Foreign-Trade Zone (FTZ) 7-Mayaguez, Puerto Rico; Notification of Proposed Production Activity; IPR Pharmaceuticals, Inc.; (Pharmaceutical Products); Canovanas, Puerto Rico

IPR Pharmaceuticals, Inc., (IPR Pharmaceuticals) submitted a notification of proposed production activity to the FTZ Board for its facility in Canovanas, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on March 15, 2021.

IPR Pharmaceuticals already has authority to produce certain pharmaceutical products within FTZ 7. The current request would add a finished product and foreign status material to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority 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 IPR Pharmaceuticals 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 and in the existing scope of authority, IPR Pharmaceuticals would be able to choose the duty rate during customs entry procedures that applies to FARXIGA\FORXIGA (dapagliflozin) tablets (duty-free). IPR Pharmaceuticals would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

The material sourced from abroad is dapagliflozin active pharmaceutical ingredient (duty rate 6.5%). The request indicates the foreign-status material is 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 May 3, 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 Christopher Wedderburn at Chris.Wedderburn@trade.gov.