Notice2025-18131
Foreign-Trade Zone (FTZ) 189, Notification of Proposed Production Activity; Grand River Aseptic Manufacturing; (Pharmaceutical Products); Caledonia and Grand Rapids, Michigan
Primary source
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Published
September 19, 2025
Issuing agencies
Commerce DepartmentForeign-Trade Zones Board
Full Text
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Page 45172]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18131]
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Notices
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Federal Register / Vol. 90, No. 180 / Friday, September 19, 2025 /
Notices
[[Page 45172]]
DEPARTMENT OF COMMERCE
Foreign-Trade Zones Board
[B-44-2025]
Foreign-Trade Zone (FTZ) 189, Notification of Proposed Production
Activity; Grand River Aseptic Manufacturing; (Pharmaceutical Products);
Caledonia and Grand Rapids, Michigan
Kent-Ottawa-Muskegon Foreign-Trade Zone Authority, grantee of FTZ
189, submitted a notification of proposed production activity to the
FTZ Board (the Board) on behalf of Grand River Aseptic Manufacturing
(GRAM) for GRAM's facilities in Caledonia and Grand Rapids within
Subzone 189H. The notification conforming to the requirements of the
Board's regulations (15 CFR 400.22) was received on September 12, 2025.
Pursuant to 15 CFR 400.14(b), FTZ production activity would be
limited to the specific foreign-status material(s)/component(s) and
specific finished product(s) 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 <a href="http://www.trade.gov/ftz">www.trade.gov/ftz</a>.
The proposed finished products are atigotatug--nivolumab 420mg and
360mg/vials (70mg and 60mg/mL) and atigotatug--nivolumab 560mg and
480mg/vials (70mg and 60mg/mL) (duty-free).
The proposed foreign-status material is nivolumab (180mg/mL) active
pharmaceutical ingredient (duty-free).
Public comment is invited from interested parties. Submissions
shall be addressed to the Board's Executive Secretary and sent to:
<a href="/cdn-cgi/l/email-protection#99ffede3d9edebf8fdfcb7fef6ef"><span class="__cf_email__" data-cfemail="086e7c72487c7a696c6d266f677e">[email protected]</span></a>. The closing period for their receipt is October 27,
2025.
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
<a href="/cdn-cgi/l/email-protection#bffcd7cdd6cc91e8dadbdbdacdddcacdd1ffcbcddedbda91d8d0c9"><span class="__cf_email__" data-cfemail="094a617b607a275e6c6d6d6c7b6b7c7b67497d7b686d6c276e667f">[email protected]</span></a>.
Dated: September 15, 2025.
Elizabeth Whiteman,
Executive Secretary.
[FR Doc. 2025-18131 Filed 9-18-25; 8:45 am]
BILLING CODE 3510-DS-P
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