Prenotification Consultation or Master File (concerning a food contact substance)

Food Additives; Food Contact Substances Notification System

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0495 can be found here:

Documents and Forms

Document Name Document Type
0495 - Form FDA 3480-instructions_exp2022.pdf Instruction
0495 - Form FDA 3480-instructions_exp2022.pdf Instruction
FDA 3480 Food Contact Substance Notification For New Use Pre-Noti 0495 - Form FDA 3480_exp2022.pdf Form
FDA 3480 Food Contact Substance Notification For New Use Pre-Noti 0495 - Form FDA 3480_exp2022.pdf Form

Information Collection (IC) Details

IC Title:	Prenotification Consultation or Master File (concerning a food contact substance)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 170 21 CFR 171

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			0495 - Form FDA 3480-instructions_exp2022.pdf		Yes	No	Printable Only
Form	FDA 3480	Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File	0495 - Form FDA 3480_exp2022.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: 150	Number of Respondents for Small Entity: 6

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	150	-40	190
Annual IC Time Burden (Hours)	75	-20	95
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.