Information Collection

New domestic facility registration

IC 6215 under ICR 202008-0910-015 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
0502 - Form FDA 3537- Added Fields.pdf	Other-e-Form screenshots
FDA 3537 Food Facility Registration Form FDA 3537 FSMA revisions.pdf	Form and Instruction

IC Title:

New domestic facility registration

Agency IC Tracking Number:

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.	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
Other-e-Form screenshots			0502 - Form FDA 3537- Added Fields.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: 9,795

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
	Approved	Previously Approved
Annual Number of Responses for this IC	9,795	9,795
Annual IC Time Burden (Hours)	26,447	26,447
Annual IC Cost Burden (Dollars)	9,344,281	9,344,281

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.