The tariff classification of Nebivolol Hydrochloride (CAS-152520-56-4) and Cinacalcet Hydrochloride (CAS-364782-34-3) in bulk form, from Italy

N107281 June 1, 2010 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2932.99.6100; 2921.49.4300 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Nebivolol Hydrochloride (CAS-152520-56-4) and Cinacalcet Hydrochloride (CAS-364782-34-3) in bulk form, from Italy Dear Ms. Forstenzer: In your letter dated May 5, 2010, you requested a tariff classification ruling. The first product, Nebivolol Hydrochloride, is a highly selective beta 1-adrenergic blocker. It is indicated for the treatment of hypertension. The second product, Cinacalcet Hydrochloride, is a calcimimetic agent that mimics the action of calcium on tissues. It is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis. It is also indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma. The applicable subheading for the Nebivolol Hydrochloride in bulk form will be 2932.99.6100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with oxygen hetero-atom(s) only: Other: Other: Aromatic: Other: Products described in additional U.S. note 3 to section VI.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. The applicable subheading for the Cinacalcet Hydrochloride in bulk form will be 2921.49.4300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Aromatic monoamines and their derivatives; Salts thereof: Other: Other: Drugs: Other.” Pursuant to General Note 13, HTSUS, 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 Harvey Kuperstein at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division