[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:

------------------------------------------------------------------------
                                                    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:

------------------------------------------------------------------------
                                  CAS number of       Chemical name of
   INN of active ingredient     active ingredient    active ingredient
------------------------------------------------------------------------
Molecular structure of active ingredient:
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[FR Doc. 04-18424 Filed 8-11-04; 8:45 am]
BILLING CODE 3190-WH-P