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

Forms and Documents

Document Name	Status
Form CMS-209 Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001 Form and Instruction	Modified
CMS-209 Response Public_Comment 2025.docx Supplementary Document	2025-05-14
CMS-209 Supporting Statement A 2024 CLEAN 12.17.24.docx Supporting Statement A	2025-05-14

IC Document Collections

IC ID	Document Title	Status
7865	Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0151	ICR Reference No: 202504-0938-016
Status: Received in OIRA	Previous ICR Reference No: 202106-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Laboratory Personnel Report (CLIA) and Supporting Regulations (CMS-209)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/14/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	8,202	0
Time Burden (Hours)	4,101	0
Cost Burden (Dollars)	0	0

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Abstract: This form is used by the State agency to determine a laboratory's compliance with personnel qualifications under CLIA. This information is needed for a laboratory's CLIA certification and recertification.

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Authorizing Statute(s): PL: Pub.L. 100 - 578 353 Name of Law: Certification of Laboratories
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 320	01/03/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 20166	05/12/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Laboratory Personnel Report (CLIA) and Supporting Regulations in 42 CFR 493.1 - 493.2001	CMS-209	Laboratory Personnel Report (CLIA)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	8,202	0	0	-1,380	0	9,582
Annual Time Burden (Hours)	4,101	0	0	-690	0	4,791
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The changes in burden are the result of an increase in the hourly wage of laboratory staff completing the CMS-209 form to $58.44 from $52.68 and a decrease in the number of compliance laboratories from 19,163 to 16,404. The burden hours decreased from 4,791 to 4,101. The wage burden decreased from $252,390 to $239,662.

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Annual Cost to Federal Government: $14,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/14/2025

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