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 regulations). 
(2) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(3) TISSUE REFERENCE GROUP.—The term ‘‘Tis-
sue Reference Group’’ means the Tissue Reference 
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— 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
(1) organ, tissue, and eye donation, including 
evidence-based methods to approach patients and 
their families; 
(2) the availability of any donor screening tests; 
and 
(3) other relevant aspects of donation. 
SEC. 4. REVIEW AND UPDATE OF EXISTING GUIDANCE. 
The Secretary, acting through the Commissioner of 
Food and Drugs, shall— 
(1) not later than 1 year after the date of the en-
actment of this Act, initiate an internal review of ex-
isting guidance for determining eligibility of donors 
of human cell and tissue products; 
(2) not later than 3 years after the date of the 
enactment of this Act, if appropriate— 
(A) update the guidance titled ‘‘Eligibility 
Determination for Donors of Human Cells, Tis-
sues, and Cellular and Tissue-Based Products; 
Guidance for Industry’’ issued August 2007; and 
(B) issue or update, as applicable, any 
guidance for industry of the Food and Drug Ad-
ministration that includes— 
(i) recommendations to reduce the risk 
of transmission of mycobacterium tuber-
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
culosis by human cells, tissues, and cellular 
and tissue-based products (HCT/Ps); or 
(ii) recommendations to reduce the risk 
of transmission of disease agents associated 
with sepsis for donors of human cells, tis-
sues, 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 expla-
nation of that determination to the Committee on En-
ergy and Commerce of the House of Representatives 
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 following: 
‘‘(d)(1) Any person who, on or after the date of the 
enactment of the Shandra Eisenga Human Cell and Tissue 
Product Safety Act, violates a requirement of subparts C 
or D of section 1271 of title 21, Code of Federal Regulations, 
(or successor regulations) with respect to human cell or tis-
sue products regulated under section 361 shall be liable to 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
the United States for a civil penalty in an amount not to 
exceed the sum of— 
‘‘(A)(i) $20,000 for each violation; and 
‘‘(ii) in the case of a violation that continues 
after the Secretary provides written notice to such 
person, $20,000 for each subsequent day on which the 
violation continues; and 
‘‘(B) an amount equal to the retail value of the 
human cell and tissue products that are the subject of 
the violation. 
‘‘(2) The total civil penalty under paragraph (1) may 
not exceed $10,000,000 for all such violations adjudicated 
in a single proceeding. 
‘‘(3) In this subsection, the term ‘human cell and tissue 
products’ has the meaning given the term ‘human cells, tis-
sues, or cellular or tissue-based products’ in section 
1271.3(d) of title 21, Code of Federal Regulations (or suc-
cessor regulations).’’. 
SEC. 
6. 
STREAMLINING 
REGULATORY 
OVERSIGHT 
OF 
HUMAN CELL AND TISSUE PRODUCTS. 
(a) INFORMATION
ON HUMAN CELL
AND TISSUE 
PRODUCTS.— 
(1) WEBSITE.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall publish 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
on the public website of the Food and Drug Adminis-
tration— 
(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 es-
tablishments 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 Janu-
ary 1, 2019, including a comparison of the num-
ber of inspections for blood establishments with 
the number of inspections for such human cell 
and tissue establishments; 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
(C) the number and type of inquiries to the 
Tissue Reference Group in the preceding year; 
and 
(D) the average response time for submis-
sions to the Tissue Reference Group in the pre-
ceding year, including average initial and final 
response time. 
(3) EDUCATION.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall, with re-
spect to the regulation of human cell and tissue prod-
ucts— 
(A) provide information to relevant stake-
holders, including industry, tissue establish-
ments, academic health centers, biomedical con-
sortia, research organizations, and patients; and 
(B) conduct workshops and other interactive 
and educational sessions for such stakeholders to 
help support regulatory predictability and sci-
entific advancement, as appropriate. 
(b) HUMAN CELL AND TISSUE PRODUCT SCIENTIFIC 
AND REGULATORY UPDATES.—Section 3205 of the Food 
and Drug Omnibus Reform Act of 2022 (title III of division 
FF of Public Law 117–328) is amended by striking ‘‘best 
practices’’ and all that follows through ‘‘other cellular thera-
pies’’ and inserting ‘‘best practices on generating scientific 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
including provisions under sections 1271.10(a) and 1271.3 
of title 21, Code of Federal Regulations, taking into ac-
count— 
(1) regulatory burden; 
(2) scientific developments; 
(3) access to human cell and tissue products reg-
ulated under section 361 of the Public Health Service 
Act (42 U.S.C. 264); and 
(4) protecting public health. 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6203
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB
Union Calendar No. 632 
118TH CONGRESS 
2D SESSION 
H. R. 7188 
[Report No. 118–766] 
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 prod-
ucts transplants, and for other purposes. 
NOVEMBER 22, 2024 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
VerDate Sep 11 2014 
01:40 Nov 23, 2024
Jkt 059200
PO 00000
Frm 00012
Fmt 6651
Sfmt 6651
E:\BILLS\H7188.RH
H7188
kjohnson on DSK7ZCZBW3PROD with $$_JOB