Clinical Laboratory Improvement Advisory Committee, 15621-15622 [2015-06648]
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Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and
Prevention
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
Advisory Committee on Breast Cancer
in Young Women (ACBCYW)
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; P41 BTRC review
(2015/05).
Date: May 27, 2015.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: Manana Sukhareva, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Suite 959,
Bethesda, MD 20892, (301) 451–3397,
sukharem@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; 2015–10 SBIR HD
Review.
Date: June 24, 2015.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: Ruth Grossman, DDS,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institute of Health, 6707 Democracy
Boulevard, Rm. 960, Bethesda, MD 20892,
(301) 496–8775, grossmanrs@mail.nih.gov.
Dated: March 19, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
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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:
Time and Date: 1:00 p.m.–4:00 p.m.
EST, April 17, 2015.
Place: This meeting is accessible by
teleconference and web access.
Teleconference and web access login
information is as follows:
Toll-Free Telephone: 1–800–369–
1856, Participant passcode: 1927394.
Net Conference and Web URL:
For Participants:
URL: https://www.mymeetings.com/
nc/join/.
Conference number: PW1978421,
Audience passcode: 1927394 and:
https://www.mymeetings.com/nc/
join.php?i=PW1978421&p=1927394
&t=c.
Status: Open to the public, limited
only by the net conference and audio
phone lines available.
Purpose: The committee provides
advice and guidance to the Secretary,
HHS; the Assistant Secretary for Health;
and the Director, CDC, regarding the
formative research, development,
implementation and evaluation of
evidence-based activities designed to
prevent breast cancer (particularly
among those at heightened risk) and
promote the early detection and support
of young women who develop the
disease. The advice provided by the
Committee will assist in ensuring
scientific quality, timeliness, utility, and
dissemination of credible appropriate
messages and resource materials.
Matters For Discussion: The agenda
will include discussions on the current
and emerging topics related to breast
cancer in young women. These may
include risk communication and health
education, as well as approaches to
increase awareness of clinicians/
practitioners regarding topics such as
breast cancer risk, breast health,
symptoms, diagnosis, and treatment of
breast cancer in young women.
Discussions for formal
recommendations will take place.
Agenda items are subject to change as
priorities dictate.
Online Registration Required: All
ACBCYW Meeting participants must
register for the meeting online at least 3
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15621
business days in advance at https://
www.cdc.gov/cancer/breast/what_cdc_is
_doing/meetings.htm. Please complete
all the required fields before submitting
your registration and submit no later
than April 14, 2015.
Contact Person For More Information:
Temeika L. Fairley, Ph.D., Designated
Federal Officer, National Center for
Chronic Disease Prevention and Health
Promotion, CDC, 4770 Buford Highway
NE., Mailstop K52, Atlanta, Georgia,
30341, Telephone (770) 488–4518, Fax
(770) 488–4760 Email: acbcyw@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 Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–06644 Filed 3–23–15; 8:45 am]
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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:
12:30 p.m.–5:00 p.m., April 15, 2014
8:30 a.m.–12:00 p.m., April 16, 2014
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
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15622
Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
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 nonregulatory 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 focus on laboratory
information exchange in health
information technology; and laboratory
safety and quality: lessons learned
through the Ebola response.
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 inperson 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/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 8, 2015 for
U.S. registrants and April 1, 2015 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.
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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, CDC, 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. 2015–06648 Filed 3–23–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: National Evaluation of the
Comprehensive Community Mental
Health Services for Children and Their
Families Program: Phase VI (OMB No.
0930–0307)—REVISION
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center of Mental Health
Services is responsible for the national
evaluation of the Comprehensive
Community Mental Health Services for
Children and Their Families Program
(Children’s Mental Health Initiative—
CMHI) that will collect data on child
mental health outcomes, family life, and
service system development. Data will
be collected on nine (9) service systems,
and approximately 2,106 children and
families and providers/administrators,
using 26 instruments. Data collection
will be decreased by 26,960 hours due
to program changes resulting from the
closing of 19 communities funded in FY
2009 that no longer require data
collection and data collection for the
Sector and Comparison Study.
Data collection for this evaluation will
be conducted over the next 3-year
period. Child and family outcomes of
interest will be collected at intake and
at 6-month follow-up. The individual
families will participate in the study for
the remaining 12 months. The outcome
measures include the following: Child
symptomatology and functioning,
family functioning, satisfaction, and
caregiver strain. The service system data
will be collected every 6 months during
the remaining 3 years of the evaluation.
Service utilization and cost data will be
tracked and submitted to the national
evaluation every 6 months using two
tools—the Flex Fund Tool and the
Services and Costs Data Tool—to
estimate average cost of treatment per
child, distribution of costs, and
allocation of costs across service
categories. Service delivery and system
variables of interest include the
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[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15621-15622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06648]
-----------------------------------------------------------------------
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:
12:30 p.m.-5:00 p.m., April 15, 2014
8:30 a.m.-12:00 p.m., April 16, 2014
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
[[Page 15622]]
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 focus on
laboratory information exchange in health information technology; and
laboratory safety and quality: lessons learned through the Ebola
response.
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/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 8, 2015 for U.S.
registrants and April 1, 2015 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, CDC,
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. 2015-06648 Filed 3-23-15; 8:45 am]
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