I 

118TH CONGRESS 

2D SESSION H. R. 8251 

To direct the Secretary of Health and Human Services to streamline regulatory oversight of human cell and tissue products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 6, 2024 

Mr. CRENSHAW (for himself and Ms. BARRAGA ́N) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

streamline regulatory oversight of human cell and tissue 

products, and for other purposes. 

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 ‘‘The HCT/P Mod5 ernization Act of 2024’’. 

6 SEC. 2. STREAMLINING REGULATORY OVERSIGHT OF 

7 HUMAN CELL AND TISSUE PRODUCTS. 

8 (a) REGULATORY CLASSIFICATION INQUIRIES.— 


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1 (1) INQUIRY DESCRIBED.—An inquiry described 

2 in this paragraph is an inquiry— 

3 (A) made by the manufacturer or sponsor 

4 of a human cell and tissue product; 

5 (B) to the Tissue Reference Group; and 

6 (C) for information regarding the regu7 latory classification of whether such product is 

8 subject to regulation solely under section 361 of 

9 the Public Health Service Act (42 U.S.C. 264) 

10 and part 1271 or title 21, Code of Federal Reg11 ulations (or successor regulations). 

12 (2) RESPONSE BY SECRETARY.—Not later than 

13 70 days after receipt of a written inquiry described 

14 in subsection (a) from a manufacturer or sponsor of 

15 a human cell and tissue product, the Secretary of 

16 Health and Human Services, acting through the 

17 Commissioner of Food and Drugs, shall provide such 

18 manufacturer or sponsor— 

19 (A) a nonbinding, written statement on 

20 whether such product is subject to regulation 

21 solely under section 361 of the Public Health 

22 Service Act (42 U.S.C. 264) and part 1271 or 

23 title 21, Code of Federal Regulations (or suc24 cessor regulations); or 


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1 (B) a notification that the manufacturer or 

2 sponsor must resubmit the inquiry with addi3 tional information. 

4 (3) REQUEST TO MEET WITH TISSUE REF5 ERENCE GROUP.— 

6 (A) REQUEST.—Upon receipt of a state7 ment under paragraph (2)(A), the manufac8 turer or sponsor of a human cell and tissue 

9 product may request a meeting with the Tissue 

10 Reference Group to discuss the decision in such 

11 statement regarding the product’s regulatory 

12 classification. 

13 (B) MEETING REQUIRED.—Upon receipt of 

14 a request under subparagraph (A), the Tissue 

15 Reference Group shall hold a meeting with the 

16 requesting manufacturer or sponsor. 

17 (b) PUBLIC MEETING.—Not later than 90 days after 

18 the date of enactment of this Act, the Secretary shall pub19 lish in the Federal Register a notice to convene a public 

20 meeting to discuss and obtain input and recommendations 

21 from relevant stakeholders, including industry, tissue es22 tablishments, academic health centers, biomedical con23 sortia, research organizations, and patients, regarding— 


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1 (1) the definition of the term ‘‘minimal manipu2 lation’’ under section 1271.3 of title 21, Code of 

3 Federal Regulations, including— 

4 (A) previous and current interpretations of 

5 such term; 

6 (B) the landscape of products which have 

7 been identified by the Food and Drug Adminis8 tration as meeting— 

9 (i) such definition of ‘‘minimal manip10 ulation’’; 

11 (ii) the definition of ‘‘more than mini12 mally manipulated’’ as used the guidance 

13 of the Food and Drug Administration ti14 tled ‘‘Regulatory Considerations for 

15 Human Cells, Tissues, and Cellular and 

16 Tissue-Based Products: Minimal Manipula17 tion and Homologous Use’’ (dated July 

18 2020) (or any successor guidance); or 

19 (iii) neither the definition referred to 

20 in clause (i) or (ii); 

21 (C) the approximate scope of use of such 

22 products; and 

23 (D) any changes to the interpretation of 

24 ‘‘minimal manipulation’’ that may be necessary 

25 to meet the risk benefit of such products; and 


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1 (2) considerations in assessing homologous use 

2 of human cell and tissue products, and the character 

3 and function of human cell and tissue products, in4 cluding— 

5 (A) previous and current considerations of 

6 such use, character, and function; and 

7 (B) potential such considerations with re8 spect to products described in paragraph 

9 (1)(B). 

10 (c) UPDATES TO REGULATIONS AND GUIDANCE.— 

11 (1) IN GENERAL.—Not later than 12 months 

12 after the date of enactment of this Act, the Sec13 retary shall update the criteria for homologous use 

14 and the other criteria under section 1271.10(a) of 

15 title 21, Code of Federal Regulations, and the defi16 nition of minimal manipulation under section 1271.3 

17 of such title 21, with the goals of— 

18 (A) minimizing regulatory burden; 

19 (B) protecting public health; and 

20 (C) maintaining the existence of the cur21 rent pathways by which certain human cell and 

22 tissue products are marketed under section 361 

23 of the Public Health Service Act (42 U.S.C. 

24 264), certain biological products are licensed 

25 under section 351 of the Public Health Service 


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1 Act (42 U.S.C. 351), and certain drugs are ap2 proved under section 505 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 355). 

4 (2) TECHNICAL ASSISTANCE; EDUCATION.—The 

5 Secretary shall, with respect to the regulation of 

6 human cell and tissue products, including the up7 dates under paragraph (1)— 

8 (A) provide technical assistance to relevant 

9 stakeholders, including industry, tissue estab10 lishments, academic health centers, biomedical 

11 consortia, research organizations, and patients; 

12 and 

13 (B) at least every six months, initiate and 

14 conduct workshops and other interactive and 

15 educational sessions for such stakeholders. 

16 (d) REPORTS TO CONGRESS.— 

17 (1) REPORT ON MEETING.—Not later than 12 

18 months after the date of enactment of this Act, the 

19 Secretary shall submit a report to the Congress on 

20 the results of the meeting under subsection (b). 

21 (2) ANNUAL REPORT.—Not later than March 1, 

22 2025, and March 1 of each calendar year thereafter, 

23 the Secretary shall, with respect to the previous cal24 endar year, submit to the Committee on Health, 

25 Education, Labor, and Pensions of the Senate and 


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1 the Committee on Energy and Commerce of the 

2 House of Representatives, and publish on the inter3 net website of the Department of Health and 

4 Human Services, a report on— 

5 (A) the number and type of inquiries re6 ceived by the Tissue Reference Group; 

7 (B) the average response time for inquiries 

8 received by the Tissue Reference Group, includ9 ing the average response times for initial and 

10 final responses; and 

11 (C) with respect to final decisions issued 

12 by the Tissue Reference Group, the number of 

13 human cell and tissue products determined to 

14 be regulated under each regulatory category. 

15 (e) DEFINITIONS.—In this section: 

16 (1) The term ‘‘human cell and tissue prod17 uct’’— 

18 (A) means a ‘‘human cells, tissues, or cel19 lular or tissue based product’’ as such term is 

20 defined in section 1271.3 of title 21, Code of 

21 Federal Regulations (or successor regulations); 

22 and 

23 (B) includes any such product regardless 

24 of whether it is approved for marketing, apVerDate Sep 11 2014 00:23 Jun 22, 2024 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H8251.IH H8251

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1 proved for investigational use, or merely pro2 posed. 

3 (2) The term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services, acting through the 

5 Commissioner of Food and Drugs. 

6 (3) The term ‘‘Tissue Reference Group’’ means 

7 the Tissue Reference Group of the Food and Drug 

8 Administration. 

Æ 


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