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⚠️ Notice: This information collection may be referencing outdated material.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

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

Information Collection (IC) Details

View Information Collection (IC)

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:

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 %

	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

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.