Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005

Resumo

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2005 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), Public Law 108-130, 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 2005. For FY 2005, the animal drug user fee rates are: $119,300 for an animal drug application; $59,650 for a supplemental animal drug application for which safety or effectiveness data is required; $3,085 for an annual product fee; $42,600 for an annual establishment fee; and $32,150 for an annual sponsor fee. FDA will issue invoices for FY 2005 product, establishment and sponsor fees by December 30, 2004, and these invoices will be due and payable by January 31, 2005. The application fee rates are effective for applications submitted on or after October 1, 2004, and will remain in effect through September 30, 2