CLA-2-98:RR:NC:2:238 K85984
Donald Harrison, Esq.
J. Christopher Wood, Esq.
Gibson, Dunn & Crutcher LLP
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036-5306
RE: The tariff classification of the SFK28 Library from the United Kingdom
Dear Messrs. Harrison and Wood:
In your letter dated May 17, 2004, on behalf of your client, BioFocus plc, you requested a tariff classification ruling.
According to your letter, the SFK28 Library (“library”) consists of approximately 1500 novel heterocyclic organic compounds that have never before been synthesized. These compounds are imported put up in 96-well containers, with each well in each tray containing a unique organic compound. The library was developed by your client solely for use in the earliest stages of drug discovery research programs. After importation, potential licensees of the library will test these compounds by means of high-throughput screening (HTS), in the hope of generating interactions or “hits” with a chosen “target” (e.g., a specific group of enzymes). Further investigation of these “hit” compounds may then lead to development of related compounds that show increased pharmacological activity and selectivity against the chosen target. These related compounds, referred to as “leads,” would then form the basis for additional research. Typically, a pharmaceutical company will engage your client to perform development work on hit compounds. Your client’s chemists would then collaborate with the pharmaceutical company to synthesize an array of compounds chemically similar to the hit compound(s) for additional screening. The goal of this collaboration would be, through an iterative process of design, synthesis and testing, to optimize leads for further research and testing.
As noted above, the compounds comprising the SFK28 Library will be used exclusively for drug testing and research. They cannot be used for any known purpose other than initial-stage drug discovery research and development. In addition, you indicate that the SFK28 compounds will be imported in limited, noncommercial quantities, in accordance with industry practice. Specifically, the quantity of each compound will usually be between 0.1 and 5 milligrams (i.e., 4 to 200 millionths of an ounce). You also indicate that the SFK28 compounds will not resold after importation into the U.S. In this regard, you state that your client’s standard contract governing the terms of compound library sales forbids a purchaser to resell any compounds purchased from them. Furthermore, you point out that the very nature of high-throughput screening makes it impossible for the compounds to be resold or incorporated into other products after testing, since these compounds generally will be consumed in testing by virtue of exposure to the media containing the targeted protein site. Lastly, you indicate that, because the majority - if not all - of the compounds in the library are unique (i.e., novel heterocyclic compounds that have never before been synthesized), it is highly unlikely that any SFK28 compound would be subject to any type of specific import restriction. Accordingly, it is our determination, pursuant to the information submitted by you, on behalf of your client, that the SFK28 Library satisfies the relevant provisions of U.S. Note 6(a), (b) and (c) to subchapter XVII of Chapter 98, HTSUS.
The applicable heading for the SFK28 Library 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.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division