CLA-2-29:RR:NC:2:238 K85024

Christopher Salentine, Ph.D.
BioMedicines, Inc.
2000 Powell Street, Suite 1640
Emeryville, CA 94608

RE: The tariff classification of Atamestane (CAS-96301-34-7), imported in bulk form, from Germany

Dear Dr. Salentine:

In your letter dated April 9, 2004, you requested a tariff classification ruling.

The subject product, Atamestane, is a synthetic steroid (antiestrogen) currently being evaluated, in FDA-regulated Phase III clinical trials, as a treatment for advanced breast cancer in postmenopausal women. Atamestane acts by inhibiting the activity of the enzyme, estrogen synthetase, which results in the suppression of estrogen production.

Pursuant to Explanatory Note 29.37(B)(4), HTS, the applicable subheading for Atamestane, imported in bulk form, will be 2937.29.9090, Harmonized Tariff Schedule of the United States (HTS), which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration (FDA). You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332. 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 Harvey Kuperstein at 646-733-3033.


Sincerely,

Robert B. Swierupski
Director,
National Commodity
Specialist Division