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  
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