[Federal Register Volume 89, Number 174 (Monday, September 9, 2024)]
[Notices]
[Pages 73094-73095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Meeting of the Clinical Laboratory Improvement Advisory Committee

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

[[Page 73095]]


ACTION: Notice of meeting.

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SUMMARY: In accordance with the Federal Advisory Committee Act, the 
Centers for Disease Control and Prevention (CDC) announces the 
following meeting for the Clinical Laboratory Improvement Advisory 
Committee (CLIAC). This is a virtual meeting. It is open to the public, 
limited only by the number of webcast lines available. Time will be 
available for public comment, and the public is also welcome to submit 
written comments in advance of the meeting (see the public 
participation section below).

DATES: The meeting will be held on November 6, 2024, from 11 a.m. to 5 
p.m., EST, and November 7, 2024, from 11 a.m. to 5 p.m., EST.

ADDRESSES: This is a virtual meeting. Meeting times are tentative and 
subject to change. The confirmed meeting times, agenda items, and 
meeting materials, including instructions for accessing the live 
meeting broadcast, will be available on the CLIAC website at https://www.cdc.gov/cliac. Check the website for the web conference link.

FOR FURTHER INFORMATION CONTACT: Heather Stang, M.S., Senior Advisor 
for Clinical Laboratories, Division of Laboratory Systems, Center for 
Laboratory Systems and Response, Office of Laboratory Science and 
Safety, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, Mailstop V24-3, Atlanta, Georgia 30329-4027. Telephone: (404) 498-
2769; Email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Purpose: The Clinical Laboratory Improvement Advisory Committee 
(CLIAC) is charged with providing scientific and technical advice and 
guidance to the Secretary, Department of Health and Human Services; the 
Assistant Secretary for Health; the Director, Centers for Disease 
Control and Prevention (CDC); the Commissioner, Food and Drug 
Administration (FDA); and the Administrator, Centers for Medicare & 
Medicaid Services (CMS). The advice and guidance pertain to general 
issues related to improvement in clinical laboratory quality and 
laboratory medicine and specific questions related to possible revision 
of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
standards. Examples include providing guidance on studies designed to 
improve quality, safety, effectiveness, efficiency, timeliness, equity, 
and patient-centeredness of laboratory services; revisions to the 
standards under which clinical laboratories are regulated; the impact 
of proposed revisions to the standards on medical and laboratory 
practice; the modification of the standards and provision of non-
regulatory guidelines to accommodate technological advances, such as 
new test methods, electronic transmission of laboratory information, 
and mechanisms to improve the integration of public health and clinical 
laboratory practices.
    Matters to be Considered: The agenda will include CDC, CMS, and FDA 
agency updates. Presentations and CLIAC discussions will focus on 
reports from two CLIAC workgroups, the Biosafety Workgroup and the Next 
Generation Sequencing Workgroup; cybersecurity requirements in the 
clinical laboratory; the determination of clinically relevant range of 
values for proficiency testing samples; and the utilization of remote 
technology for competency assessments. Agenda items are subject to 
change as priorities dictate.

Public Participation

    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments pertinent to agenda 
items.
    Oral Public Comment: Public comment periods for each agenda item 
are scheduled immediately prior to the Committee discussion period for 
that item. In general, each individual or group requesting to present 
an oral comment will be limited to a total time of five minutes (unless 
otherwise indicated). Speakers should email [email protected] or notify the 
contact person above (see FOR FURTHER INFORMATION CONTACT) at least 
five business days prior to the meeting date.
    Written Public Comment: CLIAC accepts written comments until the 
date of the meeting (unless otherwise stated). However, it is requested 
that comments be submitted at least five business days prior to the 
meeting date so that the comments may be made available to the 
Committee for their consideration and public distribution. Written 
comments should be submitted by email to [email protected] or to the 
contact person above. All written comments will be included in the 
meeting minutes posted on the CLIAC website.
    The Director, Office of Strategic Business Initiatives, Office of 
the Chief Operating Officer, Centers for Disease Control and 
Prevention, has been delegated the authority to sign Federal Register 
notices pertaining to announcements of meetings and other committee 
management activities, for both the Centers for Disease Control and 
Prevention and the Agency for Toxic Substances and Disease Registry.

Kalwant Smagh,
Director, Office of Strategic Business Initiatives, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2024-20252 Filed 9-6-24; 8:45 am]
BILLING CODE 4163-18-P