US Food and Drug Administration

FOOD AND DRUG ADMINISTRATION
User Fee History
(Dollars in Thousands)

User Fees - Appropriations
FY 1998 Appropriation FY 1999 Appropriation FY 2000 Final Appropriation

FY 2001
Current Estimate

 FY 2002 Request
Reauthorization FTE $ FTE $ FTE $ FTE $ FTE $
PDUFA:  
 -  Human Drugs 467 $84,648 504 $88,003 620 $97,053 702 $99,298 722 $106,188
 -  Biologics 192 26,606 179 28,959 204 31,385 253 32,154 253 35,344
 -  Other Activities 41 5,867 346 9,514 127 11,353 127 11,961 127 13,944
 - GSA Rent 0 0 0 5,428 0 5,643 0 5,860 0 6,240
Subtotal, PDUFA  700 117,121 729 131,904 951 145,434 1,082 149,273 1,102 161,716
MQSA - Medical Devices 53 13,965 50 14,385 50 14,817 50 15,128 50 15,590

Subtotal,  Reauthorization  

 753 131,086 799 146,289 1,001 160,251 1,132 164,401 1,152 177,306
Existing
Certification 36 4,654 35 3,764 35 3,877 38 4,492 38 4,681
Export Certification 8 2,000 8 1,000 13 1,030 13 1,500 13 1,500
Subtotal, Existing  44 6,654 43 4,764 48 4,907 51 5,992 51 6,181
Proposed:
Foods --- --- --- --- --- --- 0 0 26 8,100
Drugs 5 1,500
Biologics 2 700
Animal Drugs 2 700
Devices --- --- --- --- --- --- 0 0 12 3,700
Food Export Certification --- --- --- --- --- --- 0 0 23 5,300
Subtotal, Proposed 0 0 0 0 0 0 0 0 70 20,000
Total, FDA 797 $137,740 842 $151,053 1,049 $165,158 1,183 $170,393 1,273 $203,487
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

User Fees - Obligations
FY 1998 Actual FY 1999 Actual FY 2000 Actual
PDUFA: FTE $ FTE $ FTE $
 -  Human Drugs 470 $63,069 610 $77,876 671 $95,696
 -  Biologics 186 27,533 198 29,342 211 34,584
 -  Other Activities 52 11,013 101 9,869 127 11,353
Subtotal, PDUFA  708 101,615 909 122,515 1,009 122,515
MQSA 50 11,518 50 13,373 48 12,767
Exports 0 682 13 1,315 12 1,344
Certification 33 4,601 32 7,511 33 4,447
Subtotal, MQSA/Cert/Export 83 $16,801 95 $22,199 93 $18,558
Total, FDA  791 $118,416 1,004 $144,714 1,102 $141,073
 

 

 

 

 

 

 

 

 

 

User Fees - Collections
FY 1998 Actual FY 1999 Actual FY 2000 Current Estimate FY 2001 Current Estimate

FY 2002 Request

Reauthorization

 $ $

$

$

$
PDUFA Collections   132,671 126,580 145,434 149,273 161,716
MQSA Collections  11,240 12,668 14,817 15,128 15,590

Subtotal, Reauthorization  

 143,911 139,248 160,251 164,401 177,306
Existing
Certification 5,183 4,435 3,877 4,492 4,681
Export Certification 1,111 1,379 1,030 1,500 1,500
Subtotal, Existing  6,294 5,814 4,907 5,992 6,181
Proposed:
Foods --- --- --- 13,650 8,100
Drugs 1,500
Biologics 700
Animal Drugs 700
Devices --- --- --- 5,833 3,700
Food Export Certification --- --- --- 12,700 5,300
Subtotal, Proposed --- --- --- 32,183 20,000
Total, FDA $150,205 $145,062 $165,158 $202,576 $203,487

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Web page edited by sml 05/07/01