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NY L81011





December 13, 2004

CLA-2-29:RR:NC:2:238 L81011

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.39.4100

Mr. Joseph J. Chivini
Austin Chemical Company, Inc.
1565 Barclay Boulevard
Buffalo Grove, IL 60089

RE: The tariff classification of Sorafenib (CAS-284461-73-0), imported in bulk form, from France

Dear Mr. Chivini:

In your letter dated November 17, 2004, you requested a tariff classification ruling.

According to an article found on the World Wide Web, the subject product, Sorafenib (aka BAY 43-9006), is currently in Phase III clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic renal-cell carcinoma. Perusal of the ClinicalTrials.gov. website indicates that patients are being recruited for participation in clinical trials to evaluate Sorafenib’s efficacy in the treatment of several other types of malignancies.

The applicable subheading for Sorafenib, imported in bulk form, will be 2933.39.4100, Harmonized Tariff of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Drugs: Other.” The rate of duty will be 6.5 percent ad valorem. The rate of duty will remain the same in 2005. At the present time, Sorafenib is not 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 1-888-443-6332.

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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