Wyeth Pharmaceuticals, LLC (Wyeth) submitted a notification of proposed production activity to the FTZ Board for its facility in Andover, Massachusetts. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 13, 2021.
The Wyeth facility is located within Subzone 27R. The facility is used for the production of mRNA bulk drug substance. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Wyeth from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, Wyeth would be able to choose the duty rate during customs entry procedures that applies to mRNA bulk drug substance (duty rate—6.5%). Wyeth would be able to avoid duty on foreign-status materials/components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The materials and components sourced from abroad include: 2-Hexyldecanoic Acid; 4-Amino-1-Butanol; 2,2,6,6-Tetramethylpiperidine-1-Oxyl; ATP—adenosine 5′-triphosphate; CTP—cytidine 5′-triphosphate; GTP—guanosine 5′-triphosphate; Proteinase K; T7 RNA Polymerase; EAM1104L enzyme; and, Ribolock Rnase-Free (Animal Origin Free) (duty rate ranges from duty-free to 6.5%). The request indicates that certain materials/components are subject to duties under Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to: ftz@trade.gov. The closing period for their receipt is June 28, 2021.
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via www.trade.gov/ftz.
For further information, contact Diane Finver at Diane.Finver@trade.gov or (202) 482-1367.
Dated: May 13, 2021.
Andrew McGilvray,
Executive Secretary.
[FR Doc. 2021-10514 Filed 5-18-21; 8:45 am]
BILLING CODE 3510-DS-P