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

Table of Contents

CBER 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 214 214 214 214 214  
Share of Unallocated FTE   3 3 3 3  
Share of Increase for Meeting Workload(87 total)   16 16 16 16  
Share of Increase for Workload Adjustment(180 total) 34 34 34 34 34  
Total PDUFA IV Base FTE 267 267 267 267 267  
Payroll for PDYFA III Staff Years $28,855 $30,471 $32,178 $33,980 $35,883 $161,367
Operating Support for PDUFA Base $3,730 $3,938 $4,159 $4,392 $4,638 $20,856
Subtotal $32,585 $34,410 $36,337 $38,372 $40,520  
Base Additions for PDUFA IV
Share of Unallocated FTE $527 $556 $587 $620 $655  
Share of Increase for Meeting Workload $2,808 $2,965 $3,131 $3,307 $3,492  
Share of Increase for Workload Adjustment $5,967 $6,301 $6,654 $7,027 $7,420  
Subtotal $9,302 $9,822 $10,372 $10,953 $11,567  
SUBTOTAL-PDUFA IV Base $41,886 $44,232 $46,708 $49,325 $52,087 $234,238
PDUFA IV Enhancments Over PDUFA III
Critical Path Increase $0 $0 $0 $0 $0 $0
Additional Staff Years 0 0 0 0 0 0
Payroll for Additional Staff Years $0 $0 $0 $0 $0 $0
Operating Support $0 $0 $0 $0 $0 $0
Drug Safety/Risk Managment Increase $1,861 $1,965 $2,075 $2,191 $2,314 $10,407
Additional Staff Years 4 4 4 4 4  
Payroll for Additional Staff Years $646 $682 $720 $761 $803 $3,613
Operating Support $215 $227 $240 $253 $267 $1,202
Contract Support $1,000 $1,056 $1,115 $1,178 $1,244 $5,592
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 $2,133 $3,184 $4,324 $5,559 $6,898 $22,098
Additional Staff Years 10 14 18 22 26  
Payroll for Additional Staff Years $1,372 $2,021 $2,738 $3,529 $4,400 $14,059
Operating Support $383 $564 $764 $985 $1,228 $3,925
Contract Support $378 $599 $822 $1,045 $1,270  
Workload Adjustment Addition $0 $1,943 $2,193 $2,486 $2,777 $9,399
Additional Staff Years   10 10 10 10  
Payroll for Additional Staff Years $0 $1,603 $1,693 $1,788 $1,888 $6,971
Operating Support $0 $340 $500 $699 $890 $2,429
Contract Support $0 $0 $0 $0 $0 $0
Subtotal of PDUFA IV Additional Staff Years 14 28 32 36 40  
Subtotal for PDUFA IV Enhancements $3,994 $7,092 $8,591 $10,237 $11,990 $41,904
Total PDUFA Additive Funds--CBER $45,880 $51,324 $55,299 $59,563 $64,075 $276,142
Total PDUFA Additive Staff Years 281 295 299 303 307  

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

 

ORA Plan Summary