RFI/SSN for Host Directed Therapeutics for the Prevention of Progression to ARDS
The Administration for Strategic Preparedness and Response (ASPR) issued this combined Request for Information (RFI) and Sources Sought Notice (SSN) to support the Biomedical Advanced Research and Development Authority (BARDA) Influenza and Emerging Infectious Diseases Division (IEIDD). The government is conducting market research to refine requirements for the ARDS Preparedness and Response Program, which focuses on host-directed therapeutics designed to prevent progression to acute respiratory distress syndrome (ARDS). The project scope involves the late-stage clinical development of therapeutics for hospitalized patients with viral respiratory infections who require supplemental oxygen. BARDA anticipates establishing long-term partnerships with multiple contractors for these services under NAICS 541714, Research and Development in Biotechnology (except Nanobiotechnology), and PSC AN32, Health R&D Services; Consumer and Occupational Health and Safety; Applied Research.
The notice seeks performers capable of advancing Phase 3 clinical development plans, including dose selection for products with supportive Phase 2 efficacy data. Mandatory eligibility criteria include data demonstrating a therapeutic mechanism of action applicable to severe influenza, preclinical or clinical efficacy against viral respiratory infections, and documented FDA concurrence on Phase 3 study designs. BARDA indicates a preference for products currently in Phase 3 trials. This procurement is not subject to a set-aside, as both the acronym and explanation are listed as NONE. Performance is centered in Washington, DC, and the government may limit future competition for the resulting Request for Prototype Proposals (RPP) to eligible respondents of this notice.
Submissions are due by 3:00 pm EDT on April 15, 2026, via email to Laura Saddison. Interested parties are requested to provide a technical capabilities statement, responses to specific questions provided in Attachment A, and track-changed feedback on the draft RPP provided in Attachment B. A total of three attachments were posted with the notice on April 1, 2026, including the RFI questions, the draft RPP, and the primary SSN document. This notice is for information and planning purposes only and does not constitute a solicitation or a commitment to form a binding contract.
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Contact and place of performance
Laura Saddison
Washington, DC 20024
USA
Objective The objective of this combined Request for Information (RFI) / Sources Sought Notice (SSN) is for BARDA program officials to better refine the requirements for host directed therapeutics for the prevention of progression to acute respiratory distress syndrome (ARDS) in support of BARDA’s Influenza and Emerging Infectious Diseases Division (IEIDD)...
View more**Please see Attachment B – Draft RPP for detailed information.
SAM.Gov Sources Sought Notice (SSN)
This RFI also constitutes as a Sources Sought Notice. BARDA anticipates awards will be made to multiple contractors with the best solutions and capabilities.
Mandatory Eligibility Criteria: Proposed host-directed therapeutic(s) must meet the following minimum criteria to be considered for award:
Note: Failure to adequately document compliance of the above mandatory requirement will result in the elimination of the Offeror from further consideration. No further discussions will be held.
BARDA encourages qualified contractors to respond so we can better understand the current state of the science.
This SSN/RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the SSN/RFI that is marked as proprietary will be handled accordingly by the Government. Responses to this SSN/RFI are not considered offers and cannot be accepted by BARDA to form a binding contract. Responders are solely responsible for all expenses associated with responding to this SSN/RFI. All information submitted in response to this SSN/RFI shall remain with the Government and will not be returned.
*BARDA may compete the resulting RPP amongst eligible respondents of this RFI only.
RFI Response Format:
Interested parties are invited to submit responses to any of the questions in Attachment A as well as a technical capabilities statement. Responses to this RFI should explore the listed questions as well as similar issues to best support the successful advancement of this effort. Responses should consist of a cover page that provides administrative and contact information (contact name, title, email address, phone number) and organizational information of the responder (entity name, headquarters, mailing address). Respondents are also invited to review the draft RPP included as Attachment B and provide general feedback via track changes. Respondents are requested to provide:
Respondents must clearly mark all copyrighted information, data, and materials with appropriate restrictive legends (e.g., confidential, privileged, proprietary, trade secret). To aid in protecting your information, please segregate proprietary information. DO NOT SUBMIT ANY CLASSIFIED INFORMATION.
Responses to this RFI should explore the listed questions as well as similar issues to best support the successful advancement of this effort.
Please submit responses by email to [email protected] no later than 3:00 pm EDT April 15, 2026.
Responses:
BARDA encourages qualified performers to respond so we can better understand the current state of the science.
The full draft RPP is being provided to allow for advance planning purposes and to allow additional time for potential proposal development and/or partnering.
Please note that non-federal employees performing advisory and assistance services will have access to any submission under this RFI. All non-federal employees are required to sign a non-disclosure agreement prior to accessing the RFI responses.
Thank you for your participation in this RFI. Please contact [email protected] with any questions or concerns.