The tariff classification of ML3000 (CAS-156897-06-2), imported in bulk form, from Germany

NY F86208 November 17, 2000 CLA-2-29:RR:NC:2:238 F86208 CATEGORY: Classification TARIFF NO.: 2933.90.5590 James S. O’Kelly, Esq. Barnes, Richardson & Colburn 475 Park Avenue South New York, NY 10016 RE: The tariff classification of ML3000 (CAS-156897-06-2), imported in bulk form, from Germany Dear Mr. O’Kelly: In your letter dated November 3, 2000, on behalf of your client, Forest Laboratories, you requested a tariff classification ruling. We note that your firm’s request for a tariff classification ruling, on behalf of Forest Laboratories, was initially submitted to this office on March 6, 2000, albeit by a different attorney. We regret the delay in responding. The subject product, ML3000, is an investigational compound currently being investigated for the relief of the signs and symptoms of osteoarthritis. The Chemical Abstracts name for ML3000 is 6-(4-chlorophenyl)-2,3-dihydro-2,2-dimethyl-7-phenyl-1H-pyrrolizine-5-acetic acid. You state in your letter that Phase I and Phase II clinical trials have already been completed in Europe for ML3000, and that the FDA has recently approved your client’s Investigational New Drug (IND) application (IND #61,032) to conduct both Phase 1 and Phase 3 clinical trials for ML3000 in the United States. The applicable subheading for ML3000, imported in bulk form, will be 2933.90.5590, Harmonized Tariff Schedule of the United States (HTS), which provides for "[H]eterocyclic compounds with nitrogen hetero-atom(s) only: Other: Aromatic or modified aromatic: Other: Drugs: Drugs primarily affecting the central nervous system: Analgesics, antipyretics and nonhormonal anti-inflammatory agents: 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 Harmonized Tariff Schedule.  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