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 is listed under ICR 202509-0938-012.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification | Form and Instruction |
| Form CMS-116 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) | Form and Instruction |
 CMS-116_Supporting_Statement 6-17-25 clean.docx | Supporting Statement A |
| CMS-116_Supporting_Statement 6-17-25 clean.docx | Supporting Statement A |
 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) |
Form and Instruction |
| Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) |
Form and Instruction |