Federal Register #FDA-2026-N-7558

FDA Announces FY 2027 Animal Drug and Medical Device User Fee Rates

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has announced the user fee rates and payment procedures for animal drug and medical device applications for Fiscal Year 2027. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Center for Veterinary Medicine - Products and Services Requested: - Animal drug application fee: $621,692 per application - Supplemental animal drug application fee (requiring safety/effectiveness data): $310,846 per application - Annual animal drug product fee: $12,294 per product (estimated 710 products) - Annual animal drug establishment fee: $215,520 per establishment (estimated 39 establishments) - Annual animal drug sponsor fee: $145,476 per sponsor (estimated 60 sponsors) - Medical device premarket application base fee: $470,000 per application - OEMs and Vendors: - No specific OEMs or vendors are named; fees apply to all eligible applicants submitting animal drug or medical device applications - Unique or Notable Requirements: - Fees must be paid in full before applications are reviewed - Application fees apply to submissions on or after the start of the fiscal year and remain effective through the end of the fiscal year - Annual product, establishment, and sponsor fees are invoiced by the end of the calendar year and due by the end of January - The notice includes estimated numbers of applications, products, establishments, and sponsors subject to fees - Fee rates are set by statute and subject to inflation adjustments

Description

The Food and Drug Administration (FDA) announces the fee rates and payment procedures for fiscal year 2027 animal drug user fees as authorized by the Federal Food, Drug, and Cosmetic Act amended by the Animal Drug User Fee Amendments of 2023. The notice establishes specific fee rates for animal drug applications, supplemental applications, product fees, establishment fees, and sponsor fees. These fees apply to applications submitted on or after October 1, 2026, and remain effective through September 30, 2027. Payment deadlines and invoice issuance dates are also specified.

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