Daily Rules, Proposed Rules, and Notices of the Federal Government
Albany Molecular Research, Inc. (AMRI), operator of Subzone 121A, submitted a notification of proposed production activity for its facility in Rensselaer, New York. The notification conforming to the requirements of the regulations of the Board (15 CFR 400.22) was received on September 26, 2012.
Subzone 121A was originally approved by the Board in 1994 for the production of bulk pharmaceutical chemicals and intermediates under FTZ procedures at the former Sanofi Winthrop L.P. plant located at 33 Riverside Avenue in Rensselaer, New York, (Board Order 698, 7/20/1994, 59 FR 18318, 7/28/1994).
AMRI is now requesting to produce an active pharmaceutical ingredient, dexpramipexole dihydrochloride monohydrate, under zone procedures at the Rensselaer facility. AMRI plans to transfer the active ingredient to another FTZ facility where it will be processed into a finished dosage pharmaceutical product (duty-free).
Production under FTZ procedures could exempt AMRI from customs duty payments on the foreign status components used in export production for the additional finished product listed above. Production for the domestic market would not involve inverted tariff savings since the active ingredient is subject to the same duty rate (6.5%) as the chemical inputs. Customs duties also could possibly be deferred or reduced on foreign status production equipment. The chemicals sourced from abroad are (R)-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine and propyl 4-methylbenzenesulfonate.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the "Reading Room" section of the Board's Web site, which is accessible via
For further information, contact Diane Finver at