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601.12(f)(4)/601.45 - Changes to an Approved Application
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension
OMB: 0910-0338
IC ID: 209320
OMB.report
HHS/FDA
OMB 0910-0338
ICR 202001-0910-011
IC 209320
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:
2024-09-19 - No material or nonsubstantive change to a currently approved collection
2023-08-30 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Form 356h
601.12(f)(4)/601.45 - Changes to an Approved Application
Form and Instruction
356h Application to Market a New Drug or Biologic for Human U
FORM FDA 356h revised 2-28-14.pdf
Form and Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING F
FDA Form 2253.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
601.12(f)(4)/601.45 - Changes to an Approved Application
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Removed
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 601.12(f)(4)/601.45
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
FORM FDA 356h revised 2-28-14.pdf
Yes
Yes
Fillable Printable
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
FDA Form 2253.pdf
Yes
Yes
Fillable Printable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
114
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
95 %
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
0
0
0
-11,676
0
11,676
Annual IC Time Burden (Hours)
0
0
0
-116,760
0
116,760
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.