The tariff classification of GDC-0449 (CAS-879085-55-9) in dosage form. Correction to Ruling Number N072359

N135115 December 10, 2010 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Mr. David Adornetto Genentech, Inc. One DNA Way South San Francisco, CA 94080 RE: The tariff classification of GDC-0449 (CAS-879085-55-9) in dosage form. Correction to Ruling Number N072359 Dear Mr. Adornetto: This replaces Ruling Number N072359, dated September 9, 2009, which contained a typographical error. We have corrected the spelling of your company’s name. A complete corrected ruling follows. In your letter dated August 17, 2009, you requested a tariff classification ruling. The subject product, GDC-0449, also known as Hedgehog antagonist GDC-0449, is an orally bioavailable small molecule with potential antineoplastic activity. It is currently undergoing Phase II clinical trials for the treatment of patients with recurrent or refractory medulloblastoma. As you clarified in a telephone conversation with our office, the product will be imported in measured dosage form (capsules) for the clinical trial procedure. The applicable subheading for the GDC-0449 in dosage form will be 3004.90.9115, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … 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: Antineoplastic and immunosuppressive medicaments.” 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