[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Notices]
[Pages 1221-1222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00140]
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DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final Determination Concerning
Ponstel[supreg] (Mefenamic Acid) 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 Ponstel[supreg] (mefenamic acid) capsules. Based
upon the facts presented, CBP has concluded in the final determination
that India is the country of origin of the Ponstel (mefenamic acid)
capsules for purposes of U.S. Government procurement.
DATES: The final determination was issued on December 26, 2012. 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 on or before February 7, 2013.
FOR FURTHER INFORMATION CONTACT: Heather K. Pinnock, Valuation and
Special Programs Branch: (202) 325-0034.
SUPPLEMENTARY INFORMATION: Notice is hereby given that on December 26,
2012, pursuant to subpart B of part 177, Customs and Border Protection
Regulations (19 CFR part 177, subpart B), CBP issued a final
determination concerning the country of origin of Ponstel (mefenamic
acid) capsules, which may be offered to the U.S. Government under an
undesignated government procurement contract. This final determination,
in HQ H233356, was issued at the request of West-Ward Pharmaceutical
Corp., 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,
based upon the facts presented, mefenamic acid from India, blended with
excipients and packaged into dosage form in the United States, was not
substantially transformed in the United States, such that India is the
country of origin of the finished Ponstel (mefenamic acid) capsules 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: January 3, 2013.
Jeremy Baskin,
Acting Executive Director, Regulations and Rulings, Office of
International Trade.
Attachment
HQ H233356
December 26, 2012
MAR-2 OT:RR:CTF:VS H233356HkP
[[Page 1222]]
CATEGORY: Origin
Ms. Susan Todd
Senior Manager, Regulatory Affairs
West-Ward Pharmaceutical Corp.
435 Industrial Way West
Eatontown, NJ 07724
RE: Government Procurement; Trade Agreements Act; Country of Origin
of Ponstel[supreg] (mefenamic acid) Capsules; Substantial
Transformation
Dear Ms. Todd:
This is in response to your letter, dated August 21, 2012,
requesting a final determination on behalf of West-Ward
Pharmaceutical Corp. (``West-Ward'') pursuant to subpart B of part
177 of the U.S. Customs and Border Protection (``CBP'') Regulations
(19 C.F.R. Part 177). Under these regulations, which implement Title
III of the Trade Agreements Act of 1979 (``TAA''), as amended (19
U.S.C. Sec. 2511 et seq.), 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.
This final determination concerns the country of origin of
Ponstel (mefenamic acid) capsules. As a U.S. importer, West-Ward is
a party-at-interest within the meaning of 19 C.F.R. Sec.
177.22(d)(1) and is entitled to request this final determination.
FACTS:
West-Ward imports mefenamic acid powder in bulk form from India,
where it is manufactured. Mefenamic acid is the active
pharmaceutical ingredient (``API'') in the pharmaceutical product
Ponstel. Ponstel is indicated for the relief of mild to moderate
pain caused by primary dysmenorrhea and is approved by the U.S. Food
and Drug Administration, NDA no. 015034.
After importation, West-Ward combines the API, mefenamic acid,
with inactive ingredients and processes it into dosage form. The
inactive ingredients are lactose monohydrate, D&C Yellow No. 10,
FD&C Yellow No. 6, gelatin, titanium dioxide, and food-grade inks.
The mefenamic acid is added to a tumbler and blended. Lactose
monohydrate, a diluent, is then added to the tumbler and blended
with the API. The blend is transferred to an encapsulating machine
and used to fill capsules purchased from a U.S. supplier. The
capsules are packed into bottles of 30 capsules each, which are
packaged and shipped to the U.S.-holder of the New Drug Application
for Ponstel.
ISSUE:
What is the country of origin of Ponstel (mefenamic acid)
capsules for purposes of U.S. Government procurement?
LAW AND ANALYSIS:
Pursuant to Subpart B of Part 177, 19 CFR Sec. 177.21 et seq.,
which implements Title III of the Trade Agreements Act of 1979, as
amended (19 U.S.C. Sec. 2511 et seq.), 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.
Under the rule of origin set forth under 19 U.S.C. Sec.
2518(4)(B):
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.
See also 19 C.F.R. Sec. 177.22(a).
A substantial transformation occurs when an article emerges from
a process with a new name, character and use different from that
possessed by the article prior to processing. A substantial
transformation will not result from a minor manufacturing or
combining process that leaves the identity of the article intact.
See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940);
and, National Juice Products Association v. United States, 628 F.
Supp. 978 (Ct. Int'l Trade 1986).
In determining whether a substantial transformation occurs in
the manufacture of chemical products such as pharmaceuticals, CBP
has consistently examined the complexity of the processing and
whether the final article retains the essential identity and
character of the raw material. To that end, CBP has generally held
that the processing of pharmaceutical products from bulk form into
measured doses does not result in a substantial transformation of
the product. See e.g., Headquarters Ruling Letter (``HQ'') 561975,
dated April 3, 2002; HQ 561544, dated May 1, 2000; and, HQ 735146,
dated November 15, 1993.
For instance, in HQ 561975, the anesthetic drug sevoflurane
imported into the U.S. in bulk form and processed into dosage form
by extensive testing operations, followed by filtering and packaging
into bottles, was found not to have undergone a substantial
transformation in the U.S. There was no change in name (the product
was identified as sevoflurane in both its bulk and processed form).
The sevoflurane retained its chemical and physical properties after
the U.S. processing. Lastly, because the imported bulk sevoflurane
had a predetermined medicinal use as an inhalable anesthetic drug,
the processing in the United States resulted in no change in the
product's use.
Likewise, in HQ 561544, the testing, filtering and sterile
packaging of Geneticin Sulfate bulk powder, to create Geneticin
Selective Antibiotic, was not found to have substantially
transformed the antibiotic substance because the processing only
involved the removal of impurities from the bulk chemical and the
placement of the chemical into smaller packaging.
In HQ 735146, 100 percent pure acetaminophen imported from China
was blended with excipients in the United States, granulated and
sold to pharmaceutical companies to process into tablets for retail
sale under private labels. U.S. Customs (now CBP) found that the
process in the United States did not substantially transform the
imported product because the product was referred to as
acetaminophen both before importation and after U.S. processing, as
imported the acetaminophen was used for medicinal purposes and
continued to be so used after U.S. processing, and the granulating
process minimally affected the chemical and physical properties of
the acetaminophen.
In this case, the mefenamic acid imported from India is blended
with excipients and packaged into dosage form in the United States.
Based on the rulings above, we find that this process does not
substantially transform the mefenamic acid because its chemical
character remains the same. As such, we find that the country of
origin of the Ponstel (mefenamic acid) capsules is India, where the
mefanamic acid was manufactured.
HOLDING:
Based on the facts in this case, the blending and packaging
operations performed in the United States do not substantially
transform the mefenamic acid imported from India. Therefore, the
country of origin of the Ponstel[supreg] (mefenamic acid) capsules
is India for purposes of U.S. Government procurement.
Notice of this final determination will be given in the Federal
Register, as required by 19 C.F.R. Sec. 177.29. Any party-at-
interest other than the party which requested this final
determination may request, pursuant to 19 C.F.R. Sec. 177.31, that
CBP reexamine the matter anew and issue a new final determination.
Pursuant to 19 C.F.R. Sec. 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,
Jeremy Baskin,
Acting Executive Director, Regulations and Rulings, Office of
International Trade.
[FR Doc. 2013-00140 Filed 1-7-13; 8:45 am]
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