Form FDA 3503

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⚠️ Notice: This information collection may be referencing outdated material.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 Ma Revised Draft Form FDA 3503 for 2010.pdf Form

Information Collection (IC) Details

IC Title:	Form FDA 3503	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

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: 6	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 50 %

	Approved	Program Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	6	0	6
Annual IC Time Burden (Hours)	6	-42,554	42,560
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.