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: 0910-0614	ICR Reference No: 200805-0910-006
Status: Historical Active	Previous ICR Reference No: 200805-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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: 06/13/2008
	Date Received in OIRA: 05/13/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	06/30/2008
Responses	31	0	30
Time Burden (Hours)	728	0	720
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	31	30	1
Annual Time Burden (Hours)	728	720	8
Annual Cost Burden (Dollars)	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: The estimated total annual burden for this information collection was 720 hours in 2007. The current increase to 728 burden hours is attributed to the response to the public comment to account for any additional labeling changes not already covered by FDA regulations.

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