Clinical Laboratory Improvement Amendments (CLIA) and the ICRs Contained in the Supporting Regulations in 42 CFR 493.1-.2001

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
8211	Clinical Laboratory Improvement Amendments (CLIA) and the ICRs Contained in the Supporting Regulations in 42 CFR 493.1-.2001 Form	Migrated

ICR Details

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

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Abstract: The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entities compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by HHS. HHS conducts inspections to determine a laboratory's compliance with the CLIA requirements. CLIA implements the certificate, laboratory standards, and inspection requirements.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Clinical Laboratory Improvement Amendments (CLIA) and the ICRs Contained in the Supporting Regulations in 42 CFR 493.1-.2001	HCFA-R-26

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	631,459	149,700	0	481,759	0	0
Annual Time Burden (Hours)	17,888,923	17,888,923	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	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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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/26/1998

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