119-hr340

[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.
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