Federal Register #2026-19646

RFI for Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List

This opportunity is a Request for Information (RFI) from the Office of Management and Budget (OMB) focused on strengthening domestic and near shore manufacturing of essential generic medicines. - Government Buyer: - Office of Management and Budget (OMB), United States Federal Government - OEMs and Vendors: - No specific OEMs or vendors named; open to all qualified manufacturers except Foreign Entities of Concern (FEOC) - Products/Services Requested: - Finished Dose Forms (FDF), Active Pharmaceutical Ingredients (API), and Key Starting Materials (KSM) for medicines on the ASPR 86 list - Amoxicillin and Ciprofloxacin (not on ASPR 86 list but included due to supply chain vulnerabilities) - Requirements: - Respondents must not be owned or controlled by China, Russia, Iran, or North Korea - Information sought on idle and planned manufacturing capacity, regulatory compliance, technical capabilities, supply chain strategies, and financing needs - Data will be shared with federal agencies and may inform future acquisition and financial assistance efforts - Unique/Notable Requirements: - Focus on domestic and near shore production - Emphasis on supply chain resilience and regulatory compliance - RFI is for market research, not a direct procurement

Description

The Office of Management and Budget (OMB) is conducting market research to identify new and unused (idle) domestic, U.S.-based, and near shore production capabilities for Finished Dose Forms (FDF), Active Pharmaceutical Ingredients (API), and Key Starting Materials (KSM) associated with the Administration for Strategic Preparedness and Response (ASPR) 86 list of essential medicines. The request seeks information on manufacturing lifecycle aspects from raw material sourcing to finished product. Responses will be shared with federal agencies responsible for essential medicines and strengthening the domestic industrial base for essential generic pharmaceuticals. The information gathered may inform federal acquisition efforts and potential financial assistance to revitalize domestic manufacturing.

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