The tariff classification of AGN-150998 from Germany

N189084 November 10, 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-150998 from Germany Dear Ms. Wilkes: In your letter dated October 17, 2011, you requested a tariff classification ruling. You state in your letter, AGN-150998 is a PEGylated recombinant protein. The protein moiety consists of a designed ankyrin repeat protein (DARpin) antagonist of vascular endothelial growth factor (VEGF) with a polypeptide linker, and a carboxy-terminal cysteine covalently linked to a single molecule of methoxy maleimide polyethylene glycol 20 (mPEG20). It is a colorless to yellowish liquid solution in an isotonic phosphate buffered saline solution of ph 7.2. You further state that the recombinant protein contains a modified Fc part of human monoclonal antibody IgG2 produced by CHO cells (Chinese Hamster Ovary cells from Circetulus griseus) grown in media and purified. Currently, AGN-150998 is in phase II clinical studies evaluating the safety and efficacy in patients with exudative age-related macular degeneration. The applicable subheading for the AGN-150998 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 Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division