Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)

Forms and Documents

Document	Type	Status	Availability
CMS-R-26-Supporting_Statement_clean 04012026.docx	Supporting Statement A	Uploaded 2026-07-02	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
264338	Section 493.1359- 493.1489-1491		Unchanged
264337	Section 493.1359- 493.1489-1491		Unchanged
264336	Section 493.1278		Unchanged
225813	Section 493.1269		Unchanged
225812	Section 493.1274		Unchanged
225811	Section 493.1263		Unchanged
225810	Section 493.1262		Unchanged
225809	Section 493.1261		Unchanged
225808	Section 493.1256		Unchanged
225807	Section 493.1255		Unchanged
225806	Sections 493.1252 and 493.1254		Unchanged
225805	Section 493.1251		Unchanged
225804	Section 493.1242		Unchanged
225803	Section 493.1299		Unchanged
225802	Section 493.801 and 493.803	Instruction	Unchanged

ICR Details

OMB Control No: 0938-0612	ICR Reference No: 202606-0938-021
Status: Received in OIRA	Previous ICR Reference No: 202401-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2027
Responses	84,959,102	84,959,102
Time Burden (Hours)	15,839,779	15,839,779
Cost Burden (Dollars)	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): US Code: 42 USC 493 Name of Law: Laboratory Requirements
   PL: Pub.L. 100 - 578 353 Name of Law: Health Service Act
  

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:
	91 FR 21502	04/22/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 40538	07/02/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 15

IC Title	Form No.	Form Name
Section 493.1278
Section 493.1242
Section 493.1251
Section 493.1255
Section 493.1256
Section 493.1261
Section 493.1262
Section 493.1263
Section 493.1269
Section 493.1274
Section 493.1299
Section 493.1359- 493.1489-1491
Section 493.1359- 493.1489-1491
Section 493.801 and 493.803
Sections 493.1252 and 493.1254

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ICR Summary of Burden

	Total Request	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	84,959,102	84,959,102	0	0	0	0
Annual Time Burden (Hours)	15,839,779	15,839,779	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: $15,022

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: 07/02/2026

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