2019-03236. Foreign-Trade Zone (FTZ) 93-Raleigh/Durham, North Carolina, Notification of Proposed Production Activity, GlaxoSmithKline, PLC (Pharmaceutical Products), Zebulon, North Carolina

The Triangle J Council of Governments, grantee of FTZ 93, submitted a notification of proposed production activity to the FTZ Board on behalf of GlaxoSmithKline, PLC (GlaxoSmithKline), located in Zebulon, North Carolina. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on February 13, 2019.

GlaxoSmithKline already has authority to produce certain pharmaceutical products within Site 6 of FTZ 93. The current request would add finished products and a foreign-status material/component to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material/component (dolutegravir sodium) and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

Production under FTZ procedures could exempt GlaxoSmithKline from customs duty payments on the foreign-status material/component used in export production. On its domestic sales, for foreign-status dolutegravir sodium (duty rate, 6.5%) and foreign-status components in the existing scope of authority, GlaxoSmithKline would be able to choose the duty-free rate during customs entry procedures that applies to: Dolutegravir sodium/rilpivirine HCl; Juluca tablets® (anti-viral); dolutegravir sodium tablets (anti-viral); Tivicay tablets® (anti-viral); abacavir sulfate/dolutegravir sodium/lamivudine tablets (anti-viral); Triumeq tablets® (anti-viral); dolutegravir/lamivudine tablets (anti-viral); Dovato tablets® (anti-viral); umeclidinium bromide/vilanterol trifenatate ellipta (respiratory inhaler); Anoro Ellipta® (respiratory inhaler); umeclidinium bromide ellipta (respiratory inhaler); Incruse Ellipta® (respiratory inhaler); fluticasone furoate/umeclidinium bromide/vilanterol trifenatate ellipta (respiratory inhaler); and, Trelegy Ellipta® (respiratory inhaler). GlaxoSmithKline 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.

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 8, 2019.

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 website, which is accessible via www.trade.gov/​ftz.

For further information, contact Diane Finver at [e-mail] or [phone].

Dated: February 19, 2019.

Andrew McGilvray,

Executive Secretary.