Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States

AGENCY:

United States International Trade Commission.

ACTION:

Institution of investigation.

DATES:

Effective Date: June 12, 2006.

SUMMARY:

Following receipt of a request on May 25, 2006, from the United States Trade Representative (USTR), the Commission instituted Investigation No. 332-476, Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States, under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)).

FOR FURTHER INFORMATION CONTACT:

Information specific to these investigations may be obtained from Philip Stone, Project Leader (202-205-3424; philip.stone@usitc.gov), Office of Industries, United States International Trade Commission, Washington, DC, 20436. For information on the legal aspects of these investigations, contact William Gearhart of the Office of the General Counsel (202-205-3091; william.gearhart@usitc.gov). General information concerning the Commission may also be obtained by accessing its Internet server ( http://www.usitc.gov ).

Background: As one part of the market access tariff results of the Uruguay Round negotiations, the United States and 21 other countries agreed to reciprocal elimination of duties on certain pharmaceutical products and chemical intermediates used primarily for the production of pharmaceuticals. In the Uruguay Round Agreement Act (URAA), Congress authorized the President to grant duty-free treatment to new pharmaceutical products and chemical intermediates. One of the requirements set out in the URAA is that the President “obtain advice regarding the proposed action” from the Commission. Pursuant to section 115 of the URAA and section 332(g) of the Tariff Act of 1930, the USTR requests that the Commission provide advice in the form of additional information on the pharmaceutical products and chemical intermediates currently under consideration. The USTR specifically requests (1) a summary description of the products contained in the existing Pharmaceutical Appendix and the modifications made 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 the current U.S. imports and, where possible, current U.S. exports of the products included in the existing Pharmaceutical Appendix and the proposed additions to the Appendix.

A list of the proposed additions to the Pharmaceutical Appendix is available on the Commission's Web site at http://www.usitc.gov/ind_econ_ana/combined_tables_pharma_332.pdf. The Commission expects to provide its report to the USTR by September 1, 2006.

Written Submissions: The Commission does not plan to hold a public hearing in connection with preparation of this report. However, interested parties are invited to submit written statements containing pertinent data such as levels of exports and imports for the items included in this investigation. All submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436, and should be received no later than 5:15 p.m. EDT on June 21, 2006. 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 of the rules requires that a signed original (or a copy designated as an original) and fourteen (14) copies of each document be filed. In the event that confidential treatment of the 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 do not authorize filing submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the rules (see Handbook for Electronic Filing Procedures, http://www.usitc.gov/secretary/fed_reg_notices/rules/documents/handbook_on_electronic_filing.pdf ).

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 “nonconfidential” 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 in the Office of the Secretary to the Commission 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 or national security confidential information in the report. The report that the Commission sends to the USTR will not contain any such information. Any confidential business information received by the Commission in this investigation and used in preparing the report will not be published in a manner that would reveal the operations of the firm supplying the information.

The public record for these investigations may be viewed on the Commission's electronic docket (EDIS) at http://www.usitc.gov/secretary/edis.htm. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting our TDD terminal on 202-205-1810. 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.