Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001

Forms and Documents

Document Name	Status
Form CMS-116 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) Form and Instruction	Modified
cms116_add A2LA.pdf Supplementary Document	2015-02-27
justification to add A2LA.docx Justification for No Material/Nonsubstantive Change	2015-02-27
CMS-116_Supporting_Statement_2013_sept_13_2013.doc Supporting Statement A	2014-03-06

IC Document Collections

IC ID	Document Title	Status
8193	Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0581	ICR Reference No: 201502-0938-012
Status: Historical Active	Previous ICR Reference No: 201403-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: 21532
Title: Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/03/2015
	Date Received in OIRA: 03/02/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	08/31/2017	08/31/2017
Responses	34,200	0	34,200
Time Burden (Hours)	25,650	0	25,650
Cost Burden (Dollars)	0	0	0

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Abstract: Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process.

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Authorizing Statute(s): PL: Pub.L. 100 - 578 353 Name of Law: Clinical Laboratory Amendments of 1988
   US Code: 42 USC 493 Name of Law: Laboratory Requirement
  

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:
	78 FR 75925	12/13/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 10160	02/24/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)	CMS-116	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification

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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	34,200	34,200	0	0	0	0
Annual Time Burden (Hours)	25,650	25,650	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: There are no program changes, however, the minor revisions to the form serve to shorten forms completion for the laboratory community and to enhance the data reporting of laboratory demographics and trends. The slight burden increase is due to new labs participating in the CLIA program.

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Annual Cost to Federal Government: $298,436

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 03/02/2015

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