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NY R02702

October 24, 2005

CLA-2-98:RR:NC:2:238 R02702


TARIFF NO.: 9813.00.30; 2933.99.7900

Ms. Christine Louie
Jazz Pharmaceuticals, Inc.
3180 Porter Drive
Palo Alto, CA 94304

RE: The tariff classification of JZP-4 (CAS-212778-82-0) from Austria

Dear Ms. Louie:

In your letter dated October 18, 2005, you requested a tariff classification ruling.

The subject product, JZP-4 [IUPAC name: 3-(2,3,5-Trichlorophenyl)-pyrazine-2,6-diamine], is described by you as a voltage-dependent, sodium-channel blocker that has shown anti-epileptic activity in animal models. You indicate that Jazz Pharmaceuticals will import JZP-4 in bulk form

Two shipments of JZP-4 are expected in 2005. The first will be approximately 15 kg and the second will be approximately 35 kg., for the purpose of conducting research into appropriate pharmaceutical dosage forms, formulating prototype drug products, testing of the product for performance and stability, and [presumably, upon submission of an Investigational New Drug Application (IND) to the FDA] evaluating its efficacy as a therapeutic agent in human clinical trials. You also indicate that Jazz Pharmaceuticals has participated in the Pre-IND Consultation Program, offered by the FDA’s Center for Drug Evaluation & Research (CDER), which fosters early communication between sponsors and the various new-drug review-divisions of the CDER in order to provide guidance on the data necessary to warrant IND submission. Lastly, you state that “None of the drug product manufactured from JZP-4 will be sold and all of the materials (sic) will be consumed in the conduct of the research.”

Pursuant to the facts noted above, it is our determination that the subject product qualifies for classification under heading 9813.00.30, Harmonized Tariff Schedule of the United States (HTS), which provides for “Articles intended solely for testing, experimental or review purposes, including specifications, photographs and similar articles for use in connection with experiments or for study.” The rate of duty will be “Free, under bond, as prescribed in U.S. note 1 to this subchapter” (i.e., Subchapter XIII to Chapter 98, HTS). For the record, it is also our determination that the applicable HTS subheading for the subject product, if it were not classifiable in Subchapter XIII to Chapter 98, HTS, will be 2933.99.7900, HTS, which provides for Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI.” The rate of duty will be 6.5 percent ad valorem.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332.

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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