GRAS Notice for 21 CFR 170.36

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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3667 GRAS Notice for 21 CFR 170.36 Form
Instructions for completing Form 3667.pdf Instruction
FDA 3667 GRAS Notice FDA-3667_V06.pdf Form

Information Collection (IC) Details

IC Title:	GRAS Notice for 21 CFR 170.36	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 170.36 21 CFR 570.36

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3667	GRAS Notice	FDA-3667_V06.pdf		Yes	Yes	Fillable Fileable
Instruction			Instructions for completing Form 3667.pdf		Yes	No	Printable Only

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: 6

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	60	30	30
Annual IC Time Burden (Hours)	9,900	4,950	4,950
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.