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U.S. Department of Health and Human Services

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OC Plan Summary Tables

Table of Contents: PDUFA III Five-Year Plan

Previous Section : OC Plan Summary

OC 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
Plan		 2005
Plan		 2006
Plan		 2007
Plan		 5-Year
Total
Estimated Inflation Adjustor   104.27% 108.52% 112.95% 117.56%  

PDUFA II Additive Base

Category 2003
Plan		 2004
Plan		 2005
Plan		 2006
Plan		 2007
Plan		 5-Year
Total
PDUFA II Additive Base Staff Years 123 123 123 123 123  
 
Payroll for PDUFA II Staff Years $11,895 $12,403 $12,909 $13,435 $13,983 $64,625
Operating Support for PDUFA II Base $1,550 $1,616 $1,682 $1,751 $1,822 $8,420
 
Subtotal--To Maintain PDUFA II Levels $13,445 $14,019 $14,591 $15,186 $15,805 $73,045

PDUFA III Enhancements Over PDUFA II

Category 2003
Plan		 2004
Plan		 2005
Plan		 2006
Plan		 2007
Plan		 5-Year
Total
Enhanced Training and Staffing $1,739 $1,451 $1,604 $1,670 $1,840 $8,305
Additional Staff Years 16 12.8 13.6 13.6 14.4  
Payroll for Additional Staff Years $1,547 $1,291 $1,427 $1,486 $1,637 $7,388
Operating Support $192 $160 $177 $184 $203 $917
 
Risk Management $435 $635 $702 $731 $805 $3,307
Additional Staff Years 4 5.6 5.95 5.95 6.3  
Payroll for Additional Staff Years $387 $565 $624 $650 $716 $2,942
Operating Support $48 $70 $77 $81 $89 $365
Contract Support $0 $0 $0 $0 $0 $0
Continuous Marketing Applications $574 $898 $993 $1,033 $1,139 $4,636
Additional Staff Years 2 2.4 2.55 2.55 2.7  
Payroll for Additional Staff Years $155 $242 $268 $279 $307 $1,250
Operating Support $19 $30 $33 $35 $38  
Contract (Study) Support $400 $626 $692 $720 $794 $3,231
Efficacy Supplement Resubmissions $0 $113 $100 $104 $115 $433
Additional Staff Years 0 1 0.85 0.85 0.9  
Payroll for Additional Staff Years $0 $101 $89 $93 $102 $385
Operating Support $0 $13 $11 $12 $13 $48
 
First Cycle Reviews $400 $417 $461 $480 $529 $2,287
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 (Study) Support $400 $417 $461 $480 $529 $2,287
Expert Outside Consultants $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
Performance Management $500 $2,502 $1,302 $1,017 $940 $6,262
Contract (Study) Support $500 $2,502 $1,302 $1,017 $940 $6,262
Subtotal of PDUFA III Additional Staff Years 22 22 23 23 24  
Subtotal PDUFA III Enhancements $3,648 $6,016 $5,163 $5,035 $5,368 $25,230

Totals

Category 2003
Plan		 2004
Plan		 2005
Plan		 2006
Plan		 2007
Plan		 5-Year
Total
Total PDUFA Additive Funds--OC $17,093 $20,035 $19,753 $20,220 $21,174 $98,275
Total Without Perf. Mgmt. Contract $16,593 17,532 $18,451 $19,204 $20,233 $92,013
Total PDUFA Additive Staff Years--OC 145 145 146 146 147  

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