Clinical Laboratory Improvement Advisory Committee (CLIAC), 5684 [2019-03009]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Page 5684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03009]


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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 space available. The meeting room accommodates 
approximately 100 people. The public is also welcome to view the 
meeting by webcast. Check the CLIAC website on the day of the meeting 
for the webcast link www.cdc.gov/cliac.

DATES: The meeting will be held on April 10, 2019, 8:30 a.m. to 6:00 
p.m., EDT and April 11, 2019, 8:30 a.m. to 1:00 p.m., EDT.

ADDRESSES: The Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, Maryland 21244 and via webcast 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 
30329-4018, telephone (404) 498-2741; NAnderson@cdc.gov.

SUPPLEMENTARY INFORMATION: 
    Purpose: This Committee is charged with providing scientific and 
technical advice and guidance to the Secretary of Health and Human 
Services (HHS); the Assistant Secretary for Health; the Director, 
Centers for Disease Control and Prevention; 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 Amendment (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.
    All people attending the CLIAC meeting in-person are required to 
register for the meeting online at least five business days in advance 
for U.S. citizens and at least 15 business days in advance for 
international registrants. Register at www.cdc.gov/cliac. 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 April 2, 2019 for U.S. registrants and March 
19, 2019 for international registrants.
    It is the policy of CLIAC to accept written public comments and 
provide a brief period for oral public comments on 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 make oral comments will be limited to 
a total time of five minutes (unless otherwise indicated). To assure 
adequate time is scheduled for public comments, speakers should notify 
the contact person below 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. Written comments, one hard copy with original 
signature, should be provided to the contact person at the mailing or 
email address below, and will be included in the meeting's Summary 
Report.
    The CLIAC meeting materials will be made available to the Committee 
and the public in electronic format (PDF) on the internet instead of by 
printed copy. Check the CLIAC website on the day of the meeting for 
materials: www.cdc.gov/cliac.
    Matters to be Considered: The agenda will include agency updates 
from CDC, CMS, and FDA. Presentations and discussions will focus on an 
update from the CDC's Office of Infectious Diseases Board of Scientific 
Counselors meeting and reports from three CLIAC workgroups: the CLIA 
Personnel Regulations Workgroup, the Nontraditional Testing Workflow 
Model Workgroup, and the Next Generation Sequencing Workgroup. Agenda 
items are subject to change as priorities dictate.
    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.

Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2019-03009 Filed 2-21-19; 8:45 am]
 BILLING CODE 4163-19-P