FDA Issues Fee Rates Under Food Safety and Modernization Act for Domestic and Foreign Facility Reinspections, Failure to Comply with Recalls, and Importer Reinspection

The Food Safety and Modernization Act (FSMA) provides that the U.S. Food and Drug Administration (FDA) assess fees for certain domestic and foreign facility reinspections, failure to comply with recall orders, and importer reinspections. On August 1, 2011, the FDA announced these fees for fiscal year 2012 (effective October 1, 2011, through and including September 30, 2012). FDA is accepting comments related to implementing the user fees for fiscal year 2013, as well as comments related to the effect of the user fees on small businesses. The fees are based on an hourly rate of $225 (domestic) and $335 per hour (if foreign travel is required). FDA will assess fees in the following circumstances:

  • Reinspection under section 704 of the federal Food, Drug, and Cosmetic Act (FDCA) to determine if a corrective action has been implemented following a final classification of Official Action Indicated (OAI) after an inspection conducted by or on behalf of the FDA, if the FDA determines that noncompliance was "materially related to food safety requirements." In the case of both domestic and foreign facilities, the fees would be assessed upon a "reinspection": an inspection conducted under section 704 subsequent to the inspection that identified the material noncompliance.
  • The FDA will assess the fees on an hourly basis for noncompliance with the recall order, including:
    • Not issuing the recall as ordered by the FDA;
    • Not conducting the recall in the manner specified by the FDA; and
    • Not providing FDA with information regarding the recall.
  • Reinspection / reexamination under section 743(a)(1)(D) of the FDCA related to imported food in at least the following situations:
    • Reconditioning of imported food;
    • When the importer seeks admission of an article that has been detained;
    • Instances where the importer requests removal from an importer log for detention without physical examination; and
    • Destruction of food after it has been refused admission.
  • There are certain exceptions to each of the above-described situations in which the FDA has indicated it may not assess a user fee.

For Further Information

If you have any questions concerning this Alert, please contact Frederick R. Ball, any other lawyer in the Pharmaceutical, Pharmacy & Food industry group or the attorney in the firm with whom you are regularly in contact.

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