View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0938-0612	ICR Reference No: 199802-0938-009
Status: Historical Active	Previous ICR Reference No: 199411-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Clinical Laboratory Improvement Amendments (CLIA) and the ICRs Contained in the Supporting Regulations in 42 CFR 493.1-.2001
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: 04/27/1998
	Date Received in OIRA: 02/26/1998
Terms of Clearance: OMB approves these requirements for use through 04/2001. However OMB does not approve HCFA's requested burden adjustment at this time because of its significant implications. Prior to the next submission for OMB review, HCFA must present evidence of consultation with a representative group of industry respondents to determine whether various CLIA requirements are in fact considered "usual and customary" by the private sector, rather than Federal mandates.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2001	05/31/2001	04/30/1998
Responses	631,459	0	149,700
Time Burden (Hours)	17,888,923	0	17,888,923
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	631,459	149,700	481,759
Annual Time Burden (Hours)	17,888,923	17,888,923	0
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:

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