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

Documents and forms in this information collection
Document Name	Document Type
Form CMS-116 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)	Form and Instruction
Form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)	Form and Instruction
CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Appl CMS-116-2026-508C.pdf	Form and Instruction
CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Appl CMS-116-2026-508C.pdf	Form and Instruction
2026 CMS-116 Revision Crosswalk -508C.pdf Crosswalk	IC Document
2026 CMS-116 Revision Crosswalk -508C.pdf Crosswalk	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 42 CFR 493.1-2001

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	CMS-116				Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 308,833

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	50,236	-14,362	64,598
Annual IC Time Burden (Hours)	50,236	-14,362	64,598
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Crosswalk		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].