FDA Hikes User Fees

NEWS TRENDS

User fee rates for fiscal year 2010 have increased by 8.5%, according to an August 3 notice in the Federal Register. The standard fee for a premarket application is $217,877.

The fiscal year fees, which run from October 1, 2009, through September 30, 2010, include the following:
•Panel-track supplement, $163,340.•Real-time supplement, $15,245.•510(k) premarket notification submission, $4007.•513(g) (21 USC 360c(g)) request for classification information, $2940.•Annual establishment registration fee, $2008.
Businesses with gross receipts or sales of no more than $100 million for the most recent tax year can qualify for reduced small business user fee rates ranging from 25 to 50% of the standard user fee.
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