Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual Registration
Unchanged
23403
11702
0
Form
FDA 3673
FDA 3673
Annual Registration & Listing when Electronic Filing Waiver granted (recurring)
Unchanged
1
1
0
Annual Request for Waiver from Electronic Registration & Listing (one time)
Unchanged
1
1
0
Annual Submittal of Manufacturer Information by Initial Importers (recurring)
Unchanged
5736
574
0
Annual Update of Changes to US Agent Information
Unchanged
1615
808
0
Form
FDA 3673
FDA 3673
Annual Update of Listing Information
Unchanged
22607
11304
0
Form
FDA 3673
FDA 3673
Creation of electronic system account
Unchanged
2937
1469
0
Identification of initial importers by foreign establishments
Unchanged
12983
6492
0
Form
FDA 3673
FDA 3673
Identification of other parties that facilitate import by foreign establishments
Unchanged
12983
6492
0
Initial Registration & Listing
Unchanged
3467
3467
0
Form
FDA 3673
FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time)
Unchanged
1
1
0
Initial Request for Waiver from Electronic Registration & Listing (recurring)
Unchanged
1
1
0
Intitial Submittal of Manufacturer Information by Initial Importers (One time)
Unchanged
5736
10038
0
Labeling & Advertisement Submitted at FDA Request
Unchanged
71
71
0
Labeling & Advertisements Available for Review
Unchanged
68128
34064
0
List of Officers, Directors and Partners
Unchanged
22338
5585
0
Other Updates of Registration
Unchanged
2687
1344
0
Transfer of 510(k) Notification: Agency GFI Recommendations
New
6113
9152
0
Other-Agency Guidance
US Agent Responses to FDA Requests for Information
Unchanged
1535
384
0
Total burden requested under this ICR:
192343
102950
0
To view an IC, click on IC Title