82 FR 18151 - Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 72 (April 17, 2017)

Page Range		18151-18152
FR Document		2017-07708

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 [email protected] Registration information is available on the Web site http://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 http://www.hhs.gov/ash/carb/ on the Meetings page.

Federal Register, Volume 82 Issue 72 (Monday, April 17, 2017)

[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Pages 18151-18152]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07708]


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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.

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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 [email protected]. Registration information is available on the Web 
site http://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 http://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 http://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 http://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: [email protected].

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 http://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 http://www.hhs.gov/ash/carb/.
    Members of the public will have the opportunity to provide comments 
prior to the Advisory Council meeting by emailing [email protected]. 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

Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices 18151

serves as Director of the National Office of the Assistant Secretary for September 18, 2014, authority was given
Vaccine Program. Health. to the Secretary of HHS to establish the
During the June 2017 NVAC meeting, ACTION: Notice. Advisory Council, in consultation with
sessions will include an update on the the Secretaries of Defense and
Secretary of the Department of Health SUMMARY: As stipulated by the Federal Agriculture. Activities of the Advisory
and Human Services’ report on vaccine Advisory Committee Act, the Council are governed by the provisions
innovation to Congress in response to Department of Health and Human of Public Law 92–463, as amended (5
the 21st Century Cures Act; Services (HHS) is hereby giving notice U.S.C. App.), which sets forth standards
presentations on immunization that a meeting is scheduled to be held for the formation and use of federal
information systems and inter- for the Presidential Advisory Council on advisory committees.
jurisdictional data exchange; and an Combating Antibiotic-Resistant Bacteria The Advisory Council will provide
update on vaccine confidence-related (Advisory Council). The meeting will be advice, information, and
projects. Please note that agenda items open to the public; a public comment recommendations to the Secretary of
will be related to the charge of the session will be held during the meeting. HHS regarding programs and policies
Pre-registration is required for members intended to support and evaluate the
Committee and are subject to change as
of the public who wish to attend the implementation of Executive Order
priorities dictate. Information on the
meeting and who wish to participate in 13676, including the National Strategy
final meeting agenda will be posted
the public comment session. Individuals for Combating Antibiotic-Resistant
prior to the meeting on the NVAC Web
who wish to attend the meeting and/or Bacteria and the National Action Plan
site: http://www.hhs.gov/nvpo/nvac/
send in their public comment via email for Combating Antibiotic-Resistant
index.html.
should send an email to CARB@hhs.gov. Bacteria. The Advisory Council shall
Public attendance at the meeting is Registration information is available on function solely for advisory purposes.
limited to the available space. the Web site http://www.hhs.gov/ash/ In carrying out its mission, the
Individuals who plan to attend in carb/ and must be completed by April Advisory Council will provide advice,
person and need special assistance, 25, 2017; all in-person attendees must information, and recommendations to
such as sign language interpretation or pre-register by this date. Additional the Secretary regarding programs and
other reasonable accommodations, information about registering for the policies intended to preserve the
should notify the National Vaccine meeting and providing public comment effectiveness of antibiotics by
Program Office at the address/phone can be obtained at http://www.hhs.gov/ optimizing their use; advance research
number listed above at least one week ash/carb/ on the Meetings page. to develop improved methods for
prior to the meeting. For those unable to combating antibiotic resistance and
DATES: The meeting is scheduled to be
attend in person, a live webcast will be conducting antibiotic stewardship;
held on May 3, 2017, from 9:00 a.m. to
available. More information on strengthen surveillance of antibiotic-
5:00 p.m. ET, and May 4, 2017, from
registration and accessing the webcast resistant bacterial infections; prevent
9:00 a.m. to 3:00 p.m. ET (times are
can be found at http://www.hhs.gov/ the transmission of antibiotic-resistant
tentative and subject to change). The
nvpo/nvac/meetings/index.html. bacterial infections; advance the
confirmed times and agenda items for
Members of the public will have the the meeting will be posted on the Web development of rapid point-of-care and
opportunity to provide comments at the site for the Advisory Council at http:// agricultural diagnostics; further research
NVAC meeting during the public www.hhs.gov/ash/carb/ when this on new treatments for bacterial
comment periods designated on the information becomes available. Pre- infections; develop alternatives to
agenda. Public comments made during registration for attending the meeting in antibiotics for agricultural purposes;
the meeting will be limited to three person is required to be completed no maximize the dissemination of up-to-
minutes per person to ensure time is later than April 25, 2017; public date information on the appropriate and
allotted for all those wishing to speak. attendance at the meeting is limited to proper use of antibiotics to the general
Individuals are also welcome to submit the available space. public and human and animal
their written comments. Written healthcare providers; and improve
ADDRESSES: U.S. Department of Health
comments should not exceed three international coordination of efforts to
pages in length. Individuals submitting and Human Services, Hubert H.
combat antibiotic resistance.
written comments should email their Humphrey Building, Great Hall, 200
The first day of the public meeting,
comments to the National Vaccine Independence Avenue SW.,
May 3, 2017, will be dedicated to the
Program Office (nvpo@hhs.gov) at least Washington, DC 20201. topic of Infection Prevention and
The meeting can also be accessed
five business days prior to the meeting. Control for Animal Health. The three
through a live webcast on the day of the
Dated: March 23, 2017. working groups on Incentives for
meeting. For more information, visit
Jewel Mullen,
Diagnostics, Therapeutics/Anti-
http://www.hhs.gov/ash/carb/.
Infectives, and Vaccines, will report
Acting Director, National Vaccine Program FOR FURTHER INFORMATION CONTACT:
Office.
their preliminary findings to the full
Jomana Musmar, Acting Designated Advisory Council for deliberation on the
[FR Doc. 2017–07707 Filed 4–14–17; 8:45 am] Federal Officer, Presidential Advisory second day of the public meeting, May
BILLING CODE 4150–44–P Council on Combating Antibiotic- 4, 2017; no vote will be held. The
Resistant Bacteria, Office of the meeting agenda will be posted on the
Assistant Secretary for Health, U.S. Advisory Council Web site at http://
DEPARTMENT OF HEALTH AND Department of Health and Human www.hhs.gov/ash/carb/ when it has
mstockstill on DSK30JT082PROD with NOTICES

HUMAN SERVICES Services, Room 715H, Hubert H. been finalized. All agenda items are
Humphrey Building, 200 Independence tentative and subject to change.
Meeting of the Presidential Advisory Avenue SW., Washington, DC 20201.
Council on Combating Antibiotic- Public attendance at the meeting is
Phone: (202) 690–5566; email: CARB@ limited to the available space.
Resistant Bacteria hhs.gov. Individuals who plan to attend and
AGENCY:Department of Health and SUPPLEMENTARY INFORMATION: Under need special assistance, such as sign
Human Services, Office of the Secretary, Executive Order 13676, dated language interpretation or other

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18152 Federal Register / Vol. 82, No. 72 / Monday, April 17, 2017 / Notices

reasonable accommodations, should Secretary for Preparedness and Based on any of these four
notify the Advisory Council at the Response, Office of the Secretary, determinations, the Secretary of HHS
address/telephone number listed above Department of Health and Human may then declare that circumstances
at least one week prior to the meeting. Services, 200 Independence Avenue exist that justify the EUA, at which
For those unable to attend in person, a SW., Washington, DC 20201, Telephone point the FDA Commissioner may issue
live webcast will be available. More (202) 205–2882 (this is not a toll free an EUA if the criteria for issuance of an
information on registration and number). authorization under section 564 of the
accessing the webcast can be found at SUPPLEMENTARY INFORMATION: FD&C Act are met.
http://www.hhs.gov/ash/carb/. The Centers for Disease Control and
Members of the public will have the I. Background Prevention (CDC) requested that the
opportunity to provide comments prior Under Section 564 of the FD&C Act, FDA issue an EUA for use of an
to the Advisory Council meeting by the Commissioner of the Food and Drug injectable treatment for nerve agent and
emailing CARB@hhs.gov. Public Administration (FDA), acting under certain insecticide (organophosphorus
comments should be sent in by delegated authority from the Secretary and/or carbamate) poisoning to support
midnight April 25, 2017, and should be of the U.S. Department of Health and preparedness and response to potential
limited to no more than one page. All Human Services (HHS), may issue an public health threats posed by these
public comments received prior to April Emergency Use Authorization (EUA) agents and compounds. At this time,
25, 2017, will be provided to Advisory authorizing (1) the emergency use of an FDA-approved injectable treatments for
Council members; comments are limited unapproved drug, an unapproved or nerve agent or certain insecticide
to two minutes per speaker. uncleared device, or an unlicensed (organophosphorus and/or carbamate)
Dated: April 12, 2017. biological product; or (2) an unapproved poisoning are not available to replenish
Jewel Mullen, use of an approved drug, approved or the Department’s Strategic National
cleared device, or licensed biological Stockpile 3 inventory when the products
Acting Director, National Vaccine Program
Office. product. Before an EUA may be issued, in the current inventory expire. Pending
the Secretary of HHS must declare that the availability of such products, an
[FR Doc. 2017–07708 Filed 4–14–17; 8:45 am]
circumstances exist justifying the EUA will facilitate ensuring that the
BILLING CODE 4150–44–P
authorization based on one of four products are available in the event of a
determinations: (1) A determination by public health emergency involving
DEPARTMENT OF HEALTH AND the Secretary of Homeland Security that nerve agent or certain insecticides
HUMAN SERVICES there is a domestic emergency, or a (organophosphorus and/or carbamate).
significant potential for a domestic The determination of a significant
Determination and Declaration emergency, involving a heightened risk potential for a public health emergency,
Regarding Emergency Use of of attack with a chemical, biological, and the declaration that circumstances
Injectable Treatments for Nerve Agent radiological, or nuclear (CBRN) agent or exist justifying the authorization of
or Certain Insecticide agents; (2) the identification of a emergency use of injectable treatments
(Organophosphorus and/or material threat by the Secretary of for nerve agent or certain insecticide
Carbamate) Poisoning Homeland Security pursuant to section (organophosphorus and/or carbamate)
319F–2 of the Public Health Service poisoning by the Secretary of HHS, as
AGENCY: Office of the Secretary, described below, enables the FDA
(PHS) Act 1 sufficient to affect national
Department of Health and Human Commissioner to issue an EUA for
security or the health and security of
Services. certain injectable treatments for
United States citizens living abroad; (3)
ACTION: Notice. a determination by the Secretary of emergency use under section 564 of the
SUMMARY: The Secretary of Health and Defense that there is a military FD&C Act.
Human Services (HHS) is issuing this emergency, or a significant potential for II. Determination by the Secretary of
notice pursuant to section 564 of the a military emergency, involving a Health and Human Services
Federal Food, Drug, and Cosmetic heightened risk to United States military
forces of attack with a CBRN agent or On April 11, 2017, pursuant to section
(FD&C) Act. On April 11, 2017, the 564 of the FD&C Act, I determined that
Secretary determined that there is a agents; or (4) a determination by the
Secretary of HHS that there is a public there is a significant potential for a
significant potential for a public health public health emergency that has a
emergency that has a significant health emergency, or a significant
potential for a public health emergency, significant potential to affect national
potential to affect national security or security or the health and security of
the health and security of United States that affects, or has a significant potential
to affect, national security or the health United States citizens living abroad and
citizens living abroad, and that involves that involves nerve agents or certain
nerve agents or certain insecticides and security of United States citizens
living abroad, and that involves a CBRN insecticides (organophosphorus and/or
(organophosphorus and/or carbamate). carbamate).1
On the basis of this determination, he agent or agents, or a disease or condition
also declared that circumstances exist that may be attributable to such agent or III. Declaration of the Secretary of
justifying the authorization of agents.2 Health and Human Services
emergency use of injectable treatments 1 42 On April 11, 2017, on the basis of my
U.S.C. 247d–6b(c).
for nerve agent or certain insecticide 2 As amended by the Pandemic and All-Hazards determination of a significant potential
(organophosphorus and/or carbamate) Preparedness Reauthorization Act, Public Law 113– for a public health emergency that has
mstockstill on DSK30JT082PROD with NOTICES

poisoning pursuant to section 564 of the 5, the Secretary may make determination of a public a significant potential to affect national
FD&C Act, subject to the terms of any health emergency, or a significant potential for a
public health emergency, under section 564 of the security or the health and security of
authorization issued under that section. FD&C Act. The Secretary is no longer required to United States citizens living abroad and
DATES: The determination and make a determination of a public health emergency that involves nerve agents or certain
declaration are effective April 11, 2017. in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
insecticides (organophosphorus and/or
FOR FURTHER INFORMATION CONTACT: declaration made under section 564 of the FD&C
George Korch, Ph.D., Acting Assistant Act. 3 42 U.S.C. 247d–6b(a).

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Document Created: 2018-08-25 11:27:56
Document Modified: 2018-08-25 11:27:56

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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 http://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.
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: [email protected]
FR Citation		82 FR 18151