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Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain Products to the Pharmaceutical Appendix to the HTS

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United States International Trade Commission.


Institution of investigation and invitation to file written submissions.


Following receipt of a request dated May 27, 2010 from the United States Trade Representative (USTR) pursuant to section 115 of the Uruguay Round Agreements Act (URAA) (19 U.S.C. 3524) and section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332 (g)), the U.S. International Trade Commission (Commission) instituted investigation No. 332-520, Pharmaceutical Products and Chemical Intermediates, Fourth Review: Advice Concerning the Addition of Certain Start Printed Page 33825Products to the Pharmaceutical Appendix to the HTS.


July 14, 2010: Deadline for filing all written submissions.

September 1, 2010: Transmittal of Commission report to the United States Trade Representative.


All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW., Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at​secretary/​edis.htm.

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Information specific to this investigation may be obtained from Philip Stone, Project Leader, Office of Industries (202-205-3424 or For information on the legal aspects of this investigation, contact William Gearhart of the Commission's Office of the General Counsel (202-205-3091 or The media should contact Margaret O'Laughlin, Office of External Relations (202-205-1819 or Hearing-impaired individuals may obtain information on this matter by contacting the Commission's TDD terminal at 202-205-1810. General information concerning the Commission may also be obtained by accessing its Internet server ( Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000.

Background: As indicated in the USTR's letter, as part of the Uruguay Round negotiations, the United States and 21 other countries agreed to eliminate duties on certain pharmaceutical products and chemical intermediates used primarily for the production of pharmaceuticals (pharmaceuticals zero-for-zero initiative) and to conduct periodic reviews to identify further products that could be covered by this duty elimination initiative. As a result of multilateral negotiations in the WTO in 1996, 1998, and 2006, the United States and other participants eliminated duties on additional pharmaceutical items. The USTR indicated that participants in the zero-for-zero initiative are conducting a fourth review to determine if products can be added to the initiative. As part of the consultation and layover requirements in section 115 of the URAA relating to an action by the President to eliminate U.S. duties on additional pharmaceutical products and chemical intermediates, the President must obtain advice regarding the proposed action from the U.S. International Trade Commission.

The USTR asked the Commission to provide advice in the form of information on the pharmaceutical products and chemical intermediates proposed for addition to the pharmaceuticals zero-for-zero initiative as follows: (1) A summary description of the products currently covered under the initiative as set out in the Pharmaceutical Appendix to the U.S. Harmonized Tariff Schedule (Appendix) and those proposed to be added to that Appendix; (2) an explanation of the relationship between the various elements in the Appendix and the Harmonized Tariff Schedule of the United States; and (3) an estimate of current U.S. imports and, where possible, current U.S. exports of the products included in the current Pharmaceutical Appendix and the proposed additions to the Appendix, based on product groupings as necessary.

The Commission has posted a list of the proposed additions to the Pharmaceutical Appendix on its Web site at​research_​and_​analysis/​ongoing/​332_​520_​request_​letter.pdf. The Commission expects to provide its report to the USTR by September 1, 2010.

Written Submissions: Interested parties are invited to file written submissions concerning this investigation. All written submissions should be addressed to the Secretary, and should be received not later than 5:15 p.m., July 14, 2010. All written submissions must conform with the provisions of section 201.8 of the Commission's Rules of Practice and Procedure (19 CFR 201.8). Section 201.8 requires that a signed original (or a copy so designated) and fourteen (14) copies of each document be filed. In the event that confidential treatment of a document is requested, at least four (4) additional copies must be filed, in which the confidential information must be deleted (see the following paragraph for further information regarding confidential business information). The Commission's rules authorize filing submissions with the Secretary by facsimile or electronic means only to the extent permitted by section 201.8 of the rules (see Handbook for Electronic Filing Procedures,​secretary/​fed_​reg_​notices/​rules/​documents/​handbook_​on_​electronic_​filing.pdf). Persons with questions regarding electronic filing should contact the Secretary (202-205-2000).

Any submissions that contain confidential business information must also conform with the requirements of section 201.6 of the Commission's Rules of Practice and Procedure (19 CFR 201.6). Section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the “confidential” or “non-confidential” version, and that the confidential business information be clearly identified by means of brackets. All written submissions, except for confidential business information, will be made available for inspection by interested parties.

In his request letter, the USTR stated that he intends to make the Commission's report available to the public in its entirety, and asked that the Commission not include any confidential business information or national security classified information in the report that the Commission sends to the USTR. Any confidential business information received by the Commission in this investigation and used in preparing this report will not be published in a manner that would reveal the operations of the firm supplying the information.

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By order of the Commission.

Issued: June 9, 2010.

Marilyn R. Abbott,

Secretary to the Commission.

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[FR Doc. 2010-14236 Filed 6-14-10; 8:45 am]