LexisNexis® CLE On-Demand features premium content from partners like American Law Institute Continuing Legal Education and Pozner & Dodd. Choose from a broad listing of topics suited for law firms, corporate legal departments, and government entities. Individual courses and subscriptions available.
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:
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.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, or should be construed, as legal advice. For more information, please see the firm's full disclaimer.
For more information about LexisNexis products and solutions connect with us through our corporate site.