Foreign New Facility Registration New Data Required by FSMA

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

⚠️ Notice: This information collection may be referencing outdated material.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 Form 3537 Foreign New Facility Registration New Data Required by FSMA Form and Instruction
Draft Guidance Use of food Categories in Food Facility Registrations and Updates.pdf Other-Agency Guidance
FDA Form 3537 Food Facility Registration FDA Form 3537.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Foreign New Facility Registration New Data Required by FSMA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA Form 3537	Food Facility Registration	FDA Form 3537.pdf		Yes	Yes	Fillable Fileable
Other-Agency Guidance			Draft Guidance Use of food Categories in Food Facility Registrations and Updates.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 23,370	Number of Respondents for Small Entity: 99

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 94 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	23,370	23,370
Annual IC Time Burden (Hours)	9,348	9,348
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.