Information Collection

601.12(f)(2) - Changes to an Approved Application

IC 209319 under ICR 201701-0910-012 · OMB 0910-0338.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 356h 601.12(f)(2) - 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

IC Title:

601.12(f)(2) - 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(f)(2)

Information Collection Instruments:

table that charts list of 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: 60

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	109	-19	128
Annual IC Time Burden (Hours)	2,180	-380	2,560
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.