Inactive

The objectives of this contract are: 1) to acquire a U.S. Food and Drug Administration (FDA) approved treatment for use in a mass casualty event where thrombocytopenia or platelet loss is a major conc... The objectives of this contract are: 1) to acquire a U.S. Food and Drug Administration (FDA) approved treatment for use in a mass casualty event where thrombocytopenia or platelet loss is a major concern. The total procurement may be up to 170,000 unit doses. The initial procurement shall be up to 51,000 doses. In each option period additional pharmaceutical doses shall be procured to reach the 170,000 level. The product selected will be procured in stages (i.e., initial purchase of up to 51,000 unit doses, plus up to five additional potential deliveries all over a 10-year period to build towards the requirement need-based quantity); and 2) for the Contractor to provide, as part of the annualized acquisition, a contractor-managed inventory (e.g., VMI) with rotation of stock to control product expiry. The inventory management plan shall also include a plan to provide the SNS with an accurate inventory of product as well as location(s) should the U.S. Government (USG) have an immediate need for product in an emergency situation. The Contractor's plan to deliver the product as needed by the government, the Quality Agreement with the Assistant Secretary of Preparedness and Response (ASPR), shall be negotiated to align with the USG’s specific product use during a mass casualty event. In order to meet the above objectives, the Contractor shall have evidence that the labeling, storage, distribution and transport programs are secure and controlled.

Inactive

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 (H... 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) intends to use Project BioShield (PBS) to procure a U.S. Food and Drug Administration (FDA) approved thrombopoietin receptor agonist, for use as a MCM that can treat thrombocytopenia arising as a pathology of acute exposure to ionizing radiation that may be a consequence of a radiological/nuclear mass casualty event . The procured therapeutic will be delivered to the ASPR/Strategic National Stockpile and maintained as vendor managed inventory. The USG seeks therapeutics that meet the following mandatory criteria: 1) The approved label indication shall be to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation H-ARS and 2) The approved label shall state the drug’s mechanism of action is through stimulation of thrombopoiesis and/or treatment of thrombocytopenia resulting in a statistically significant increase in platelet counts and 3) The MCM is effective when administered at 24-hours or more post-radiation exposure.