2025-00543. Foreign-Trade Zone (FTZ) 49, Notification of Proposed Production Activity; Merck, Sharp & Dohme LLC; (Pharmaceutical Products for Research and Development); Rahway, New Jersey

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Department of Commerce

Foreign-Trade Zones Board

1. [B-2-2025]

( print page 3173)

Merck, Sharp & Dohme LLC submitted a notification of proposed production activity to the FTZ Board (the Board) for its facility in Rahway, New Jersey, within Subzone 49Y. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on January 3, 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 www.trade.gov/​ftz. The proposed finished product(s) and material(s)/component(s) 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 MK-0616 macrocycle metabolic disorders drug product, MK-6204 metabolic disorders drug product and MK-5608 immunological disorder macrocyclic peptide drug product (duty-free).

The proposed foreign-status materials/components include: MK-0616 macrocycle metabolic disorders active pharmaceutical ingredient; MK-6204 metabolic disorders alkaloid active pharmaceutical ingredient; MK-6204 metabolic disorders monoclonal antibody active pharmaceutical ingredient; MK-5608 macrocyclic peptide immunological disorder active pharmaceutical ingredient; sodium caprate; microcrystalline cellulose; and, empty hydroxypropyl methylcellulose (HPMC) capsules (duty rate ranges from duty-free to 6.5%). 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 February 24, 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 Diane Finver at [e-mail].

Dated: January 7, 2025.

Elizabeth Whiteman,

Executive Secretary.