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HHS/CMS RIN: 0938-AS04 Publication ID: Fall 2016 
Title: Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing (CMS-3271-F) 
Abstract:

This final rule amends the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 493   
Legal Authority: 42 U.S.C. 263a   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/07/2014  79 FR 66348   
NPRM Comment Period End  01/06/2015 
Final Action  11/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Daralyn Hassan
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:410 786-9360
Email: daralyn.hassen@cms.hhs.gov