Submission of Petitions: Food 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⚠️ Notice: This information collection may be referencing outdated material.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
Form Form FDA 3503 Submission of Petitions: Food Additive Including Labeling Form
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: Food Additive Including Labeling	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 171.1

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
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
Instruction			Form FDA 3503 Instructions.pdf	http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM277923.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: 3	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	3	3
Annual IC Time Burden (Hours)	21,279	21,279
Annual IC Cost Burden (Dollars)	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.