View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0560	ICR Reference No: 202605-0910-007
Status: Active	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
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/21/2026
	Date Received in OIRA: 06/12/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2029	36 Months From Approved
Responses	2,981,605,207	0	0
Time Burden (Hours)	23,072,135	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,981,605,207	-5,371,888	2,986,977,095
Annual Time Burden (Hours)	23,072,135	4,227,299	18,844,836
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Christopher Colburn 301-415-6157 cxc7@nrc.gov

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