Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0256	ICR Reference No: 202303-0910-019
Status: Historical Active	Previous ICR Reference No: 202209-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Infant Formula Requirements
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: 05/01/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/27/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved	04/30/2023
Responses	8,130	0	8,110
Time Burden (Hours)	132,340	0	132,715
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	8,130	8,110	20
Annual Time Burden (Hours)	132,340	132,715	-375
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: Since OMB approval of our emergency request for 115 responses and 4,185 hours, we have adjusted the number of submissions per respondent under the enforcement discretion policy. At the same time, we have added 20 responses and 5 hours which we attribute to the voluntary submission of sample testing results as recommended in our constituent letter of March 8, 2023. Cumulatively these changes and adjustments result in an increase of 20 responses and a decrease of 375 hours annually to the information collection.

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