Clinical Laboratory Improvement Advisory Committee, 8192 [2014-02858]
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8192
Federal Register / Vol. 79, No. 28 / Tuesday, February 11, 2014 / Notices
Control and Prevention, 1600 Clifton Road
NE., M/S E–07, Atlanta, Georgia 30333,
telephone (404) 639–8317; Email: zkr7@
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
both the 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 (CDC).
[FR Doc. 2014–02859 Filed 2–10–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
tkelley on DSK3SPTVN1PROD 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.–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 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
VerDate Mar<15>2010
17:58 Feb 10, 2014
Jkt 232001
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: 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 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.
https://wwwn.cdc.gov/cliac/
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
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
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]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0129]
Application of Physiologically-Based
Pharmacokinetic Modeling To Support
Dose Selection; Notice of Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public workshop entitled
‘‘Application of Physiologically-Based
Pharmacokinetic (PBPK) Modeling to
Support Dose Selection.’’ The purpose
of the workshop is to obtain input on
scientific approaches for the conduct
and assessment of physiologically-based
pharmacokinetic (PBPK) modeling
within the framework of drug
development and regulatory
decisionmaking. The input from the
workshop may be used to refine FDA’s
thinking on the various applications of
PBPK. Preliminary elements of a draft
concept paper will be presented to
facilitate discussion at this public
workshop.
DATES: The workshop will be held on
March 10, 2014, from 8:30 a.m. to 4:30
p.m. Individuals who wish to attend the
SUMMARY:
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 79, Number 28 (Tuesday, February 11, 2014)]
[Notices]
[Page 8192]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02858]
-----------------------------------------------------------------------
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: 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 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. 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 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 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 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]
BILLING CODE 4163-18-P
