CLA-2-30:OT:RR:NC:2:238
Mr. Herbert J. Lynch
Sullivan & Lynch, P.C.
56 Roland Street
Boston, MA 02129-1223
RE: The tariff classification, country of origin marking of KANUMA™ (sebelipase alfa) in dosage form and the applicability of subheading 9801.00.10, HTSUS
Dear Mr. Lynch:
In your letter dated March 5, 2015, on behalf of Synageva BioPharma Corp., you requested a tariff classification, country of origin marking ruling as well as the applicability of subheading 9801.00.10, HTSUS, regarding American Goods Returned. No samples were submitted.
KANUMA™ is the proposed tradename for sebelipase alfa. Sebelipase alfa is an investigational recombinant form of the human lysosomal acid lipase (LAL) enzyme being developed by Synageva as an enzyme replacement therapy for LAL deficiency. It has been granted orphan designation by the U.S. Food and Drug Administration (FDA). Currently, this product is under FDA Phase 3 clinical trials for the treatment of children and adults suffering from LAL deficiency.
In your letter, you state that your client has petitioned the United States Patent and Trademark Office for the registration of the trade name KANUMA™ for use in the commercial marketing of sebelipase alfa. KANUMA™ (sebelipase alfa) consists of the active pharmaceutical ingredient (API) sebelipase alfa mixed with 1% human serum albumin (HSA). The API, sebelipase alfa (INN), is a human lysosomal acid lipase/cholesteryl ester hydrolase glycosylated (produced in transgenic Gallus) which is also known as SBC-102.
You state that all of the production processes to produce sebelipase alfa occur in the United States and that in the final production step, HSA is added as an excipient. Afterwards, KANUMA™ (sebelipase alfa) in liquid form will be packaged in bulk (5L hyclone bags) and exported to Italy and/or Germany under cold chain conditions. In Italy and/or Germany, the bulk liquid is pumped through sterilized flexible silicone tubing into 10 mL sterile disposable vials. The vials are then stoppered, tampered sealed and packaged in trays containing up to 144 vials per tray and shipped back to the United States. Upon return to the United States, KANUMA™ (sebelipase alfa) in 10 mL disposable vials will be labeled and packaged for use in the treatment of LAL deficiency.
The applicable subheading for the KANUMA™ (sebelipase alfa) put up in 10 mL disposable vials, in dosage form, will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments (…) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free.
You also requested for applicability of subheading 9801.00.10, HTSUS, which provides for the free entry of products of the U.S. that are exported and returned without having been advanced in value or improved in condition by any process of manufacturer or other means while aboard. In United States v. John V. Carr & Sons. Inc., 69 Cust. Ct. 78, C.D. 4377, 347 F.Supp. 1390 (1972, 61 CCPA 52, C.A.D. 1118, 496 F.2d 1225 (1974), the court stated that, absent some alteration or change in the item itself, the mere repackaging of the item, even for the purpose of resale to the ultimate consumer, is not sufficient to preclude the merchandise from being classified in subheading 9801.00.10, HTSUS. Thus, we find that the operations performed in Italy and/or Germany, specifically, the filling of KANUMA™ (sebelipase alfa) into 10 mL disposable sterile vials, does not result in an advancement in value or improvement in condition. If the documentary requirements of 19 C.F.R. §10.1 are satisfied, the applicable subheading for the KANUMA™ (sebelipase alfa) in dosage form will be 9801.00.1028, HTSUS, which provides for “Products of the United States when returned after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad. Other: Articles provided for in chapter 30.” Products classified in subheading 9801.00.1028, HTSUS, are free of duty.
Additionally, you requested for the country of origin marking requirements concerning KANUMA™ (sebelipase alfa) when returned to the United States after filling in Italy and/or Germany into sterile disposable vials. Since the KANUMA™ (sebelipase alfa), imported in 10 mL vials, qualifies as a product of the United States exported and returned, it is excepted from marking requirements pursuant to Customs Regulations (19 CFR 134.32(m)).
The marking statute, section 304 Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 134) implements the country or origin marking requirements and exceptions of 19 U.S.C. 1304. Since KANUMA™ (sebelipase alfa), is considered to be a good of the United States, it is also not subject to the marking requirements of 19 U.S.C. 1304.
With respect to the marking requirements for the subject vials, we agree, that the vials in which the KANUMA™ (sebelipase alfa) is filled are “disposable containers,” as defined in 19 C.F.R. § 134.24(a). In accordance with 19 C.F.R. § 134.24(d), the disposable vials are not required to be marked to show the country of their own origin. Ordinarily, such containers would be required to be marked to indicate the origin of their contents. However, in this case, since the contents are a United States product, no country of origin marking would be required on the container.
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 ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
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.
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,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division