RADIOLOGICAL OR NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT (PDS)

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health within the Department of Health and Human Services, is soliciting proposals under solicitation number 75N93026R00005 for the development and support of medical countermeasures (MCMs) against radiological and nuclear threats. This Indefinite Delivery, Indefinite Quantity (IDIQ) contract aims to advance candidate MCMs, including biodosimetric approaches for measuring radiation exposure, toward FDA approval or licensure for acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARE). The contract has an anticipated seven-year period of performance beginning around July 1, 2027, with no options included in the base award, though individual task orders may contain both term and quantity options. Work will span multiple phases including early research, non-clinical studies, chemistry, manufacturing and control (CMC) support, Phase I clinical trials, and post-marketing activities, requiring close collaboration with NIAID, the Food and Drug Administration, and other federal entities involved in MCM development. Proposals must be submitted online through the NIAID electronic Contract Proposal Submission (eCPS) portal by August 31, 2026, and submission via email or fax is prohibited. The NAICS code for this procurement is 541715, and no set-aside is in effect. Offerors will be evaluated on their technical approach and methodology, organizational capabilities and experience in developing MCMs for radiological and nuclear agents, and the adequacy of their personnel, facilities, equipment, project management structures, and compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). The contract requires strict adherence to these regulatory standards across all stages of product development, from preclinical testing to clinical studies. While specific pricing, CLIN structures, and contract value ceilings are not provided, the award will be made based on the evaluated technical merit and capability of the offeror. The place of performance remains unspecified at this time, and no formal list of attachments or detailed inspection procedures are outlined in the solicitation documents. Primary and secondary points of contact are listed for questions and further information regarding the solicitation.