Development of Radiation/Nuclear Medical Countermeasures (MCMs) or Biodosimetry Devices

The goal of this BAA is to solicit proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment.

This BAA is intended to support research and development of promising new approaches to mitigate or treat tissue injuries arising from unintended exposure to ionizing radiation, which may include biologics (e.g., cytokines and free radical scavengers), cellular therapies, or drugs (e.g., anti-inflammatory agents, antibiotics, and anti-fibrotics). The lead MCM to be supported by this initiative should be easy to distribute and use in a mass casualty incident (i.e., preferred routes of administration are oral, subcutaneous, inhalation, transdermal, topical, or intramuscular). Cellular therapies, which may require intravenous administration, may also be supported.

For H-ARS products, candidates must demonstrate advantages over existing FDA-approved H-ARS MCMs to be considered responsive to the BAA (e.g., efficacious when administered at 48 hours post-radiation exposure or later, more advantageous route of administration for mass-casualty scenario, lower cost, improved mass casualty-amenable storage, etc.).

This BAA is intended to support further development of biodosimetry biomarkers (biological indicators of radiationinduced tissue injuries), and/or diagnostic systems (point-of-care field, or definitive care devices) to rapidly assess levels and types of radiation exposure using minimally invasive biological sampling (e.g., a minimal quantity of blood, hair follicles, skin swabs, saliva, serum, or urine; rather than samples like spinal fluid or tissue biopsies).

Please see solicitation attachment "BAA-75N93022R00021 Development of Radiation_Nuclear Medical Countermeasures (MCMs) or Biodosimetry Devices" for details. 

Amendment 1 to BAA-75N93022R00021 is posted as an attachement on 01/24/2023. 

Amendment 2 to BAA-75N93022R00021 is posted as an attachement on 02/10/2023.

The goal of this BAA is to solicit proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment.

This BAA is intended to support research and development of promising new approaches to mitigate or treat tissue injuries arising from unintended exposure to ionizing radiation, which may include biologics (e.g., cytokines and free radical scavengers), cellular therapies, or drugs (e.g., anti-inflammatory agents, antibiotics, and anti-fibrotics). The lead MCM to be supported by this initiative should be easy to distribute and use in a mass casualty incident (i.e., preferred routes of administration are oral, subcutaneous, inhalation, transdermal, topical, or intramuscular). Cellular therapies, which may require intravenous administration, may also be supported.

For H-ARS products, candidates must demonstrate advantages over existing FDA-approved H-ARS MCMs to be considered responsive to the BAA (e.g., efficacious when administered at 48 hours post-radiation exposure or later, more advantageous route of administration for mass-casualty scenario, lower cost, improved mass casualty-amenable storage, etc.).

This BAA is intended to support further development of biodosimetry biomarkers (biological indicators of radiationinduced tissue injuries), and/or diagnostic systems (point-of-care field, or definitive care devices) to rapidly assess levels and types of radiation exposure using minimally invasive biological sampling (e.g., a minimal quantity of blood, hair follicles, skin swabs, saliva, serum, or urine; rather than samples like spinal fluid or tissue biopsies).

Please see solicitation attachment "BAA-75N93022R00021 Development of Radiation_Nuclear Medical Countermeasures (MCMs) or Biodosimetry Devices" for details. 

Amendment 1 to BAA-75N93022R00021 is posted as an attachement on 01/24/2023. 

The goal of this BAA is to solicit proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment.

This BAA is intended to support research and development of promising new approaches to mitigate or treat tissue injuries arising from unintended exposure to ionizing radiation, which may include biologics (e.g., cytokines and free radical scavengers), cellular therapies, or drugs (e.g., anti-inflammatory agents, antibiotics, and anti-fibrotics). The lead MCM to be supported by this initiative should be easy to distribute and use in a mass casualty incident (i.e., preferred routes of administration are oral, subcutaneous, inhalation, transdermal, topical, or intramuscular). Cellular therapies, which may require intravenous administration, may also be supported.

For H-ARS products, candidates must demonstrate advantages over existing FDA-approved H-ARS MCMs to be considered responsive to the BAA (e.g., efficacious when administered at 48 hours post-radiation exposure or later, more advantageous route of administration for mass-casualty scenario, lower cost, improved mass casualty-amenable storage, etc.).

This BAA is intended to support further development of biodosimetry biomarkers (biological indicators of radiationinduced tissue injuries), and/or diagnostic systems (point-of-care field, or definitive care devices) to rapidly assess levels and types of radiation exposure using minimally invasive biological sampling (e.g., a minimal quantity of blood, hair follicles, skin swabs, saliva, serum, or urine; rather than samples like spinal fluid or tissue biopsies).

Please see solicitation attachment "BAA-75N93022R00021 Development of Radiation_Nuclear Medical Countermeasures (MCMs) or Biodosimetry Devices" for details.