Reserves and Balance Available for Allocation: FY 2011 AGDUFA Financial Report

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Table 5 provides a summary of carryover balances as of September 30, 2011, and anticipated claims on those balances.  

The only claim on the carryover balance is $100,000 for prudent operations that require a reserve be kept aside for potential refunds.  That leaves a total of $2,627,350 available for allocation.  This amount will fund about five and a half months of estimated FY 2012 operations from user fee revenues.

AGDUFA authorizes FDA to have up to three months of available carryover balance at the end of FY 2013. FDA will estimate the amount of carryover balance it expects to have available for obligation in August of 2012, when fees are set for FY 2013. FDA will also estimate the amount of AGDUFA fee revenues needed to sustain operations at FY 2013 levels for the first three months of FY 2014. If carryover balances are less than the amount FDA needs to fund three months of operations in 2014, FDA may add up to the full shortfall amount to the fee revenues when fees for FY 2013 are set in August 2012. 

Table 5
Summary Statement of Generic Animal Drug User Fee
Carryover Balance
as of September 30, 2011

Next Section: Total Cost of the Process for the Review of Abbreviated Applications for Generic New Animal Drugs – FY 2011 AGDUFA Financial Report