Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2007

Resumo

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2007 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2007. For FY 2007, the animal drug user fee rates are: $168,600 for an animal drug application; $84,300 for a supplemental animal drug application for which safety or effectiveness data is required; $4,115 for an annual product fee; $51,350 for an annual establishment fee; and $44,850 for an annual sponsor fee. FDA will issue invoices for FY 2007 product, establishment, and sponsor fees by December 30, 2006, and these invoices will be due and payable by January 31, 2007. The application fee rates are effective for applications submitted on or after October 1, 2006, and will remain in effect through September 30, 2007. Applications w