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U.S. Department of Health and Human Services

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PDUFA II Fee and Revenue Estimation Worksheet - FY 2001 Update

 

Actual Amounts Collected as of 9/30/00 shown for FY 1998, FY 1999 and FY 2000
Forecast for 2001 and 2002 based Regression Analysis Trendline of Submissions from FY 1993 through FY 2000
Fiscal Year 1998 Actual3 1999 Actual3 2000 Actual3 2001 Estimate 2002 Estimate
Statutory Full Application Fee $250,704 $256,338 $256,338 $267,606 $258,451
Cumulative Inflation Percentage since 19971 2.45% 6.22% 11.47% 15.71% 20.00%
Fee per Full Application, after Inflation $256,846 $272,282 $285,740 $309,647 $310,130
Estimated Equivalent of Full Applications 2 119 151 153.5 163.6 171
Est. Total Application Fee Revenue
After Accounting for Waivers
$30,493,387 $38,636,530 $48,066,442 $50,658,249 $53,032,278
Est. Total Product Fee Revenue $41,513,476 $41,833,192 $43,829,964 $50,658,249 $53,032,278
Estimated # of Products 2225 2134 2262 2314 2314
Product Fee $18,459 $18,364 $19,959 $21,892 $22,918
Est. Total Establishment Fee Revenue $45,439,914 $41,541,794 $45,802,541 $50,658,249 $53,032,278
Estimated # of Establishments 320 315 318 347 347
Establishment Fee $141,966 $128,435 $137,928 $145,989 $152,831
Estimate of Total Revenue $117,122,000 4 $122,011,516 $137,698,947 $149,273,0005 $159,096,835
        Five-Year Total: $685,202,298
1 Based on increases of 2.45% in 1998, 3.68% in 1999, 4.94% in 2000, 3.81% in 2001,and estimated at 3.7% for FY 2002.
2 Number after allowing for Exemptions and Waivers--FY 2001 and FY 2002 Estimates Based on Latest Trendline.
3 Actual Figures are as of 9/30/1999 and will be adjusted by both accounts receivable collected and waivers granted.
4 Actual Total for FY 1998 is $117,446,776. The amount shown as the total is the amount appropriated from fees in
FY 1998. Fees collected in excess of $117,122,000, after all appeals and waivers are decided, will be used to offset collections in a later year.
5 The President’s FY 2001 Budget estimates $149,273,000 million; but data available after that budget was submitted indicate that
about a higher amount will be collected in FY 2001. A supplemental budget request supporting this larger amount is under discussion.