The Food and Drug Administration published on August 1 its schedule for fees associated with facility reinspections, failure to comply with a recall order and import reinspections. FDA established an hourly fee of $217 for all domestic work, slightly lower than 2014 rates, and $305 if foreign travel is required, which is slightly higher than the rates that were in place during the previous year.
Although the fees will be in effect October 1, 2014, through September 30, 2015, FDA said no invoices will be issued until it publishes guidance for small businesses and importer reinspections.
Under the Food Safety Modernization Act, FDA has the authority to assess and collect fees from domestic facilities, importers and U.S. agents of foreign facilities subject to a reinspection to cover reinspection related costs. FDA may also collect fees to cover recall activity costs for domestic facilities and importers that do not comply with recall orders.
The fees apply to facilities reinspected by FDA following a previous inspection that had a final classification of Official Action Indicated (OAI) and where FDA determined the non-compliance was materially related to food safety requirements. FDA will reinspect to determine whether corrective and effective actions have been implemented and compliance has been achieved to the agency's satisfaction.
Waiting on Guidance
FDA continues to advise that no invoices will be issued for fees related to recalls or reinspections until the agency publishes guidance that details how small businesses may request a reduction in fees. That means all companies, regardless of size, should not be billed until the new guidance is issued.
Also, according to the Frequently Asked Questions section on the FDA website, importer reinspection fees will not be assessed until the agency has resolved “particular complexities” associated with assessing and collecting the fees and the public is notified. However, the fee rates published last week will be used to determine any importer reinspection fees assessed in FY 2015 once the agency begins to assess fees.
Members with questions may contact Clay Detlefsen, vice president of regulatory affairs, at email@example.com.