Summary
The U.S. Department of Health and Human Services (HHS), through its Administration for Strategic Preparedness and Response (ASPR), has issued a Request for Information (RFI) aimed at strengthening the domestic production landscape for essential medicines. This RFI, managed by ASPR’s Center for Industrial Base Management and Supply Chain (IBMSC), is part of a broader national effort to ensure an agile and sustainable supply of domestic essential medicines.
Understanding the RFI
The Public Health Industrial Base Capabilities and Capacities: Essential Medicines RFI is seeking detailed input from domestic manufacturers and industry stakeholders to better understand the current capabilities and constraints in producing a list of 28 designated essential medicines. The scope includes everything from chemical precursors and key starting materials (KSMs) to active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs).
The goal is to inform future government planning efforts by mapping out the production landscape and identifying where existing infrastructure can be scaled, modernized, or repurposed. The RFI is part of ASPR’s ReShoreRx initiative, which aims to secure long-term U.S. manufacturing capacity to prepare for and respond to public health emergencies.
RFI Details and Requirements
Respondents are encouraged to provide comprehensive technical and operational details on their ability to produce the required materials for the essential medicines list. Specific areas of interest include:
- Regulatory holdings (e.g., DMF, ANDA, NDA, BLA) and FDA compliance.
- Current and potential manufacturing scale.
- Equipment, manufacturing processes, and readiness levels (MRLs).
- Supply chain dependencies, particularly on foreign-sourced materials.
- Existing and future capacity.
- Flexibility and adaptability of production lines to support multiple products.
- Commercial pipeline and customer engagement status.
- Long-term sustainability concerns and investment requirements.
Key Dates to Know
ASPR-IBMSC has outlined the following deadline for this RFI: June 16th, 2025, by 5:00 PM EST
Funding and Follow-Up
While this is not a funding opportunity in itself, the RFI will inform future projects, which may be released through full and open competition. As such, this RFI presents a strategic opportunity for companies to position themselves early for potential federal investments.
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