601.12(c)(1) and (c)(3) - Changes to an Approved Application

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

Documents and Forms

Document Name Document Type
Form 356h 601.12(c)(1) and (c)(3) - 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

IC Title:	601.12(c)(1) and (c)(3) - Changes to an Approved Application	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.12(c)(3) 21 CFR 601.12(c)(1)

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 120	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	Previously Approved
Annual Number of Responses for this IC	574	574
Annual IC Time Burden (Hours)	28,700	28,700
Annual IC Cost Burden (Dollars)	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.