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Carryover Balances

Back to Table of Contents:  FY 2009 PDUFA Financial Report

Under PDUFA, fees collected and appropriated but not obligated by the end of a fiscal year continue to remain available to FDA in future fiscal years.  These revenues are referred to as carryover balances.  The net result of operations in FY 2009 increased the carryover balances by $6,941,251.  Much of this increase was the result of receiving additional FY 2008 fees in the first quarter of FY 2009.

The table below captures the changes in carryover balances from FY 1993.
 

FOOD AND DRUG ADMINISTRATION
STATEMENT OF COLLECTIONS, OBLIGATIONS, AND
CARRYOVER BALANCES BY FISCAL YEAR
As of the end of each fiscal year shown
and not including payments for next fiscal year

Fiscal
Year

Beginning
Carryover

Net
Collections

Fee Revenue
Obligations

Year-End
Carryover

1993

-

$28,531,996

$8,949,000

$19,582,996

1994

$19,582,996

$53,730,244

$39,951,020

$33,362,220

1995

$33,362,220

$70,953,500

$74,064,015

$30,251,705

1996

$30,251,705

$82,318,400

$85,053,030

$27,517,075

1997

$27,517,075

    $93,234,125

$84,289,046

$36,462,154

1998

$36,462,154

$132,671,143

$101,615,000

$67,518,297

1999

$67,518,297

$126,580,456

$122,515,000

$71,583,753

2000

$71,583,753

$133,060,339

$147,276,000

$57,368,092

2001

$57,368,092

$138,761,294

$160,713,000

$35,416,386

2002

$35,416,386

$149,078,939

$161,812,100

$22,683,225

2003

$22,683,224

$209,667,051

$200,154,500

$32,159,776

2004

$32,195,776

$251,617,821

$232,081,500

$51,732,097

2005

$51,732,097

$283,491,495

$269,433,800

$65,789,792

2006

$65,789,792

$315,502,786

$305,644,137

$75,648,440

2007

$75,648,440

$375,597,273

$320,429,620

$130,816,093

2008

$130,816,093

$485,165,229

$450,786,835

$165,194,487

2009

$165,194,487

$518,992,651

$512,051,400

$172,135,738

2010

$172,135,738

-

-

-

 

The balances above reflect cumulative cash at the beginning/end of each fiscal year, and the net cash collected during each fiscal year for all cohort years, but do not reflect any cash received for future fiscal year cohorts.  The figures do not include accounts receivable.  The net collections balance shown above for FY 2009 of $518,992,651 is greater than the FY 2009 cohort year collections balance on page three ($513,236,152).  This is because the FY 2009 net collections figure above also includes some prior years’ receivables that FDA collected in FY 2009. 

There are also a number of claims on these carryover funds, as explained on the following page.  
 

COLLECTION CEILINGS, POTENTIAL REFUNDS AND OFFSETS


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 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 following table depicts the net collections, the collection amounts specified in appropriations, and the amounts that FDA may have to use to offset future collections in FY 2012.

FOOD AND DRUG ADMINISTRATION
STATEMENT OF FEES COLLECTED, COLLECTION CEILINGS, AND POTENTIAL REFUNDS
As of September 30, 2009

Fiscal YearCollections
 Realized
Collection
Ceiling
Potential Offset to Future Collections
1998$117,849,016$117,122,000$727,016
1999$125,729,367$132,273,000-
2000$141,134,682$145,434,000-
2001$138,421,429$149,273,000-
2002$141,408,975$161,716,000-
2003$218,302,684$222,900,000-
2004$258,333,700$249,825,000$8,508,700
2005$287,178,231$284,394,000$2,784,231
2006$313,659,988$305,332,000$8,327,988
2007$370,934,966$352,200,000$18,734,966
2008$480,285,876$459,412,000$20,873,876
2009$513,236,152$510,665,000$2,571,152
Total:$62,527,929
Amount offset when fees for FY 2007 were set$7,957,922
Balance remaining to be offset when FY 2012 fees are set$54,570,007


RESERVE FOR REFUNDS AND OFFSET FOR FUTURE COLLECTIONS


Total fees collected exceeded the appropriations limit in FY 1998, and in FY 2004 through FY 2009, by the amounts shown in the table above, $62,527,929.   Beginning with PDUFA IV (FY 2008), if fees collected are less than fees appropriated in any year, the amount less than the amount appropriated is to be treated as a reduction in cumulative appropriations.  When FDA set fees for FY 2007 in August 2006, the amount of fees established for FY 2007 was offset by $7,957,922 of collections in excess of appropriations.  A total of $54,570,007 remains to be offset.  Under PDUFA IV, an offset will be made at the time when fees are set for FY 2012 for the cumulative amount of excess collections through FY 2010 and projected through FY 2011.  In the meantime, this $54,570,007 must be held in reserve for an offset in FY 2012, unless collections in the years from FY 2009 through FY 2011 should fall below amounts appropriated for user fees in those years.  The amount to be held in reserve for future offset will be recalculated in the annual financial report each year.

 

OTHER RESERVES AND BALANCE AVAILABLE FOR ALLOCATION


The table below provides a summary of carryover balances as of September 30, 2009, and anticipated claims on those balances.  The first line shows a reserve of $2,500,000 for refunds of fees paid.  The second line sets forth the amount collected in excess of appropriations through FY 2010, which FDA may have to use as an offset against fees collected in excess of appropriations when fees for FY 2012 are established in August 2011.  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 FTE allocated in 2009 to cope with increased PDUFA workload.  The fifth line shows the amount of carryover balances available for allocation after these four set-asides.

Due to a change in PDUFA requiring establishment and product fees to be paid for FY 2003 and subsequent years by the first of the fiscal year, FDA no longer needs to have a 3-month reserve for future operations at the end of each fiscal year—at least until the end of FY 2012. FDA currently estimates that it will need to obligate about $64.2 million per month in FY 2013 to sustain FY 2012 operations. The carryover amount shown as available for allocation in the table below ($33,686,731) is enough to fund estimated FY 2013 operations for approximately 0.5 months.


FOOD AND DRUG ADMINISTRATION
SUMMARY STATEMENT OF CARRYOVER BALANCE
As of September 30, 2009

 

 Status of Carryover FundsAmount
Reserve for Refunds$2,500,000
Reserve for Future Collection Offset$54,570,007
Reserve for CBER move to White Oak$37,896,000
Allocation of Additional 53 FTE, FY 2010-2012$43,483,000
Available for Allocation$33,686,731
TOTAL Carryover Balance$172,135,738
 

Next Section:  Total Costs of the Process for the Review of Human Drug Applications