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NY I80658




April 22, 2002

CLA-2-29:RR:NC:2:238 I90658

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.99.3000

Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Avenue, 39th Floor
New York, NY 10017

RE: The tariff classification of Ecteinascidin 743 (CAS-114899-77-3), imported in bulk form, from Spain

Dear Mr. Leo. :

In your letter dated April 11, 2002, on behalf of your client, Ortho McNeil Pharmaceutical, Inc., you requested a tariff classification ruling.

According to the thirteenth edition of The Merck Index, Ecteinascidin 743 is a tetrahydroisoquinoline alkaloid isolated from the Caribbean tunicate, Ecteinascidin turbinata. An article located on the World Wide Web, at clinicaltrials.gov, indicates that Ecteinascidin 743 is currently being evaluated in FDA Phase II clinical trials to determine its efficacy as a treatment for patients with inoperable malignant mesothelioma.

The Encarta® World English Dictionary defines “tunicate” as “[a] sac-shaped marine chordate animal (emphasis added) such as a sea squirt or ascidian that has a tough leathery or rubbery outer coat.” Therefore, since the product is not a vegetable alkaloid, nor a derivative thereof, it is excluded from classification under heading 2939, HTS.

Pursuant to the general notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, Vol 34, No. 21, May 24, 2000), the applicable subheading for Ecteinascidin 743, imported in bulk form, will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTS), 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. For the record, we note that the subject product is not presently listed in the Pharmaceutical Appendix to the 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 646-733-3033.

Sincerely,

Robert B. Swierupski

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