FDA Sets Fees for Import & Facility Reinspections, Etc. for FY 2016; Still No Invoices
The Food and Drug Administration set potential fiscal year 2016 fees (here) 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. The agency set FY 2015 fees of $221/hour for domestic services and $315/hour if foreign travel is required. Last year, the agency set FY 2014 at $217/hour and $305/hour, respectively. 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 FY 2016 fee rates will be used to determine any importer reinspection fees that may be assessed in FY 2016.