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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
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