Federal Register #FDA-2026-N-7712

FDA FY 2027 User Fee Rates for Third-Party Certification and Animal Generic Drug Programs

This opportunity involves the Food and Drug Administration (FDA), under the Department of Health and Human Services, announcing the fiscal year 2027 user fee rates for its Third-Party Certification Program and Animal Generic Drug User Fee Program. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Office of Financial Management - OEMs and Vendors: - No specific OEMs or commercial vendors are named; the notice is directed at accreditation bodies, certification bodies, and animal drug sponsors. - Products/Services Requested: - Accreditation and certification services for food safety (Third-Party Certification Program) - Application, annual, and renewal fees for accreditation bodies and certification bodies - Animal generic drug user fee program services, including abbreviated applications, JINAD file submissions, product fees, and sponsor fees - Key fee line items: - $56,272 for initial application (accreditation/certification bodies) - $2,612–$3,266 for annual fees (accreditation/certification bodies) - $34,311 for renewal applications - $26,960 for annual fee (directly accredited certification bodies) - $132,614 or $66,307 for abbreviated animal drug applications - $50,000 for JINAD file requests/submissions - $15,670 for generic new animal drug product fee - $132,005–$264,009 for sponsor fees - Unique or Notable Requirements: - Fees must be paid in U.S. currency via electronic methods - Payment deadlines and consequences for non-payment are specified - Fee rates are set for a defined annual period and are subject to inflation adjustments - No specific products or part numbers; all items are regulatory service fees

Description

The Food and Drug Administration (FDA) announces the fiscal year 2027 annual fee rates for recognized accreditation bodies and accredited certification bodies under the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act. The notice details the fee rates applicable from October 1, 2026, through September 30, 2027, including fees for initial and renewal accreditation applications and direct FDA accreditation. The fees support FDA's mission to protect public health through science-based approaches to food safety and include provisions for payment procedures and inflation adjustments.

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