Solicitation
Prototype development for Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination
Department of Defense · Defense Health Agency (DHA)
AI summaryThe Defense Health Agency (DHA) wants one company to develop a battlefield wound product: a physical barrier that releases antibacterial and/or antifungal agents, with Food and Drug Administration (FDA) approval or clearance. The award is a prototype Other Transaction agreement (pOTA, a flexible agreement outside the usual Federal Acquisition Regulation rules) for an estimated 54 months. The response due date is November 6, 2026, 12:00 PM Eastern, and the proposer must serve as the FDA sponsor. More in the summary
A newer version of this notice was posted Oct 19, 2026. It moves the due date from Oct 23, 2026 to Nov 6, 2026, which is the date shown on this page. See the latest version.
AI summary Beta
Summary of another version of this notice: check what changed on SAM.gov. This summary may miss requirements: 3 of 15 attachments weren't read (Attachment G1 - Cost Sheet Template.xlsx, Attachment G2 - Firm Fixed Price Sheet Template.xlsx and 1 more). Check the attachments on SAM.gov.
The Defense Health Agency (DHA) wants one company to develop a battlefield wound product: a physical barrier that releases antibacterial and/or antifungal agents, with Food and Drug Administration (FDA) approval or clearance. The award is a prototype Other Transaction agreement (pOTA, a flexible agreement outside the usual Federal Acquisition Regulation rules) for an estimated 54 months. The response due date is November 6, 2026, 12:00 PM Eastern, and the proposer must serve as the FDA sponsor.
Who can bid (5)
- Meet one of the statutory conditions for a prototype Other Transaction: a nontraditional defense contractor (NDC, a business without recent Department of Defense work under full cost accounting standards coverage; nearly all small businesses qualify) or nonprofit research institute takes a significant part, or every significant participant is a small business or NDC, or at least one third of the cost is paid by non-Government parties.
- Written confirmation that you will serve as the FDA sponsor for the effort, including the sponsor form FDA 1571.
- Active SAM.gov registration with a Unique Entity ID, kept active through performance; NAICS code 541715 must be listed in SAM.gov before award.
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- A completed Attachment F, Warranties and Representations.
- An accounting system that can track costs to individual agreements and follows Generally Accepted Accounting Principles, described in the proposal.
How to submit: Email in writing to Bryan Heickman (bryan.g.heickman.civ@health.mil) and Julie Burns (julia.l.burns3.civ@health.mil) at the Defense Health Agency Contracting Activity. What to include is under Full summary below. Check the solicitation's instructions on SAM.gov.
Things to watch (7)
From the version posted Oct 19, 2026.
- Serious: Must show nontraditional or small business participation, or cost share. Proposals that don't prove one of the statutory conditions are the main reason for elimination in the first screening.
- Serious: You must be the FDA sponsor and run human clinical trials. This is a 54-month development effort with clinical trials, regulatory filings and manufacturing controls, so you need clinical, regulatory and manufacturing capability, alone or with partners.
- Worth checking: FDA filing, not approval, is required inside the effort. The RPP says the final product must have FDA approval or clearance, while the statement of objectives says approval may not come during the effort but must be submitted before it ends.
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- Worth checking: Other Transaction terms, not a standard contract. You must return a red-lined copy of the draft agreement terms, and the Federal Acquisition Regulation does not apply except where the agreement says so.
- Worth checking: Liability insurance required. You must buy liability insurance that covers bodily injury, product and professional liability and trial medical expenses, which can be costly for a small firm.
- Worth checking: Approvals needed before blood-sample testing. Work with human or animal blood samples needs prior animal-care committee and Army research oversight approvals, which can add time.
- Minor: Response due date moved by Amendment 0002. Amendment 0002 moves the response due date to November 6, 2026, 12:00 PM Eastern from October 23, 2026, 12:00 PM Eastern in the original RPP.
Read from the notice and 12 attachments. 3 of 15 not read. Show which files.
- HT9427-26-R-E020-Amendment 0002-RPP for BWI-PT-Barrier (pOTA).pdf (read)
- HT9427-26-R-E020-RPP for BWI-PT-Barrier (pOTA).pdf (read)
- Attachment A - Statement of Objectives (SOO).pdf (read)
- Attachment H - Statement of Work Template (see Section 11).docx (read)
- Attachment B - Contract Data Requirements List (CDRL).pdf (read)
- Attachment C - Data Item Description (DID) DI-TCSP-82040 (REFERENCE ONLY).pdf (read)
- Attachment E - Draft Agreement Terms and Conditions.pdf (read)
- Attachment F - Warranties and Representatives.docx (read)
- Attachment I1 - Technology Readiness Level (TRL) for drug and biologics (REFERENCE ONLY).pdf (read)
- Attachment I2-Technology Readiness Level (TRL) for diagnostics and devices (REFERENCE ONLY).pdf (read)
- Attachment D2 - FDA Form 1571 Instructions (REFERENCE ONLY).pdf (read)
- Attachment D1 - FDA Form 1571.pdf (read)
- Attachment G1 - Cost Sheet Template.xlsx: not read (the AI doesn't read this file type yet): open it on SAM.gov
- Attachment G2 - Firm Fixed Price Sheet Template.xlsx: not read (the AI doesn't read this file type yet): open it on SAM.gov
- Attachment J - Offeror question form.xlsx: not read (the AI doesn't read this file type yet): open it on SAM.gov
Full summary
What they want
- Develop one Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination prototype: a wound barrier infused or impregnated with antibacterial and/or antifungal agents.
- Objective 1 (about 24 months): hold a kick-off meeting, give a spend plan, send monthly reports and an integrated master schedule, and finish the preclinical testing needed for an FDA investigational new drug or device exemption filing.
- Objective 2 (about 24 months): run adult clinical studies, write a regulatory strategy with a target product profile, set up manufacturing and quality controls, and prepare the FDA submission.
- Objective 3 (about 6 months): give the Government notice of the FDA approval or clearance response.
- Deliver up to fifty final design prototypes with instructions for use for operational test and evaluation.
- Meet the end-of-effort attributes: Technology Readiness Level (TRL, a 1-to-9 scale of technology maturity) 7 when filed with the FDA, shelf life of at least 12 months, prevents bacterial infection, and stays intact on the wound at least 24 hours.
- Copy the Government's Agreements Officer's Representative (AOR) on all FDA calls, meetings and correspondence, and get animal and human research oversight approvals before using blood samples.
- The Government expects the cleared product to be sold through the Defense Logistics Agency e-catalog, and may judge a follow-on production purchase after the prototype.
- Contract type
- Prototype Other Transaction agreement (pOTA) under 10 U.S.C. 4022; firm-fixed-price preferred, cost-plus-fixed-fee acceptable; incrementally funded
- Period of performance
- Estimated 54 months in all: Objective 1 about 24 months, Objective 2 about 24 months (Objectives 1 and 2 may overlap but not exceed 48 months together), Objective 3 about 6 months
- Place of performance
- Frederick, MD, USA (as SAM.gov gives it)
- Estimated value
- Not stated
- Offers due
- November 6, 2026, 12:00 PM Eastern
- How to submit
- Email in writing to Bryan Heickman (bryan.g.heickman.civ@health.mil) and Julie Burns (julia.l.burns3.civ@health.mil) at the Defense Health Agency Contracting Activity
What to include when you submit
- Organize the proposal in three volumes: Volume I Technical, Volume II Management, Volume III Administrative and Cost.
- Send written confirmation that you will serve as the FDA sponsor, including the Form FDA 1571 (Attachment D1).
- Fill out and submit Attachment F (Warranties and Representations) showing a nontraditional defense contractor, nonprofit research institution or cost-share role.
- Return a red-lined copy of the draft agreement terms and conditions (Attachment E).
- Fill out the cost sheet (Attachment G1) for cost-plus pricing or the price sheet (Attachment G2) for firm-fixed-price pricing.
- Fill in the statement of work template tasks (Attachment H).
- Give current indirect rates with your rate agreement if you have one; if you use the de minimis rate, propose up to 15%.
- Include signed letters of commitment for each subcontractor and consultant, and say which are named in the proposal.
- Describe how your accounting system meets the agreement's requirements, and give the cognizant Defense Contract Management Agency and Defense Contract Audit Agency contacts if you hold other federal contracts or grants.
- Describe your funding strategy and financial stability, and say whether liability insurance is in your indirect costs or billed separately.
- Disclose any proposal or award for the same or similar work, and any Small Business Innovation Research Phase I or II work this effort builds on, each in a separate attachment.
After award, you must have
- Liability insurance covering bodily injury or death, product and professional liability and protocol-driven medical expenses; the policy copy goes to the Government after award. From HT9427-26-R-E020-Amendment 0002-RPP for BWI-PT-Barrier (pOTA).pdf:
A copy of policy shall be provided to the government 30 days from award.
Not in the notice text
- Parts of the RPP and several attachments weren't read, including the proposal instructions, page limits and eligibility details in the middle of the RPP and Amendment 0002; check the full files on SAM.gov.
- Attachment G1 (cost sheet), Attachment G2 (firm-fixed-price sheet) and Attachment J (question form) are attached but not read.
- Attachment B, the Contract Data Requirements List, couldn't be read; check it on SAM.gov.
- The evaluation factors and their order of importance are not listed in the text read.
- The notice says another amendment will list offerors' questions and the Government's answers; that amendment is not in the text read.
- No budget, ceiling or price estimate is given; an incremental funding schedule will come at award.
- SAM.gov does not state a set-aside for this notice.
Eligibility and how to respond
- No set-aside: any business, large or small, can bid unless the notice says otherwise.
- How to submit, from the AI summary: Email in writing to Bryan Heickman (bryan.g.heickman.civ@health.mil) and Julie Burns (julia.l.burns3.civ@health.mil) at the Defense Health Agency Contracting Activity. Check it in the notice before you send anything.
Notice details
- Posted
- Sep 23, 2026
- Notice type
- Solicitation
- Office
- Defense Health Agency, Fort Detrick, MD
- Product/service code
- AN13 · Health R&D Services; Health Care Services; Experimental Development
- Business type
- Engineering, architecture & research (FedReady's grouping, from NAICS 541715)
- Versions
4 versions have been posted, newest first.
- Oct 19, 2026 · Amendment 0003Due Nov 6, 2026
- Oct 19, 2026 · Amendment 0002Due Nov 6, 2026 (changed)
- Sep 24, 2026 · Amendment 0001Due Oct 23, 2026
- Sep 23, 2026 · Solicitation (this version)Due Oct 23, 2026
- Attachments
Past awards and competition
Who has won work like this before, the likely incumbent, and what similar contracts paid, from USAspending.gov.
Before you respond
- How to respond to a solicitation (8 steps)
- How to read a government solicitation
- How to price a government contract
Terms on this notice: Solicitation
Full notice text from SAM.gov
This RPP is being issued by the Defense Health Agency Contracting Activity (DHACA), in support of the Defense Health Agency’s Portfolio Acquisition Executive (PAE) Medical Products (MP) Warfighter Protection (WPAC) & Acute Care Program Management Office (PMO) Care located in Frederick, Maryland at Fort Detrick. The Warfighter Protection and Acute Care Project Management Office (WPAC PMO) has a requirement for the development of a Barrier Combination product. The Barrier Combination product is defined as being composed of both a physical barrier to protect a wound and an antibacterial and/or antifungal activity released from the barrier to prevent the spread of organisms and avoid systemic infections. This RPP will result in one award to develop the Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination (BC) prototype product. The final product MUST be a combination wound treatment that includes a barrier component that is either infused or impregnated with antimicrobial and/or antifungal properties and have U.S. Food Drug Administration (FDA) approval (or clearance). The award, as a result of this RPP, will be awarded under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022. NOTE: Another amendment will be posted which will include Offeror questions and Government responses. (Amendment 0002 only extends the proposal due date).
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