Meeting of the National Vaccine Advisory Committee, 18150-18151 [2017-07707]
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Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
advisory committee meeting. The
nominators of these substances will be
invited to make a short presentation
supporting the nomination.
Use(s) reviewed
Nicotinamide adenine dinucleotide ..........................................
Nicotinamide adenine dinucleotide disodium reduced .............
Nettle (Urtica dioica) whole plant .............................................
Ubiquinol ...................................................................................
Vanadyl sulfate .........................................................................
Artemisinin ................................................................................
mstockstill on DSK30JT082PROD with NOTICES
Drug
Reducing fatigue in multiple sclerosis.
Reduce symptoms of fatigue in chronic fatigue syndrome.
Glycemic control.
Glycemic control.
Diabetes, hypoglycemia, hyperlipidemia, heart disease, preventing cancer.
Malaria, protozoal infections (particularly toxoplasmosis), helminthic infections,
stomach ulcers, cancer.
The committee also intends to discuss
oral solid modified release drug
products that employ coated systems,
which were nominated for the Difficult
to Compound List. The nominators will
be invited to make a short presentation
supporting the nomination.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before April 24, 2017, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 10:15
a.m. and 10:25 a.m., 11:35 a.m. and
11:45 a.m., 1:45 p.m. and 1:55 p.m., 2:50
p.m. and 3 p.m., and 4:10 p.m. and 4:20
p.m. on May 8, 2017, and between
approximately 10 a.m. and 10:10 a.m.
and 11:35 a.m. and 11:50 a.m. on May
9, 2017. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 14, 2017. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
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speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 17, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Cindy Hong at
least 7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–07667 Filed 4–14–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
Office of the Secretary, Office
of the Assistant Secretary for Health,
National Vaccine Program Office,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that a
meeting is scheduled to be held for the
National Vaccine Advisory Committee
(NVAC). The meeting will be open to
SUMMARY:
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the public; public comment sessions
will be held during the meeting.
DATES: The meeting will be held on June
6 and 7, 2017. The meeting times and
agenda will be posted on the NVAC
Web site at https://www.hhs.gov/nvpo/
nvac/meetings/ as soon as
they become available.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
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 participate in the
public comment session should register
at https://www.hhs.gov/nvpo/nvac/
meetings/. Participants may
also register by emailing nvpo@hhs.gov
or by calling (202) 690–5566 and
providing their name, organization and
email address.
The meeting can also be accessed
through a live webcast on both days of
the meeting. For more information, visit
https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, 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: nvpo@
hhs.gov.
Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The NVAC was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
SUPPLEMENTARY INFORMATION:
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17APN1
Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
serves as Director of the National
Vaccine Program.
During the June 2017 NVAC meeting,
sessions will include an update on the
Secretary of the Department of Health
and Human Services’ report on vaccine
innovation to Congress in response to
the 21st Century Cures Act;
presentations on immunization
information systems and interjurisdictional data exchange; and an
update on vaccine confidence-related
projects. Please note that agenda items
will be related to the charge of the
Committee and are subject to change as
priorities dictate. Information on the
final meeting agenda will be posted
prior to the meeting on the NVAC Web
site: https://www.hhs.gov/nvpo/nvac/
index.html.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend in
person and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the National Vaccine
Program Office at the address/phone
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/
nvpo/nvac/meetings/.
Members of the public will have the
opportunity to provide comments at the
NVAC meeting during the public
comment periods designated on the
agenda. Public comments made during
the meeting will be limited to three
minutes per person to ensure time is
allotted for all those wishing to speak.
Individuals are also welcome to submit
their written comments. Written
comments should not exceed three
pages in length. Individuals submitting
written comments should email their
comments to the National Vaccine
Program Office (nvpo@hhs.gov) at least
five business days prior to the meeting.
Dated: March 23, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2017–07707 Filed 4–14–17; 8:45 am]
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BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Department of Health and
Human Services, Office of the Secretary,
AGENCY:
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Office of the Assistant Secretary for
Health.
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
(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 April
25, 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 May 3, 2017, from 9:00 a.m. to
5:00 p.m. ET, and May 4, 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. Preregistration for attending the meeting in
person is required to be completed no
later than April 25, 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
SUMMARY:
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18151
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
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,
May 3, 2017, will be dedicated to the
topic of Infection Prevention and
Control for Animal Health. The three
working groups on Incentives for
Diagnostics, Therapeutics/AntiInfectives, and Vaccines, will report
their preliminary findings to the full
Advisory Council for deliberation on the
second day of the public meeting, May
4, 2017; no vote will be held. 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
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]]>Agencies
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18150-18151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the National Vaccine Advisory Committee
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, National Vaccine Program Office, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services is hereby giving notice that a
meeting is scheduled to be held for the National Vaccine Advisory
Committee (NVAC). The meeting will be open to the public; public
comment sessions will be held during the meeting.
DATES: The meeting will be held on June 6 and 7, 2017. The meeting
times and agenda will be posted on the NVAC Web site at https://www.hhs.gov/nvpo/nvac/meetings/ as soon as they become
available.
ADDRESSES: U.S. Department of Health and Human Services, Hubert H.
Humphrey Building, Great Hall, 200 Independence Avenue SW., Washington,
DC 20201.
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 participate
in the public comment session should register at https://www.hhs.gov/nvpo/nvac/meetings/. Participants may also register by
emailing nvpo@hhs.gov or by calling (202) 690-5566 and providing their
name, organization and email address.
The meeting can also be accessed through a live webcast on both
days of the meeting. For more information, visit https://www.hhs.gov/nvpo/nvac/meetings/.
FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office, 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: nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public
Health Service Act (42 U.S.C. 300aa-1), the Secretary of Health and
Human Services was mandated to establish the National Vaccine Program
to achieve optimal prevention of human infectious diseases through
immunization and to achieve optimal prevention against adverse
reactions to vaccines. The NVAC was established to provide advice and
make recommendations to the Director of the National Vaccine Program on
matters related to the Program's responsibilities. The Assistant
Secretary for Health
[[Page 18151]]
serves as Director of the National Vaccine Program.
During the June 2017 NVAC meeting, sessions will include an update
on the Secretary of the Department of Health and Human Services' report
on vaccine innovation to Congress in response to the 21st Century Cures
Act; presentations on immunization information systems and inter-
jurisdictional data exchange; and an update on vaccine confidence-
related projects. Please note that agenda items will be related to the
charge of the Committee and are subject to change as priorities
dictate. Information on the final meeting agenda will be posted prior
to the meeting on the NVAC Web site: https://www.hhs.gov/nvpo/nvac/.
Public attendance at the meeting is limited to the available space.
Individuals who plan to attend in person and need special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify the National Vaccine Program Office at
the address/phone 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/nvpo/nvac/meetings/.
Members of the public will have the opportunity to provide comments
at the NVAC meeting during the public comment periods designated on the
agenda. Public comments made during the meeting will be limited to
three minutes per person to ensure time is allotted for all those
wishing to speak. Individuals are also welcome to submit their written
comments. Written comments should not exceed three pages in length.
Individuals submitting written comments should email their comments to
the National Vaccine Program Office (nvpo@hhs.gov) at least five
business days prior to the meeting.
Dated: March 23, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program Office.
[FR Doc. 2017-07707 Filed 4-14-17; 8:45 am]
BILLING CODE 4150-44-P
