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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
Market Impact Map
Action Timeline
2025-01-13
Referred to the House Committee on Energy and Commerce.
2025-01-13
Introduced in House
2025-01-13
Introduced in House
Full Bill Text
117 HR 340 IH: The HCT/P Modernization Act of 2025 U.S. House of Representatives 2025-01-13 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 119th CONGRESS 1st Session H. R. 340 IN THE HOUSE OF REPRESENTATIVES January 13, 2025 Mr. Crenshaw (for himself and Ms. Barragán ) 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. 1. Short title This Act may be cited as the The HCT/P Modernization Act of 2025 . 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. 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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