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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifiers: CMS-209]

# AGENCY:

Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

# ACTION:

Notice.

# SUMMARY:

                        The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the                         **Federal Register**                         concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.                    

# DATES:

Comments must be received by March 4, 2025.

# ADDRESSES:

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

                        1.                         *Electronically.*                         You may send your comments electronically to                         *http://www.regulations.gov.*                         Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.                    

                        2.                         *By regular mail.*                         You may mail written comments to the following address:                    

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: __,  Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

                        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:                         *https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.*

# FOR FURTHER INFORMATION CONTACT:

William N. Parham at (410) 786-4669.

# SUPPLEMENTARY INFORMATION:

## Contents

                    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see                     **ADDRESSES**                    ).                

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

                    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the                     **Federal Register**                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.                

## Information Collections

                    1.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Laboratory Personnel Report (CLIA) and Supporting Regulations;                     *Use:*                     The information collected on this survey form is used in the administrative pursuit of the Congressionally-mandated program                           ( print page 321)                        with regard to regulation of laboratories participating in CLIA. The surveyor will provide the laboratory with the CMS-209 form. While the surveyor performs other aspects of the survey, the laboratory will complete the CMS-209 by recording the personnel data needed to support their compliance with the personnel requirements of CLIA. For this submission, we are making minor revisions to the collection instrument. We revised the instructions for clarity and removed the references to specific regulations.                     *Form Number:*                     CMS-209 (OMB control number 0938-0151);                     *Frequency:*                     Biennially;                     *Affected Public:*                     Private Sector—State, Local, or Tribal Governments; and Federal Government;                     *Number of Respondents:*                     16,404;                     *Total Annual Responses:*                     8,202;                     *Total Annual Hours:*                     4,101. (For policy questions regarding this collection contact Penny Keller at 410-786-2035.)                

William N. Parham, III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2024-31553 Filed 1-2-25; 8:45 am]

BILLING CODE 4120-01-P