Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
PRA - 0560 Comment FDA_2025_N_4250_0002-020926.pdf	Public Comments	Uploaded 2026-05-28	Available
PRA-0560-SSA_2026.docx	Supporting Statement A	Uploaded 2026-05-28	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6282	Additional Traceability Records for Certain Foods - Recordkeeping		Modified
257025	Additional Traceability Records for Certain Foods - Reporting		Modified
183803	ONE-TIME Burden to review and implement new requirements		Removed

ICR Details

OMB Control No: 0910-0560	ICR Reference No: 202605-0910-007
Status: Received in OIRA	Previous ICR Reference No: 202211-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods
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: 06/12/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,981,605,207	0
Time Burden (Hours)	23,072,135	0
Cost Burden (Dollars)	0	0

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Abstract: This information collection request supports agency rulemaking to establish additional recordkeeping requirements pertaining to the traceability of foods. Respondents to the information collection are persons who manufacture, process, pack, or hold foods.

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

Citations for New Statutory Requirements: PL: Pub.L. 111 - 353 101 Name of Law: FSMA; Additional Traceability Records for Certain Foods

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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 57074	12/09/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 35486	06/11/2026
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Additional Traceability Records for Certain Foods - Recordkeeping
Additional Traceability Records for Certain Foods - Reporting
ONE-TIME Burden to review and implement new requirements

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ICR Summary of Burden

table that charts list 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	2,981,605,207	0	0	-5,371,888	0	2,986,977,095
Annual Time Burden (Hours)	23,072,135	0	0	4,227,299	0	18,844,836
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Our estimated burden for the information collection reflects an overall increase of 4,227,299 hours but a corresponding decrease of 5,371,888 records. We attribute the increase in hours to the return of burden for part 1, subpart J along with adjustments to the average burden per recordkeeping. We attribute the decrease in records due to the reconsideration of activities such as learning new requirements and training staff and incorporating the time for these activities as part of the actual information collection.

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Annual Cost to Federal Government: $583,500

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: 06/12/2026

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