CLA-2-30:OT:RR:E:NC:N2:238
Ms. Paula Swanson
Sanofi Pasteur, Inc.
Discovery Drive
Swiftwater, PA 18370
RE: The tariff classification of Finished Vaccine Concentrates from France
Dear Ms. Swanson:
In your letter dated September 13, 2011, you requested a tariff classification ruling. We apologize for the delay as the information was submitted to our Laboratory for analysis.
The subject product, finished vaccine concentrates, is an intermediate substance used in the production of the French influenza vaccine, Vaxigrip®. According to your letter, the vaccine concentrates are specifically monovalent concentrates that are inactivated split virion influenza vaccine components cultivated in embryonated eggs, concentrated, purified by zonal centrifugation in a sucrose gradient, split by triton x -100, inactivated by formaldehyde and diluted in a phosphate buffered saline solution. You state in your letter the component materials of the finished vaccine concentrate consists of viral matter, sodium phosphate, sodium chloride, formaldehyde, triton x-100, sucrose and neomycin. Additionally, you state that it will be imported in ten milliliter aliquots stored in plastic Nalgene bottle and it will be solely used for in-vitro analysis. Based upon our laboratory analysis, the finished vaccine concentrates contain ingredients that are consistent with those of other finished virus based vaccines.
The applicable subheading for the finished vaccine concentrates will be 3002.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Vaccines for human medicine”. 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,
Robert B. Swierupski
Director
National Commodity Specialist Division