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View ICR - OIRA Conclusion

OMB Control No: 0910-0442	ICR Reference No: 201105-0910-002
Status: Historical Active	Previous ICR Reference No: 200804-0910-007
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: 12/12/2011
	Date Received in OIRA: 05/10/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved	12/31/2011
Responses	17,915	0	259,177
Time Burden (Hours)	621,279	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	17,915	259,177	-241,262
Annual Time Burden (Hours)	621,279	3,407,184	-2,785,905
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 burden hours and responses have been adjusted as the result of re-estimating and re-evaluating submissions and tracking data by the agency. FDA attributes the reduction to the decreased number of tracking orders issued since original estimates were provided. More specifically, while the Safe Medical Devices Act of 1990 required tracking by all manufacturers of certain devices, FDAMA (enacted in 1997) provides that devices subject to tracking would be determined at the Agency's discretion and only upon order by FDA.

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