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NY M82972




May 5, 2006

CLA-2-29:RR:NC:2:238 M82972

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.59.5300

Ms. Maria Marcos
IPR Pharmaceuticals, Inc.
PO Box 1624
Canóvanas, PR 00729-1624

RE: The tariff classification of Vandetanib (CAS-443913-73-3), imported in bulk form, from the United Kingdom

Dear Ms. Marcos:

In your letter dated April 25, 2006, you requested a tariff classification ruling.

The subject product, Vandetanib (formerly known as “ZD 6474”), is the nonproprietary name adopted by the USAN Council for an investigational new drug your firm intends to import for use in FDA-regulated, Phase III clinical trials. The purpose of the trials will be to evaluate Vandetanib’s suitability for use in the treatment of cancer. The Vandetanib molecule contains an unfused piperidine ring (hydrogenated pyridine ring), a pyrimidine ring fused to a benzene ring, and an unfused benzene ring.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000; Rule 3(c) and Rule 6 of the General Rules of Interpretation, HTSUS; and Section VI, note 2(a), HTSUS, the applicable subheading for Vandetanib, imported in bulk form, will be 2933.59.5300, Harmonized Tariff of the United States (HTS), which provides for “Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” The rate of duty will be 6.5 percent ad valorem. At the present time, Vandetanib is not listed in the Pharmaceutical Appendix to the Tariff Schedule.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at: www.fda.gov.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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