FDA Sets Fees for Import and Facility Reinspections for FY 2025; Invoices Remain on Hold
The FDA set potential FY 2025 fees for import reinspections, domestic and foreign facility reinspections, and recall activities the agency performs if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, it said in a notice. The agency set FY 2025 fees of $340 per hour for domestic services involving travel and $373 hourly if foreign travel is required.
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The fees are effective Oct. 1, the start of FY 2025. The FDA again said it won't send invoices for recall activity and foreign facility reinspection fees until it publishes a guidance to outline the process through which small businesses may request a fee reduction, although fees will be assessed at the fee level in effect at the time of the activity (unless fees are reduced).
Fees for importer reinspection also remain on hold until "various issues" are resolved and the agency notifies the public (see 11100412), but these fee rates will be used to determine any importer reinspection fees that may be assessed in FY 2025. The FDA said it still intends to issue a guidance document on fees the agency may assess and collect from importers to cover reinspection-related costs.