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OMB Control No: 0938-0612	ICR Reference No: 199411-0938-008
Status: Historical Active	Previous ICR Reference No: 199205-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 -- REGULATION HSQ-176-FC, SECTION 42 CFR PART 493
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/15/1995
	Date Received in OIRA: 11/17/1994
Terms of Clearance: Approved for use through 02/98 with the understanding that the next submission for OMB review will: 1) provide estimates of the burden imposed by standard laboratory procedures (such as in sections 493.1105 -- Test requisition, 493.1107 - Test records, and 493.1109 -- Test report) since these procedures are referenced in Federal regulations and thus should be considered Federally imposed; and 2) provide estimates of particularly burdensome requirements such as cytotechnologist work load reporting in section 493.1257 -- Cytology and quality control procedures set forth in section 493.1217 -- Calibration and calibration verification.

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

Abstract: CLIA REQUIRES EVERY LABORATORY, WITH CERTAIN EXCEPTIONS CONTAINED IN T REGULATION, THAT PERFORMS TESTING ON HUMAN SPECIMENS TO MEET PERFORMAN REQUIREMENTS IN ORDER TO BE CERTIFIED BY DHHS. THIS RULE IMPLEMENTS T CERTIFICATE, LABORATORY STANDARDS, AND INSPECTION REQUIREMENTS OF CLIA

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 -- REGULATION HSQ-176-FC, SECTION 42 CFR PART 493	HCFA-R-26

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	149,700	149,700
Annual Time Burden (Hours)	17,888,923	17,888,923
Annual Cost Burden (Dollars)	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

View ICR - OIRA Conclusion