CLA-2-35:OT:RR:NC:N2:235
Ms. Fabiola Alcerreca
Genzyme Corporation
675 West Kendall Street
Cambridge, MA 02142
RE: The tariff classification of acid-a-glucosidase from Belgium. Correction to Ruling Number N023324
Dear Ms. Alcerreca:
This replaces Ruling Number N023324, dated March 6, 2008, which contained a typographical error. The product name Myozyme® was mispelled in the original ruling. A complete corrected ruling follows.
In your letter dated February 13, 2008, you requested a tariff classification ruling.
Your ruling request consists of 3 different products which you state are intermediate products produced during the manufacture of Myozyme®, also known as aglucosidase alpha. Myozyme ® you indicate is an FDA approved therapy for the treatment of Pompe disease. You state that your subsidiary facility in Gel, Belgium, is currently awaiting FDA approval to manufacture the products listed in your ruling request.
The first product, acid-a-glucosidase (GAA) Formulated Bulk is a purified bulk liquid containing GAA along with the excipients mannitol and Tween 80. You indicate that this represents the final stage prior to lyophilization and filling into the final dosage form. These imports are said to be for analytical testing initially and then upon FDA approval of the facility they will be used in fill/finish operations.
The second product, acid-a-glucosidase (GAA) Un-formulated Bulk is a purified bulk liquid containing GAA which will be imported in quantities ranging from 5 to 500 milliliters and will be used for analytical testing.
The third product, acid-a-glucosidase (GAA) In-process samples are partially purified un-formulated liquid samples of the Myozyme® active ingredient GAA. These samples will range from 2 to 30 milliliters, and will be imported for analytical testing.
The applicable subheading for the first product, acid-a-glucosidase (GAA) Formulated Bulk liquid will be 3003.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments…consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Other." The rate of duty will be free.
The applicable subheading for the second and third products, acid-a-glucosidase (GAA) Un-formulated Bulk and acid-a-glucosidase (GAA) In-process, will be 3507.90.7000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: "Enzymes; prepared enzymes not elsewhere specified or included: 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 http://www.usitc.gov/tata/hts/.
This merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Additional requirements may be imposed on this product by the Food and Drug Administration. Information on the Bioterrorism Act can be obtained by calling FDA at telephone number (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.
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 Paul Hodgkiss at 646-733-3046.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division