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 January 16, 2014, you requested a tariff classification ruling on the applicability of subheading 9817.85.01 ("Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes") for the importation of 250 kg of RPX7009 (REBO-07).
The subject product, RPX7009 (REBO-07), is a Beta-lactamase inhibitor that prevents the destruction of Beta-lactam antibiotics. In your letter, you indicated that the importation of RPX7009 (REBO-07) into the United States will be used for the purpose of an ongoing Phase 3 clinical trials for the treatment of bacterial infections. It will be converted into a dosage form for intravenous administration for use in these ongoing Phase 3 clinical trials. You also stated that Phase I clinical trials have been completed under IND # 113406.
Pursuant to the General Notice entitled "Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research," published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for the RPX7009 (REBO-07), imported in bulk form, will be 2934.99.4700, 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: Drugs.” The rate of duty will be 3.7 percent ad valorem.
We note that this office, in NY Ruling Letter N245704, issued to you on October 31, 2013, ruled on the tariff classification applicability of subheading 9817.85.01 for the importation of 45 kg of RPX7900 (REBO-07) for use in Phase 2 and Phase 3 clinical trials purposes only under IND # 113406. However, in this case, you intend to import 250 kg of RPX7900 (REBO-07), which will be used exclusively for the purpose of determining its efficacy for the treatment of bacterial infections in phase 3 clinical trials.
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 importation of 250 kg of RPX7009 (REBO-07), imported in bulk form, for the sole purpose of phase III clinical trials 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.
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