Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001

Laboratory Personnel Report (CLIA) and Supporting Regulations (CMS-209)

Documents and Forms

Document Name Document Type
Form CMS-209 Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001 Form and Instruction
CMS-209 Laboratory Personnel Report (CLIA) FINAL CMS-209-508 compliant 09.17.24.pdf Form and Instruction
2024 CMS-209 Revision Crosswalk.docx Crosswalk IC Document

Information Collection (IC) Details

IC Title:	Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 42 CFR 493.1-493.2001

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	CMS-209	Laboratory Personnel Report (CLIA)	FINAL CMS-209-508 compliant 09.17.24.pdf		Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 16,404	Number of Respondents for Small Entity: 8,905

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	8,202	-1,380	9,582
Annual IC Time Burden (Hours)	4,101	-690	4,791
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Crosswalk	2024 CMS-209 Revision Crosswalk.docx	05/13/2025

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