Notice of Issuance of Final Determination Concerning Ponstel® (Mefenamic Acid) Capsules, 1221-1222 [2013-00140]
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Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Notices
the CBP Regulations). This is a proposed
extension of an information collection
that was previously approved. CBP is
proposing that this information
collection be extended with no change
to the burden hours. This document is
published to obtain comments from the
public and affected agencies. This
information collection was previously
published in the Federal Register (77
FR 64533) on October 22, 2012,
allowing for a 60-day comment period.
Two comments were received. This
notice allows for an additional 30 days
for public comments. This process is
conducted in accordance with 5 CFR
1320.10.
Written comments should be
received on or before February 7, 2013.
ADDRESSES: Interested persons are
invited to submit written comments on
this information collection to the Office
of Information and Regulatory Affairs,
Office of Management and Budget.
Comments should be addressed to the
OMB Desk Officer for U.S. Customs and
Border Protection, Department of
Homeland Security, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 799 9th Street NW.,
5th Floor, Washington, DC 20229–1177,
at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and affected
Federal agencies to submit written
comments and suggestions on proposed
and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13). Your comments should address one
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agency/component estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
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techniques or other forms of
information.
Title: Regulations Relating to
Recordation and Enforcement of
Trademark and Copyrights (Part 133 of
the CBP Regulations).
OMB Number: 1651–0123.
Form Number: None.
Abstract: In accordance with 19 CFR
part 133, trademark and trade name
owners and those claiming copyright
protection may submit information to
CBP to enable CBP officers to identify
violating articles at the borders. Parties
seeking to have merchandise excluded
from entry must provide proof to CBP of
the validity of the rights they seek to
protect. The information collected by
CBP is used to identify infringing goods
at the borders and determine if such
goods infringe on intellectual property
rights for which federal law provides
import protection. Respondents may
submit their information to CBP
electronically at https://apps.cbp.gov/erecordations/, or they may submit their
information on paper in accordance
with 19 CFR 133.2 and 133.3 for
trademarks, or 19 CFR 133.32 and
133.33 for copyrights.
Current Actions: This submission is
being made to extend the expiration
date.
Type of Review: Extension (without
change).
Affected Public: Businesses and
Individuals.
Estimated Number of Respondents:
2,000.
Estimated Time per Respondent: 2
hours.
Estimated Total Annual Burden
Hours: 4,000.
Dated: January 3, 2013.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2013–00144 Filed 1–7–13; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning Ponstel®
(Mefenamic Acid) Capsules
1221
origin of Ponstel® (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.
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
Dated: January 3, 2013.
Jeremy Baskin,
Acting Executive Director, Regulations and
Rulings, Office of International Trade.
This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
HQ H233356
AGENCY:
SUMMARY:
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Attachment
December 26, 2012
MAR-2 OT:RR:CTF:VS H233356HkP
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Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Notices
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® (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. § 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. § 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
§ 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
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19:11 Jan 07, 2013
Jkt 229001
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. § 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. § 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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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® (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. § 177.29. Any party-at-interest other
than the party which requested this final
determination may request, pursuant to 19
C.F.R. § 177.31, that CBP reexamine the
matter anew and issue a new final
determination. Pursuant to 19 C.F.R.
§ 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]
BILLING CODE;P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Quarterly IRS Interest Rates Used in
Calculating Interest on Overdue
Accounts and Refunds on Customs
Duties
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: General notice.
AGENCY:
This notice advises the public
of the quarterly Internal Revenue
Service interest rates used to calculate
interest on overdue accounts
(underpayments) and refunds
(overpayments) of customs duties. For
the calendar quarter beginning January
1, 2013, the interest rates for
SUMMARY:
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE;P
