Legis Daily

FDA Modernization Act 3.0

USA119th CongressHR-2821| House 
| Updated: 4/10/2025
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (38)
Diana Harshbarger (Republican)Julie Johnson (Democratic)Mark Pocan (Democratic)Darren Soto (Democratic)Mike Carey (Republican)Claudia Tenney (Republican)Troy A. Carter (Democratic)Eugene Simon Vindman (Democratic)Rosa L. DeLauro (Democratic)Ken Calvert (Republican)Ted Lieu (Democratic)Maria Elvira Salazar (Republican)Thomas H. Kean (Republican)Gus M. Bilirakis (Republican)Christopher H. Smith (Republican)Hillary J. Scholten (Democratic)Daniel S. Goldman (Democratic)Raja Krishnamoorthi (Democratic)Jerrold Nadler (Democratic)Josh Harder (Democratic)Laurel M. Lee (Republican)Eleanor Holmes Norton (Democratic)Scott Fitzgerald (Republican)Joe Neguse (Democratic)Lois Frankel (Democratic)David G. Valadao (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Randy K. Sr. Weber (Republican)Josh Gottheimer (Democratic)Nanette Diaz Barragán (Democratic)Michael Lawler (Republican)Jason Crow (Democratic)Lloyd Doggett (Democratic)Nicole Malliotakis (Republican)Vern Buchanan (Republican)Judy Chu (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The FDA Modernization Act 3.0 requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish an interim final rule within one year of the bill's enactment. This rule is designed to implement recent amendments to the Federal Food, Drug, and Cosmetic Act, specifically those made by the Consolidated Appropriations Act, 2023. The core purpose of this interim final rule is to update various sections of Title 21, Code of Federal Regulations. It mandates the replacement of all references to "animal" tests, data, studies, models, and research with the broader term " nonclinical " tests, data, studies, models, and research. Additionally, the rule will incorporate the definition of "nonclinical test" from section 505(z) of the Federal Food, Drug, and Cosmetic Act into several specified regulatory sections. This interim final rule will become effective immediately upon publication, without the usual requirement for demonstrating good cause. The bill also includes a technical amendment to section 505 of the Federal Food, Drug, and Cosmetic Act, redesignating a duplicate subsection (z) as subsection (aa) to ensure proper statutory numbering.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 117-2565
FDA Modernization Act of 2021

Bill from Previous Congress

HR 118-7248
FDA Modernization Act 3.0
Apr 10, 2025
Introduced in House
Apr 10, 2025
Referred to the House Committee on Energy and Commerce.
Dec 17, 2025

Latest Companion Bill Action

S 119-355
Held at the desk.
  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • Bill from Previous Congress

    HR 118-7248
    FDA Modernization Act 3.0


  • April 10, 2025
    Introduced in House


  • April 10, 2025
    Referred to the House Committee on Energy and Commerce.


  • December 17, 2025

    Latest Companion Bill Action

    S 119-355
    Held at the desk.

Health

FDA Modernization Act 3.0

USA119th CongressHR-2821| House 
| Updated: 4/10/2025
The FDA Modernization Act 3.0 requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish an interim final rule within one year of the bill's enactment. This rule is designed to implement recent amendments to the Federal Food, Drug, and Cosmetic Act, specifically those made by the Consolidated Appropriations Act, 2023. The core purpose of this interim final rule is to update various sections of Title 21, Code of Federal Regulations. It mandates the replacement of all references to "animal" tests, data, studies, models, and research with the broader term " nonclinical " tests, data, studies, models, and research. Additionally, the rule will incorporate the definition of "nonclinical test" from section 505(z) of the Federal Food, Drug, and Cosmetic Act into several specified regulatory sections. This interim final rule will become effective immediately upon publication, without the usual requirement for demonstrating good cause. The bill also includes a technical amendment to section 505 of the Federal Food, Drug, and Cosmetic Act, redesignating a duplicate subsection (z) as subsection (aa) to ensure proper statutory numbering.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 117-2565
FDA Modernization Act of 2021

Bill from Previous Congress

HR 118-7248
FDA Modernization Act 3.0
Apr 10, 2025
Introduced in House
Apr 10, 2025
Referred to the House Committee on Energy and Commerce.
Dec 17, 2025

Latest Companion Bill Action

S 119-355
Held at the desk.
  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • Bill from Previous Congress

    HR 118-7248
    FDA Modernization Act 3.0


  • April 10, 2025
    Introduced in House


  • April 10, 2025
    Referred to the House Committee on Energy and Commerce.


  • December 17, 2025

    Latest Companion Bill Action

    S 119-355
    Held at the desk.
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (38)
Diana Harshbarger (Republican)Julie Johnson (Democratic)Mark Pocan (Democratic)Darren Soto (Democratic)Mike Carey (Republican)Claudia Tenney (Republican)Troy A. Carter (Democratic)Eugene Simon Vindman (Democratic)Rosa L. DeLauro (Democratic)Ken Calvert (Republican)Ted Lieu (Democratic)Maria Elvira Salazar (Republican)Thomas H. Kean (Republican)Gus M. Bilirakis (Republican)Christopher H. Smith (Republican)Hillary J. Scholten (Democratic)Daniel S. Goldman (Democratic)Raja Krishnamoorthi (Democratic)Jerrold Nadler (Democratic)Josh Harder (Democratic)Laurel M. Lee (Republican)Eleanor Holmes Norton (Democratic)Scott Fitzgerald (Republican)Joe Neguse (Democratic)Lois Frankel (Democratic)David G. Valadao (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Randy K. Sr. Weber (Republican)Josh Gottheimer (Democratic)Nanette Diaz Barragán (Democratic)Michael Lawler (Republican)Jason Crow (Democratic)Lloyd Doggett (Democratic)Nicole Malliotakis (Republican)Vern Buchanan (Republican)Judy Chu (Democratic)

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted