Radiological or Nuclear Medical Countermeasure Product Development Support (PDS)

The National Institutes of Health (NIH) is seeking information from qualified small businesses to support the development of radiological or nuclear medical countermeasures. The goal is to establish a robust research and development framework to facilitate the progression of candidate medical countermeasures towards obtaining FDA approval, licensure, or clearance. The work will involve administrative and technical support, animal model development, non-clinical studies, chemistry, manufacturing, and control support, and Phase I clinical studies. • Task Area A: Administrative and Technical Support • Task Area B: Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs • Task Area C: Non-Clinical Studies in Support of Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Application (BLA) Submissions • Task Area D: Chemistry, Manufacturing, and Control (CMC) Support • Task Area E: Phase I Clinical Studies and Support