Description

Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology, leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. NIAID, Division of Allergy, Immunology and Transplantation (DAIT) requires advanced product development by the Biomedical Advanced Research and Development Authority or acquisition under the Project BioShield Act of 2004. Description The National Institute of Allergy and Infectious Diseases (NIAID) intends to solicit proposals for a contract entitled “Radiological or Nuclear Medical Countermeasure Product Development Support (PDS)” to advance the development of candidate medical countermeasures (MCMs), including biodosimetric approaches to determine radiation exposure. NIAID anticipates that research and development studies supported by this RFP will advance candidate MCMs toward eventual FDA approval or licensure for acute radiation syndrome (ARS) or delayed effects of acute radiation exposure (DEARE). It is anticipated that candidate MCMs will enter the evaluation and development pathway at various stages, from early research to post-marketing (for drugs or biologics that are already licensed or approved for other indications). The Contractor will collaborate with NIAID and, under the direction of NIAID, with organizations that have developed MCMs and with other federal authorities, including the Food and Drug Administration (FDA). The proposals will be evaluated on the comprehensiveness, soundness, adequacy, and suitability of the proposed scientific approach and methodology used to support the advancement of candidate MCMs for the mitigation or treatment of ARS/DEARE towards FDA approval or licensure under the Animal Efficacy Rule and the organizational capabilities, experience, and understanding of the development of MCMs against radiological and nuclear agents. The evaluation will also be based on the adequacy of the scientific and technical personnel, facilities, equipment, Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP) compliance, and project management. It is anticipated that one Indefinite Delivery, Indefinite Quantity (IDIQ) type contract will be awarded for a 7-year period of performance beginning on or about 7/1/2027. The Task Areas will include Administrative and Technical Support, Animal Model and New Approach Methodologies (NAMs) Development, and Efficacy Testing of Candidate MCMs, Non-Clinical Studies in Support of Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Application (BLA) Submissions, Chemistry, Manufacturing and Control (CMC) Support, and Phase I Clinical Studies and Support. The first Task Area is anticipated to enco…

Classification

Contracting Office

Contacts

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• Attachment 1