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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Biological Products: Reporting of Biolgical Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
Modified
2133
533
0
Form and Instruction
3486
Biological Product Deviation Report
Form and Instruction
FDA 3486A
BPDR SUPPLEMENTAL INFORMATION
Form
FDA 3486A
Recall Classification
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
Modified
9311
18622
0
Form and Instruction
3486
Biological Product Deviation Report
Form and Instruction
FDA 3486A
BPDR SUPPLEMENTAL INFORMATION
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
Modified
401
802
0
Form and Instruction
3486
Biological Product Deviation Report
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
Modified
32958
65916
0
Form and Instruction
3486
Biological Product Deviation Report
Total burden requested under this ICR:
44803
85873
0
To view an IC, click on IC Title