View Information Collection Request (ICR) Package

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: 0910-0734	ICR Reference No: 201601-0910-002
Status: Historical Active	Previous ICR Reference No: 201211-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/20/2016
	Date Received in OIRA: 01/12/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	449	0	203
Time Burden (Hours)	1,880	0	824
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	449	203	246
Annual Time Burden (Hours)	1,880	824	1,056
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: The adjustments to the currently approved burden hours of 824 are based on the latest data. The new burden hours are 1,880 total hours. This is a renewal of information collection without any program changes.

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