Information Collection

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

IC 8193 under ICR 201403-0938-003 · 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⚠️ Notice: This information collection may be referencing outdated material.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 CLIA Application for Certification Final CLIA116.11.6.13.pdf	Form and Instruction
Crosswalk_2013_sept_13_2013.doc Crosswalk	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	CLIA Application for Certification	Final CLIA116.11.6.13.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 242,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

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

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	34,200	2,680	31,520
Annual IC Time Burden (Hours)	25,650	2,010	23,640
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Crosswalk	Crosswalk_2013_sept_13_2013.doc	03/04/2014

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