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

Citation86 FR 14578
CourtForeign-trade Zones Board
Publication Date17 Mar 2021
Record Number2021-05478
Federal Register, Volume 86 Issue 50 (Wednesday, March 17, 2021)
[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
                [Page 14578]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2021-05478]
                Foreign-Trade Zones Board
                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
                 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
                 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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