FDA Extends Comment Period on $224/Hr Fees to Release Detained Food, Etc.
In response to requests, the Food and Drug Administration is extending the comment period to November 30, 2011 (from October 31, 2011) on its August notice announcing the fiscal year 2012 $224-$325 hourly fees on the food and feed industry for FDA (i) import reinspection activities (including addressing requests to remove a product from an Import Alert, to release detained articles, etc.1); (ii) facility reinspections; and (iii) recall activities resulting from a firm's non-compliance with a food recall order.
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(Fees for these three types of activities were authorized by the Food Safety Modernization Act. In August, FDA announced the FY 2012 fee rates of $224/hour (or $325/hour if foreign travel is required) and described the circumstances in which they would be applied. See ITT’s Online Archives 11080114, 11091514 and 11092922 for summaries and reminders on the fees.)
Facility Reinspection & Recall Fees Began Oct 1, Import Reinspection Fees Were Delayed
Note that these high hourly fees went into effect on October 1, 2011 as originally announced for FDA facility reinspections and recall activities described under (ii) and (iii) above, but FDA has since delayed the fees for its import reinspection activities described in (i). When FDA announced the delay, it stated that there are particular complexities associated with its import reinspection activities, and it was still reviewing comments on the issue.
(See ITT’s Online Archives 11100412 for summary of the partial delay.)
Seeks Comments on FY 2012 Fees, Will Consider in Implementing FY 2013 Fees
FDA seeks comments on the establishment of all of these FY 2012 fees and intends to consider these comments, as well as experience and additional data gained in implementing the user fees in FY 2012, in establishing the fee rates for FY 2013.
(FDA also extended the comment period until November 30, 2011 on its request for comments on the burden of these FY 2012 fees on small businesses. See ITT’s Online Archives 11101814 for summary of this extension.)
1FDA stated in its notice announcing the fees that the import reinspection fees would apply in “at least” the following four situations (with certain exceptions) if non-compliance materially related to food safety results in FDA activities to address: (1) reconditioning requests; (2) requests for admission of detained articles; (3) requests to remove a product from Import Alert; and (4) requests for destruction.
FDA contact - Amy Waltrip Amy.Waltrip@fda.hhs.gov
(FR Pub 10/27/11, D/N FDA-2011-N-0528)