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FDA Seeks Comments on New Guidance Document on Reinspection and Recall Fee Reductions

Thursday, November 24, 2011
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is seeking comments by Dec. 15 on a new guidance document that outlines the criteria and process through which firms may request a reduction 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. FDA has requested emergency processing of this proposed information collection to be able to issue such guidance no later than Jan. 2012. FDA indicates that it needs to publish this guidance as soon as possible in order to issue invoices and provide important information for qualified firms to apply for fee reductions, which will help them to sustain their businesses.

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