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PDUFA IV 5-Year Financial Plan (2008): CDER Plan Summary Tables

Table of Contents

CDER Plan Summary

Plan For Funds From PDUFA Fee Revenues ($000)

Numbers are rounded and may not add correctly

Category 2008 Plan 2009 Plan 2010 Plan 2011 Plan 2012 Plan 5-Year Total
Inflation Adjustment Estimate            
Annual Inflation Estimate   5.60% 5.60% 5.60% 5.60%  
Cumulative 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 Years 1,065 1,065 1,065 1,065 1,065  
Share of Unallocated FTE   17 17 17 17  
Share of Increase for Meeting Workload(87 total)   66 66 66 66  
Share of Increase for Workload Adjustment(180 total) 137 137 137 137 137  
Total PDUFA IV Base FTE 1285 1285 1285 1285 1285  
Payroll for PDYFA III Staff Years $154,299 $162,939 $172,064 $181,700 $191,875  
Operating Support for PDUFA Base $27,762 $29,316 $30,958 $32,692 $34,522  
Risk Management Contracts $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-PDUFA IV Base $226,352 $239,027 $252,405 $266,552 $281,469 $1,265,805
PDUFA IV Enhancments Over PDUFA III
Critical Path Increase $3,753 $3,964 $4,185 $4,420 $4,667 $20,990
Additional Staff Years 19 19 19 19 19  
Payroll for Additional Staff Years $2,761 $2,915 $3,078 $3,251 $3,433 $15,438
Operating Support $993 $1,048 $1,107 $1,169 $1,234 $5,551
Drug Safety/Risk Managment Increase $20,384 $21,525 $22,730 $24,004 $25,348 $113,991
Additional Staff Years 73 73 73 73 73  
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 0 0 0 0 0  
Payroll for Additional Staff Years $0 $0 $0 $0 $0 $0
Operating Support $0 $0 $0 $0 $0 $0
Contract Support $0 $0 $0 $0 $0 $0
Additional Drug Safety Increase $17,720 $26,974 $37,231 $48,577 $61,094 $191,595
Additional Staff Years 68 95 122 149 176  
Payroll for Additional Staff Years $9,890 $14,566 $19,735 $25,438 $31,717 $101,346
Operating Support $2,749 $3,800 $4,959 $6,237 $7,642 $25,387
Contract Support $5,081 $8,608 $12,537 $16,901 $21,735  
Workload Adjustment Addition $0 $9,052 $9,752 $10,481 $11,289 $40,573
Additional Staff Years   46 46 46 46  
Payroll for Additional Staff Years $0 $7,374 $7,787 $8,223 $8,683 $32,066
Operating Support $0 $1,678 $1,965 $2,258 $2,605 $8,506
Contract Support $0 $0 $0 $0 $0 $0
Subtotal of PDUFA IV Additional Staff Years 161 233 260 287 314  
Subtotal for PDUFA IV Enhancements $41,857 $61,515 $73,898 $87,481 $102,397 $367,148
Total PDUFA Additive Funds--CDER $268,209 $300,542 $326,303 $354,034 $383,865 $1,632,953
Total PDUFA Additive Staff Years 1,446 1,519 1,546 1,572 1,599  

CBER Plan Summary