The tariff classification of Freeze Dried BCG Vaccine and Freeze Dried Tuberculin, Purified Protein Derivative (PPD) from Japan

N201840 March 27, 2012 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.20.0000; 3006.30.1000 Mr. Makiwo Satoshi Chew Japan Machinery Co. 8 Floor, Nakajima Shoji Bldg 8-5-6, Ginza, Chuo-ku Tokyo RE: The tariff classification of Freeze Dried BCG Vaccine and Freeze Dried Tuberculin, Purified Protein Derivative (PPD) from Japan Dear Mr. Chew: In your letter dated January 29, 2012, you requested a tariff classification ruling on behalf of your client, Japan BCG Laboratory. We apologize for the delay as the information was submitted to our laboratory for analysis. The first product, Freeze Dried BCG Vaccine for percutaneous use consists of live Bacillus Calmette, Guerin and Monosodium L-Glutamate Monohydrate as a stabilizer. According to Japan BCG Laboratory’s website, this product is indicated for the active immunization against tuberculosis. The second product, Freeze Dried Tuberculin, Purified Protein Derivative (PPD) is a diagnostic reagent consisting of the antigen PPD, extracted from M. tuberculosis Aoyama B Strain, and lactose. According to Japan BCG Laboratory’s website, this product is indicated for the intradermal Mantoux test for the diagnosis of tuberculosis infection.  The applicable subheading for the Freeze Dried BCG Vaccine will be 3002.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; … , cultures of micro-organisms (excluding yeasts) and similar products: Vaccines for human medicine.” The rate of duty will be free. The applicable subheading for the Freeze Dried Tuberculin, Purified Protein Derivative (PPD) will be 3006.30.1000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Pharmaceutical goods specified in note 4 to this chapter: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient: Containing antigens or antisera.” 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