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NY I81075

April 26, 2002

CLA-2-30:RR:NC:2:238 I81075


TARIFF NO.: 3004.90.1000

Mr. Daniel Wackerman
John A. Steer Co.
28 S. Second Street
Philadelphia, PA 19106

RE: The tariff classification of Gelclair™, put up in measured-dose form, from the United Kingdom

Dear Mr. Wackerman. :

In your letter dated April 17, 2002, on behalf of your client, Cell Pathways, Inc., you requested a tariff classification ruling.

The subject product, Gelclair™, is a clear viscous gel, put up in measured doses, containing Hyaluronate Sodium (CAS-9067-32-7) and Polyvinylpyrrolidone (CAS-9003-39-8) as the active ingredients. A press release dated January 23, 2002, found on the World Wide Web, indicates the following: “The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to market Gelclair™ in December 2001 for use in the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. These applications include oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces or ill-fitting dentures or disease. Gelclair™ is also indicated for treatment of diffuse aphthous ulcers.”

The applicable subheading for the subject product will be 3004.90.1000, 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: Containing antigens or hyaluronic acid or its sodium salt.” 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.


Robert B. Swierupski

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