Requirements for Quality Factors GMS Exemption

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⚠️ Notice: This information collection may be referencing outdated material.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 Requirements for Quality Factors GMS Exemption 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:	Requirements for Quality Factors GMS Exemption	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 106.96(c)

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4	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	36	2	34
Annual IC Time Burden (Hours)	720	40	680
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.