[Federal Register Volume 88, Number 50 (Wednesday, March 15, 2023)]
[Notices]
[Pages 16014-16015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05294]


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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 
for the Clinical Laboratory Improvement Advisory Committee (CLIAC). 
This meeting is open to the public, limited only by the number of 
webcast lines available. Time will be available for public comment.

DATES: The meeting will be held on April 12, 2023, from 11 a.m. to 5:30 
p.m., EDT, and April 13, 2023, from 11 a.m. to 5 p.m., EDT.

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 on the day of the meeting for the 
web conference link.

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: 
    Purpose: The Clinical Laboratory Improvement Advisory Committee 
(CLIAC) is charged with providing scientific and technical advice and 
guidance to the Secretary, HHS; the Assistant Secretary for Health; the 
Director, 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 reports from two CLIAC workgroups: the CLIA Regulations Assessment 
Workgroup and the CLIA Certificate of Waiver and Certificate for 
Provider-performed Microscopy Procedures Workgroup, and on the 
laboratory's role in advancing health equity. 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

[[Page 16015]]

included in the meeting minutes posted on the CLIAC website.
    The Director, Strategic Business Initiatives Unit, 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, Strategic Business Initiatives Unit, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2023-05294 Filed 3-14-23; 8:45 am]
BILLING CODE 4163-18-P