Battlefield Pain Management – Analgesic (HT942726RE009)
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The Defense Health Agency (DHA), through the Defense Health Agency Contracting Activity (DHACA), is seeking proposals to develop an FDA-approved, single-use analgesic product for battlefield use to treat moderate to severe acute pain. The product is intended for Tactical Combat Casualty Care (TCCC), Prolonged Casualty Care (PCC), casualty evacuation (CASEVAC/MEDEVAC), and all Roles of Care.
The Government expects to make no more than two prototype Other Transaction Authority (pOTA) awards under 10 U.S.C. 4022. A successfully completed prototype project may lead to a follow-on production contract or transaction.
Proposal deadline: 30 July 2026. Companies pursuing this opportunity should begin preparing immediately because the solicitation requires a comprehensive technical, management, regulatory, and cost proposal with extensive FDA development planning.
How much funding would I receive?
The solicitation does not specify:
Total program funding
Individual award value
Maximum or minimum award amount
The Government states only that it intends to make no more than two awards.
What could I use the funding for?
Funding is intended to support development of an FDA-approved, single-use analgesic product for battlefield use, including activities such as:
Non-clinical studies
Clinical studies and trials
FDA regulatory strategy and submission
Development activities compliant with:
21 CFR Part 58
21 CFR Part 11
Applicable FDA guidance documents
Manufacturing planning
Quality management
Commercial manufacturing planning
The objective is to obtain FDA approval for a rapid, single-dose analgesic indicated for moderate to severe acute pain that can be used in austere military environments.
Are there any additional benefits I would receive?
The solicitation states that:
A successfully completed prototype project may lead to a follow-on production contract or transaction under 10 U.S.C. 4022(f).
The product could ultimately be fielded as part of the Battlefield Pain Management Family of Systems and potentially become part of standard issue equipment for the Joint Force.
What is the timeline to apply and when would I receive funding?
The solicitation provides the following timeline:
Request issued: 29 June 2026
Questions due: 10 July 2026
Proposal deadline: 30 July 2026
The solicitation estimates an overall project period of performance of eight years, consisting of:
Objective 1: 3 years
Objective 2 (non-clinical studies): 2 years
Objective 3: 3 years
Funding is anticipated to be incremental, with the funding schedule provided after award.
The solicitation does not specify when awards will be made or when initial funding will be received.
Where does this funding come from?
Funding comes from:
Defense Health Agency (DHA)
Portfolio Acquisition Executive Medical Products (PAE MP)
Warfighter Protection and Acute Care Project Management Office (WPAC PMO)
The solicitation is administered by the:
Defense Health Agency Contracting Activity (DHACA)
Awards will be made using Prototype Other Transaction Authority (pOTA) under 10 U.S.C. 4022.
Who is eligible to apply?
To be eligible for award, a proposal must demonstrate at least one of the following:
At least one nontraditional defense contractor participates to a significant extent.
At least one nonprofit research institute participates to a significant extent.
All significant non-government participants are small businesses or nontraditional defense contractors.
At least one-third of total project costs are provided by non-federal sources.
Additional requirements include:
Prime awardees must maintain an active SAM registration.
Prime awardees must use their SAM Unique Entity Identifier (UEI).
NAICS Code 541714 must be listed in SAM prior to award.
Who is not eligible to apply?
Companies that fail to demonstrate one of the statutory eligibility conditions described above may be determined ineligible.
The Government also states proposals may be eliminated if they:
Fail preliminary screening
Do not comply with proposal instructions
Fail to demonstrate required nontraditional participation or cost sharing (when applicable)
The solicitation does not identify additional ineligible applicant categories.
What companies and projects are likely to win?
Based on the stated evaluation criteria, the most competitive proposals will demonstrate:
A strong technical approach for achieving FDA approval
Well-developed non-clinical and clinical development plans
A credible FDA regulatory strategy
Relevant FDA approval and commercialization experience
Strong project management
Realistic scheduling and risk management
Quality management systems
Commercial manufacturing planning
Realistic, reasonable, and complete cost proposals
Projects must clearly address the Government's objectives for developing a battlefield-ready, single-use analgesic product.
How competitive will this solicitation be?
The solicitation is expected to be highly competitive.
Indicators include:
No more than two awards are anticipated.
Proposals undergo technical, management, and cost evaluations.
Vendors must satisfy statutory OTA participation requirements.
Extensive FDA regulatory planning and commercialization planning are required.
The Government reserves the right to make no award depending on proposal quality and funding availability.
Are there any restrictions I should know about?
Key restrictions include:
Proposal must be submitted as three separate volumes:
Technical
Management
Administrative and Cost
Cost information may appear only in Volume III.
Technical proposals must include FDA regulatory strategy.
Project Management Plan must include:
Integrated Master Schedule
Risk Management Plan
Spend Plan
Quality Management Plan
Work Breakdown Structure
Microsoft Project schedule is required.
Searchable PDF submissions are required.
Files may not be password protected.
Files may not contain hyperlinks.
Labor escalation may not exceed 3% per year.
Foreign organizations or collaborators require additional justification.
Accounting systems must comply with GAAP for expenditure-based agreements.
Prime awardees must maintain active SAM registration throughout performance.
How long will it take me to prepare an application?
The solicitation does not specify an expected proposal preparation time.
However, the required submission includes:
Technical volume
Management volume
Administrative and Cost volume
FDA regulatory strategy
Statement of Work
Integrated Master Schedule
Project Management Plan
Commercial Manufacturing Sales Plan
Detailed cost proposal
Supporting documentation
Required certifications and representations
Preparing a compliant submission is likely to require significant coordination across technical, regulatory, manufacturing, management, and finance teams.
How can BW&CO help?
BW&CO can support applicants by helping develop a compliant proposal package, including:
Proposal strategy
Technical narrative development
Project management documentation
Regulatory strategy alignment
Cost proposal development
Compliance review
Proposal management through final submission