II 

118TH CONGRESS 

2D SESSION H. R. 7188 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 17 (legislative day, DECEMBER 16), 2024 

Received 

AN ACT 

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 RDS

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 tissue12 based products’’ in section 1271.3(d) of title 21, 

13 Code of Federal Regulations (or successor regula14 tions). 

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

16 the Secretary of Health and Human Services. 

17 (3) TISSUE REFERENCE GROUP.—The term 

18 ‘‘Tissue Reference Group’’ means the Tissue Ref19 erence Group of the Food and Drug Administration. 

20 SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 

21 PUBLIC AWARENESS CAMPAIGN. 

22 The Secretary shall support the development and dis23 semination of educational materials to inform health care 

24 professionals and other appropriate professionals about 

25 issues surrounding— 


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HR 7188 RDS

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 

11 enactment of this Act, initiate an internal review of 

12 existing guidance for determining eligibility of do13 nors 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; 

20 and 

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

22 guidance for industry of the Food and Drug 

23 Administration that includes— 

24 (i) recommendations to reduce the 

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1 berculosis by human cells, tissues, and cel2 lular and tissue-based products (HCT/Ps); 

3 or 

4 (ii) recommendations to reduce the 

5 risk of transmission of disease agents asso6 ciated with sepsis for donors of human 

7 cells, tissues, and cellular and tissue-based 

8 products (HCT/Ps); and 

9 (3) if the Secretary determines that issuing or 

10 updating guidance as specified in paragraph (2) is 

11 not appropriate, provide a written statement of ex12 planation of that determination to the Committee on 

13 Energy and Commerce of the House of Representa14 tives and the Committee on Health, Education, 

15 Labor, and Pensions of the Senate. 

16 SEC. 5. CIVIL PENALTIES FOR VIOLATION OF REQUIRE17 MENTS FOR HUMAN CELL AND TISSUE PROD18 UCTS. 

19 Section 368 of the Public Health Service Act (42 

20 U.S.C. 271) is amended by adding at the end the fol21 lowing: 

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

23 enactment of the Shandra Eisenga Human Cell and Tis24 sue Product Safety Act, violates a requirement of subparts 

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1 lations, (or successor regulations) with respect to human 

2 cell or tissue products regulated under section 361 shall 

3 be liable to the United States for a civil penalty in an 

4 amount not to exceed the sum of— 

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

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

7 after the Secretary provides written notice to such 

8 person, $20,000 for each subsequent day on which 

9 the violation continues; and 

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

11 human cell and tissue products that are the subject 

12 of the violation. 

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

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

15 in a single proceeding. 

16 ‘‘(3) In this subsection, the term ‘human cell and tis17 sue products’ has the meaning given the term ‘human 

18 cells, tissues, or cellular or tissue-based products’ in sec19 tion 1271.3(d) of title 21, Code of Federal Regulations 

20 (or successor regulations).’’. 

21 SEC. 6. STREAMLINING REGULATORY OVERSIGHT OF 

22 HUMAN CELL AND TISSUE PRODUCTS. 

23 (a) INFORMATION ON HUMAN CELL AND TISSUE

24 PRODUCTS.— 


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

2 the Commissioner of Food and Drugs, shall publish 

3 on the public website of the Food and Drug Admin4 istration— 

5 (A) educational materials about the Tissue 

6 Reference Group; and 

7 (B) best practices for obtaining a timely, 

8 accurate recommendation regarding human cell 

9 and tissue products from the Tissue Reference 

10 Group. 

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

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

13 annually for the subsequent 3 years, the Secretary, 

14 acting through the Commissioner of Food and 

15 Drugs, shall publish on the public website of the 

16 Food and Drug Administration— 

17 (A) the number of human cell and tissue 

18 establishments that registered with the Food 

19 and Drug Administration on or after January 

20 1, 2019; 

21 (B) the number of inspections conducted 

22 by the Food and Drug Administration of 

23 human cell and tissue establishments on or 

24 after January 1, 2019, including a comparison 

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1 ments with the number of inspections for such 

2 human cell and tissue establishments; 

3 (C) the number and type of inquiries to 

4 the Tissue Reference Group in the preceding 

5 year; and 

6 (D) the average response time for submis7 sions to the Tissue Reference Group in the pre8 ceding year, including average initial and final 

9 response time. 

10 (3) EDUCATION.—The Secretary, acting 

11 through the Commissioner of Food and Drugs, shall, 

12 with respect to the regulation of human cell and tis13 sue products— 

14 (A) provide information to relevant stake15 holders, including industry, tissue establish16 ments, academic health centers, biomedical con17 sortia, research organizations, and patients; and 

18 (B) conduct workshops and other inter19 active and educational sessions for such stake20 holders to help support regulatory predictability 

21 and scientific advancement, as appropriate. 

22 (b) HUMAN CELL AND TISSUE PRODUCT SCIENTIFIC

23 AND REGULATORY UPDATES.—Section 3205 of the Food 

24 and Drug Omnibus Reform Act of 2022 (title III of divi25 sion FF of Public Law 117–328) is amended by striking 


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1 ‘‘best practices’’ and all that follows through ‘‘other cel2 lular therapies’’ and inserting ‘‘best practices on gener3 ating scientific data necessary to further facilitate the de4 velopment of certain human cell-, tissue-, and cellular5 based medical products (and the latest scientific informa6 tion about such products), namely, stem cell and other cel7 lular therapies’’. 

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

9 the date of the enactment of this Act, the Secretary shall 

10 establish a public docket to receive written comments re11 lated to— 

12 (1) the approaches recommended for discussion 

13 during the public workshop described in section 

14 3205 of the Food and Drug Omnibus Reform Act of 

15 2022 (title III of division FF of Public Law 117– 

16 328); and 

17 (2) modernizing the regulation of human cell 

18 and tissue products, including considerations associ19 ated with assessing minimal manipulation and ho20 mologous use (as such terms are defined in section 

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

22 successor regulations)) of human cell and tissue 

23 products. 

24 (d) REPORT TO CONGRESS.—Not later than Sep25 tember 30, 2026, the Secretary shall summarize the apVerDate Sep 11 2014 23:31 Jan 04, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H7188.RDS H7188

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1 proaches discussed in the public workshop described in 

2 section 3205 of the Food and Drug Omnibus Reform Act 

3 of 2022 (title III of division FF of Public Law 117–328) 

4 and the public docket described in subsection (c), and de5 velop recommendations regarding the regulation of human 

6 cell and tissue products, including provisions under sec7 tions 1271.10(a) and 1271.3 of title 21, Code of Federal 

8 Regulations, taking into account— 

9 (1) regulatory burden; 

10 (2) scientific developments; 

11 (3) access to human cell and tissue products 

12 regulated under section 361 of the Public Health 

13 Service Act (42 U.S.C. 264); and 

14 (4) protecting public health. 

Passed the House of Representatives December 16, 

2024. 

Attest: KEVIN F. MCCUMBER, 

Clerk. 


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