View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0577	ICR Reference No: 201202-0910-003
Status: Historical Active	Previous ICR Reference No: 200902-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
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: 05/11/2012
	Date Received in OIRA: 02/07/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2015	36 Months From Approved	05/31/2012
Responses	404	0	1,000
Time Burden (Hours)	40	0	100
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	404	1,000	-596
Annual Time Burden (Hours)	40	100	-60
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 number of disclosures has decreased from 1,000 to 404 due to a decrease in the number of SUDs listed by reprocessors. This adjustment has resulted in a 60-hour decrease of the total hour burden.

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