CLA-2-29:OT:RR:NC:N3:140
Dr. Debra Wallace
Cyteir Therapeutics
128 Spring Street
Lexington, MA 02421
RE: The tariff classification of a chemical intermediate from the United Kingdom.
Dear Ms. Wallace:
In your letter dated February 15, 2023 you requested a tariff classification ruling.
The product, CYT-0851 Spray Dried Intermediate is an intermediate pharmaceutical product created when CYT-0851(CAS# 2301085-04-9) from the United States is sent to the United Kingdom for further processing into the above mentioned intermediate. The country of origin of this intermediate is the United Kingdom. This compound will be imported in noncommercial quantities solely for further processing into a final drug capsule form to be used for clinical studies in developmental clinical trials.
The applicable subheading for the CYT-0851 Spray Dried Intermediate will be 2935.90.7500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: Sulfonamides: Other: Other: Other: Products described in additional U.S. note 3 to section VI. The rate of duty will be 6.5 percent ad valorem.
You also asked for a determination for the instant products for its applicability for duty exemption under SUBCHAPTER XVII OTHER SPECIAL CLASSIFICATION PROVISIONS. Subchapter XVII. Note 7 provides that:
7. 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).
The imported chemical is in the pre-production stage and would be used exclusively for development and testing of new pharmaceuticals and is also imported in “noncommercial quantities.” Therefore, we find that the “CYT-0851 Spray Dried Intermediate” as imported meets the definition of “prototype” and all the requirements of Subchapter XVII, Note 7. It is our opinion that the the imported compound qualifies as a prototype of subheading 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.
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 the 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, please contact National Import Specialist Evan Thomas at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division