Notice2022-19569
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
September 12, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
In accordance with the Federal Advisory Committee Act, the 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 87 Issue 175 (Monday, September 12, 2022)</title>
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[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Page 55812]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19569]
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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 the Federal Advisory Committee Act, the 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 November 9, 2022, from 11:00 a.m. to
6:00 p.m., EST, and November 10, 2022, from 11:00 a.m. to 6:00 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 <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, Deputy Chief,
Quality and Safety Systems Branch, Division of Laboratory Systems,
Center for Surveillance, Epidemiology, and Laboratory Services, Deputy
Director for Public Health Science and Surveillance, 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#b3fbe0c7d2ddd4f3d0d7d09dd4dcc5"><span class="__cf_email__" data-cfemail="2a62795e4b444d6a494e49044d455c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Purpose: This Committee 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 the clinical and public health response to the monkeypox outbreak,
efforts to address public health and clinical laboratory workforce
challenges, and reports from two CLIAC workgroups: the CLIA Regulations
Assessment Workgroup and the CLIA Certificate of Waiver and Provider-
performed Microscopy Procedures Workgroup. 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#53101f1a1210133037307d343c25"><span class="__cf_email__" data-cfemail="07444b4e46444764636429606871">[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#c88b8481898b88abacabe6afa7be"><span class="__cf_email__" data-cfemail="0447484d4547446760672a636b72">[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, 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. 2022-19569 Filed 9-9-22; 8:45 am]
BILLING CODE 4163-18-P
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