FDA estimates reinspection fees, asks for comments
FDA filed a notice in the Federal Register on Aug. 1 estimating the facility reinspection, recall and importer reinspection fees.
Under the Food Safety Modernization Act, FDA is to assess fees on companies that require a reinspection. The act requires FDA to recover 100 percent of the agency’s cost for a reinspection or recall, which it has done based on man-hours and the number of inspection it conducted in 2010, adjusted for inflation.
Beginning in fiscal year 2012, FDA will charge a fee of $224 per hour for reinspections and recall activities if no foreign travel is required. If the agency does have to send inspectors outside the United States, the billable rate will be $335 per hour (based on an average cost of more than $11,000 and three weeks time for foreign inspections). The hourly fee will be based on the number of hous spent conducting the reinspections, as well as making preparations and arrangements, traveling to and from the facility, preparing reports, analyzing samples or performing other related activities. For recall activiites, FDA will bill for all direct hours related to issuing a recall, tracking affected food, writing reports and all related activities.
To read the notice in the Federal Register, click here. FDA is accepting comments on the proposed fee, specifically as they apply to small business, and industry members can submit comments here.
