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View ICR - OIRA Conclusion

OMB Control No: 0938-0612	ICR Reference No: 200706-0938-009
Status: Historical Active	Previous ICR Reference No: 200402-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR 493.1-.2001 (CMS-R-26)
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: 12/07/2007
	Date Received in OIRA: 06/29/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	36 Months From Approved	12/31/2007
Responses	756,240	0	111,354,920
Time Burden (Hours)	11,363,280	0	9,823,934
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	756,240	111,354,920	-110,598,680
Annual Time Burden (Hours)	11,363,280	9,823,934	1,539,346
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: There are no program changes. There has been a slight increase in burden based on calculations for labs under Section 493.1274 Cytology. In the former burden write-up from 2003, we only spoke about the 30% of the total Cytology labs that we had anticipated to be affected by the 2003 CLIA Final Rule. At that time, we estimated that 70% of the Cytology labs were already in compliance; therefore, we did not include all of those hours for that population. We have now calculated the burden using the entire universe of Cytology labs which total 4,478. This is the reason for the burden increase.

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