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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Reliable and Effective 

5 Growth for Regenerative Health Options that Improve 

6 Wellness’’ or the ‘‘REGROW Act’’. 

7 SEC. 2. CELLULAR THERAPEUTICS. 

8 (a) CURRENT PATHWAYS.—Nothing in this Act, or 

9 the amendments made by this Act, shall be applied or in10 terpreted as restricting or otherwise modifying any pathVerDate Sep 11 2014 07:09 Mar 17, 2016 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4762.IH H4762

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1 way to market which is (as of the day immediately before 

2 the date of enactment of this Act) provided under regula3 tions promulgated by the Food and Drug Administration, 

4 including pathways under sections 351 and 361 of the 

5 Public Health Service Act (42 U.S.C. 262 and 264). 

6 (b) APPROVAL FOR THERAPIES.—Subpart 1 of part 

7 F of title III of the Public Health Service Act (42 U.S.C. 

8 262 et seq.) is amended by adding after section 351A the 

9 following: 

10 ‘‘SEC. 351B. APPROVAL FOR CELLULAR THERAPIES. 

11 ‘‘(a) CONDITIONAL APPROVAL OF CELLULAR OR TIS12 SUE THERAPEUTIC.—Not later than 1 year after the date 

13 of enactment of this section, the Secretary shall establish 

14 a program to conditionally approve a cellular therapeutic 

15 product if the sponsor of such product demonstrates pre16 liminary clinical evidence of safety, and a reasonable ex17 pectation of effectiveness, without initiation of phase III 

18 investigations. 

19 ‘‘(b) ADDITIONAL REQUIREMENTS FOR CONDI20 TIONAL APPROVAL.—A conditionally approved product 

21 under subsection (a) shall, for a 5-year conditional use pe22 riod, be manufactured, introduced into interstate com23 merce, and used consistent with the regulations in effect 

24 at the time of such use, including good manufacturing 


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1 practices, without the approval of an application under 

2 section 351(a), if all of the following apply: 

3 ‘‘(1) Such cells or tissues are adult human cells 

4 or tissues. 

5 ‘‘(2) Such cells or tissues have been evaluated 

6 to examine immunogenicity and do not provoke a 

7 significant unintended immune response in the re8 cipient. 

9 ‘‘(3) Such cells or tissues are— 

10 ‘‘(A) minimally manipulated for a non11 homologous use; or 

12 ‘‘(B) more-than-minimally manipulated for 

13 a homologous or nonhomologous use, but are 

14 not genetically modified. 

15 ‘‘(4) Such cells or tissues are produced for a 

16 specific indication. 

17 ‘‘(5) Such cells or tissues are produced exclu18 sively for a use that performs, or helps achieve or re19 store, the same, or similar, function in the recipient 

20 as in the donor. 

21 ‘‘(6) Within 5 years of the safety and effective22 ness determination described in this section, the 

23 sponsor of the conditionally approved new product 

24 prepares and submits an application for approval of 

25 a biological product under section 351(a), demVerDate Sep 11 2014 07:09 Mar 17, 2016 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4762.IH H4762

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1 onstrating potency, purity, safety, and efficacy of the 

2 use. The Secretary may permit continued use of 

3 such product until the Secretary completes the re4 view of the application and makes a determination. 

5 Upon a determination by the Secretary not to ap6 prove the application, use of the cellular therapeutic 

7 shall not be permitted. 

8 ‘‘(7) During the conditional approval period, 

9 and before approval of an application under section 

10 351(a), the sponsor shall prepare and submit annual 

11 reports and adverse event reports to the Secretary 

12 containing all the information required for approved 

13 biological products. 

14 ‘‘(8) The sponsor has submitted an application 

15 under section 505(i) of the Federal Food, Drug, and 

16 Cosmetic Act for the treatment of the patients dur17 ing the 5-year conditional use period. 

18 ‘‘(9) The sponsor has not previously received 

19 conditional approval for such product for the same 

20 indication. 

21 ‘‘(c) INFORMED USE.—The individual administering 

22 a product approved under subsection (b) shall inform each 

23 individual who uses such product that the product has 

24 been conditionally approved based on studies in a limited 


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1 population, without proof of efficacy, and that the Sec2 retary is requiring additional studies of the product. 

3 ‘‘(d) STEM CELL BANKING.—To be eligible to pro4 vide cells for the uses described under subsection (b), pub5 lic and private cord blood banks, tissue banks, and bone 

6 marrow repositories shall be in full compliance with good 

7 tissue practice requirements under part 1271 of title 21, 

8 Code of Federal Regulations (or successor regulations), as 

9 applicable.’’. 

10 SEC. 3. DEVICES USED IN RECOVERY, PROCESSING, AND 

11 DELIVERY OF CELLULAR THERAPEUTICS. 

12 (a) CLEARANCE.—Section 510(k) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is 

14 amended— 

15 (1) in paragraph (1), by striking ‘‘, and’’ and 

16 inserting ‘‘;’’; 

17 (2) in paragraph (2), by striking the period and 

18 inserting ‘‘; and’’; and 

19 (3) by inserting after paragraph (2) the fol20 lowing: 

21 ‘‘(3) in the case of a cellular therapeutic de22 scribed in section 351B(a) of the Public Health 

23 Service Act, the general function of the device used 

24 for the recovery, isolation, processing, or delivery of 

25 such cellular therapeutic.’’. 


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1 (b) CLEARANCE OR APPROVAL OF CELLULAR

2 THERAPEUTICS.—Chapter V of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 

4 inserting after section 515A the following: 

5 ‘‘SEC. 515B. CLASSIFICATION OF CELLULAR THERA6 PEUTICS. 

7 ‘‘Clearance or approval of a device that is a cellular 

8 therapeutic described in section 351B(a) of the Public 

9 Health Service Act shall be based on in vitro performance 

10 testing and not in vivo human clinical trials, as appro11 priate. The Secretary shall classify devices in accordance 

12 with section 513 used for cell therapy (as described in sec13 tion 351B(a) of the Public Health Service Act), focusing 

14 on the general use of such devices for harvesting, delivery, 

15 or processing cells and sustaining the viability and func16 tions of the cells in vivo. The classification regulation shall 

17 not require that such devices be cleared under section 

18 510(k) or approved under section 515 for use with only 

19 specific types of cells or for specific uses unless unique 

20 to the intended use of the device. If the Secretary deter21 mines that no predicate exists, or that a device classified 

22 as class III is sufficiently low risk to justify a lower classi23 fication, the Secretary shall apply the procedure outlined 

24 in section 513(f)(2) to permit the review and marketing 

25 of the device.’’. 


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1 (c) COMBINATION PRODUCTS.—Section 503(g)(1) of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 353(g)(1)) is amended— 

4 (1) in subparagraph (B), by striking ‘‘or’’; 

5 (2) in subparagraph (C), by striking the period 

6 and inserting ‘‘, or’’; and 

7 (3) by adding at the end the following: 

8 ‘‘(D) cellular components, the agency center 

9 charged with premarket review of biological products 

10 shall have primary jurisdiction.’’. 

11 SEC. 4. GUIDANCE; AMENDED REGULATIONS. 

12 (a) GUIDANCE.—Within 1 year of the date of enact13 ment of this Act, the Secretary of Health and Human 

14 Services (referred to in this section as the ‘‘Secretary’’) 

15 may issue draft guidance on clarifying the requirements 

16 with respect to cellular therapeutics, as set forth in section 

17 351B of the Public Health Service Act, as added by sec18 tion 2, and devices used in processing or delivery of cel19 lular therapeutics, as set forth in section 510(k)(3) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 360(k)(3)) and section 515B of such Act, as added by sec22 tion 3(b). The Secretary shall issue final guidance not 

23 later than 180 days after the close of the comment period 

24 (including any extensions of such period) for the draft 

25 guidance. Such comment period may not exceed 60 days. 


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1 (b) AMENDED REGULATIONS.— 

2 (1) IN GENERAL.—If the Secretary determines 

3 that it is appropriate to amend the regulations 

4 under title 21, Code of Federal Regulations, in order 

5 to clarify the requirements of section 351B of the 

6 Public Health Service Act, as added by section 2, 

7 the Secretary shall amend such regulations not later 

8 than 1 year after the date of enactment of this Act. 

9 (2) PROCEDURE.—In amending regulations 

10 under paragraph (1), the Secretary shall— 

11 (A) issue a notice of proposed rulemaking 

12 that includes the proposed regulations; 

13 (B) provide a period of not more than 60 

14 days for comments on the proposed regulations; 

15 and 

16 (C) publish the final regulations not less 

17 than 30 days before the effective date of such 

18 regulations. 

19 (c) PUBLIC MEETING.—In carrying out this Act, in20 cluding the amendment made by section 2 and the amend21 ments made by section 3, the Secretary, not later than 

22 90 days after the date of enactment of this Act, shall have 

23 not less than 1 public meeting on the relevant regulatory 

24 policies relating to cell and tissue products, including any 

25 changes to such policies necessary to encourage innovation 


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1 and regulatory certainty with regard to the development 

2 of regenerative medicine products. 

3 SEC. 5. REGENERATIVE MEDICINE STANDARDS. 

4 The Secretary shall work with stakeholders, including 

5 regenerative product manufacturers, academic institu6 tions, standards setting organizations, and the National 

7 Institute of Standards and Technology, to promote and 

8 facilitate an effort to develop, through a transparent pub9 lic process, standards that will facilitate regulatory pre10 dictability regarding manufacturing processes and controls 

11 for regenerative medicine products. 

Æ 


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