FDA Announces FSMA Fees for FY2018

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FDA Announces FSMA Fees for FY2018

On August 2, 2017, 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 2018The fees are $248 per hour if domestic travel is required and $285 per hour if foreign travel is required.  The fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

For FY2017 the fees for domestic activities were $221 per hour and for foreign activities $285 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.

Please see this Lieberman PLLC regulatory alert for additional information.  Please contact Erik Lieberman at 202.830.0300 or erl1@liebermanpllc.com if you have questions.

By | 2017-08-04T10:31:16+00:00 August 4th, 2017|Food Safety Modernization Act, FSMA, Reinspection Fees|0 Comments