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

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 FTZ 49. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on March 8, 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 for research and development include: drug products containing the following active pharmaceutical ingredients: MK–7962 Sotatercept, MK–3475A monoclonal antibody, MK–2060 monoclonal antibody, MK–6024 Efinopegdutide, and, MK–5475 hypertension; clinical placebos; and, blinded clinical trial kits (duty rate ranges from duty-free to 6.5%, and 40 cents/kg+10.4%).

The proposed foreign-status materials and components include: active pharmaceutical ingredients: MK–5475 Hypertension, MK–6024 Efinopegdutide, MK–7962 Sotatercept, MK–3475A monoclonal antibody, and MK–2060 monoclonal antibody; syringes and syringe parts: barrels, hubs, plungers, needles; autoinjectors and autoinjector subassemblies: casings and dosing mechanisms; and, empty gelatin 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: ftz@trade.gov. The closing period for their receipt April 29, 2024.

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 Diane.Finver@trade.gov.