Information Collection

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

IC 8193 under ICR 201908-0938-006 · OMB 0938-0581.

⚠️ Notice: This information collection may be referencing outdated material.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

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
CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Appl CMS-116 updated form (non-subtantive 2019).pdf	Form and Instruction
2017.CMS-116.Revision.crosswalk.doc Crosswalk	IC Document
CMS116 non-substantive change - tracked change form.pdf non-substantive change - tracked changed form	IC Document

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:

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	CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Application for Certification	CMS-116 updated form (non-subtantive 2019).pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 257,000

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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	51,000	51,000
Annual IC Time Burden (Hours)	51,000	51,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Crosswalk	2017.CMS-116.Revision.crosswalk.doc	08/29/2017
non-substantive change - tracked changed form	CMS116 non-substantive change - tracked change form.pdf	08/26/2019

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