PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Adverse Drug Event Recordkeeping -- 314.80(i)
Modified
399998
6399968
22000
Adverse Drug Experience Reporting -- 310.305(c)(5)
Modified
3
3
0
Adverse Event Recordkeeping -- 310.305(f)
Modified
25
400
0
Adverse Event Reporting -- 314.80(c)(2)
Modified
15195
911700
25000
Adverse Event Reporting--314.80(c)(1)(iii)
Modified
5
5
0
Total burden requested under this ICR:
415226
7312076
47000
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