[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Notices]
[Page 14578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05478]


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DEPARTMENT OF COMMERCE

Foreign-Trade Zones Board

[B-20-2021]


Foreign-Trade Zone (FTZ) 177--Evansville, Indiana; Notification 
of Proposed Production Activity; AstraZeneca Pharmaceuticals LP 
(Pharmaceutical Products); Mount Vernon, Indiana

    AstraZeneca Pharmaceuticals LP (AstraZeneca) submitted a 
notification of proposed production activity to the FTZ Board for its 
facility in Mount Vernon, Indiana. The notification conforming to the 
requirements of the regulations of the FTZ Board (15 CFR 400.22) was 
received on March 9, 2021.
    AstraZeneca already has authority to produce certain 
pharmaceuticals products within Subzone 177A. The current request would 
add finished products and foreign status materials to the scope of 
authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would 
be limited to the specific foreign-status materials 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 AstraZeneca 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, AstraZeneca would be able to choose the duty rates during 
customs entry procedures that apply to: CALQUENCE (acalabrutinib) 
capsules; DAKLINZA (daclatasvir) tablets; FARXIGA\FORXIGA 
(dapagliflozin) tablets; KOMBIGLYZE IR (metformin hydrochloride and 
saxagliptin hydrochloride) tablets; KOMBIGLYZE XR (metformin 
hydrochloride and saxagliptin hydrochloride) tablets; METFORMIN IR 
(metformin hydrochloride) tablets; ONGLYZA (saxagliptin hydrochloride) 
tablets; QTERN (dapagliflozin and saxagliptin hydrochloride) tablets; 
QTERNMET XR (dapagliflozin, metformin hydrochloride and saxagliptin 
hydrochloride) tablets; TAGRISSO (osimertinib mesylate) tablets; XIGDUO 
IR (dapagliflozin and metformin hydrochloride) tablets; and, XIGDUO XR 
(dapagliflozin and metformin hydrochloride) tablets (duty-free). 
AstraZeneca 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 materials sourced from abroad include: Metformin hydrochloride 
active pharmaceutical ingredient (API); dapagliflozin API; daclatasvir 
API; osimertinib mesylate API; acalabrutinib API; and, saxagliptin 
hydrochloride API (duty rate ranges from 3.7% to 6.5%). The request 
indicates that certain materials 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: 
[email protected]. The closing period for their receipt is April 26, 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 
[email protected].

    Dated: March 11, 2021.
Andrew McGilvray,
Executive Secretary.
[FR Doc. 2021-05478 Filed 3-16-21; 8:45 am]
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