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PDUFA IV Five-Year Financial Plan - 2009 Update: CBER Plan Summary Tables
PDUFA IV Five-Year Financial Plan-2009 Update
CBER Plan Summary Tables - PDUFA IV
Plan for Funds from PDUFA Fee Revenues ($000)
Note: Numbers Are Rounded and May Not Add
| 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% | ||
| Cummulative 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 | 214 | 214 | 214 | 214 | 214 | |
| Share of unallocated FTE Increase | 3 | 3 | 3 | 3 | 3 | |
| Share of Increase for Meeting Workload (87 total) | 16 | 16 | 16 | 16 | 16 | |
| Share of Increase for Workload Adjustment (180) | 34 | 34 | 34 | 34 | 34 | |
| Total PDUFA IV Base FTE | 267 | 267 | 267 | 267 | 267 | |
| Payroll for PDUFA III Staff Years | $28,855 | $30,471 | $32,178 | $33,980 | $35,883 | |
| Operating Support for PDUFA III Base | $3,730 | $3,938 | $4,159 | $4,392 | $4,638 | |
| Subtotal | $32,585 | $34,410 | $36,337 | $38,372 | $40,520 | |
| Base Additions for PDUFA IV | ||||||
| Share of unallocated FTE | $527 | $556 | $587 | $620 | $655 | |
| Share of Increase for Meeting Workload | $2,808 | $2,965 | $3,131 | $3,307 | $3,492 | |
| Share of Increase for Workload Adjustment | $5,967 | $6,301 | $6,654 | $7,027 | $7,420 | |
| Subtotal | $9,302 | $9,822 | $10,372 | $10,953 | $11,567 | |
| Subtotal--PFUFA IV Base | $41,886 | $44,232 | $46,709 | $49,325 | $52,087 | $234,240 |
| PDUFA IV Enhancements Over PDUFA III | ||||||
| Critical Path Increase | $0 | $0 | $0 | $0 | $0 | $0 |
| Additional Staff Years | ||||||
| Payroll for Additional Staff Years | $0 | |||||
| Operating Support | $0 | |||||
| Drug Safety/Risk Management Increase | $1,861 | $1,965 | $2,075 | $2,191 | $2,314 | $10,407 |
| Additional Staff Years | 4 | 4 | 4 | 4 | 4 | |
| Payroll for Additional Staff Years | $646 | $682 | $720 | $761 | $803 | $3,613 |
| Operating Support | $215 | $227 | $240 | $253 | $267 | $1,202 |
| Contract Support | $1,000 | $1,056 | $1,115 | $1,178 | $1,244 | $5,592 |
| IT Increase | $0 | $0 | $0 | $0 | $0 | $0 |
| Additional Staff Years | ||||||
| Payroll for Additional Staff Years | $0 | |||||
| Operating Support | $0 | |||||
| Contract Support | $0 | |||||
| Additional Drug Safety Increase | $2,133 | $3,184 | $4,324 | $5,559 | $6,898 | $22,098 |
| Additional Staff Years | 10 | 14 | 18 | 22 | 26 | |
| Payroll for Additional Staff Years | $1,372 | $2,021 | $2,738 | $3,529 | $4,400 | $14,060 |
| Operating Support | $383 | $564 | $764 | $985 | $1,228 | $3,925 |
| Contract Support | $378 | $599 | $822 | $1,045 | $1,270 | |
| Workload Adjustment Addition | $1,943 | $4,450 | $7,253 | $10,542 | $24,188 | |
| Additional Staff Years | 10 | 21 | 32 | 44 | ||
| Payroll for Additional Staff Years | $1,603 | $3,555 | $5,720 | $8,306 | $19,184 | |
| Operating Support | $340 | $895 | $1,533 | $2,236 | $5,004 | |
| Contract Support | ||||||
| Subtotal of PDUFA III Additional Staff Years | 28 | 43 | 58 | 74 | ||
| Subtotal PDUFA IV Enhancements | $3,994 | $7,092 | $10,849 | $15,004 | $19,754 | $56,693 |
| Total PDUFA Additive Funds--CBER | $45,880 | $51,324 | $57,558 | $64,329 | $71,841 | $290,932 |
| Total PDUFA Additive Staff Years--CBER | 281 | 295 | 310 | 325 | 341 | |
Next Section: ORA Plan Summary
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