Appendix_B_-_Summary_of_Volume_Submissions.doc

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Offsite Document Control and Records Management Federal contract opportunity
Solicitation number
FDA-Off-Site-RIM-000141
Issued by
Department of Health and Human Services Food and Drug Administration

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Appendix B - Summary of Volume Submissions

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PAGE

APPENDIX B: SUMMARY OF VOLUME SUBMISSIONS BY CENTER

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

CDRH

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

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

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

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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