GRAS Notice under 21 CFR Parts 170 and 570

Substances Generally Recognized as Safe: Notification Procedure

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0342 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 3667 GRAS Notice under 21 CFR Parts 170 and 570 Form and Instruction
Form FDA 3667 GRAS Notification Form FDA 3667.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	GRAS Notice under 21 CFR Parts 170 and 570	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 570.210-570.270 21 CFR 170.210-170.270

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 3667	GRAS Notification	Form FDA 3667.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: 125	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 70 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	125	50	75
Annual IC Time Burden (Hours)	21,250	8,500	12,750
Annual IC Cost Burden (Dollars)	1,159,400	1,159,400	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.