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
50724 Federal Register / Vol. 86, No. 173 / Friday, September 10, 2021 / Notices 

3See World Trade Organization, Agreement on 

Government Procurement, Parties, Observers and 

Accessions, https://www.wto.org/english/tratop_e/ 

gproc_e/memobs_e.htm (last visited Aug. 2, 2021). 

Calcitriol capsules are used for vitamin 

D3 deficiency. 

The raw ingredients originate from 

Switzerland. The active ingredient is 

Calcitriol USP. The inactive ingredients, 

which serve as coloring agents, 

preservatives, and fillers, consist of 

medium-chain triglycerides, butylated 

hydroxyanisole, butylated 

hydroxytoluene, noncrystallizing liquid 

sorbitol, glycerin, gelatin, methyl 

paraben, propylparaben, ferric oxide 

(red and yellow), titanium dioxide, 

triethyl citrate, isopropyl alcohol, and 

opacode black. 

All of the Swiss ingredients are 

shipped to India where capsules are 

manufactured. During the 

manufacturing process, the Calcitriol is 

dissolved in medium chain triglycerides 

along with other inactive ingredients to 

form a clear drug solution. Gelatin is 

mixed along with purified water and 

other inactive ingredients under specific 

temperature and vacuumed with help of 

a gelatin melter. The resulting gelatin 

mass is fed into an encapsulation 

machine to form soft gelatin capsules 

with drug solution inside. The capsules 

pass into a tumble dryer to remove 

excess moisture. After the capsules are 

dried and polished, they are printed 

with food grade ink. Finally, the 

capsules are inspected, packed in 

containers, and labelled. 

ISSUE: 

What is the country of origin of the 

subject Calcitriol capsules for purposes 

of U.S. Government procurement? 

LAW AND ANALYSIS: 

U.S. Customs and Border Protection 

(‘‘CBP’’) issues country of origin 

advisory rulings and final 

determinations as to whether an article 

is or would be a product of a designated 

country or instrumentality for the 

purposes of granting waivers of certain 

‘‘Buy American’’ restrictions in U.S. law 

or practice for products offered for sale 

to the U.S. Government, pursuant to 

subpart B of Part 177, 19 CFR 177.21– 

177.31, which implements Title III of 

the TAA, as amended (19 U.S.C. 2511– 

2518). 

CBP’s authority to issue advisory 

rulings and final determinations is set 

forth in 19 U.S.C. 2515(b)(1), which 

states: 

For the purposes of this subchapter, the 

Secretary of the Treasury shall provide for 

the prompt issuance of advisory rulings and 

final determinations on whether, under 

section 2518(4)(B) of this title, an article is 

or would be a product of a foreign country 

or instrumentality designated pursuant to 

section 2511(b) of this title. 

The rule of origin set forth under 19 

U.S.C. 2518(4)(B) states: 

An article is a product of a country or 

instrumentality only if (i) it is wholly the 

growth, product, or manufacture of that 

country or instrumentality, or (ii) in the case 

of an article which consists in whole or in 

part of materials from another country or 

instrumentality, it has been substantially 

transformed into a new and different article 

of commerce with a name, character, or use 

distinct from that of the article or articles 

from which it was so transformed. 

A product of a foreign country or 

instrumentality designated pursuant to 

19 U.S.C. 2511(b)(1), in pertinent part, 

is a country or instrumentality which is 

a party to the Agreement on 

Government Procurement (‘‘GPA’’), 

referred to in 19 U.S.C. 3511(d)(17), and 

as annexed to the World Trade 

Organization (‘‘WTO’’) Agreement.3

Switzerland is a WTO GPA country. 

Title 48, CFR Section 25.003 defines 

‘‘WTO GPA country end product’’ as an 

article that: 

(1) Is wholly the growth, product, or 

manufacture of a WTO GPA country; or 

(2) In the case of an article that consists in 

whole or in part of materials from another 

country, has been substantially transformed 

in a WTO GPA country into a new and 

different article of commerce with a name, 

character, or use distinct from that of the 

article or articles from which it was 

transformed. The term refers to a product 

offered for purchase under a supply contract, 

but for purposes of calculating the value of 

the end product includes services (except 

transportation services) incidental to the 

article, provided that the value of those 

incidental services does not exceed that of 

the article itself. 

Sun Pharma asserts that no 

substantial transformation occurs in 

India because the identity of the raw 

materials originating from Switzerland 

remains intact. We concur. The 

processing of the Calcitriol into dosage 

form as soft gel capsules will not result 

in a substantial transformation. See 

Headquarters Ruling Letter (‘‘HQ’’) 

H284694, dated Aug. 22, 2017 (Dutchorigin bulk calcium acetate produced in 

the Netherlands and combined with 

inactive ingredients in India resulted in 

calcium acetate capsules originating 

from the Netherlands); HQ H233356, 

dated Dec. 26, 2012 (The blending of the 

mefenamic acid of Indian origin with 

inactive ingredients in the U.S. to form 

mefenamic acid capsules did not 

substantially transform the mefenamic 

acid from India). The Calcitriol is 

produced in Switzerland and is 

encapsulated in India. No change in 

name occurs in India because the 

product is referred to as ‘‘Calcitriol’’ 

both before and after encapsulation. The 

Calcitriol is the only active ingredient. 

After being mixed with the inactive 

ingredients serving as coloring agents, 

preservatives, and fillers, it retains its 

chemical and physical properties and is 

merely put into a dosage form in India. 

Finally, no change in use occurs in 

India because the Calcitriol retains the 

same predetermined medicinal use for 

vitamin D3 deficiency. As a result, no 

substantial transformation occurs during 

the encapsulation process in India and 

the country of origin of the final 

Calcitriol capsules remains Switzerland, 

a WTO GPA country, where the 

Calcitriol is produced. 

Accordingly, the instant Calcitriol 

capsules would be products of a foreign 

country or instrumentality designated 

pursuant to 19 U.S.C. 2511(b)(1). 

HOLDING: 

Based on the facts presented, the 

country of origin of the Calcitriol 

capsules is Switzerland, a WTO GPA 

country, for purposes of U.S. 

Government procurement. Therefore, 

the Calcitriol soft-shell capsules would 

be products of a foreign country or 

instrumentality designated pursuant to 

19 U.S.C. 2511(b)(1). 

Notice of this final determination will 

be given in the Federal Register, as 

required by 19 CFR 177.29. Any partyat-interest other than the party which 

requested this final determination may 

request pursuant to 19 CFR 177.31 that 

CBP reexamine the matter anew and 

issue a new final determination. 

Pursuant to 19 CFR 177.30, any partyat-interest may, within 30 days of 

publication of the Federal Register 

Notice referenced above, seek judicial 

review of this final determination before 

the Court of International Trade. 

Sincerely, 

Alice A. Kipel, 

Executive Director, Regulations and Rulings, 

Office of Trade. 

[FR Doc. 2021–19515 Filed 9–9–21; 8:45 am] 

BILLING CODE 9111–14–P 


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