Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (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⚠️ Notice: This information collection may be referencing outdated material.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 CLIA Application for Certification Final CLIA116.11.6.13.pdf Form and Instruction
Crosswalk_2013_sept_13_2013.doc 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	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 %

	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

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.