RFI - Medical Countermeasures for the Treatment of Drug-Resistant Fungal Infections
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), is issuing a Request for Information (RFI) for Medical Countermeasures for the Treatment of Drug-Resistant Fungal Infections. This RFI seeks feedback from current and prospective antifungal development partners to inform future acquisitions and programs. Responses are due by June 21, 2026, 5 P.M. EST.
Purpose
This RFI is for planning purposes only, intended to strengthen BARDA’s understanding of the current and future marketplace for medical countermeasures against drug-resistant fungal infections. It is not a solicitation and does not constitute an obligation to award a contract.
Scope of Information Requested
BARDA is specifically interested in first-in-class antifungals for treating drug-resistant Candida species (including Candida auris) and/or Aspergillus species. Respondents, including Other than Small Businesses (OTSB) and Small Businesses (SB), are asked to provide detailed information on:
- Antifungal Candidate Overview: Pathogens targeted, differentiation, clinical indications, commercial formulation, FDA correspondence, IP status, and proposed NDA submission timeline.
- Clinical Development Status: Details on Phase 1, 2, and 3 trials, including design, endpoints, enrollment, safety data, and completion status.
- Nonclinical Studies: Efficacy, pharmacology/pharmacodynamics, ADME, toxicology, and safety data.
- Manufacturing: Manufacturing process, status of registration/primary batches, process validation, stability testing, manufacturing scale, Contract Manufacturing Organization (CMO) status, with a focus on US domestic capacity.
- Procurement: How respondents would meet requirements for delivery to ASPR/SNS or vendor-managed inventory (VMI) for stockpiling.
- Commercialization: Current or planned commercial strategy, corporate sustainability strategy, and Target Product Profile (TPP).
Contract & Timeline
- Type: Request for Information (RFI) / Sources Sought
- Agency: BARDA, ASPR, HHS
- Response Due: June 21, 2026, 5 P.M. EST
- Published: May 21, 2026
- Set-Aside: None specified (open to all business sizes, including Small Businesses and Other than Small Businesses)
Submission Requirements
- Responses should be limited to 12 single-sided pages.
- Respondents must state if they are registered as a small business.
- Submit responses electronically to Audrey.Glover@hhs.gov and Jonathan.Gonzalez@hhs.gov.
- Questions should be directed to the same email addresses.
Additional Notes
This RFI is for informational and planning purposes only. No costs incurred in response will be reimbursed. The government reserves the right to use submitted information as deemed necessary. Responses will not be considered adequate responses to a future solicitation.