FDA has released two Federal Register Notices to establish fee amounts and due dates for applications pending on October 1, 2012 (referred to as backlog applications) and new generic drug submissions received as of October 1.

Please find these notices at:
 

• Generic Drug User Fee—Backlog Fee Rate for Fiscal Year 2013

 

http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26257.pdf?source=govdelivery

 

• Generic Drug User Fee—Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013

 

http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26256.pdf?source=govdelivery