The HCT/P Modernization Act of 2025
This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.
The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products.
Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.)
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 340 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 340
To direct the Secretary of Health and Human Services carry out
activities to streamline regulatory oversight of human cell and tissue
products, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 13, 2025
Mr. Crenshaw (for himself and Ms. Barragan) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services carry out
activities to streamline regulatory oversight of human cell and tissue
products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``The HCT/P Modernization Act of
2025''.
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 ``Tissue Reference
Group'' means the Tissue Reference Group of the Food and Drug
Administration.
SEC. 3. 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 Administration--
(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
establishments 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 submissions to
the Tissue Reference Group in the preceding 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 tissue products--
(A) provide information to relevant stakeholders,
including industry, tissue establishments, academic
health centers, biomedical consortia, research
organizations, and patients; and
(B) conduct workshops and other interactive and
educational sessions for such stakeholders 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 division FF of Public Law 117-328) is amended by striking
``best practices'' and all that follows through ``other cellular
therapies'' and inserting ``best practices on generating scientific
data necessary to further facilitate the development of certain human
cell-, tissue-, and cellular-based medical products (and the latest
scientific information about such products), namely, stem cell and
other cellular 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 related 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 associated with assessing
minimal manipulation and homologous 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 September 30, 2026, the
Secretary shall summarize the approaches 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 develop recommendations
regarding the regulation of human cell and tissue products, including
provisions under sections 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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