Notice of Issuance of Final Determination Concerning Rybix® (Tramadol Hydrochloride) Tablets, 2416-2418 [2013-00414]

Agencies

• DEPARTMENT OF HOMELAND SECURITY
• U.S. Customs and Border Protection

[Federal Register Volume 78, Number 8 (Friday, January 11, 2013)]
[Notices]
[Pages 2416-2418]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00414]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Notice of Issuance of Final Determination Concerning 
Rybix[supreg] (Tramadol Hydrochloride) Tablets

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 Rybix[supreg] (tramadol hydrochloride) tablets. 
Based upon the facts presented, CBP has concluded in the final 
determination that India is the country of origin of the Rybix 
(tramadol hydrochloride) tablets 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 Sec.  177.22(d), may seek judicial review of this 
final determination on or before February 11, 2013.

FOR FURTHER INFORMATION CONTACT: Karen S. Greene, Valuation and Special 
Programs Branch: (202) 325-0041.

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 Rybix (tramadol 
hydrochloride) tablets, which may be offered to the U.S. Government 
under an undesignated government procurement contract. This final 
determination, in HQ H215656, was issued at the request of Shionogi 
Inc., 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, tramadol hydrochloride from India, 
blended with excipients and packaged into dosage form in France, was 
not substantially transformed in France,

[[Page 2417]]

such that India is the country of origin of the finished Rybix 
(tramadol hydrochloride) tablets 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: December 26, 2012.
Jeremy Baskin,
Acting Executive Director, Regulations and Rulings, Office of 
International Trade.

Attachment

HQ H215656

December 26, 2012

MAR-02 OT:RR:CTF:VS KSG

CATEGORY: Origin

Alan M. Kirschenbaum
Hyman, Phelps & McNamara P.C.
700 13th Street, NW.
Suite 1200
Washington, DC 20815
RE: U.S. Government procurement; Trade Agreement Act; Country of 
Origin of Rybix ODT; substantial transformation

    Dear Mr. Kirschenbaum:
    This is in response to your eruling request, submitted April 6, 
2012, requesting a final determination on behalf of Shionogi Inc., 
pursuant to subpart B of Part 177 of the U.S. Customs and Border 
Protection (``CBP'') Regulations (19 CFR Part 177) which was 
forwarded to this office for a response. Under these regulations, 
which implement Title III of the Trade Agreements Act of 1979 
(``TAA''), as amended (19 U.S.C. 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 Rybix 
ODT (tramadol hydrochloride orally disintegrating tablets). As a 
U.S. importer, Shionogi Inc. is a party-at-interest within the 
meaning of 19 CFR 177.22(d)(1), and is entitled to request this 
final determination.

FACTS:

    Rybix ODT is a pharmaceutical product used for the management of 
moderate to moderately severe pain in adults. The active 
pharmaceutical ingredient (``API''), tramadol hydrochloride, is 
manufactured in India. The API is shipped to France where it 
undergoes four stages of manufacturing. Inactive ingredients 
(excipients) used in production in France are: aspartame, 
copovidone, crospovidone, ethylcellulose, magnesium stearate, 
mannitol 60, mannitol M300, mint rootbeer flavor, and silicon 
dioxide.
    The first stage of French manufacturing is preparation of 
tramadol hydrochloride granules (the API). The API and silicon 
dioxide are de-lumped and granulated with a suspension of 
ethylcellulose, copovidone, silicon dioxide, and ethanol. The 
uncoated granules are sieved and sized. These granules are then 
coated and sieved to remove any granules larger than 710 microns.
    The second stage of French manufacturing is preparation of the 
tablet blend. A number of excipients such as mint rootbeer flavor, 
aspartame, crospovidone, mannitol 60, and mannitol M300, are de-
lumped by passing them through a sieve. An excipient is defined on 
www.thefreedictionary.com as ``an inactive substance that serves as 
the vehicle or medium for a drug'' or ``a substance, such as sugar 
or gum, used to prepare a drug or drugs in a form suitable for 
administration.'' The excipients are combined to make a flavor 
preblend. The tramadol hydrochloride coated granules are also de-
lumped by passing them through a screen and then the flavor preblend 
is added and blended. The blended product is discharged into 
polyethylene-lined drums.
    The third stage of French manufacturing is tablet compression. 
Magnesium stearate is sprayed onto upper and lower punch faces on a 
tablet press (to prevent sticking) and tablets are formed. The bulk 
tablets are collected in polyethylene-lined foil bags, which are 
heat-sealed and packaged in fiberboard drums.
    The fourth stage of French manufacturing is packaging in child-
resistant blister packs. The tablets are fed through a tablet feeder 
and packaged into cold form blisters sealed with child-resistant 
blister lidstock. The blister pack cards are then packed into 
cartons of 30 tablets each with FDA-compliant labeling, packaged in 
cartons and shipped to the importer's warehouses in the U.S.

ISSUE:

    What is the country of origin of imported Rybix ODT (tramadol 
hydrochloride), processed as described above?

LAW AND ANALYSIS:

    Pursuant to Subpart B of Part 177, 19 CFR 177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. 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 if 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. 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 CFR 
177.22(a).
    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, filtering and packaging does not result in a 
substantial transformation. See Headquarters Ruling Letter (``HRL'') 
H197582, dated August 9, 2012, HRL 561975, dated April 3, 2002, HRL 
561544, dated May 1, 2000.
    In HRL 561975, dated April 3, 2002, an anesthetic drug known as 
sevofurane was imported in bulk form from Japan and in the U.S., 
processed into dosage form, filtered and subjected to FDA testing. 
CBP held that the imported good did not undergo a substantial 
transformation in the U.S.--the chemical and physical properties of 
the drug remained the same, and the medicinal use did not change.
    Likewise, in HRL 561544, dated May 1, 2000, 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 HRL H040735, dated January 21, 2009, CBP considered whether 
imported Sumatriptan was substantially transformed in the UK, where 
it was compounded with sodium chloride and water using helium USP 
for a processing aid to reduce dissolved air. The pharmaceutical 
then went through a series of sterilizing filters, and was filled 
into an empty capsule subassembly. The drug capsule subassembly, 
which contained the dose of sumatriptan succinate, and the actuator 
subassembly, which consisted of a nitrogen gas powered ram and 
piston, were then combined. CBP held that the active ingredient 
which was produced in India, did not undergo a substantial 
transformation even though the injection system was sophisticated 
and valuable. The active ingredient did not undergo a change in 
character.
    In this case, the processing in France does not result in a 
change in the medicinal use of the finished product and the active 
ingredient retains its chemical and physical properties and is 
merely put into a dosage form and packaged. The active ingredient 
does not undergo a change in name, character or use. Accordingly, we 
find that there no substantial transformation occurs in France, and 
the imported product would be considered a product of India for 
purposes of government procurement.

HOLDING:

    Based upon the facts in this case, we find that the imported 
Rybix ODT (tramadol hydrochloride) is not substantially transformed 
in France. The country of origin for government procurement purposes 
is India.
    Notice of this final determination will be given in the Federal 
Register, as required by 19 C.F.R. 177.29. Any party-at-interest 
other

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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,

    Jeremy Baskin

Acting Executive Director
Office of Regulations and Rulings,
Office of International Trade

[FR Doc. 2013-00414 Filed 1-10-13; 8:45 am]
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