OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

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

IC 8193 under ICR 202509-0938-012 · OMB 0938-0581.

Documents and Forms
Document Name
Document Type
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)
 
No Modified
 
Mandatory
 
42 CFR 493.1-2001

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification CMS-116-2026-508C.pdf Yes Yes Fillable Fileable

Health Health Care Services

 

308,833 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 50,236 0 -14,362 0 0 64,598
Annual IC Time Burden (Hours) 50,236 0 -14,362 0 0 64,598
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Crosswalk 2026 CMS-116 Revision Crosswalk -508C.pdf 09/12/2025
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].