Sec. 5. Streamlining regulatory oversight of human cell and tissue products
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The Secretary, acting through the Commissioner of Food and Drugs, shall publish on the public website of the Food and Drug Administration— educational materials about the Tissue Reference Group; and best practices for obtaining a timely, accurate recommendation regarding human cell and tissue products from the Tissue Reference Group. 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— the number of human cell and tissue establishments that registered with the Food and Drug Administration on or after January 1, 2019; 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; the number and type of inquiries to the Tissue Reference Group in the preceding year; and the average response time for submissions to the Tissue Reference Group in the preceding year, including average initial and final response time.
The Secretary, acting through the Commissioner of Food and Drugs, shall, with respect to the regulation of human cell and tissue products— provide information to relevant stakeholders, including industry, tissue establishments, academic health centers, biomedical consortia, research organizations, and patients; and conduct workshops and other interactive and educational sessions for such stakeholders to help support regulatory predictability and scientific advancement, as appropriate.
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 .
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— 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 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.
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— regulatory burden; scientific developments; access to human cell and tissue products regulated under section 361 of the Public Health Service Act ( 42 U.S.C. 264 ); and protecting public health.
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Sec. 5
Streamlining regulatory oversight of human cell and tissue products
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