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Bill > HR7248

US HR7248

US HR7248
FDA Modernization Act 3.0

summary

Introduced
02/06/2024
In Committee
02/09/2024
Crossed Over
Passed
Dead
01/03/2025

Introduced Session

118th Congress

Bill Summary

A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes.

AI Summary

This bill, the FDA Modernization Act 3.0, aims to establish a process at the Food and Drug Administration (FDA) for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for biological products or other drugs. The bill requires the FDA to initiate a process for the qualification of nonclinical testing methods, establish eligibility criteria, review requests for qualification, and expedite the development and review of drug applications that utilize qualified nonclinical testing methods. The bill also requires the FDA to submit annual reports to Congress on the process and estimated animal savings. Additionally, the bill requires the FDA to hold a public meeting and issue guidance on the qualification process.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (47)

Buddy Carter (R)*,  Don Bacon (R),  Nanette Barragán (D),  Gus Bilirakis (R),  Vern Buchanan (R),  Tim Burchett (R),  Ken Calvert (R),  Tony Cárdenas (D),  Mike Carey (R),  Troy Carter (D),  Judy Chu (D),  Dan Crenshaw (R),  Jason Crow (D),  Anthony D'Esposito (R),  Don Davis (D),  Rosa DeLauro (D),  Lloyd Doggett (D),  Scott Fitzgerald (R),  Brian Fitzpatrick (R),  Lois Frankel (D),  Andrew Garbarino (R),  Chuy García (D),  Dan Goldman (D),  Lance Gooden (R),  Josh Gottheimer (D),  Josh Harder (D),  Diana Harshbarger (R),  Mike Lawler (R),  Susie Lee (D),  Zoe Lofgren (D),  Nancy Mace (R),  Nicole Malliotakis (R),  Kevin Mullin (D),  Jerry Nadler (D),  Joe Neguse (D),  Troy Nehls (R),  Eleanor Holmes Norton (D),  Jay Obernolte (R),  Brittany Pettersen (D),  Deborah Ross (D),  Hillary Scholten (D),  Chris Smith (R),  Claudia Tenney (R),  Dina Titus (D),  Rashida Tlaib (D),  David Valadao (R),  Michael Waltz (R), 

Last Action

Referred to the Subcommittee on Health. (on 02/09/2024)

Bill Topics

Health
  • ‐ Regulation of Drug Industry and Pharmacies
  • ‐ Research and Development
(1 Companion Bills)

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Document Type Source Location Created
State Bill Page https://www.congress.gov/bill/118th-congress/house-bill/7248/all-info 02/07/2024
BillText https://www.congress.gov/118/bills/hr7248/BILLS-118hr7248ih.pdf 02/16/2024
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