The tariff classification of RSD1235 (CAS-748810-28-8), imported in bulk form, from Switzerland

NY M82969 May 5, 2006 CLA-2-29:RR:NC:2:238 M82969 CATEGORY: Classification TARIFF NO.: 2933.99.5300 Eric R. Rock, Esq. Katten Muchin Rosenman LLP 525 W. Monroe Street Chicago, IL 60661-3693 RE: The tariff classification of RSD1235 (CAS-748810-28-8), imported in bulk form, from Switzerland Dear Mr. Rock: In your letter dated April 20, 2006, on behalf of your client, Astellas Pharma Manufacturing, Inc., you requested a tariff classification ruling. The subject product, RSD1235, is an investigational new drug for the treatment of atrial fibrillation. A press release dated March 31, 2006 announced that your client has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA), in order to gain approval to market an intravenous formulation containing RSD1235 as the active ingredient. You assert that the proper tariff classification for RSD1235 is subheading 2942.00.0500, HTSUS, which provides for “Other organic compounds: Aromatic or modified aromatic: Other: Drugs.” We disagree. The chemical structure of RSD1235 shows the presence of a heterocyclic ring containing only a nitrogen hetero-atom. Therefore, RSD1235 conforms to the terms of heading 2933, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only.” In addition, since RSD1235 contains a benzene ring in the structure, it is also “aromatic,” for tariff purposes. Pursuant to Rule 1, General Rules of Interpretation, HTSUS, the applicable subheading for RSD1235, imported in bulk form, will be 2933.99.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Cardiovascular drugs: Other.” 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