[Federal Register Volume 75, Number 48 (Friday, March 12, 2010)]
[Notices]
[Pages 11986-11988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5482]


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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE


Public Comments for Multilateral Negotiations in the World Trade 
Organization on Expansion of the Lists 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 
comments from the public 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 midnight, April 9, 2010.

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 
Fred Fischer or Mary Thornton, Office of Small Business, Market Access, 
and Industrial Competitiveness, USTR, telephone (202) 395-5656.

SUPPLEMENTARY INFORMATION: The Chairman of the TPSC invites comments in 
writing from the public on the expansion of the lists of pharmaceutical 
products receiving duty-free treatment from certain Members of the 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 the 
latter part

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of April 2010 in the WTO with a view to adding new pharmaceuticals to 
the list of products subject to a zero tariff rate. Any amendments to 
the lists of pharmaceuticals will be subject to approval by all 
participants in the negotiations. A copy of the initial lists of 
proposed items is available on the USTR Web site at: http://www.ustr.gov under the ``Federal Register Notices'' tab in the middle 
of the home page. The list is also available on the Regulations.gov Web 
site at: http://www.regulations.gov under the keyword ``USTR-2010-
0006.''

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 lists of pharmaceuticals subject to a zero 
tariff rate. As a result of multilateral negotiations under the 
auspices of 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. An additional 630 such products were 
added on July 1, 1999. The most recent update incorporating 1,300 
additional products were added on December 29, 2006 (72 FR 429, January 
4, 2007).
    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. An electronic 
version of the HTSUS can be found at: http://www.usitc.gov and on the 
Web site. The current Pharmaceutical Appendix to the HTSUS can be found 
at: http://www.usitc.gov/publications/docs/tata/hts/bychapter/1000PHARMAPPX.pdf.
    The Pharmaceutical Appendix of the HTSUS consists of three tables. 
Table 1 lists active pharmaceutical ingredients and dosage-form 
products by their INNs from the World Health Organization (WHO). (Table 
1 currently includes INNs from WHO lists 1-93.) 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.

2. Public Comments

    Comments are requested on pharmaceutical items which would be in 
the interest of the United States to add to the WTO Pharmaceutical 
Agreement. Negotiators will be reviewing the INNs on the most recent 
WHO lists (i.e., lists 94-99) 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. If that information is not available, 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 
the intermediate is incorporated, the CAS number of this active 
ingredient, and a diagram of the molecular structure of this active 
ingredient. 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.

3. Requirements for Submissions

    Persons submitting comments must do so in English and must identify 
(on the first page of the submission) the ``Pharmaceutical Appendix 
Update.'' In order to be assured of consideration, comments should be 
submitted by April 9, 2010.
    In order to ensure the timely receipt and consideration of 
comments, USTR strongly encourages commenters to make on-line 
submissions, using the http://www.regulations.gov Web site. Comments 
should be submitted under the following docket: USTR-2010-0006. To find 
the docket, enter the docket number in the ``Enter Keyword or ID'' 
window at the http://www.regulations.gov home page and click 
``Search.'' The site will provide a search-results page listing all 
documents associated with this docket. Find a reference to this notice 
by selecting ``Notices'' ' under ``Document Type'' on the search-
results page, and click on the link entitled ``Submit a Comment.'' (For 
further information on using the www.regulations.gov Web site, please 
consult the resources provided on the Web site by clicking on the 
``Help'' tab.)
    The http://www.regulations.gov Web site provides the option of 
making submissions by filling in a comments field, or by attaching a 
document. USTR prefers submissions to be provided in an attached 
document. If a document is attached, it is sufficient to type ``See 
attached'' in the ``Type comment & Upload File'' field. USTR prefers 
submissions in Microsoft Word (.doc) or Adobe Acrobat (.pdf). If the 
submission is in an application other than those two, please indicate 
the name of the application in the ``Comments'' field.
    For any comments submitted electronically containing business 
confidential information, the file name of the business confidential 
version should begin with the characters ``BC.'' Any page containing 
business confidential information must be clearly marked ``BUSINESS 
CONFIDENTIAL'' on the top of that page. Filers of submissions 
containing business confidential information must also submit a public 
version of their comments. The file name of the public version should 
begin with the character ``P.'' The ``BC'' and ``P'' should be followed 
by the name of the person or entity submitting the comments or reply 
comments. Filers submitting comments containing no business 
confidential information should name their file using the character 
``P,'' followed by the name of the person or entity submitting the 
comments.
    Please do not attach separate cover letters to electronic 
submissions; rather, include any information that might appear in a 
cover letter in the comments themselves. Similarly, to the extent 
possible, please include any exhibits, annexes, or other attachments in 
the same file as the submission itself, not as separate files.

4. Public Inspection of Submissions

    Comments will be placed in the docket and open to public inspection 
pursuant to 15 CFR 2006.13, except confidential business information 
exempt from public inspection in accordance with 15 CFR 2006.15. 
Comments may be viewed on the http://www.regulations.gov Web site by 
entering docket number USTR-2010-

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0006 in the search field on the home page.
    USTR strongly urges submitters to file comments through 
regulations.gov, if at all possible. Any alternative arrangements must 
be made with Ms. Blue in advance of transmitting a comment. Ms. Blue 
should be contacted at (202) 395-3475. General information concerning 
USTR is available at http://www.ustr.gov.

Carmen Suro-Bredie,
Chair, Trade Policy Staff Committee.
[FR Doc. 2010-5482 Filed 3-11-10; 8:45 am]
BILLING CODE 3190-W0-P