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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