The tariff classification of the LiRIS® (Lidocaine Releasing Intravesical System)

N285491 May 9, 2017 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9245 Ms. Marjorie G. McIntyre Allergan 2525 Dupont Drive Irvine, CA 92620 RE: The tariff classification of the LiRIS® (Lidocaine Releasing Intravesical System) Dear Ms. McIntyre: In your letter dated April 18, 2017, you requested a tariff classification ruling. LiRIS® (Lidocaine Releasing Intravesical System) is a pretzel-shaped lidocaine-releasing drug device which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. LiRIS is indicated for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and delivers a steady supply of the local anesthetic drug, lidocaine into the bladder for two weeks at a time. The applicable subheading for the LiRIS (Lidocaine Releasing Intravesical System) will be 3004.90.9245, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Dermatological agents and local anesthetics.” 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