For Industry
-
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
-
-
