Exempt Infant Formula; Notification Requirements

Infant Formula Requirements

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0256 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 3978 Exempt Infant Formula; Notification Requirements Form and Instruction
0811 Exempt IF Production Guidance 2019.pdf www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm Other-Agency Guidance
0811 Exempt IF Production Guidance 2019.pdf www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm Other-Agency Guidance
Form FDA 3978 Infant Formula Tracking System 0256 IFTRACK II Wireframes v4.pdf Form and Instruction
Form FDA 3978 Infant Formula Tracking System 0256 IFTRACK II Wireframes v4.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Exempt Infant Formula; Notification Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 107.50(e)(2)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3978	Infant Formula Tracking System	0256 IFTRACK II Wireframes v4.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			0811 Exempt IF Production Guidance 2019.pdf	https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1	-2	3
Annual IC Time Burden (Hours)	4	-8	12
Annual IC Cost Burden (Dollars)	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.