January 13, 2025
Mr. Crenshaw (for himself and Ms. Barragán) introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
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.