HR 1082
Shandra Eisenga Human Cell and Tissue Product Safety Act
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Bill overview
The Shandra Eisenga Human Cell and Tissue Product Safety Act aims to improve public awareness and regulation of human cell and tissue products. It establishes civil penalties for violations of existing FDA regulations, requires the FDA to conduct a public education campaign about donation and transplant risks and benefits, and mandates the FDA to publish data on inspections, inquiries to the Tissue Reference Group, and response times. The bill also directs the FDA to establish a public docket for feedback and to submit a report to Congress with recommendations for modernizing the regulation of these products.
Key provisions
- Establishes civil penalties for violations of FDA regulations regarding human cell and tissue products.
- Requires the FDA to conduct a national public awareness campaign on organ, tissue, and eye donation.
- Mandates the FDA to publish educational materials about the Tissue Reference Group and best practices for obtaining recommendations.
- Requires the FDA to publish data on human cell and tissue establishment inspections and inquiries to the Tissue Reference Group.
- Directs the FDA to establish a public docket for stakeholder feedback.
- Requires the FDA to submit a report to Congress with recommendations for regulating human cell and tissue products.
- Amends the Public Health Service Act to include civil penalties for non-compliance with specific FDA regulations.
- Updates FDA regulations to include best practices for generating scientific data related to stem cell and other cellular therapies.
Who is affected
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119th CONGRESS — 1st Session
H. R. 1082
IN THE HOUSE OF REPRESENTATIVES
A BILL
To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
This Act may be cited as the Shandra Eisenga Human Cell and Tissue Product Safety Act
.
In this Act:
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).
The term Secretary means the Secretary of Health and Human Services.
The term Tissue Reference Group means the Tissue Reference Group of the Food and Drug Administration.
The Secretary shall support the development and dissemination of educational materials to inform health care professionals and other appropriate professionals about issues surrounding—
organ, tissue, and eye donation, including evidence-based methods to approach patients and their families;
the availability of any donor screening tests; and
other relevant aspects of donation.
Section 368 of the Public Health Service Act (42 U.S.C. 271) is amended by adding at the end the following:
Any person who, on or after the date of the enactment of the
Shandra Eisenga Human Cell and Tissue Product Safety Act
, violates a requirement of subparts C or D of section 1271 of title 21, Code of Federal Regulations, (or successor regulations) with respect to human cell or tissue products regulated under section 361 shall be liable to the United States for a civil penalty in an amount not to exceed the sum of—$20,000 for each violation; and
an amount equal to the retail value of the human cell and tissue products that are the subject of the violation.
The total civil penalty under paragraph (1) may not exceed $10,000,000 for all such violations adjudicated in a single proceeding.
In this subsection, the term human cell and tissue products has 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).
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
regulatory burden;
scientific developments;
protecting public health.