Information Collection

New domestic facility registration

IC 6215 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 DHHS/FDA Food Facility Registration New domestic 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 Submission.jpeg	Other- Registration of Food Faciliti
Food Facility Registration User Guide instructions.jpeg	Instruction
Form 3537 - Baby Formula Mockups.pdf	Other-Mock up Draft
FDA 3537 DHHS/FDA Food Facility Registration Form FDA 3537_2026-IF cat draft.pdf	Form and Instruction
0502 - 83-C_2026-IF catergories.docx OMB 0910-0502 83-C Infant Formula Categories	IC Document
Form 3537 - Baby Formula Mockups.pdf Form 3537 - Baby Formula Markups	IC Document

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
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
Other- Registration of Food Facilities and Other Submissions Webpage		Yes	No	Printable Only
Instruction		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: 7,420

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	7,420	7,420
Annual IC Time Burden (Hours)	20,034	20,034
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB 0910-0502 83-C Infant Formula Categories		07/19/2026
Form 3537 - Baby Formula Markups		07/19/2026

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].