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HHS/CMS RIN: 0938-AT47 Publication ID: Fall 2017 
Title: ●Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations under CLIA (CMS-3326-NC) 

This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments(CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its proficiency testing samples to another laboratory and has reported the other laboratory’s result as their own.

This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding 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.

We intend to consider public comments received in response to this request for information when we draft proposals to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.

Agency: Department of Health and Human Services(HHS)  Priority: Info./Admin./Other 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 42 U.S.C. 263a, 1302, 1395x(e)   
Legal Deadline:  None
Action Date FR Cite
Notice  11/00/2017 
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 
Agency Contact:
Sarah Bennett
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 Blvd,
Baltimore, MD 21244
Phone:410 786-3354