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PDUFA IV Five-Year Financial Plan - 2009 Update: CDER Plan Summary Tables

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PDUFA IV Five-Year Financial Plan - 2009 Update
CDER Plan Summary Tables - PDUFA IV
Plan for Funds from PDUFA Fee Revenues ($000)

Note: Numbers Are Rounded and May Not Add

Category2008 Plan2009 Plan 2010 Plan2011 Plan2012 Plan5-Year Total
Inflation Adjustment Estimate
Annual Inflation Estimate 5.60%5.60%5.60%5.60% 
Cummulative Inflation Estimate 5.60%11.51%17.76%24.35% 
Estimated Inflation Adjustor 105.60%111.51%117.76%124.35% 
PDUFA III Additive Base
PDUFA III Additive Base Staff Years1,0651065106510651065 
Share of unallocated FTE1717171717 
Share of Increase for Meeting Workload (87 total)6666666666 
Share of Increase for Workload Adjustment (180)137137137137137 
Total PDUFA IV Base FTE12851285128512851285 
Payroll for PDUFA III Staff Years$154,299$162,939$172,064$181,700$191,875 
Operating Support for PDUFA III Base$27,762$29,316$30,958$32,692$34,522 
Risk Management Contracts 1$5,374$5,675$5,992$6,328$6,682 
   Subtotal$187,434$197,930$209,014$220,719$233,079 
Base Additions for PDUFA IV
Share of Unallocated FTE$3,007$3,176$3,354$3,541$3,740 
Share of Increase for Meeting Workload $11,675$12,329$13,020$13,749$14,519 
Share of Increase for Workload Adjustment$24,235$25,592$27,026$28,539$30,137 
     Subtotal$38,918$41,097$43,399$45,829$48,396 
Subtotal--PFUFA IV Base$226,352 $239,027 $252,413 $266,549 $281,475 $1,265,816
PDUFA IV Enhancements Over PDUFA III
Critical Path Increase$3,753 $3,964 $4,186 $4,420 $4,667 $20,990
Additional Staff Years1919191919 
Payroll for Additional Staff Years $2,761$2,915$3,079$3,251$3,433$15,439
Operating Support  $993$1,048$1,107$1,169$1,234$5,551
Drug Safety/Risk Management Increase$20,384 $21,525 $22,731 $24,004 $25,348 $113,991
Additional Staff Years7373737373 
Payroll for Additional Staff Years $11,378$12,015$12,688$13,399$14,149$63,630
Operating Support  $3,056$3,227$3,407$3,598$3,800$17,087
Contract Support $5,950$6,283$6,635$7,007$7,399$33,274
IT Increase$0 $0 $0 $0 $0 $0
Additional Staff Years      
Payroll for Additional Staff Years      $0
Operating Support       $0
Contract Support      $0
Additional Drug Safety Increase$17,720 $26,974 $37,208 $48,585 $61,094 $191,581
Additional Staff Years6895122149176 
Payroll for Additional Staff Years $9,890$14,566$19,736$25,438$31,717$101,347
Operating Support  $2,749$3,800$4,959$6,237$7,642$25,387
Contract Support$5,081$8,608$12,513$16,910$21,735 
Workload Adjustment Addition$0 $9,052 $22,900 $37,079 $53,216 $122,247
Additional Staff Years 46111170232 
Payroll for Additional Staff Years  $7,374$18,790$30,389$43,794$100,346
Operating Support   $1,678$4,111$6,690$9,422$21,901
Contract Support      
Subtotal of PDUFA III Additional Staff Years161233325411500 
Subtotal PDUFA IV Enhancements$41,857 $61,515 $87,025 $114,088 $144,325 $448,809
Total PDUFA Additive Funds--CDER$268,209 $300,542 $339,437 $380,636 $425,800 $1,714,625
Total PDUFA Additive Staff Years--CDER1,446 1,519 1,611 1,696 1,785  

1 Risk Management Contract support for both CDER and CBER is included in the CDER plan. CDER is managing these funds for both centers. 

Next Section: CBER Plan Summary