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

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 2021-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form CMS-116 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) Form and Instruction
CMS-116_Supporting_Statement.2023.Clean_508 7-10-23.docx Supporting Statement A
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) Form and Instruction

All Historical Document Collections

202309-0938-015 Approved with change	Revision of a currently approved collection	2023-09-27
202203-0938-007 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-03-18
202010-0938-010	Revision of a currently approved collection	2020-10-21
201908-0938-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-08-27
201708-0938-023 Approved with change	Revision of a currently approved collection	2017-08-29
201502-0938-012 Approved without change	No material or nonsubstantive change to a currently approved collection	2015-03-02
201403-0938-003 Approved without change	Revision of a currently approved collection	2014-03-11
201012-0938-013 Approved without change	Revision of a currently approved collection	2010-12-16
200709-0938-005 Approved without change	Revision of a currently approved collection	2007-09-25
200408-0938-001 Approved with change	Extension without change of a currently approved collection	2004-08-11
200107-0938-011 Approved without change	Extension without change of a currently approved collection	2001-07-26
199807-0938-014 Approved without change	Revision of a currently approved collection	1998-07-23
199609-0938-001 Approved without change	Extension without change of a currently approved collection	1996-09-04
199502-0938-006 Approved without change	Extension without change of a currently approved collection	1995-02-23
199312-0938-004 Approved without change	Revision of a currently approved collection	1993-12-21
199303-0938-001 Approved without change	Revision of a currently approved collection	1993-03-17
199212-0938-001 Approved without change	Revision of a currently approved collection	1992-12-17
199206-0938-001 Approved without change	Revision of a currently approved collection	1992-06-12
199104-0938-006 Approved with change	No material or nonsubstantive change to a currently approved collection	1991-04-24
199103-0938-001 Approved without change	New collection (Request for a new OMB Control Number)	1991-03-18