Waterway Suitability Assessment for Operation of Liquefied Natural Gas Terminal; Cameron, LA, 31763-31764 [2018-14596]
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Mechanisms and
Treatments of Lower Urinary Tract
Dysfunction after Spinal Cord Injury.
Date: July 23, 2018.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Paul A. Rushing, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7345, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8895,
rushingp@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Urologic P20
Applications.
Date: August 2–3, 2018.
Time: 8:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Ryan G. Morris, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7015, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–4721,
ryan.morris@nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Diabetes Ancillary
Studies (R01).
Date: August 2, 2018.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7119, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, 301–594–2242,
jerkinsa@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: July 2, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–14648 Filed 7–6–18; 8:45 am]
BILLING CODE 4140–01–P
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18:00 Jul 06, 2018
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2017–0915]
Waterway Suitability Assessment for
Operation of Liquefied Natural Gas
Terminal; Cameron, LA
Coast Guard, DHS.
Notice of inquiry; request for
comments.
AGENCY:
ACTION:
We are requesting your
comments on a Letter of Intent and
Preliminary Waterway Suitability
Assessment we received from Sabine
Pass LNG, L.P. (SPLNG) regarding
SPLNG’s plans to construct a new berth
at its Cameron Parish, LA facility and to
increase the number of liquefied natural
gas vessels calling at the facility from
approximately 400 to 580 annually. The
Coast Guard is notifying the public of
this proposed increase in LNG marine
traffic on the Sabine-Neches Waterway
and is soliciting comments relevant to
the Coast Guard’s preparation of a Letter
of Recommendation for issuance to the
federal, state, or local agency with
jurisdiction over the proposed facility.
DATES: Comments and related material
must be received on or before August 8,
2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2017–0915 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for further instructions on
submitting comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
inquiry, call or email Mr. Scott K.
Whalen, Vessel Traffic Service Director,
Marine Safety Unit Port Arthur, U.S.
Coast Guard; telephone 409–719–5086,
email Scott.K.Whalen@uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port Marine
Safety Unit Port Arthur
DHS Department of Homeland
Security
LNG Liquefied Natural Gas
LOI Letter of Intent
LOR Letter of Recommendation
NVIC Navigation and Vessel
Inspection Circular
U.S.C. United States Code
WSA Waterway Suitability
Assessment
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
31763
II. Background and Purpose
Under 33 CFR 127.007(a), an owner or
operator planning to build a new facility
handling liquefied natural gas (LNG), or
an owner or operator planning new
construction to expand or modify
marine terminal operations in an
existing facility handling LNG, where
the construction, expansion, or
modification would result in an increase
in the size and/or frequency of LNG
marine traffic on the waterway
associated with the proposed facility or
modification to an existing facility, must
submit a Letter of Intent (LOI) to the
Captain of the Port of the zone in which
the facility is or will be located. Under
33 CFR 127.007(e), an owner or operator
planning such new construction or
expansion of an existing facility must
also file or update a Waterway
Suitability Assessment (WSA) that
addresses the proposed increase in LNG
marine traffic in the associated
waterway.
Under 33 CFR 127.009, after receiving
an LOI, the Captain of the Port issues a
Letter of Recommendation (LOR) as to
the suitability of the waterway for LNG
marine traffic to the appropriate
jurisdictional authorities. The LOR is
based on a series of factors listed in 33
CFR 127.009 that relate to the physical
nature of the affected waterway and
issues of safety and security associated
with LNG marine traffic on the affected
waterway.
III. Information Requested
On January 29, 2018, Sabine Pass
LNG, L.P. (SPLNG), located in Cameron
Parish, LA, submitted an LOI and
Preliminary WSA regarding the
company’s proposed plans to develop a
new marine berth and expand the
number of vessels calling on the facility
each year from approximately 400 to
580. The purpose of this notice is to
solicit public comments on the
proposed increase in LNG marine traffic
on the Sabine-Neches Waterway. The
Coast Guard believes that public input
may be useful to the Captain of the Port
Marine Safety Unit Port Arthur (COTP)
with respect to validating the
information provided in SPLNG’s
Preliminary WSA and development of
the LOR. A brief summary of SPLNG’s
proposal is available in the docket
where indicated under ADDRESSES.
On January 24, 2011, the Coast Guard
published Navigation and Vessel
Inspection Circular (NVIC) 01–2011,
titled ‘‘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. The
E:\FR\FM\09JYN1.SGM
09JYN1
31764
Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices
Coast Guard will refer to NVIC 01–2011
for process information and guidance in
evaluating SPLNG’s WSA. NVIC 01–
2011 is available in the docket where
indicated under ADDRESSES and also on
the Coast Guard’s website at https://
www.dco.uscg.mil/Portals/9/
DCO%20Documents/5p/5ps/NVIC/
2011/NVIC%2001-2011%20Final.pdf.
IV. Public Participation and Request for
Comments
We encourage you to submit
comments through the Federal 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. In your
submission, please include the docket
number for this notice of inquiry and
provide a reason for each suggestion or
recommendation.
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, visit https://
www.regulations.gov/privacyNotice.
Documents mentioned in this notice
of inquiry as being available in the
docket, and all public comments, will
be in our online docket at https://
www.regulations.gov and can be viewed
by following that website’s instructions.
This document is issued under
authority of 5 U.S.C. 552 (a).
Dated: July 2, 2018.
Jacqueline Twomey,
Captain, U.S. Coast Guard, Captain of the
Port Marine Safety Unit Port Arthur.
[FR Doc. 2018–14596 Filed 7–6–18; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning Malarone
Tablets
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
origin of Malarone tablets. Based upon
the facts presented, CBP has concluded
that the country of origin of the
SUMMARY:
VerDate Sep<11>2014
18:00 Jul 06, 2018
Jkt 244001
Malarone tablets is Canada for purposes
of U.S. Government procurement.
DATES: This final determination was
issued on July 2, 2018. A copy of the
final determination is attached. Any
party-at-interest may seek judicial
review of this final determination
within August 8, 2018.
FOR FURTHER INFORMATION CONTACT: Ross
M. Cunningham, Valuation and Special
Programs Branch, Regulations and
Rulings, Office of Trade, (202) 325–
0034.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that on July 2, 2018,
pursuant to subpart B of Part 177, U.S.
Customs and Border Protection
Regulations (19 CFR part 177, subpart
B), CBP issued one final determination
concerning the country of origin of
Malarone tablets, which may be offered
to the U.S. Government under an
undesignated government procurement
contract. This final determination (HQ
H290684) was issued under procedures
set forth at 19 CFR part 177, subpart B,
which implements Title III of the Trade
Agreements Act of 1979, as amended
(19 U.S.C. 2511–18). In the final
determination, CBP concluded that the
processing in Canada will result in a
substantial transformation. Therefore,
the country of origin for purposes of
U.S. Government procurement of the
Malarone tablets is Canada.
Section 177.29, CBP Regulations (19
CFR 177.29), provides that a notice of
final determination shall be published
in the Federal Register within 60 days
of the date the final determination is
issued. Section 177.30, CBP Regulations
(19 CFR 177.30), provides that any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of a
final determination within 30 days of
publication of such determination in the
Federal Register.
Dated: July 2, 2018.
Alice A. Kipel,
Executive Director, Regulations and Rulings,
Office of Trade.
HQ H290684
July 2, 2018
OT:RR:CTF:VS H290684 RMC
CATEGORY: Origin
Nicolas Guzman
Drinker Biddle & Reath LLP
1500 K Street NW
Suite 1100
Washington, DC 20005–1209
Re: U.S. Government Procurement;
Country of Origin of Malarone
Tablets; Substantial Transformation
Dear Mr. Guzman:
This is in response to your letter,
dated September 13, 2017, requesting a
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
final determination on behalf of
GlaxoSmithKline LLP (‘‘GSK’’) pursuant
to subpart B of Part 177 of the U.S.
Customs and Border Protection (‘‘CBP’’)
Regulations (19 C.F.R. Part 177). A
teleconference was held with counsel
for GSK on June 8, 2018.
This final determination concerns the
country of origin of Malarone tablets. As
a U.S. importer, GSK is a party-atinterest within the meaning of 19 C.F.R.
§ 177.22(d)(1) and is entitled to request
this final determination.
FACTS:
GSK is a global healthcare company
that researches, develops, and
manufactures pharmaceutical
medicines, vaccines, and consumer
healthcare products. At issue in this
case are tablets sold under the brand
name Malarone, which are indicated for
the prevention and treatment of acute,
uncomplicated Plasmodium falciparum
malaria. GSK states that Malarone
tablets have been shown to be effective
in regions where other malaria drugs
such as chloroquine, halofantrine,
mefloquine, and amodiaquine may have
unacceptable failure rates, presumably
due to drug resistance.
According to the FDA prescribing
information, Malarone is a fixed-dose
combination of atovaquone and
proguanil hydrochloride. See
Prescribing Information, https://
www.fda.gov/ohrms/dockets/ac/05/
briefing/2005-4089b1_05_05_
atovaquone.pdf (last visited Dec. 11,
2017). The chemical name of
atovaquone 11 is trans-2-[4-(4
chlorophenyl)cyclohexyl]-3-hydroxy1,4-naphthalenedione and the molecular
formula for atovaquone is C22H19ClO3.
The chemical name of proguanil
hydrochloride is 1-(4-chlorophenyl)-5isopropyl-biguanide hydrochloride and
the chemical formula for proguanil
hydrochloride is C11H16ClN5•HCl.
Each Malarone Tablet contains 250
milligrams of atovaquone and 100
milligrams of proguanil hydrochloride.
The FDA prescribing information also
describes the microbiology or
‘‘mechanism of action’’ of atovaquone
and proguanil hydrochloride. It states
that atovaquone and proguanil
hydrochloride ‘‘interfere with 2
different pathways involved in the
biosynthesis of pyrimidines required for
nucleic acid replication. Atovaquone is
a selective inhibitor of parasite
mitochondrial electron transport.
Proguanil hydrochloride primarily
exerts its effect by means of the
metabolite cycloguanil, a dihydrofolate
reductase inhibitor. Inhibition of
dihydrofolate reductase in the malaria
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31763-31764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14596]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2017-0915]
Waterway Suitability Assessment for Operation of Liquefied
Natural Gas Terminal; Cameron, LA
AGENCY: Coast Guard, DHS.
ACTION: Notice of inquiry; request for comments.
-----------------------------------------------------------------------
SUMMARY: We are requesting your comments on a Letter of Intent and
Preliminary Waterway Suitability Assessment we received from Sabine
Pass LNG, L.P. (SPLNG) regarding SPLNG's plans to construct a new berth
at its Cameron Parish, LA facility and to increase the number of
liquefied natural gas vessels calling at the facility from
approximately 400 to 580 annually. The Coast Guard is notifying the
public of this proposed increase in LNG marine traffic on the Sabine-
Neches Waterway and is soliciting comments relevant to the Coast
Guard's preparation of a Letter of Recommendation for issuance to the
federal, state, or local agency with jurisdiction over the proposed
facility.
DATES: Comments and related material must be received on or before
August 8, 2018.
ADDRESSES: You may submit comments identified by docket number USCG-
2017-0915 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section below for
further instructions on submitting comments.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of inquiry, call or email Mr. Scott K. Whalen, Vessel Traffic
Service Director, Marine Safety Unit Port Arthur, U.S. Coast Guard;
telephone 409-719-5086, email [email protected].
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port Marine Safety Unit Port Arthur
DHS Department of Homeland Security
LNG Liquefied Natural Gas
LOI Letter of Intent
LOR Letter of Recommendation
NVIC Navigation and Vessel Inspection Circular
U.S.C. United States Code
WSA Waterway Suitability Assessment
II. Background and Purpose
Under 33 CFR 127.007(a), an owner or operator planning to build a
new facility handling liquefied natural gas (LNG), or an owner or
operator planning new construction to expand or modify marine terminal
operations in an existing facility handling LNG, where the
construction, expansion, or modification would result in an increase in
the size and/or frequency of LNG marine traffic on the waterway
associated with the proposed facility or modification to an existing
facility, must submit a Letter of Intent (LOI) to the Captain of the
Port of the zone in which the facility is or will be located. Under 33
CFR 127.007(e), an owner or operator planning such new construction or
expansion of an existing facility must also file or update a Waterway
Suitability Assessment (WSA) that addresses the proposed increase in
LNG marine traffic in the associated waterway.
Under 33 CFR 127.009, after receiving an LOI, the Captain of the
Port issues a Letter of Recommendation (LOR) as to the suitability of
the waterway for LNG marine traffic to the appropriate jurisdictional
authorities. The LOR is based on a series of factors listed in 33 CFR
127.009 that relate to the physical nature of the affected waterway and
issues of safety and security associated with LNG marine traffic on the
affected waterway.
III. Information Requested
On January 29, 2018, Sabine Pass LNG, L.P. (SPLNG), located in
Cameron Parish, LA, submitted an LOI and Preliminary WSA regarding the
company's proposed plans to develop a new marine berth and expand the
number of vessels calling on the facility each year from approximately
400 to 580. The purpose of this notice is to solicit public comments on
the proposed increase in LNG marine traffic on the Sabine-Neches
Waterway. The Coast Guard believes that public input may be useful to
the Captain of the Port Marine Safety Unit Port Arthur (COTP) with
respect to validating the information provided in SPLNG's Preliminary
WSA and development of the LOR. A brief summary of SPLNG's proposal is
available in the docket where indicated under ADDRESSES.
On January 24, 2011, the Coast Guard published Navigation and
Vessel Inspection Circular (NVIC) 01-2011, titled ``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. The
[[Page 31764]]
Coast Guard will refer to NVIC 01-2011 for process information and
guidance in evaluating SPLNG's WSA. NVIC 01-2011 is available in the
docket where indicated under ADDRESSES and also on the Coast Guard's
website at https://www.dco.uscg.mil/Portals/9/DCO%20Documents/5p/5ps/NVIC/2011/NVIC%2001-2011%20Final.pdf.
IV. Public Participation and Request for Comments
We encourage you to submit comments through the Federal 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. In your submission, please include the docket number for
this notice of inquiry and provide a reason for each suggestion or
recommendation.
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, visit https://www.regulations.gov/privacyNotice.
Documents mentioned in this notice of inquiry as being available in
the docket, and all public comments, will be in our online docket at
https://www.regulations.gov and can be viewed by following that
website's instructions.
This document is issued under authority of 5 U.S.C. 552 (a).
Dated: July 2, 2018.
Jacqueline Twomey,
Captain, U.S. Coast Guard, Captain of the Port Marine Safety Unit Port
Arthur.
[FR Doc. 2018-14596 Filed 7-6-18; 8:45 am]
BILLING CODE 9110-04-P
