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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

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

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

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