Submission of Petitions Generally Recognized As Safe Affirmation

Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0016 can be found here:

Documents and Forms

Document Name Document Type
Instructions - Revised Draft Form FDA 3503.pdf Instruction
3503 Food additive Petition; Color Additive Petition;; Food M Revised Draft Form FDA 3503 for 2010.pdf Form

Information Collection (IC) Details

IC Title:	Submission of Petitions Generally Recognized As Safe Affirmation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 170.35

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			Instructions - Revised Draft Form FDA 3503.pdf		Yes	Yes	Printable Only
Form	3503	Food additive Petition; Color Additive Petition;; Food Master File; Color Master File	Revised Draft Form FDA 3503 for 2010.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: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	1	-1	2
Annual IC Time Burden (Hours)	2,614	2,612	2
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.