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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU
New
150
6000
0
PART 314: Subparts E through I
Unchanged
45045
444697
0
Form
FDA 3938
Drug Master File
Requirements for failures in implementation of an ACNU
New
150
1200
0
Submission of separate application for nonprescription drug product with an ACNU
New
6
1920
0
Subpart B - Applications
Unchanged
66924
1234195
0
Form and Instruction
FDA 3331a
NDA - Field Alert Report
Form
FDA 2252
Transmittal of annual drug and biologic report under 314.81
Instruction
Form
FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Instruction
Other-Performance Goals
Other-Legislative Authority
Form and Instruction
FDA 3542
Patent Information After Approval
Form and Instruction
FDA 3542a
Patent Information Prior to Approval
Other-Statutory Authority
Form
FDA 356h
Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
Instruction
Subpart C - Abbreviated Applications
Unchanged
27334
2439794
0
Other-Agency Guidance
Subpart D - FDA Action on Applications
Unchanged
6666
83778
0
Other-Agency Guidance
Other-Agency Guidance
Total burden requested under this ICR:
146275
4211584
0
To view an IC, click on IC Title