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NY R00794

September 16, 2004

CLA-2-30:RR:NC:2:238 R00794


TARIFF NO.: 2934.99.4700

James C. McMahon, Ph.D.
Guidant Corporation
26531 Ynez Road
Temecula, CA 92591

RE: The tariff classification of Everolimus (CAS-159351-69-6), imported in bulk form, from Switzerland

Dear Dr. McMahon:

In your letter dated September 3, 2004, you requested a tariff classification ruling.

The subject product, Everolimus, a macrocycylic lactone (macrolide), is an investigational immunosuppressive drug currently awaiting approval, pursuant to a new drug application (NDA) filed with the FDA (NDA-21-560), for use in reducing graft vasculopathy. You have indicated, vía telephone, to a member of my staff that Everolimus is a semisynthetic derivative of Rapamycin, currently known as Sirolimus

See New York Ruling Letter H85786, dated December 11, 2001.. In this respect, we note that one of the chemical names for Everolimus is, in fact, 42-O-(2-hydroxyethyl)rapamycin. However, we are unable to find - nor have you furnished - any scientific evidence that - unlike Sirolimus - Everolimus has the ability to kill or inhibit the growth of microorganisms. Accordingly, pursuant to Lonza, Inc. v. U.S. [46 F.3d 1098 (Fed. Cir. 1995)] and the Explanatory Notes to heading 2941, HTS, it is our determination that Everolimus is precluded from classification as an antibiotic, for tariff purposes.

The applicable subheading for Everolimus, imported in bulk form, will be 2934.99.4700, 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: Other: Drugs.” The rate of duty will be 3.7 percent ad valorem.

You state in your letter that “Everolimus should be eligible for Special Treatment pursuant to the Agreement on Trade in Pharmaceutical Products, Special Notes ‘K’ of the Harmonized Tariff Schedule of the United States, Supplement 1.” However, please be advised that, at the present time, Everolimus 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.


Robert B. Swierupski

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