FDA will charge US$221 per hour if no foreign travel is required and US$289 per hour if foreign travel is required. The new rates will take effect on October 1 and will be effective through September 30, 2013. FDA intends to reassess the rates for the fiscal year starting October 1, 2013. The rates for the upcoming fiscal year are lower than present rates charged, which are US$224 per hour is no foreign travel is required and US$325 per hour if foreign travel is required.
The fee structure under the Food Safety Modernization Act represents hourly rates charged by each FDA inspector who participates in any type of billable activity related to a given case. Billable activity includes, but is not limited to, conducting reinspection at a facility, making preparations and arrangements for reinspection, traveling to and from a facility, analyzing records, analyzing samples, preparing reports or examining labels, and performing any other activity deemed necessary to determine compliance with the regulation or statute found to be violated in an initial inspection.
FDA is currently developing a guidance document to outline the process through which small businesses may request a reduction of fees and says that “FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.”