Registration of Food Facilities

Forms and Documents

Document Name	Status
Form FDA 3537 New domestic facility registration Form	Modified
Form FDA 3537a Registration cancellations Form	Modified
Form FDA 3537 Registration updates Form	Modified
Form FDA 3537 New foreign facility registration Form	Modified
Form FDA 3537 Biennial renewal of registration Form	Modified
0502 Food Facility Registration SSA 2025 Ext.docx Supporting Statement A	2025-09-29

IC Document Collections

IC ID	Document Title	Status
6215	New domestic facility registration Form	Modified
46700	Registration cancellations Form	Modified
46699	Registration updates Form	Modified
46698	New foreign facility registration Form	Modified
222475	U.S. Agency verification	Modified
222474	Third party registration verification	Modified
203888	Biennial renewal of registration Form	Modified

ICR Details

OMB Control No: 0910-0502	ICR Reference No: 202509-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202205-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Registration of Food Facilities
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2025
Responses	260,805	279,927
Time Burden (Hours)	361,775	278,382
Cost Burden (Dollars)	0	0

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Abstract: Respondents to the information collection are manufacturers, processors, holders, and distributors of foods who must register with the agency. Through this registration program and the information provided under the regulations, the agency is able to identify firms in the event of food-related emergencies as well as ensure that contaminated food products are quickly and efficiently removed from the marketplace.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 27619	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 46222	09/25/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Biennial renewal of registration	FDA 3537	Food Facility Registration
New domestic facility registration	FDA 3537	Food Facility Registration
New foreign facility registration	FDA 3537	Food Facility Registration
Registration cancellations	FDA 3537a	Cancellation of Food Facility Registration
Registration updates	FDA 3537	Food Facility Registration
Third party registration verification
U.S. Agency verification

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	260,805	279,927	0	0	-19,122	0
Annual Time Burden (Hours)	361,775	278,382	0	0	83,393	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 83,393 hours (from 278,382 to 361,775), although the number of responses decreased by 19,122 (from 279,927 to 260,805). Among other considerations, we attribute this adjustment primarily due to a significant increase in the number of foreign facility registrations and updates submitted coupled with a drastic decrease in the number of cancellations and third-party registration and U.S. Agent verifications submitted.

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Annual Cost to Federal Government: $2,387,558

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/30/2025

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