Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26)

OMB 0938-0612

OMB 0938-0612

The ICRs referenced in 42 CFR part 493 outline the requirements necessary to determine an entities compliance with CLIA. CLIA requires laboratories that perform testing on human beings to meet performance requirements (quality standards) in order to be certified by HHS. HHS conducts inspections to determine a laboratory's compliance with the CLIA requirements. CLIA implements the certificate, laboratory standards, and inspection requirements.

The latest form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations (CMS-R-26) expires 2024-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
All Historical Document Collections
 Revision of a currently approved collection 2024-01-12
Revision of a currently approved collection 2020-08-14
Approved with change
 Extension without change of a currently approved collection 2017-02-27
Approved without change
 Extension without change of a currently approved collection 2014-01-09
Approved without change
 Extension without change of a currently approved collection 2010-12-27
Approved with change
 Extension without change of a currently approved collection 2007-06-29
Approved without change
 Revision of a currently approved collection 2004-02-18
Approved without change
 Extension without change of a currently approved collection 2001-04-02
Approved without change
 Extension without change of a currently approved collection 1998-02-26
Approved without change
 Reinstatement without change of a previously approved collection 1994-11-17
Approved without change
 New collection (Request for a new OMB Control Number) 1992-05-04
OMB Details

Section 493.801 and 493.803

Federal Enterprise Architecture: Health - Health Care Services

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