601.12(c)(5) - Changes to an Approved Application

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

⚠️ Notice: This information collection may be referencing outdated material.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 2567 601.12(c)(5) - Changes to an Approved Application Form and Instruction
2567 Transmittal of Labels and Circulars FORM 2567 11-5-13.pdf 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

Information Collection (IC) Details

IC Title:	601.12(c)(5) - Changes to an Approved Application	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.12(c)(5)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	2567	Transmittal of Labels and Circulars	FORM 2567 11-5-13.pdf		Yes	Yes	Fillable Printable
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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 18	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Previously Approved
Annual Number of Responses for this IC	29	29
Annual IC Time Burden (Hours)	1,450	1,450
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.