CLA-2-05:OT:RR:NC:N2:231
Ms. Nina Mohseni
Sandler Travis & Rosenberg PA
225 W. Washington
Suite 1640
Chicago, IL 60606
RE: The tariff classification of Human Tissue Specimens. Correction to Ruling Number N286658
Dear Ms. Mohseni:
This replaces Ruling Number N286658, dated June 19, 2017, which contained a clerical error. The product was specified in error as Human Liver Tissue Specimen. A complete corrected ruling follows.
In your letter dated May 24, 2017 you requested a tariff classification ruling on behalf of Roche Diagnostic Operations, Inc. (Indianapolis, IN). You did not provide the country of origin.
The subject merchandise is three different forms of human tissue samples as follows:
The first item is Formalin-fixed Paraffin Embedded (FFPE) Tissue Block. You state that once the tissue sample is collected, it is immediately fixed in 10 percent neutral buffered formalin to preserve the morphology and cellular details of the sample. The fixed tissue is then embedded into paraffin blocks.
The second item is Formalin-fixed Paraffin Embedded Tissue (unstained slides). You state that once the tissue sample is collected, it is fixed in neutral buffered formalin and embedded into paraffin blocks then four micrometer-thick slices of the sample are mounted onto Superfrost® Plus Micro Slides. The product is subsequently air dried for at least an hour.
The third item is Fresh (Wet) Tissue Biopsy. You state that once collected the tissue sample is immediately placed in a 60 milliliter pre-filled polypropylene container that contains 30 milliliters of 10 percent neutral buffered formalin.
All three items will be imported for diagnostic analysis.
The applicable subheading for the various Human Tissue Specimens will be 0511.99.4070, Harmonized Tariff Schedule of the United States (HTSUS), which provides for: Animal products not elsewhere specified or included; dead animals of chapter 1 or 3, unfit fit for human consumption: Other: Other: Other: Other. The rate of duty will be 1.1 percent ad valorem.
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 merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling the FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.
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 Ekeng Manczuk at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division