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User Fee History
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| FOOD AND DRUG ADMINISTRATION User Fee History (Dollars in Thousands) |
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| USER FEES: Appropriations |
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| User Fees | FY 2002 Actual |
FY 2003 Actual |
FY 2004 Actual |
FY 2005 Enacted |
FY 2006 Estimate |
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| FTE | $ | FTE | $ | FTE | $ | FTE | $ | FTE | $ | |
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Definite Appropriations: |
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PDUFA |
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| - Human Drugs | 658 | $104,093 | 742 | $125,103 | 972 | $162,653 | 1015 | $199,762 | 1032 | $213,908 |
| - Biologics | 237 | $38,257 | 269 | $44,959 | 217 | $40,170 | 214 | $38,353 | 216 | $44,933 |
| - Office of Regulartory Affairs | 47 | $6,531 | 41 | $5,629 | 41 | $5,808 | 40 | $7,134 | 41 | $8,675 |
| - Other Activities | 118 | $11,891 | 149 | $15,745 | 122 | $13,535 | 146 | $23,738 | 150 | $25,116 |
| - Other Rent and Rent Related Activities | 0 | $0 | 0 | $0 | 0 | $3,770 | 0 | $3,000 | 0 | $0 |
| - GSA Rent | 0 | $1,040 |
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$8,719 | 0 | $6,146 | 0 | $12,407 | 0 | $12,700 |
| Subtotal, PDUFA | 1,060 | $161,812 | 1,201 | $200,155 | 1,352 | $232,082 | 1,415 | $284,394 | 1,439 | $305,332 |
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MDUFMA |
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| - Biologics |
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5 | $2,157 | 21 | $3,437 | 36 | $7,850 | 37 | $8,412 |
| - Medical Devices and Radiological Health |
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14 | $10,661 | 100 | $17,253 | 152 | $17,786 | 158 | $22,173 |
| - Office of Regulartory Affairs |
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4 | $449 | 6 | $676 | 10 | $912 | 10 | $1,194 |
| - Other Activities |
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10 | $1,071 | 10 | $1,142 | 22 | $4,061 | 22 | $4,535 |
| - Other Rent and Rent Related Activities |
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0 | $100 | 0 | $287 | 0 | $686 | 0 | $783 |
| - GSA Rent |
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0 | $400 | 0 | $1,080 | 0 | $2,643 | 0 | $3,203 |
| Subtotal, MDUFMA |
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33 | $14,838 | 137 | $23,875 | 220 | $33,938 | 227 | $40,300 |
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ADUFA |
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| - Animal Drugs and Feeds |
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3 | $983 | 58 | $7,748 | 76 | $9,301 |
| - Other Activities |
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0 | $0 | 2 | $235 | 6 | $646 |
| - GSA Rent |
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0 | $100 | 0 | $371 | 0 | $1,371 |
| Subtotal, ADUFA |
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3 | $1,083 | 60 | $8,354 | 82 | $11,318 |
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Indefininate |
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MQSA |
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| - Devices and Radiological Health | 47 | $13,695 | 36 | $12,870 | 26 | $4,039 | 32 | $5,174 | 26 | $5,337 |
| - Office of Regulartory Affairs |
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8 | $8,463 | 16 | $11,543 | 16 | $11,624 |
| -Other Activities | 2 | $192 | 2 | $204 | 2 | $214 | 2 | $202 | 2 | $212 |
| Subtotal, MQSA | 49 | $13,887 | 38 | $13,074 | 36 | $12,716 | 50 | $16,919 | 44 | $17,173 |
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| Export Certification | 15 | $1,657 | 13 | $1,663 | 11 | $1,806 | 13 | $1,615 | 13 | $1,639 |
| Certification Fund | 33 | $5,237 | 32 | $7,855 | 35 | $6,128 | 38 | $5,223 | 38 | $6,001 |
| Total, User Fees | 1,157 | $182,593 | 1,317 | $237,585 | 1,574 | $277,690 | 1,796 | $350,443 | 1,843 | $381,763 |
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USER FEES: |
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| FY 2002 Actual |
FY 2003 Actual |
FY 2004 Actual |
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| FTE | $ | FTE | $ | FTE | $ | |||||
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PDUFA: |
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| - Human Drugs | 658 | $104,093 | 742 | $125,103 | 972 | $162,653 | ||||
| - Biologics | 237 | $38,257 | 269 | $44,959 | 217 | $40,170 | ||||
| - Office of Regulartory Affairs | 47 | $6,531 | 41 | $5,629 | 41 | $5,808 | ||||
| - Other Rent and Rent Related Activities | 118 | $11,891 | 149 | $15,745 | 122 | $13,535 | ||||
| - Other Activities | 0 | $0 | 0 | $0 | 0 | $3,770 | ||||
| - GSA Rent | 0 | $1,040 |
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$8,719 | 0 | $6,146 | ||||
| Subtotal, PDUFA | 1,060 | $161,812 | 1,201 | $200,155 | 1,352 | $232,082 | ||||
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MDUFMA |
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| - Biologics |
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5 | $2,157 | 21 | $3,437 | ||||
| - Medical Devices and Radiological Health |
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14 | $10,661 | 100 | $17,253 | ||||
| - Office of Regulatory Affairs |
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4 | $449 | 6 | $676 | ||||
| - Other Activities |
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10 | $1,071 | 10 | $1,142 | ||||
| - Other Rent and Rent Related Activities |
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0 | $100 | 0 | $287 | ||||
| - GSA Rent |
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0 | $400 | 0 | $1,080 | ||||
| Subtotal, MDUFMA |
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33 | $14,838 | 137 | $23,875 | ||||
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MQSA |
49 | $13,887 | 38 | $13,074 | 36 | $12,716 | ||||
| Export Certification | 15 | $1,657 | 13 | $1,663 | 11 | $1,806 | ||||
| Certification Fund | 33 | $5,237 | 32 | $7,855 | 35 | $6,128 | ||||
| Subtotal | 97 | $20,781 | 83 | $22,592 | 82 | $20,650 | ||||
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| Total, FDA | 1,157 | $182,593 | 1,317 | $237,585 | 1,571 | $276,607 | ||||
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| USER FEES: Collections |
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| FY 2002 Actual |
FY 2003 Actual |
FY 2004 Actual |
FY 2005 Estimate |
FY 2006 Estimate |
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| $ | $ | $ | $ | $ | ||||||
| PDUFA Collections | $149,079 | $348,489 | $274,055 | $284,394 | $305,332 | |||||
| MDUFMA Collections | $0 | $21,596 | $27,169 | $33,938 | $40,300 | |||||
| ADUFA Collections | $0 | $0 | $4,866 | $8,354 | $11,318 | |||||
| MQSA Collections | $12,709 | $12,295 | $13,926 | $16,919 | $17,173 | |||||
| Export Certification | $1,584 | $2,025 | $1,806 | $1,615 | $1,639 | |||||
| Certification Fund | $4,988 | $5,142 | $5,180 | $5,223 | $6,001 | |||||
| Total, User Fees | $168,360 | $389,547 | $327,002 | $350,443 | $381,763 | |||||
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