[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Notices]
[Pages 1221-1222]
From the Federal Register Online via the Government Publishing 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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