N319149

N319149 May 27, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3002.90.5150; 9811.00.60 Mr. Jon P. Cowley Baker & McKenzie LLP 300 East Randolph Street Chicago, IL 60601 RE: The tariff classification of ADSTILADRIN® (nadofaragene firadenovec-nrpl) in dosage form and a demonstration unit for Adstiladrin from Finland Dear Mr. Cowley: In your letter dated April 28, 2021, on behalf of Ferring International Center SA, you requested a tariff classification ruling. Adstiladrin, imported in 4 x 20 mL single dose vials, is a sterile suspension for intravesical instillation containing nadofaragene firadenovec-nrpl, a non-replicating recombinant type 5 adenovirus vector containing the human interferon alfa-2b gene, as the active ingredient. Adstiladrin is an adenovirus vector-based gene therapy expressing interferon alfa-2b indicated for the treatment of high-grade, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer. The applicable subheading for the Adstiladrin in dosage form 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. Samples of the demonstration unit for Adstiladrin will also be imported. In your letter, you stated the demonstration unit for Adstiladrin is identical to the Adstiladrin, except the demonstration unit will lack the active pharmaceutical ingredient (nadofaragene firadenovec-nrpl) and will instead contain only sterile water. As indicated in the photos included in the ruling request, the demonstration unit is a carton containing 4 x 20 mL single dose vials. The carton and each vial are labeled with "Demo: Not for Human Use. Does not contain drug product." You state that the demonstration unit will only be used for medical professionals, and will not be used for clinical trials or any other scientific purpose. You further state the imported demonstration unit will be unsuitable for sale or use other than as a sample for soliciting orders for Adstiladrin from Finland. You suggested the demonstration unit for Adstiladrin should be classified in subheading 9811.00.60, HTSUS, which provides for “Any sample (except samples covered by heading 9811.00.20 or 9811.00.40), valued not over $1 each, or marked, torn, perforated or otherwise treated so that it is unsuitable for sale or for use otherwise than as a sample, to be used in the United States only for soliciting orders for products of foreign countries.” Based upon the information submitted, duty-free treatment under subheading 9811.00.60, HTSUS, may apply provided the article is marked DEMO: Not for Human Use. Does not contain drug product and the additional words “not for sale” are added. The applicable subheading for the demonstration unit for Adstiladrin will be 9811.00.60, HTSUS, which provides for “Any sample (except samples covered by heading 9811.00.20 or 9811.00.40), valued not over $1 each, or marked, torn, perforated or otherwise treated so that it is unsuitable for sale or for use otherwise than as a sample, to be used in the United States only for soliciting orders for products of foreign countries.” 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 the 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division