Name | Type | Posted | Actions |
|---|---|---|---|
Presolicitation.pdf | May 18, 2026 |
RADIOLOGICAL OR NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT (PDS)
Contact and place of performance
Karen Telphia
USA
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 disease...
View moreIt 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 encompass a cost-reimbursement, term (level of effort) Task Order, and the other completion type cost reimbursement Task Orders.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 2, 2026, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract or Task Order. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or email is not acceptable.
For directions on using eCPS, go to the website https://ecps.nih.gov/ and then click on "How to Submit."
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, intends to solicit proposals for the Radiological or Nuclear Medical Countermeasure Product Development Support (PDS) program. This initiative focuses on advancing the development of candidate medical countermeasures (MCMs) and biodosimetric approaches intended to mitigate or treat acute radiation syndrome (ARS) and the delayed effects of acute radiation exposure (DEARE). The contractor will collaborate with NIAID, federal authorities, and external organizations to move candidate MCMs through various stages of the evaluation and development pathway, ranging from early research to post-marketing studies for drugs or biologics already approved for other indications. The primary objective is to advance these candidates toward eventual Food and Drug Administration (FDA) approval or licensure under the Animal Efficacy Rule.
This requirement is identified under NAICS code 541715 for Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) and PSC code AN12 for Health R&D Services; Health Care Services; Applied Research. NIAID anticipates awarding one Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a seven-year period of performance beginning on or about July 1, 2027. The scope of work involves five distinct Task Areas: administrative and technical support; animal model and new approach methodologies (NAMs) development and efficacy testing; non-clinical studies in support of IND, NDA, or BLA submissions; chemistry, manufacturing, and control (CMC) support; and Phase I clinical studies. The initial task order is expected to be a cost-reimbursement, level-of-effort arrangement, while subsequent orders will be completion-type cost-reimbursement tasks.
The solicitation for this requirement, numbered 75N93026R00005, is expected to be released on or about June 2, 2026, which is also the established response deadline. Evaluation of proposals will be based on the suitability of the proposed scientific methodology, organizational capabilities, and the adequacy of technical personnel and facilities. Compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP) is required. The place of performance is within the United States, and all proposals must be submitted through the NIAID electronic Contract Proposal Submission (eCPS) website. One attachment, a presolicitation PDF, was issued with the notice on May 18, 2026.
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