Commercial Customs Operations Advisory Committee (COAC), 32885-32886 [2018-15107]
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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
heightened risk of an enemy attack with
agents of military combat, including
firearms, projectiles, and explosive
devices, that may cause major and
imminently life-threatening combat
casualties involving uncontrolled
hemorrhage.
On the basis of this determination, on
July 9, 2018 the Secretary declared that
circumstances exist justifying the
authorization of emergency use of
Freeze Dried Plasma (FDP) to treat
uncontrolled hemorrhage due to agents
of military combat (e.g., firearms,
projectiles, and explosive devices) in
emergency situations when plasma is
not available for use or its use is not
practical, pursuant to section 564 of the
FD&C Act, subject to the terms of any
authorization issued under that section.
DATES: The declaration is effective July
9, 2018.
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, MD, MTM&H, MS,
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:
sradovich on DSK3GMQ082PROD with NOTICES
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 biological, chemical, 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
1 42 U.S.C. 247d–6b, which states: ‘‘[t]he
Homeland Security Secretary, in consultation with
the Secretary and the heads of other agencies as
appropriate, shall on an ongoing basis—(i) assess
current and emerging threats of chemical,
biological, radiological, and nuclear agents; and (ii)
determine which of such agents present a material
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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, including
personnel operating under the authority
of title 10 or title 50, of attack with (i)
a biological, chemical, radiological, or
nuclear agent or agents; or (ii) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary 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.
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 determination of
a military emergency or significant
potential for a military emergency by
the Deputy Secretary of Defense, and the
declaration that circumstances exist
justifying emergency use of French FDP
by the Secretary of HHS, as described
below, enable the FDA Commissioner to
issue an EUA for FDP in emergency
situations when plasma is not available
for use or its use is not practical for
emergency use under section 564 of the
FD&C Act.
II. Determination of a Military
Emergency or Significant Potential for a
Military Emergency by the Deputy
Secretary of Defense
On June 7, 2018, Patrick M.
Shanahan, Deputy Secretary of Defense,
determined in accordance with section
564(b)(1)(B) of the Federal Food, Drug
and Cosmetic Act, 21 U.S.C. 360bbb–
3(b)(1)(B), as delegated by the Secretary
of Defense, that there is a military
emergency or significant potential for a
military emergency, involving a
heightened risk to U.S. military forces of
an attack with an agent or agents that
may cause, or are otherwise associated
with an imminently life-threatening and
specific risk to those forces. The Deputy
Secretary further stated that, more
threat against the United States population
sufficient to affect national security.’’
PO 00000
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Fmt 4703
Sfmt 4703
32885
specifically, U.S. Forces are now
deployed in multiple locations where
they serve at heightened risk of an
enemy attack with agents of military
combat, including firearms, projectiles,
and explosive devices, that may cause
major and imminently life-threatening
combat casualties involving
uncontrolled hemorrhage.
III. Declaration of the Secretary of
Health and Human Services
On July 9, 2018, on the basis of the
Deputy Secretary of Defense’s
determination that there is a military
emergency or significant potential for a
military emergency involving a
heightened risk to U.S. military forces of
an attack with an agent or agents that
may cause, or are otherwise associated
with an imminently life-threatening and
specific risk to those forces, I declared
that circumstances exist justifying the
authorization of emergency use of FDP
to treat uncontrolled hemorrhage due to
agents of military combat (e.g., firearms,
projectiles, and explosive devices) in
emergency situations when plasma is
not available for use or its use is not
practical, pursuant to section 564 of the
FD&C Act, subject to the terms of any
authorization issued under that section.
Notice of any EUAs issued by the
FDA Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
Register as required under section 564
of the FD&C Act.
Alex M. Azar II,
Secretary.
[FR Doc. 2018–15152 Filed 7–13–18; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP–2018–0026]
Commercial Customs Operations
Advisory Committee (COAC)
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security (DHS).
ACTION: Committee management; notice
of Federal Advisory Committee meeting.
AGENCY:
The Commercial Customs
Operations Advisory Committee (COAC)
will hold its public meeting on
Wednesday, August 1, 2018 via
webinar. The meeting will be open to
the public.
DATES: The COAC will meet on
Wednesday, August 1, 2018 from 1:00
p.m. to 4:00 p.m. EST. Please note that
SUMMARY:
E:\FR\FM\16JYN1.SGM
16JYN1
sradovich on DSK3GMQ082PROD with NOTICES
32886
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
the meeting may close early if the
committee has completed its business.
ADDRESSES: The meeting will be held
via webinar. The webinar link and
conference phone number will be
provided to all registrants by 5:00 p.m.
on July 31, 2018. For information on
services for individuals with disabilities
or to request special assistance at the
meeting, contact Ms. Florence ConstantGibson, Office of Trade Relations, U.S.
Customs & Border Protection, at (202)
344–1440 as soon as possible.
Pre-Registration: Members of the
public who plan to attend the meeting,
please register online at: https://
teregistration.cbp.gov/index.asp?w=137
by 4 p.m. EST, July 31, 2018. Please feel
free to share this information with other
interested members of your organization
or association.
Members of the public who are preregistered to attend via webinar and
later need to cancel, please do so by
9:00 a.m. EST on August 1, 2018
utilizing the following link: https://
teregistration.cbp.gov/
cancel.asp?w=137.
To facilitate public participation, we
are inviting public comment on the
issues the committee will consider prior
to the formulation of recommendations
as listed in the Agenda section below.
Comments must be submitted in
writing no later than 5:00 p.m. EST on
July 31, 2018, and must be identified by
Docket No. USCBP–2018–0026, and
may be submitted by one (1) of the
following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Email: tradeevents@dhs.gov.
Include the docket number in the
subject line of the message.
• Fax: (202) 325–4290, Attention
Florence Constant-Gibson.
• Mail: Ms. Florence ConstantGibson, Office of Trade Relations, U.S.
Customs and Border Protection, 1300
Pennsylvania Avenue NW, Room 3.5A,
Washington, DC 20229.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number (USCBP–2018–0026) for this
action. Comments received will be
posted without alteration at https://
www.regulations.gov. Please do not
submit personal information to this
docket.
Docket: For access to the docket or to
read background documents or
comments, go to https://
www.regulations.gov and search for
Docket Number USCBP–2018–0026. To
submit a comment, click the ‘‘Comment
Now!’’ button located on the top-right
hand side of the docket page.
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
There will be multiple public
comment periods held during the
meeting on August 1, 2018. Speakers are
requested to limit their comments to
two (2) minutes or less to facilitate
greater participation. Contact the
individual listed below to register as a
speaker. Please note that the public
comment period for speakers may end
before the time indicated on the
schedule that is posted on the CBP web
page, https://www.cbp.gov/trade/
stakeholder-engagement/coac.
FOR FURTHER INFORMATION CONTACT: Ms.
Florence Constant-Gibson, Office of
Trade Relations, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW, Room 3.5A, Washington,
DC 20229; telephone (202) 344–1440;
facsimile (202) 325–4290; or Mr.
Bradley Hayes, Executive Director,
Office of Trade Relations and
Designated Federal Officer for COAC at
(202) 344–1440.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C.
Appendix. The Commercial Customs
Operations Advisory Committee (COAC)
provides advice to the Secretary of
Homeland Security, the Secretary of the
Treasury, and the Commissioner of U.S.
Customs and Border Protection (CBP) on
matters pertaining to the commercial
operations of CBP and related functions
within the Department of Homeland
Security and the Department of the
Treasury.
Agenda
The Designated Federal Officer will
introduce the newly appointed, reappointed, and alternate COAC
members. The COAC will also hear from
the following subcommittees on the
topics listed below and then will
review, deliberate, provide observations,
and formulate recommendations on how
to proceed:
1. The Exports Subcommittee will
discuss a path forward for its work and
the work of the Export Manifest
Working Group for the 15th Term
COAC. There will also be an update on
the automated export manifest pilots,
and on progress in implementing a postdeparture filing pilot as part of the
ocean pilot.
2. The Trusted Trader Subcommittee
will present an update from the
C–TPAT Minimum Security Criteria
Working Group on its recommendation
regarding CBP’s plans to roll out new
C–TPAT criteria. The subcommittee will
also provide an update on the progress
on the Trusted Trader Strategy and the
formation of a new Trade Compliance
Working Group.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
3. The Trade Modernization
Subcommittee will discuss the progress
of the Regulatory Reform Working
Group’s efforts to identify and prioritize
areas of regulations administered by
CBP which can be reformed and the
Foreign Trade Zone Regulations
Working Group. In addition, the
subcommittee will discuss the progress
being made in the E-Commerce Working
Group.
4. The Trade Enforcement and
Revenue Collection (TERC)
Subcommittee will provide updates
from the Anti-Dumping/Countervailing
Duties (AD/CVD), Bond, Forced Labor
and Intellectual Property Rights
Working Groups and will also speak to
the lessons learned from the risk-based
bonding tabletop exercise.
Meeting materials will be available by
July 31, 2018 at: https://www.cbp.gov/
trade/stakeholder-engagement/coac/
coac-public-meetings.
Dated: July 11, 2018.
Bradley F. Hayes,
Executive Director, Office of Trade Relations.
[FR Doc. 2018–15107 Filed 7–13–18; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7001–N–36]
30-Day Notice of Proposed Information
Collection: Human Trafficking Housing
Partnership
Office of the Chief Information
Officer, HUD.
ACTION: Notice.
AGENCY:
HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
parties on the proposed collection of
information. The purpose of this notice
is to allow for 30 days of public
comment.
SUMMARY:
DATES:
Comments Due Date: August 15,
2018.
Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
HUD Desk Officer, Office of
Management and Budget, New
Executive Office Building, Washington,
DC 20503; fax: 202–395–5806, Email:
OIRA_Submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Anna P. Guido, Reports Management
ADDRESSES:
E:\FR\FM\16JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32885-32886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15107]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP-2018-0026]
Commercial Customs Operations Advisory Committee (COAC)
AGENCY: U.S. Customs and Border Protection (CBP), Department of
Homeland Security (DHS).
ACTION: Committee management; notice of Federal Advisory Committee
meeting.
-----------------------------------------------------------------------
SUMMARY: The Commercial Customs Operations Advisory Committee (COAC)
will hold its public meeting on Wednesday, August 1, 2018 via webinar.
The meeting will be open to the public.
DATES: The COAC will meet on Wednesday, August 1, 2018 from 1:00 p.m.
to 4:00 p.m. EST. Please note that
[[Page 32886]]
the meeting may close early if the committee has completed its
business.
ADDRESSES: The meeting will be held via webinar. The webinar link and
conference phone number will be provided to all registrants by 5:00
p.m. on July 31, 2018. For information on services for individuals with
disabilities or to request special assistance at the meeting, contact
Ms. Florence Constant-Gibson, Office of Trade Relations, U.S. Customs &
Border Protection, at (202) 344-1440 as soon as possible.
Pre-Registration: Members of the public who plan to attend the
meeting, please register online at: https://teregistration.cbp.gov/index.asp?w=137 by 4 p.m. EST, July 31, 2018. Please feel free to share
this information with other interested members of your organization or
association.
Members of the public who are pre-registered to attend via webinar
and later need to cancel, please do so by 9:00 a.m. EST on August 1,
2018 utilizing the following link: https://teregistration.cbp.gov/cancel.asp?w=137.
To facilitate public participation, we are inviting public comment
on the issues the committee will consider prior to the formulation of
recommendations as listed in the Agenda section below.
Comments must be submitted in writing no later than 5:00 p.m. EST
on July 31, 2018, and must be identified by Docket No. USCBP-2018-0026,
and may be submitted by one (1) of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Email: [email protected]. Include the docket number in
the subject line of the message.
Fax: (202) 325-4290, Attention Florence Constant-Gibson.
Mail: Ms. Florence Constant-Gibson, Office of Trade
Relations, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue
NW, Room 3.5A, Washington, DC 20229.
Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number (USCBP-2018-
0026) for this action. Comments received will be posted without
alteration at https://www.regulations.gov. Please do not submit
personal information to this docket.
Docket: For access to the docket or to read background documents or
comments, go to https://www.regulations.gov and search for Docket
Number USCBP-2018-0026. To submit a comment, click the ``Comment Now!''
button located on the top-right hand side of the docket page.
There will be multiple public comment periods held during the
meeting on August 1, 2018. Speakers are requested to limit their
comments to two (2) minutes or less to facilitate greater
participation. Contact the individual listed below to register as a
speaker. Please note that the public comment period for speakers may
end before the time indicated on the schedule that is posted on the CBP
web page, https://www.cbp.gov/trade/stakeholder-engagement/coac.
FOR FURTHER INFORMATION CONTACT: Ms. Florence Constant-Gibson, Office
of Trade Relations, U.S. Customs and Border Protection, 1300
Pennsylvania Avenue NW, Room 3.5A, Washington, DC 20229; telephone
(202) 344-1440; facsimile (202) 325-4290; or Mr. Bradley Hayes,
Executive Director, Office of Trade Relations and Designated Federal
Officer for COAC at (202) 344-1440.
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. Appendix. The Commercial
Customs Operations Advisory Committee (COAC) provides advice to the
Secretary of Homeland Security, the Secretary of the Treasury, and the
Commissioner of U.S. Customs and Border Protection (CBP) on matters
pertaining to the commercial operations of CBP and related functions
within the Department of Homeland Security and the Department of the
Treasury.
Agenda
The Designated Federal Officer will introduce the newly appointed,
re-appointed, and alternate COAC members. The COAC will also hear from
the following subcommittees on the topics listed below and then will
review, deliberate, provide observations, and formulate recommendations
on how to proceed:
1. The Exports Subcommittee will discuss a path forward for its
work and the work of the Export Manifest Working Group for the 15th
Term COAC. There will also be an update on the automated export
manifest pilots, and on progress in implementing a post-departure
filing pilot as part of the ocean pilot.
2. The Trusted Trader Subcommittee will present an update from the
C-TPAT Minimum Security Criteria Working Group on its recommendation
regarding CBP's plans to roll out new C-TPAT criteria. The subcommittee
will also provide an update on the progress on the Trusted Trader
Strategy and the formation of a new Trade Compliance Working Group.
3. The Trade Modernization Subcommittee will discuss the progress
of the Regulatory Reform Working Group's efforts to identify and
prioritize areas of regulations administered by CBP which can be
reformed and the Foreign Trade Zone Regulations Working Group. In
addition, the subcommittee will discuss the progress being made in the
E-Commerce Working Group.
4. The Trade Enforcement and Revenue Collection (TERC) Subcommittee
will provide updates from the Anti-Dumping/Countervailing Duties (AD/
CVD), Bond, Forced Labor and Intellectual Property Rights Working
Groups and will also speak to the lessons learned from the risk-based
bonding tabletop exercise.
Meeting materials will be available by July 31, 2018 at: https://www.cbp.gov/trade/stakeholder-engagement/coac/coac-public-meetings.
Dated: July 11, 2018.
Bradley F. Hayes,
Executive Director, Office of Trade Relations.
[FR Doc. 2018-15107 Filed 7-13-18; 8:45 am]
BILLING CODE 9111-14-P
