[House Report 119-160]
[From the U.S. Government Publishing Office]
119th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 119-160
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SHANDRA EISENGA HUMAN CELL AND TISSUE PRODUCT
SAFETY ACT
_______
June 12, 2025.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Guthrie, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1082]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1082) 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, having
considered the same, reports favorably thereon without
amendment and recommends that the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Committee Action................................................. 2
Committee Votes.................................................. 3
Oversight Findings and Recommendations........................... 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 3
Statement of General Performance Goals and Objectives............ 3
Duplication of Federal Programs.................................. 3
Related Committee and Subcommittee Hearings...................... 4
Committee Cost Estimate.......................................... 4
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 4
Advisory Committee Statement..................................... 4
Applicability to Legislative Branch.............................. 4
Section-by-Section Analysis of the Legislation................... 5
Changes in Existing Law Made by the Bill, as Reported............ 5
Purpose and Summary
H.R. 1082 comes as a response to the passing of Shandra
Eisenga of Marion, Michigan due to complications from a
tuberculosis infection after receiving a tissue donation from
an infected donor.\1\ The bill would help educate and inform
healthcare providers and other healthcare professionals
regarding human cell and tissue product transplants and
donations through a public awareness campaign. The bill would
provide the Food and Drug Administration (FDA) enforcement
authority, through the issuance of civil monetary penalties,
for violations of donor eligibility requirements and good
tissue practices. It would also direct FDA to take additional
steps to promote public health by publishing educational
materials, best practices, and other relevant information on
FDA's public website, as well as by conducting workshops and
other educational sessions for relevant stakeholders and
establish a public docket for related comments. Lastly, the
bill would require the Secretary of Health and Human Services
(HHS) to report to Congress on recommendations for the
regulation of human cell and tissue products.
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\1\Melissa Nann Burke, House passes bill after TB death of Michigan
woman who received tainted bone graft material, The Detroit News
(December 16, 2024), https://www.detroitnews.com/story/news/local/
michigan/2024/12/16/michigan-woman-dies-tuberculosis-tb-death-
contaminated-bone-graft-material-congress-bill/77031681007/; See also
Jonathan M. Wortham, MD et al., Second Nationwide Tuberculosis Outbreak
Caused by Bone Allografts Containing Live Cells--United States, 2023,
Centers for Disease Control and Prevention Morbidity & Mortality Weekly
Report, Vol. 72, No. 52-53 (Jan. 5, 2024), https://www.cdc.gov/mmwr/
volumes/72/wr/pdfs/mm725253-H.pdf.
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Background and Need for Legislation
Ms. Eisenga was one of 36 patients across seven states to
contract tuberculosis from a tissue donation originating from
an infected donor, resulting in two deaths.\2\ This bill will
increase public awareness, patient safety, and public trust in
these lifesaving medical products to help ensure this
preventable tragedy occurred for the last time.
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\2\Id.
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Committee Action
On February 29, 2024, the Subcommittee on Health held a
hearing on H.R. 7188.\3\ The title of the hearing was
``Legislative Proposals to Support Patients with Rare
Diseases.'' The Subcommittee received testimony from:
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\3\Provisions of H.R. 7188 were reintroduced in the 119th Congress
as H.R. 1082.
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Terence Flotte, MD, Provost and Dean of
UMass Chan Medical School, Vice President of American
Society of Gene and Cell Therapy (ASGCT);
Alexander Bassuk, MD, PhD, Physician-in-
Chief, University of Iowa Stead Family Children's
Hospital; Chair and Professor, Stead Family Department
of Pediatrics;
Aaron Kesselheim, MD, JD, MPH, Professor of
Medicine, Harvard Medical School; Director, Program On
Regulation, Therapeutics, And Law (PORTAL) at Brigham
and Women's Hospital;
Jeromie Ballreich, PhD, Associate Research
Professor, Johns Hopkins Bloomberg School of Public
Health;
Alice Chen, PhD, Senior Fellow, USC
Schaeffer Center for Health Policy and Economics;
Associate Professor and Vice Dean for Research, USC Sol
Price School of Public Policy; and
Khrystal Davis, JD, Founding President,
Texas Rare Alliance.
On May 16, 2024, the Subcommittee on Health met in open
markup session and forwarded H.R. 7188, as amended, to the full
Committee by a record vote of 27 yeas to 0 nays.
On September 18, 2024, the full Committee on Energy and
Commerce met in open markup session and ordered H.R. 7188, as
amended, favorably reported to the House by a record vote of 40
yeas and 0 nays.
On April 29, 2025, the full Committee on Energy and
Commerce met in open markup session and ordered H.R. 1082
favorably reported to the House by voice vote.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. There were no record votes taken in connection with
ordering H.R. 1082 reported.
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 1082 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to
increase public awareness, patient safety, and public trust in
human cell and tissue products.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 1082 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Related Committee and Subcommittee Hearings
Pursuant to clause 3(c)(6) of rule XIII, the following
related hearing was used to develop or consider H.R. 1082:
On February 29, 2024, the Subcommittee on
Health held a hearing on H.R. 7188.\4\ The title of the
hearing was ``Legislative Proposals to Support Patients
with Rare Diseases.'' The Subcommittee received
testimony from:
---------------------------------------------------------------------------
\4\Provisions of H.R. 7188 were reintroduced in the 119th Congress
as H.R. 1082.
---------------------------------------------------------------------------
Terence Flotte, MD, Provost and
Dean of UMass Chan Medical School, Vice
President of American Society of Gene and Cell
Therapy (ASGCT);
Alexander Bassuk, MD, PhD,
Physician-in-Chief, University of Iowa Stead
Family Children's Hospital; Chair and
Professor, Stead Family Department of
Pediatrics;
Aaron Kesselheim, MD, JD, MPH,
Professor of Medicine, Harvard Medical School;
Director, Program On Regulation, Therapeutics,
And Law (PORTAL) at Brigham and Women's
Hospital;
Jeromie Ballreich, PhD,
Associate Research Professor, Johns Hopkins
Bloomberg School of Public Health;
Alice Chen, PhD, Senior Fellow,
USC Schaeffer Center for Health Policy and
Economics; Associate Professor and Vice Dean
for Research, USC Sol Price School of Public
Policy; and
Khrystal Davis, JD, Founding
President, Texas Rare Alliance.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. At the time this report was
filed, the estimate was not available.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 1082 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
This section provides that the Act may be cited as the
``Shandra Eisenga Human Cell and Tissue Product Safety Act.''
Section 2. Definitions
This section provides the meaning of the terms present in
the bill.
Section 3. Human cell and tissue products transplant public awareness
campaign
This section would require the Secretary of Health and
Human Services (HHS) to conduct a national education campaign
to increase public and health care provider awareness regarding
human cell and tissue product transplants and donations.
Section 4. Civil penalties for violation of requirements for human cell
and tissue products
This section provides the Food and Drug Administration
(FDA) enforcement authority, through issuance of civil monetary
penalties, for violations of donor eligibility requirements and
good tissue practices with respect to human cell and tissue
products.
Section 5. Streamlining regulatory oversight of human cell and tissue
products
This section would direct FDA to take additional steps to
provide information on regulatory oversight of human cell and
tissue products, including by publishing educational materials,
best practices, and other relevant information on FDA's public
website, as well as by conducting workshops and other
educational sessions for relevant stakeholders, and establish a
public docket for related comments. Lastly, the bill would
require the Secretary of HHS to report to Congress on
recommendations for the regulation of human cell and tissue
products.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part G--Quarantine and Inspection
* * * * * * *
penalties
Sec. 368. (a) Any person who violates any regulation
prescribed under section 361, 362, or 363, or any provision of
section 366 or any regulation prescribed thereunder, or who
enters or departs from the limits of any quarantine station,
ground, or anchorage in disregard of quarantine rules and
regulations or without permission of the quarantine officer in
charge, shall be punished by a fine of not more than $1,000 or
by imprisonment for not more than one year, or both.
(b) Any vessel which violates section 366, or any regulations
thereunder or under section 364, or which enters within or
departs from the limits of any quarantine station, ground, or
anchorage in disregard of the quarantine rules and regulations
or without permission of the officer in charge, shall forfeit
to the United States not more than $5,000, the amount to be
determined by the court, which shall be a lien on such vessel,
to be recovered by proceedings in the proper district court of
the United States. In all such proceedings the United States
attorney shall appear on behalf of the United States; and all
such proceedings shall be conducted in accordance with the
rules and laws governing cases of seizure of vessels for
violation of the revenue laws of the United States.
(c) With the approval of the Secretary, the Surgeon General
may, upon application therefor, remit or mitigate any
forfeiture provided for under subsection (b) of this section,
and he shall have authority to ascertain the facts upon all
such applications.
(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).
* * * * * * *
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FOOD AND DRUG OMNIBUS REFORM ACT OF 2022
* * * * * * *
DIVISION FF--HEALTH AND HUMAN SERVICES
* * * * * * *
TITLE III--FOOD AND DRUG ADMINISTRATION
* * * * * * *
Subtitle B--Drugs and Biologics
CHAPTER 1--RESEARCH, DEVELOPMENT, AND COMPETITION IMPROVEMENTS
* * * * * * *
SEC. 3205. PUBLIC WORKSHOP ON CELL THERAPIES.
Not later than 3 years after the date of the enactment of
this Act, the Secretary, acting through the Commissioner of
Food and Drugs, shall convene a public workshop with relevant
stakeholders to discuss [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) that are regulated as drugs under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and biological
products under section 351 of the Public Health Service Act (42
U.S.C. 262), namely, stem cell and other cellular therapies]
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.
* * * * * * *
[all]