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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual Registration
Modified
23403
11702
0
Form
FDA 3673
FDA 3673
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Modified
1
1
0
Annual Request for Waiver from Electronic Registration & Listing (one time)
Modified
1
1
0
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Modified
5736
574
0
Annual Update of Changes to US Agent Information
Modified
1615
808
0
Form
FDA 3673
FDA 3673
Annual Update of Listing Information
Modified
22607
11304
0
Form
FDA 3673
FDA 3673
Creation of electronic system account
Modified
2937
1469
0
Identification of initial importers by foreign establishments
Modified
12983
6492
0
Form
FDA 3673
FDA 3673
Identification of other parties that facilitate import by foreign establishments
Modified
12983
6492
0
Initial Registration & Listing
Modified
3467
3467
0
Form
FDA 3673
FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Modified
1
1
0
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Modified
1
1
0
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Modified
5736
10038
0
Labeling & Advertisement Submitted at FDA Request
Modified
71
71
0
Labeling & Advertisements Available for Review
Modified
68128
34064
0
List of Officers, Directors and Partners
Modified
22338
5585
0
Other Updates of Registration
Modified
2687
1344
0
US Agent Responses to FDA Requests for Information
Modified
1535
384
0
Total burden requested under this ICR:
186230
93798
0
To view an IC, click on IC Title