[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