Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 38912-38913 [2017-17322]
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38912
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
2016, requesting that Upsher-Smith
provide the requested bioequivalence
data within 30 calendar days or
voluntarily seek withdrawal of ANDA
078706 under section 314.150(d) (21
CFR 314.150(d)).
In a letter dated September 15, 2016,
Upsher-Smith informed FDA that it did
not intend to submit the requested
bioequivalence data and requested that
the Agency withdraw approval of
ANDA 078706 for ZALEPLON Capsules
under section 314.150(d). In that letter,
Upsher-Smith also waived any
opportunity for a hearing otherwise
provided under section 314.150(a).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
314.150(d), approval of ANDA 078706,
and all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of this product in interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).
Dated: August 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–17301 Filed 8–15–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Tick-Borne
Disease Working Group; Amendment
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice; amendment.
AGENCY:
A notice was published in the
Federal Register on Monday, July 17,
2017 (Vol. 82, No. 135, pages 32711–
32712), to solicit nominations of
individuals who are interested in being
considered for appointment to the TickBorne Disease Working Group (Working
Group). The nomination period is
scheduled to end close of business on
August 16, 2017. The notice is being
amended to extend the solicitation
period for one week to allow more time
for interested individuals to submit
nominations.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
The solicitation period has been
extended. All nominations are due to be
submitted on or before August 23, 2017.
ADDRESSES: All nominations should be
sent to: CAPT Richard Henry; Office of
VerDate Sep<11>2014
18:33 Aug 15, 2017
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Dated: August 10, 2017.
Donald Wright,
Acting Assistant Secretary for Health.
[FR Doc. 2017–17323 Filed 8–15–17; 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 Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
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
(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
September 5, 2017; 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 September 13, 2017, from 9:00
a.m. to 5:00 p.m. ET, and September 14,
2017, from 9:00 a.m. to 3:00 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
SUMMARY:
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DATES:
the Assistant Secretary for Health;
Department of Health and Human
Services; 330 C Street SW., Suite L100,
Washington, DC 20024. Nomination
materials, including attachments, also
may be submitted electronically to
tickbornedisease@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
CAPT Richard Henry, Office of the
Assistant Secretary for Health;
Department of Health and Human
Services; Telephone: (202) 795–7615;
Email address: richard.henry@hhs.gov.
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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 September 5,
2017; 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 can also 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:
Jomana Musmar, Acting Designated
Federal Officer, Presidential Advisory
Council on Combating AntibioticResistant 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) 690–5566; email: CARB@
hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. 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 and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. 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
E:\FR\FM\16AUN1.SGM
16AUN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
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 first day of the public meeting,
September 13, 2017, will be dedicated
to the topic of Stewardship of Antibiotic
Prescription and Use. The three working
groups on Incentives for Diagnostics,
Therapeutics/Anti-Infectives, and
Vaccines, will report their final findings
to the full Advisory Council for
deliberation on the second day of the
public meeting, September 14, 2017,
and the Advisory Council will
deliberate and vote on the final report
presented. Additionally, federal
agencies will provide updates on their
achievements as stipulated in the goals
with corresponding objectives and
milestones of the National Action Plan
on Combating Antibiotic Resistant
Bacteria. The meeting agenda will be
posted on the Advisory Council Web
site at https://www.hhs.gov/ash/carb/
when it has been finalized. All agenda
items are tentative and subject to
change.
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 September 5, 2017, and
should be limited to no more than one
page. All public comments received
prior to September 5, 2017, will be
provided to Advisory Council members;
comments are limited to two minutes
per speaker.
Dated: August 2, 2017.
Jomana F. Musmar,
Acting Designated Federal Officer,
Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, Committee
Manager.
[FR Doc. 2017–17322 Filed 8–15–17; 8:45 am]
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VerDate Sep<11>2014
18:33 Aug 15, 2017
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Division of Epidemiology and Disease
Prevention Epidemiology Program for
American Indian/Alaska Native Tribes
and Urban Indian Communities
Announcement Type: Competing
Supplement
Funding Announcement Number: HHS–
2017–IHS–EPI–0001
Catalog of Federal Domestic Assistance
Number: 93.231
Key Dates
Application Deadline Date: September
19, 2017
Review Date: September 21, 2017
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Office of Public Health Support,
Division of Epidemiology and Disease
Prevention (DEDP), is accepting
applications for a cooperative agreement
for competitive supplemental funds to
enhance activities in the Epidemiology
Program for American Indian/Alaska
Native (AI/AN) Tribes and Urban Indian
communities. This program is
authorized under: The Public Health
Service Act, at 42 U.S.C. 241, 247b(k)(2),
282, 284 and 285t. Funding for this
award will be provided by: The Centers
for Disease Control and Prevention’s
(CDC) National Center for
Environmental Health (NCEH) and the
National Institutes of Health’s (NIH)
National Institute on Minority Health
and Health Disparities (NIMHD). The
authorities will be exercised through an
Intra-Departmental Delegation of
Authority (IDDA) with IHS to create a
new funding opportunity for Tribal
Epidemiology Centers: This program is
described in the Catalog of Federal
Domestic Assistance (CFDA) under
93.231.
Background
The Tribal Epidemiology Center (TEC)
program was authorized by Congress in
1998 as a way to provide public health
support to multiple Tribes and Urban
Indian communities in each of the IHS
Areas. The funding opportunity
announcement is open to eligible
Tribes, Tribal organizations, Indian
organizations, intertribal consortia, and
Urban Indian organizations, including
currently-funded TECs.
TECs are uniquely positioned within
Tribes, Tribal and Urban Indian
organizations to conduct disease
surveillance, research, prevention and
PO 00000
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38913
control of disease, injury, or disability,
and to assess the effectiveness of AI/AN
public health programs. In addition,
they can fill gaps in data needed for
Government Performance and Results
Act and Healthy People 2020 measures.
Some of the existing TECs have already
developed innovative strategies to
monitor the health status of Tribes and
Urban Indian communities, including
development of Tribal health registries
and use of sophisticated record linkage
computer software to correct existing
state data sets for racial
misclassification. TECs work in
partnership with IHS DEDP to provide
a more accurate national picture of
Indian health status. This program will
utilize CDC and NIH funding to further
the ongoing work of IHS and the TECs.
The mission of NIMHD is to promote
minority health and to lead, coordinate,
support, and assess the NIH effort to
reduce and ultimately eliminate health
disparities.
The NCEH has identified a public
health gap in the nation’s ability to link
environmental hazards and exposure to
chronic disease issues, and to provide
information to a variety of audiences
from a nationwide network of integrated
health and environmental data that
drives actions to improve health
outcomes. The NCEH is seeking,
through this announcement, to support
the creation of a mechanism by which
Tribal data can be submitted to the
Environmental Public Health Tracking
Network and further explore the
application of Tribal data to
environmental public health.
Purpose
The purpose of this cooperative
agreement is to strengthen public health
capacity and to fund Tribes, Tribal and
Urban Indian organizations, and
intertribal consortia in identifying
relevant health status indicators and
priorities using sound epidemiologic
principles. Work-plans submitted in
response to this announcement must
clearly state the grantee’s desired
objectives and address at least one of the
Recipient Activities under this
announcement. Recipient Activities
may address one or all of the below two
groups of activities:
A. NIH, NIMHD Activities
(1) Development and implementation
of data collection efforts to identify and
document health disparities
experienced by AI/AN populations;
(2) Compilation of existing data (e.g.,
healthcare utilization, vital statistics
data) to generate health profiles and
document health disparities in AI/AN
populations;
E:\FR\FM\16AUN1.SGM
16AUN1
Agencies
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Notices]
[Pages 38912-38913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17322]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, 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 (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 September 5,
2017; 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 September 13, 2017, from
9:00 a.m. to 5:00 p.m. ET, and September 14, 2017, from 9:00 a.m. to
3:00 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 September
5, 2017; 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 can also 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: Jomana Musmar, Acting 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) 690-5566; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September
18, 2014, authority was given to the Secretary of HHS to establish the
Advisory Council, in consultation with the Secretaries of Defense and
Agriculture. 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 and the National Action Plan for Combating
Antibiotic-Resistant Bacteria. 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
[[Page 38913]]
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 first day of the public meeting, September 13, 2017, will be
dedicated to the topic of Stewardship of Antibiotic Prescription and
Use. The three working groups on Incentives for Diagnostics,
Therapeutics/Anti-Infectives, and Vaccines, will report their final
findings to the full Advisory Council for deliberation on the second
day of the public meeting, September 14, 2017, and the Advisory Council
will deliberate and vote on the final report presented. Additionally,
federal agencies will provide updates on their achievements as
stipulated in the goals with corresponding objectives and milestones of
the National Action Plan on Combating Antibiotic Resistant Bacteria.
The meeting agenda will be posted on the Advisory Council Web site at
https://www.hhs.gov/ash/carb/ when it has been finalized. All agenda
items are tentative and subject to change.
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 September 5, 2017, and should be
limited to no more than one page. All public comments received prior to
September 5, 2017, will be provided to Advisory Council members;
comments are limited to two minutes per speaker.
Dated: August 2, 2017.
Jomana F. Musmar,
Acting Designated Federal Officer, Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria, Committee Manager.
[FR Doc. 2017-17322 Filed 8-15-17; 8:45 am]
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