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: 0910-0577	ICR Reference No: 201504-0910-002
Status: Historical Active	Previous ICR Reference No: 201202-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
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: 05/27/2015
	Date Received in OIRA: 04/23/2015
Terms of Clearance: FDA is reminded to submit collections as a "revision" when there is an associated program change (i.e., not a change to agency estimate).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	422	0	404
Time Burden (Hours)	43	0	40
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	422	404	18
Annual Time Burden (Hours)	43	40	3
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The number of respondents has increased due to an increase in the number of establishments registered in the FURLS database as reprocessors of SUDs.

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