CLA-2-05: RR: NC: SP: 231

Ms. Jamie l. Miller, PH.D.
Institute for Scientific Research, Inc.
1000 Galliher Drive
Fairmont, WV 26554-8843

RE: The tariff classification of human dental pulp cells in vials and hepatic colon carcinoma tissue arrays from Spain.

Dear Ms. Miller:

In your letter dated November 21, 2006 on behalf of your client Biopharmance Incorporated, you requested a tariff classification ruling.

The human dental pulp cells in vials are isolated from non-erupted intact molars by mechanical and enzymatic digestion of internal dental pulp tissue. All cells test negative for human immunodeficiency virus-1 (HIV-1), hepatitis C (HCV), human T-lymphotrophic virus (HTLV I/II), hepatitis B virus (HBV) and mycoplasma (small microorganisms). You indicate that the cells have a 99 percent purity rate and are in a concentration of 500,000 cells per vial. These cells are for non-clinical research use only and are not for the diagnosis, treatment, cure or prevention of diseases.

The human hepatic colon carcinoma tissue arrays are small cylinders of tissue that are extracted from standard histological paraffin-embedded blocks and fixated on individual slides. All cells test negative for HIV-1, HCV, HTLV I/II, HBV, and mycoplasma. These tissue arrays are used for non-clinical research use only and are not for the diagnosis, treatment, cure or prevention of diseases.

The applicable subheading for the primary human dental pulp cells in vials and human hepatic colon carcinoma tissue arrays (slides) 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.

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 telephone number (301) 575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.

This merchandise may also be subject to the regulations of the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, Office of Health and Safety, Biosafety Branch. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number 404-633-5313.

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 http://www.usitc.gov/tata/hts/.

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 Nathan Rosenstein at 646-733-3030.

Sincerely,

Robert B. Swierupski
Director,
National Commodity
Specialist Division