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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
203.11 Applications for reimportation to provide emergency care
Modified
1
1
0
203.23(a) and (b) - Recordkeeping; Credit memo for returned drugs
Modified
158380
39595
0
203.23(c) - Recordkeeping; Proper storage, handling, and shipping conditions for returned drugs
Modified
158380
12670
0
203.30(a)(2) and 203.31(a)(2) - Recordkeeping; Verification of Licensing
Modified
220800
110400
0
203.30(a)(3), (a)(4) and (c) Drug Sample Receipts
Modified
743532
44612
0
203.31(a)(1) and (b) Drug sample requests for samples distributed by means other than mail or a common carrier
Modified
31367925
1254717
0
203.31(a)(3), (a)(4) and (c) Drug sample receipts for samples distributed by means other than mail or a common carrier
Modified
31367925
941038
0
203.31(d)(1) and (d)(2) - Recordkeeping; Inventory Record and Reconciliation report
Modified
2208
88320
0
203.31(d)(4) - Recordkeeping; Discrepancies and Significant Losses
Modified
442
10608
0
203.31(e) - Recordkeeping; Lists of manufacturers' and distributors' representatives
Modified
2208
2208
0
203.34 - Recordkeeping; Policies and Procedures for administrative systems
Modified
90
3600
0
203.37(a) - Recordkeeping;Falsification of Drug Sample records
Modified
200
1200
0
203.37(a) Investigation of falsification of records
Modified
200
50
0
203.37(b) - Recordkeeping; Report of investigation of significant loss or known theft
Modified
2000
12000
0
203.37(b) Investigation of significant loss or known theft
Modified
2000
500
0
203.37(c) Notification of conviction of certain offenses involving drug samples
Modified
1
1
0
203.37(d) Notification of the individual responsible for RFI
Modified
50
4
0
203.39(d) - Recordkeeping; Samples destroyed or returned by charitable institutions
Modified
65
65
0
203.39(e) - Recordkeeping; Samples donated to charitable institutions
Modified
3221
1611
0
203.39(f) - Recordkeeping; Donation and distribution or other disposition of donated drug samples
Modified
3221
25768
0
203.39(g) - Recordkeeping; Inventor and reconciliation of donations to charitable institutions
Modified
3221
25768
0
203.39(g) Preparation of reconciliation report for donated samples
Modified
1
1
0
203.50(a) - Third Party Disclosure; Drug Origin Statement
Modified
12500
2125
0
203.50(b) - Recordkeeping; Retention of drug origin statement
Modified
12500
6250
0
203.50(d) - Recordkeeping; List of authorized distributors
Modified
691
1382
0
203.30(a)(1) and (b) Drug sample requests
Modified
743532
44612
0
Total burden requested under this ICR:
64805294
2629106
0
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