[Federal Register Volume 62, Number 248 (Monday, December 29, 1997)]
[Notices]
[Pages 67683-67684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33751]
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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 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, January 30, 1998.
ADDRESSES: Office of the U.S. Trade Representative, 600 17th Street,
N.W., Washington, D.C. 20508.
FOR FURTHER INFORMATION CONTACT: Barbara Chattin, Director for Tariff
Negotiations, USTR, (202-395-5097).
[[Page 67684]]
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, 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
take place during 1998 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.
Background
During the Uruguay Round of multilateral trade negotiations, the
United States and 16 trading partners agreed to reciprocal elimination
of duties on approximately 7,000 pharmacuticals on January 1, 1995.
Participants also recognized the need to periodically update the zero
duty list of pharmaceuticals in order to keep pace with the dynamic
nature of the industry. As a result of multilateral negotiations in the
World Trade Organization (WTO) during 1996, the United States and other
participants in the negotiations eliminated duties on an additional 750
pharmaceuticals on April 1, 1997.
The results of the Uruguay Round agreement on pharmaceuticals and
the subsequent update by WTO members is reflected in the Pharmaceutical
Appendix to the Harmonized Tariff Schedule of the United States
(HTSUS). The HTSUS can be purchased from the United States Government
Printing Office. An electronic version of HTSUS can be found at
www.usitc.gov. the Pharmaceutical Appendix of the HTSUS consists of
three tables. Table 1 lists active pharmaceutical ingredients and
dosage-form products by their International Nonproprietary Names (INNs)
from the World Heatlh Organization (WHO). Currently, the items in Table
1 are drawn from the INN lists 1-73 of the WHO. Prefixes and suffixes
that can be associated with an INN in Table 1 are contained in Table 2.
Chemical intermediates intended for the manufacture of pharmaceuticals
are listed in Table 3. Working with appropriate industry associations
and private sector advisory groups, the interagency TPSC committee led
by USTR 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 agreement.
Negotiators will be reviewing the more recent INN lists (e.g., 74-
78) in the updating exercise. Comments pertaining to the pharmaceutical
active ingredients covered by INN list 74 and higher 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 attached. 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, regardless of
what proportion the intermediate represents in the final molecule of
the active ingredient; 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.
Persons submitting written comments should provide a statement, in
twenty copies, by noon, January 30, 1998 to Gloria Blue, Executive
Secretary, TPSC, Office of the U.S. Trade Representative, Room 503, 600
17th Street, NW., Washington, D.C. 20508. In addition, a helpful
supplement to the written statement would be to provide a disk
containing as much of the technical details of the submission as
possible, either in a spreadsheet format or in a word processing table
format. The disk should have a label identifying the software used and
the submitter. Non-confidential information received will be available
for public inspection by appointment in the USTR Reading Room, Room
101, Monday through Friday, 10:00 a.m. to 12:00 noon and 1:00 p.m. to
4:00 p.m. For an appointment call Brenda Webb on 202-395-6186. Business
confidential information will be subject to the requirements of 15 CFR
2003.6. Any business confidential material must be clearly marked as
such on the cover letter or page and each succeeding page, and must be
accompanied by a non-confidential summary thereof.
Frederick L. Montgomery,
Chairman, Trade Policy Staff Committee.
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Chemical name
(e.g., chemical
HS code (6-digit) CAS number abstracts index
name
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Molecular structure
For all chemical intermediates, the following information is
provided on the pharmaceutical active ingredient into which the
intermediate is incorporated.
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Chemical name of
INN of active ingredient CAS number of active
active ingredient ingredient
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Molecular structure of active ingredient
[FR Doc. 97-33751 Filed 12-24-97; 8:45 am]
BILLING CODE 3190-01-M
