Submission of Petitions, Color Additive Including Labeling

Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; 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⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3503 Instructions.pdf www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM277923.pdf Instruction
Form FDA 3503 Food Additive; Color Additive; Food Master File; Color M Form FDA 3503.pdf www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076891.pdf Form

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 70.25 21 CFR 71.1

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			Form FDA 3503 Instructions.pdf	http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM277923.pdf	Yes	Yes	Fillable Fileable
Form	Form FDA 3503	Food Additive; Color Additive; Food Master File; Color Master File Submissions	Form FDA 3503.pdf	http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076891.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: 30 %

	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.