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OMB Control No: 0910-0256	ICR Reference No: 202610-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202412-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Infant Formula Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/16/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	8,044	8,140
Time Burden (Hours)	142,065	145,194
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	8,044	8,140	-96
Annual Time Burden (Hours)	142,065	145,194	-3,129
Annual Cost Burden (Dollars)	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: We have revised the information collection to include recommended activities and attendant burden found in the draft guidance titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula” (December 2024). At the same time, we have removed burden attributable to the guidance “Infant Formula Transition Plan for Exercise of Enforcement Discretion” (September 2022) as we are no longer experiencing disruptions in the supply of infant formula in the United States and therefore did not extend the guidance’s end date. Cumulatively the change results in 96 fewer responses and 3,129 fewer burden hours annually. We have made no adjustments or changes to any other of the information collection elements.

Annual Cost to Federal Government: $272,773

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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