Animal 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 provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly.
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.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2023-09-20 | Calendars | Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210. | Senate |
| 2023-07-18 | IntroReferral | Received in the Senate. | Senate |
| 2023-07-17 | Floor | Motion to reconsider laid on the table Agreed to without objection. | House floor actions |
| 2023-07-17 | Floor | On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623) | House floor actions |
| 2023-07-17 | Floor | DEBATE - The House proceeded with forty minutes of debate on H.R. 1418. | House floor actions |
| 2023-07-17 | Floor | Considered under suspension of the rules. (consideration: CR H3620-3624) | House floor actions |
| 2023-07-17 | Floor | Mr. Bilirakis moved to suspend the rules and pass the bill, as amended. | House floor actions |
| 2023-06-09 | Calendars | Placed on the Union Calendar, Calendar No. 80. | House floor actions |
| 2023-06-09 | Committee | Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104. | House floor actions |
| 2023-05-24 | Committee | Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0. | House committee actions |
| 2023-05-24 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2023-05-17 | Committee | Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 . | House committee actions |
| 2023-05-17 | Committee | Subcommittee Consideration and Mark-up Session Held. | House committee actions |
| 2023-03-17 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2023-03-07 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2023-03-07 | IntroReferral | Introduced in House | Library of Congress |