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 CDER FIRST ACTION PERFORMANCE FOR ORIGINAL MANUFACTURING SUPPLEMENTS
Data as of FY 2005 Close-Out Cohort

CDER


 NO.
SUBMITTED		  

RF
or WF

  

UN

  

NO.
FILED

 NUMBER OF FIRST ACTIONS
WITHIN GOAL		 PDUFA
GOALS		 NUMBER OF FIRST ACTIONS
OVERDUE
          AP AE NA WD TOTAL   AP AE NA WD TOTAL
                  NO. PERCENT           NO. PERCENT
FY93
as of 9/30/96		 1059 14 0 1045 450 22 44 10 526 50% no goal  287 21 194 17 519 50%
 
FY94
as of 3/31/97		 884 11 2 871 391 39 137 5 572 66% 55% 248 12 34 5 299 34%
 
FY95
as of 3/31/97		 1285 34 2 1249 752 60 271 38 1121 90% 70% 83 7 34 4 128 10%
 
FY96
as of 2/28/98		 1238 20 0 1218 991 60 87 32 1170 96% 80% 27 5 16 0 48 4%
 
FY97
as of 11/30/98		 1267 5 0 1262 1034 126 72 9 1241 98% 90% 14 2 3 2 21 2%
FY98
as of 01/31/00		 1477 11 3 1463 1235 76 108 23 1442 99% 90% 19 1 1 0 21 1%
 
 FY99
as of 12/31/00		 Prior Approval 913 10 1 902 536 70 45 9 660 73% 30% in 4 mos.*          
694 107 72 16 889 99% 90% in 6 mos. 8 2 3 0 13 1%
CBE 567 10 0 557 494 36 13 4 547 98% 90% 7 1 2 0 10 2%
  Total 1480 20 1 1459                        
                           
 FY00
as of 10/31/01		 Prior Approval 700 11 5 684 401 64 31 13 509 74% 50% in 4 mos.*          
517 86 44 15 662 97% 90% in 6 mos. 11 7 4 0 22 3%
CBE 766 12 0 754 685 28 18 7 738 98% 90% 14 2 0 0 16 2%
  Total 1466 23 5 1438                        
                           
 FY01
as of 09/30/02		 Prior Approval 589 9 1 579 364 69 39 10 482 83% 70% in 4 mos.*          
429 78 49 11 567 98% 90% in 6 mos. 6 4 2 0 12 2%
CBE 913 9 9 895 825 30 13 12 880 98% 90% 13 2 0 0 15 2%
  Total 1502 18 10 1474                        
                           
 FY02
as of 02/29/04		 Prior Approval 618 9 7 602 431 90 37 5 563 94% 90% in 4 mos.  21 15 2 1 39 6%
CBE 1212 50 5 1157 1012 93 10 8 1123 97% 90% in 6 mos. 33 1 0 0

34

 3%
  Total 1830 59 12 1759                        
                           
 FY03
as of 10/31/04		 Prior Approval 624 7 0 617 436 122 37 5 600 97% 90% in 4 mos. 12 4 1 0 17 3%
CBE 1101 20 2 1079 993 50 6 14 1063 99% 90% in 6 mos. 12 4 0 0 16 1%
  Total 1725 27 2 1696                        
                           
 FY04
as of 8/31/06		 Prior Approval 535 5 6 524 387 76 23 5 491 94% 90% in 4 mos. 25 7 0 1 33 6%
CBE 1108 9 6 1093 1023 33 7 9 1072 98% 90% in 6 mos. 16 4 0 1 21 2%
  Total 1643 14 12 1617                        
                           
 FY05
as of 10/31/06		 Prior Approval 636 5 1 630 508 77 18 9 612 97% 90% in 4 mos. 16 2 0 0 18 3%
CBE 1085 16 4 1065 1000 38 4 8 1050 99% 90% in 6 mos. 15 0 0 0 15 1%
  Total 1721 21 5 1695                        

*The Prior Approval 4-month goal and performance figures are a subset of the 6-month goal and performance figures. These supplements are only considered overdue when they exceed the 6-month goal.

Abbreviations:

AP             Approved
AE             Approvable
NA            Not approvable
WD            Withdrawn   
RF             Refuse to file
WF            Withdrawn from filing
UN            Unacceptable for filing because user fee not received

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Date created: November 14, 2006; Updated January 17, 2007
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