The tariff classification of AN2728 (CAS 906673-24-3) in bulk form and as a prototype under subheading 9817.85.01 from Spain

N258845 November 24, 2014 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2934.99.3000; 9817.85.01 Mr. Herbert Lynch Sullivan & Lynch, P.C. 56 Roland Street Boston, MA 02129 RE: The tariff classification of AN2728 (CAS 906673-24-3) in bulk form and as a prototype under subheading 9817.85.01 from Spain Dear Mr. Lynch: In your letter dated October 27, 2014, you requested a tariff classification ruling on behalf of Anacor Pharmaceuticals, Inc. AN2728 is an investigational anti-inflammatory PDE-4 inhibitor that is currently in development for the treatment of atopic dermatitis and psoriasis. In your letter, you indicated that AN2728 will be used for the purpose of two Phase 3 clinical studies and one long-term safety study for the treatment of atopic dermatitis. After importation into the United States, AN2728 will be mixed with excipients and formulated into a topical preparation which will be used in these ongoing Phase 3 clinical studies. You also state that Phase 1 and Phase 2 human clinical trials have been completed under FDA’s Investigational New Drug (IND) Application Number 077537. The applicable subheading for the AN2728, imported 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% ad valorem. You also inquired about whether the imported AN2728 qualifies for duty free treatment as a prototype under subheading 9817.85.01, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” You state that Anacor intends to import AN2728 in quantities ranging from 65 kilograms to 100 kilograms which are necessary to support Phase 3 clinical studies and FDA’s requirement for safety and stability testing as part of the new drug approval process. You further state that Anacor will not incorporate AN2728 into other products that will be sold and any remaining AN2728 will be disposed of in accordance with applicable regulations. Finally, you state that AN2728 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 AN2728, imported in bulk form, qualifies for duty free treatment as a prototype under subheading 9817.85.01, provided that all of the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States, (HTSUS) are satisfied. 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 [email protected]. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division