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PDUFA IV 5-Year Financial Plan (2008): FDA Plan Summary Tables

Table of Contents

FDA Plan Summary

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

Annual Reassessments