I 

118TH CONGRESS 

2D SESSION H. R. 7188 

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 

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. 

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: 


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1 (1) HUMAN CELL AND TISSUE ESTABLISH2 MENT.—The term ‘‘human cell and tissue establish3 ment’’ means an establishment (as defined in section 

4 1271.3(b) of title 21, Code of Federal Regulations 

5 (or a successor regulation)) regulated by the Center 

6 for Biologics Evaluation and Research under part 

7 1271 of title 21, Code of Federal Regulations. 

8 (2) HUMAN CELL AND TISSUE PRODUCTS.— 

9 The term ‘‘human cell and tissue products’’ has the 

10 meaning given the term ‘‘human cells, tissues, or 

11 cellular or tissue-based products’’ in section 

12 1271.3(d) of title 21, Code of Federal Regulations 

13 (or a successor regulation). 

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

15 the Secretary of Health and Human Services. 

16 SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 

17 PUBLIC AWARENESS CAMPAIGN. 

18 (a) IN GENERAL.—The Secretary shall conduct a na19 tional, evidence-based education campaign to increase 

20 public and health care provider awareness regarding the 

21 potential risks and benefits of human cell and tissue prod22 ucts transplants. 

23 (b) CONSIDERATION OF ADVICE OF STAKEHOLDER

24 EXPERTS.—The Secretary shall develop the education 

25 campaign under subsection (a) after taking into considerVerDate Sep 11 2014 20:57 Feb 06, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7188.IH H7188

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1 ation the advice of stakeholder experts, including the Cen2 ters for Disease Control and Prevention and professional 

3 associations that represent stakeholders of human cell and 

4 tissue establishments that manufacture human cell and 

5 tissue products with the highest risk of transmitting infec6 tions to their patients. 

7 (c) GRANTS.— 

8 (1) IN GENERAL.—The Secretary may award 

9 grants to nonprofit organizations to carry out activi10 ties described in paragraph (2). 

11 (2) USE OF FUNDS.—A recipient of a grant 

12 under paragraph (1) shall use the grant funds— 

13 (A) to increase the knowledge and aware14 ness of the public about the potential risks and 

15 benefits of human cell and tissue products 

16 transplants, including the risks that such trans17 plants may lead to infectious diseases, including 

18 tuberculosis, latent tuberculosis infection, and 

19 sepsis; or 

20 (B) to increase the knowledge and aware21 ness of health care providers and health care 

22 leaders about the potential risks and benefits of 

23 human cell and tissue products transplants, in24 cluding the risks that such transplants may 


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1 lead to infectious diseases, including tuber2 culosis, latent tuberculosis infection, and sepsis. 

3 (d) MEDIA CAMPAIGNS.— 

4 (1) IN GENERAL.—In carrying out the edu5 cation campaign under subsection (a), the Secretary, 

6 after taking into consideration the advice of stake7 holder experts, may award grants to, or enter into 

8 contracts with, entities to establish national multi9 media campaigns to increase public and health care 

10 provider awareness regarding the potential risks of 

11 human cell and tissue products transplants. 

12 (2) INCLUSIONS.—The multimedia campaigns 

13 under paragraph (1) may include advertising 

14 through television, radio, print media, billboards, 

15 posters, all forms of existing and emerging social 

16 networking media, other internet media, and any 

17 other medium determined appropriate by the Sec18 retary. 

19 SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIRE20 MENTS FOR HUMAN CELL AND TISSUE PROD21 UCTS. 

22 (a) IN GENERAL.—Any person who violates a re23 quirement of section 361 of the Public Health Service Act 

24 (42 U.S.C. 264) or part 1271 of title 21, Code of Federal 

25 Regulations (or successor regulations) with respect to 


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1 human cell or tissue products shall be liable to the United 

2 States for a civil penalty in an amount not to exceed the 

3 sum of— 

4 (1)(A) $20,000 for each violation; or 

5 (B) $20,000 for each day of a continuing viola6 tion; and 

7 (2) an amount equal to the retail value of the 

8 human cell and tissue products that are the subject 

9 of the violation. 

10 (b) MAXIMUM PENALTY.—The total civil penalty 

11 under subsection (a) shall not exceed $10,000,000 for all 

12 such violations adjudicated in a single proceeding. 

13 SEC. 5. REPORT TO CONGRESS. 

14 Not later than 2 years after the date of enactment 

15 of this Act, the Secretary shall submit to Congress a re16 port that describes actions Congress and the Food and 

17 Drug Administration could take to improve the safety of 

18 human cell and tissue products, including— 

19 (1) an examination of existing regulations and 

20 guidance relating to human cell and tissue products; 

21 (2) documentation of the number of human cell 

22 and tissue establishments that have registered with 

23 the Food and Drug Administration since 1998; 

24 (3) how often the Food and Drug Administra25 tion has inspected human cell and tissue establishVerDate Sep 11 2014 20:57 Feb 06, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7188.IH H7188

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1 ments since 1998, including a comparison of the in2 spection rates for blood establishments and Source 

3 Plasma establishments with the inspection rates for 

4 such human cell and tissue establishments, potential 

5 causes of declines in such inspections, if applicable, 

6 and recommendations to increase Food and Drug 

7 Administration resources, if applicable; and 

8 (4) recommendations on potential guidance or 

9 regulations that could be issued or promulgated, as 

10 applicable, to improve donor screening for human 

11 cell and tissue products. 

12 SEC. 6. REVIEW AND UPDATE OF EXISTING GUIDANCE. 

13 The Secretary, acting through the Commissioner of 

14 Food and Drugs, shall— 

15 (1) not later than 1 year after the date of en16 actment of this Act, initiate an internal review of ex17 isting guidance for determining eligibility of donors 

18 of human cell and tissue products; and 

19 (2) not later than 3 years after the date of en20 actment of this Act, issue updated guidance for de21 termining eligibility of donors of human cell and tis22 sue products to comply with part 1271 of title 21, 

23 Code of Federal Regulations (or successor regula24 tions), including compliance in determining donor 

25 eligibility in accordance with subpart C of part 1271 


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1 of title 21, Code of Federal Regulations (or suc2 cessor regulations). 

Æ 


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