The tariff classification of AGN-150894 Anticalins from Germany

N155056 March 28, 2011 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0190 Ms. Freya Wilkes Allergan 2525 Dupont Drive Irvine, CA 92623 RE: The tariff classification of AGN-150894 Anticalins from Germany Dear Ms. Wilkes: In your letter dated March 18, 2011, you requested a tariff classification ruling. You state in your letter that AGN-150894 anticalins are potentially therapeutic proteins belonging to the class of antibody mimetics. They are derived from human lipocalins, which are a family of naturally binding proteins typically found in blood plasma and other body fluids. AGN-150894 was derived by modifying human lipocalins in a microbial expression system to generate variants with a high affinity for vascular endothelial growth factor (VEGF). The anticalins are being used in research in lieu of monoclonal antibodies. AGN-150894 is imported frozen in a buffer solution. After importation, the product is mixed with excipients, filtered, and stored as a frozen liquid or a lyophilized powder. You further state that AGN-150894 is currently undergoing non-clinical investigation as a research compound for ophthalmic indications. The applicable subheading for the AGN-150894 Anticalins will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free. 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 merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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