Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures

概要

The Food and Drug Administration (FDA) is announcing the rates for application fees for fiscal year (FY) 2004 and payment procedures for those 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 document establishes the application fee rates for FY 2004. A separate document will be published in the Federal Register establishing fee rates and payment procedures for annual product, establishment, and sponsor fees for FY 2004. The application fee rates are $61,000 for an animal drug application and $30,500 for a supplemental animal drug application for which safety or effectiveness data are required. (In this document, supplemental animal drug applications are referred to as "supplements"; animal drug applications and supplemental animal drug applications are collectively referred to as "applications".) These rates are effective for