August 1, 2012
The Food and Drug Administration (FDA) announced rates and payment procedures for fiscal year FY 2013 animal drug user fees in a notice published in the August 1, 2012, Federal Register. 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 2013, the fee is $435,200 per application for an animal drug application and $217,600 for a supplemental animal drug application which requires safety or effectiveness data. The annual product fee is $8,640, the annual establishment fee is $104,600, and the annual sponsor fee is $87,700. FDA will issue invoices for FY 2013 product, establishment, and sponsor fees by December 31, 2012. Payment will be due 30 days from the date of the invoice. FDA will not accept an application for filing unless the sponsor has paid all fees required.
The notice also provides procedures to animal drug sponsors for paying FY 2013 fees. The application fee rates are effective for applications received by FDA’s Center for Veterinary Medicine (CVM) from October 1, 2012, until September 30, 2013.
For more information, contact Lisa Kable, CVM (HFV-10), FDA, 7529 Standish Place, Rockville, MD 20855, 240-276-9718. General inquiries can be sent to email@example.com.