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U.S. Department of Health and Human Services

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CDER Plan Summary Tables

Table of Contents: PDUFA III Five-Year Plan

Previous Section : CDER Plan Summary

CDER 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 678 762 762 762 762  
 
Payroll for PDUFA II Staff Years $78,239 $90,717 $94,418 $98,271 $102,280 $463,925
Operating Support for PDUFA II Base $18,330 $20,212 $21,036 $21,895 $22,788 $104,261
 
Subtotal--To Maintain PDUFA II Levels $96,569 $110,929 $115,455 $120,165 $125,068 $568,186

PDUFA III Enhancements Over PDUFA II

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
Enhanced Training and Staffing $4,466 $11,583 $19,573 $23,965 $26,410 $85,996
Additional Staff Years 34 85 138 162 172  
Payroll for Additional Staff Years $3,723 $9,720 $16,425 $20,115 $22,168 $72,151
Operating Support $742 $1,863 $3,147 $3,849 $4,242 $13,844
 
Risk Management $5,757 $8,122 $12,020 $13,957 $16,281 $56,137
Additional Staff Years 10 23 43 68 78  
Payroll for Additional Staff Years $1,152 $2,659 $5,182 $8,429 $10,101 $27,523
Operating Support $125 $291 $565 $919 $1,102 $3,002
Contract Support1 $4,480 $5,172 $6,273 $4,608 $5,079 $25,612
Continuous Marketing Applications $982 $1,830 $2,809 $3,314 $3,652 $12,588
Additional Staff Years 8 14 21 24 26  
Payroll for Additional Staff Years $886 $1,650 $2,532 $2,987 $3,292 $11,347
Operating Support $96 $181 $277 $327 $361 $1,242
Efficacy Supplement Resubmissions $589 $1,152 $1,536 $1,716 $1,891 $6,884
Additional Staff Years 5 9 12 12 13  
Payroll for Additional Staff Years $532 $1,038 $1,384 $1,547 $1,705 $6,205
Operating Support $58 $114 $152 $169 $187 $679
 
First Cycle Reviews $295 $339 $375 $390 $430 $1,830
Additional Staff Years 2 3 3 3 3  
Payroll for Additional Staff Years $266 $306 $338 $352 $388 $1,649
Operating Support $29 $33 $37 $38 $42 $180
Expert Outside Consultants $56 $95 $107 $112 $122 $492
Additional Staff Years 0 1 1 1 1  
Payroll for Additional Staff Years $44 $75 $83 $86 $95 $382
Operating Support $12 $20 $25 $26 $27 $110
Subtotal of PDUFA III Additional Staff Years 60 135 218 270 293  
Subtotal PDUFA III Enhancements $12,145 $23,121 $36,420 $43,454 $48,787 $163,927

Totals

Category 2003
Plan
2004
Plan2
2005
Plan
2006
Plan
2007
Plan
5-Year
Total
Total PDUFA Additive Funds--CDER $108,715 $134,050 $151,875 $163,619 $173,855 $732,113
Total PDUFA Additive Staff Years--CDER 738 897 980 1,032 1,054  

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 : CBER Plan Summary