CLA-2-30:OT:RR:NC:N2:238
Mr. Joseph Issa
Merck & Co
2 Merck Access Road
Whitehouse Station, NJ 08889
RE: The tariff classification of OncoTICE®
Dear Mr. Issa:
In your letter dated June 20, 2016, you requested a tariff classification ruling.
OncoTICE® consists of freeze-dried Bacillus Calmette and Guerin (BCG), strain TICE®, which is a live, attenuated strain of Mycobacterium bovis. OncoTICE® is indicated for treatment of primary or relapsing flat urothelial cell carcinoma in situ (CIS) of the urinary bladder, and as an adjuvant therapy after TUR of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage TA (grade 2 or 3) or Tl (grade 1, 2 or 3). OncoTICE® is put up in vials, each containing 1 to 8 x 108 colony forming units (CFU) of TICE® BCG which is equivalent to approximately 50 mg wet weight. In a follow-up conversation with a member of my staff, you stated that the country of origin is the United States but you are also considering importing the product.
Although, the OncoTICE® is not a vaccine as stated in the literature you included with your ruling request, you suggest classification in subheading 3002.20.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for vaccines for human medicine. In our opinion, OncoTICE® is a culture of micro-organisms which contains Bacillus Calmette and Guerin (BCG), strain TICE®, a bacterium in a sauton medium which you stated is necessary for the viability of the micro-organisms.
The applicable subheading for the OncoTICE® put up in vials will be 3002.90.5150, HTSUS, which provides for “Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; 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 https://hts.usitc.gov/current.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division