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Notice

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

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AGENCY:

Office of the United States Trade Representative.

ACTION:

Notice and request for comments.

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: FR0435@ustr.gov. Submissions by facsimile: Gloria Blue, Executive Secretary, Trade Policy Staff Committee, at (202) 395-6143.

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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.

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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 Start Printed Page 49941three 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).

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Carmen Suro-Bredie,

Chair, Trade Policy Staff Committee.

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Suggested format for submissions:

HS code (6-digit)CAS numberChemical name (e.g., chemical abstracts index name)
Molecular structure:

For all chemical intermediates, the following information is provided on the pharmaceutical active ingredient into which the intermediate is incorporated:

INN of active ingredientCAS number of active ingredientChemical name of active ingredient
Molecular structure of active ingredient:
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[FR Doc. 04-18424 Filed 8-11-04; 8:45 am]

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