Development of Radiological/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices

Form / Attachment / Pricing Sheet

This document provides additional instructions and uniform cost assumptions for developing the business proposal for BAA 75N93026R00004, "Development of Radiological/Nuclear Medical Countermeasures (MCMS) and Biodosimetry Devices." It supplements Section L of the Broad Agency Announcement (BAA) and offers guidance for cost estimation and proposal structure.

• Proposal Cover Sheet: Use form NIH 2043.
• Cost or Price Support: Refer to Section L of the BAA for minimum documentation requirements.
• Uniform Cost Assumptions:
  • Technical Cost Assumptions: Business proposals must include a line-item breakdown of costs (Direct Labor, Materials, Animal costs, Subcontracts, Consultants, Travel). Costs must be broken down by milestone and for the entire project period. A detailed Gantt chart showing timelines for milestones, tasks, subtasks, and budgets is required.
  • Travel Assumptions: Specific uniform cost assumptions for various travel requirements are provided, including:
    • Contract Initiation Meeting (Rockville, MD)
    • Annual Site Visits (Contractor's facilities)
    • Annual Programmatic Meetings (Rockville, MD)
    • Scientific Meetings (for presenting findings)
    • Subcontractor Site Visits
    • Note: Government personnel travel costs are not to be included in the proposal.
  • Government Furnished Property: Clarifies that it is offered, but its purchase is not authorized as a direct charge.
• Options: Each option must be budgeted separately with delineated cost assumptions.
• Documentation Requirements: Refer to Section L of the BAA for required documentation.

This attachment is critical for bidders to understand the specific requirements for structuring their business proposals, including detailed cost breakdowns, milestone budgeting, Gantt chart requirements, and specific assumptions for estimating travel costs. Adhering to these instructions is essential for a compliant and competitive proposal.

Form / Attachment / Pricing Sheet

This document provides "Additional Technical Proposal Instructions" for the "Development of Radiological/Nuclear Medical Countermeasures (MCMs) and Biodosimetry Devices" Broad Agency Announcement (BAA) 75N93026R00004. It is intended to guide offerors in formatting and preparing their Technical Proposals, supplementing the generic instructions found in Section L of the BAA.

• Technical Proposal Structure: Details the required sections for the technical proposal, including a Title Page, Technical Proposal Overview, Statement of Work (SOW) format, Technical Discussions, Scientific and Technical Personnel, Project Management, Facilities/Equipment/Resources, and Other Considerations.
• Statement of Work (SOW) Format: Outlines the required components of the SOW, including Scope and Technical Requirements, with specific guidance on product development plans, regulatory compliance, quality control, and communication.
• Personnel Requirements: Specifies the need to detail the experience, qualifications, and level of effort for the Principal Investigator and other key scientific and technical personnel.
• Project Management: Requires a comprehensive Project Management Plan, including staffing, management systems, and communication protocols.
• Resources: Mandates documentation of available facilities, equipment, and other resources, including safety and security procedures.
• Collaboration and Communication: Emphasizes collaboration with other contractors, participation in meetings (initiation, annual review, teleconferences, site visits), and communication with the FDA.

This document is crucial for bidders as it dictates the specific format, content, and structure required for their technical proposals. Adhering to these instructions is essential for a compliant and competitive submission. It highlights key areas of focus for the government, such as product development, regulatory pathways, personnel qualifications, project management, and resource allocation.

Form / Attachment / Pricing Sheet

This document, "ATTACHMENT 6: REPORTING REQUIREMENTS AND DELIVERABLES," outlines the specific technical reports and deliverables required under the contract for the "DEVELOPMENT OF RADIOLOGICAL/NUCLEAR MEDICAL COUNTERMEASURES (MCMS) AND BIODOSIMETRY DEVICES" (BAA 75N93026R00004). It details the types of reports, their content, submission frequency, and related processes.

• Technical Reports: Includes requirements for Monthly Progress Reports, Quarterly Progress Reports, Semi-Annual Progress Reports, and Annual Progress Reports. Each report type specifies its content, such as descriptions of activities, summation of previous reports, and results achieved.
• Final Report: A comprehensive summation of work performed and results obtained for the entire contract period, to be submitted by the last day of the contract performance period. A draft is required 30 days prior to the final delivery date, with a 15-day review period for comments.
• Summary of Salient Results: A brief summary (not exceeding 200 words) to be submitted with the Final Report.
• Other Reports: Mentions potential requirements for reports on Select Agents or Toxins, Human Subjects IRB Annual Report, Information Security, Source Code, Invention Reports, Dual Use Research of Concern, USDA-Designated Biobased Products, and other special reports that may be developed post-negotiation.
• Packaging, Marking, and Shipping: Special instructions will be provided in a separate attachment after proposal receipt and SOW finalization.
• Delivery Schedule: Delivery of other reports and deliverables will be proposed in the technical proposal and further developed after contract finalization.

This attachment is crucial for bidders to understand the ongoing reporting and deliverable obligations associated with the contract. It details the types of progress and final reports required, including specific content and submission timelines, which will impact the contractor's project management and resource allocation. Bidders must consider these requirements when developing their technical proposals and pricing.

Amendment / Modification

This amendment (Amendment One) to Solicitation BAA-75N93026R00004 provides:

• New versions of Attachment 6 (Reporting Requirements and Deliverables), Attachment 7 (Additional Technical Proposal Instructions), and Attachment 8 (Additional Business Instructions).

• Responses to questions from potential offerors.

• Attachments 6, 7, and 8 have been revised.

• The document clarifies questions regarding foreign eligibility, intellectual property, award instrument type, indirect cost rates, subcontracting, options structure, and proposal page limits.

• Specifically, Attachment 7 regarding "Options" has been revised to remove references to "Options 1-6 Extend the Term of the Contract" and "Options 7-41 Increase Level of Effort." Pricing is now only required for the Base Period, Option Period 1, and Option Period 2.

• The proposal due date and time remain unchanged (May 4, 2026, at 3:00 PM, Local Time).

• Offerors must acknowledge receipt of this amendment by identifying the amendment number and date on their proposal submission. Failure to do so may result in rejection.

Solicitation / RFP / RFQ

This solicitation, BAA-75N93026R00004, is for the "Development of Radiological/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices." The primary goals are to support the development of safe and effective MCMs to mitigate and/or treat normal tissue injuries arising from exposure to ionizing radiation, and to advance biodosimetry biomarkers and/or devices to inform triage and treatment strategies for use during a radiation public health emergency. Proposals must address only one goal; if both are intended, two separate proposals are required.

• Development of MCMs to mitigate/treat radiation injuries, with a focus on those efficacious 24 hours or later post-exposure. Lead MCM candidates must demonstrate clinical relevance, safety, and a defined Target Product Profile.

• Advancement of biodosimetry biomarkers or devices to assess radiation exposure levels and tissue injuries, with a focus on rapid, accurate, and sensitive assays/techniques. Point-of-care devices must distinguish between exposed and unexposed populations with a sample-to-answer time of 30 minutes or less. Definitive care devices must measure absorbed radiation exposure and tissue injury within 7 days post-exposure.

• Proposals must include plans for translational research and development, and potentially Investigational New Drug (IND) or Investigational Use Only (IUO) applications.

• Contract Type: Anticipated to be a multiple-year Cost-Reimbursement type Completion contract.

• Period of Performance: Base period TBD through TBD, with two (2) option periods.

• Estimated Cost: Base Period is TBD; Fixed Fee is TBD. Total estimated amount for Base Period is TBD.

• Awards: Anticipated 1-2 awards with a total planned set aside of $12 million over three years.

• Proposal Submission Deadline: May 4, 2026, by 3:00 PM Eastern Time.

• Proposal Validity: 120 days unless otherwise specified.

• Questions Deadline: March 3, 2026.

• Submission Instructions: Detailed in Attachment 1 (Packaging and Delivery of Proposals).

• Evaluation Criteria: Technical (50%), Scientific and Technical Personnel (20%), Project Management (15%), and Organizational Facilities, Equipment, and Other Resources (15%).

• Not set-aside for small business.

• NAICS Code: 541715

• Small Business Size Standard: 1,000 employees.

• Offerors must be registered in the System for Award Management (SAM).

• Key personnel are essential; any changes require Contracting Officer approval.

• Specific clauses regarding human subjects, animal welfare, data management, and ICT accessibility are incorporated.