USA - FDA Announces FY 2011 Animal Drug User Fees

The Food and Drug Administration is publishing a notice in the Federal Register on August 3, 2010, announcing the rates and payment procedures for animal drug user fees for fiscal year (FY) 2011. The Animal Drug User Fee Amendments of 2008 (ADUFA II) reauthorizes FDA to collect user fees for certain animal drug applications, products, establishments, sponsors and investigational animal drug submissions.

For FY 2011, the fee is $316,200 per application for an animal drug application and $158,100 for a supplemental animal drug application, which requires safety or effectiveness data. The annual product fee is $7,235, the annual establishment fee is $83,100, and the annual sponsor fee is $64,000. FDA will issue invoices for FY 2011 product, establishment, and sponsor fees by December 31, 2010, and the fees will be due 30 days from the issuance of the invoice. FDA will not accept an application for filing unless the sponsor has paid all the fees it owes.

The notice also provides instructions for paying the FY 2011 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine from October 1, 2010 to September 30, 2011.

For more information, contact Lisa Kable at 1.240-276-9718. For general ADUFA questions, contact cvmadufa@fda.hhs.gov.