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OMB Control No: 0938-0581	ICR Reference No: 202509-0938-012
Status: Received in OIRA	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	Date Submitted to OIRA: 09/12/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2027
Responses	50,236	64,598
Time Burden (Hours)	50,236	64,598
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	50,236	64,598	-14,362
Annual Time Burden (Hours)	50,236	64,598	-14,362
Annual Cost Burden (Dollars)	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.

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

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