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View ICR - OIRA Conclusion

OMB Control No: 0910-0256	ICR Reference No: 201502-0910-012
Status: Historical Active	Previous ICR Reference No: 201407-0910-003
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: 04/10/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/04/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	10/31/2017
Responses	16,901	0	16,901
Time Burden (Hours)	78,536	0	78,513
Cost Burden (Dollars)	765,439	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	16,901	16,901	0
Annual Time Burden (Hours)	78,536	78,513	23
Annual Cost Burden (Dollars)	765,439	0	765,439

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: Burden increase of 23 hours reflects one-time burden for respondents to include selenium content in nutrient labeling. This is discussed in the accompanying supporting statement.