CDER SBIA Update: Fiscal Year 2017 User Fee Rates

The FDA is announcing the following fee rates for fiscal year (FY) 2017, effective from October 1, 2016 through September 30, 2017:

• Prescription Drug User Fee Rates for Fiscal Year 2017

The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products.

• Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2017

The FD&C Act, as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference.  

• Biosimilar User Fee Rates for Fiscal Year 2017

The FD&C Act, as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application.

• Outsourcing Facility Fee Rates for Fiscal Year 2017

The  Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility.