[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70685-70686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24785]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee Meeting
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 p.m., EDT, November 2, 2016.
8:30 a.m.-12 p.m., EDT, November 3, 2016.
Place: CDC, 1600 Clifton Road NE., Tom Harkin Global Communications
Center, Building 19, Auditorium B, Atlanta, Georgia 30329.
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 a report
on the cytology workload assessment and time measure study; an update
on CLIAC recommendations for laboratory biosafety; laboratory
preparedness and response: The case of Zika; a report from the
Institute of Medicine (IOM) CLIAC workgroup; and future CLIAC topics.
Agenda items are subject to change as priorities dictate.
Webcast: The meeting will also be webcast. Persons interested in
viewing
[[Page 70686]]
the webcast can access information at: http://cdclabtraining.adobeconnect.com/novembercliac/.
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://wwwn.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 October 27, 2016 for U.S. registrants and
October 20, 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. Public comment periods for each agenda
item are scheduled immediately prior to the Committee discussion period
for that item.
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 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.
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/Meetings/MeetingDetails.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 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; 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 Centers for Disease Control and Prevention 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. 2016-24785 Filed 10-12-16; 8:45 am]
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