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:
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