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Animal Drug User Fee Policies for Fiscal Year 2017 (August 2016)

The Food and Drug Administration (FDA) is issuing new animal drug user fee policies for the 2017 fiscal year. The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to adjust fees, which are modified to account for inflation and workload changes. The Federal Register posted a notice specifying the following types of user drug fees listed under Section 740 of the FD&C Act, the breakdown of each component’s contribution to the total fee revenue and their respective rates. A summary of fees for the 2017 fiscal year are illustrated in the table below:

Types of Fees Drug User Fee Rates
Animal drug application and supplemental application fee $350,700 (application) + $175,350 (supplemental application)
Annual product fee $8,195
Annual establishment fee $111,900
Annual sponsor fee $103,100

Invoices for product, establishment and sponsor fees for the 2017 fiscal year will be distributed on December 31, 2016 and must be paid by January 1, 2017. Fee rates for applications apply to those submitted on and after October 1, 2016. The FDA will not review applications until payments have been fulfilled.

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