Information Collection

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

IC 204985 under ICR 202512-0910-012 · OMB 0910-0495.

Documents and Forms

Document Name Document Type
Form FDA 3480 Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File Prenotification Consultation or Master File (concerning a food contact substance) Form
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

View Information Collection (IC)

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

Is this a Common Form? No		IC Status: Unchanged

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	Previously Approved
Annual Number of Responses for this IC	150	150
Annual IC Time Burden (Hours)	75	75
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.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].