Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2018

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2018 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2018.