Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Forms and Documents

Document Name	Status
0752_Supporting Statement A_2025.docx Supporting Statement A	2025-07-29

IC Document Collections

IC ID	Document Title	Status
208153	RECORDS under 1.512(b)(3); written assurances from very small importer/certain small foreign supplier	Modified
208152	RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status	Modified
208151	RECORDS under 1.511(b); written assurances for food produced under dietary supplement CGMPs	Modified
208138	RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions	Modified
208137	RECORDS under 1.502(b); Controls for Low Acid Canned Food	Modified
208136	REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.	Modified
208135	REPORT under 1.501(c); exemption for food for research	Modified

ICR Details

OMB Control No: 0910-0752	ICR Reference No: 202507-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202204-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: OII
Title: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/29/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	15,591,118	0
Time Burden (Hours)	2,670,131	0
Cost Burden (Dollars)	0	0

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Abstract: The FSVP regulations require importers of most imported foods to take steps to verify that the foods they import into the United States are produced so they are safe and properly labeled with respect to allergens. These regulations are intended to work in tandem with other provisions of FSMA and the FD&C Act to create a more seamless system of food safety to protect U.S. consumers. Respondents to the collection are persons who import food into the United States subject to agency regulations.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 301 Name of Law: Food Safety Modernization Act
  

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 18682	05/01/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 35695	07/29/2025
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
RECORDS supporting FSVP including hazard determination; written procedures; reevaluation; audits; and corrective actions
RECORDS under 1.502(b); Controls for Low Acid Canned Food
RECORDS under 1.511(b); written assurances for food produced under dietary supplement CGMPs
RECORDS under 1.512(b)(1); document very small importer/certain foreign supplier status
RECORDS under 1.512(b)(3); written assurances from very small importer/certain small foreign supplier
REPORT under 1.501(c); exemption for food for research
REPORT under 1.509(a), 1.511(c), 1.512(b)(2); importer identification information for filing with CBP.

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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	15,591,118	0	0	0	15,591,118	0
Annual Time Burden (Hours)	2,670,131	0	0	0	2,670,131	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 made no adjustments to the currently approved burden estimate. However, a miscalculation in the burden estimate was identified during a review of the prior renewal and has been corrected.

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Annual Cost to Federal Government: $3,785,655

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.     No

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: 07/29/2025

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