The tariff classification of AZD0530 Difumarate (CAS-893428-72-3) in bulk form, from United Kingdom

N054444 March 17, 2009 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2934.99.3000 Mr. Angel Suarez IPR Pharmaceuticals, Inc. P.O. Box 1624 Canóvanas, PR 00729-1624 RE: The tariff classification of AZD0530 Difumarate (CAS-893428-72-3) in bulk form, from United Kingdom Dear Mr. Suarez: In your letter dated March 6, 2009, you requested a tariff classification ruling. The subject product, ADZ0530 Difumarate, is an orally available 5-, 7-substituted anilinoquinazoline with anti-invasive and anti-tumor activities. AZD0530 is a dual-specific inhibitor of Src and Abl protein tyrosine kinases that are overexpressed in chronic myeloid leukemia cells. This agent binds to and inhibits these tyrosine kinases and their effects on cell motility, cell migration, adhesion, invasion, proliferation, differentiation, and survival. Specifically, AZD0530 inhibits Src kinase-mediated osteoclast bone resorption. This product is currently in various Phase II FDA clinical trials as an Investigational New Drug (IND). 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, the applicable subheading for the ADZ0530 imported in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5 percent ad valorem. 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 Director National Commodity Specialist Division