Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications

Forms and Documents

Document Name	Status
0910-0750_Supporting Statement A_2025.docx Supporting Statement A	2025-09-29

IC Document Collections

IC ID	Document Title	Status
208274	Reporting ABs and CBs Other-FDA 3997 eForm User Guide	Modified
208272	Certification bodies (CBs) - recordkeeping	Modified
208271	Accreditation bodies (ABs) - recordkeeping	Modified
208270	Contract Modifications	Modified

ICR Details

OMB Control No: 0910-0750	ICR Reference No: 202411-0910-012
Status: Received in OIRA	Previous ICR Reference No: 202206-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications
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	65,459	65,560
Time Burden (Hours)	33,014	33,753
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from recognized accreditation bodies and accredited auditors/certification bodies regarding food and feed products of eligible entities that offer their food or feed for import to the United States. Eligible entities will participate in FDA Third Party program to obtain food safety audits and certifications from third party auditors/certification bodies on an annual basis for the purpose of verifying that the food is produced in compliance with applicable regulations.

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Authorizing Statute(s): US Code: 21 USC 384d Name of Law: FFDCA
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 307 Name of Law: Food Safety Modernization Act

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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 27625	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 46602	09/29/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Accreditation bodies (ABs) - recordkeeping
Certification bodies (CBs) - recordkeeping
Contract Modifications
Reporting ABs and CBs

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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	65,459	65,560	0	0	-101	0
Annual Time Burden (Hours)	33,014	33,753	0	0	-739	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 our 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: $0

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: 09/30/2025

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