View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0511	ICR Reference No: 200611-0910-006
Status: Historical Active	Previous ICR Reference No: 200305-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Device User Fee Cover Sheet - FDA Form 3601
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: 01/09/2007
	Date Received in OIRA: 11/16/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	4,600	0	5,000
Time Burden (Hours)	1,380	0	1,500
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,600	5,000	-400
Annual Time Burden (Hours)	1,380	1,500	-120
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: Miscellaneous Actions

Short Statement: There was a slight decrease ( adjustment) of the previous burden estamte, i.e. from 1500 hrs to 1380 hrs due to the Center reevaluating the data for this collection of information

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