For Industry
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PDUFA IV 5-Year Financial Plan (2008): CDER Plan Summary Tables
Plan For Funds From PDUFA Fee Revenues ($000)
Numbers are rounded and may not add correctly
| Category | 2008 Plan | 2009 Plan | 2010 Plan | 2011 Plan | 2012 Plan | 5-Year Total |
|---|---|---|---|---|---|---|
| Inflation Adjustment Estimate | ||||||
| Annual Inflation Estimate | 5.60% | 5.60% | 5.60% | 5.60% | ||
| Cumulative Inflation Estimate | 5.60% | 11.51% | 17.76% | 24.35% | ||
| Estimated Inflation Adjustor | 105.60% | 111.51% | 117.76% | 124.35% | ||
| PDUFA III Additive Base | ||||||
| PDUFA III Additive Base Staff Years | 1,065 | 1,065 | 1,065 | 1,065 | 1,065 | |
| Share of Unallocated FTE | 17 | 17 | 17 | 17 | ||
| Share of Increase for Meeting Workload(87 total) | 66 | 66 | 66 | 66 | ||
| Share of Increase for Workload Adjustment(180 total) | 137 | 137 | 137 | 137 | 137 | |
| Total PDUFA IV Base FTE | 1285 | 1285 | 1285 | 1285 | 1285 | |
| Payroll for PDYFA III Staff Years | $154,299 | $162,939 | $172,064 | $181,700 | $191,875 | |
| Operating Support for PDUFA Base | $27,762 | $29,316 | $30,958 | $32,692 | $34,522 | |
| Risk Management Contracts | $5,374 | $5,675 | $5,992 | $6,328 | $6,682 | |
| Subtotal | $187,434 | $197,930 | $209,014 | $220,719 | $233,079 | |
| Base Additions for PDUFA IV | ||||||
| Share of Unallocated FTE | $3,007 | $3,176 | $3,354 | $3,541 | $3,740 | |
| Share of Increase for Meeting Workload | $11,675 | $12,329 | $13,020 | $13,749 | $14,519 | |
| Share of Increase for Workload Adjustment | $24,235 | $25,592 | $27,026 | $28,539 | $30,137 | |
| Subtotal | $38,918 | $41,097 | $43,399 | $45,829 | $48,396 | |
| SUBTOTAL-PDUFA IV Base | $226,352 | $239,027 | $252,405 | $266,552 | $281,469 | $1,265,805 |
| PDUFA IV Enhancments Over PDUFA III | ||||||
| Critical Path Increase | $3,753 | $3,964 | $4,185 | $4,420 | $4,667 | $20,990 |
| Additional Staff Years | 19 | 19 | 19 | 19 | 19 | |
| Payroll for Additional Staff Years | $2,761 | $2,915 | $3,078 | $3,251 | $3,433 | $15,438 |
| Operating Support | $993 | $1,048 | $1,107 | $1,169 | $1,234 | $5,551 |
| Drug Safety/Risk Managment Increase | $20,384 | $21,525 | $22,730 | $24,004 | $25,348 | $113,991 |
| Additional Staff Years | 73 | 73 | 73 | 73 | 73 | |
| Payroll for Additional Staff Years | $11,378 | $12,015 | $12,688 | $13,399 | $14,149 | $63,630 |
| Operating Support | $3,056 | $3,227 | $3,407 | $3,598 | $3,800 | $17,087 |
| Contract Support | $5,950 | $6,283 | $6,635 | $7,007 | $7,399 | $33,274 |
| IT Increase | $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 |
| Contract Support | $0 | $0 | $0 | $0 | $0 | $0 |
| Additional Drug Safety Increase | $17,720 | $26,974 | $37,231 | $48,577 | $61,094 | $191,595 |
| Additional Staff Years | 68 | 95 | 122 | 149 | 176 | |
| Payroll for Additional Staff Years | $9,890 | $14,566 | $19,735 | $25,438 | $31,717 | $101,346 |
| Operating Support | $2,749 | $3,800 | $4,959 | $6,237 | $7,642 | $25,387 |
| Contract Support | $5,081 | $8,608 | $12,537 | $16,901 | $21,735 | |
| Workload Adjustment Addition | $0 | $9,052 | $9,752 | $10,481 | $11,289 | $40,573 |
| Additional Staff Years | 46 | 46 | 46 | 46 | ||
| Payroll for Additional Staff Years | $0 | $7,374 | $7,787 | $8,223 | $8,683 | $32,066 |
| Operating Support | $0 | $1,678 | $1,965 | $2,258 | $2,605 | $8,506 |
| Contract Support | $0 | $0 | $0 | $0 | $0 | $0 |
| Subtotal of PDUFA IV Additional Staff Years | 161 | 233 | 260 | 287 | 314 | |
| Subtotal for PDUFA IV Enhancements | $41,857 | $61,515 | $73,898 | $87,481 | $102,397 | $367,148 |
| Total PDUFA Additive Funds--CDER | $268,209 | $300,542 | $326,303 | $354,034 | $383,865 | $1,632,953 |
| Total PDUFA Additive Staff Years | 1,446 | 1,519 | 1,546 | 1,572 | 1,599 | |
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