Federal Register #FDA-2026-N-7498

FDA Announces FY 2027 User Fee Rates for Animal and Human Generic Drug Programs

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has announced the official user fee rates for the Animal Generic Drug User Fee Act (AGDUFA IV) and the Generic Drug User Fee Amendments (GDUFA III) for Fiscal Year 2027. - Government Buyer: - Food and Drug Administration (FDA), Center for Veterinary Medicine - Department of Health and Human Services - Products/Services Requested: - User fee payments for: - Abbreviated applications for generic new animal drugs (full and half rates) - Generic Investigational New Animal Drug (JINAD) file submissions - Generic new animal drug product fees - Tiered sponsor fees (100%, 75%, 50%) - Abbreviated New Drug Applications (ANDA) for human generics - Drug Master Files (DMF) - Facility fees for Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF), both domestic and foreign - Contract Manufacturing Organization (CMO) facility fees - Applicant program fees for large, medium, and small generic drug operations - Fee Rates (examples): - $132,614 for full abbreviated animal drug application - $66,307 for half-rate application - $50,000 for JINAD file - $15,670 per generic new animal drug product - $264,009 (100%), $198,007 (75%), $132,005 (50%) for sponsor fees - $375,684 for ANDA, $109,899 for DMF - Facility fees range from $39,680 to $245,033 - Applicant program fees up to $1,927,291 - Unique/Notable Requirements: - Fees apply to all eligible applicants submitting relevant applications or maintaining facilities/products during the fiscal year - Payment is required before FDA review or action - No specific OEMs or vendors are named; fees are applicable to all qualifying manufacturers and sponsors - Fee rates are subject to statutory and inflation adjustments - This is a regulatory announcement establishing fee rates, not a solicitation for goods or services.

Description

The Food and Drug Administration (FDA) announces the fee rates and payment procedures for fiscal year 2027 generic new animal drug program user fees. These fees apply to abbreviated applications for generic new animal drugs, requests to establish JINAD files, and submissions related to JINAD files. The fee rates are effective for applications submitted on or after October 1, 2026, through September 30, 2027. The notice details specific fee amounts for various application types and sponsor fees, and outlines payment deadlines and procedures.

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