Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Form FDA 3486A; Web-based Addendum Modified 442 111 0 Form FDA 3486A Biological Product Deviation Report; web-based Addendum
HCT/P deviations Modified 206 412 0 Form and Instruction FDA 3486 Biological Product Deviation Report
Reporting of Biological Product Deviations by Licensed Manufacturer Modified 707 1414 0 Other-IT Landing Page Screenshot
Form and Instruction FDA 3486 Biological Product Deviation Report
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Modified 13821 27642 0 Form and Instruction FDA 3486 Biological Product Deviation Report
Total burden requested under this ICR: 15176 29579 0  
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