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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Cardiovascular Outcome Claim Supplement Submission
New
4
80
6120
Instruction
Drug labeling requirements; prescription drugs
Unchanged
549
1838601
0
Exemption Request from Bar Code Label Requirements
New
2
48
0
Labeling requirements; medical gas containers
Unchanged
432380
73505
0
Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen
New
36
216
16200
Instruction
Safety Labeling Changes; Posting Approved Labeling on Application Holder's website
New
351
1404
105300
Instruction
Submission to Docket Number FDA-2008-D-0150
New
1
10
1530
Instruction
Total burden requested under this ICR:
433323
1913864
129150
To view an IC, click on IC Title