Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)

Forms and Documents

Document Name	Status
Form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification Form and Instruction	Modified
Form CMS-116 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) Form and Instruction	Modified
CMS-116_Supporting_Statement 6-17-25 clean.docx Supporting Statement A	2025-09-12
CMS-116_Supporting_Statement 6-17-25 clean.docx Supporting Statement A	2025-09-12

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	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification
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: 202509-0938-012
Status: Active	Previous ICR Reference No: 202309-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/07/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/12/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved	03/31/2027
Responses	50,236	0	64,598
Time Burden (Hours)	50,236	0	64,598
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): US Code: 42 USC 493 Name of Law: Laboratory Requirement
   PL: Pub.L. 100 - 578 353 Name of Law: Clinical Laboratory Amendments of 1988
  

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:
	90 FR 29870	07/07/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 44192	09/12/2025
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 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	50,236	64,598	0	-14,362	0	0
Annual Time Burden (Hours)	50,236	64,598	0	-14,362	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden decrease is due to a decrease in the number of new laboratories participating in the CLIA program (from 24,400 to 17,900) and a decrease in the number of laboratories reporting changes (from 31,575 to 23,687). The number of laboratories using the form and burden hours has decreased from 64,598 to 50,236.

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Annual Cost to Federal Government: $567,461

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 09/12/2025

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