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HHS/CMS RIN: 0938-AT47 Publication ID: Fall 2023 
Title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326) 

This final rule updates histocompatibility and personnel regulations under CLIA to address obsolete regulations and updates regulations to incorporate changes in technology. This rule also makes a change to regulations related to the imposition of alternative sanction for Certificate of Waiver (CoW) laboratories in order to more closely align the regulations with the CLIA statute.  Additionally, this rule updates fees for determination of program compliance and additional fees for laboratories established under CLIA regulations as well as the collection of other fees we are authorized to collect, such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions.  

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 493   
Legal Authority: 42 U.S.C. 263a    42 U.S.C. 1302    42 U.S.C. 1395x(e)   
Legal Deadline:  None
Action Date FR Cite
RFI Notice With Comment Period  01/09/2018  83 FR 1004   
RFI Comment Period End  03/12/2018 
NPRM  07/26/2022  87 FR 44896   
NPRM Comment Period End  08/25/2022 
NPRM Comment Period Extension Notice  08/29/2022  87 FR 52712   
NPRM Comment Period Extension End  09/26/2022 
Final Action  12/00/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related Agencies: Joint: HHS/CDC; 
Agency Contact:
Cameron Ingram
Special Assistant
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: C2-22-13, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:202 690-5443