Notice2023-05294
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
March 15, 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 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.
Full Text
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<title>Federal Register, Volume 88 Issue 50 (Wednesday, March 15, 2023)</title>
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[Federal Register Volume 88, Number 50 (Wednesday, March 15, 2023)]
[Notices]
[Pages 16014-16015]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.cdc.gov/cliac">https://www.cdc.gov/cliac</a>. 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: <a href="/cdn-cgi/l/email-protection#e3abb097828d84a3808780cd848c95"><span class="__cf_email__" data-cfemail="c08893b4a1aea780a3a4a3eea7afb6">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#de9d92979f9d9ebdbabdf0b9b1a8"><span class="__cf_email__" data-cfemail="1556595c5456557671763b727a63">[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#9fdcd3d6dedcdffcfbfcb1f8f0e9"><span class="__cf_email__" data-cfemail="a0e3ece9e1e3e0c3c4c38ec7cfd6">[email protected]</span></a> 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
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