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Agenda
Reg Review
ICR
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
To view an IC, click on IC Title