Federal Register #FDA-2026-N-7896

FDA Announces FY 2027 Regulatory Fee Rates for Facility Reinspections, Recall Compliance, Importer Reinspections, and OTC Monograph Drug Facilities

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has announced fiscal year 2027 fee rates for regulatory services related to food and drug safety compliance. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Services Requested: - Reinspection of domestic and foreign food facilities to verify corrective actions and compliance with food safety requirements - Oversight and enforcement actions for failures to comply with FDA recall orders - Reinspection of importers for food safety compliance - Over-the-Counter (OTC) Monograph Drug Facility Fees for manufacturers and contract manufacturing organizations (CMOs) - Fees for OTC Monograph Order Requests (OMORs), including Tier 1 and Tier 2 submissions - Fee Structure: - Fees are assessed based on direct hours worked, with rates of $354/hour for domestic travel and $414/hour for foreign travel - Annual facility fees for OTC monograph drug manufacturers and reduced rates for CMOs - Fees for OMOR submissions, with different rates for Tier 1 and Tier 2 requests - Unique/Notable Requirements: - No specific OEMs or vendors are named; this is a regulatory fee schedule, not a procurement of products - Special provisions for small businesses and guidance on fee reductions - Fees apply to both domestic and foreign entities subject to FDA oversight - No products are being procured; all items relate to regulatory services and compliance activities

Description

The Food and Drug Administration (FDA) announces the fiscal year 2027 fee rates for domestic and foreign facility reinspections, failures to comply with recall orders, and importer reinspections as authorized by the Federal Food, Drug, and Cosmetic Act amended by the FDA Food Safety Modernization Act. These fees apply from October 1, 2026, through September 30, 2027. The fees cover costs related to reinspection activities, recall order compliance, and importer reinspections, with specific hourly rates for domestic and foreign travel. The notice includes details on fee assessment, payment methods, and consequences of non-payment.

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