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⚠️ Notice: This information collection may be referencing outdated material.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 Clinical Laboratory Improvement Amendments (CLIA) Applic CMS-116 Form.doc Form and Instruction
CMS-116 crosswalk with track changes.doc Crosswalk for revised CMS-116 IC Document
Response to Terms of Clearance.doc Response to Terms of Clearance 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 Form.doc		No	No	Fillable Printable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 187,000	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	17,960	1,960	16,000
Annual IC Time Burden (Hours)	22,450	2,450	20,000
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Crosswalk for revised CMS-116	CMS-116 crosswalk with track changes.doc	08/29/2007
Response to Terms of Clearance	Response to Terms of Clearance.doc	08/29/2007

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