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View ICR - OIRA Conclusion

OMB Control No: 0910-0381	ICR Reference No: 202412-0910-006
Status: Active	Previous ICR Reference No: 202404-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Food Labeling Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/28/2025
	Date Received in OIRA: 12/20/2024
Terms of Clearance: Approved, following a delay of the final rule's effective date (published on 2/25/2025, 90 FR 10592).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2028	36 Months From Approved	05/31/2027
Responses	3,006,114	0	3,001,845
Time Burden (Hours)	2,214,100	0	2,210,781
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	3,006,114	3,001,845	4,269
Annual Time Burden (Hours)	2,214,100	2,210,781	3,319
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The information collection includes a one-time burden of 7,109 responses and 7,109 hours to reflect relabeling activities. (For the purpose of ROCIS entry, however, we have entered one-third of the respondents, one-third of the total annualized burden hours and one-third of the total capital costs for the one-time relabeling.) The information collection will also result in an additional 1,900 records and 950 hours annually, which we attribute to new recordkeeping requirements.

Annual Cost to Federal Government: $6,542,114

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: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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