[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10862-10863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04590]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the following committee meeting.
Times And Dates: 8:30 a.m.-5:00 p.m., April 13, 2016; 8:30 a.m.-
12:00 p.m., April 14, 2016.
Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications
Center, Building 19, Auditorium B, Atlanta, Georgia 30333.
Status: Open to the public, limited only by the space available.
The meeting room accommodates approximately 100 people. This meeting
will also be webcast, please see information below.
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.
Matters For Discussion: The agenda will include agency updates from
CDC, CMS, and FDA. Presentations and discussions will include methods
for improving the effectiveness/efficiency of CLIAC meetings; an
overview of the CMS Advisory Panel on Clinical Diagnostic Laboratory
Tests; laboratory interoperability including the Office of the National
Coordinator for Health Information Technology (ONC) policies and
engagement with clinical laboratories; update on the cytology workload
project; update on laboratory biosafety in clinical laboratories; and
future CLIAC topics.
Agenda items are subject to change as priorities dictate.
Webcast: The meeting will also be webcast. Persons interested in
viewing the webcast can access information at: http://cdclabtraining.adobeconnect.com/aprilcliac/.
In-Person Attendance Online Registration Required: All people
attending the CLIAC meeting in-person are required to register for the
meeting online at least 5 business days in advance for U.S. citizens
and at least 10 business days in advance for international registrants.
Register at: http://www.cdc.gov/cliac/Meetings/MeetingDetails.aspx#.
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 7, 2016 for U.S.
registrants and March 31, 2016 for international registrants.
Providing Oral or Written Comments: It is the policy of CLIAC to
accept written public comments and provide a brief period for oral
public comments on agenda items whenever possible.
Oral Comments: In general, each individual or group requesting to
make oral comments will be limited to a total time of five minutes
(unless otherwise indicated). Speakers must also submit their comments
in writing for inclusion in the meeting's Summary Report. To assure
adequate time is scheduled for public comments, speakers should notify
the contact person below at least one week prior to the meeting date.
Written Comments: 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 one week prior to the meeting date so that the
comments may be made available to the Committee for their consideration
and for public distribution. Written comments, one hard copy with
original signature, should be provided to the contact person listed
below, and will be included in the meeting's Summary Report.
Availability of Meeting Materials: To support the green initiatives
of the federal government, 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 Web site on
the day of the meeting for materials: http://wwwn.cdc.gov/cliac/cliac_meeting_all_documents.aspx.
Note: If using a mobile device to access the materials, please
verify that the device's browser is able to download the files from
the CDC's Web site before the meeting. Alternatively, the files can
be downloaded to
[[Page 10863]]
a computer and then emailed to the portable device. An internet
connection, power source, and limited hard copies may be available
at the meeting location, but cannot be guaranteed.
Contact Person for Additional Information: Nancy Anderson, Chief,
Laboratory Practice Standards Branch, 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 F-11, Atlanta, Georgia
30329-4018; telephone (404) 498-2741; or via email at
[email protected].
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register Notices pertaining to
announcements of meetings and other committee management activities,
for CDC and the Agency for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2016-04590 Filed 3-1-16; 8:45 am]
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