Clinical Laboratory Improvement Advisory Committee (CLIAC), 56803 [2014-22532]
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Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices
who wishes to provide comments to the
Committee utilizing electronic data
projection submit the necessary material
to the Designated Federal Officer prior
to the close of business on November
10, 2014.
Dated: September 17, 2014.
James J. Berger,
Designated Federal Officer and Senior
Advisor for Blood and Tissue Safety Policy.
[FR Doc. 2014–22527 Filed 9–22–14; 8:45 am]
BILLING CODE 4150–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee (CLIAC)
mstockstill on DSK4VPTVN1PROD with NOTICES
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.–5:00 p.m.,
November 5, 2014; 8:30 a.m.–12:00 p.m.,
November 6, 2014.
Place: CDC, Century Center, 2500 Century
Parkway NE., Room 1200/1201, Atlanta,
Georgia 30345.
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 patientcenteredness 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 for Discussion: The agenda will
include agency updates from CDC, CMS, and
FDA. Presentations and discussions will
include the FDA Draft Guidance on
VerDate Sep<11>2014
17:55 Sep 22, 2014
Jkt 232001
Laboratory Developed Tests; CLIA-waived
testing, including the process and criteria for
waiver approval; a report from the workgroup
charged with providing input to CLIAC
regarding the acceptability and application of
virtual cross-matching in lieu of serologic
cross-matching for transplantation; and
issues related to laboratory biosafety in the
United States.
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: https://
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 https://wwwn.cdc.gov/cliac/default.aspx by
scrolling down and clicking the link under
‘‘Meeting 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 October 29, 2014 for U.S.
registrants and October 22, 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.
https://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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
56803
Standards Branch, Division of Laboratory
Science and Standards, Laboratory Science,
Policy and Practice Program Office, Office of
Surveillance, Epidemiology and Laboratory
Services, CDC, 1600 Clifton Road NE.,
Mailstop F–11, Atlanta, Georgia 30329–4018;
telephone (404) 498–2741; fax (404) 498–
2210; or via email at NAnderson@cdc.gov.
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
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–22532 Filed 9–22–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The Centers for Disease Control and
Prevention (CDC) Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP): Initial
Review, Epi-Centers for the Prevention
of Healthcare-Associated Infections,
Antimicrobial Resistance and Adverse
Events, Funding Opportunity
Announcement (FOA) CK11–
0010401SUPP14, held an initial review
of applications on June 3, 2014. Due to
administrative oversight, a notice was
not published in the Federal Register.
A notice should have published prior
to May 16, 2014 according to the 15 day
notice requirement of the Federal
Advisory Committee Act (FACA)
https://intranet.cdc.gov/maso/cmppa/
pdfs/faca.pdf and the GSA Final Rule
https://www.gsa.gov/graphics/ogp/
FACAFinalRule_R2E-cNZ_0Z5RDZi34K-pR.pdf.
The intent of 15 day prior notice is to
advise the public of scheduled meetings
open to the public. The meeting of June
3, 2014 was a closed meeting, having
met the standard for exemptions to open
meeting requirements due to the
personal and/or proprietary information
included in grant applications. Public
participation was not impacted as a
result of the notice not getting
published.
Contact Person for More Information:
Catherine Ramadei, Acting Chief,
Federal Advisory Committee
Management Branch, Management
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Page 56803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22532]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee (CLIAC)
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.-5:00 p.m., November 5, 2014; 8:30 a.m.-
12:00 p.m., November 6, 2014.
Place: CDC, Century Center, 2500 Century Parkway NE., Room 1200/
1201, Atlanta, Georgia 30345.
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 and the
electronic transmission of laboratory information.
Matters for Discussion: The agenda will include agency updates
from CDC, CMS, and FDA. Presentations and discussions will include
the FDA Draft Guidance on Laboratory Developed Tests; CLIA-waived
testing, including the process and criteria for waiver approval; a
report from the workgroup charged with providing input to CLIAC
regarding the acceptability and application of virtual cross-
matching in lieu of serologic cross-matching for transplantation;
and issues related to laboratory biosafety in the United States.
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: https://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
https://wwwn.cdc.gov/cliac/default.aspx by scrolling down and
clicking the link under ``Meeting 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 October 29, 2014 for U.S. registrants and October 22,
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. https://wwwn.cdc.gov/cliac/
cliacmeetingalldocuments.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
Science and Standards, Laboratory Science, Policy and Practice
Program Office, Office of Surveillance, Epidemiology and Laboratory
Services, CDC, 1600 Clifton Road NE., Mailstop F-11, Atlanta,
Georgia 30329-4018; telephone (404) 498-2741; fax (404) 498-2210; or
via email at NAnderson@cdc.gov.
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 the Centers for Disease Control and Prevention and
the Agency for Toxic Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 2014-22532 Filed 9-22-14; 8:45 am]
BILLING CODE 4163-18-P
