FDA Notice on Info Collection on FSMA Hardship Fee Reductions
The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) concerning a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
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Written comments are due within 20 days of November 25, 2011.
(Note that above information is a short transcription from the opening paragraph of the FDA's notice. A detailed ITT summary will follow once certain questions regarding the notice are answered by FDA officials.)