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, including labeling and requests for samples
Modified
65814
812607
0
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form and Instruction
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Other-Agency Guidance
Form
FDA 3988
Transmittal of PMR/PMC Submissions for Drugs and Biological Products
Instruction
Form
FDA 3989
PMR/PMC Annual Status Report for Drugs and Biological Products
Instruction
Form
FDA 3674
Certification of Compliance
Instruction
Other-Agency Guidance
Other-Agency Guidance
Form and Instruction
356h
Application for FDA Approval to Market a New Drug
Changes to an approved application
Modified
4741
47410
0
DISCLOSURE: Notifications of suspensions
Modified
20
7
0
Guidance documents issued in accordance with 601.29
Modified
9
27
0
Other-Agency Guidance
Other-Agency Guidance
PHS Section 402 Submission Certification
New
371
105
0
Other-Statutory Authority
Form and Instruction
FDA 3674
Certification of Compliance (42 CFR part 11)
Part 680 additional standards
New
10
20
0
Requests for exceptions under 610.15
New
1
1
0
Total burden requested under this ICR:
70966
860177
0
To view an IC, click on IC Title
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