DRIVe Broad Agency Announcement

The mission of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats (Section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241), "Research and Investigations"; Section 319L of the PHS Act (42 U.S.C. 247d-7e), "Biomedical Advanced Research and Development Authority."). The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) located in Washington, D.C. has a mission to support research and development efforts to provide medical countermeasures (MCM) that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. BARDA supports the transition of medical countermeasures such as vaccines, drugs, diagnostics, and medical devices from research through advanced development towards consideration for approval by the Food and Drug Administration (FDA) and inclusion into the Strategic National Stockpile. BARDA's support includes providing funding, technical assistance and core services. To date, with our industry partners, BARDA's support has resulted in 35 FDA approvals for 31 unique products addressing CBRN, pandemic influenza, and emerging infectious disease threats. BARDA's mission is accomplished through successful public-private partnerships with industry to share risk, improve efficiency and accelerate development all while sustaining a marketplace that ensures continued access to countermeasures vital to our national security. Major challenges with addressing 21st Century health security threats require breakthrough solutions. The Assistant Secretary for Preparedness and Response under HHS has charged BARDA with launching a new Division for Research, Innovation and Ventures (DRIVe) to accelerate the research, development, and availability of transformative countermeasures to protect Americans from natural and intentional health security threats. The BARDA DRIVe BAA will specifically aim to accelerate the research, development, and availability of transformative products to protect Americans from natural and intentional health security threats by soliciting revolutionary technologies and innovations in health security. Areas of Interest: The purpose of this Broad Agency Announcement (BAA) is to solicit proposals that focus on one or more of the following areas of interest (AOI): Research and Development AOI: 1. Area of Interest #1: Solving Sepsis: Sepsis is a leading cause of death in hospitals and often arises from infections associated with Chemical, Biological, Radiological and Nuclear (CBRN) insults, as well as, seasonal or pandemic influenza. BARDA's mission is to deliver a comprehensive portfolio of medical countermeasures to address these naturally occurring or intentional threats. DRIVe is interested in a suite of approaches as an initial investment towards "solving sepsis". 2. Area of Interest #2: Early Notification to Act, Control and Treat (ENACT): The goal of ENACT is to prevent illnesses and deaths by solving the problem of late, or lack of, identification of exposures to harmful agents or infections and posterior cascading signals to illness and death. Late, or no diagnosis of infections, including those from influenza, biological threat exposure, and other respiratory diseases delays or prevents treatment and also contributes to increased risk of further transmission. DRIVe is interested in a suite of approaches that empowers the patient with early notification of exposure that enables providers to act, control and treat the illness. The Office of Acquisitions Management, Contracts, and Grants (AMCG) on behalf of The BARDA DRIVe, is soliciting innovative research proposals to investigate translational and translatable approaches that enable revolutionary advances in science, technologies, or systems at the intersection of biology with engineering and the physical and computer sciences. Specifically excluded is basic science, research that primarily results in evolutionary improvements to the existing state of the art. DRIVe seeks unconventional approaches that are outside the mainstream, challenge assumptions, and have the potential to radically change established practice, lead to extraordinary outcomes, and create entirely new fields that will protect Americans from 21st Century Health Threats. DRIVe anticipates that research and development activities awarded under this solicitation will serve to advance candidate medical countermeasures towards licensure or approval by the U.S. Food and Drug Administration (FDA). This solicitation will also serve to advance the knowledge and scientific understanding of candidates' platform technologies and visual analytics. The Government intends to have a full and open competition for this requirement in the form of a BAA. This synopsis is not a solicitation; a solicitation itself is anticipated to be posted on or about June 4, 2018. The Government expects to make one or more awards, subject to the availability of funds. The open period of the solicitation will be specified in the solicitation itself.