Waterway Suitability Assessment for Construction and Operation of Liquefied Gas Terminals; Sabine-Neches Waterway, Vidor, TX, 40891-40892 [2016-14910]
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Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
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Send one self-addressed adhesive label
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FOR FURTHER INFORMATION CONTACT:
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4307,
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0498, or FAERSESUB@fda.hhs.gov; or
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Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
I. Background
On February 21, 2014, FDA issued a
Federal Register notice (79 FR 9908)
announcing the availability of a final
guidance for industry entitled ‘‘E2B (R3)
Electronic Transmission of Individual
Case Safety Reports (ICSRs)
Implementation Guide—Data Elements
and Message Specification’’ (ICH
E2B(R3) guidance) and an appendix to
the guidance entitled ‘‘ICSRs: Appendix
to the Implementation Guide—
Backwards and Forward Compatibility’’
(BFC appendix). The ICH E2B(R3)
guidance and BFC appendix were
issued as a package that included
schema files and additional technical
information to be used for creating
compatible ICSR files. The preface to
the ICH E2B(R3) implementation
guidance makes clear that any future
‘‘technical specifications document
associated with that guidance would be
provided as a stand-alone document’’
but incorporated by reference into that
guidance. Accordingly, in this notice,
we are announcing the availability of a
technical specifications document that
will be incorporated into that final
guidance.
This technical specifications
document, which is available on the
FDA Guidance Web page at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/ucm274966.htm, is to assist
interested parties in electronically
submitting individual case safety
reports (ICSRs) (and any ICSR
attachments) to CDER and CBER. This
VerDate Sep<11>2014
17:24 Jun 22, 2016
Jkt 238001
document describes FDA’s technical
approach for submitting ICSRs, for
incorporating its regionally controlled
terminology, and for adding its regional
data elements that are not addressed in
the ICH E2B (R3) guidance for the
following FDA-regulated products: Drug
products marketed for human use with
approved new drug applications and
abbreviated new drug applications;
prescription drug products marketed for
human use without an approved
application; nonprescription (over-thecounter) human drug products marketed
without an approved application; and
biological products marketed for human
use with approved biologic license
applications.
II. Electronic Access
Persons with access to the Internet
may obtain a copy of the FDA Regional
Implementation Specifications for ICH
E2B(R3) at https://www.fda.gov/drugs/
guidancecomplianceregulatory
information/surveillance/adversedruge
ffects/ucm115894.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: June 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14845 Filed 6–22–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2016–0374]
Waterway Suitability Assessment for
Construction and Operation of
Liquefied Gas Terminals; SabineNeches Waterway, Vidor, TX
Coast Guard, DHS.
Notice and request for
comments.
AGENCY:
ACTION:
Jefferson Railport Terminal 1
(Texas) LLC, has submitted a Letter of
Intent and Preliminary Waterway
Suitability Assessment to the Coast
Guard Captain of the Port (COTP), Port
Arthur, TX regarding the company’s
plans to construct, own and operate a
waterfront facility handling and storing
Liquefied Hazardous Gas (LHG) at its
Vidor, TX facility located on the SabineNeches Waterway. The Coast Guard is
notifying the public of this action to
solicit public comments on the
proposed increase in LHG marine traffic
on the Sabine-Neches Waterway.
SUMMARY:
PO 00000
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Fmt 4703
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40891
Comments must be submitted to
the online docket via https://
www.regulations.gov, or reach the
Docket Management Facility, on or
before July 25, 2016.
ADDRESSES: You may submit comments
identified by docket number USCG–
2016–0374 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
FOR FURTHER INFORMATION CONTACT: For
further information about this notice,
call or email Chief Petty Officer Jamie L.
Merriman, U.S. Coast Guard; telephone
409–719–5033, email
jamie.l.merriman@uscg.mil.
SUPPLEMENTARY INFORMATION:
DATES:
Public Participation and Comments
We encourage you to submit
comments or related material in
response to this notice. We will
consider all submissions and may adjust
our final action based on your
comments. If you submit a comment,
please include the docket number for
this notice, indicate the specific section
of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that Web site’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted or a final rule is
published.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
2005, issue of the Federal Register (70
FR 15086).
Discussion, Basis, and Purpose
Under 33 CFR 127.007(a), an owner or
operator planning to build a new facility
E:\FR\FM\23JNN1.SGM
23JNN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
40892
Federal Register / Vol. 81, No. 121 / Thursday, June 23, 2016 / Notices
handling Liquefied Natural Gas (LNG)
or Liquefied Hazardous Gas (LHG),
where the construction, expansion, or
modification would result in an increase
in the size and/or frequency of LNG or
LHG marine traffic on the waterway
associated with the facility, must submit
a Letter of Intent (LOI) to the COTP of
the zone in which the facility is located.
Under 33 CFR 127.007(e), an owner or
operator planning such an expansion
must also file or update a Waterway
Suitability Assessment (WSA) that
addresses the proposed increase in LNG
or LHG marine traffic in the associated
waterway. Jefferson Railport Terminal 1
(Texas) LLC, located in Vidor, TX
submitted an LOI and WSA on March 7,
2016, regarding the company’s proposed
construction and operation of LHG
capabilities at its Vidor, TX facility.
Under 33 CFR 127.009, after receiving
an LOI, the COTP issues a Letter of
Recommendation (LOR) as to the
suitability of the waterway for LNG or
LHG marine traffic to the appropriate
jurisdictional authorities. The LOR is
based on a series of factors outlined in
33 CFR 127.009 that relate to the
physical nature of the affected waterway
and issues of safety and security
associated with LNG or LHG marine
traffic on the affected waterway.
The purpose of this notice is to solicit
public comments on the proposed
increase in LHG marine traffic on the
Sabine-Neches Waterway. The Coast
Guard believes that input from the
public may be useful to the COTP with
respect to development of the LOR.
Additionally, the Coast Guard intends to
task the Area Maritime Security
Committee, Port Arthur, TX and the
Southeast Texas Waterways Advisory
Council with forming a subcommittee
comprised of affected port users and
stakeholders. The goal of this
subcommittee will be to gather
information to help the COTP assess the
suitability of the associated waterway
for increased LHG marine traffic as it
relates to navigational safety and
security.
On January 24, 2011, the Coast Guard
published Navigation and Vessel
Inspection Circular (NVIC) 01–2011,
‘‘Guidance Related to Waterfront
Liquefied Natural Gas (LNG) Facilities’’.
NVIC 01–2011 provides guidance for
owners and operators seeking approval
to build and operate LNG facilities.
While NVIC 01–2011 is specific to LNG,
it provides useful process information
and guidance for owners and operators
seeking approval to build and operate
LHG facilities as well. The Coast Guard
will refer to NVIC 01–2011 for process
information and guidance in evaluating
Jefferson Railport Terminal 1’s WSA. A
VerDate Sep<11>2014
17:24 Jun 22, 2016
Jkt 238001
copy of NVIC 01–2011 is available for
viewing in the public docket for this
notice and also on the Coast Guard’s
Web site at https://www.uscg.mil/hq/cg5/
nvic/2010s.asp.
This notice is issued under authority
of 33 U.S.C. 1223–1225, Department of
Homeland Security Delegation Number
0170.1(70), 33 CFR 127.009, and 33 CFR
103.205.
Dated: May 27, 2016.
R.S. Ogrydziak,
Captain, U.S. Coast Guard, Captain of the
Port, Port Arthur.
[FR Doc. 2016–14910 Filed 6–22–16; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0111]
Agency Information Collection
Activities: Arrival and Departure
Record (Forms I–94 and I–94W) and
Electronic System for Travel
Authorization
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day Notice and request for
comments; revision of an existing
collection of information.
AGENCY:
U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: CBP Form I–94 (Arrival/
Departure Record), CBP Form I–94W
(Nonimmigrant Visa Waiver Arrival/
Departure), and the Electronic System
for Travel Authorization (ESTA). This is
a proposed extension and revision of an
information collection that was
previously approved. CBP is proposing
that this information collection be
extended with a revision to the
information collected. This document is
published to obtain comments from the
public and affected agencies.
DATES: Written comments should be
received on or before August 22, 2016
to be assured of consideration.
ADDRESSES: Written comments may be
mailed to U.S. Customs and Border
Protection, Attn: Paperwork Reduction
Act Officer, Regulations and Rulings,
Office of Trade, 90 K Street NE., 10th
Floor, Washington, DC 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
should be directed to Paperwork
Reduction Act Officer, U.S. Customs
and Border Protection, Regulations and
Rulings, Office of Trade, 90 K Street
NE., 10th Floor, Washington, DC 20229–
1177, or by telephone at 202–325–0123.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
The comments should address: (a)
Whether the collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual cost burden to respondents or
record keepers from the collection of
information (total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for OMB approval. All
comments will become a matter of
public record. In this document, CBP is
soliciting comments concerning the
following information collection:
Title: Arrival and Departure Record,
Nonimmigrant Visa Waiver Arrival/
Departure, and Electronic System for
Travel Authorization (ESTA).
OMB Number: 1651–0111.
Form Numbers: I–94 and I–94W.
Abstract
Background
CBP Forms I–94 (Arrival/Departure
Record) and I–94W (Nonimmigrant Visa
Waiver Arrival/Departure Record) are
used to document a traveler’s admission
into the United States. These forms are
filled out by aliens and are used to
collect information on citizenship,
residency, passport, and contact
information. The data elements
collected on these forms enable the
Department of Homeland Security
(DHS) to perform its mission related to
the screening of alien visitors for
potential risks to national security and
the determination of admissibility to the
United States. The Electronic System for
Travel Authorization (ESTA) applies to
aliens seeking to travel to the United
States under the Visa Waiver Program
(VWP) and requires that VWP travelers
provide information electronically to
CBP before embarking on travel to the
E:\FR\FM\23JNN1.SGM
23JNN1
Agencies
[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Notices]
[Pages 40891-40892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14910]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2016-0374]
Waterway Suitability Assessment for Construction and Operation of
Liquefied Gas Terminals; Sabine-Neches Waterway, Vidor, TX
AGENCY: Coast Guard, DHS.
ACTION: Notice and request for comments.
-----------------------------------------------------------------------
SUMMARY: Jefferson Railport Terminal 1 (Texas) LLC, has submitted a
Letter of Intent and Preliminary Waterway Suitability Assessment to the
Coast Guard Captain of the Port (COTP), Port Arthur, TX regarding the
company's plans to construct, own and operate a waterfront facility
handling and storing Liquefied Hazardous Gas (LHG) at its Vidor, TX
facility located on the Sabine-Neches Waterway. The Coast Guard is
notifying the public of this action to solicit public comments on the
proposed increase in LHG marine traffic on the Sabine-Neches Waterway.
DATES: Comments must be submitted to the online docket via https://www.regulations.gov, or reach the Docket Management Facility, on or
before July 25, 2016.
ADDRESSES: You may submit comments identified by docket number USCG-
2016-0374 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: For further information about this
notice, call or email Chief Petty Officer Jamie L. Merriman, U.S. Coast
Guard; telephone 409-719-5033, email jamie.l.merriman@uscg.mil.
SUPPLEMENTARY INFORMATION:
Public Participation and Comments
We encourage you to submit comments or related material in response
to this notice. We will consider all submissions and may adjust our
final action based on your comments. If you submit a comment, please
include the docket number for this notice, indicate the specific
section of this document to which each comment applies, and provide a
reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted or a final rule is published.
We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
Discussion, Basis, and Purpose
Under 33 CFR 127.007(a), an owner or operator planning to build a
new facility
[[Page 40892]]
handling Liquefied Natural Gas (LNG) or Liquefied Hazardous Gas (LHG),
where the construction, expansion, or modification would result in an
increase in the size and/or frequency of LNG or LHG marine traffic on
the waterway associated with the facility, must submit a Letter of
Intent (LOI) to the COTP of the zone in which the facility is located.
Under 33 CFR 127.007(e), an owner or operator planning such an
expansion must also file or update a Waterway Suitability Assessment
(WSA) that addresses the proposed increase in LNG or LHG marine traffic
in the associated waterway. Jefferson Railport Terminal 1 (Texas) LLC,
located in Vidor, TX submitted an LOI and WSA on March 7, 2016,
regarding the company's proposed construction and operation of LHG
capabilities at its Vidor, TX facility.
Under 33 CFR 127.009, after receiving an LOI, the COTP issues a
Letter of Recommendation (LOR) as to the suitability of the waterway
for LNG or LHG marine traffic to the appropriate jurisdictional
authorities. The LOR is based on a series of factors outlined in 33 CFR
127.009 that relate to the physical nature of the affected waterway and
issues of safety and security associated with LNG or LHG marine traffic
on the affected waterway.
The purpose of this notice is to solicit public comments on the
proposed increase in LHG marine traffic on the Sabine-Neches Waterway.
The Coast Guard believes that input from the public may be useful to
the COTP with respect to development of the LOR. Additionally, the
Coast Guard intends to task the Area Maritime Security Committee, Port
Arthur, TX and the Southeast Texas Waterways Advisory Council with
forming a subcommittee comprised of affected port users and
stakeholders. The goal of this subcommittee will be to gather
information to help the COTP assess the suitability of the associated
waterway for increased LHG marine traffic as it relates to navigational
safety and security.
On January 24, 2011, the Coast Guard published Navigation and
Vessel Inspection Circular (NVIC) 01-2011, ``Guidance Related to
Waterfront Liquefied Natural Gas (LNG) Facilities''. NVIC 01-2011
provides guidance for owners and operators seeking approval to build
and operate LNG facilities. While NVIC 01-2011 is specific to LNG, it
provides useful process information and guidance for owners and
operators seeking approval to build and operate LHG facilities as well.
The Coast Guard will refer to NVIC 01-2011 for process information and
guidance in evaluating Jefferson Railport Terminal 1's WSA. A copy of
NVIC 01-2011 is available for viewing in the public docket for this
notice and also on the Coast Guard's Web site at https://www.uscg.mil/hq/cg5/nvic/2010s.asp.
This notice is issued under authority of 33 U.S.C. 1223-1225,
Department of Homeland Security Delegation Number 0170.1(70), 33 CFR
127.009, and 33 CFR 103.205.
Dated: May 27, 2016.
R.S. Ogrydziak,
Captain, U.S. Coast Guard, Captain of the Port, Port Arthur.
[FR Doc. 2016-14910 Filed 6-22-16; 8:45 am]
BILLING CODE 9110-04-P