HOUSE 1418118th CongressRead twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Last Action: 9/20/2023

Actions

2023-09-20Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
2023-07-18Received in the Senate.
2023-07-17Motion to reconsider laid on the table Agreed to without objection.
2023-07-17On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
2023-07-17Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
2023-07-17DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.
2023-07-17Considered under suspension of the rules. (consideration: CR H3620-3624)
2023-07-17Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
2023-06-09Placed on the Union Calendar, Calendar No. 80.
2023-06-09Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
2023-06-09Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
2023-05-24Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.
2023-05-24Committee Consideration and Mark-up Session Held.
2023-05-17Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .
2023-05-17Subcommittee Consideration and Mark-up Session Held.

Showing 15 of 19 actions. Full history on Congress.gov.

CRS Summary

As of 2023-07-17 (53)

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

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.

Cosponsors (2)

Kim Schrier (D-WA)
Susie Lee (D-NV)

Subjects

Research and development
User charges and fees
Veterinary medicine and animal diseases

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