[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Page 8192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02858]
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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 meeting of the aforementioned
committee:
Times and Dates:
8:30 a.m.-4:30 p.m., March 5, 2014
8:30 a.m.-12:00 p.m., March 6, 2014
Place: CDC, 1600 Clifton Road NE., Tom Harkin Global
Communications Center, Building 19, Auditorium B, Atlanta, Georgia
30333. This meeting will also be Webcast, please see information
below.
Status: Open to the public, limited only by the space available.
The meeting room accommodates approximately 100 people.
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 and the
electronic transmission of laboratory information.
Matters To Be Discussed: The agenda will include agency updates
from CDC, CMS, and FDA. Presentations and discussions will include
the CMS implementation of Individualized Quality Control Plan (IQCP)
as a new CLIA quality control option based on risk management for
laboratories performing nonwaived testing; CDC's strategic priority
for strengthening public health and health care collaborations; and
quality improvement tools for managing laboratory testing in
ambulatory settings.
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://wwwn.cdc.gov/cliac/default.aspx.
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/default.aspx by scrolling down and
clicking the appropriate link under ``Meeting Registration'' (either
U.S. Citizen Registration or Non-U.S. Citizen Registration) and
completing all forms according to the instructions given. Please
complete all the required fields before submitting your registration
and submit no later than February 26, 2014 for U.S. registrants and
February 19, 2014 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 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 public
distribution. Written comments, one hard copy with original
signature, should be provided to the contact person 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. 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. http://wwwn.cdc.gov/cliac/cliac_meeting_all_documents.aspx 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
Programs, Standards, and Services, 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. 2014-02858 Filed 2-10-14; 8:45 am]
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