For Industry
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PDUFA IV 5-Year Financial Plan (2008): CBER 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 | 214 | 214 | 214 | 214 | 214 | |
| Share of Unallocated FTE | 3 | 3 | 3 | 3 | ||
| Share of Increase for Meeting Workload(87 total) | 16 | 16 | 16 | 16 | ||
| Share of Increase for Workload Adjustment(180 total) | 34 | 34 | 34 | 34 | 34 | |
| Total PDUFA IV Base FTE | 267 | 267 | 267 | 267 | 267 | |
| Payroll for PDYFA III Staff Years | $28,855 | $30,471 | $32,178 | $33,980 | $35,883 | $161,367 |
| Operating Support for PDUFA Base | $3,730 | $3,938 | $4,159 | $4,392 | $4,638 | $20,856 |
| 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-PDUFA IV Base | $41,886 | $44,232 | $46,708 | $49,325 | $52,087 | $234,238 |
| PDUFA IV Enhancments Over PDUFA III | ||||||
| Critical Path Increase | $0 | $0 | $0 | $0 | $0 | $0 |
| Additional Staff Years | 0 | 0 | 0 | 0 | 0 | 0 |
| Payroll for Additional Staff Years | $0 | $0 | $0 | $0 | $0 | $0 |
| Operating Support | $0 | $0 | $0 | $0 | $0 | $0 |
| Drug Safety/Risk Managment 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 | 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 | $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 | $14,059 |
| Operating Support | $383 | $564 | $764 | $985 | $1,228 | $3,925 |
| Contract Support | $378 | $599 | $822 | $1,045 | $1,270 | |
| Workload Adjustment Addition | $0 | $1,943 | $2,193 | $2,486 | $2,777 | $9,399 |
| Additional Staff Years | 10 | 10 | 10 | 10 | ||
| Payroll for Additional Staff Years | $0 | $1,603 | $1,693 | $1,788 | $1,888 | $6,971 |
| Operating Support | $0 | $340 | $500 | $699 | $890 | $2,429 |
| Contract Support | $0 | $0 | $0 | $0 | $0 | $0 |
| Subtotal of PDUFA IV Additional Staff Years | 14 | 28 | 32 | 36 | 40 | |
| Subtotal for PDUFA IV Enhancements | $3,994 | $7,092 | $8,591 | $10,237 | $11,990 | $41,904 |
| Total PDUFA Additive Funds--CBER | $45,880 | $51,324 | $55,299 | $59,563 | $64,075 | $276,142 |
| Total PDUFA Additive Staff Years | 281 | 295 | 299 | 303 | 307 | |
Some Risk Management contract support for both CBER and CDER is included in the CDER plan. CDER is managing these funds for both centers
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