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 $237 for all domestic work and $302 if foreign travel is required. The fees, which are slightly higher than the 2013 rates, will be in effect October 1, 2013, through September 30, 2014.
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.
Highlights for FY 2014
- No invoices will be issued for fees related to recalls or reinspections until FDA 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.
- In last year’s notice, FDA said it would not assess importer reinspection fees until some of the complex issues raised about the fees in comments have been resolved and the public is notified. Although the statement is not included in the new announcement, it likely will remain in effect because FDA has not issued a public notice saying it will start to assess importer reinspection fees.
For more details, members may login below to read a memorandum from Hogan Lovells, IDFA's outside legal counsel.
Members with questions may contact Clay Detlefsen, vice president of regulatory affairs, at email@example.com.
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