CLA-1-28:OT:RR:NC:1:136
Mr. Irving Sucholeiki
Aquilus Pharmaceuticals, Inc.
3H Gill Street, Suite 300
Woburn, MA 01890
RE: The tariff classification of “AQU118, CAS # 1233393-02-6” from The Netherlands
Dear Mr. Sucholeiki:
In your letter dated October 10, 2017, you requested a tariff classification ruling on “AQU118, CAS # 1233393-02-6.”
In your submission, you state that the product at issue is an experimental drug/chemical, which will be used for research purposes for potentially treating two neurological disorders. Due to the fact that “AQU118, CAS # 1233393-02-6” will be undergoing preclinical testing and is not an approved drug, it will not be classified within the drug provisions of the Harmonized Tariff Schedule of the United States (HTSUS). The U.S. Customs & Border Protection New York Laboratory has determined that this product is a deuterium chemical compound.
The applicable subheading for “AQU118, CAS # 1233393-02-6” will be 2845.90.0000, HTSUS, which provides for Isotopes other than those of heading 2844; compounds, inorganic or organic, of such isotopes, whether or not chemically defined: Other. The general rate of duty will be free.
In your letter, you also requested 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 product at issue is an experimental drug/chemical, which will be used for research purposes only.
Note 7 in Subchapter XVII of Chapter 98 defines prototypes for the purposes of HTSUS subheading 9817.85.01 and sets forth certain conditions and limitations governing classification in the subheading.
The following provisions apply to heading 9817.85.01:
(a) For purposes of this subchapter, including heading 9817.85.01, the term "prototypes" means originals or models of articles that-
(i) are either in the preproduction, production, or postproduction stage and are to be used exclusively for development, testing, product evaluation, or quality control purposes; and
(ii) in the case of originals or models of articles that are either in the production or postproduction stage, are associated with a design change from current production (including a refinement, advancement, improvement, development, or quality control in either the product itself or the means for producing the product). For purposes of clause (i), automobile racing for purse, prize, or commercial competition shall not be considered to be “development, testing, product evaluation, or quality control."
(b) (i) Prototypes may be imported only in limited noncommercial quantities in accordance with industry practice.
(ii) Except as provided for by the Secretary of the Treasury, prototypes or parts of prototypes may not be sold after importation into the United States or be incorporated into other products that are sold.
(c) Articles subject to quantitative restrictions, antidumping orders, or countervailing duty orders may not be classified as prototypes under this note. Articles subject to licensing requirements, or which must comply with laws, rules, or regulations administered by agencies other than the United States Customs Service before being imported, may be classified as prototypes if they comply with all applicable provisions of law and otherwise meet the definition of “prototypes" under paragraph (a).
Pursuant to Section XXII, Subchapter XVII, U.S. Note 7(a), (b) and (c), the applicable subheading for “AQU118, CAS # 1233393-02-6” will be 9817.85.01, HTSUS, which provides for "Prototypes to be used exclusively for development, testing, product evaluation, or quality control purposes." The general rate of duty will be free.
This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency. Information on the TSCA can be obtained by contacting the EPA at 1200 Pennsylvania Avenue, N.W., Mail Code 70480, Washington, D.C., by telephone at (202) 554-1404, or by visiting their website at www.epa.gov.
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 https://hts.usitc.gov/current.
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 Nuccio Fera at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division