BILLING CODE 4163-18 P

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.
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 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, 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: HStang@cdc.gov.
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 Providerperformed 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 CLIAC@cdc.gov 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
CLIAC@cdc.gov 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: 9/9/2022 8:45 am; Publication Date: 9/12/2022]