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: 200004-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Device Tracking (Amended)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/30/2000
	Date Received in OIRA: 04/18/2000
Terms of Clearance: This collection is approved as it pertains to the previous rule approved in 1993. OMB files comment on this collection as it pertains to the new proposed rule, and FDA will resubmit this collection with any changes along with the final rule. In drafting the final rule and paperwork submission, FDA should consider uses of appropriate technology (e.g. electronic submission of information) that could reduce burden. This collection was used without OMB approval by FDA in conjunction with a previous rule. FDA will take steps to ensure that this does not happen with future collections.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2003	05/31/2003
Responses	10,175,490	0	0
Time Burden (Hours)	2,790,693	0	0
Cost Burden (Dollars)	0	0	0

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