The tariff classification of rFVIII Membrane Adsorber Eluate Formulated (MAEF) and KOVALTRY®

N278899 September 30, 2016 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0290 Mr. Mark D. Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of rFVIII Membrane Adsorber Eluate Formulated (MAEF) and KOVALTRY® Dear Pinchok: In your letter dated August 25, 2016, on behalf of Bayer HealthCare LLC, you requested a tariff classification ruling. MAEF is described as a human blood protein, recombinant Factor VIII (rFVIII), obtained by biotechnological processes which is used to clot blood. In your letter, you stated that the MAEF process stream is derived from the first purification step after the material is harvested from recombinant cell culture fluid from a bioreactor. This process stream is further purified to make the final recombinant FVIII drug substance and drug product. The drug substance is then formulated and lyophilized to obtain the finished KOVALTRY® drug product. KOVALTRY®, antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A. It is used for on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes. KOVALTRY® is available as lyophilized powder in single use vials. The applicable subheading for the rFVIII Membrane Adsorber Eluate Formulated (MAEF) and KOVALTRY® will be 3002.10.0290, Harmonized Tariff Schedule of the United States (HTSUS), which provides for which provides for “Antisera, other blood fractions and 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 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 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