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