Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Form FDA 3486A; Web-based Addendum Modified 826 207 0 Form FDA 3486A
HCT/P deviations Modified 212 424 0 Form and Instruction FDA 3486
Reporting of Biological Product Deviations by Licensed Manufacturer Modified 503 1006 0 Other-IT Landing Page Screenshot
Form and Instruction FDA 3486
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Modified 16277 32554 0 Form and Instruction FDA 3486
Total burden requested under this ICR: 17818 34191 0  
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