New foreign facility registration

Registration of Food Facilities

⚠️ Notice: This information collection may be referencing outdated material.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 and Instruction
FDA 3537 Food Facility Registration Form FDA 3537 FSMA revisions.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	New foreign facility registration	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1.230-1.233

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3537	Food Facility Registration	Form FDA 3537 FSMA revisions.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: 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	Previously Approved
Annual Number of Responses for this IC	13,697	13,697
Annual IC Time Burden (Hours)	119,164	119,164
Annual IC Cost Burden (Dollars)	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.