Comment on FR Doc # 2026-10128

Johnson & Johnson appreciates the DEA’s ongoing efforts to prevent diversion of controlled substances while safeguarding patient access to essential medicines. We commend initiatives to modernize quota administration, clarify regulatory requirements, and enhance supply‑chain visibility, which together support public health objectives. As a global manufacturer, we believe robust diversion controls and a predictable, transparent quota framework are mutually reinforcing: strong oversight protects public safety, while clear processes support patient access and commercial continuity. We stand ready to provide practical operational data — including production cycles, supplier lead times, and inventory management information — and respectfully suggest that clearer allocation assumptions, processing timelines, and quota decision criteria would further strengthen planning. Consistent guidance and quota timelines are essential to effective operational planning; absent them, manufacturers may face inefficiencies such as the disposition of short‑dated APIs, clinical trial delays, launch timing challenges, and supply constraints that could affect patients. Johnson & Johnson welcomes the opportunity to engage with the DEA and offer operationally grounded recommendations to support implementation and minimize the risk of unintended supply disruptions.