Legis Daily

FDA Modernization Act 3.0

USA119th CongressHR-2821| House 
| Updated: 7/21/2026
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (41)
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)Young Kim (Republican)Rosa L. DeLauro (Democratic)Shri Thanedar (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)Nicholas A. Langworthy (Republican)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)

Health Subcommittee, 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.

Bill Text Versions

View Text
3 versions available

Suggested Questions

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Timeline

Bill from Previous Congress

HR 118-7248
FDA Modernization Act 3.0

Bill from Previous Congress

HR 117-2565
FDA Modernization Act of 2021
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.
Apr 10, 2026
Referred to the Subcommittee on Health.
May 13, 2026
Subcommittee Consideration and Mark-up Session Held
May 13, 2026
Forwarded by Subcommittee to Full Committee by Voice Vote.
May 21, 2026
Ordered to be Reported by the Yeas and Nays: 44 - 0.
May 21, 2026
Committee Consideration and Mark-up Session Held
Jun 18, 2026
Placed on the Union Calendar, Calendar No. 614.
Jun 18, 2026
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Jul 20, 2026
Mr. Guthrie moved to suspend the rules and pass the bill.
Jul 20, 2026
Considered under suspension of the rules. (consideration: CR H4639-4640)
Jul 20, 2026
DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
Jul 20, 2026
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Jul 20, 2026
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Jul 20, 2026
Motion to reconsider laid on the table Agreed to without objection.
Jul 21, 2026
Received in the Senate.
  • Bill from Previous Congress

    HR 118-7248
    FDA Modernization Act 3.0


  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • 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.


  • April 10, 2026
    Referred to the Subcommittee on Health.


  • May 13, 2026
    Subcommittee Consideration and Mark-up Session Held


  • May 13, 2026
    Forwarded by Subcommittee to Full Committee by Voice Vote.


  • May 21, 2026
    Ordered to be Reported by the Yeas and Nays: 44 - 0.


  • May 21, 2026
    Committee Consideration and Mark-up Session Held


  • June 18, 2026
    Placed on the Union Calendar, Calendar No. 614.


  • June 18, 2026
    Reported by the Committee on Energy and Commerce. H. Rept. 119-706.


  • July 20, 2026
    Mr. Guthrie moved to suspend the rules and pass the bill.


  • July 20, 2026
    Considered under suspension of the rules. (consideration: CR H4639-4640)


  • July 20, 2026
    DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.


  • July 20, 2026
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)


  • July 20, 2026
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)


  • July 20, 2026
    Motion to reconsider laid on the table Agreed to without objection.


  • July 21, 2026
    Received in the Senate.

Health

Related Bills

  • S 119-355: FDA Modernization Act 3.0
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding

FDA Modernization Act 3.0

USA119th CongressHR-2821| House 
| Updated: 7/21/2026
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.

Bill Text Versions

View Text
3 versions available

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 118-7248
FDA Modernization Act 3.0

Bill from Previous Congress

HR 117-2565
FDA Modernization Act of 2021
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.
Apr 10, 2026
Referred to the Subcommittee on Health.
May 13, 2026
Subcommittee Consideration and Mark-up Session Held
May 13, 2026
Forwarded by Subcommittee to Full Committee by Voice Vote.
May 21, 2026
Ordered to be Reported by the Yeas and Nays: 44 - 0.
May 21, 2026
Committee Consideration and Mark-up Session Held
Jun 18, 2026
Placed on the Union Calendar, Calendar No. 614.
Jun 18, 2026
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Jul 20, 2026
Mr. Guthrie moved to suspend the rules and pass the bill.
Jul 20, 2026
Considered under suspension of the rules. (consideration: CR H4639-4640)
Jul 20, 2026
DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
Jul 20, 2026
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Jul 20, 2026
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Jul 20, 2026
Motion to reconsider laid on the table Agreed to without objection.
Jul 21, 2026
Received in the Senate.
  • Bill from Previous Congress

    HR 118-7248
    FDA Modernization Act 3.0


  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • 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.


  • April 10, 2026
    Referred to the Subcommittee on Health.


  • May 13, 2026
    Subcommittee Consideration and Mark-up Session Held


  • May 13, 2026
    Forwarded by Subcommittee to Full Committee by Voice Vote.


  • May 21, 2026
    Ordered to be Reported by the Yeas and Nays: 44 - 0.


  • May 21, 2026
    Committee Consideration and Mark-up Session Held


  • June 18, 2026
    Placed on the Union Calendar, Calendar No. 614.


  • June 18, 2026
    Reported by the Committee on Energy and Commerce. H. Rept. 119-706.


  • July 20, 2026
    Mr. Guthrie moved to suspend the rules and pass the bill.


  • July 20, 2026
    Considered under suspension of the rules. (consideration: CR H4639-4640)


  • July 20, 2026
    DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.


  • July 20, 2026
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)


  • July 20, 2026
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)


  • July 20, 2026
    Motion to reconsider laid on the table Agreed to without objection.


  • July 21, 2026
    Received in the Senate.
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (41)
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)Young Kim (Republican)Rosa L. DeLauro (Democratic)Shri Thanedar (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)Nicholas A. Langworthy (Republican)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)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 119-355: FDA Modernization Act 3.0
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding