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NY I84126





August 1, 2002

CLA-2-30:RR:NC:2:238 I84126

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9185

Mr. Subru Bhat
Rigel, Inc.
240 East Grand Avenue
South San Francisco, CA 94080

RE: The tariff classification of a nasal spray, imported for use in clinical trials, from Canada

Dear Mr. Bhat:

In your letter dated June 6, 2002, resubmitted on July 16, 2002, you requested a tariff classification ruling.

The subject product consists of a nasal spray containing the investigational drug “R926112 HCl” as the active ingredient. You state that the spray is intended for use in FDA-regulated Phase 1 clinical trials, in order to determine the efficacy of the active ingredient in treating allergic rhinitis.

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 the subject product will be 3004.90.9185, 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 eyes, ears or respiratory system: Other: 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 646-733-3033.

Sincerely,

Robert B. Swierupski

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