[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