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PDUFA IV 5-Year Financial Plan (2008): FDA Plan Summary Tables
FDA Plan Summary Tables--PDUFA IV ($000)
Numbers are rounded and may not add correctly
Table 1: PDUFA IV Fee Base After PDUFA IV Adjustments
| Item/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate | 5-Year Total | 5-Year Percent |
|---|---|---|---|---|---|---|---|
| Pay and Benefits for Centers(ORA) | $226,758 | $239,456 | $252,857 | $267,030 | $281,973 | $1,268,074 | 57% |
| Base Operating Funds--Centers(ORA) | $47,359 | $50,011 | $52,810 | $55,770 | $58,891 | $264,841 | 12% |
| OC--Salaries and Operating/Contract $ | $33,259 | $35,122 | $37,087 | $39,166 | $41,358 | $185,993 | 8% |
| Information Technology | $33,145 | $35,001 | $36,960 | $39,032 | $41,216 | $185,353 | 8% |
| Rent and Rent Related | $28,629 | $30,232 | $31,924 | $33,714 | $35,600 | $160,100 | 7% |
| Central Accounts | $27,372 | $28,905 | $30,522 | $32,233 | $34,037 | $153,069 | 7% |
| Subtotal PDUFA III Additive Base | $396,522 | $418,727 | $442,161 | $466,945 | $493,075 | $2,217,431 | 100% |
| Subtotal PDUFA IV Enhancements | $62,890 | $91,843 | $108,469 | $126,676 | $146,574 | $536,451 | |
| Total Estimated PDUFA Fees Expended | $459,412 | $510,570 | $550,630 | $593,621 | $639,649 | $2,753,882 |
Table 2: Funds Planned For Enhancements--By Organization or Cost Component
| Component/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate | 5-Year Total | 5-Year Percent |
|---|---|---|---|---|---|---|---|
| CDER | $41,857 | $61,515 | $73,898 | $87,481 | $102,397 | 367,148 | 68% |
| CBER | $3,994 | $7,092 | $8,591 | $10,237 | $11,990 | $41,904 | 8% |
| ORA | $0 | $0 | $0 | $0 | $0 | $0 | 0% |
| OC--Salaries and Operating/Contract $ | $3,318 | $4,881 | $5,377 | $5,914 | $6,493 | $25,982 | 5% |
| Information Technology | $7,480 | $7,899 | $8,341 | $8,808 | $9,302 | $41,830 | 8% |
| Rent and Rent Related | $3,138 | $5,539 | $6,450 | $7,446 | $8,533 | $31,106 | 6% |
| Central Accounts | $3,104 | $4,917 | $5,811 | $6,790 | $7,860 | $28,483 | 5% |
| Total PDUFA IV Enhancements | $62,890 | $91,843 | $108,469 | $126,676 | $146,574 | $536,451 | 100% |
Table 3: Funds Planned for Enhancement--By Enhancement Category
| Expense Category/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate | 5-Year Total | 5-Year Percent |
|---|---|---|---|---|---|---|---|
| Critical Path | $4,600 | $4,858 | $5,129 | $5,417 | $5,720 | $25,724 | 5% |
|
Drug Safety/Risk Management |
$25,810 | $27,255 | $28,781 | $30,393 | $32,095 | $144,335 | |
|
IT Amount for Drug Safety/Risk Mgmt |
$3,480 | $3,675 | $3,881 | $4,098 | $4,327 | $19,461 | |
| Drug Safety/Risk Mgmt Total | $29,290 | $30,930 | $32,662 | $34,491 | $36,423 | $163,796 | 31% |
| Information Technology | $4,000 | $4,224 | $4,461 | $4,710 | $4,975 | $22,369 | 4% |
| Additional Drug Safety Increase | $25,000 | $36,960 | $50,179 | $64,768 | $80,827 | $257,735 | 48% |
| Workload Adjustment | $0 | $14,871 | $16,038 | $17,290 | $18,631 | $66,829 | 12% |
| Total PDUFA IV Enhancements | $62,890 | $91,843 | $108,469 | $126,676 | $146,574 | $536,451 | 100% |
Table 4: Summary of All PDUFA IV Additive Resources--By Organization or Cost Component
| Component/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate | 5-Year Total | 5-Year Percent |
|---|---|---|---|---|---|---|---|
| CDER | $268,209 | $300,542 | $326,303 | $354,034 | $383,865 | $1,632,953 | 59% |
| CBER | $45,880 | $51,324 | $55,299 | $59,563 | $64,075 | $276,142 | 10% |
| ORA | $5,878 | $6,207 | $6,555 | $6,922 | $7,310 | $32,873 | 1% |
| Overhead | $36,576 | $40,002 | $42,464 | $45,080 | $47,851 | $211,974 | 8% |
| Information Technology | $40,625 | $42,900 | $45,301 | $47,840 | $50,517 | $227,183 | 8% |
| Rent and Rent Related | $31,767 | $35,771 | $38,375 | $41,159 | $44,133 | $191,206 | 7% |
| Central Accounts | $30,475 | $33,822 | $36,334 | $39,023 | $41,897 | $181,552 | 7% |
| Total | $459,412 | $510,570 | $550,630 | $593,621 | $639,649 | $2,753,881 | 100% |
Table 5: Summary of All PDUFA IV Additive Resources--By Expense Category
| Expense Category/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate | 5-Year Total | 5-Year Percent |
|---|---|---|---|---|---|---|---|
| Pay and Benefits | $280,266 | $310,764 | $333,292 | $357,397 | $383,125 | $1,664,844 | 60% |
| Operating Expenses | $76,278 | $87,313 | $97,329 | $108,210 | $119,977 | $489,098 | 18% |
| Information Technology | $40,625 | $42,900 | $45,301 | $47,840 | $50,517 | $227,183 | 8% |
| Rent and Rent Related | $31,767 | $35,771 | $38,375 | $41,159 | $44,133 | $191,206 | 7% |
| Central Accounts | $30,475 | $33,822 | $36,334 | $39,023 | $41,897 | $181,552 | 7% |
| Total | $459,412 | $510,570 | $550,630 | $593,621 | $639,649 | $2,753,881 | 100% |
Table 6: FDA Summary of All Drug Review Staff Years By Funding Source
| FTE Category/Year | 2008 Estimate | 2009 Estimate | 2010 Estimate | 2011 Estimate | 2012 Estimate |
|---|---|---|---|---|---|
| Base Staff Years Paid From Appropriations | 1,202 | 1,181 | 1,158 | 1,132 | 1,104 |
| PDUFA IV Base Staff Years | 1,806 | 1,806 | 1,806 | 1,806 | 1,806 |
| Staff Years Added For PDUFA III | 183 | 277 | 309 | 341 | 373 |
| Total | 3,191 | 3,264 | 3,273 | 3,279 | 3,282 |
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