The tariff classification of Brazikumab (MEDI2070) and Brazikumab (AMG 139 MEDI2070) (CAS No. 1610353-18-8) in dosage form, from the United States and imported from Ireland

N301102 November 7, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3002.15.0000 Ms. Freya S. Wilkes Allergan Sales LLC 2525 DuPont Drive Irvine, CA 92612 RE: The tariff classification of Brazikumab (MEDI2070) and Brazikumab (AMG 139 MEDI2070) (CAS No. 1610353-18-8) in dosage form, from the United States and imported from Ireland Dear Ms. Wilkes: In your letter dated October 11, 2018, you requested a tariff classification ruling. Brazikumab (MEDI2070) (INN) is a human monoclonal antibody designed for the treatment of Crohn's disease. Brazikumab (AMG 139, MEDI2070) is a fully human anti-IL23A monoclonal antibody in clinical development for autoimmune indications. In a follow-up email to this office, you stated Brazikumab will be imported in measured dosage form put up in pre-filled glass syringes. The applicable subheading for the Brazikumab (MEDI2070) and Brazikumab (AMG 139 MEDI2070) in dosage form will be 3002.15.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not obtained by means of biotechnological processes: Immunological products, put up in measured doses or in forms or packings for retail sale.” 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 the World Wide Web at https://hts.usitc.gov/current. 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 merchandise may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address cdcinfo@cdc.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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division