I 
119TH CONGRESS 
1ST SESSION H. R. 1082 
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 6, 2025 
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 PRODUCT.—The 
terms ‘‘human cell and tissue product’’ and ‘‘human 
cell and tissue products’’ have 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 successor regula-
tions). 
(2) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(3) TISSUE
REFERENCE
GROUP.—The term 
‘‘Tissue Reference Group’’ means the Tissue Ref-
erence Group of the Food and Drug Administration. 
SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 
PUBLIC AWARENESS CAMPAIGN. 
The Secretary shall support the development and dis-
semination of educational materials to inform health care 
professionals and other appropriate professionals about 
issues surrounding— 
(1) organ, tissue, and eye donation, including 
evidence-based methods to approach patients and 
their families; 
(2) the availability of any donor screening tests; 
and 
(3) other relevant aspects of donation. 
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SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIRE-
MENTS FOR HUMAN CELL AND TISSUE PROD-
UCTS. 
Section 368 of the Public Health Service Act (42 
U.S.C. 271) is amended by adding at the end the fol-
lowing: 
‘‘(d)(1) Any person who, on or after the date of the 
enactment of the Shandra Eisenga Human Cell and Tis-
sue Product Safety Act, violates a requirement of subparts 
C or D of section 1271 of title 21, Code of Federal Regu-
lations, (or successor regulations) with respect to human 
cell or tissue products regulated under section 361 shall 
be liable to the United States for a civil penalty in an 
amount not to exceed the sum of— 
‘‘(A)(i) $20,000 for each violation; and 
‘‘(ii) in the case of a violation that continues 
after the Secretary provides written notice to such 
person, $20,000 for each subsequent day on which 
the violation continues; and 
‘‘(B) an amount equal to the retail value of the 
human cell and tissue products that are the subject 
of the violation. 
‘‘(2) The total civil penalty under paragraph (1) may 
not exceed $10,000,000 for all such violations adjudicated 
in a single proceeding. 
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