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

Streszczenie

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