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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:
CDER
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 314.50-314.90
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
3331
NDA-Field Alert Report
FORM FDA 3331 1-19-2016.pdf
Yes
Yes
Fillable Fileable
Form
2252
Transmittal of Annual Report for Drug and Biologics for Human Use
FORM FDA 2252 9-11-14.pdf
Yes
Yes
Fillable Fileable
Form
2253
Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
FORM FDA 2253 9-11-14.pdf
Yes
Yes
Fillable Fileable
Form
356
Application to Market a New or Abbreviated New Drug or Biologic for Human Use
FORM 356h - 9-11-14.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 %
Approved
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
69,553
0
0
69,402
0
151
Annual IC Time Burden (Hours)
2,641,415
0
0
2,351,042
0
290,373
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
FDA Form 3331
FORM FDA 3331 1-19-2016.pdf
01/19/2016
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.