(B) a notification that the manufacturer or 
sponsor must resubmit the inquiry with addi-
tional information. 
(3) REQUEST
TO
MEET
WITH
TISSUE
REF-
ERENCE GROUP.— 
(A) REQUEST.—Upon receipt of a state-
ment under paragraph (2)(A), the manufac-
turer or sponsor of a human cell and tissue 
product may request a meeting with the Tissue 
Reference Group to discuss the decision in such 
statement regarding the product’s regulatory 
classification. 
(B) MEETING REQUIRED.—Upon receipt of 
a request under subparagraph (A), the Tissue 
Reference Group shall hold a meeting with the 
requesting manufacturer or sponsor. 
(b) PUBLIC MEETING.—Not later than 90 days after 
the date of enactment of this Act, the Secretary shall pub-
lish in the Federal Register a notice to convene a public 
meeting to discuss and obtain input and recommendations 
from relevant stakeholders, including industry, tissue es-
tablishments, academic health centers, biomedical con-
sortia, research organizations, and patients, regarding— 
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(1) the definition of the term ‘‘minimal manipu-
lation’’ under section 1271.3 of title 21, Code of 
Federal Regulations, including— 
(A) previous and current interpretations of 
such term; 
(B) the landscape of products which have 
been identified by the Food and Drug Adminis-
tration as meeting— 
(i) such definition of ‘‘minimal manip-
ulation’’; 
(ii) the definition of ‘‘more than mini-
mally manipulated’’ as used the guidance 
of the Food and Drug Administration ti-
tled 
‘‘Regulatory 
Considerations 
for 
Human Cells, Tissues, and Cellular and 
Tissue-Based Products: Minimal Manipula-
tion and Homologous Use’’ (dated July 
2020) (or any successor guidance); or 
(iii) neither the definition referred to 
in clause (i) or (ii); 
(C) the approximate scope of use of such 
products; and 
(D) any changes to the interpretation of 
‘‘minimal manipulation’’ that may be necessary 
to meet the risk benefit of such products; and 
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(2) considerations in assessing homologous use 
of human cell and tissue products, and the character 
and function of human cell and tissue products, in-
cluding— 
(A) previous and current considerations of 
such use, character, and function; and 
(B) potential such considerations with re-
spect to products described in paragraph 
(1)(B). 
(c) UPDATES TO REGULATIONS AND GUIDANCE.— 
(1) IN GENERAL.—Not later than 12 months 
after the date of enactment of this Act, the Sec-
retary shall update the criteria for homologous use 
and the other criteria under section 1271.10(a) of 
title 21, Code of Federal Regulations, and the defi-
nition of minimal manipulation under section 1271.3 
of such title 21, with the goals of— 
(A) minimizing regulatory burden; 
(B) protecting public health; and 
(C) maintaining the existence of the cur-
rent pathways by which certain human cell and 
tissue products are marketed under section 361 
of the Public Health Service Act (42 U.S.C. 
264), certain biological products are licensed 
under section 351 of the Public Health Service 
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Act (42 U.S.C. 351), and certain drugs are ap-
proved under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355). 
(2) TECHNICAL ASSISTANCE; EDUCATION.—The 
Secretary shall, with respect to the regulation of 
human cell and tissue products, including the up-
dates under paragraph (1)— 
(A) provide technical assistance to relevant 
stakeholders, including industry, tissue estab-
lishments, academic health centers, biomedical 
consortia, research organizations, and patients; 
and 
(B) at least every six months, initiate and 
conduct workshops and other interactive and 
educational sessions for such stakeholders. 
(d) REPORTS TO CONGRESS.— 
(1) REPORT ON MEETING.—Not later than 12 
months after the date of enactment of this Act, the 
Secretary shall submit a report to the Congress on 
the results of the meeting under subsection (b). 
(2) ANNUAL REPORT.—Not later than March 1, 
2025, and March 1 of each calendar year thereafter, 
the Secretary shall, with respect to the previous cal-
endar year, submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and 
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the Committee on Energy and Commerce of the 
House of Representatives, and publish on the inter-
net website of the Department of Health and 
Human Services, a report on— 
(A) the number and type of inquiries re-
ceived by the Tissue Reference Group; 
(B) the average response time for inquiries 
received by the Tissue Reference Group, includ-
ing the average response times for initial and 
final responses; and 
(C) with respect to final decisions issued 
by the Tissue Reference Group, the number of 
human cell and tissue products determined to 
be regulated under each regulatory category. 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘human cell and tissue prod-
uct’’— 
(A) means a ‘‘human cells, tissues, or cel-
lular or tissue based product’’ as such term is 
defined in section 1271.3 of title 21, Code of 
Federal Regulations (or successor regulations); 
and 
(B) includes any such product regardless 
of whether it is approved for marketing, ap-
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proved for investigational use, or merely pro-
posed. 
(2) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services, acting through the 
Commissioner of Food and Drugs. 
(3) The term ‘‘Tissue Reference Group’’ means 
the Tissue Reference Group of the Food and Drug 
Administration. 
Æ 
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