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CBER Plan Summary Tables

Table of Contents: PDUFA III Five-Year Plan

Previous Section : CBER Plan Summary

CBER Plan Summary Tables--PDUFA III
Plan for Funds from PDUFA Fee Revenues ($000)

Note: Numbers Are Rounded and May Not Add

Inflation Adjustment Estimate

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
Annual Inflation Estimate   4.27% 4.08% 4.08% 4.08%  
Cumulative Inflation Estimate   4.27% 8.52% 12.95% 17.56%  
Estimated Inflation Adjustor   104.27% 108.52% 112.95% 117.56%  

PDUFA II Additive Base

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
PDUFA II Additive Base Staff Years 246 162 162 162 162  
 
Payroll for PDUFA II Staff Years $25,774 $17,737 $18,461 $19,214 $19,998 $101,183
Operating Support for PDUFA II Base $3,100 $2,133 $2,220 $2,311 $2,405 $12,168
 
Subtotal--To Maintain PDUFA II Levels $28,873 $19,870 $20,681 $21,525 $22,403 $113,352

PDUFA III Enhancements Over PDUFA II

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
Enhanced Training and Staffing $1,348 $2,040 $3,487 $4,412 $4,862 $16,150
Additional Staff Years 12 17 29 35 37  
Payroll for Additional Staff Years $1,204 $1,822 $3,115 $3,941 $4,343 $14,424
Operating Support $144 $218 $373 $471 $520 $1,726
 
Risk Management $539 $556 $820 $1,210 $1,568 $4,694
Additional Staff Years 5 5 7 10 12  
Payroll for Additional Staff Years $481 $497 $733 $1,081 $1,401 $4,193
Operating Support $58 $59 $88 $129 $168 $502
Contract Support1 $0 $0 $0 $0 $0 $0
Continuous Marketing Applications $359 $371 $615 $712 $784 $2,842
Additional Staff Years 3 3 5 6 6  
Payroll for Additional Staff Years $321 $331 $550 $636 $700 $2,538
Operating Support $38 $40 $66 $76 $84 $304
Efficacy Supplement Resubmissions $180 $247 $342 $356 $392 $1,517
Additional Staff Years 2 2 3 3 3  
Payroll for Additional Staff Years $160 $221 $305 $318 $350 $1,355
Operating Support $19 $26 $37 $38 $42 $162
 
First Cycle Reviews $90 $62 $68 $71 $78 $370
Additional Staff Years 1 1 1 1 1  
Payroll for Additional Staff Years $80 $55 $61 $64 $70 $330
Operating Support $10 $7 $7 $8 $8 $39
Expert Outside Consultants $103 $71 $80 $83 $91 $428
Additional Staff Years 0.8 0.528 0.561 0.561 0.594  
Payroll for Additional Staff Years $80 $55 $61 $64 $70 $330
Operating Support $23 $16 $19 $20 $21 $98
Subtotal of PDUFA III Additional Staff Years 23 29 44 54 59  
Subtotal PDUFA III Enhancements $2,619 $3,348 $5,413 $6,844 $7,777 $26,000

Totals

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
Total PDUFA Additive Funds--CBER $31,492 $23,218 $26,094 $28,368 $30,179 $139,352
Total PDUFA Additive Staff Years--CBER 269 191 207 216 221  

1 Risk Management Contract support includes funds for both CDER and CBER, but funds for both centers are being managed by CDER.
2 Estimates for 2004 and beyond include transfer of 34% of CBER's PDUFA resources along with the transfer of CBER therapeutic product review functions to CDER.

Next Section : ORA Plan Summary