User Fee Rates for FY 2009 Announced

Rockville, MD (Aug. 7)-The US Food and Drug Administration released its user fee rates for fiscal year (FY) 2009 last Friday. The new fees take effect Oct. 1, 2008, and remain in effect through Sept. 30, 2009.

FDA derives its authority to issue user fees from the Federal Food, Drug, and Cosmetic Act, and the Prescription Drug User Fee Amendments of 2007 (PDUFA IV). Below is a list of the new fees:

• Application fees requiring clinical data: $1,247,200

• Application fees not requiring clinical data: $623,600

• Establishment fees: $425,600

• Product fees: $71,520.

FDA estimates that there will be 25 establishment fee waivers in FY 2008 and probably another 10 in FY 2009 tied to orphan drugs per the Food and Drug Administration Amendments Act of 2007. The agency estimates there will be approximately 70 waivers, including exemptions tied to orphan drugs, for product fees in FY 2009 as there were in FY 2008.

The total fee revenue amount for FY 2009 is $510,665,000, including $35 million for drug safety compared with FY 2008 drug-safety fees of $25 million.

The new fee information is detailed in the Aug. 1 Federal Register, Docket No. FDA-2008-N-04271.