Information Collection

New foreign facility registration

IC 46698 under ICR 202607-0910-005 · OMB 0910-0502.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3537 Food Facility Registration New foreign facility registration	Form
Form FDA 3537 DHHS/FDA Food Facility Registration New foreign facility registration	Form and Instruction
Food Facility Registration webpage.jpeg	Other-Online Registration of Food Fa
FIS landing page.jpeg	Other-FIS landing page
Food Facility Registration burden statement.jpeg	Other-Instruction Burden Statement
Food Facility Registration User Guide instructions.jpeg	Instruction
Food Facility Registration Submission.jpeg	Other-Registration of Food Facilitie
Form 3537 - Baby Formula Mockups.pdf	Other-Mock Up Draft
FDA 3537 Food Facility Registration Form FDA 3537_exp 08.31.22.pdf	Form
FDA 3537 DHHS/FDA Food Facility Registration Form FDA 3537_2026-IF cat draft.pdf	Form and Instruction

IC Title:

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.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3537	Yes	Yes	Fillable Fileable
Other-Online Registration of Food Facilities Webpage		Yes	No	Printable Only
Other-FIS landing page		Yes	No	Printable Only
Other-Instruction Burden Statement		Yes	No	Printable Only
Instruction		Yes	No	Printable Only
Other-Registration of Food Facilities and Other Submissions Webpage		Yes	No	Printable Only
Form and Instruction	FDA 3537	Yes	Yes	Fillable Fileable
Other-Mock Up Draft		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 17,592

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
	Requested	Previously Approved
Annual Number of Responses for this IC	17,592	17,592
Annual IC Time Burden (Hours)	153,050	153,050
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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