50722 Federal Register / Vol. 86, No. 173 / Friday, September 10, 2021 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Sudha Veeraraghavan, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–435–1504, 

sudha.veeraraghavan@nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Biophysics of Neural Systems 

Study Section. 

Date: October 14–15, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Geoffrey G. Schofield, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040–A, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1235, geoffreys@csr.nih.gov. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences Integrated Review Group; Human 

Studies of Diabetes and Obesity Study 

Section. 

Date: October 14–15, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Hui Chen, MD, Scientific 

Review Officer, Center for Scientific Review 

National, Institutes of Health, 6701 

Rockledge Drive, Room 6164, Bethesda, MD 

20892, 301–435–1044, chenhui@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 3, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–19534 Filed 9–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Chimeric Live-Attenuated 

Vaccine for West Nile Virus (WNV) 

AGENCY: National Institutes of Health, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases, an 

institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Commercialization 

Patent License to practice the inventions 

embodied in the Patents and Patent 

Applications listed in the Summary 

Information section of this notice to 

Blue Water Vaccines, Inc. (BWV), 

having a place of business in Cincinnati, 

Ohio, U.S.A. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Institute of 

Allergy and Infectious Diseases’ 

Technology Transfer and Intellectual 

Property Office on or before September 

27, 2021 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

Exclusive Commercialization Patent 

License should be directed to: Peter 

Soukas, Technology Transfer and Patent 

Specialist, Technology Transfer and 

Intellectual Property Office, National 

Institute of Allergy and Infectious 

Diseases, National Institutes of Health; 

Email: ps193c@nih.gov; Telephone: 

(301) 496–2644; Facsimile: (240) 627– 

3117. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

Number 60/347,281, filed January 10, 

2002, PCT Patent Application Number 

PCT/US2003/00594, filed January 9, 

2003, U.S. Patent Application Number 

10/871,775 filed June 18, 2004 (now 

U.S. Patent Number 8,778,671), U.S. 

Patent Application Number 14/305,572, 

filed June 16, 2014 (now U.S. Patent 

Number 10,058,602), U.S. Patent 

Application Number 16/025,624, filed 

July 2, 2018 (now U.S. Patent Number 

10,456,461), U.S. Patent Application 

Number 16/596,175, filed October 8, 

2019 (now U.S. Patent Number 

10,869,920), U.S. Patent Application 

Number 16/952,864, filed November 19, 

2020, Israeli Patent Application Number 

162949, filed January 9, 2003 (now 

Israeli Patent Number 162949), Israeli 

Patent Application Number 209342, 

filed January 9, 2003 (now Israeli Patent 

Number 209342), Canadian Patent 

Application Number 2472468, filed 

January 9, 2003 (now Canadian Patent 

Number 2472468), Canadian Patent 

Application Number 2903126, filed 

August 27, 2015 (now Canadian Patent 

Number 2903126), Australian Patent 

Application Number 2003216046, filed 

January 9, 2003 (now Australian Patent 

Number 2003216046), Australian Patent 

Application Number 2008203442 filed 

July 31, 2008 (now Australian Patent 

Number 2008203442), Australian Patent 

Application Number 2011250694, filed 

November 10, 2011 (now Australian 

Patent Number 2011250694), Australian 

Patent Application Number 

2017203108, filed May 10, 2017 (now 

Australian Patent Number 2017203018), 

Australian Patent Application Number 

2019203166, filed May 6, 2019 (now 

Australian Patent Number 2019203166), 

Australian Patent Application Number 

2021203089, filed May 17, 2021, 

Japanese Patent Application Number 

2003–559545, filed January 9, 2003 

(now Japanese Patent Number 4580650), 

European Patent Application Number 

11000126.0, filed January 9, 2003 (now 

European Patent Number 2339011, 

validated in Belgium, Great Britain, the 

Netherlands, Norway, Germany, 

Denmark and France), entitled 

‘‘Construction of West Nile Virus and 

Dengue Virus Chimeras for use in a Live 

Virus Vaccine to Prevent Disease Cause 

by West Nile Virus,’’ [HHS Reference 

No. E–357–2001–0,1]; and U.S. and 

foreign patent applications claiming 

priority to the aforementioned 

applications. 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive licensed 

territory may be worldwide, and the 

field of use may be limited to: 

‘‘Chimeric Live-Attenuated Vaccines for 

West Nile Virus (WNV) for use in 

animals or humans.’’ 

West Nile virus (WNV) is a positivestrand RNA virus of the family 

Flaviviridae, part of the Japanese 

encephalitis virus serocomplex that 

includes important human pathogens 

such as Murray Valley encephalitis, 

Japanese encephalitis, and St. Louis 

encephalitis viruses. WNV has been 

present in Africa and Asia for decades 

and has usually been associated with 

mild illness that includes symptoms of 

low-grade fever, headache, rash, 

myalgia, and arthralgia. Recently, WNV 

has spread rapidly across the Western 

hemisphere and is now the major 

vector-borne cause of viral encephalitis 

in the United States. By 2010, 3 million 

adults were estimated to have been 

infected with WNV in the United States, 

with nearly 13,000 cases of 

neuroinvasive disease, almost half of 

which occurred in adults greater than 60 

years of age. In this age group, WNV 

infection can cause hepatitis, 

meningitis, and encephalitis, leading to 

paralysis, coma, and death. In 2012, 286 

people in the United States died of 

WNV, according to the U.S. Centers for 

Disease Control and Prevention (CDC). 

Preliminary data for 2013 indicate over 

1,200 cases of neuroinvasive disease 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 173 / Friday, September 10, 2021 / Notices 50723 

1See Sun Pharma, About Us, https://

sunpharma.com/about-us/ (last visited Aug. 2, 

2021). 

2The Calcitriol’s National Drug Code Directory 

numbers are: 62756–967–83, 62756–967–88 and 

62756–968–88. 

and 114 deaths due to WNV. During 

2009–2018, a total of 21,869 confirmed 

or probable cases of WNV disease, 

including 12,835 (59%) WNV 

neuroinvasive disease cases, were 

reported to CDC from all 50 states, the 

District of Columbia, and Puerto Rico. 

WNV presents a significant public 

health threat. This epidemiological 

trend of WNV suggests that the United 

States can expect periodic WNV 

outbreaks, underscoring the need for a 

safe and effective vaccine to protect atrisk populations, especially older 

adults. 

WNV is also a significant worldwide 

public health threat. Starting in the mid1990s, the frequency, severity, and 

geographic range of WNV outbreaks 

increased. The virus can be found 

throughout Africa, regions of Europe 

and the Middle East, West Asia, 

Australia, Canada, Venezuela, and the 

United States. Outbreak areas are 

typically found along major bird 

migratory routes, with the largest 

outbreaks having occurred in Greece, 

Israel, Russia, Romania, and the United 

States. In the approximately eighty (80) 

years since its discovery, the virus has 

propagated to a vast region of the globe 

and is now considered the most 

important causative agent of viral 

encephalitis worldwide. 

No vaccine exists today to prevent 

WNV in humans. The methods and 

compositions of this invention provide 

a means for prevention of WNV 

infection by immunization with live 

attenuated, immunogenic viral vaccines 

against WNV. 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published notice, the National 

Institute of Allergy and Infectious 

Diseases receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR part 404. 

Complete applications for a license in 

the prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive patent 

commercialization license. In response 

to this Notice, the public may file 

comments or objections. Comments and 

objections, other than those in the form 

of a license application, will not be 

treated confidentially, and may be made 

publicly available. License applications 

submitted in response to this Notice 

will be presumed to contain business 

confidential information, and any 

release of information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: September 7, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–19566 Filed 9–9–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning Certain 

Calcitriol Soft-Shell Capsules 

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 certain Calcitriol soft-shell 

capsules. Based upon the facts 

presented, CBP has concluded in the 

final determination that the Calcitriol 

capsules would be products of a foreign 

country or instrumentality designated 

pursuant to CBP regulations for 

purposes of U.S. Government 

procurement. 

DATES: The final determination was 

issued on August 27, 2021. A copy of 

the final determination is attached. Any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of 

this final determination no later than 

October 12, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Albena Peters, Valuation and Special 

Programs Branch, Regulations and 

Rulings, Office of Trade, at (202) 325– 

0321. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on August 27, 2021, 

CBP issued a final determination 

concerning the country of origin of 

Calcitriol capsules for purposes of Title 

III of the Trade Agreements Act of 1979. 

This final determination, HQ H319605, 

was issued at the request of the partyat-interest, 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 has concluded that, 

based upon the facts presented, the 

Calcitriol soft-shell capsules would be 

products of a foreign country or 

instrumentality designated pursuant to 

19 U.S.C. 2511(b) for purposes of U.S. 

Government procurement. 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-atinterest, 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: September 3, 2021. 

Alice A. Kipel, 

Executive Director, Regulations and Rulings, 

Office of Trade. 

HQ H319605 

August 27, 2021 

OT:RR:CTF:VS H319605 AP 

CATEGORY: Origin 

Steven Lerner, Supply Chain Analyst, 

Sun Pharmaceutical Industries Ltd., 2 

Independence Way, Princeton, NJ 

08540 

RE: U.S. Government Procurement; Title 

III, Trade Agreements Act of 1979 

(19 U.S.C. 2511); Subpart B, Part 

177, CBP Regulations; Country of 

Origin of Calcitriol Capsules 

Dear Mr. Lerner: 

This is in response to your July 13, 

2021 request, on behalf of Sun 

Pharmaceutical Industries Ltd. (‘‘Sun 

Pharma’’), for a final determination 

concerning the country of origin of 

Calcitriol soft-shell capsules. This 

request is being sought because the 

company wants to confirm eligibility of 

the merchandise for U.S. government 

procurement purposes under Title III of 

the Trade Agreements Act of 1979 

(‘‘TAA’’), as amended (19 U.S.C. 2511 et 

seq.). Sun Pharma is a party-at-interest 

within the meaning of 19 CFR 

177.22(d)(1) and 177.23(a). 

FACTS: 

Sun Pharma is among the largest 

specialty generic pharmaceutical 

companies in the world with more than 

40 manufacturing facilities.1 The 

company manufactures and imports 

Calcitriol 2 in the form of soft-shell 

capsules (0.25 mcg and 0.5 mcg). The 


jbell on DSKJLSW7X2PROD with NOTICES