The US Food and Drug Administration (US FDA) has now issued the order for the rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013.
The total fee revenue amount for FY 2013 is $299,000,000, as set in the statute section 744B(b)(1)(A) of the FD&C Act. Under that provision, FDA uses the yearly revenue amount as a starting point to set the fees. The GDUFA statute states that the backlog fee will make up $50,000,000 of the total revenue collected for FY 2013 in section 744B(b)(1)(A)(i) of the FD&C Act. The information collection is scheduled to expire on November 30, 2012.
According to the notice titled Vol. 77, No. 207 issued on October 25, 2012 , the Federal Food, Drug, and Cosmetic 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 associated with human generic drug products. The order is related for applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on type II API drug master files (DMFs) to be made available for reference.
GDUFA directs FDA to establish each year the Generic Drug User Fee rates for the upcoming year. In the first year of GDUFA which is FY 2013, some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY. The document stabilizes the FY 2013 rate for the backlog fee is $17,434 which is effective on October 1, 2012.
To make payment of the backlog fee, the pharma industry should complete a generic drug user fee cover sheet, available on the FDA website to generate a user fee payment identification (ID) number. Payment must be made in US currency drawn on a US bank by electronic check, check, bank draft, US postal money order or wire transfer.
In this regard, the regulatory authority has now partnered with the US Department of the Treasury to utilize Pay.gov, a web-based payment application, for online electronic payment..
The Abbreviated New Drug Application (ANDA) and Prior Approval Supplement ( PAS) fees will make up 24 per cent of the $249,000,000, which is $59,760,000.In order to calculate the ANDA fee, FDA needed to estimate the number of full application equivalents (FAEs) that will be submitted in FY 2013. Over the past 4 years, the average number of ANDAs that would have been subject to the fee was approximately 850. This is because the number of prior approval supplements submitted in FY 2012 is significantly lower than the number submitted in the 2 previous years, FDA has utilized available data concerning FY 2012 to estimate the number of such supplements for FY 2013. The estimated number of PASs to be received in FY 2013 is 576 based on an annualized estimate of the number of receipts for FY 2012, according to the regulatory authority.