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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3733 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 3733

  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

                            February 5, 2024

  Mr. Peters (for himself and Ms. Stabenow) 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 establishment.--The term ``human 
        cell and tissue establishment'' means an establishment (as 
        defined in section 1271.3(b) of title 21, Code of Federal 
        Regulations (or a successor regulation)) regulated by the 
        Center for Biologics Evaluation and Research under part 1271 of 
        title 21, Code of Federal Regulations.
            (2) Human cell and tissue products.--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 
        a successor regulation).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT PUBLIC AWARENESS 
              CAMPAIGN.

    (a) In General.--The Secretary shall 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.
    (b) Consideration of Advice of Stakeholder Experts.--The Secretary 
shall develop the education campaign under subsection (a) after taking 
into consideration the advice of stakeholder experts, including the 
Centers for Disease Control and Prevention and professional 
associations that represent stakeholders of human cell and tissue 
establishments that manufacture human cell and tissue products with the 
highest risk of transmitting infections to their patients.
    (c) Grants.--
            (1) In general.--The Secretary may award grants to 
        nonprofit organizations to carry out activities described in 
        paragraph (2).
            (2) Use of funds.--A recipient of a grant under paragraph 
        (1) shall use the grant funds--
                    (A) to increase the knowledge and awareness of the 
                public about the potential risks and benefits of human 
                cell and tissue products transplants, including the 
                risks that such transplants may lead to infectious 
                diseases, including tuberculosis, latent tuberculosis 
                infection, and sepsis; or
                    (B) to increase the knowledge and awareness of 
                health care providers and health care leaders about the 
                potential risks and benefits of human cell and tissue 
                products transplants, including the risks that such 
                transplants may lead to infectious diseases, including 
                tuberculosis, latent tuberculosis infection, and 
                sepsis.
    (d) Media Campaigns.--
            (1) In general.--In carrying out the education campaign 
        under subsection (a), the Secretary, after taking into 
        consideration the advice of stakeholder experts, may award 
        grants to, or enter into contracts with, entities to establish 
        national multimedia campaigns to increase public and health 
        care provider awareness regarding the potential risks of human 
        cell and tissue products transplants.
            (2) Inclusions.--The multimedia campaigns under paragraph 
        (1) may include advertising through television, radio, print 
        media, billboards, posters, all forms of existing and emerging 
        social networking media, other internet media, and any other 
        medium determined appropriate by the Secretary.

SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIREMENTS FOR HUMAN CELL 
              AND TISSUE PRODUCTS.

    (a) In General.--Any person who violates a requirement of section 
361 of the Public Health Service Act (42 U.S.C. 264) or part 1271 of 
title 21, Code of Federal Regulations (or successor regulations) with 
respect to human cell or tissue products shall be liable to the United 
States for a civil penalty in an amount not to exceed the sum of--
            (1)(A) $20,000 for each violation; or
            (B) $20,000 for each day of a continuing violation; and
            (2) an amount equal to the retail value of the human cell 
        and tissue products that are the subject of the violation.
    (b) Maximum Penalty.--The total civil penalty under subsection (a) 
shall not exceed $10,000,000 for all such violations adjudicated in a 
single proceeding.

SEC. 5. REPORT TO CONGRESS.

    Not later than 2 years after the date of enactment of this Act, the 
Secretary shall submit to Congress a report that describes actions 
Congress and the Food and Drug Administration could take to improve the 
safety of human cell and tissue products, including--
            (1) an examination of existing regulations and guidance 
        relating to human cell and tissue products;
            (2) documentation of the number of human cell and tissue 
        establishments that have registered with the Food and Drug 
        Administration since 1998;
            (3) how often the Food and Drug Administration has 
        inspected human cell and tissue establishments since 1998, 
        including a comparison of the inspection rates for blood 
        establishments and Source Plasma establishments with the 
        inspection rates for such human cell and tissue establishments, 
        potential causes of declines in such inspections, if 
        applicable, and recommendations to increase Food and Drug 
        Administration resources, if applicable; and
            (4) recommendations on potential guidance or regulations 
        that could be issued or promulgated, as applicable, to improve 
        donor screening for human cell and tissue products.

SEC. 6. 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 enactment of 
        this Act, initiate an internal review of existing guidance for 
        determining eligibility of donors of human cell and tissue 
        products; and
            (2) not later than 3 years after the date of enactment of 
        this Act, issue updated guidance for determining eligibility of 
        donors of human cell and tissue products to comply with part 
        1271 of title 21, Code of Federal Regulations (or successor 
        regulations), including compliance in determining donor 
        eligibility in accordance with subpart C of part 1271 of title 
        21, Code of Federal Regulations (or successor regulations).
                                 <all>
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