Foreign-Trade Zone (FTZ) 177-Evansville, Indiana; Notification of Proposed Production Activity; AstraZeneca Pharmaceuticals LP (Pharmaceutical Products); Mount Vernon, Indiana
| Published date | 17 March 2021 |
| Record Number | 2021-05478 |
| Section | Notices |
| Court | Foreign-trade Zones Board |
Federal Register, Volume 86 Issue 50 (Wednesday, March 17, 2021)
[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]
BILLING CODE 3510-DS-P
