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View ICR - OIRA Conclusion

OMB Control No: 0910-0598	ICR Reference No: 201304-0910-004
Status: Historical Active	Previous ICR Reference No: 201002-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 19288
Title: CLIA Waiver Applications
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: 07/02/2013
	Date Received in OIRA: 04/23/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	07/31/2013
Responses	40	0	40
Time Burden (Hours)	160,000	0	143,200
Cost Burden (Dollars)	350,000	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	40	40	0
Annual Time Burden (Hours)	160,000	143,200	16,800
Annual Cost Burden (Dollars)	350,000	0	350,000

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: FDA revised the title of the information collection for clarity. Based on information received from industry in comments on the 60-day Federal Register notice, we have adjusted the average burden per response for CLIA waiver applications, as well as the estimated operating and maintenance costs. As a result, the total estimated reporting burden has increased by 16,800 hours and the operating and maintenance costs have increased by $238,800 from $66,200 to $350,000. FDA did not originally report the $66,200 in ICRAS (however, it was in the last Supporting Statement), so the whole $350,000 will show up as new.

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