Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Form FDA 3486A; Web-based Addendum Modified 2322 580 26123 Form FDA 3486A Biological Product Deviation Report; web-based Addendum
HCT/P deviations Modified 243 486 21870 Form and Instruction FDA 3486 Biological Product Deviation Report
Reporting of Biological Product Deviations by Licensed Manufacturer Modified 571 1142 51390 Form and Instruction FDA 3486 Biological Product Deviation Report
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Modified 46192 92384 4157280 Form and Instruction FDA 3486 Biological Product Deviation Report
Total burden requested under this ICR: 49328 94592 4256663  
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