[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Page 51894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Clinical Laboratory Improvement Advisory Committee (CLIAC)

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 webcast lines available. Check the CLIAC website on the day 
of the meeting for the web conference link www.cdc.gov/cliac.

DATES: The meeting will be held on November 3, 2021, from 11:00 a.m. to 
6:00 p.m., EDT, and November 4, 2021, from 11:00 a.m. to 6:00 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 www.cdc.gov/cliac.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Senior 
Advisor for Clinical Laboratories, Division of Laboratory Systems, 
Center for Surveillance, Epidemiology and Laboratory Services, Office 
of Public Health Scientific Services, Centers for Disease Control and 
Prevention, 1600 Clifton Road NE, Mailstop V24-3, Atlanta, Georgia 
30329-4027, Telephone: (404) 498-2741; [email protected].

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 
and Medicaid Services (CMS). The advice and guidance pertain to general 
issues related to improvement in clinical laboratory quality and 
laboratory medicine practice 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 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. In addition to the general updates, agency 
presentations will include an overview of the FDA's Center for 
Biologics Evaluation and Research, a laboratory safety update, and a 
status report on the new CLIA regulations assessment workgroup. 
Presentations and CLIAC discussion will focus on next generation 
sequencing in clinical and public health laboratories and laboratory 
data exchange and harmonization. Agenda items are subject to change as 
priorities dictate.
    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments pertinent to agenda 
items. 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 at least five business days prior to the meeting date. For 
individuals or groups unable to attend the meeting, 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. All written comments will be included in the meeting 
Summary Report 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. 2021-20151 Filed 9-16-21; 8:45 am]
BILLING CODE 4163-18-P