The tariff classification of ML3000 tablets from Germany

NY F85660 May 3, 2000 CLA-2-30:RR:NC:2:238 F85660 CATEGORY: Classification TARIFF NO.: 3004.90.9028 Robert H. Schor, Esq. Barnes, Richardson & Colburn 475 Park Avenue South New York, NY 10016 RE: The tariff classification of ML3000 tablets from Germany Dear Mr. Schor: In your letter dated March 15, 2000, resubmitted April 18, 2000, on behalf of your client, Forest Laboratories, Inc, you requested a tariff classification ruling. The subject product, ML3000 tablets, is an investigational medicament, put up in tablet form, containing ML3000 (the code designation for [6-(4-chlorophenyl)-2,2-dimethyl-7-phenyl-2,3-dihydro-1H-pyrrolizine-5-yl]-acetic acid), as the active ingredient. You indicate in your letter that ML3000 has the following Chemical Abstracts Service (CAS) registry number: 156897-06-2. A document supplied by your client, submitted by you on their behalf, indicates that “ML3000 will be investigated for the relief of the signs and symptoms of osteoarthritis.” This document further indicates that, “[T]o date, pharmacology and toxicology non-clinical studies and several human Phase 1 and 2 studies have been conducted and are ongoing in Europe … to investigate both the safety and efficacy of ML3000 for the proposed indication.” Finally, the document states that your client “[i]ntends to submit an IND for ML3000 third/fourth quarter 2000 in order to initiate Phase 3 clinical studies in the U.S. for the same indication.” The applicable subheading for the subject product will be 3004.90.9028, Harmonized Tariff Schedule of the United States (HTS), which provides for "Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: Other." The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.  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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division