NIH & NIAID | RADIOLOGICAL OR NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT (PDS)
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is seeking a single organization capable of providing comprehensive product development support for radiological and nuclear medical countermeasures (MCMs) and biodosimetry technologies. The awardee will support the development of products intended to achieve FDA approval, licensure, or clearance through a series of government-funded task orders. This opportunity is designed for organizations with broad product development capabilities spanning animal models, efficacy testing, nonclinical development, manufacturing, quality systems, and Phase I clinical studies. The proposal deadline is August 31, 2026 at 3:00 PM, Local Time. NIAID has explicitly stated that this deadline will not be extended.
How much funding would I receive?
The solicitation is structured as a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract.
Contract minimum: $2,500
Contract maximum: $135,000,000
One IDIQ contract is expected to be awarded.
The solicitation does not specify the value of individual task orders. Most sample task orders included in the solicitation list estimated costs as "TBD."
What could I use the funding for?
Funding will support product development activities related to radiological or nuclear medical countermeasures and biodosimetry technologies. The contractor must be capable of supporting activities across five task areas:
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 supporting IND, NDA, and BLA submissions
Task Area D: Chemistry, Manufacturing, and Controls (CMC) Support
Task Area E: Phase I Clinical Safety Studies and Support
Examples of supported activities include:
Animal model development
Efficacy testing in rodent and large animal models
Biodosimetry support
Pharmacology and toxicology studies
Manufacturing and formulation development
Quality assurance activities
Phase I clinical safety studies
Regulatory support toward FDA approval, licensure, or clearance
Are there any additional benefits I would receive?
The solicitation does not specify any non-financial benefits such as mentorship, commercialization support, technical assistance, networking programs, or investor introductions.
However, the contractor will work directly with NIAID through government-directed task orders and support the development of medical countermeasures intended for FDA approval, licensure, or clearance.
What is the timeline to apply and when would I receive funding?
Key dates include:
Solicitation issued: June 2, 2026
Recommended deadline for questions: July 2, 2026 at 3:00 PM EST
Proposal deadline: August 31, 2026 at 3:00 PM, Local Time (Unchanged)
Contract period of performance: July 1, 2027 through June 30, 2034
The solicitation does not specify an anticipated award date.
Work and funding will be provided through task orders issued under the IDIQ contract after award.
Where does this funding come from?
Funding comes from:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
U.S. Department of Health and Human Services (HHS)
Who is eligible to apply?
The solicitation does not provide a specific eligibility section limiting applicants by company type.
The solicitation states that one IDIQ contract will be awarded to an organization capable of providing comprehensive product development services and notes that products may originate from industry, academia, and government agencies.
Offerors must:
Be registered in the System for Award Management (SAM) prior to award.
Demonstrate the facilities, expertise, personnel, and capabilities necessary to perform all required task areas.
Who is not eligible to apply?
The solicitation does not explicitly identify categories of organizations that are ineligible to apply.
However, organizations that cannot demonstrate the required technical capabilities, facilities, staffing, regulatory compliance, and ability to perform across the required task areas may not be competitive. The solicitation also requires SAM registration prior to award.
What companies and projects are likely to win?
The solicitation strongly favors organizations capable of operating as a full-service product development partner for NIAID.
Competitive offerors will likely demonstrate:
Experience developing radiological or nuclear medical countermeasures
GLP-compliant animal efficacy testing capabilities
Large-animal research capabilities
Biodosimetry support capabilities
Nonclinical pharmacology and toxicology expertise
Current Good Manufacturing Practice (cGMP) manufacturing capabilities
Regulatory support experience for INDs, NDAs, BLAs, and FDA submissions
Phase I clinical research capabilities
Ability to execute work across all five task areas through internal resources and/or integrated subcontractor teams
The solicitation states that the contractor must be capable of carrying out task orders in each of the five task areas identified in the Statement of Work.
How competitive will this solicitation be?
This solicitation is likely to be highly competitive.
Reasons include:
Only one IDIQ contract is anticipated.
Maximum contract ceiling of $135,000,000.
Requirement to support all five technical task areas.
Significant infrastructure, regulatory, manufacturing, animal research, and clinical capabilities are required.
The solicitation does not state the expected number of proposals or anticipated success rate.
Are there any restrictions I should know about?
Examples include:
Offerors must comply with extensive human subjects, animal welfare, clinical trial, data reporting, and information security requirements.
NIH-funded clinical trials must be registered and reported through ClinicalTrials.gov.
Contract funds may not be used for abortion activities, human embryo research, or gene-editing technologies in human embryos.
Contract funds may not be used for needle exchange programs.
Contract funds may not be used to disseminate false or deliberately misleading information.
Certain direct costs may require prior approval, including foreign travel, consultant fees, subcontracts, and other specified costs.
Proposal restrictions include:
Technical proposal page limit is 250 pages inclusive of attachments, as clarified by Amendment 1.
CVs may not exceed 3 pages.
Pages exceeding the limitation will not be considered.
How long will it take me to prepare an application?
The solicitation does not specify an estimated preparation time.
However, the proposal requires:
Detailed technical responses
Responses to task-order scenarios
Cost proposals
Regulatory and compliance documentation
Staffing and organizational information
Potential subcontracting plans
Capability demonstrations across five major technical areas
Given the complexity and breadth of the requirements, applicants should plan for a substantial proposal development effort.
How can BW&CO help?
BW&CO can help organizations:
Assess fit before investing in proposal development
Interpret the solicitation requirements
Build a compliant proposal strategy
Coordinate technical, management, and cost volume development
Manage subcontractor contributions
Develop win themes aligned with NIAID priorities
Review proposals for compliance with page limits, formatting requirements, and evaluation criteria
Support final submission preparation
