FDA Extends Comment Date on Burden of FSMA $224/Hr Fees on Small Business
In response to requests, the Food and Drug Administration is extending the comment period until November 30, 2011 (from October 17) regarding its recent request for comments on the burden to small businesses of the Food Safety Modernization Act fee amounts of $224/$325 per hour for certain FDA activities. FDA is interested in obtaining comments to help in its preparation of a proposed set of guidelines on the burden of fee amounts on small business.
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Seeks Info on Appropriateness of Reduced Fees, Definition of Small Business
In particular, FDA is seeking comments on whether a reduction of fees or other considerations for small business is appropriate, and if so, what factors it should consider for each. In addition, FDA requests comment on how small business should be defined or recognized.
(In 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 other hourly fees under (ii) and (iii). See ITT's Online Archives 11100412 for summary of the delay.)
(See ITT's Online Archives 11072933 for summary of FDA's original request for comments.
See ITT's Online Archives 11081712 for summary of FDA stating it would issue guidance on FSMA food safety rules for small business.)