Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 31763 

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 

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 http://

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: 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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 

http://www.regulations.gov. If your 

material cannot be submitted using 

http://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 http://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

the docket, visit http://

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 http://

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 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determination. 

SUMMARY: 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 

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 

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)-5- 

isopropyl-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 


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