FDA Sets Fees for Import and Facility Reinspections for FY20; Invoices Remain on Hold
The Food and Drug Administration set potential fiscal year 2020 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA 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 FY20 fees of $258/hour for domestic services involving travel and $301/hour if foreign travel is required. The fees are effective Oct. 1.
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FDA again said it will not 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 are also still on hold until certain issues are resolved and FDA notifies the public (see 11100412), but these FY20 fee rates will be used to determine any importer reinspection fees that may be assessed in FY19. FDA still intends to issue a guidance document on fees the agency may assess and collect from importers to cover reinspection-related costs, it said.
(Federal Register 07/25/19)