2020-16887. Foreign-Trade Zone (FTZ) 49-Newark and Elizabeth, New Jersey; Notification of Proposed Production Activity; Catalent Pharma Solutions (Pharmaceutical Products); Somerset, New Jersey

Catalent Pharma Solutions (Catalent) submitted a notification of proposed production activity to the FTZ Board for its facility in Somerset, New Jersey. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on July 17, 2020.

The applicant indicates that it will be submitting a separate application for FTZ designation at the company's facility under FTZ 49. The facility is used for the production of encorafenib bulk capsules. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status material 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 Catalent from customs duty payments on the foreign-status material used in export production. On its domestic sales, for the foreign-status material noted below, Catalent would be able to choose the duty rate during customs entry procedures that applies to BRAFTOVI (encorafenib bulk capsules) (duty-free). Catalent would be able to avoid duty on foreign-status material which becomes scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

The material sourced from abroad is encorafenib API (duty rate 6.5%).

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to: [e-mail]. The closing period for their receipt is September 14, 2020.

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 Christopher Wedderburn at [e-mail] or [phone].

Dated: July 28, 2020.

Andrew McGilvray,

Executive Secretary.