Table 3 captures the changes in carryover balances from FY 1993.

 

 

 

The balances above reflect cumulative cash at the beginning/end of each fiscal year, and the net cash collected during each fiscal year. The figures do not include accounts receivable. The net collections balance shown above for FY 2010 of $551,734,260 is greater than the FY 2010 cohort year collections balance in Table 1 on page 3 ($529,276,543) because the FY 2010 net collections figure above also includes some FY 2009 product and establishment fees that were counted in the FY 2009 cohort year revenue in the chart on page 3, but are reflected in Table 3 as part of the total collections that occurred in FY 2010. There are also a number of restrictions on the use of these carryover funds, as explained below.

 

 

PDUFA I prohibited FDA from keeping fees in excess of the amount specified in appropriations (collection ceiling) each fiscal year through FY 1997. Amounts collected that exceeded collection ceilings through FY 1997 were required to be refunded.  A total of $6.3 million surplus collections from this period were refunded in FY 2000 and FY 2001.  Under PDUFA II and III, collections in excess of fee amounts appropriated after FY 1997 may be kept and used to reduce fees that would otherwise be assessed in a later fiscal year.  The first such offset (for excess collections in 1998 and 2004) was made when fees were set for FY 2007, as reflected in the table below.  At the time fees were set for FY 2007 (August 2006), there were no excess collections for other years. Collections since then have resulted in additional excess collections. Under the provisions of PDUFA IV, if cumulative collections from FY 2008 through FY 2010 and estimated for FY 2011 exceed cumulative fee appropriations for the same period, FDA will reduce fees when fees are set for FY 2012 by the cumulative amount by which fees collected over this period exceed fees appropriated over the same period. The table below depicts the net collections, the collection amounts specified in appropriations, and the amounts that FDA may have to use to offset future collections.

 

 

 

Table 5 provides a summary of reserves of carryover balances for potential claims on those balances. The first line sets forth the amount collected in excess of appropriations through PDUFA III, which FDA will offset against fees collected when fees are set in a subsequent fiscal year. The second line shows a reserve of $2,500,000 for refunds of fees paid. The third line sets aside funds to be paid from PDUFA fees for the move of CBER components to White Oak in the future. The fourth line shows the cost through 2012 of additional FTEs allocated in 2009 to address increased PDUFA workload. The fifth line shows the amount of all claims/reserved amounts.

 

Total carryover balances exceed limitations and claims by a total of $49,469,639. This amount is available for allocation, or for holding in reserve in FY 2011 against any revenue shortfalls in FY 2011 and FY 2012, or towards operating costs in FY 2013. 

 

PDUFA IV authorizes FDA to have up to 3 months of available carryover balance at the end of FY 2012. FDA currently estimates that it will need a total of $184.3 million in fee revenues ($61.4 million per month) to cover PDUFA operations in the first 3 months of FY 2013. How much of that will have to be added to 2012 fee collections will be determined when fees are set for 2012 in August of 2011.