I
119THCONGRESS
1
STSESSION 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
FEBRUARY6, 2025
Mr. M
OOLENAAR(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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Shandra Eisenga 4
Human Cell and Tissue Product Safety Act’’. 5
SEC. 2. DEFINITIONS. 6
In this Act: 7
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(1) HUMAN CELL AND TISSUE PRODUCT .—The 1
terms ‘‘human cell and tissue product’’ and ‘‘human 2
cell and tissue products’’ have the meaning given the 3
term ‘‘human cells, tissues, or cellular or tissue- 4
based products’’ in section 1271.3(d) of title 21, 5
Code of Federal Regulations (or successor regula-6
tions). 7
(2) S
ECRETARY.—The term ‘‘Secretary’’ means 8
the Secretary of Health and Human Services. 9
(3) T
ISSUE REFERENCE GROUP .—The term 10
‘‘Tissue Reference Group’’ means the Tissue Ref-11
erence Group of the Food and Drug Administration. 12
SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 13
PUBLIC AWARENESS CAMPAIGN. 14
The Secretary shall support the development and dis-15
semination of educational materials to inform health care 16
professionals and other appropriate professionals about 17
issues surrounding— 18
(1) organ, tissue, and eye donation, including 19
evidence-based methods to approach patients and 20
their families; 21
(2) the availability of any donor screening tests; 22
and 23
(3) other relevant aspects of donation. 24
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SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIRE-1
MENTS FOR HUMAN CELL AND TISSUE PROD-2
UCTS. 3
Section 368 of the Public Health Service Act (42 4
U.S.C. 271) is amended by adding at the end the fol-5
lowing: 6
‘‘(d)(1) Any person who, on or after the date of the 7
enactment of the Shandra Eisenga Human Cell and Tis-8
sue Product Safety Act, violates a requirement of subparts 9
C or D of section 1271 of title 21, Code of Federal Regu-10
lations, (or successor regulations) with respect to human 11
cell or tissue products regulated under section 361 shall 12
be liable to the United States for a civil penalty in an 13
amount not to exceed the sum of— 14
‘‘(A)(i) $20,000 for each violation; and 15
‘‘(ii) in the case of a violation that continues 16
after the Secretary provides written notice to such 17
person, $20,000 for each subsequent day on which 18
the violation continues; and 19
‘‘(B) an amount equal to the retail value of the 20
human cell and tissue products that are the subject 21
of the violation. 22
‘‘(2) The total civil penalty under paragraph (1) may 23
not exceed $10,000,000 for all such violations adjudicated 24
in a single proceeding. 25
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‘‘(3) In this subsection, the term ‘human cell and tis-1
sue products’ has the meaning given the term ‘human 2
cells, tissues, or cellular or tissue-based products’ in sec-3
tion 1271.3(d) of title 21, Code of Federal Regulations 4
(or successor regulations).’’. 5
SEC. 5. STREAMLINING REGULATORY OVERSIGHT OF 6
HUMAN CELL AND TISSUE PRODUCTS. 7
(a) I
NFORMATION ON HUMANCELL ANDTISSUE 8
P
RODUCTS.— 9
(1) W
EBSITE.—The Secretary, acting through 10
the Commissioner of Food and Drugs, shall publish 11
on the public website of the Food and Drug Admin-12
istration— 13
(A) educational materials about the Tissue 14
Reference Group; and 15
(B) best practices for obtaining a timely, 16
accurate recommendation regarding human cell 17
and tissue products from the Tissue Reference 18
Group. 19
(2) P
UBLIC INFORMATION.—Not later than 1 20
year after the date of the enactment of this Act, and 21
annually for the subsequent 3 years, the Secretary, 22
acting through the Commissioner of Food and 23
Drugs, shall publish on the public website of the 24
Food and Drug Administration— 25
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(A) the number of human cell and tissue 1
establishments that registered with the Food 2
and Drug Administration on or after January 3
1, 2019; 4
(B) the number of inspections conducted 5
by the Food and Drug Administration of 6
human cell and tissue establishments on or 7
after January 1, 2019, including a comparison 8
of the number of inspections for blood establish-9
ments with the number of inspections for such 10
human cell and tissue establishments; 11
(C) the number and type of inquiries to 12
the Tissue Reference Group in the preceding 13
year; and 14
(D) the average response time for submis-15
sions to the Tissue Reference Group in the pre-16
ceding year, including average initial and final 17
response time. 18
(3) E
DUCATION.—The Secretary, acting 19
through the Commissioner of Food and Drugs, shall, 20
with respect to the regulation of human cell and tis-21
sue products— 22
(A) provide information to relevant stake-23
holders, including industry, tissue establish-24
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•HR 1082 IH
ments, academic health centers, biomedical con-1
sortia, research organizations, and patients; and 2
(B) conduct workshops and other inter-3
active and educational sessions for such stake-4
holders to help support regulatory predictability 5
and scientific advancement, as appropriate. 6
(b) H
UMANCELL ANDTISSUEPRODUCTSCIENTIFIC 7
ANDREGULATORYUPDATES.—Section 3205 of the Food 8
and Drug Omnibus Reform Act of 2022 (title III of divi-9
sion FF of Public Law 117–328) is amended by striking 10
‘‘best practices’’ and all that follows through ‘‘other cel-11
lular therapies’’ and inserting ‘‘best practices on gener-12
ating scientific data necessary to further facilitate the de-13
velopment of certain human cell-, tissue-, and cellular- 14
based medical products (and the latest scientific informa-15
tion about such products), namely, stem cell and other cel-16
lular therapies’’. 17
(c) P
UBLICDOCKET.—Not later than 60 days after 18
the date of the enactment of this Act, the Secretary shall 19
establish a public docket to receive written comments re-20
lated to— 21
(1) the approaches recommended for discussion 22
during the public workshop described in section 23
3205 of the Food and Drug Omnibus Reform Act of 24
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2022 (title III of division FF of Public Law 117– 1
328); and 2
(2) modernizing the regulation of human cell 3
and tissue products, including considerations associ-4
ated with assessing minimal manipulation and ho-5
mologous use (as such terms are defined in section 6
1271.3 of title 21, Code of Federal Regulations (or 7
successor regulations)) of human cell and tissue 8
products. 9
(d) R
EPORT TOCONGRESS.—Not later than Sep-10
tember 30, 2026, the Secretary shall summarize the ap-11
proaches discussed in the public workshop described in 12
section 3205 of the Food and Drug Omnibus Reform Act 13
of 2022 (title III of division FF of Public Law 117–328) 14
and the public docket described in subsection (c), and de-15
velop recommendations regarding the regulation of human 16
cell and tissue products, including provisions under sec-17
tions 1271.10(a) and 1271.3 of title 21, Code of Federal 18
Regulations, taking into account— 19
(1) regulatory burden; 20
(2) scientific developments; 21
(3) access to human cell and tissue products 22
regulated under section 361 of the Public Health 23
Service Act (42 U.S.C. 264); and 24
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(4) protecting public health. 1
Æ
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