Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 10877-10878 [2016-04473]
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Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–04535 Filed 3–1–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
National Advisory Council on the
National Health Service Corps; Notice
of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
the National Health Service Corps
(NACNHSC).
Dates and Times: March 21–22, 2016,
8:30 a.m.–4:30 p.m. EST.
Place: U.S. Department of Health and
Human Services, Health Resources and
Services Administration, Conference
Room #5E29, 5600 Fishers Lane,
Rockville, Maryland 20857, In-Person
Meeting and Conference Call Format.
Status: This advisory council meeting
will be open to the public.
Purpose: The NACNHSC provides
advice and recommendations to the
Secretary of the U.S. Department of
Health and Human Services and, by
designation, the Administrator of the
Health Resources and Services
Administration, on a range of issues
including identifying the priorities for
NHSC, and policy revisions.
Agenda: The NACNHSC will continue
its discussion on clinician recruitment
and retention and explore questions on
diversity and workforce analysis. The
Council will draft potential policy
recommendations for the National
Health Service Corps scholarship and
loan repayment programs with respect
to clinician retention in underserved
communities. The content of the agenda
is subject to change prior to the meeting.
The NACNHAC final agenda will be
available on the NACNHSC Web site 3
days in advance of the meeting.
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Further
information regarding the NACNHSC
including the roster of members, past
meetings summaries is available at the
following Web site: https://
nhsc.hrsa.gov/corpsexperience/aboutus/
nationaladvisorycouncil/.
Members of the public and interested
parties may request to participate in the
meeting by contacting Ashley Carothers
via email at ACarothers@hrsa.gov to
obtain access information. Access will
be granted on a first-come, first-served
basis. Space is limited. Public
participants may submit written
statements in advance of the scheduled
meeting. If you would like to provide
oral public comment during the
meeting, please register with the Ashley
Carothers. Public comment will be
limited to 3 minutes per speaker.
Statements and comments can be
addressed to Ashley Carothers by
emailing her at ACarothers@hrsa.gov.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the contact person listed above at
least 10 days prior to the meeting. In
addition, please be advised that
committee members are given copies of
all written statements submitted from
the public. Any further public
participation will be solely at the
discretion of the Chair, with approval of
the Designated Federal Official.
Registration through the designated
contact for the public comment session
is required.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the NACNHSC should contact
Ashley Carothers, Bureau of Health
Workforce, Health Resources and
Services Administration, in one of three
ways: (1) Send a request to the following
address: Ashley Carothers, Bureau of
Health Workforce, Health Resources and
Services Administration, Room 14N108,
5600 Fishers Lane, Rockville, Maryland
20857; (2) call (301) 443–7229; or (3)
send an email to ACarothers@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–04534 Filed 3–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Secretary, Office
of the Assistant Secretary for Health,
AGENCY:
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10877
Department of Health and Human
Services.
ACTION: Notice.
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(the Advisory Council). The meeting
will be open to the public; a public
comment session will be held during
the meeting. Pre-registration is required
for members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
the meeting and/or send in their public
comment via email should send an
email to CARB@hhs.gov. Registration
information is available on the Web site
https://www.hhs.gov/ash/carb/ and must
be completed by March 21, 2016; all inperson attendees must pre-register by
this date. Additional information about
registering for the meeting and
providing public comment can be
obtained at https://www.hhs.gov/ash/
carb/ on the Meetings page.
DATES: The meeting is scheduled to be
held on March 30, 2016, from 10:00 a.m.
to 5:00 p.m. ET, and March 31, 2016,
from 9:00 a.m. to 4:00 p.m. ET (times are
tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the Web
site for the Advisory Council at https://
www.hhs.gov/ash/carb/ when this
information becomes available. Preregistration for attending the meeting in
person is required to be completed no
later than March 21, 2016; public
attendance at the meeting is limited to
the available space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
The meeting also can be accessed
through a live webcast on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Bruce Gellin, Designated Federal
Officer, Presidential Advisory Council
on Combating Antibiotic-Resistant
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
715H, Hubert H. Humphrey Building,
200 Independence Avenue SW.,
Washington, DC 20201. Phone: (202)
260–6638; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
SUMMARY:
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10878
Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices
September 18, 2014, authority was given
to the Secretary of Health and Human
Services to establish the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council), in consultation with the
Secretaries of Defense (DoD) and
Agriculture (USDA). Activities of the
Advisory Council are governed by the
provisions of Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of federal advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria (Strategy) and the National
Action Plan for Combating AntibioticResistant Bacteria (Action Plan). The
Advisory Council shall function solely
for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The March public meeting will be
dedicated to presentations by the five
currently active working groups of the
Advisory Council, which are: Antibiotic
Stewardship; One Health Surveillance;
Diagnostic Innovations; Treatment,
Prevention and Control Research and
Development; and International
Collaboration on Combating AntibioticResistant Bacteria (CARB). The
Advisory Council will deliberate and
vote on the working groups’ findings
and recommendations. In addition, the
Advisory Council will be presented
with a new task(s) from the Secretary of
HHS, in consultation with USDA and
DoD. The meeting agenda will be posted
VerDate Sep<11>2014
19:10 Mar 01, 2016
Jkt 238001
on the Advisory Council Web site at
https://www.hhs.gov/ash/carb when it
has been finalized.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Advisory Council at the
address/telephone number listed above
at least one week prior to the meeting.
For those unable to attend in person, a
live webcast will be available. More
information on registration and
accessing the webcast can be found at
https://www.hhs.gov/ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
comments should be sent in by
midnight March 21, 2016, and should be
limited to no more than one page. All
public comments received prior to
March 21, 2016, will be provided to
Advisory Council members and read
during the public comment period
designated on the agenda; comments are
limited to two minutes per speaker.
Dated: February 25, 2016.
Bruce Gellin,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Deputy Assistant Secretary
for Health.
[FR Doc. 2016–04473 Filed 3–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination and Declaration
Regarding Emergency Use of in Vitro
Diagnostic Tests for Detection of Zika
Virus and/or Diagnosis of Zika Virus
Infection
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564 of the
Federal Food, Drug, and Cosmetic
(FD&C) Act, 21 U.S.C. 360bbb–3. On
February 26, 2016, the Secretary
determined that there is a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of United States citizens living
abroad and that involves Zika virus.
On the basis of this determination,
she also declared that circumstances
exist justifying the authorization of
SUMMARY:
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emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection
pursuant to section 564 of the FD&C
Act, subject to the terms of any
authorization issued under that section.
DATES: The determination and
declaration are effective February 26,
2016.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, M.D., MSPH, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act,
the Commissioner of the Food and Drug
Administration (FDA), acting under
delegated authority from the Secretary
of HHS, may issue an Emergency Use
Authorization (EUA) authorizing (1) the
emergency use of an unapproved drug,
an unapproved or uncleared device, or
an unlicensed biological product; or (2)
an unapproved use of an approved drug,
approved or cleared device, or licensed
biological product. Before an EUA may
be issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of four determinations: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a chemical, biological, radiological,
or nuclear (CBRN) agent or agents; (2)
the identification of a material threat by
the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act 1 sufficient to
affect national security or the health and
security of United States citizens living
abroad; (3) a determination by the
Secretary of Defense that there is a
military emergency, or a significant
potential for a military emergency,
involving a heightened risk to United
States military forces of attack with a
CBRN agent or agents; or (4) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad, and
that involves a CBRN agent or agents, or
1 42
U.S.C. 247d–6b.
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]]>Agencies
[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10877-10878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04473]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that a meeting is scheduled to be held for the Presidential Advisory
Council on Combating Antibiotic-Resistant Bacteria (the Advisory
Council). The meeting will be open to the public; a public comment
session will be held during the meeting. Pre-registration is required
for members of the public who wish to attend the meeting and who wish
to participate in the public comment session. Individuals who wish to
attend the meeting and/or send in their public comment via email should
send an email to CARB@hhs.gov. Registration information is available on
the Web site https://www.hhs.gov/ash/carb/ and must be completed by
March 21, 2016; all in-person attendees must pre-register by this date.
Additional information about registering for the meeting and providing
public comment can be obtained at https://www.hhs.gov/ash/carb/ on the
Meetings page.
DATES: The meeting is scheduled to be held on March 30, 2016, from
10:00 a.m. to 5:00 p.m. ET, and March 31, 2016, from 9:00 a.m. to 4:00
p.m. ET (times are tentative and subject to change). The confirmed
times and agenda items for the meeting will be posted on the Web site
for the Advisory Council at https://www.hhs.gov/ash/carb/ when this
information becomes available. Pre-registration for attending the
meeting in person is required to be completed no later than March 21,
2016; public attendance at the meeting is limited to the available
space.
ADDRESSES: U.S. Department of Health and Human Services, Hubert H.
Humphrey Building, Great Hall, 200 Independence Avenue SW., Washington,
DC 20201.
The meeting also can be accessed through a live webcast on the day
of the meeting. For more information, visit https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT: Bruce Gellin, Designated Federal
Officer, Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria, Office of the Assistant Secretary for Health, U.S.
Department of Health and Human Services, Room 715H, Hubert H. Humphrey
Building, 200 Independence Avenue SW., Washington, DC 20201. Phone:
(202) 260-6638; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated
[[Page 10878]]
September 18, 2014, authority was given to the Secretary of Health and
Human Services to establish the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria (Advisory Council), in
consultation with the Secretaries of Defense (DoD) and Agriculture
(USDA). Activities of the Advisory Council are governed by the
provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets
forth standards for the formation and use of federal advisory
committees.
The Advisory Council will provide advice, information, and
recommendations to the Secretary of HHS regarding programs and policies
intended to support and evaluate the implementation of Executive Order
13676, including the National Strategy for Combating Antibiotic-
Resistant Bacteria (Strategy) and the National Action Plan for
Combating Antibiotic-Resistant Bacteria (Action Plan). The Advisory
Council shall function solely for advisory purposes.
In carrying out its mission, the Advisory Council will provide
advice, information, and recommendations to the Secretary regarding
programs and policies intended to preserve the effectiveness of
antibiotics by optimizing their use; advance research to develop
improved methods for combating antibiotic resistance and conducting
antibiotic stewardship; strengthen surveillance of antibiotic-resistant
bacterial infections; prevent the transmission of antibiotic-resistant
bacterial infections; advance the development of rapid point-of-care
and agricultural diagnostics; further research on new treatments for
bacterial infections; develop alternatives to antibiotics for
agricultural purposes; maximize the dissemination of up-to-date
information on the appropriate and proper use of antibiotics to the
general public and human and animal healthcare providers; and improve
international coordination of efforts to combat antibiotic resistance.
The March public meeting will be dedicated to presentations by the
five currently active working groups of the Advisory Council, which
are: Antibiotic Stewardship; One Health Surveillance; Diagnostic
Innovations; Treatment, Prevention and Control Research and
Development; and International Collaboration on Combating Antibiotic-
Resistant Bacteria (CARB). The Advisory Council will deliberate and
vote on the working groups' findings and recommendations. In addition,
the Advisory Council will be presented with a new task(s) from the
Secretary of HHS, in consultation with USDA and DoD. The meeting agenda
will be posted on the Advisory Council Web site at https://www.hhs.gov/ash/carb when it has been finalized.
Public attendance at the meeting is limited to the available space.
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
notify the Advisory Council at the address/telephone number listed
above at least one week prior to the meeting. For those unable to
attend in person, a live webcast will be available. More information on
registration and accessing the webcast can be found at https://www.hhs.gov/ash/carb/.
Members of the public will have the opportunity to provide comments
prior to the Advisory Council meeting by emailing CARB@hhs.gov. Public
comments should be sent in by midnight March 21, 2016, and should be
limited to no more than one page. All public comments received prior to
March 21, 2016, will be provided to Advisory Council members and read
during the public comment period designated on the agenda; comments are
limited to two minutes per speaker.
Dated: February 25, 2016.
Bruce Gellin,
Designated Federal Officer, Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, Deputy Assistant Secretary for Health.
[FR Doc. 2016-04473 Filed 3-1-16; 8:45 am]
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