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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7188 Engrossed in House (EH)]

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118th CONGRESS
  2d Session
                                H. R. 7188

_______________________________________________________________________

                                 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. REVIEW AND UPDATE OF EXISTING GUIDANCE.

    The Secretary, acting through the Commissioner of Food and Drugs, 
shall--
            (1) not later than 1 year after the date of the enactment 
        of this Act, initiate an internal review of existing guidance 
        for determining eligibility of donors of human cell and tissue 
        products;
            (2) not later than 3 years after the date of the enactment 
        of this Act, if appropriate--
                    (A) update the guidance titled ``Eligibility 
                Determination for Donors of Human Cells, Tissues, and 
                Cellular and Tissue-Based Products; Guidance for 
                Industry'' issued August 2007; and
                    (B) issue or update, as applicable, any guidance 
                for industry of the Food and Drug Administration that 
                includes--
                            (i) recommendations to reduce the risk of 
                        transmission of mycobacterium tuberculosis by 
                        human cells, tissues, and cellular and tissue-
                        based products (HCT/Ps); or
                            (ii) recommendations to reduce the risk of 
                        transmission of disease agents associated with 
                        sepsis for donors of human cells, tissues, and 
                        cellular and tissue-based products (HCT/Ps); 
                        and
            (3) if the Secretary determines that issuing or updating 
        guidance as specified in paragraph (2) is not appropriate, 
        provide a written statement of explanation of that 
        determination to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate.

SEC. 5. 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. 6. 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 December 16, 2024.

            Attest:

                                                                 Clerk.
118th CONGRESS

  2d Session

                               H. R. 7188

_______________________________________________________________________

                                 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.
```