‘‘(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. 5. 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— 
VerDate Sep 11 2014 
05:30 Mar 05, 2025
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1082.IH
H1082
kjohnson on DSK7ZCZBW3PROD with $$_JOB
(A) the number of human cell and tissue 
establishments that registered with the Food 
and Drug Administration on or after January 
1, 2019; 
(B) the number of inspections conducted 
by the Food and Drug Administration of 
human cell and tissue establishments on or 
after January 1, 2019, including a comparison 
of the number of inspections for blood establish-
ments with the number of inspections for such 
human cell and tissue establishments; 
(C) the number and type of inquiries to 
the Tissue Reference Group in the preceding 
year; and 
(D) the average response time for submis-
sions to the Tissue Reference Group in the pre-
ceding year, including average initial and final 
response time. 
(3) 
EDUCATION.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs, shall, 
with respect to the regulation of human cell and tis-
sue products— 
(A) provide information to relevant stake-
holders, including industry, tissue establish-
VerDate Sep 11 2014 
05:30 Mar 05, 2025
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1082.IH
H1082
kjohnson on DSK7ZCZBW3PROD with $$_JOB
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 
VerDate Sep 11 2014 
05:30 Mar 05, 2025
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1082.IH
H1082
kjohnson on DSK7ZCZBW3PROD with $$_JOB
2022 (title III of division FF of Public Law 117– 
328); and 
(2) modernizing the regulation of human cell 
and tissue products, including considerations associ-
ated with assessing minimal manipulation and ho-
mologous use (as such terms are defined in section 
1271.3 of title 21, Code of Federal Regulations (or 
successor regulations)) of human cell and tissue 
products. 
(d) REPORT TO CONGRESS.—Not later than Sep-
tember 30, 2026, the Secretary shall summarize the ap-
proaches discussed in the public workshop described in 
section 3205 of the Food and Drug Omnibus Reform Act 
of 2022 (title III of division FF of Public Law 117–328) 
and the public docket described in subsection (c), and de-
velop recommendations regarding the regulation of human 
cell and tissue products, including provisions under sec-
tions 1271.10(a) and 1271.3 of title 21, Code of Federal 
Regulations, taking into account— 
(1) regulatory burden; 
(2) scientific developments; 
(3) access to human cell and tissue products 
regulated under section 361 of the Public Health 
Service Act (42 U.S.C. 264); and 
VerDate Sep 11 2014 
05:30 Mar 05, 2025
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H1082.IH
H1082
kjohnson on DSK7ZCZBW3PROD with $$_JOB
(4) protecting public health. 
Æ 
VerDate Sep 11 2014 
05:30 Mar 05, 2025
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H1082.IH
H1082
kjohnson on DSK7ZCZBW3PROD with $$_JOB