AstraZeneca Pharmaceuticals, LP submitted a notification of proposed production activity to the FTZ Board (the Board) for its facility in Mount Vernon, Indiana within Subzone 177A. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on February 14, 2022.
Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status materials and specific finished products described in the submitted notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via www.trade.gov/ftz. The proposed finished products and materials would be added to the production authority that the Board previously approved for the operation, as reflected on the Board's website.
The proposed finished products include: ARIMIDEX (anastrozole) tablets; BRILINTA (ticagrelor) tablets; CRESTOR (rosuvastatin calcium) tablets; LYNPARZA (olaparib) tablets; SEROQUEL IR (quetiapine fumarate) tablets; and, SEROQUEL XR (quetiapine fumarate) tablets (duty-free).
The proposed foreign-status materials include: Anastrozole active pharmaceutical ingredient (API); microcrystalline cellulose; olaparib API; quetiapine fumarate API; rosuvastatin calcium API; and, ticagrelor API (duty rate ranges from 5.2% to 6.5%). The request indicates that olaparib API and ticagrelor API 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: ftz@trade.gov. The closing period for their receipt is April 5, 2022.
A copy of the notification will be available for public inspection in the “Online FTZ Information System” section of the Board's website.
For further information, contact Christopher Wedderburn at Chris.Wedderburn@trade.gov.
Dated: February 17, 2022.
Andrew McGilvray,
Executive Secretary.
[FR Doc. 2022-03896 Filed 2-23-22; 8:45 am]
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