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NY L83243




March 14, 2005

CLA-2-30:RR:NC:2:238 L83243

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.20.0000

Mr. Henry E. Schea III
Avax Technologies, Inc.
2000 Hamilton Street, Suite 204
Philadelphia, PA 19130

RE: The tariff classification of an investigational vaccine from France

Dear Mr. Schea:

In your letter dated March 1, 2005, you requested a tariff classification ruling.

The subject product consists of an investigational vaccine intended for use in an FDA-regulated clinical trial in order to evaluate its safety and efficacy in the treatment of melanoma. The clinical trial, which will take approximately eight months to complete, is being conducted pursuant to an Investigational New Drug application filed by your firm with the FDA (IND No. 10658). The vaccine is composed of a frozen suspension of human melanoma cells in an aqueous solution of salt and sucrose. The frozen suspension will be put up in plastic freezing vials and supplied in packages containing 8 to 12 vials per package. These packages will then be shipped on dry ice directly from the manufacturer to the various clinical-trial sites in the U.S.

The applicable subheading for the subject product will be 3002.20.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Vaccines for human medicine.” 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 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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