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H.R. 340

U.S. House•In House Committee

Summary

H.R. 340, the The HCT/P Modernization Act of 2025, was introduced in the House on Jan 13, 2025 by Rep. Dan Crenshaw (R) with 1 co-sponsor. It was referred to Energy And Commerce, and last saw action on Jan 13, 2025: Referred to the House Committee on Energy and Commerce.

Record

Text

H.R. 340 has 1 co-sponsor.

hb340/introduced-in-house.txt
117 HR 340 IH: The HCT/P Modernization Act of 2025
 U.S. House of Representatives
 2025-01-13
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 I  119th CONGRESS  1st Session  H. R. 340  IN THE HOUSE OF REPRESENTATIVES   January 13, 2025   Mr. Crenshaw  (for himself and  Ms. Barragán ) introduced the following bill; which was referred to the  Committee on Energy and Commerce    A BILL
To direct the Secretary of Health and Human Services carry out activities to streamline regulatory oversight of human cell and tissue products, and for other purposes.
1.
Short title
This Act may be cited as the   The HCT/P Modernization Act of 2025  .
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.
3.
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.

Tracker

The tracker indicates the progress of this legislation as it moves through the legislative process.

  1. Introduced2025-01-13
  2. Passed House
  3. Passed Senate
  4. Conference
  5. To President
  6. Became Law

CRS Summary

The summaries are the Congressional Research Service’s, one per stage. Read them in full.

Introduced in House Jan 13, 2025

hb340/introduced-in-house.md

Shown Here:
Introduced in House (01/13/2025)

The HCT/P Modernization Act of 2025

This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.

The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products.

Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.)

Sponsors

Rep. Dan Crenshaw (R) sponsors H.R. 340, and 1 member has co-sponsored it from the day it was introduced.

Committees

H.R. 340 went before 1 committee: Energy and Commerce.

Energy and Commerce
Energy and Commerce
Referred To · Jan 13, 2025 · 1,636 Bills

Actions

H.R. 340 has taken 2 actions since Jan 13, 2025.

ChamberAction
Jan 13, 2025
House
Introduced in House
Jan 13, 2025
House
Referred to the House Committee on Energy and Commerce.Energy and Commerce Committee

Votes

H.R. 340 has not gone to a roll call.

2 bills are related to H.R. 340.

Titles

H.R. 340 goes by 3 titles, 1 of them short titles.

  • The HCT/P Modernization Act of 2025 — Display Title
  • The HCT/P Modernization Act of 2025 — Short Title(s) as Introduced
  • To direct the Secretary of Health and Human Services carry out activities to streamline regulatory oversight of human cell and tissue products, and for other purposes. — Official Title as Introduced

Classification

The Congressional Research Service files H.R. 340 under Health, one of its 31 policy areas, and gives it 8 legislative subjects.

CRS Subjects

CRS assigns every bill one policy area from its 31; H.R. 340’s is Health.

hr340/policy-areas.txt
HealthAgriculture and FoodAnimalsArmed Forces and National SecurityArts, Culture, ReligionCivil Rights and Liberties, Minority IssuesCommerceCongressCrime and Law EnforcementEconomics and Public FinanceEducationEmergency ManagementEnergyEnvironmental ProtectionFamiliesFinance and Financial SectorForeign Trade and International FinanceGovernment Operations and PoliticsHousing and Community DevelopmentImmigrationInternational AffairsLabor and EmploymentLawNative AmericansPublic Lands and Natural ResourcesScience, Technology, CommunicationsSocial WelfareSports and RecreationTaxationTransportation and Public WorksWater Resources Development

Legislative Subjects

H.R. 340 carries 8 of CRS’s legislative subjects, from Administrative law and regulatory procedures to Organ and tissue donation and transplantation.

hr340/subjects.txt
Administrative law and regulatory proceduresCell biology and embryologyCongressional oversightDepartment of Health and Human ServicesGovernment information and archivesHealth information and medical recordsInternet, web applications, social mediaOrgan and tissue donation and transplantation

Constitutional authority

The clause the sponsor cites as Congress’s power to enact H.R. 340, as entered in the Congressional Record.

[Congressional Record Volume 171, Number 6 (Monday, January 13, 2025)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. CRENSHAW:H.R. 340.Congress has the power to enact this legislation pursuantto the following:Section 8 of article I of the Constitution.[Page H112]

Source: congress.gov · legiscan.com