CLA-2-29:OT:RR:NC:2:238
Mr. Scott J. Hecker
Rempex Pharmaceuticals, Inc.
11535 Sorrento Valley Road
San Diego, CA 92121
RE: The tariff classification of RPX7009 (REBO-07) (CAS -1360457-46-0) in bulk form and as a prototype under subheading 9817.85.01 from Austria
Dear Mr. Hecker:
In your letter dated August 28, 2013, you requested a tariff classification ruling.
The subject product, RPX7009 (REBO-07), is a Beta-lactamase inhibitor that prevents the destruction of Beta-lactam antibiotics. It is an investigational new drug (IND) that is currently being studied in phase I clinical trials to determine its safety and efficacy for the treatment of bacterial infections. The technical literature you submitted states that RPX7009 (REBO-07), is a novel boronate, that is used to protect the carbapenem biapenem against Enterobacteriaceae with KPC and other carbapenemases. Additionally, the document states that RPX7009 (REBO-07) lacks inherent antibiotic activity.
The applicable subheading for the RPX7009 (REBO-07), imported in bulk form, will be 2934.99.9000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Other: Other.” The rate of duty will be 6.5 percent ad valorem.
In a follow-up letter dated October 24, 2013, you also requested for eligibility under the prototypes provision of subheading 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” You stated that the first shipment of RPX7009 (REBO-07), imported in bulk form, will consist of approximately 45 kg for use in Phase 2 and Phase 3 clinical trials purposes only under IND # 113406. It will be converted into dosage form for intravenous administration. You also stated that none of these materials will be used for commercial purposes or sold and any material not consumed in testing will be destroyed.
Finally, you indicated that RPX7009 (REBO-07), imported in bulk form, will be not be sold or incorporated into products that will be sold and it is not subject to any of the restrictions detailed in paragraph (c) of U.S. Note 7 to chapter 98, HTSUS.
Based on the information presented, we find that the first shipment of RPX7009, imported in bulk form, qualifies for duty free treatment as prototypes under subheading 9817.85.01, provided that all the conditions delineated in U.S. Note 7, Chapter 98, Subchapter XVII, Harmonized Tariff Schedule of the United States, (HTSUS) are satisfied.
Pursuant to Section XXII, Subchapter XVII, U.S. Note 7(a), (b) and (c), the applicable subheading for the subject merchandise will be 9817.85.01, HTSUS, which provides for “Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes.” The rate of duty will be free.
Your inquiry does not provide enough information for us to give a classification ruling on the second shipment of RPX7009 (REBO-07), consisting of approximately 100 kg. Please provide specific details regarding the research and development activities related to this shipment. When this information is available, you may wish to consider resubmission of your request. If you decide to resubmit your request for a classification ruling on this product, please provide the requested information and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, Attn: Binding Rulings Section.
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,
Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division