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FDA Plan Summary Tables
Table of Contents: PDUFA III Five-Year Plan
Previous Section : FDA Plan Summary
FDA Plan Summary Tables--PDUFA III ($000)
Note: Numbers Are Rounded and May Not Add
Table 1: PDUFA II Additive Base, and Estimated Funds Available
| Item\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
Five-Year Percent |
|---|---|---|---|---|---|---|---|
| Pay and Benefits for Centers/ORA | $107,696 | $112,295 | $116,877 | $121,645 | $126,608 | $585,121 | 60% |
| Base Operating Funds--Centers/ORA | $22,598 | $23,563 | $24,524 | $25,525 | $26,566 | $122,776 | 13% |
| OC--Salaries and Operating/Contract $ | $13,445 | $14,019 | $14,591 | $15,186 | $15,805 | $73,045 | 7% |
| Information Technology | $18,750 | $19,551 | $20,348 | $21,179 | $22,043 | $101,870 | 10% |
| Rent | $7,813 | $8,147 | $8,479 | $8,825 | $9,185 | $42,451 | 4% |
| Central Accounts | $9,197 | $9,590 | $9,981 | $10,388 | $10,812 | $49,969 | 5% |
| Total--PDUFA II Additive Base | $179,499 | $187,164 | $194,800 | $202,748 | $211,020 | $975,232 | 100% |
| Estimated Fee Receipts | $222,900 | $240,864 | $273,481 | $292,885 | $304,834 | $1,334,964 | |
| Reserve for Application Fee Shortfalls | $14,860 | $16,058 | $18,232 | $19,526 | $20,322 | $88,998 | |
| Available for Enhancements | $28,541 | $37,642 | $60,449 | $70,611 | $73,492 | $270,734 | |
Table 2: Funds Planned for Enhancements--by Organization or Cost Component
| Component\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
Five-Year Percent |
|---|---|---|---|---|---|---|---|
| CDER | $12,145 | $23,121 | $36,420 | $43,454 | $48,787 | $163,927 | 59% |
| CBER | $2,619 | $3,348 | $5,413 | $6,844 | $7,777 | $26,000 | 9% |
| ORA | $0 | $0 | $0 | $0 | $0 | $0 | 0% |
| OC--Salaries and Operating/Contract $ | $3,648 | $6,016 | $5,163 | $5,035 | $5,368 | $25,230 | 9% |
| Information Technology | $4,906 | $5,465 | $6,870 | $7,518 | $8,286 | $33,045 | 12% |
| Rental Payments to GSA | $1,000 | $1,749 | $2,733 | $3,431 | $3,859 | $12,771 | 5% |
| Central Accounts | $1,280 | $2,410 | $3,879 | $4,922 | $5,552 | $18,043 | 6% |
| Total | $25,597 | $42,109 | $60,477 | $71,204 | $79,629 | $279,015 | 100% |
Table 3: Funds Planned for Enhancements--by Enhancement Category
| Expense Category\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
Five-Year Percent |
|---|---|---|---|---|---|---|---|
| Enhanced Training and Staffing | $8,900 | $17,652 | $28,845 | $35,140 | $38,726 | $129,263 | 46% |
| Risk Management | $7,154 | $10,070 | $14,827 | $17,864 | $21,029 | $70,943 | 25% |
| Electronic Submissions | $4,906 | $5,465 | $6,870 | $7,518 | $8,286 | $33,045 | 12% |
| Continuous Marketing Applications | $2,193 | $3,549 | $5,095 | $5,845 | $6,441 | $23,123 | 8% |
| Efficacy Supplement Resubmissions | $904 | $1,787 | $2,335 | $2,567 | $2,829 | $10,423 | 4% |
| First Cycle Reviews | $852 | $889 | $983 | $1,023 | $1,127 | $4,873 | 2% |
| Expert Outside Consultants | $188 | $196 | $221 | $230 | $251 | $1,085 | 0% |
| Performance Management | $500 | $2,502 | $1,302 | $1,017 | $940 | $6,262 | 2% |
| Total | $25,597 | $42,109 | $60,477 | $71,204 | $79,629 | $279,015 | 100% |
Table 4: Difference Between Plans & Available Funds, with Year-end Carry-Over Balances
| Category\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
|---|---|---|---|---|---|---|
| Difference Between Plan & Available | $2,944 | ($4,467) | ($29) | ($593) | ($6,137) | |
| Est. Carry-Over Balance-Year Beginning | $22,683 | $25,627 | $21,160 | $21,131 | $20,538 | |
| Est. Carry-Over Balance-Year End | $25,627 | $21,160 | $21,131 | $20,538 | $14,401 |
Table 5: FDA Summary of all PDUFA Additive Resources--by Organization or Cost Component
| Component\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
Five-Year Percent |
|---|---|---|---|---|---|---|---|
| CDER | $108,715 | $134,050 | $151,875 | $163,619 | $173,855 | $732,113 | 58% |
| CBER | $31,492 | $23,218 | $26,094 | $28,368 | $30,179 | $139,352 | 11% |
| ORA | $4,852 | $5,059 | $5,265 | $5,480 | $5,704 | $26,359 | 2% |
| Overhead | $17,093 | $20,035 | $19,753 | $20,220 | $21,174 | $98,275 | 8% |
| Information Technology | $23,656 | $25,016 | $27,218 | $28,697 | $30,328 | $134,915 | 11% |
| Rental Payments to GSA | $8,813 | $9,896 | $11,212 | $12,256 | $13,045 | $55,221 | 4% |
| Central Accounts | $10,477 | $12,000 | $13,861 | $15,310 | $16,365 | $68,013 | 5% |
| Total | $205,096 | $229,273 | $255,278 | $273,952 | $290,649 | $1,254,248 | 100% |
Table 6: FDA Summary of all PDUFA Additive Resources--by Expense Category
| Expense Category\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
Five-Year Total |
Five-Year Percent |
|---|---|---|---|---|---|---|---|
| Pay and Benefits | $130,611 | $145,325 | $162,962 | $177,205 | $188,036 | $804,139 | 64% |
| Operating Expenses | $31,540 | $37,037 | $40,026 | $40,483 | $42,876 | $191,961 | 15% |
| Information Technology | $23,656 | $25,016 | $27,218 | $28,697 | $30,328 | $134,915 | 11% |
| Rental Payments to GSA | $8,813 | $9,896 | $11,212 | $12,256 | $13,045 | $55,221 | 4% |
| Central Accounts | $10,477 | $12,000 | $13,861 | $15,310 | $16,365 | $68,013 | 5% |
| Total | $205,096 | $229,273 | $255,278 | $273,952 | $290,649 | $1,254,248 | 100% |
Table 7: FDA Summary of all PDUFA Staff Years for CDER, CBER, ORA, and OC
| FTE Category\Year | 2003 Estimate |
2004 Estimate |
2005 Estimate |
2006 Estimate |
2007 Estimate |
|---|---|---|---|---|---|
| Base Staff Years Paid from Appropriations | 1,277 | 1,277 | 1,277 | 1,277 | 1,277 |
| PDUFA II Base Staff Years | 1,088 | 1,088 | 1,088 | 1,088 | 1,088 |
| Staff Years Added for PDUFA III | 104 | 185 | 285 | 347 | 376 |
| Total | 2,469 | 2,550 | 2,650 | 2,712 | 2,741 |
Next Section : Annual Reassessments
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