Notice2023-18448
Clinical Laboratory Improvement Advisory Committee
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 28, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 165 (Monday, August 28, 2023)</title>
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[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Notices]
[Pages 58584-58585]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.cdc.gov/cliac/upcoming-meeting.html">https://www.cdc.gov/cliac/upcoming-meeting.html</a>. 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 <a href="https://www.cdc.gov/cliac/upcoming-meeting.html">https://www.cdc.gov/cliac/upcoming-meeting.html</a>.
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: <a href="/cdn-cgi/l/email-protection#95ddc6e1f4fbf2d5f6f1f6bbf2fae3"><span class="__cf_email__" data-cfemail="bef6edcadfd0d9fedddadd90d9d1c8">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#e6a5aaafa7a5a6858285c8818990"><span class="__cf_email__" data-cfemail="de9d92979f9d9ebdbabdf0b9b1a8">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#e0a3aca9a1a3a0838483ce878f96"><span class="__cf_email__" data-cfemail="9ad9d6d3dbd9daf9fef9b4fdf5ec">[email protected]</span></a> 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
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