New fees related to the Food Safety Modernization Act have been announced by the Food and Drug Administration. An Aug. 1 notice in the Federal Register said the fee rates will be effective Oct. 1 and will remain effect through Sept. 30, 2012.
The fees apply to domestic and foreign facility reinspections, failure to comply with a recall order and importer reinspections, according to the notice. The agency said it will accept comments on the fees through Oct. 31 and consider those comments when considering fees for fiscal year 2013.
The FDA said the fees would be billed on at a rate of $224 per hour for direct work of FDA staff, excluding foreign inspection travel costs. The agency plans to charge $335 per hour for direct staff work requiring travel to another country.
According the Federal Register, the food safety act requires that fees account for 100% of the cost of the activities and the revenues generated can only pay for those activities.
The invoice for FDA fees will be sent to the responsible party after the agency completes the work. Payment must be made within 30 days of the invoice date, or the fee shall be considered as a claim of the U.S. government subject to provisions of U.S. code, which allows for reduction of tax refunds and wage garnishment.
FDA recognizes, however, that for some small businesses the cost of reinspection or recall oversight could impose severe economic hardship, and there may be unique circumstances in which some relief would be appropriate.
“Thus, during fiscal year 2012, FDA will consider waiving in limited cases some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.”
According to the notice, Congress directed the FDA to consider the burden of fee amounts on small businesses, including reduced fees. However, according to the Federal Register, the FDA wants to gather more information before establishing those guidelines. There will be no separate small business fee schedule for fiscal year 2012.