[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7188 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 7188
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.
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IN THE HOUSE OF REPRESENTATIVES
February 1, 2024
Mr. Moolenaar (for himself and Mrs. Dingell) introduced the following
bill; which was referred to the Committee on Energy and Commerce
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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).
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