Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 18151-18152 [2017-07708]
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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]
mstockstill on DSK30JT082PROD with NOTICES
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:
VerDate Sep<11>2014
17:14 Apr 14, 2017
Jkt 241001
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:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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
E:\FR\FM\17APN1.SGM
17APN1
18152
Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices
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 April 25, 2017, and should be
limited to no more than one page. All
public comments received prior to April
25, 2017, will be provided to Advisory
Council members; comments are limited
to two minutes per speaker.
Dated: April 12, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2017–07708 Filed 4–14–17; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination and Declaration
Regarding Emergency Use of
Injectable Treatments for Nerve Agent
or Certain Insecticide
(Organophosphorus and/or
Carbamate) Poisoning
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. On April 11, 2017, 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
nerve agents or certain insecticides
(organophosphorus and/or carbamate).
On the basis of this determination, he
also declared that circumstances exist
justifying the authorization of
emergency use of injectable treatments
for nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning 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 April 11, 2017.
FOR FURTHER INFORMATION CONTACT:
George Korch, Ph.D., Acting Assistant
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:14 Apr 14, 2017
Jkt 241001
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 the U.S. Department of Health and
Human Services (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 a disease or condition
that may be attributable to such agent or
agents.2
1 42
U.S.C. 247d–6b(c).
amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.
2 As
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
authorization under section 564 of the
FD&C Act are met.
The Centers for Disease Control and
Prevention (CDC) requested that the
FDA issue an EUA for use of an
injectable treatment for nerve agent and
certain insecticide (organophosphorus
and/or carbamate) poisoning to support
preparedness and response to potential
public health threats posed by these
agents and compounds. At this time,
FDA-approved injectable treatments for
nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning are not available to replenish
the Department’s Strategic National
Stockpile 3 inventory when the products
in the current inventory expire. Pending
the availability of such products, an
EUA will facilitate ensuring that the
products are available in the event of a
public health emergency involving
nerve agent or certain insecticides
(organophosphorus and/or carbamate).
The determination of a significant
potential for a public health emergency,
and the declaration that circumstances
exist justifying the authorization of
emergency use of injectable treatments
for nerve agent or certain insecticide
(organophosphorus and/or carbamate)
poisoning by the Secretary of HHS, as
described below, enables the FDA
Commissioner to issue an EUA for
certain injectable treatments for
emergency use under section 564 of the
FD&C Act.
II. Determination by the Secretary of
Health and Human Services
On April 11, 2017, pursuant to section
564 of the FD&C Act, I 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 nerve agents or certain
insecticides (organophosphorus and/or
carbamate).1
III. Declaration of the Secretary of
Health and Human Services
On April 11, 2017, on the basis of my
determination of 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 nerve agents or certain
insecticides (organophosphorus and/or
3 42
E:\FR\FM\17APN1.SGM
U.S.C. 247d–6b(a).
17APN1
]]>Agencies
[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18151-18152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
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 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. Pre-registration 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 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 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, 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/Anti-
Infectives, 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
[[Page 18152]]
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 April 25, 2017, and should be
limited to no more than one page. All public comments received prior to
April 25, 2017, will be provided to Advisory Council members; comments
are limited to two minutes per speaker.
Dated: April 12, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program Office.
[FR Doc. 2017-07708 Filed 4-14-17; 8:45 am]
BILLING CODE 4150-44-P
