RADIOLOGICAL OR NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT (PDS)

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking a contractor to provide radiological or nuclear medical countermeasure product development support. The contractor will be required to provide facilities, expertise, and capabilities to develop additional radiological or nuclear medical countermeasures and support NIAID's biodosimetry efforts. The contract will be for a period of 7 years, with a minimum value of $2,500 and a maximum value of $135,000,000. The contractor will be required to provide a range of services, including developing animal models, conducting efficacy tests, assessing DEARE, and managing manufacturing and formulation processes. Some key points of this opportunity include: • Developing animal models and New Approach Methodologies (NAMs) • Conducting efficacy tests in rodent and large animal models • Assessing DEARE in rodent and large animal models • Facilitating large animal sample distribution for testing candidate biodosimetry methods • Evaluating radionuclide decorporation agents in rodent and canine models • Performing animal safety studies, including pharmacokinetic and pharmacodynamic assessments • Managing manufacturing and formulation processes • Overseeing quality assurance activities • Conducting Phase I Clinical Safety Studies