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Federal forms, ICRs, and supporting documents

OMB control number

Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)

OMB 0938-0581 · HHS/CMS.

OMB 0938-0581

Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process.

The latest form for Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) expires 2029-04-30 and can be found here.

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Name
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Form and Instruction
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Supporting Statement A
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 Revision of a currently approved collection 2025-09-12
Approved with change
 Revision of a currently approved collection 2023-09-27
Approved without change
 No material or nonsubstantive change to a currently approved collection 2022-03-18
Revision of a currently approved collection 2020-10-21
Approved without change
 No material or nonsubstantive change to a currently approved collection 2019-08-27
Approved with change
 Revision of a currently approved collection 2017-08-29
Approved without change
 No material or nonsubstantive change to a currently approved collection 2015-03-02
Approved without change
 Revision of a currently approved collection 2014-03-11
Approved without change
 Revision of a currently approved collection 2010-12-16
Approved without change
 Revision of a currently approved collection 2007-09-25
Approved with change
 Extension without change of a currently approved collection 2004-08-11
Approved without change
 Extension without change of a currently approved collection 2001-07-26
Approved without change
 Revision of a currently approved collection 1998-07-23
Approved without change
 Extension without change of a currently approved collection 1996-09-04
Approved without change
 Extension without change of a currently approved collection 1995-02-23
Approved without change
 Revision of a currently approved collection 1993-12-21
Approved without change
 Revision of a currently approved collection 1993-03-17
Approved without change
 Revision of a currently approved collection 1992-12-17
Approved without change
 Revision of a currently approved collection 1992-06-12
Approved with change
 No material or nonsubstantive change to a currently approved collection 1991-04-24
Approved without change
 New collection (Request for a new OMB Control Number) 1991-03-18