The tariff classification of Andexanet Alfa in bulk form, from Spain

N304133 November 4, 2019 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3002.12.0090 Ms. Andrea Abraham Meeks, Sheppard, Leo & Pillsbury 4 Corporate Drive, Suite 292 Shelton, CT 06484 RE: The tariff classification of Andexanet Alfa in bulk form, from Spain Dear Ms. Abraham: In your letter dated April 29, 2019, on behalf of your client, Portola Pharmaceuticals, Inc., you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis. Andexanet alfa is an inactivated coagulation Factor Xa protein indicated for patients treated with anticoagulants rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening and uncontrolled bleeding. According to our laboratory, Andexanet alfa is a modified form of blood coagulation Factor Xa that is produced by biotechnological processes. The applicable subheading for the Andexanet alfa in bulk form will be 3002.12.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes: Antisera and other blood fractions: 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 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