[House Report 118-766]
[From the U.S. Government Publishing Office]
118th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 118-766
======================================================================
SHANDRA EISENGA HUMAN CELL AND TISSUE PRODUCT SAFETY ACT
_______
November 22, 2024.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mrs. Rodgers of Washington, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 7188]
The Committee on Energy and Commerce, to whom was referred
the bill (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, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 4
Committee Action................................................. 4
Committee Votes.................................................. 4
Oversight Findings and Recommendations........................... 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 6
Statement of General Performance Goals and Objectives............ 6
Duplication of Federal Programs.................................. 6
Related Committee and Subcommittee Hearings...................... 6
Committee Cost Estimate.......................................... 7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
Purpose and Summary
H.R. 7188 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. The bill would help raise awareness
regarding the potential risks and benefits of human cell and
tissue product transplants through a public awareness campaign.
It would also call on the Food and Drug Administration (FDA) to
take additional steps to promote the public health by issuing
and updating relevant guidance for industry on determining
eligibility of donors of human cell and tissue products and
grants the FDA additional authorities to enforce such
requirements. Lastly, the bill would require the Secretary of
Health and Human Services (HHS) to conduct workshops for
stakeholders, establish a public docket, and report to Congress
with recommendations for modernizing the regulation of human
cell and tissue products.
Background and Need for Legislation
Ms. Eisenga was one of 36 patients in seven states to
contract TB from a tissue donation originating from an infected
donor, resulting in two deaths. This bill will increase patient
safety and public trust in these lifesaving medical products to
help ensure that this preventable tragedy occurred for the last
time.
Committee Action
On February 29, 2024, the Subcommittee on Health held a
hearing on H.R. 7188. The title of the hearing was
``Legislative Proposals to Support Patients with Rare
diseases.'' The Subcommittee received testimony from:
Terence Flotte, MD, Provost and Dean of
UMass Chan Medical School, Vice President of American
Society of Gene and Cell Therapy;
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 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 vote of 40 yeas
and 0 nays.
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. The following reflects the record votes taken during
the Committee consideration:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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. 7188 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 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. 7188 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. 7188:
On February 29, 2024, the Subcommittee on
Health held a hearing on H.R. 7188. The title of the
hearing was ``Legislative Proposals to Support Patients
with Rare Diseases.'' The Subcommittee received
testimony from:
Terence Flotte, MD, Provost and
Dean of UMass Chan Medical School, Vice
President of American Society of Gene and Cell
Therapy;
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. 7188 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, evidence-based
education campaign to increase public and health care provider
awareness regarding the potential risks and benefits of human
cell and tissue product transplants.
Section 4. Review and update of existing guidance
This section would require the Food and Drug Administration
(FDA) to issue and update relevant guidance for industry on
determining eligibility of donors of human cell and tissue
products.
Section 5. Civil penalties for violation of requirements for human cell
and tissue products
This section provides the Food and Drug Administration
(FDA) authority to enforce requirements for donor eligibility
and good tissue practices with respect to human cell and tissue
products regulated under section 361 of the Public Health
Services Act through civil monetary penalties.
Section 6. Streamlining regulatory oversight of human cell and tissue
products
This section would require the Secretary of Health and
Human Services (HHS) to provide resources, public information,
and educational materials and to conduct workshops for
stakeholders, establish a public docket, and report to Congress
with recommendations for modernizing 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).
* * * * * * *
----------
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]