is (as of the day immediately before 
the date of enactment of this Act) provided under regula-
tions promulgated by the Food and Drug Administration, 
including pathways under sections 351 and 361 of the 
Public Health Service Act (42 U.S.C. 262 and 264). 
(b) APPROVAL FOR THERAPIES.—Subpart 1 of part 
F of title III of the Public Health Service Act (42 U.S.C. 
262 et seq.) is amended by adding after section 351A the 
following: 
‘‘SEC. 351B. APPROVAL FOR CELLULAR THERAPIES. 
‘‘(a) CONDITIONAL APPROVAL OF CELLULAR OR TIS-
SUE THERAPEUTIC.—Not later than 1 year after the date 
of enactment of this section, the Secretary shall establish 
a program to conditionally approve a cellular therapeutic 
product if the sponsor of such product demonstrates pre-
liminary clinical evidence of safety, and a reasonable ex-
pectation of effectiveness, without initiation of phase III 
investigations. 
‘‘(b) ADDITIONAL
REQUIREMENTS
FOR
CONDI-
TIONAL APPROVAL.—A conditionally approved product 
under subsection (a) shall, for a 5-year conditional use pe-
riod, be manufactured, introduced into interstate com-
merce, and used consistent with the regulations in effect 
at the time of such use, including good manufacturing 
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practices, without the approval of an application under 
section 351(a), if all of the following apply: 
‘‘(1) Such cells or tissues are adult human cells 
or tissues. 
‘‘(2) Such cells or tissues have been evaluated 
to examine immunogenicity and do not provoke a 
significant unintended immune response in the re-
cipient. 
‘‘(3) Such cells or tissues are— 
‘‘(A) minimally manipulated for a non-
homologous use; or 
‘‘(B) more-than-minimally manipulated for 
a homologous or nonhomologous use, but are 
not genetically modified. 
‘‘(4) Such cells or tissues are produced for a 
specific indication. 
‘‘(5) Such cells or tissues are produced exclu-
sively for a use that performs, or helps achieve or re-
store, the same, or similar, function in the recipient 
as in the donor. 
‘‘(6) Within 5 years of the safety and effective-
ness determination described in this section, the 
sponsor of the conditionally approved new product 
prepares and submits an application for approval of 
a biological product under section 351(a), dem-
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onstrating potency, purity, safety, and efficacy of the 
use. The Secretary may permit continued use of 
such product until the Secretary completes the re-
view of the application and makes a determination. 
Upon a determination by the Secretary not to ap-
prove the application, use of the cellular therapeutic 
shall not be permitted. 
‘‘(7) During the conditional approval period, 
and before approval of an application under section 
351(a), the sponsor shall prepare and submit annual 
reports and adverse event reports to the Secretary 
containing all the information required for approved 
biological products. 
‘‘(8) The sponsor has submitted an application 
under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act for the treatment of the patients dur-
ing the 5-year conditional use period. 
‘‘(9) The sponsor has not previously received 
conditional approval for such product for the same 
indication. 
‘‘(c) INFORMED USE.—The individual administering 
a product approved under subsection (b) shall inform each 
individual who uses such product that the product has 
been conditionally approved based on studies in a limited 
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population, without proof of efficacy, and that the Sec-
retary is requiring additional studies of the product. 
‘‘(d) STEM CELL BANKING.—To be eligible to pro-
vide cells for the uses described under subsection (b), pub-
lic and private cord blood banks, tissue banks, and bone 
marrow repositories shall be in full compliance with good 
tissue practice requirements under part 1271 of title 21, 
Code of Federal Regulations (or successor regulations), as 
applicable.’’. 
SEC. 3. DEVICES USED IN RECOVERY, PROCESSING, AND 
DELIVERY OF CELLULAR THERAPEUTICS. 
(a) CLEARANCE.—Section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 
amended— 
(1) in paragraph (1), by striking ‘‘, and’’ and 
inserting ‘‘;’’; 
(2) in paragraph (2), by striking the period and 
inserting ‘‘; and’’; and 
(3) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) in the case of a cellular therapeutic de-
scribed in section 351B(a) of the Public Health 
Service Act, the general function of the device used 
for the recovery, isolation, processing, or delivery of 
such cellular therapeutic.’’. 
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(b) CLEARANCE
OR
APPROVAL
OF
CELLULAR 
THERAPEUTICS.—Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 515A the following: 
‘‘SEC. 
515B. 
CLASSIFICATION 
OF 
CELLULAR 
THERA-
PEUTICS. 
‘‘Clearance or approval of a device that is a cellular 
therapeutic described in section 351B(a) of the Public 
Health Service Act shall be based on in vitro performance 
testing and not in vivo human clinical trials, as appro-
priate. The Secretary shall classify devices in accordance 
with section 513 used for cell therapy (as described in sec-
tion 351B(a) of the Public Health Service Act), focusing 
on the general use of such devices for harvesting, delivery, 
or processing cells and sustaining the viability and func-
tions of the cells in vivo. The classification regulation shall 
not require that such devices be cleared under section 
510(k) or approved under section 515 for use with only 
specific types of cells or for specific uses unless unique 
to the intended use of the device. If the Secretary deter-
mines that no predicate exists, or that a device classified 
as class III is sufficiently low risk to justify a lower classi-
fication, the Secretary shall apply the procedure outlined 
in section 513(f)(2) to permit the review and marketing 
of the device.’’. 
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(c) COMBINATION PRODUCTS.—Section 503(g)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353(g)(1)) is amended— 
(1) in subparagraph (B), by striking ‘‘or’’; 
(2) in subparagraph (C), by striking the period 
and inserting ‘‘, or’’; and 
(3) by adding at the end the following: 
‘‘(D) cellular components, the agency center 
charged with premarket review of biological products 
shall have primary jurisdiction.’’. 
SEC. 4. GUIDANCE; AMENDED REGULATIONS. 
(a) GUIDANCE.—Within 1 year of the date of enact-
ment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) 
may issue draft guidance on clarifying the requirements 
with respect to cellular therapeutics, as set forth in section 
351B of the Public Health Service Act, as added by sec-
tion 2, and devices used in processing or delivery of cel-
lular therapeutics, as set forth in section 510(k)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(k)(3)) and section 515B of such Act, as added by sec-
tion 3(b). The Secretary shall issue final guidance not 
later than 180 days after the close of the comment period 
(including any extensions of such period) for the draft 
guidance. Such comment period may not exceed 60 days. 
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(b) AMENDED REGULATIONS.— 
(1) IN GENERAL.—If the Secretary determines 
that it is appropriate to amend the regulations 
under title 21, Code of Federal Regulations, in order 
to clarify the requirements of section 351B of the 
Public Health Service Act, as added by section 2, 
the Secretary shall amend such regulations not later 
than 1 year after the date of enactment of this Act. 
(2) PROCEDURE.—In amending regulations 
under paragraph (1), the Secretary shall— 
(A) issue a notice of proposed rulemaking 
that includes the proposed regulations; 
(B) provide a period of not more than 60 
days for comments on the proposed regulations; 
and 
(C) publish the final regulations not less 
than 30 days before the effective date of such 
regulations. 
(c) PUBLIC MEETING.—In carrying out this Act, in-
cluding the amendment made by section 2 and the amend-
ments made by section 3, the Secretary, not later than 
90 days after the date of enactment of this Act, shall have 
not less than 1 public meeting on the relevant regulatory 
policies relating to cell and tissue products, including any 
changes to such policies necessary to encourage innovation 
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and regulatory certainty with regard to the development 
of regenerative medicine products. 
SEC. 5. REGENERATIVE MEDICINE STANDARDS. 
The Secretary shall work with stakeholders, including 
regenerative product manufacturers, academic institu-
tions, standards setting organizations, and the National 
Institute of Standards and Technology, to promote and 
facilitate an effort to develop, through a transparent pub-
lic process, standards that will facilitate regulatory pre-
dictability regarding manufacturing processes and controls 
for regenerative medicine products. 
Æ 
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