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

Documents and forms in this information collection
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

IC Title:

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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction					Yes	No	Printable Only
Form	FDA 3480				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 %

table that charts list of burden
	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

table that charts IC Documents
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.

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