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NY H82517




June 20, 2001

CLA-2-30:RR:NC:2:238 H82517

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9020

Wendi V. Rodrigueza, Ph.D.
Esperion Therapeutics, Inc.
3621 S. State Street
695 KMS Place
Ann Arbor, MI 48108

RE: The tariff classification of ETC-216 from the Netherlands

Dear Dr. Rodrigueza:

In your letter dated May 23, 2001, you requested a tariff classification ruling.

The subject product, designated as ETC-216, consists of a mixture composed of equal amounts of a recombinant protein, known as Apolipoprotein A-Imilano (AIM), and 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC, CAS RN 26853-31-6). You indicate that ETC-216 will be imported put up in single-dose vials for use, pending FDA approval of your Investigational New Drug Application, in Phase I clinical trials, in order to evaluate its efficacy for future use as a cardiovascular medicament.

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 ETC-216, imported put up in single-dose vials, will be 3004.90.9020, 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: Cardiovascular medicaments." 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 212-637-7068.

Sincerely,

Robert B. Swierupski

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