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Animal Drug and Animal Generic Drug User Fee Amendments of 2023

H.R. 1418 Rep. Greg Pence (R-IN-6) Passed House
Bill text PDF
  1. Introduced Mar 7
  2. Committee Mar 7
  3. Passed House Jul 17
  4. Passed Senate Next
  5. To President Not yet
  6. Law Not yet
Where it stands
Passed House, Jul 17, 2023Next: Senate vote
1134d ago Sep 20, 2023: Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
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Summary

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Full summary3 paragraphs

This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements.

The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria).

Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

Library of Congress summary, Jul 17, 2023

Summary versions
  • Passed HouseJul 17, 2023
  • Reported to HouseJun 9, 2023
  • Introduced in HouseMar 7, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.