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NY L80189

October 19, 2004

CLA-2-98:RR:NC:2:238 L80189


TARIFF NO.: 9817.85.01

Don Zarin, Esq.
Dechert LLP
1775 I Street, N.W.
Washington, DC 20006-2401

RE: The tariff classification of organic chemical compounds for use exclusively in the early stages of drug discovery testing and research

Dear Mr. Zarin:

In your letter dated October 6, 2004, on behalf of your client, SmithKleinBeecham Corporation d/b/a GlaxoSmithKline (“GSK”), you requested a tariff classification ruling on whether certain organic compounds imported by GSK would be classified as prototypes under subheading 9817.85.01, HTS.

GSK is engaged in the research, testing, development and manufacture of pharmaceutical products, and will be importing millions of unique, organic compounds for use exclusively in the early stages of drug discovery testing and research. These compounds will be tested to determine if they possess properties that may be of interest for further pharmaceutical research and development. They are originals of articles in the preproduction stage, and will be imported in limited, noncommercial quantities. They will not be sold after importation into the United States, or incorporated into products that are sold, and are not subject to quantitative or other restrictions.

The organic compounds will be imported in plastic microtitre plates measuring approximately 3” x 5” x 1”. Each plate contains 384 wells, 352 of which will be filled with 352 unique, organic compounds (i.e., a single, different compound in each well). The remaining 32 wells will be left empty, and will be filled with liquid controls during testing. Each well contains approximately 0.5mg of one of the organic compounds, dissolved in dimethyl sulfoxide. In addition, each plate will be accompanied by 352 small, plastic tubes fitted into a plastic holder with a detachable lid. Each tube will contain up to 2.5mg of one of the organic compounds (also dissolved in dimethyl sulfoxide) corresponding to the same compound found on the plate. (A sample of the microtitre plate and tubes were submitted with your ruling request.)

The microtitre plates serve as “archive plates,” and are stored with the tubes in a “library.” Over a period of four months, a portion of the solution contained in each well of the archive plate is transferred to a “working plate.” A portion of the solution contained in each well of the working plate is then transferred to “assay plates” for testing, via high-throughput screening (“HTS”)

HTS is a testing procedure which permits high-speed testing on very small quantities of compounds. The purpose of HTS testing is to determine, by means of machine readers employing a specific detection mode, if a compound is “active,” i.e., whether it can inhibit or activate a certain reaction. It is the first test performed to assess the potential of a discovery compound. Generally, for each project, a series of “runs” will be conducted to complete the testing of approximately 750,000 to 1,000,000 different compounds. , in order to generate “hits” for a chosen target (e.g., a specific enzyme). The working plates (and any remaining compounds contained therein) are incinerated at the end of the four-month period, while the assay plates (and the compounds contained therein) are incinerated after the completion of the HTS process.

Upon conclusion of a series of HTS tests, those compounds identified as “active” (i.e., ”hits”) will be subjected to additional testing. (For these additional tests, the compound material contained in the tubes, with or without slight modifications, would generally be used.) Compounds found to be promising would undergo additional testing and modification, with each test becoming more stringent. Eventually, some compounds will be identified as appropriate for testing on animals and, subsequently, depending on the results of those animal studies, for evaluation in human clinical trials.

Pursuant to Section XXII, Subchapter XVII, U.S. note 6(a), (b) and (c), the applicable subheading for the subject merchandise will be 9817.85.01, Harmonized Tariff Schedule of the United States (HTS), which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which is administered by the U.S. Environmental Protection Agency. You may contact them at 401 M Street, S.W., Washington, D.C. 20460, telephone number (202) 554-1404, or EPA Region II at (212) 637-3526.

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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