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  
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