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: 201702-0910-006
Status: Historical Active	Previous ICR Reference No: 201502-0910-012
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: 03/01/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/15/2017
Terms of Clearance: Given that draft electronic Form FDA 3978 is being deployed as a pilot, if FDA decides to continue use of the electronic form the agency must report findings of the pilot to OMB as part of the renewal request.

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

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	16,901	16,901
Annual Time Burden (Hours)	78,536	78,536
Annual Cost Burden (Dollars)	765,439	765,439

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: 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.