On August 1, 2016, the U.S. Food and Drug Administration (FDA) published in the Federal Register the Domestic and Foreign Facility Reinspection, Recall and Importer Reinspection Fee Rates for Fiscal Year 2017. The fees are $221 per hour if domestic travel is required and $285 per hour if foreign travel is required. The fees are effective on October 1, 2016, and will remain in effect through September 30, 2017. Please see this Lieberman PLLC Regulatory Alert for additional details.
For FY2016 the fees for domestic reinspections were $221 per hour and for foreign reinspections $315 per hour.
Section 107 of FSMA added section 743 (21 USC 379j-31) to the Federal Food, Drug and Cosmetic Act (FDCA) to provide FDA with the authority to assess and collect fees from in part: (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection to cover reinspection related-costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection related costs.
For more information, please contact Erik Lieberman at erl1@liebermanpllc.com or 202.830.0300.
