The tariff classification of Agomelatine (CAS-138112-76-2), imported in bulk form, from Germany

N008455 March 26, 2007 CLA-2-29:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2924.29.6250 Mr. Joseph J. Chivini Austin Chemical Company, Inc. 1565 Barclay Boulevard Buffalo Grove, IL 60089 RE: The tariff classification of Agomelatine (CAS-138112-76-2), imported in bulk form, from Germany Dear Mr. Chivini: In your letter dated March 2, 2007, you requested a tariff classification ruling. The subject product, Agomelatine, is an investigational new drug (IAD) being studied in a Phase III clinical trial (study start: December 2006) for its efficacy, safety and tolerability in the treatment of major depressive disorder. The applicable subheading for Agomelatine, imported in bulk form, will be 2924.29.6250, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. 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