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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 Addendum
Modified
2747
687
0
Form and Instruction
3486A
Biological Product Deviation Report - Addendum
Reporting - 1271.350(b)
Modified
250
500
0
Form and Instruction
3486
Biological Product Deviation Report
Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14
Modified
702
1404
0
Form and Instruction
3486
Biological Product Deviation Report
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171
Modified
54954
109908
0
Form and Instruction
3486
Biological Product Deviation Report
Total burden requested under this ICR:
58653
112499
0
To view an IC, click on IC Title
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