Establishment of Animal Drug User Fee Rates and Payment Procedures for Product, Establishment, and Sponsor Fees for Fiscal Year 2004

Resumo

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for product, establishment, and sponsor fees for fiscal year (FY) 2004. 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 product, establishment, and sponsor fee rates for FY 2004. A separate notice was published establishing fee rates and payment procedures for animal drug application fees for FY 2004. For FY 2004, the product fee rate is $1,750, the establishment fee rate is $23,950, and the sponsor fee rate is $15,450. FDA will issue invoices for FY 2004 product, establishment, and sponsor fees on or about May 1, 2004. Those invoices will be due and payable within 30 days of the date of the invoice.