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View ICR - OIRA Conclusion

OMB Control No: 0938-0612	ICR Reference No: 202606-0938-021
Status: Active	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
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/26/2026
	Date Received in OIRA: 07/02/2026
Terms of Clearance: This ICR, 0938-0612, is approved for 1 year under the following terms: the ICR associated with the proposed rule titled, Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes [RIN: 0938-AV89], must be updated to reflect the increased burden hours under the proposed rule and resubmitted concurrent with publication of the proposed rule. Any further burden changes in the final rule must be reflected in a revised, resubmitted ICR upon its publication.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2027	36 Months From Approved	06/30/2027
Responses	84,959,102	0	84,959,102
Time Burden (Hours)	15,905,686	0	15,839,779
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	84,959,102	84,959,102	0
Annual Time Burden (Hours)	15,905,686	15,839,779	65,907
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: No

Burden Reduction Due to:

Short Statement: This revision does not add any one time burden hours. There are 200 ongoing annual hours (see the table above) added due to incorrect calculations. Costs increased due to updating labor wages.

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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