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 $221 for all domestic work and $289 if foreign travel is required. The fees, which are slightly lower than the 2012 rates, will be in effect October 1, 2012, through September 30, 2013.
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 2013
- FDA plans to issue additional guidance this year to provide more information about the circumstances that would trigger reinspection fees.
- No invoices will be issued for fees related to recalls or re-inspections until FDA publishes guidance that details how small businesses may request a reduction in fees. That means all companies, regardless of size, will not be billed until the new guidance is issued.
- FDA will not assess importer reinspection fees until some of the complex issues raised about the fees in comments have been resolved.
- FDA will accept comments regarding the fees until the October 31 deadline.
For more details, read this memo, "FDA Announces FSMA Fee Scheduled for Fiscal Year 2013," from Hogan Lovells, IDFA's outside legal counsel."
Members with questions may contact Clay Detlefsen, vice president of regulatory affairs, at firstname.lastname@example.org.