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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
20355
15266
0
Form
FDA 3673
3673
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
New
4
4
0
Annual Registration of Foreign Establishments
Removed
0
0
0
Form
FDA 3673
3673
Annual Request for Waiver from Electronic Registration & Listing (one time)
Modified
14
14
0
Annual Update of Changes to US Agent Information
Modified
1615
808
0
Form
3673
FDA 3673
Annual Update of Listing Information
Modified
19875
19875
0
Form
3673
FDA 3673
Creation of electronic system account
New
3559
1780
0
Identification of initial importers by foreign establishments
New
10329
5165
0
Form
3673
FDA 3673
Identification of other parties that facilitate import by foreign establishments
New
10329
5165
0
Initial Registration & Listing
Modified
3539
1770
0
Form
FDA 3673
FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
New
14
14
0
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Modified
4
4
0
Labeling & Advertisement Submitted at FDA Request
New
71
71
0
Labeling & Advertisements Available for Review
Modified
46984
23492
0
List of Officers, Directors and Partners
Modified
23806
5952
0
Other Updates of Registration
New
4176
2088
0
Submittal of Manufacturer Information by Initial Importers (One time)
New
8594
15040
0
Submittal of Manufacturer Information by Initial Importers (recurring)
New
25782
2578
0
US Agent Responses to FDA Requests for Information
New
1535
384
0
Total burden requested under this ICR:
180585
99470
0
To view an IC, click on IC Title