Submission of Petitions, Color Additive Including Labeling

Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503

⚠️ Notice: This information collection may be referencing outdated material.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
FDA 3503 Instructions.pdf Instruction
3503 Food and Color Additive Petition and Food and Color Mast FDA 3503.pdf Form

Information Collection (IC) Details

IC Title:	Submission of Petitions, Color Additive Including Labeling	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 71.1 21 CFR 70.25

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			FDA 3503 Instructions.pdf		Yes	Yes	Fillable Fileable
Form	3503	Food and Color Additive Petition and Food and Color Master File	FDA 3503.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: 2	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 80 %

	Approved	Previously Approved
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	2,674	2,674
Annual IC Cost Burden (Dollars)	5,600	5,600

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.