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
(RULE) ACNU statement
New
6
54
0
(RULE) Disclosure of information on the principal display panel or within Drug Facts Labeling
New
6
90
0
Format & content for new OTC drug products (included FDA recommendations on statutory requirements)
Unchanged
29116
133525
0
Other-Statutory Authority
Other-Agency Guidance
Format and Content Requirements; exemptions and deferrals
Unchanged
1
24
0
OTC User Fee Program
Unchanged
1
575
0
Form
FDA 5009
OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET
Total burden requested under this ICR:
29130
134268
0
To view an IC, click on IC Title
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