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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-0581 can be found here:

Documents and Forms

Document Name Document Type
Form CMS-116 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-116-508 3-17-22.pdf Form and Instruction
2022. NonSubstantive Revision CMS-116 Chart.docx CMS-116 Crosswalk IC Document

Information Collection (IC) Details

View Information Collection (IC)

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

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-116-508 3-17-22.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 267,000	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 %

	Approved	Previously Approved
Annual Number of Responses for this IC	52,140	52,140
Annual IC Time Burden (Hours)	52,140	52,140
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
CMS-116 Crosswalk	2022. NonSubstantive Revision CMS-116 Chart.docx	03/17/2022

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.