Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Annual Registration & Listing when Electronic Filing Waiver granted (recurring) Removed 0 0 0
Annual Request for Waiver from Electronic Registration & Listing (one time) Unchanged 1 1 0
Annual Submittal of Manufacturer Information by Initial Importers (recurring) Removed 0 0 0
Annual Update of Changes to US Agent Information Removed 0 0 0 Form FDA 3673 FDA 3673
Annual Update of Listing Information Removed 0 0 0 Form FDA 3673 FDA 3673
Identification of initial importers by foreign establishments Removed 0 0 0 Form FDA 3673 FDA 3673
Identification of other parties that facilitate import by foreign establishments Removed 0 0 0
Initial Registration & Listing Removed 0 0 0 Form FDA 3673 FDA 3673
Initial Registration & Listing when Electronic Filing Waiver Granted (one time) Removed 0 0 0
Initial Request for Waiver from Electronic Registration & Listing (recurring) Unchanged 1 1 0
Intitial Submittal of Manufacturer Information by Initial Importers (One time) Removed 0 0 0
Labeling & Advertisement Submitted at FDA Request Removed 0 0 0
Labeling & Advertisements Available for Review Removed 0 0 0
List of Officers, Directors and Partners Removed 0 0 0
Other Updates of Registration Removed 0 0 0
Registration & listing of devices: RECORDKEEPING Modified 101979 42527 0
Registration & listing of devices: REPORTING Modified 118794 71303 0 Form FDA 3673 FDA 3673
Transfer of 510(k) Notification: Agency GFI Recommendations Removed 0 0 0 Other-Agency Guidance
US Agent Responses to FDA Requests for Information Removed 0 0 0
Total burden requested under this ICR: 220775 113832 0  
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