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OMB Control No: 0938-0612	ICR Reference No: 202610-0938-008
Status: Received in OIRA	Previous ICR Reference No: 202606-0938-021
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 11/03/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2027
Responses	40,605,495	84,959,102
Time Burden (Hours)	8,726,395	15,905,686
Cost Burden (Dollars)	0	0

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. This is a revision of the information collection. Based on notice of proposed rulemaking, CMS-3478-P (91 FR 64480) published on October 8, 2026, we are revising the ICR.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV89	Proposed rulemaking	91 FR 64480	10/08/2026

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	40,605,495	84,959,102	-44,353,607
Annual Time Burden (Hours)	8,726,395	15,905,686	-7,179,291
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This decrease of 7,179,291 hours from the previous collection is a result of a combination of issues. Following the end of the SARS-CoV-2 Public Health Emergency (PHE), the number of laboratories for each certificate type decreased. There are 27,040 fewer labs than in the previous collection, including 15,691 fewer CoC and CoA labs. The previous collection also contained errors in the number of labs included in the calculations. At §493.1256, both CoC and CoA were included in the previous collection. Based on a review of historical collections, this should include only CoC labs. At §493.1261, all microbiology labs were included in the previous collection instead of only those with the subspecialty of bacteriology. In addition, the data now available is more specific. At §493.1299, the previous collection included all labs instead of only non-waived labs. Waived labs are not subject to §493.1299 but were not previously separated out in the data.

Annual Cost to Federal Government: $12,018

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

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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