FDA Sets Fees for Your Pet's Next Drug Approval Adventure
Published Date: 7/30/2026
Notice
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 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 2027.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 3 costs, 0 mixed.
FY2027 Animal Drug Fee Levels
If you submit or sponsor animal drug applications, FY2027 fees are set at these rates: animal drug application $621,692; supplemental application $310,846; product fee $12,294; establishment fee $215,520; sponsor fee $145,476. These fee rates apply to applications submitted on or after October 1, 2026 and remain in effect through September 30, 2027.
Invoice Timing and Payment Deadlines
FDA will issue invoices for FY2027 product, establishment, and sponsor fees by December 31, 2026, and payment for those invoices is due by January 31, 2027. Application fees are effective for submissions on or after October 1, 2026; payments can be made online via Pay.gov or by wire transfer using the Treasury account info provided.
Full Payment Required Before Review
FDA will not accept an animal drug application for review until it has received full payment of the application fee and any other ADUFA fees owed. That requirement applies to applications submitted on or after October 1, 2026.
Barrier-to-Innovation Waiver Rules
FDA may waive or reduce ADUFA fees under a 'Barrier to Innovation' test if an applicant both (1) is pursuing an innovative product/technology and (2) would face a significant barrier because of limited resources. For FY2027, FDA uses an inflation-adjusted financial resource ceiling of $25,493,000 to identify limited resources. Waiver requests must be submitted in writing no later than 180 days from when fees are due and a granted waiver is valid for one fiscal year.
Operating Reserve Reduced FY2027 Fees
FDA applied an operating reserve adjustment of $5,834,940 because projected carryover user fees exceeded the 18-week threshold; this decreased the FY2027 target fee revenue to $32,328,000. That lowered target revenue was used to set the FY2027 fee amounts listed in the fee schedule.
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Key Dates
Department and Agencies
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