CLA-5-21:OT:RR:NC:N5:231
Mr. Mark Anderson
Almac Diagnostic Services
4328 Technology Drive
Durham, NC 27704
RE: The tariff classification of Human Tissue Specimens from the United Kingdom
Dear Mr. Anderson:
In your letter dated February 10, 2025, you requested a tariff classification ruling.
The subject merchandise is four types of biological tissue specimens taken from the human body during surgeries or biopsies. The merchandise is said to be used for therapeutic clinical trials, and to help researchers understand disease mechanisms, develop treatments, and evaluate the safety and efficacy of medical interventions. The four items are imported not for commercial sale or resale and with no commercial value, as follows:
The first item is Formalin-Fixed Paraffin Embedded (FFPE) Tissue Block. You state that once the human tissue specimen is collected, it is fixed in formalin and embedded in paraffin wax. The blocks are shipped at room temperature or with cold packs to maintain stability.
The second item is Frozen Tissue. You state that the human tissue specimens are snap frozen in liquid nitrogen and shipped on dry ice to preserve molecular integrity.
The third item is Fresh Tissue. You state that the fresh human tissue specimens are collected soon after being removed from the body, placed in an unspecified medium, and shipped with ice packs to keep them cool.
The fourth item is Human Tissue Slides. You state that the human tissue sections are mounted on slides and shipped at room temperature or with cold packs, depending on specified requirements.
The applicable subheading for the 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 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 the World Wide Web at https://hts.usitc.gov/current.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of CBP and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. 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 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). This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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 Ekeng Manczuk at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division