The tariff classification of the Kyleena™ intrauterine system from Finland

N283970 March 17, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3006.60.0000 Mr. Mark D. Pinchok Bayer International Trade Services Corporation 651 Colliers Way, Suite 414 Weirton, WV 26062 RE: The tariff classification of the Kyleena™ intrauterine system from Finland Dear Mr. Pinchok: In your letter dated February 28, 2017, on behalf of Bayer HealthCare LLC, you requested a tariff classification ruling. Kyleena™ is a progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to 5 years. Kyleena™ is comprised of one sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 19.5 mg of the active ingredient levonorgestrel, a progestin hormone, packaged within a sterile inserter. Release rate of levonorgestrel (LNG) is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years. The applicable subheading for the Kyleena™ intrauterine system will be 3006.60.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4 to this chapter: Chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides.” 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