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.
The bill establishes fees to expedite the animal drug development process and review of new and supplemental animal drug applications.
The bill sets revenue amounts for the required fees for fiscal years 2024 through 2028, totaling $33,500,000.
Fees will be assessed on requests to establish a generic investigational new animal drug file and submissions to an established file.
The bill includes reporting requirements, such as data analysis on changes in the number of individuals hired and funded by fees collected, changes in fee revenue amounts and costs, and the average hours required for the review of each type of animal drug application.
The bill requires reports on activities to support antimicrobial stewardship and the development of new drugs for bacterial diseases in animals.
