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HHS/CMS RIN: 0938-AT47 Publication ID: Fall 2021 
Title: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Personnel, Histocompatibility, Alternative Sanctions for Certificate of Waiver Laboratories, and Fees (CMS-3326) 

This proposed rule would update histocompatibility and personnel regulations under CLIA to address obsolete regulations and update regulations to incorporate changes in technology. This rule would also make 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 would update 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: Proposed 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  03/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related Agencies: Joint: HHS/CDC; 
Agency Contact:
Jessica Wright
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-3838