Please note that the balances in Table 3 reflect the cumulative cash from the beginning to the end of each fiscal year, and net cash collected during each fiscal year for all cohort years. The numbers do not include any accounts receivable. Therefore these numbers for FY 2009 and FY 2010 are different from the numbers on page 3, which reflect total net collections for the cohort years only.

 

 

Under ADUFA II, if cumulative collections through FY 2011, including an estimate for FY 2012, exceed the fee revenue amounts specified in the Appropriations Acts for that period, FDA will reduce the fee rates for FY 2013 by the cumulative amount that fees exceeded the appropriations during that period. The beginning total for the offset includes any remaining ADUFA I collections that were collected after the final adjustment was made when fees were set for FY 2010. Table 4 depicts FY 2010 fee collections realized (the same as Total Collections in the table on page 3), collection ceilings specified in the Appropriations Act, and amounts that must be set aside to be used to offset future collections.

 

 

 

As discussed earlier on page 3, previous cohort year collections realized in FY 2009 have been updated from last year’s report. The update reflects net collections for each cohort year through September 30, 2010. Any and all cohort year fees collected subsequent to September 30, 2010 will be reported in the FY 2011 financial report.

 

Table 5 provides a summary of carryover balances as of September 30, 2010, and anticipated claims on those balances.

 

The first anticipated claim is the reserve for future offsets of $394,256 shown above. In addition, prudent operations require that a reserve be kept aside for other potential refunds. For that purpose a total of $500,000 is being set aside. That leaves a total of $2,334,181 available for allocation. This amount will fund about 1.4 months of estimated FY 2011 operations from user fee revenue.