2024-28026. Foreign-Trade Zone (FTZ) 35, Notification of Proposed Production Activity; PCI Pharma Services; (Pharmaceutical Products); Croydon and Philadelphia, Pennsylvania

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Department of Commerce

Foreign-Trade Zones Board

1. B-59-2024]

PCI Pharma Services (PCI) submitted a notification of proposed production activity to the FTZ Board (the Board) for its facilities in Croydon, Pennsylvania and Philadelphia, Pennsylvania within Subzone 35L. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on November 21, 2024.

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 www.trade.gov/​ftz.

The proposed finished products include: tulisokibart dosages packed in assembled device in single or multi-dose packaging and sotatercept dosages packed in assembled device in single or multi-dose packaging (duty-free).

The proposed foreign-status materials/components include: auto-injector sub assembly for sotatercept; auto-injector sub assembly for tulisokibart; tulisokibart in pre-filled syringes; and sotatercept in pre-filled syringes (duty-free). The request indicates that certain materials/components 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: [e-mail]. The closing period for their receipt is January 8, 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 Kolade Osho at [e-mail].

Dated: November 22, 2024.

Elizabeth Whiteman,

Executive Secretary.