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HHS/CMS RIN: 0938-AS04 Publication ID: Fall 2014 
Title: Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing (CMS-3271-P) 
Abstract:

This final rule amends the Clinical Laboratory Improvement Amendments (CLIA) regulations to specify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the rule removes the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.

 
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 USC 263a   
Legal Deadline:
Action Source Description Date
Final  Statutory  MMA Section 902  11/07/2017 
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