💰FDA Announces Animal Drug User Fee Rates for FY 2026
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2026 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2026.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice outlines new animal drug user fees and payment procedures per the FD&C Act, impacting businesses submitting animal drug applications. Adoption of these fees impacts operational costs, compliance mandates, and financial planning for animal drug manufacturers and sponsors.