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

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

⚠️ Notice: This information collection may be referencing outdated material.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.Final.508compliant.2June 2020.pdf Form and Instruction
CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Appl CMS-116.Final.508compliant.2June 2020.pdf Form and Instruction
2020.CMS-116.Revision.Summay.pdf Crosswalk IC Document
2020.CMS-116.Revision.Summay.pdf Crosswalk IC Document

Information Collection (IC) Details

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.Final.508compliant.2June 2020.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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	52,140	1,140	51,000
Annual IC Time Burden (Hours)	52,140	1,140	51,000
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Crosswalk	2020.CMS-116.Revision.Summay.pdf	10/21/2020

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