2013-28353. 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 November 18, 2013.

The GlaxoSmithKline facility is located within Site 6 of FTZ 93. The facility is used for the production and packaging of pharmaceutical products. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products listed 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 components used in export production. On its domestic sales, GlaxoSmithKline would be able to choose the duty rates during customs entry procedures that apply to inhalers, tablets, and capsules which treat a variety of medical conditions (duty rates range from free to 6.4%) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign status production equipment.

The finished products include devices such as respiratory placebo inhalers, Relenza anti-viral inhalers, Seretide/Advair, Serevent and Flovent diskus respiratory inhalers, Advair and Ventolin HFA respiratory inhalers, and the following tablets and capules—Lovaza antihyperlipidemic, Paxil depression, Avandamet metabolic, Avandary metabolic, Avandia metabolic, Lamictal central nervous system (CNS), Potiga CNS, Amerge CNS, Horizant CNS, Imitrex CNS, Lamictal ODT CNS, Requip/Requip XL CNS, Treximet CNS, Telzir anti-viral, Valtrex anti-viral, Zovirax anti-viral, Wellbutrin/Buproprion depression, Zantac gastrointestinal (GI), Zofran GI, Votrient urology, Coreg CR cardiovascular, Rythmol cardiovascular, Innopran XL hypertension, Jalyn urology, Avodart urology, Lanoxin cardiovascular, Malarone anti-malarial, Promacta immune thrombocytopenia (ITP), and Tykerb oncology.

The components and materials sourced from abroad include corn starch, carnuba wax, lactose monohydrate, fluticasone/salmeterol placebo diskus (a type of inhaler), respiratory placebo inhaler, silica colloidal anhydrous, precipitated calcium carbonate, pharmaceutical talc, zephex 134a propellant, mannitol, magnesium stearate, stearic acid, potassium sorbate, propafenon hcl, bupropion hydrochloride, melphalan, albuterol sufate, salbuterol sulfate, salmeterol, vilanterol trifenatate, umeclidinium api, paracetamol, ezogabine (retigabine), paracetamol, metformin hydrochloride, ranitidine hydrochloride, zanamivir, ondansetron hydrochloride, abacavir sulfate, valacyclovir hydrochloride, lamotrigine, rosiglitazone maleate, paroxetine hydrochloride, lamivudine, zidovudine, pazopanib, fluticasone propionate, fluticasone furoate, dutasteride, Lovaza capsules, breo ellipta inhalers, avodart capsules, flovent diskus, Paxil tablets, lexiva oral suspension, sumatriptan succinate/naproxen (Treximet), abacavir/lamivudine tablets (epzicom) tablets, atovaquone and proguanil hcl tablets, combivir tablets, dolutegravir tablets, epivir tablets, epzicom tablets, malarone tablets, ziagen tablets, Zantac tablets, mekinist tablets, trametinib tablets, pazopanib tablets, tafinlar capsules, votrient tablets, coreg cr capsules, flolan for injection, propafenon sr, Rythmol (proafenon) sr, Amerge tablets, imigran injection, imitrex bulk pack, sumatriptan succinate 85mg/naproxen, lamictal, parnate tablets, ondansetron odt bulk, requip tablets, soriatane (acitretin) capsules, Zofran, Ventolin actuator dose counter, Advair diskus, Advair diskus inhalation powder, fluticasone/salmeterol aerosol inhalers, Ventolin samples, Seretide, argatroban, arixtra, Avandamet tablets, Avandia tablets, dutasteride-tamsulosin hcl fdc capsules, eltrombopag, flolan sterile diluent, Jalyn fixed dose combination capsules, panadol tablets, opadry (an excipient), starch pregel, Avandamet placebo tablets, placebo diskus, nasal spray demo pack, respiratory placebo, triacetin, crospovidone, povidone, spectracel, alginic acid ep, 20 micron aluminum powder, empty aerosol cans, pressure can spray valves, diskus subassemblies, multi-dose powder inhalers, novel dry powder inhalers, multi-dose powder inhaler subassembly and placebo, multi-dose powder inhaler diskus devices, actuators—and their dose counters and assemblies (duty rates range from free to 6.5%).

Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is January 6, 2014.

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 FTZ Board's Web site, which is accessible via www.trade.gov/​ftz.

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

Dated: November 19, 2013.

Andrew McGilvray,

Executive Secretary.