IB 

Union Calendar No. 632 

118TH CONGRESS 

2D SESSION H. R. 7188 

[Report No. 118–766] 

To require the Secretary of Health and Human Services to conduct a national, 

evidence-based education campaign to increase public and health care 

provider awareness regarding the potential risks and benefits of human 

cell and tissue products transplants, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 1, 2024 

Mr. MOOLENAAR (for himself and Mrs. DINGELL) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

NOVEMBER 22, 2024 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on February 1, 2024] 


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•HR 7188 RH

A BILL 

To require the Secretary of Health and Human Services 

to conduct a national, evidence-based education campaign 

to increase public and health care provider awareness 

regarding the potential risks and benefits of human cell 

and tissue products transplants, and for other purposes. 


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•HR 7188 RH

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 ‘‘Shandra Eisenga 

5 Human Cell and Tissue Product Safety Act’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 

8 (1) HUMAN CELL AND TISSUE PRODUCT.—The 

9 terms ‘‘human cell and tissue product’’ and ‘‘human 

10 cell and tissue products’’ have the meaning given the 

11 term ‘‘human cells, tissues, or cellular or tissue-based 

12 products’’ in section 1271.3(d) of title 21, Code of 

13 Federal Regulations (or successor regulations). 

14 (2) SECRETARY.—The term ‘‘Secretary’’ means 

15 the Secretary of Health and Human Services. 

16 (3) TISSUE REFERENCE GROUP.—The term ‘‘Tis17 sue Reference Group’’ means the Tissue Reference 

18 Group of the Food and Drug Administration. 

19 SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 

20 PUBLIC AWARENESS CAMPAIGN. 

21 The Secretary shall support the development and dis22 semination of educational materials to inform health care 

23 professionals and other appropriate professionals about 

24 issues surrounding— 


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•HR 7188 RH

1 (1) organ, tissue, and eye donation, including 

2 evidence-based methods to approach patients and 

3 their families; 

4 (2) the availability of any donor screening tests; 

5 and 

6 (3) other relevant aspects of donation. 

7 SEC. 4. REVIEW AND UPDATE OF EXISTING GUIDANCE. 

8 The Secretary, acting through the Commissioner of 

9 Food and Drugs, shall— 

10 (1) not later than 1 year after the date of the en11 actment of this Act, initiate an internal review of ex12 isting guidance for determining eligibility of donors 

13 of human cell and tissue products; 

14 (2) not later than 3 years after the date of the 

15 enactment of this Act, if appropriate— 

16 (A) update the guidance titled ‘‘Eligibility 

17 Determination for Donors of Human Cells, Tis18 sues, and Cellular and Tissue-Based Products; 

19 Guidance for Industry’’ issued August 2007; and 

20 (B) issue or update, as applicable, any 

21 guidance for industry of the Food and Drug Ad22 ministration that includes— 

23 (i) recommendations to reduce the risk 

24 of transmission of mycobacterium tuberVerDate Sep 11 2014 01:40 Nov 23, 2024 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H7188.RH H7188

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1 culosis by human cells, tissues, and cellular 

2 and tissue-based products (HCT/Ps); or 

3 (ii) recommendations to reduce the risk 

4 of transmission of disease agents associated 

5 with sepsis for donors of human cells, tis6 sues, and cellular and tissue-based products 

7 (HCT/Ps); and 

8 (3) if the Secretary determines that issuing or 

9 updating guidance as specified in paragraph (2) is 

10 not appropriate, provide a written statement of expla11 nation of that determination to the Committee on En12 ergy and Commerce of the House of Representatives 

13 and the Committee on Health, Education, Labor, and 

14 Pensions of the Senate. 

15 SEC. 5. CIVIL PENALTIES FOR VIOLATION OF REQUIRE16 MENTS FOR HUMAN CELL AND TISSUE PROD17 UCTS. 

18 Section 368 of the Public Health Service Act (42 

19 U.S.C. 271) is amended by adding at the end the following: 

20 ‘‘(d)(1) Any person who, on or after the date of the 

21 enactment of the Shandra Eisenga Human Cell and Tissue 

22 Product Safety Act, violates a requirement of subparts C 

23 or D of section 1271 of title 21, Code of Federal Regulations, 

24 (or successor regulations) with respect to human cell or tis25 sue products regulated under section 361 shall be liable to 


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1 the United States for a civil penalty in an amount not to 

2 exceed the sum of— 

3 ‘‘(A)(i) $20,000 for each violation; and 

4 ‘‘(ii) in the case of a violation that continues 

5 after the Secretary provides written notice to such 

6 person, $20,000 for each subsequent day on which the 

7 violation continues; and 

8 ‘‘(B) an amount equal to the retail value of the 

9 human cell and tissue products that are the subject of 

10 the violation. 

11 ‘‘(2) The total civil penalty under paragraph (1) may 

12 not exceed $10,000,000 for all such violations adjudicated 

13 in a single proceeding. 

14 ‘‘(3) In this subsection, the term ‘human cell and tissue 

15 products’ has the meaning given the term ‘human cells, tis16 sues, or cellular or tissue-based products’ in section 

17 1271.3(d) of title 21, Code of Federal Regulations (or suc18 cessor regulations).’’. 

19 SEC. 6. STREAMLINING REGULATORY OVERSIGHT OF 

20 HUMAN CELL AND TISSUE PRODUCTS. 

21 (a) INFORMATION ON HUMAN CELL AND TISSUE

22 PRODUCTS.— 

23 (1) WEBSITE.—The Secretary, acting through 

24 the Commissioner of Food and Drugs, shall publish 


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•HR 7188 RH

1 on the public website of the Food and Drug Adminis2 tration— 

3 (A) educational materials about the Tissue 

4 Reference Group; and 

5 (B) best practices for obtaining a timely, 

6 accurate recommendation regarding human cell 

7 and tissue products from the Tissue Reference 

8 Group. 

9 (2) PUBLIC INFORMATION.—Not later than 1 

10 year after the date of the enactment of this Act, and 

11 annually for the subsequent 3 years, the Secretary, 

12 acting through the Commissioner of Food and Drugs, 

13 shall publish on the public website of the Food and 

14 Drug Administration— 

15 (A) the number of human cell and tissue es16 tablishments that registered with the Food and 

17 Drug Administration on or after January 1, 

18 2019; 

19 (B) the number of inspections conducted by 

20 the Food and Drug Administration of human 

21 cell and tissue establishments on or after Janu22 ary 1, 2019, including a comparison of the num23 ber of inspections for blood establishments with 

24 the number of inspections for such human cell 

25 and tissue establishments; 


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1 (C) the number and type of inquiries to the 

2 Tissue Reference Group in the preceding year; 

3 and 

4 (D) the average response time for submis5 sions to the Tissue Reference Group in the pre6 ceding year, including average initial and final 

7 response time. 

8 (3) EDUCATION.—The Secretary, acting through 

9 the Commissioner of Food and Drugs, shall, with re10 spect to the regulation of human cell and tissue prod11 ucts— 

12 (A) provide information to relevant stake13 holders, including industry, tissue establish14 ments, academic health centers, biomedical con15 sortia, research organizations, and patients; and 

16 (B) conduct workshops and other interactive 

17 and educational sessions for such stakeholders to 

18 help support regulatory predictability and sci19 entific advancement, as appropriate. 

20 (b) HUMAN CELL AND TISSUE PRODUCT SCIENTIFIC

21 AND REGULATORY UPDATES.—Section 3205 of the Food 

22 and Drug Omnibus Reform Act of 2022 (title III of division 

23 FF of Public Law 117–328) is amended by striking ‘‘best 

24 practices’’ and all that follows through ‘‘other cellular thera25 pies’’ and inserting ‘‘best practices on generating scientific 


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•HR 7188 RH

1 data necessary to further facilitate the development of cer2 tain human cell-, tissue-, and cellular-based medical prod3 ucts (and the latest scientific information about such prod4 ucts), namely, stem cell and other cellular therapies’’. 

5 (c) PUBLIC DOCKET.—Not later than 60 days after the 

6 date of the enactment of this Act, the Secretary shall estab7 lish a public docket to receive written comments related to— 

8 (1) the approaches recommended for discussion 

9 during the public workshop described in section 3205 

10 of the Food and Drug Omnibus Reform Act of 2022 

11 (title III of division FF of Public Law 117–328); and 

12 (2) modernizing the regulation of human cell 

13 and tissue products, including considerations associ14 ated with assessing minimal manipulation and ho15 mologous use (as such terms are defined in section 

16 1271.3 of title 21, Code of Federal Regulations (or 

17 successor regulations)) of human cell and tissue prod18 ucts. 

19 (d) REPORT TO CONGRESS.—Not later than September 

20 30, 2026, the Secretary shall summarize the approaches dis21 cussed in the public workshop described in section 3205 of 

22 the Food and Drug Omnibus Reform Act of 2022 (title III 

23 of division FF of Public Law 117–328) and the public dock24 et described in subsection (c), and develop recommendations 

25 regarding the regulation of human cell and tissue products, 


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1 including provisions under sections 1271.10(a) and 1271.3 

2 of title 21, Code of Federal Regulations, taking into ac3 count— 

4 (1) regulatory burden; 

5 (2) scientific developments; 

6 (3) access to human cell and tissue products reg7 ulated under section 361 of the Public Health Service 

8 Act (42 U.S.C. 264); and 

9 (4) protecting public health. 


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Union Calendar No. 632 

118TH CONGRESS 

2D SESSION H. R. 7188 

[Report No. 118–766] 

A BILL 

To require the Secretary of Health and Human 

ucts transplants, and for other purposes. risks and benefits of human cell and tissue prodcare provider awareness regarding the potential education campaign to increase public and health Services to conduct a national, evidence-based 

NOVEMBER 22, 2024 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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