Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009

요약

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 for user fees under the Animal Drug User Fee Act program (ADUFA). The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA I), and the Animal Drug User Fee Amendments of 2008 (ADUFA II), 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 2009. For FY 2009, the animal drug user fee rates are: $246,300 for an animal drug application; $123,150 for a supplemental animal drug application for which safety or effectiveness data is required and for an animal drug application subject to certain criteria; $4,925 for an annual product fee; $59,450 for an annual establishment fee; and $52,700 for an annual sponsor fee. FDA will issue invoices for FY 2009 product, establishment, and sponsor fees by December 31, 2008, and these invoices will be due and payable on or before Jan