Shandra Eisenga Human Cell and Tissue Product Safety Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4885 Introduced in Senate (IS)]

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119th CONGRESS
  2d Session
                                S. 4885

  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.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             June 24, 2026

  Mr. Peters (for himself and Mr. Marshall) introduced the following
  bill; which was read twice and referred to the Committee on Health,
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 subpart 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.
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