For Industry
-
PDUFA IV 5-Year Financial Plan (2008): ORA 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 | 39 | 39 | 39 | 39 | 39 | |
| Share of Unallocated FTE | 1 | 1 | 1 | 1 | 1 | |
| Share of Increase for Meeting Workload(87 total) | ||||||
| Share of Increase for Workload Adjustment(180 total) | ||||||
| Total PDUFA IV Base FTE | 40 | 40 | 40 | 40 | 40 | |
| Payroll for PDYFA III Staff Years | $4,255 | $4,493 | $4,745 | $5,011 | $5,291 | $23,794 |
| Operating Support for PDUFA Base | $1,480 | $1,563 | $1,650 | $1,743 | $1,850 | $8,278 |
| IT Operating Contracts | $0 | $0 | $0 | $0 | ||
| Subtotal | $5,735 | $6,056 | $6,395 | $6,753 | $7,131 | |
| Base Additions for PDUFA IV | $0 | $0 | $0 | $0 | $0 | |
| Share of Unallocated FTE | $144 | $152 | $160 | $169 | $178 | |
| Share of Increase for Meeting Workload | $0 | $0 | $0 | $0 | $0 | |
| Share of Increase for Workload Adjustment | $0 | $0 | $0 | $0 | $0 | |
| Subtotal | $144 | $152 | $160 | $169 | $178 | |
| SUBTOTAL-PDUFA IV Base | $5,878 | $6,207 | $6,554 | $6,922 | $7,310 | $32,872 |
| 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 | $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 |
| 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 | $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 |
| Workload Adjustment Addition | $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 |
| Subtotal of PDUFA IV Additional Staff Years | - | - | - | - | - | |
| Subtotal for PDUFA IV Enhancements | $0 | $0 | $0 | $0 | $0 | $0 |
| Total PDUFA Additive Funds--ORA | $5,878 | $6,20 | $6,555 | $6,922 | $7,310 | $32,873 |
| Total PDUFA Additive Staff Years | 40 | 40 | 40 | 40 | 40 | |
-
-







