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: 0910-0442	ICR Reference No: 200804-0910-007
Status: Historical Active	Previous ICR Reference No: 200503-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Device Tracking
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 with change	Conclusion Date: 05/29/2008
	Date Received in OIRA: 04/25/2008
Terms of Clearance: This information collection request is approved conditional upon the following term of clearance: FDA will amend the guidance document to add the PRA burden statement and OMB number and expiration date for this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2011	36 Months From Approved	05/31/2008
Responses	259,177	0	1,481,939
Time Burden (Hours)	3,407,184	0	3,407,184
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	259,177	1,481,939	-1,222,762
Annual Time Burden (Hours)	3,407,184	3,407,184	0
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:

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