The tariff classification of Cediranib Maleate (CAS-857036-77-2), imported in bulk form, from the United Kingdom

N009397 April 12, 2007 CLA-2-29:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2933.59.5300 Ms. Maria Marcos IPR Pharmaceuticals, Inc. P.O. Box 1624 Canóvanas, PR 00729-1624 RE: The tariff classification of Cediranib Maleate (CAS-857036-77-2), imported in bulk form, from the United Kingdom Dear Ms. Marcos: In your letter dated April 2, 2007, you requested a tariff classification ruling. The subject product, Cediranib Maleate, is the maleate salt of Cediranib (code designation: AZD2171; proposed International Nonproprietary Name: Cediranib; trade name: Recentin™), an investigational new drug being studied in Phase I, II/III clinical trials for its safety and efficacy as an anti-tumor agent. The drug functions by interfering with, or inhibiting, VEGF (vascular endothelial growth factor), which helps tumors proliferate by supporting the growth of blood vessels bringing nutrients to the tumor. Pursuant to Rule 6 of the General Rules of Interpretation, HTSUS, and the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000), the applicable subheading for Cediranib Maleate (code designation: AZD2171; proposed International Nonproprietary Name: Cediranib; trade name: Recentin™), imported in bulk form, will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: 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. We note that, at the present time, the subject product is not listed in the Pharmaceutical Appendix to the Tariff Schedule. 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. 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 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 Director, National Commodity Specialist Division