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View ICR - OIRA Conclusion

OMB Control No: 0910-0256	ICR Reference No: 201903-0910-014
Status: Historical Active	Previous ICR Reference No: 201804-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Infant Formula Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/19/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/18/2019
Terms of Clearance: Approved with the understanding that existing collecting 0910-0811 will be discontinued.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	05/31/2021	05/31/2021
Responses	7,997	0	6,092
Time Burden (Hours)	128,838	0	42,940
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	7,997	6,092	2	1,903
Annual Time Burden (Hours)	128,838	42,940	8	85,890
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: Consolidating recordkeeping from ICR 0910-0811.

Annual Cost to Federal Government: $981,052

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? Uncollected

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