The tariff classification of Tivozanib Hydrochloride (CAS-682745-41-1) in bulk form and as a prototype under subheading 9817.85.01 from Japan

N234620 January 14, 2013 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2934.99.3000; 9817.85.01 Mr. Edward F. Juliano, Jr. 303 Wyman Street, Suite 300 Waltham, MA 02451 RE: The tariff classification of Tivozanib Hydrochloride (CAS-682745-41-1) in bulk form and as a prototype under subheading 9817.85.01 from Japan Dear Mr. Juliano: In your letter dated October 19, 2012 you requested a tariff classification ruling on behalf of AVEO Pharmaceuticals, Inc. We apologize for the delay as the information submitted was sent to our laboratory for analysis. The subject product, Tivozanib Hydrochloride, is an investigational tyrosine kinase inhibitor designed to optimize blockade of the vascular endothelial growth factor (VEGF) pathway while minimizing off-target toxicities by providing potent, selective and long half-life inhibition of all three VEGF receptors. In your letter, you indicated that it is currently undergoing phase III clinical studies for the treatment of advanced renal cell carcinoma. The applicable subheading for the Tivozanib Hydrochloride in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5 percent ad valorem. In your letter, you also requested for eligibility under the prototypes provision of subheading 9817.85.01, HTSUS, which provides for "Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes." You stated that the first shipment of Tivozanib Hydrochloride imported in bulk form will consists of three drums of approximately 5 kgs each for quality control and development testing purposes only. You also stated that none of these materials will be used for commercial purpose or sold and any material not consumed in testing will be destroyed and tracked by AVEO and its contractors. The second shipment of Tivozanib Hydrochloride imported in bulk form will consist of no more than four 5 kg drums for quality control and development testing purposes as well as for clinical trial purposes only. You stated that these materials will be used in phase II clinical trials for the treatment of colorectal cancer and breast cancer. It will be also be used in phase III clinical trials for the treatment of renal cell carcinoma. You also stated that none of these materials will be used for commercial purpose or sold and any material not consumed in testing and clinical trials will be destroyed. Finally, you indicated that both shipments of Tivozanib Hydrochloride in bulk form will be not be sold or incorporated into products that will be sold and it is not subject to any of the restrictions detailed in paragraph (c) of U.S. Note 7 to chapter 98, HTSUS. Based on the information presented, we find that the importation of Tivozanib Hydrochloride in bulk form qualifies for duty free treatment as prototypes under subheading 9817.85.01, provided that all the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States, (HTSUS) are satisfied. Pursuant to Section XXII, Subchapter XVII, U.S. Note 7(a), (b) and (c), the applicable subheading for the subject merchandise will be 9817.85.01, HTSUS, which provides for "Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes." 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 http://www.usitc.gov/tata/hts/. 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 (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division