The tariff classification of YESCARTA® (Axicabtagene Ciloleucel) from the United States or Netherlands

N315919 December 10, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Ms. Justine H. Bacani Kite Pharma, Inc. 2225 Colorado Avenue Santa Monica, CA 90404 RE: The tariff classification of YESCARTA® (Axicabtagene Ciloleucel) from the United States or Netherlands Dear Ms. Bacani: In your letter dated November 16, 2020, you requested a tariff classification ruling. Yescarta (Axicabtagene Ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. It is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta is available as a cell suspension for infusion and comprises a suspension of 2 × 10^6 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 10^8 CAR-positive viable T cells in approximately 68 mL. The applicable subheading for the Yescarta (Axicabtagene Ciloleucel) will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: 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 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 [email protected]. 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division