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: 
(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. 
SEC. 4. 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 the 
enactment of this Act, initiate an internal review of 
existing guidance for determining eligibility of do-
nors of human cell and tissue products; 
(2) not later than 3 years after the date of the 
enactment of this Act, if appropriate— 
(A) update the guidance titled ‘‘Eligibility 
Determination for Donors of Human Cells, Tis-
sues, and Cellular and Tissue-Based Products; 
Guidance for Industry’’ issued August 2007; 
and 
(B) issue or update, as applicable, any 
guidance for industry of the Food and Drug 
Administration that includes— 
(i) recommendations to reduce the 
risk of transmission of mycobacterium tu-
berculosis by human cells, tissues, and cel-
lular and tissue-based products (HCT/Ps); 
or 
(ii) recommendations to reduce the 
risk of transmission of disease agents asso-
ciated with sepsis for donors of human 
cells, tissues, and cellular and tissue-based 
products (HCT/Ps); and 
(3) if the Secretary determines that issuing or 
updating guidance as specified in paragraph (2) is 
not appropriate, provide a written statement of ex-
planation of that determination to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
SEC. 5. 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. 
‘‘(3) In this subsection, the term ‘human cell and tis-
sue products’ has the meaning given the term ‘human 
cells, tissues, or cellular or tissue-based products’ in sec-
tion 1271.3(d) of title 21, Code of Federal Regulations 
(or successor regulations).’’. 
SEC. 6. STREAMLINING REGULATORY OVERSIGHT OF 
HUMAN CELL AND TISSUE PRODUCTS. 
(a) INFORMATION ON HUMAN CELL AND TISSUE 
PRODUCTS.—
(1) WEBSITE.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall publish 
on the public website of the Food and Drug Admin-
istration— 
(A) educational materials about the Tissue 
Reference Group; and 
(B) best practices for obtaining a timely, 
accurate recommendation regarding human cell 
and tissue products from the Tissue Reference 
Group. 
(2) PUBLIC INFORMATION.—Not later than 1 
year after the date of the enactment of this Act, and 
annually for the subsequent 3 years, the Secretary, 
acting through the Commissioner of Food and 
Drugs, shall publish on the public website of the 
Food and Drug Administration— 
(A) the number of human cell and tissue 
establishments that registered with the Food 
and Drug Administration on or after January 
1, 2019; 
(B) the number of inspections conducted 
by the Food and Drug Administration of 
human cell and tissue establishments on or 
after January 1, 2019, including a comparison 
of the number of inspections for blood establish-
ments with the number of inspections for such 
human cell and tissue establishments; 
(C) the number and type of inquiries to 
the Tissue Reference Group in the preceding 
year; and 
(D) the average response time for submis-
sions to the Tissue Reference Group in the pre-
ceding year, including average initial and final 
response time. 
(3) 
EDUCATION.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs, shall, 
with respect to the regulation of human cell and tis-
sue products— 
(A) provide information to relevant stake-
holders, including industry, tissue establish-
ments, academic health centers, biomedical con-
sortia, research organizations, and patients; and 
(B) conduct workshops and other inter-
active and educational sessions for such stake-
holders to help support regulatory predictability 
and scientific advancement, as appropriate. 
(b) HUMAN CELL AND TISSUE PRODUCT SCIENTIFIC 
AND REGULATORY UPDATES.—Section 3205 of the Food 
and Drug Omnibus Reform Act of 2022 (title III of divi-
sion FF of Public Law 117–328) is amended by striking
‘‘best practices’’ and all that follows through ‘‘other cel-
lular therapies’’ and inserting ‘‘best practices on gener-
ating scientific data necessary to further facilitate the de-
velopment of certain human cell-, tissue-, and cellular- 
based medical products (and the latest scientific informa-
tion about such products), namely, stem cell and other cel-
lular therapies’’. 
(c) PUBLIC DOCKET.—Not later than 60 days after 
the date of the enactment of this Act, the Secretary shall 
establish a public docket to receive written comments re-
lated to— 
(1) the approaches recommended for discussion 
during the public workshop described in section 
3205 of the Food and Drug Omnibus Reform Act of 
2022 (title III of division FF of Public Law 117– 
328); and 
(2) modernizing the regulation of human cell 
and tissue products, including considerations associ-
ated with assessing minimal manipulation and ho-
mologous use (as such terms are defined in section 
1271.3 of title 21, Code of Federal Regulations (or 
successor regulations)) of human cell and tissue 
products. 
(d) REPORT TO CONGRESS.—Not later than Sep-
tember 30, 2026, the Secretary shall summarize the ap-
proaches discussed in the public workshop described in 
section 3205 of the Food and Drug Omnibus Reform Act 
of 2022 (title III of division FF of Public Law 117–328) 
and the public docket described in subsection (c), and de-
velop recommendations regarding the regulation of human 
cell and tissue products, including provisions under sec-
tions 1271.10(a) and 1271.3 of title 21, Code of Federal 
Regulations, taking into account— 
(1) regulatory burden; 
(2) scientific developments; 
(3) access to human cell and tissue products 
regulated under section 361 of the Public Health 
Service Act (42 U.S.C. 264); and 
(4) protecting public health. 
Passed the House of Representatives December 16, 
2024. 
Attest: 
Clerk.
118TH CONGRESS 
2D SESSION 
H. R. 7188 
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 prod-
ucts transplants, and for other purposes.