The tariff classification of Purified Neisseria Meningitidis Serogroup C Capsular Polysaccharide Antigen, from France

N160455 May 11, 2011 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Ms. Paula Swanson Sanofi Pasteur 1 Discovery Drive Swiftwater, PA 18370 RE: The tariff classification of Purified Neisseria Meningitidis Serogroup C Capsular Polysaccharide Antigen, from France Dear Ms. Swanson: In your letter dated April 13, 2011, you requested a tariff classification ruling. The subject product, Purified Neisseria Meningitidis Serogroup C Capsular Polysaccharide Antigen (lot numbers FA399767, FA306707 and FA351354) will be imported in purified powder form. In your letter, you state that the antigen is produced by microbial fermentation using animal derived additives. An antigen is a substance or molecule that, when introduced into the body, triggers the production of an antibody by the immune system which will then kill or neutralize the antigen that is recognized as a foreign and potentially harmful invader. You also state in your letter that the product will only be used for in vitro laboratory characteristic analysis and is not intended for the prevention, treatment, diagnosis, or cure of diseases, injuries, or conditions in humans. The applicable subheading for the Purified Neisseria Meningitidis Serogroup C Capsular Polysaccharide Antigen will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; …; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.” 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