Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR 493.1-.2001 (CMS-R-26)

Forms and Documents

Document Name	Status
2007%20CLIA%20Aggregate%20Burden%20Chart(1).xls Supplementary Document	2007-11-30
60-day FR.pdf Supplementary Document	2007-06-21
CMS-R-26 2007 Form 83 - Part 2 Worksheet STATE LOCAL.doc Supplementary Document	2007-06-21
CMS-R-26 2007 Form 83 - Part 2 Worksheet PRIVATE SECTOR.doc Supplementary Document	2007-06-21
CMS-R-26 2007 Form 83 - Part 1 Worksheet.doc Supplementary Document	2007-06-21
CMS-R-26 2007 Form 83 - Part 2 Worksheet FEDERAL.doc Supplementary Document	2007-06-21
CMS-R-26 Current Supporting Statement 10-5-2007.doc Supporting Statement A	2007-11-30

IC Document Collections

IC ID	Document Title	Status
8213	Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR Part 493.1-.2001 (CMS-R-26)	Modified
180973	CLIA and ICRs contained in 493.1-.2001	New
180972	CLIA and ICRs contained in 42 CFR 493.1-.2001 (CMS-R-26)	New

ICR Details

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

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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): PL: Pub.L. 100 - 578 353 Name of Law: Health Service Act
   US Code: 42 USC 493 Name of Law: Laboratory Requirements
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 18658	04/13/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 35711	06/29/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
CLIA and ICRs contained in 493.1-.2001
Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR Part 493.1-.2001 (CMS-R-26)
CLIA and ICRs contained in 42 CFR 493.1-.2001 (CMS-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	756,240	111,354,920	0	0	-110,598,680	0
Annual Time Burden (Hours)	11,363,280	9,823,934	0	0	1,539,346	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: 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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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: 06/29/2007

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