CLA-2-38:OT:RR:NC:N1:139

Frank W. Waligora
Curis Inc.
4 Maguire Rd.
Lexington, MA 02421

RE: The Classification of CAf-170 from India Dear Mr. Waligora:

In your letter dated August 28, 2017, you requested a tariff classification ruling for CAf-170.

Your submission describes CAf-170 as an experimental synthetic chemical drug substance material for further manufacturing processing of a drug product to be used in FDA approved phase 1 clinical trials. Its chemical composition is stated as (((S)-3-amino-1-(3-((R)-1-amino-2-hydroxyethyl)-1,2,4-oxadiazol-5-yl)-3-oxopropyl)carbamoyl)-L-threonine (AUPM70). There is no associated CAS number for this product.

You request this product be classified in 2933.99.7900, Harmonized Tariff Schedule of the United States (HTSUS), which provides for heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Other: Products described in additional U.S. note 3 to section VI.

This office disagrees with your request for classification in 2933.99.7900, HTSUS. This compound contains an other heterocyclic compound and is not a nitrogen-heteroatom only heterocyclic compound.  The only ring in the structure is an oxadiazole, which is a 5-member ring containing two nitrogens and one oxygen. 

The applicable classification for CAf-170 will be in subheading 2934.99.9001, HTSUS, which provides for Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Other: Other. The General rate of duty will be 6.5 percent ad valorem.

You further request that this product be designated as a prototype in subheading 9817.85.01, HTSUS.

The item under consideration has been identified as an experimental synthetic chemical drug substance material for further manufacturing processing of a drug product to be used in FDA approved phase 1 clinical trials. 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. This Note provides: For purposes of this subchapter, including heading 9817.85.01, the term "prototypes" means originals or models of articles that – are either in the pre-production, production, or postproduction stage and are to be used exclusively for development, testing, product evaluation, or quality control purposes; and 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). In addition, eligibility for prototype treatment also requires that the item not be subject to any of the restrictions in subparagraph (c) of Note 7, i.e. quantitative restrictions, antidumping or countervailing duty orders. Based on the information provided, we find that there is insufficient information provided to grant prototype status under subheading 9817.85.01. If you still require a review of the status as a prototype, please submit a new request and provide additional information as detailed in the Heading 9817 notes above. Please provide a reference to this completed ruling in that request.

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 Patrick Day at patrick.day@cbp.dhs.gov.

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division