The Food and Drug Administration has announced its fiscal year 2016 fee rates for certain domestic and foreign food facility reinspections, failures to comply with a recall order, and importer reinspections. Fees for these services will be assessed at the rate of $221 per hour if domestic travel is required (up from $217) and $315 per hour if foreign travel is required (up from $305). These fees will be effective as of Oct. 1, 2015, and remain in effect through Sept. 30, 2016.
It is possible, however, that the fees will not actually be assessed during all or part of this period. This is because the FDA (a) does not intend to issue invoices for reinspection or recall order fees until it publishes a guidance document on how small businesses may request a reduction of those fees given the “severe economic hardship” that paying them could cause, and (b) is still considering various issues associated with the assessment and collection of importer reinspection fees.
Under the Food Safety Modernization Act the FDA may assess a fee for a reinspection that is (a) conducted to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction at a facility that manufactures, processes, packs or holds food for consumption and (b) necessitated as a result of a previous inspection of the facility that had a final classification of Official Action Indicated when the FDA determined that the non-compliance was materially related to food safety requirements of the Federal Food, Drug and Cosmetic Act. This fee may be collected from the responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection.
The FDA is also authorized to assess fees for not complying with a recall order; e.g., not initiating a recall as ordered by the FDA, not conducting a recall in the manner specified by the FDA in a recall order, or not providing the FDA with requested information regarding an FDA- ordered recall. Such fees are to be paid by the responsible party for a domestic facility and an importer who does not comply with a recall order.
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