Revised_Appendix_3_-_Summary_of_Volume_of_Submissions_by_Center.pdf
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- FDA-Off-Site-RIM-000141
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Revised Appendix 3
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APPENDIX #3: SUMMARY OF VOLUME SUBMISSIONS BY CENTER 1
CENTER
FY’13 ANNUAL
VOLUME OF
SUBMISSIONS ANNUAL % PAPER
ANNUAL %
ELECTRONIC
CDER DCC 446,888 50% 50%
CDER OC 4,000
CDER DSIR 6,200
CVM 13,747 33% 67%
CFSAN 36,190
CBER 75% 25%
CTP
CDRH MDR Processing 2013 876,538 70% 30%
CDRH DCC 2013 23,500
CENTER
FY’12 ANNUAL
VOLUME OF
SUBMISSIONS ANNUAL % PAPER
ANNUAL %
ELECTRONIC
CDER DCC 446,888 50% 50%
CDER OC 4,000
CDER DSIR 6,200
CVM 13,747 33% 67%
CFSAN 36,190
CBER 75% 25%
CTP
CDER DCC FY’09 THRU FY’12 SUMMARY
All Paper (Paper, mixed, digitized)
App type 2009 2010 2011 2012 Total
ANDA 20013 19092 16945 14462 70512
NDA 8464 6736 5787 4736 25723
MF 21376 21019 22233 22470 87098
IND 58640 50303 38425 30325 177693
BLA 0 0 0 0 0
Marketing (OPDP) 32506 32764 31349 23699 120318
Total 140999 129914 114739 95692 481344
All Electronic (includes gateway)
App type 2009 2010 2011 2012 Total
ANDA 13245 18311 25498 29196 86250
NDA 13779 15513 17772 17778 64842
MF 685 1254 2007 2500 6446
IND 28488 39346 49660 57394 174888
BLA 0 0 0 0 0
Marketing (OPDP) 0 12 7451 20884 28347
Total 56197 74436 102388 127752 360773
APPENDIX #3: SUMMARY OF VOLUME SUBMISSIONS BY CENTER 2
Total (Both Paper and Electronic)
App type 2009 2010 2011 2012 Total
ANDA 33258 37403 42443 43658 156762
NDA 22243 22249 23559 22514 90565
MF 22061 22273 24240 24970 93544
IND 87128 89649 88085 87719 352581
BLA 0 0 0 0 0
Marketing (OPDP) 32506 32776 38800 44583 148665
Total 197196 204350 217127 223444 842117
APPENDIX #3: SUMMARY OF VOLUME SUBMISSIONS BY CENTER 3
CFSAN FY’12 Submissions & File Maintenance
Document Types # of Submissions
Submitted # of Resubmissions
# of Submissions Created
*AF/LACF 18, 001 4,103 766
File Maintenance
# of Folders Created
# of Folders Updated
CAERS
(paper files)
7,995 9943
OCompliance 1,057
EOS 141 141
Total: 36,190 15,313
2012 CFSAN Document Imaging & eDCR Maintenance
Document Types
# of Pages Imaged
# of pages uploaded
EOS 72,337 72,337
LACF 1,500,000 1,500,000
OCompliance 224,415 224,415
OFS 172,827 172,827
OM
32,781 32,781
Total: 2,002,360 2,002,360
APPENDIX #3: SUMMARY OF VOLUME SUBMISSIONS BY CENTER 4
CVM Number of Submissions Scanned FY’12
New Submissions
Old Files
Jan 21769 49686
Feb 52703 29885
Mar 36013 45588
Apr 34190 63643
May 27476 67669
Jun 22276 72011
Jul 44714 55501
Aug 16854 92104
Sep 24716 53410
Oct 17764 132525
Nov 48509 113969
Dec 38896 90374
Total 385880 866365
CVM Number of Incoming New Applications and Submissions 2012
Applications Submissions
ANADA 18 652
MIF 5 21
FAP 3 23
GC 65 431
GRAS 2 15
IFA 12 79
INAD 48 1639
JINAD 112 302
NADA 9 1308
PMF 0 185
VMF 27 573
DER 0 5683
ADE 0 2836
Total 301 13747
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