Information Collection

New foreign facility registration

IC 46698 under ICR 202205-0910-011 · OMB 0910-0502.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0502 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3537 New foreign facility registration	Form
Food Facility Registration webpage.jpeg	Other-Online Registration of Food Fa
Food Facility Registration webpage.jpeg	Other-Online Registration of Food Fa
FIS landing page.jpeg	Other-FIS landing page
FIS landing page.jpeg	Other-FIS landing page
Food Facility Registration burden statement.jpeg	Other-Instruction Burden Statement
Food Facility Registration burden statement.jpeg	Other-Instruction Burden Statement
Food Facility Registration User Guide instructions.jpeg	Instruction
Food Facility Registration User Guide instructions.jpeg	Instruction
Food Facility Registration Submission.jpeg	Other-Registration of Food Facilitie
Food Facility Registration Submission.jpeg	Other-Registration of Food Facilitie
FDA 3537 Food Facility Registration Form FDA 3537_exp 08.31.22.pdf	Form
FDA 3537 Food Facility Registration Form FDA 3537_exp 08.31.22.pdf	Form

IC Title:

New foreign facility registration

Agency IC Tracking Number:

CFSAN

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.230-1.233

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3537	Food Facility Registration	Form FDA 3537_exp 08.31.22.pdf	Yes	Yes	Fillable Fileable
Other-Online Registration of Food Facilities Webpage			Food Facility Registration webpage.jpeg	Yes	No	Printable Only
Other-FIS landing page			FIS landing page.jpeg	Yes	No	Printable Only
Other-Instruction Burden Statement			Food Facility Registration burden statement.jpeg	Yes	No	Printable Only
Instruction			Food Facility Registration User Guide instructions.jpeg	Yes	No	Printable Only
Other-Registration of Food Facilities and Other Submissions Webpage			Food Facility Registration Submission.jpeg	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 13,697

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	13,697	0	13,697
Annual IC Time Burden (Hours)	119,164	0	119,164
Annual IC Cost Burden (Dollars)	0	-12,904,008	12,904,008

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.