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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Shandra Eisenga 
Human Cell and Tissue Product Safety Act’’. 
SEC. 2. DEFINITIONS. 
In this Act: 
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(1) HUMAN
CELL
AND
TISSUE
ESTABLISH-
MENT.—The term ‘‘human cell and tissue establish-
ment’’ means an establishment (as defined in section 
1271.3(b) of title 21, Code of Federal Regulations 
(or a successor regulation)) regulated by the Center 
for Biologics Evaluation and Research under part 
1271 of title 21, Code of Federal Regulations. 
(2) HUMAN
CELL
AND
TISSUE
PRODUCTS.— 
The term ‘‘human cell and tissue products’’ has the 
meaning given the term ‘‘human cells, tissues, or 
cellular 
or 
tissue-based 
products’’ 
in 
section 
1271.3(d) of title 21, Code of Federal Regulations 
(or a successor regulation). 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 
PUBLIC AWARENESS CAMPAIGN. 
(a) IN GENERAL.—The Secretary shall conduct a na-
tional, evidence-based education campaign to increase 
public and health care provider awareness regarding the 
potential risks and benefits of human cell and tissue prod-
ucts transplants. 
(b) CONSIDERATION OF ADVICE OF STAKEHOLDER 
EXPERTS.—The Secretary shall develop the education 
campaign under subsection (a) after taking into consider-
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ation the advice of stakeholder experts, including the Cen-
ters for Disease Control and Prevention and professional 
associations that represent stakeholders of human cell and 
tissue establishments that manufacture human cell and 
tissue products with the highest risk of transmitting infec-
tions to their patients. 
(c) GRANTS.— 
(1) IN GENERAL.—The Secretary may award 
grants to nonprofit organizations to carry out activi-
ties described in paragraph (2). 
(2) USE OF FUNDS.—A recipient of a grant 
under paragraph (1) shall use the grant funds— 
(A) to increase the knowledge and aware-
ness of the public about the potential risks and 
benefits of human cell and tissue products 
transplants, including the risks that such trans-
plants may lead to infectious diseases, including 
tuberculosis, latent tuberculosis infection, and 
sepsis; or 
(B) to increase the knowledge and aware-
ness of health care providers and health care 
leaders about the potential risks and benefits of 
human cell and tissue products transplants, in-
cluding the risks that such transplants may 
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lead to infectious diseases, including tuber-
culosis, latent tuberculosis infection, and sepsis. 
(d) MEDIA CAMPAIGNS.— 
(1) IN
GENERAL.—In carrying out the edu-
cation campaign under subsection (a), the Secretary, 
after taking into consideration the advice of stake-
holder experts, may award grants to, or enter into 
contracts with, entities to establish national multi-
media campaigns to increase public and health care 
provider awareness regarding the potential risks of 
human cell and tissue products transplants. 
(2) INCLUSIONS.—The multimedia campaigns 
under paragraph (1) may include advertising 
through television, radio, print media, billboards, 
posters, all forms of existing and emerging social 
networking media, other internet media, and any 
other medium determined appropriate by the Sec-
retary. 
SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIRE-
MENTS FOR HUMAN CELL AND TISSUE PROD-
UCTS. 
(a) IN GENERAL.—Any person who violates a re-
quirement of section 361 of the Public Health Service Act 
(42 U.S.C. 264) or part 1271 of title 21, Code of Federal 
Regulations (or successor regulations) with respect to 
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human cell or tissue products shall be liable to the United 
States for a civil penalty in an amount not to exceed the 
sum of— 
(1)(A) $20,000 for each violation; or 
(B) $20,000 for each day of a continuing viola-
tion; and 
(2) an amount equal to the retail value of the 
human cell and tissue products that are the subject 
of the violation. 
(b) MAXIMUM PENALTY.—The total civil penalty 
under subsection (a) shall not exceed $10,000,000 for all 
such violations adjudicated in a single proceeding. 
SEC. 5. REPORT TO CONGRESS. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary shall submit to Congress a re-
port that describes actions Congress and the Food and 
Drug Administration could take to improve the safety of 
human cell and tissue products, including— 
(1) an examination of existing regulations and 
guidance relating to human cell and tissue products; 
(2) documentation of the number of human cell 
and tissue establishments that have registered with 
the Food and Drug Administration since 1998; 
(3) how often the Food and Drug Administra-
tion has inspected human cell and tissue establish-
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ments since 1998, including a comparison of the in-
spection rates for blood establishments and Source 
Plasma establishments with the inspection rates for 
such human cell and tissue establishments, potential 
causes of declines in such inspections, if applicable, 
and recommendations to increase Food and Drug 
Administration resources, if applicable; and 
(4) recommendations on potential guidance or 
regulations that could be issued or promulgated, as 
applicable, to improve donor screening for human 
cell and tissue products. 
SEC. 6. REVIEW AND UPDATE OF EXISTING GUIDANCE. 
The Secretary, acting through the Commissioner of 
Food and Drugs, shall— 
(1) not later than 1 year after the date of en-
actment of this Act, initiate an internal review of ex-
isting guidance for determining eligibility of donors 
of human cell and tissue products; and 
(2) not later than 3 years after the date of en-
actment of this Act, issue updated guidance for de-
termining eligibility of donors of human cell and tis-
sue products to comply with part 1271 of title 21, 
Code of Federal Regulations (or successor regula-
tions), including compliance in determining donor 
eligibility in accordance with subpart C of part 1271 
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of title 21, Code of Federal Regulations (or suc-
cessor regulations). 
Æ 
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