Legis Daily

FDA Modernization Act 3.0

USA118th CongressHR-7248| House 
| Updated: 2/9/2024
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (46)
Diana Harshbarger (Republican)Tim Burchett (Republican)Lance Gooden (Republican)Mike Carey (Republican)Claudia Tenney (Republican)Troy A. Carter (Democratic)Dina Titus (Democratic)Tony Cárdenas (Democratic)Donald G. Davis (Democratic)Rosa L. DeLauro (Democratic)Andrew R. Garbarino (Republican)Michael Waltz (Republican)Ken Calvert (Republican)Gus M. Bilirakis (Republican)Don Bacon (Republican)Christopher H. Smith (Republican)Nancy Mace (Republican)Hillary J. Scholten (Democratic)Daniel S. Goldman (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Troy E. Nehls (Republican)Josh Harder (Democratic)Eleanor Holmes Norton (Democratic)Scott Fitzgerald (Republican)Anthony D'Esposito (Republican)Joe Neguse (Democratic)Lois Frankel (Democratic)David G. Valadao (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Deborah K. Ross (Democratic)Josh Gottheimer (Democratic)Zoe Lofgren (Democratic)Nanette Diaz Barragán (Democratic)Michael Lawler (Republican)Jesús G. "Chuy" García (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Susie Lee (Democratic)Rashida Tlaib (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
FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals. Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method. The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.
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Timeline

Bill from Previous Congress

HR 117-2565
FDA Modernization Act of 2021
Feb 6, 2024
Introduced in House
Feb 6, 2024
Referred to the House Committee on Energy and Commerce.
Feb 9, 2024
Referred to the Subcommittee on Health.
Dec 16, 2024

Latest Companion Bill Action

S 118-5046
Held at the desk.
  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • February 6, 2024
    Introduced in House


  • February 6, 2024
    Referred to the House Committee on Energy and Commerce.


  • February 9, 2024
    Referred to the Subcommittee on Health.


  • December 16, 2024

    Latest Companion Bill Action

    S 118-5046
    Held at the desk.

Health

Related Bills

  • S 118-5046: FDA Modernization Act 3.0
Administrative law and regulatory proceduresAnimal protection and human-animal relationshipsCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesInternet, web applications, social mediaPrescription drugs

FDA Modernization Act 3.0

USA118th CongressHR-7248| House 
| Updated: 2/9/2024
FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals. Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method. The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.
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
Feb 6, 2024
Introduced in House
Feb 6, 2024
Referred to the House Committee on Energy and Commerce.
Feb 9, 2024
Referred to the Subcommittee on Health.
Dec 16, 2024

Latest Companion Bill Action

S 118-5046
Held at the desk.
  • Bill from Previous Congress

    HR 117-2565
    FDA Modernization Act of 2021


  • February 6, 2024
    Introduced in House


  • February 6, 2024
    Referred to the House Committee on Energy and Commerce.


  • February 9, 2024
    Referred to the Subcommittee on Health.


  • December 16, 2024

    Latest Companion Bill Action

    S 118-5046
    Held at the desk.
Earl L. "Buddy" Carter

Earl L. "Buddy" Carter

Republican Representative

Georgia

Cosponsors (46)
Diana Harshbarger (Republican)Tim Burchett (Republican)Lance Gooden (Republican)Mike Carey (Republican)Claudia Tenney (Republican)Troy A. Carter (Democratic)Dina Titus (Democratic)Tony Cárdenas (Democratic)Donald G. Davis (Democratic)Rosa L. DeLauro (Democratic)Andrew R. Garbarino (Republican)Michael Waltz (Republican)Ken Calvert (Republican)Gus M. Bilirakis (Republican)Don Bacon (Republican)Christopher H. Smith (Republican)Nancy Mace (Republican)Hillary J. Scholten (Democratic)Daniel S. Goldman (Democratic)Jerrold Nadler (Democratic)Brittany Pettersen (Democratic)Troy E. Nehls (Republican)Josh Harder (Democratic)Eleanor Holmes Norton (Democratic)Scott Fitzgerald (Republican)Anthony D'Esposito (Republican)Joe Neguse (Democratic)Lois Frankel (Democratic)David G. Valadao (Republican)Dan Crenshaw (Republican)Brian K. Fitzpatrick (Republican)Jay Obernolte (Republican)Deborah K. Ross (Democratic)Josh Gottheimer (Democratic)Zoe Lofgren (Democratic)Nanette Diaz Barragán (Democratic)Michael Lawler (Republican)Jesús G. "Chuy" García (Democratic)Kevin Mullin (Democratic)Jason Crow (Democratic)Susie Lee (Democratic)Rashida Tlaib (Democratic)Lloyd Doggett (Democratic)Nicole Malliotakis (Republican)Vern Buchanan (Republican)Judy Chu (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 118-5046: FDA Modernization Act 3.0
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresAnimal protection and human-animal relationshipsCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesInternet, web applications, social mediaPrescription drugs