[Federal Register Volume 69, Number 155 (Thursday, August 12, 2004)]
[Notices]
[Pages 49940-49942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18424]
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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
Trade Policy Staff Committee; Public Comments for Multilateral
Negotiations in the World Trade Organization on Expansion of the List
of Pharmaceutical Products Receiving Zero Duties
AGENCY: Office of the United States Trade Representative.
ACTION: Notice and request for comments.
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SUMMARY: The Trade Policy Staff Committee (TPSC) is requesting written
public comments with respect to the expansion of the list of
pharmaceuticals subject to reciprocal duty elimination by certain
members of the World Trade Organization (WTO). The specific information
being sought is described in the background section below.
DATES: Public comments are due by noon, September 17, 2004.
ADDRESSES: Office of the U.S. Trade Representative, 600 17th Street,
NW., Washington, DC 20508. Submissions by electronic mail:
[email protected]. Submissions by facsimile: Gloria Blue, Executive
Secretary, Trade Policy Staff Committee, at (202) 395-6143.
FOR FURTHER INFORMATION CONTACT: For procedural questions concerning
public comments, contact Gloria Blue, Executive Secretary, TPSC, Office
of the USTR, 1724 F Street, NW., Washington, DC 20508, telephone (202)
395-3475. Questions concerning the expansion of the list of
pharmaceutical products receiving zero duties should be addressed to
Sarah Bovim or Jean Janicke, Director, Market Access, USTR (202) 395-
4994.
SUPPLEMENTARY INFORMATION: The Chairman of the TPSC invites written
comments from the public on the expansion of the list of pharmaceutical
products receiving duty-free treatment from certain members of the
World Trade Organization (WTO), specifically additions to the lists of
pharmaceutical active ingredients; prefixes and suffixes that could be
associated with an active ingredient in order to designate its salt,
ester or hydrate form; or chemical intermediates intended for the
manufacture of pharmaceutical active ingredients. Negotiations will
begin in 2004 in the WTO with a view to adding new pharmaceuticals to
the zero duty list. Any amendments to the list of pharmaceuticals will
be subject to approval by all participants in the negotiations. A copy
of the initial list of proposed items is available on the USTR Web site
at: http://www.ustr.gov.
1. Background Information
During the Uruguay Round of multilateral trade negotiations, the
United States and 16 trading partners agreed to the reciprocal
elimination of duties on approximately 7,000 pharmaceutical products
and chemical intermediates on January 1, 1995. Participants also agreed
to periodically update the zero duty list of pharmaceuticals. As a
result of multilateral negotiations in the WTO during 1996 and again in
1998, the United States and other participants in the negotiations
eliminated duties on an additional 750 international nonproprietary
names (INNs) and chemical intermediates on April 1, 1997, and on an
additional 630 such products on July 1, 1999.
The Pharmaceutical Appendix to the Harmonized Tariff Schedule of
the United States (HTSUS) enumerates the products and chemical
intermediates that are eligible to enter free of duty as a result of
the Uruguay Round zero for zero agreement on pharmaceuticals and the
subsequent updates by WTO members. The HTSUS can be purchased from the
United States Government Printing Office. An electronic version of the
HTSUS can be found at http://www.usitc.gov. The Pharmaceutical Appendix
of the HTSUS consists of
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three tables. Table 1 lists active pharmaceutical ingredients and
dosage-form products by their International Nonproprietary Names (INNs)
from the World Health Organization (WHO).
Table 1 currently includes INNs from WHO lists 1-78. Prefixes and
suffixes that could be associated with the INNs in Table 1, potentially
resulting in multiple permutations in derivatives, are enumerated in
Table 2. Chemical intermediates intended for the manufacture of
pharmaceuticals are listed in Table 3. The interagency TPSC committee,
led by USTR and with input from appropriate industry association and
private sector advisory groups, is in the process of preparing
negotiating positions. Comments are requested for pharmaceutical items
which would be in the interest of the United States to add to the
existing WTO zero for zero agreement.
Negotiators will be reviewing the INNs on the most recent WHO lists
(i.e., lists 79-90) in this latest review cycle. Comments pertaining to
the pharmaceutical active ingredients covered by these lists need only
provide the INN name and reference the appropriate WHO list. Otherwise,
the following information must be supplied for each pharmaceutical
active ingredient or chemical intermediate to provide the technical
basis for reviewing the submissions: (1) The precise chemical name; (2)
the Chemical Abstracts Service (CAS) registry number; (3) a diagram of
the molecular structure; and (4) the six-digit Harmonized System
classification number. Submissions of chemical intermediates also must
provide the INN and chemical name of the active ingredient into which
it is incorporated, the CAS number of this active ingredient, and a
diagram of the molecular structure of this active ingredient. A
suggested format for presenting this information is presented below. In
addition, submissions of chemical intermediates must demonstrate that
the product meets the following conditions: (1) The chemical is a sole-
pharmaceutical use intermediate; (2) some portion of the intermediate
is incorporated in the final active ingredient molecule, and (3) the
intermediate is used in producing an active ingredient that has reached
at least Phase III of clinical trials of the Food and Drug
Administration (or other national equivalent). Comments pertaining to
the additions to the list of prefixes or suffixes for salt, ester or
hydrate forms of an INN active ingredient should state a rationale for
the nomination. Only comments containing all of the above information
will be considered in developing U.S. positions for the negotiations.
2. Requirements for Submissions
In order to facilitate prompt processing of submissions, USTR
strongly urges and prefers electronic (e-mail) submissions in response
to this notice.
Persons making submissions by e-mail should use the following
subject line: ``Expansion of the List of Pharmaceutical Products
Receiving Zero Duties'' followed by ``Written Comments.'' Documents
should be submitted as either WordPerfect, MSWord, or text (.txt)
files. Supporting documentation submitted as spreadsheets are
acceptable as Quattro Pro or Excel. More detailed information regarding
the content of the submissions is listed below.
For any document containing business confidential information
submitted electronically, the file name of the business confidential
version should begin with the characters ``BC-'', and the file name of
the public version should begin with the characters ``P-''. The ``P-''
or ``BC-'' should be followed by the name of the submitter. Persons who
make submissions by e-mail should not provide separate cover letters;
information that might appear in a cover letter should be included in
the submission itself. To the extent possible, any attachments to the
submission should be included in the same file as the submission
itself, and not as separate files.
Written comments submitted in response to this request will be
placed in a file open to public inspection pursuant to 15 CFR 2003.5,
except business confidential information exempt from public inspection
in accordance with 15 CFR 2003.6. Business confidential information
submitted in accordance with 15 CFR 2003.6 must be clearly marked
``Business Confidential'' at the top of each page, including any cover
letter or cover page, and must be accompanied by a nonconfidential
summary of the confidential information. All public documents and
nonconfidential summaries shall be available for public inspection in
the USTR Reading Room. The USTR Reading Room is open to the public, by
appointment only, from 10 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday
through Friday. An appointment to review the file must be scheduled at
least 48 hours in advance and may be made by calling (202) 395-6186.
General information concerning the Office of the United States
Trade Representative may be obtained by accessing its Internet Web site
(http://www.ustr.gov).
Carmen Suro-Bredie,
Chair, Trade Policy Staff Committee.
Suggested format for submissions:
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Chemical name (e.g.,
HS code (6-digit) CAS number chemical abstracts
index name)
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Molecular structure:
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For all chemical intermediates, the following information is
provided on the pharmaceutical active ingredient into which the
intermediate is incorporated:
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CAS number of Chemical name of
INN of active ingredient active ingredient active ingredient
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Molecular structure of active ingredient:
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[[Page 49942]]
[FR Doc. 04-18424 Filed 8-11-04; 8:45 am]
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