Clinical Laboratory Improvement Advisory Committee, 58584-58585 [2023-18448]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Notices]
[Pages 58584-58585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee

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

ACTION: Notice of meeting.

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SUMMARY: In accordance with regulatory provisions, the Centers for 
Disease Control and Prevention (CDC) announces the following meeting of 
the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is 
a hybrid meeting, accessible both in person and virtually. It is open 
to the public, limited only by the in-person space available. The 
public is also welcome to view the meeting by joining the audio 
conference (information below). 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 8, 2023, from 8:30 a.m. to 
5:30 p.m., EST, and November 9, 2023, from 8:30 a.m. to 12 p.m., EST.

ADDRESSES: Centers for Disease Control and Prevention, 2400 Century 
Parkway NE, Room 1020/1023, Atlanta, Georgia 30345. The conference room 
will have seating for approximately 60 people.
    Meeting Information: All people attending the CLIAC meeting in 
person are required to register online for the meeting at least five 
business days in advance for U.S. citizens and at least 20 business 
days in advance for international registrants. Register at: https://www.cdc.gov/cliac/upcoming-meeting.html. Register by scrolling down and 
clicking the ``Register for this Meeting'' button and completing all 
forms according to the instructions given. Please complete all the 
required fields before submitting your registration and submit no later 
than November 1, 2023, for U.S. registrants and October 11, 2023, for 
international registrants. 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/upcoming-meeting.html.

FOR FURTHER INFORMATION CONTACT: Heather Stang, MS, Senior Advisor for 
Clinical Laboratories, Division of Laboratory Systems, 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: 

[[Page 58585]]

    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; and the modification of the standards and provision of non-
regulatory guidelines to accommodate technological advances, such as 
new test methods, the 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 agency updates 
from CDC, CMS, and FDA. Presentations and CLIAC discussions will focus 
on the final report from the CLIA Regulations Assessment Workgroup, 
efforts to address the CLIA top 10 laboratory deficiencies, 
standardization of test result communication, and the role of the 
laboratory in antibiotic stewardship. 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. 2023-18448 Filed 8-25-23; 8:45 am]
BILLING CODE 4163-18-P