[Federal Register Volume 86, Number 173 (Friday, September 10, 2021)]
[Notices]
[Pages 50723-50724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19515]
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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.
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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 party-at-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-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: 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
[[Page 50724]]
Calcitriol capsules are used for vitamin D3 deficiency.
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\1\ See Sun Pharma, About Us, https://sunpharma.com/about-us/
(last visited Aug. 2, 2021).
\2\ The Calcitriol's National Drug Code Directory numbers are:
62756-967-83, 62756-967-88 and 62756-968-88.
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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.
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\3\ See 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).
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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 (Dutch-origin 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 party-at-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 party-at-
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