View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0442	ICR Reference No: 200202-0910-002
Status: Historical Active	Previous ICR Reference No: 200004-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Device Tracking Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/12/2002
	Date Received in OIRA: 02/07/2002
Terms of Clearance: Approved consistent with clarification in FDA memo of 4-11-02.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2005	04/30/2005	05/31/2003
Responses	10,174,876	0	10,175,490
Time Burden (Hours)	2,790,329	0	2,790,693
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	10,174,876	10,175,490	-614
Annual Time Burden (Hours)	2,790,329	2,790,693	-364
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: Yes

Burden Reduction Due to:

Short Statement:

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