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
Applications and infringement notifications
Modified
31
18938
0
Other-Agency Performance Goals
Other-FDA Reauthorization Act
Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey
Modified
60
30
0
Form and Instruction
Form FDA 3792
Biosimilar User Fee Cover Sheet
Formal Meeting Requests; Meeting Packages
Modified
311
6661
0
Other-Agency Guidance
Pediatric Study Plan
New
11
420
0
Other-Agency Guidance
Requests for discontinuation from BPD program and /or to move products to discontinued section.
Modified
6
6
0
Other-Agency Guidance
Total burden requested under this ICR:
419
26055
0
To view an IC, click on IC Title
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