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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
Subpart B - Applications
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 314.50-314.90
21 CFR 310.306
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
FDA 3331a
NDA - Field Alert Report
Form FDA 3331a DRAFT FEB 2020.pdf
https://www.fda.gov/drugs/surveillance/field-alert-reports
Yes
Yes
Fillable Fileable
Form
FDA 2252
Transmittal of annual drug and biologic report under 314.81
FDA 2252 reports rev 2021.pdf
Yes
Yes
Fillable Fileable
Instruction
2252 instructions rev 2021.pdf
Yes
Yes
Fillable Fileable
Form
FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form FDA 2253 propchanges 9-9-2021.pdf
Yes
Yes
Fillable Fileable
Instruction
FDA-2253-Instructions rev 2021.pdf
Yes
Yes
Fillable Fileable
Other-Performance Goals
PDUFA Committment Goals.pdf
Yes
Yes
Paper Only
Other-Legislative Authority
FDARA 2017.pdf
Yes
Yes
Paper Only
Form and Instruction
FDA 3542
Patent Information After Approval
FDA 3542 patent info.pdf
Yes
Yes
Fillable Fileable
Form and Instruction
FDA 3542a
Patent Information Prior to Approval
FDA-form-3542A_instructional-supplement_R2.1_secured.pdf
Yes
Yes
Fillable Fileable
Other-Statutory Authority
21 USC 355 New Drugs.pdf
Yes
Yes
Fillable Fileable
Form
FDA 356h
Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
Form FDA 356h with comments noting changes Aug 2022.pdf
Yes
Yes
Fillable Fileable
Instruction
FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
378
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
99 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
66,924
0
0
0
0
66,924
Annual IC Time Burden (Hours)
1,234,195
0
0
0
0
1,234,195
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.