The Food and Drug Administration (FDA) announced today, August 1, the fiscal year (FY) 2014 fee rates for domestic and foreign facility re-inspections, failures to comply with a recall order, and importer re-inspections authorized by the Food Safety Modernization Act (FSMA, Public Law 111-353).
Specifically, Section 107 of FSMA added section 743 to the Food Drug & Cosmetic Act (FD&C Act, 21 U.S.C. 379j-31) providing FDA with the authority to assess and collect fees from:
1. The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a re-inspection, to cover re-inspection-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 re-inspection to cover re-inspection-related costs.
Section 743 of the FD&C Act directs FDA to establish fees for each of these activities and is based on an estimate of 100 percent of the costs of each activity for each year. These fees must be made available solely to pay for the costs of each activity for which the fee was incurred.
FSMA Fee Schedule for FY 2014
|Fee Category||Fee Rates for FY 2014|
|Hourly rate if domestic travel is required||
|Hourly rate if foreign travel is required||
These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.
Fees will be assessed for a re-inspection conducted to determine whether corrective actions have been implemented and are effective and in compliance at the discretion of the Secretary of Health and Human Services. Such re-inspections will occur at a facility that manufactures, processes, packs or holds food for consumption in which, as a result of a previous inspection, a final classification of Official Action Indicated (OAI) was determined by FDA.
In FY 2014, FDA is estimated to increase collection of total user fees by 61.5%, from $1.3 billion to $2.1 billion. FDA’s FY 2013 enacted budget level was $2.466 billion.
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