Request for Information (RFI): Colony Stimulating Factor(s) (G?CSF or GM?CSF) for mitigation of Neutropenia arising from exposure to ionizing radiation

The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities' ability to withstand adversity, strengthening our health and response systems, and enhancing national health security. The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and procurement of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA supports the advanced research, development, and procurement of medical countermeasures (MCMs) against a variety of Chemical, Biological, Radiological and Nuclear (CBRN) threats and in recent years has significantly expanded its investment in therapeutics for radiation exposure. Current BARDA initiatives include the development of MCMs to mitigate systemic injuries caused by exposure to ionizing radiation. The bone marrow is the organ system most sensitive to whole-body or extensive partial-body exposure to radiation. Multiple cellular components of the hematopoietic system may be affected, but only Neutropenia will be discussed here. Neutrophils are involved in innate immunity and provide the first line of non-specific defenses against a broad range of bacteria and fungi. The half-life of neutrophils in blood is about 6-8 hours; their half-life in other tissues is in the range of hours to days. As a consequence of infection, neutrophils leave the circulation and target tissues that manifest bacteremia or sepsis. Dying neutrophils are replaced under physiological conditions by ongoing production in the bone marrow. Approximately two weeks are normally required for maturation of neutrophil precursors in the bone marrow until their release into the circulation as mature neutrophils. In the Neutropenia associated with hematopoietic syndrome, the loss of circulating neutrophils is a consequence from depletion of the marrow reserves and the death of the rapidly-dividing, early progenitor cells in the bone marrow. Thus, the loss of progenitor cells and the predictive kinetics of neutrophil production and release account for the delayed onset of the hematopoietic syndrome. In the case of a physical chemical or biologic agent that undermines the integrity and homeostasis of neutrophil number and function (i.e., neutropenia), the most common clinical treatment to shorten or reduce time to neutrophil recovery is the use of Colony Stimulating Factor(s) (CSF) as either Granulocyte (G) or Granulocyte?Macrophage (GM) products. The USG has a requirement for the production and maintenance of up to 260,000 regimens of Colony Stimulating Factor(s) (G? or GM?CSF) for mitigation of Neutropenia arising from exposure to ionizing radiation, where a regimen equals product for 14 days of treatment. Maintenance could include inventory storage and rotation at the Vendor site. This RFI is for planning purposes only and is issued in accordance with FAR Clause 52.215-3. No solicitation document exists at this time. The information provided in the RFI is subject to change and is not binding on the Government. Issuance of this notice does not constitute any obligation on the part of the Government to procure the supplies or to issue a solicitation. In addition, the Government is under no obligation to pay direct or indirect costs or charges that arise as a result of Responder submission of responses to this RFI or the Government's use of such information. Responses to this notice cannot be accepted as offers. The Government reserves the right to reject, in whole or in part, any Contractor's input resulting from this RFI. No contract will be awarded from this announcement. ASPR/BARDA has not made a commitment to contract any products or services, and release of this RFI should not be construed as a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned. Any information that the vendor considers proprietary should be clearly marked as such. Information is being requested in order to make potential future requirements better for industry and the Government.