FDA May Reduce $224/Hr FSMA Fees for Severe Hardship, Etc.
The Food and Drug Administration is requesting comments on a proposed information collection regarding a guidance document on company requests, in cases of severe economic hardship or unique circumstances, to reduce the $224-$325 hourly fees for FDA reinspection and recall activities that are mandated by the Food Safety Modernization Act (FSMA).
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(Note that only two of the three FSMA-mandated user fees1 are currently being assessed, and FDA is delaying invoicing for all of the fees until January 2012, while it works on certain guidance documents.)
Comments are due by December 15, 2011.
Seeks Expedited Approval of Info Collection to Facilitate Reductions in FY 2012
FDA is asking the Office of Management and Budget to approve the proposed information collection by January 6, 2012 on an expedited basis so that it can consider waiving, during fiscal year (FY) 2012 (October 1, 2011 -- September 30, 2012), some or all of an invoiced fee based on a severe economic hardship or unique circumstances in which some relief would be appropriate.
Estimates 235 Small Businesses Would Seek Fee Reductions
According to FDA estimates, 510 facilities will be subject to the FSMA fees annually. Of these, FDA estimates that 46% (or 235 firms) will be small businesses with annual gross sales under $250,000. If each of the 235 firms submits one request for a reduction of fees with an average burden of two hours, the total annual burden hours would be 470.
Requests Comments on Info Collection, Ways to Minimize Its Burden, Etc.
FDA seeks comments on (1) whether the proposed collection of information in the guidelines is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Working on Separate Guides for Small Business & Economic Hardship
FDA explains that it is currently developing two related documents on these FSMA fees. One is a proposed set of guidelines on the burden of the fees on small business, which may include proposed fee reductions. However, any such fee reductions for small business would be subject to rulemaking, which would mean that they would likely only be implemented in FY 2013. (See ITT’s Online Archives 11072933 and 11101814 for summaries of FDA seeking comment for these guidelines.)
FDA recognizes that, meanwhile, for some small businesses the reinspection or the recall user fees could impose severe economic hardship, and there may be unique circumstances in which some relief would be appropriate. Therefore, it is also working on a guidance, which will outline the criteria and the process through which firms may request a reduction of fees based on severe economic hardship during FY 2012.
Considers "Hardship" Relief Temporary until Establishes Small Business Fee Reductions
FDA sources state that they consider this relief an interim measure until FDA establishes more permanent procedures and guidelines for granting fee reductions for small business. (Note that this summary has been updated since publication to add this updated information.)
1In August, FDA announced the FSMA FY 2012 fee rates of $224/hour (or $325/hour if foreign travel is required) that would be applied starting October 1, 2011 for its (i) food/feed import reinspection activities (including addressing requests to remove a product from an Import Alert, to release detained articles, etc.); (ii) food facility reinspections; and (iii) FDA recall activities resulting from a firm's non-compliance with a food recall order. (See ITT’s Online Archives 11080114, 11091514 and 11092922 for summaries and reminders on the fees.)
FDA later announced that it was delaying the hourly fees for the import reinspection activities laid out in (i) above but moving forward with the fees under (ii) and (iii). FDA also announced that it would not issue invoices for any of the fees until January 2012. (See ITT's Online Archives 11100412 for summary.)
(See ITT’s Online Archives 11112329 for previous ITT summary announcing this information collection.)
FDA contact - Denver Presley (301) 796-3793
(FR Pub 11/25/11, D/N FDA-2011-N-0841)