FDA releases fiscal year 2013 fees

08/02/2012 04:40:00 PM
Tom Karst

The Food and Drug Administration has announced fiscal year 2013 fee rates for reinspections and failure to comply with a recall order.

The fees cover domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections. They are effective Oct. 1. Comments on the new fees can be submitted through Oct. 31, according to a Federal Register notice.

The agency said fees will be addressed on an hourly rate of $221 if domestic travel is required and $289 per hour if foreign travel is required.

The FDA has the authority to assess and collect fees from, in part:

  • The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection-related costs;
  • The responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and
  • Each importer subject to a reinspection to cover reinspection-related costs.
  • In fiscal year 2011, the FDA said the it spent $4.5 million for domestic regulatory inspection travel costs related to more than 12,700 domestic inspections.

The FDA spent $2.1 million in travel costs in fiscal year 2011 on 229 foreign inspections, according to the notice.



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