Bill Details
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This bill would improve safety and public awareness around donated human cells and tissues used for transplants and related medical products. It directs the Department of Health and Human Services and the FDA to run an evidence-based education effort for the public and health care workers, make regulatory information easier to find, and collect public input on how these products should be overseen. It also creates stronger financial penalties for breaking existing safety rules and asks the government to review whether current regulations should be updated to better match modern science while still protecting patients.
- It requires HHS to develop and share educational materials about donation of organs, tissues, and eyes, including better ways for health care workers to talk with patients and families, as well as information about donor screening tests.
- It increases civil penalties for violations of current safety rules for human cell and tissue products to as much as $20,000 per violation, plus $20,000 for each day the problem continues after notice, and the value of the products involved. Total penalties in one case could reach $10 million.
- It tells the FDA to publish more public information on its website, including details about the Tissue Reference Group, the number of establishments registered and inspected, the kinds of requests made to the group, and how long responses take. It also directs the agency to hold workshops and share guidance with industry, researchers, hospitals, and patients.
- It opens a public comment docket on modernizing the rules for these products and requires a report to Congress by September 30, 2026 with recommendations that weigh scientific progress, access to products, the burden on regulated groups, and public health protection.
Official Summaries
Shandra Eisenga Human Cell and Tissue Product Safety Act
This bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. (Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.)
Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products.
Also, the bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion on 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 report to Congress with recommendations. The bill also requires the FDA to support the development of educational materials for health care professionals regarding organ, tissue, and eye donations and related topics.
Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group (a working group within the FDA) and best practices for obtaining a recommendation from them about human cell and tissue products. Also, annually for three years, the FDA must publish on its website information on inquiries submitted to the Tissue Reference Group and FDA registrations and inspections regarding human cell and tissue manufacturers.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1082 Referred in Senate (RFS)]
<DOC>
119th CONGRESS
1st Session
H. R. 1082
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 24, 2025
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
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.
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 ``Shandra Eisenga Human Cell and
Tissue Product Safety Act''.
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. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT PUBLIC AWARENESS
CAMPAIGN.
The Secretary shall support the development and dissemination of
educational materials to inform health care professionals and other
appropriate professionals about issues surrounding--
(1) organ, tissue, and eye donation, including evidence-
based methods to approach patients and their families;
(2) the availability of any donor screening tests; and
(3) other relevant aspects of donation.
SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIREMENTS FOR HUMAN CELL
AND TISSUE PRODUCTS.
Section 368 of the Public Health Service Act (42 U.S.C. 271) is
amended by adding at the end the following:
``(d)(1) 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--
``(A)(i) $20,000 for each violation; and
``(ii) in the case of a violation that continues after the
Secretary provides written notice to such person, $20,000 for
each subsequent day on which the violation continues; and
``(B) an amount equal to the retail value of the human cell
and tissue products that are the subject of the violation.
``(2) The total civil penalty under paragraph (1) may not exceed
$10,000,000 for all such violations adjudicated in a single proceeding.
``(3) 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).''.
SEC. 5. 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.
Passed the House of Representatives June 23, 2025.
Attest:
KEVIN F. MCCUMBER,
Clerk.