CLA-2-29:OT:RR:E:NC:2:239

Ms. Shana Dobson
Operations Manager
Tetraphase Pharmaceuticals, Inc.
480 Arsenel St.
Watertown, MA 02472

RE: The tariff classification of (4aS,8aS,9S)-3-(Benzyloxy)-4a-(tert-butyldimethylsilyloxy)-9-(dimethylamino-8a,9-dihydronaphtho[2,3-d]isoxazole-4,5(4aH,8H)-dione (CAS 852821-06-8) as Prototypes under Subheading 9817.85.01 from China

Dear Ms. Dobson:

In your letter dated May 21, 2009, you requested a tariff classification ruling on the applicability of subheading 9817.85.01 ("Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes") for (4aS,8aS,9S)-3-(Benzyloxy)-4a-(tert-butyldimethylsilyloxy)-9-(dimethylamino-8a,9-dihydronaphtho[2,3-d]isoxazole-4,5(4aH,8H)-dione. The imported product will be used as a chemical synthetic intermediate for the exclusive purpose of being transformed into clinical grade Tetracycline analog “TP-434”, which you have stated is an antibiotic active against many common pathogens including tetracycline-resistant strains. Neither the imported chemical nor the TP-434 test article will be sold or otherwise be made commercially available, and that immediate shipments will be in quantities of less than ten kilograms. You state that this is a non-commercial quantity in accordance with industry practice.

We do not agree with your claim that the imported compound, (4aS,8aS,9S)-3-(Benzyloxy)-4a-(tert-butyldimethylsilyloxy)-9-(dimethylamino-8a,9-dihydronaphtho[2,3-d]isoxazole-4,5(4aH,8H)-dione, should be allowed duty-free treatment as a prototype imported for testing under subheading 9817.85.01 Harmonized Tariff Schedule of the United States (HTSUS). United States (U.S.) Customs and Border Protection determinations are based on the "condition as imported". (4aS,8aS,9S)-3-(Benzyloxy)-4a-(tert-butyldimethylsilyloxy)-9-(dimethylamino-8a,9-dihydronaphtho[2,3-d]isoxazole-4,5(4aH,8H)-dione, in its condition as imported, is not intended for testing in the U.S. It is undergoing more than the purposes specified in subheading 9817.85.01, wherein the article entered as a prototype must be used "exclusively for development, testing, product evaluation, or quality control purposes." The imported product is being used in the manufacture of a new and different product, TP-434, which is produced in the U.S. Therefore, it cannot qualify as a prototype under subheading 9817.85.01, HTSUS.

The applicable subheading will be 2934.99.3900, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: 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.   

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

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 Richard Dunkel at 646-733-3032.


Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division