HT942526MBRPTTDA_GG.pdf

This broad agency announcement must be read in conjunction with the General Submission Instructions, version CD26_01.

Broad Agency Announcement for the Defense Health Agency

Military Burn Research Program

Technology/Therapeutic Development Award

Funding Opportunity Number: HT942526MBRPTTDA

Preapplication/Preproposal Due: July 7, 2026

Application/Proposal Due: October 21, 2026

FY26 Military Burn Technology/Therapeutic Development Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant/offeror organization and Principal Investigator

Program Description Describes the program mission and intent of the Technology/Therapeutic Development Award; provides key award information and considerations; and outlines funding details

Application/Proposal Contents Presents the two-step application/proposal process and instructions for preparing a preapplication/preproposal and full application/proposal

Submission Requirements Provides locations for application/proposal packages, instructions for submitting preapplications/preproposals and full applications/proposals, and describes application/proposal verification

Review Information Outlines the processes for compliance review, preapplication/preproposal and full application/proposal selection/notification, and risk assessment. Also, details the review criteria for preapplication/preproposal screening and both tiers of the CDMRP review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant/offeror can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application/proposal rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application/proposal components to facilitate submission

Appendix 2 Acronym List

Appendix 3 Technology Readiness Levels and Knowledge Readiness Levels

FY26 Military Burn Technology/Therapeutic Development Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application/proposal submission. User registration for each of these websites can take several weeks or longer. Each applicant/offeror must ensure their registrations are active and up to date prior to application/proposal preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application/proposal materials. It is the responsibility of the applicant/offeror to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application/proposal process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to preapplication/proposal or intramural full application/proposal submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov

Section Shortcuts Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements

Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Military Burn Research Program (MBRP) Technology/Therapeutic Development Award (TTDA) is a burn-focused, product-driven award mechanism intended to provide support for the translation of promising preclinical findings into burn products for clinical application in an austere, resource-limited, distributed operational environment.

Distinctive Features: The technology or therapeutic product(s) to be developed must be product-oriented (e.g., medical device, drug, or clinical practice guidelines involving a therapeutic or technology). The product(s) to be developed may be tangible or knowledge supporting the development of a tangible product and must address one or more of the FY26 MBRP TTDA focus areas. Knowledge products are allowable, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-tangible, non-materiel product that results from research with the potential to improve individual or public health.)

• New for FY26: The FY26 MBRP TTDA offers a Mentorship Option at a higher funding level to support a synergistic relationship between an experienced researcher (Mentor) and one to two junior researchers (Mentees). The dual purpose of this award is to fund a primary research study addressing a critical gap in combat burn care while simultaneously fostering the development of the next generation of military burn research leaders.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $5M to fund approximately three TTDA applications/proposals with total cost caps of $1.6M for the Single PI or $1.8M for the TTDA Mentorship Option. The maximum period of performance is 3 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Preapplication/Preproposal (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 7, 2026

• Invitation to Submit an Application/Proposal: August 26, 2026

• Application/Proposal Submission Deadline: 11:59 p.m. ET, October 21, 2026

• End of Application/Proposal Verification Period: 5:00 p.m. ET, October 28, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526MBRPTTDA

Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements

Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 5

2. Eligibility Information

2.1. Eligible Applicants/Offerors

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

Extramural Organization: A foreign or domestic non-DOW organization. Examples of extramural organizations include, but are not limited to, academic institutions, biotechnology companies, foundations, federal government organizations other than the DOW (i.e., intragovernmental organizations) and research institutes.

Intramural DOW Organization: A subset of intragovernmental organizations; refers specifically to DOW organizations, including DOW laboratories, DOW military treatment facilities and/or DOW activities embedded within a civilian medical center.

In accordance with Department of Defense Instruction (DoDI) 5000.77 and FAR 35.4, Federally Funded Research and Development Centers (FFRDCs) are not eligible to directly receive awards under this Broad Agency Announcement (BAA). However, teaming arrangements between FFRDCs and eligible organizations are allowed as long as they are permitted under the sponsoring agreement between the federal government and the specific FFRDC.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application/proposal, regardless of ethnicity, nationality or citizenship status.

There are no limitations on the number of applications/proposals for which an investigator may be named as a PI.

Mentorship Option: Applications naming clinical or post-doctoral fellows as Mentees are encouraged. A Mentorship Plan (Attachment 9) is required for all applicants selecting the Mentorship Option at the full application stage.

• Principal Investigator (Mentor): Independent investigators affiliated with an eligible organization who demonstrate a record of research success in a burn-relevant field are eligible to be named PI.

• Mentee(s): Must be a clinical fellow or post-doctoral fellow (or junior researcher as determined by their organization) within five years of terminal degree completion. The Mentee(s) must commit a significant level of effort (e.g., at least 50%) to the proposed research project. The application must include a signed Letter of Support from the institution for the Mentor/Mentee relationship.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement for contracts or assistance agreements but may exist if Research Other Transaction (OT) or prototype OT is the selected funding instrument.

Cost-sharing requirements for OTs are stated in 10 USC 4021 for Research OTs and 10 USC 4022 for Prototype OTs.

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements

Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 6

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the General Submission Instructions (GSI), Appendix 1, for additional awardee qualification requirements.

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 7

3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications/proposals to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Military Burn Research Program (MBRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the MBRP in 2011 to address the medical needs of traumatically burn-injured military Service Members. Appropriations for the MBRP from FY11 through FY25 totaled $130M. The FY26 appropriation is $10M.

Burn injuries sustained by military Service Members while in the line of duty, whether in the military operational battlespace or in a military training environment, represent a continuous health burden on both the injured Service Member and the DOW health care systems in which they receive care. Historically, burn injuries afflicted between 5% to 20% of casualties during post-World War II conflicts.1 In more recent conflicts, burn injury affected 9% to 10% of combat casualties,2,3,4 and 20% of those burn injuries are characterized as severe.4 While thermal burns represent the most common mechanism of burn injury, other mechanisms such as frostbite, high-voltage electrical, chemical, directed energy, and radiation/nuclear exposure represent additional formidable threats to the health and well-being of Service Members. Regardless of mechanism, combat-associated burn injuries are often devastating due, in part, to the high incidence of concomitant severe traumatic injuries. In addition, compared to burns sustained in a non-combat setting, combat burn injuries are more likely to progress to deep partial- or full-thickness burns, become infected, and lead to additional complications. The majority of combat burn injuries incurred during modern conflicts resulted from explosive device detonation, leading to a greater Injury Severity Score, an increase in inhalation injuries, and deeper, larger burns.3 Military planners anticipate that future conflicts will include more powerful weaponry than that seen in the past,5 likely resulting in a higher number of casualties with significant traumatic injuries and larger, more severe burns. Furthermore, compromised evacuation capabilities and interruptions to the medical supply chain could extend battlespace burn care from days to weeks, thereby increasing the risk of negative clinical outcomes. Accurate burn wound assessment and proper treatment of burn wounds and associated complications in a prolonged distributed operational care environment remain difficult. Burn researchers are challenged to innovate, develop, refine, and test novel burn therapies, technologies, and/or clinical guidelines that facilitate delivery of high-quality burn care in an austere, resource-limited, distributed operational environment for the improvement of both short- and long-term outcomes.

1David S. Kauvar et al, “Burn Hazards of the Deployed Environment in Wartime: Epidemiology of Noncombat Burns From Ongoing United States Military Operations,” Journal of the American College of Surgeons 209, no. 4 (2009):

453-60, https://doi.org/10.1016/j.jamcollsurg.2009.06.367.

2Sandra M. Escolas et al, “Postdischarge Cause-of-Death Analysis of Combat-Related Burn Patients,” Journal of Burn Care and Research: Official Publication of the American Burn Care Association 38, no. 1 (2015): e158-64, https://doi.org/10.1097/BCR.0000000000000319.

3David S. Kauver et al, “Comparison of Combat and Non-Combat Burns From Ongoing U.S. Military Operations,” The Journal of Surgical Research 132, no. 2 (2006): 195-200, https://doi.org/10.1016/j.jss.2006.02.043.

4Kevin K. Chung et al., “Evolution of Burn Resuscitation in Operation Iraqi Freedom,” Journal of Burn Care & Research 27, no. 5 (2006): 606-11, https://doi.org/10.1097/01.BCR.0000235466.57137.f2.

5“Global Trends 2040: The Future of the Battlefield,” Office of the Director of National Intelligence, National

Intelligence Council, last modified March 2021, https://www.dni.gov/index.php/gt2040-home/gt2040-deeper-looks/ future-of-the-battlefield.

https://doi.org/10.1016/j.jamcollsurg.2009.06.367 https://doi.org/10.1097/BCR.0000000000000319 https://doi.org/10.1016/j.jss.2006.02.043 https://doi.org/10.1097/01.BCR.0000235466.57137.f2 https://www.dni.gov/index.php/gt2040-home/gt2040-deeper-looks/future-of-the-battlefield https://www.dni.gov/index.php/gt2040-home/gt2040-deeper-looks/future-of-the-battlefield

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FY26 Military Burn Technology/Therapeutic Development Award 8

The MBRP seeks to fund research that enhances the ability of non-burn specialists to accurately assess burn severity, adequately treat burns, mitigate, and/or treat burn-associated complications, and prevent progression of burn depth in an austere, resource-limited, combat environment. Enhancing the ability to provide high-quality burn care within a resource-limited, distributed operational battle space is expected to shorten the time to recovery and improve the long-term physical and psychological health and well-being of burn-injured Service Members, with the potential for benefit among Veterans, military beneficiaries, and the American public.

Within this context, the MBRP is interested in research proposals that address specific gaps in the ability to care for combat burn casualties at or close to the point of injury, and in the early acute phase of care where evacuation delays are likely and medical resources are limited.

3.1. Award History

The MBRP first offered the Technology/Therapeutic Development Award (TTDA) mechanism in FY22. Since then, the MBRP has received 139 applications/proposals, and recommended 12 for funding.

3.2. Intent of the Technology/Therapeutic Development Award

The MBRP TTDA is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into burn products for clinical application in an austere, resource-limited, distributed operational environment, particularly within the pre-hospital, and/or early, acute phase of care.

The technology or therapeutic to be developed must be product-oriented (e.g., medical device, drug, or clinical practice guidelines involving a therapeutic or technology). The deliverable resulting from this research may be a tangible item, such as a medical device or pharmacologic agent (including, but not limited to, drugs or biologics), or it may be knowledge applicable to a technology or therapeutic under development. A “knowledge product” is a non-tangible, non-materiel product that results from research with the potential to improve individual or public health. A knowledge product is based on current evidence, aims to transition clinical practice standards, training, or tools into clinical practice, or supports materiel solutions [systems to develop, acquire, provide, and/or sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes. Tangible or knowledge products developed under the MBRP TTDA must address an identified need in one or more of the FY26 MBRP TTDA Focus Areas.

TTDA-Mentorship Option: The TTDA with Mentorship Option requires a single PI who will serve as the Mentor for one to two designated Mentees. The full application must name the Mentee(s) and detail a comprehensive Mentorship Plan. The proposed research should be of sufficient scope to support the progressive development of the Mentee’s knowledge, skills, and abilities in burn research.

The application/proposal must include a primary study and at least one pilot project, sub-study, or major task tailored to the development of the Mentee. The pilot project/sub-study/major task must complement the primary research aims and be completed by the Mentee(s) under the supervision of the Mentor.

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 9

3.2.1. Focus Areas for the TTDA

The proposed study, including the pilot/sub-study if selecting the Mentorship Option, must address at least one of the following focus areas:

• Development and/or validation of methods to triage, treat, and/or prevent complications of cold injury.

• Research to innovate best practices in the acute burn care continuum in a combat setting.

• Development and/or validation of methods for use in a combat setting to prevent, assess, and/or treat burn injury-related complications, including:

○ Over/under fluid resuscitation

○ Endotheliopathy

○ Sepsis

○ Inhalation injuries

○ Fungal infections

○ Hypermetabolism

• Interventions applied during the early, acute phase of burn injury that prevent or mitigate later development of chronic pain, neuropathy, pruritus and temperature dysregulation.

3.2.2. Key Elements for the TTDA

The following are important aspects of the FY26 MBRP TTDA:

Impact: The overall impact of the proposed research is a key component of this award mechanism. The application must clearly demonstrate the project’s potential to impact the care provided to burn casualties in an austere, resource-limited, distributed operational environment.

High-impact research will, if successful, lead to the development and translation of therapeutic or technologic advances such as detection, diagnosis, treatment, or burn complication prevention for clinical application in the care of combat burn-injured casualties at or close to the point of injury, or in the early acute phase of care within a prolonged field care combat environment.

Relevance to Military Health: Relevance to the care of burn-injured military Service Members in an austere, resource-limited, distributed operational battle space is a key feature of this award.

Preliminary Data: Proof-of-concept (in vivo or other well-established testing) AND a prototype/ preliminary version of the proposed product demonstrating its stated utility must be well-established at the time of preapplication/preproposal submission. Full applications/proposals must include relevant data that support the rationale for the proposed study. These data may be from published and/or unpublished literature.

Technology Readiness: At the time of preapplication/preproposal submission, the proposed product must have achieved a minimum technology readiness level (TRL) or knowledge readiness level (KRL) of 4 (Appendix 3).

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FY26 Military Burn Technology/Therapeutic Development Award 10

This award mechanism is intended to facilitate progression of a technology or therapeutic product beyond TRL 4. The proposed research must be supported by significant preliminary data. Examples of tasks that may be supported include, but are not limited to:

• Validation testing of new therapeutic or technologic modalities (e.g., agents, delivery systems, chemical modification of lead compounds, device testing and/or validation) using established preclinical systems/models.

• Designing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or technologies for use in advanced preclinical studies.

• Developing pharmacologic agents through absorption, distribution, metabolism, excretion and toxicity studies.

• Investigational New Drug-enabling or Investigational Device Exemption-enabling studies.

• Initiate scalable and reproducible manufacturing processes.

• Product design validation and verification testing to support regulatory submission at design freeze.

• Shelf Life/Product Stability studies.

Mentorship Option: Supports a synergistic relationship between an experienced researcher (Mentor) and one to two junior researchers (Mentees). The dual purpose of this award is to fund a primary research study addressing a critical gap in combat burn care while simultaneously fostering the development of the next generation of military burn research leaders.

Clinical trials and clinical research studies ARE NOT PERMITTED under this award mechanism. Enrollment of human subjects is NOT PERMITTED under this award mechanism. Projects involving limited use of de-identified and/or commercially available human cells or anatomical specimens are permitted, provided that the use of such specimens is necessary for device or product development and human subject consent is not required. Applicants/Offerors interested in proposing clinical research should consider submitting to the FY26 MBRP Patient-Centered Research Award mechanism

(HT942526MBRPPCRA).

3.2.3. Other Important Considerations for the TTDA

This BAA is issued under the provisions of the Competition in Contracting Act (CICA) of 1984 (Public Law 98-369), as implemented in Federal Acquisition Regulation (FAR) 6.101(b)(3) and

35.102 and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 35.102, projects funded under this BAA must be for basic or applied research, as well as that part of development not related to developing a specific system or hardware procurement.

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical research (including clinical trials) is not allowed within this funding opportunity.

A clinical trial is defined in the Code of Federal Regulations, Title 32, Part 219.102 (32 CFR 219.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. An https://www.ecfr.gov/current/title-32/subtitle-A/chapter-I/subchapter-M/part-219/section-219.102 https://www.ecfr.gov/current/title-32/subtitle-A/chapter-I/subchapter-M/part-219/section-219.102

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 11 intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

• Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

Research meeting this definition may include but is not limited to: (a) mechanisms of human disease; (b) diagnostic or detection studies (e.g., biomarker or imaging); (c) health disparity studies; and (d) development of new technologies.

• Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

• Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in ARRIVE 2.0 guidelines and in SC Landis et al., “A call for transparent reporting to optimize the predictive value of preclinical research,” Nature 490 (2012): 187-191, https://doi.org/10.1038/nature11556.

Applications (Proposals) from investigators within the DOW and applications/proposals involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are encouraged but not required.

These relationships can leverage knowledge, infrastructure and access to unique research resources, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application/proposal must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

3.3. Funding Instrument

The funding instrument for awards made under this BAA will be assistance agreements, contracts, or OTs. The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. The DHACA will also consider the use of OTs as a vehicle for award, in accordance with the conditions in 10 USC 4021 and 10 USC 4022.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104 https://arriveguidelines.org/arrive-guidelines https://doi.org/10.1038/nature11556

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FY26 Military Burn Technology/Therapeutic Development Award 12

An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of CDMRP during the project’s period of performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of CDMRP is anticipated, a grant will be made (31 USC 6304).

Conversely, if “substantial involvement” on the part of CDMRP is anticipated, a cooperative agreement will be made (31 USC 6305). Substantial involvement means that, after award, CDMRP staff will assist, guide, coordinate, or participate in project activities.

A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government (31 USC 6303).

An “OT” is utilized for certain awards when the government determines execution of the project requires flexibility (10 USC 4021 and 10 USC 4022). Such flexibility may allow for incorporation of dynamic commercial industry standards and best practices or adjustment of project scope to evolving requirements of government use cases.

The award type, along with the start date, will be determined during the negotiation process.

3.4. Funding Details

Period of Performance: The maximum period of performance is 3 years.

Cost Cap: The application/proposal’s total costs budgeted for the entire period of performance should not exceed $1.6M for the Single PI or $1.8M for the TTDA Mentorship Option. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant/offeror may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Mentees will be considered key personnel for purposes of prior approval.

Direct Cost Restrictions: For this award mechanism, direct costs:

Must be requested for:

• Travel Costs for the PI to present project information or disseminate project results at one DOW-sponsored meeting (e.g., Military Health System Research Symposium) in Year 2 or 3 of the period of performance.

• Mentorship Option Applicants Only: Travel costs for mentee(s) to attend one annual burn-relevant research meeting or DOW-sponsored meeting (e.g., Military Health System Research Symposium)

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Travel costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 MBRP TTDA. These travel costs are in addition to those allowed for a DOW-sponsored meeting.

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 13

Must not be requested for:

• Clinical trial or clinical research costs.

• Costs for travel to scientific/technical meeting(s) beyond the limits stated above.

• Tuition.

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FY26 Military Burn Technology/Therapeutic Development Award 14

4. Application/Proposal Contents and Format

4.1. Application/Proposal Overview

Application/proposal submission is a two-step process requiring both a preapplication/preproposal submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application/proposal submitted through eBRAP or Grants.gov.

Depending on the submission portal, certain aspects of the application/proposal will differ.

Intramural DOW organizations submitting a full application/proposal should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application/proposal must follow instructions for submission through Grants.gov.

4.2. Preapplication/Preproposal Components

Preapplication/preproposal submissions must include the following components.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GSI, Appendix 2.

• Preproposal Narrative (three-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the preapplication/ preproposal.

The Preproposal Narrative should include the following:

○ Research Idea: State the ideas and reasoning on which the proposed work is based.

State how the research addresses an important problem relevant to combat burn care in an austere, resource-limited, distributed operational environment. Describe the proposed product that will address an unmet need, and briefly elucidate how the product will advance combat burn care. Provide a description of the current TRL including product optimization information and initial demonstration of safety and efficacy in a relevant preclinical model (if applicable). Applicants are not required to provide general burn statistics or broad military burn epidemiologic information unless specifically relevant to the research proposed.

○ Research Strategy: State the hypothesis to be tested and/or the objective(s) to be reached. Briefly describe the preliminary findings that support the proposed study.

Provide a description of how proof-of-concept has been established.

○ Focus Area: Describe how the proposed project addresses at least one of the FY26 MBRP Focus Areas.

○ Impact: Describe the potential impact of the research, both short term and long term.

Describe how the proposed research will lead to the development and translation of a therapeutic or technologic advancement for clinical application in the care of combat burn-injured casualties at the point of injury or in the early acute phase of care within a prolonged combat care environment. Describe how the proposed project, if successful, https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements

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FY26 Military Burn Technology/Therapeutic Development Award 15 will represent an improvement over currently available diagnostics, treatments, interventions and/or standards of burn care.

○ Relevance to Military Health: Describe how the proposed product is expected to be relevant to combat burn care in an austere, resource-limited environment.

○ Mentorship Option: Indicate your intent to mentor up to two Mentees by including a brief description of your plan to foster a new generation of burn researchers. A full Mentorship Plan is not required at the preapplication/preproposal stage.

• Preapplication/Preproposal Supporting Documentation: The items to be included as supporting documentation for the preapplication/preproposal must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers, and publisher, as appropriate).

○ List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms, and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished. Refer to the GSI, Section IV.C. (i) for detailed information.

For Mentorship Option Applicants, Mentees are considered key personnel.

4.3. Full Application/Proposal Components

Applicants/Offerors must receive an invitation to submit a full application/proposal. Uninvited full application/proposal submissions will be rejected.

Each application/proposal submission must include the completed full application/proposal package for this BAA. See Appendix 1 for a checklist of the full application/proposal components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only): Refer to the GSI, Section IV.B.(a), for detailed information.

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during preapplication/preproposal submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application/proposal components must be uploaded as an individual file in the format specified and in accordance with the formatting listed in the GSI, Appendix 2.

○ Attachment 1: Project Narrative (15-page limit): Upload as “ProjectNarrative.pdf”.

The Project Narrative is the main body of the application/proposal. The page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application/proposal.

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FY26 Military Burn Technology/Therapeutic Development Award 16

Describe the proposed project in detail using the outline below.

– Background: Describe how the proposed research project addresses at least one of the FY26 MBRP Focus Areas. Describe the proposed product and how the product will advance combat burn care. Concisely state the scientific rationale for the primary study, and if applicable, for pilot projects/sub-studies/major tasks assigned to a Mentee (Mentorship Option only). Cite relevant literature. Describe previous experience most pertinent to the project. Include relevant preliminary data and/or promising preclinical findings that demonstrate proof of concept of the product or prototype/preliminary version of the product; these data may be from published or unpublished literature. Provide a description of the current TRL including product optimization information and initial demonstration of safety and efficacy in a relevant preclinical model (if applicable). State how the research addresses an important problem relevant to combat burn care in an austere, resource-limited, distributed operational environment. The background section should clearly support the choice of study variables and should explain the basis for the study questions and/or study hypotheses. This section should establish the relevance of the study and explain the applicability of the proposed research outcomes to the relevant populations.

– Hypothesis/Objectives: Clearly state the hypothesis to be tested (if applicable), a purpose statement and the objective(s) to be reached for the primary study.

– Specific Aims: Concisely explain the project’s specific aims. These aims should agree with the primary aims and associated tasks described in the Statement of Work (SOW). If the proposed work is part of a larger study, present only aims that this DOW award would fund.

– Research Strategy and Feasibility: Describe the proposed research strategy and feasibility of the approach, addressing the following:

▪ Describe the study design, methods, and analyses, including appropriate controls.

▪ Briefly describe the preliminary findings that support the proposed study.

▪ Define the specific study outcomes and how they will be measured.

▪ Explain how the study is designed to achieve reproducible and rigorous results, including (if applicable) controls, sample size estimation, power analysis, blinding, randomization and data handling.

▪ Address potential problems and present alternative methods and approaches.

▪ Describe data collection and handling, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, and the identification of primary endpoints/outcomes.

▪ Describe the statistical plan and the rationale for the statistical methodology, if applicable.

▪ If animal studies are proposed, briefly describe the key elements of the study/ studies as they relate to the overall project. Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives, and how it is optimal for addressing the study aims and facilitates rapid development and translation of solutions for the Warfighter. Describe how animal research will be conducted in accordance with the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments). Further details of research

Basic Information | Eligibility | Program Description | Application/Proposal Contents | Submission Requirements

Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Military Burn Technology/Therapeutic Development Award 17 involving animals will be required in Attachment 8, Animal Research Plan, as applicable.

▪ Describe the availability of and access to the necessary study resources. If human-derived biological specimens will be used, describe the sourcing and/or acquisition of samples. If human-derived specimens will be obtained from military Service Members, military Families and/or Veteran population(s) or dataset(s), describe the feasibility of accessing the samples/dataset(s). Clinical research (including Clinical Trials) is not allowed under the Technology/Therapeutic Development Award.

▪ If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the GSI, Appendix 4, for additional considerations.

▪ Describe how the research project will be completed within the proposed period of performance.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”. Begin each document on a new page. The Supporting Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures or drawings. These items should be included in the Project Narrative. Submitting material that is not requested may be viewed as an attempt to gain an unfair competitive advantage; such material will be removed, or the application/proposal may be administratively withdrawn. Letters of support not requested in the broad agency announcement, such as those from members of Congress, will be removed from the application/proposal package.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (one-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work, including support for engaging in a Mentor/Mentee relationship if selecting the

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FY26 Military Burn Technology/Therapeutic Development Award 18

Mentorship Option. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria, including an attestation that the PI possesses a record of research success in a burn-relevant field if selecting the Mentorship Option. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Letters of Collaboration (if applicable) (one-page limit per letter is recommended): Provide a signed letter from each collaborating individual and/or organization demonstrating that the PI has the support and resources necessary for the proposed work. If an investigator at an intramural DOW organization is named as a collaborator on a full application/proposal submitted through an extramural organization, the application/proposal must include a letter from the collaborator’s Commander or Commanding Officer at the intramural DOW organization authorizing the collaborator’s involvement. If selecting the Mentorship Option, provide a signed letter from the Mentee(s) stating the intent to engage in a Mentor/Mentee relationship for the proposed research.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Background and Proprietary Information: Provide a list of all background intellectual property to be used in the project or provide a statement that none will be used. All software and data first produced under this BAA are subject to a federal purpose license. Therefore, it is important to disclose/list any intellectual property (software, data, patents, etc.) that will be used in performance of the project. If applicable, all proprietary information to be provided to the government should be stated and identified; the applicant/offeror should indicate whether a waiver of the federal purpose license will be required. Additional information can be found in the 2 CFR 200.315, “Intangible Property.”

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work.