The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD Act), as amended by the Prescription Drug User Fee Amendments of 2012 (Title 1 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-144, which was signed by the President on July 9, 2012) (PDUFA V)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments.
Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2013 for application fees for an application requiring clinical data ($1,958,800), for an application not requiring clinical data or a supplement requiring clinical data ($979,400), for establishment fees ($526,500), and for product fees ($98,380). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. For applications and supplements that are submitted on or after October 1, 2012, the new fee schedule must be used. Invoices for establishment and product fees for FY 2013 will be issued in August 2012 using the new fee.
To access the full notice at the Federal Register, click here.