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HHS/CMS RIN: 0938-AS04 Publication ID: Spring 2014 
Title: Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing (CMS-3271-P) 
Abstract: This proposed rule would amend 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 proposed rule would remove 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:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2014   
Regulatory Flexibility Analysis Required: Undetermined  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:
Judith Yost
Director, Division of Laboratory Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S-2-09-27, Center for Clinical Standards and Quality, Mail Stop C2-21-16, 7500 Security Boulevard,
Baltimore, MD 21244-1850
Phone:410 786-3531
Email: judith.yost@cms.hhs.gov

 
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