HT942526CRRPTRA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Combat Readiness – Medical Research Program

Translational Research Award

Funding Opportunity Number: HT942526CRRPTRA

Pre-Application Due: August 17, 2026

Application Due: November 18, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Combat Readiness – Medical Translational Research 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 organization and Principal Investigator

Program Description Describes the program mission and intent of the Translational Research Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

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

Federal Award Notices Outlines what a successful applicant 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 rejection, modification, withdrawal and withhold

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

Appendix 2 Acronym List

Appendix 3 Technology Readiness Levels and Knowledge Readiness Levels

FY26 Combat Readiness – Medical Translational Research Award 3

Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant 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 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.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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

FY26 Combat Readiness – Medical Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Combat Readiness – Medical Research Program (CRRP) Translational Research Award (TRA) supports hypothesis-driven innovative, high-impact translational research that will accelerate the movement of promising ideas and/or technologies in trauma care into solutions to maximize casualty survivability, improve patient care closer to the point of injury and/or trauma care guidelines. Preliminary data are required.

Research using well-validated animal models is allowed.

Distinctive Features:

• **NEW for FY26** An investigator may be named as the Principal Investigator (PI) on only one FY26 CRRP TRA application.

• Research supported by the FY26 CRRP TRA must represent a mature, translational research effort with a minimum biomedical technology readiness level (TRL) of 4 or knowledge readiness level (KRL) of 4.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.37M to fund approximately three Translational Research Award applications with total cost caps of $2.45M per award, of which $1.45M of FY26 funds will be used for a base award. A $1.00M optional research effort (Option Phase) may be funded with future funds, if appropriated. The maximum period of performance is 2 years for the base award, with an optional research effort of 1 year. 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

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 17, 2026

• Invitation to Submit an Application: October 14, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 18, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 23, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526CRRPTRA

Assistance Listing Number: 12.420

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2. Eligibility Information

2.1. Eligible Applicants

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.

2.1.2. Principal Investigator

Independent investigators at all career levels affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named on only one FY26 CRRP application as a PI.

Individuals in a mentored position (e.g., postdoctoral fellows, clinical fellows) are not considered independent investigators.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications 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 Combat Readiness – Medical Research Program (CRRP). 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 CRRP in 2019 to focus on the medical needs of the Warfighter on the battlefield, with a focus on addressing life-threatening injuries closer to the point of injury. Appropriations for the CRRP from FY19 through FY24 totaled $55 million (M).

The FY26 appropriation is $5M.

The CRRP vision is to increase survivability and readiness of the Warfighter. The program seeks to develop innovative high-impact solutions to increase medical readiness; triage, diagnose and treat life-threatening injuries; reduce morbidity and mortality; and promote positive long-term outcomes for the Warfighter. While the CRRP considers medical priorities that contribute to Warfighter readiness, innovations developed by CRRP-supported research may be applied proactively to enhance medical readiness ahead of deployment, in operational settings at the point of injury, during periods of prolonged care, or during transport/en route between roles of care. These solutions will not only help to minimize the morbidity and mortality of combat-related injuries sustained by the Warfighter but will often translate to civilian care.

A 2009 DOW mandate established a policy that Warfighters should be provided with lifesaving care within 60 minutes of injury, a time span that is referred to as the “golden hour.” Achieving this metric is supported through increased infrastructure enabling rapid transportation of battlefield casualties from the point of injury to forward surgical teams (Role of Care, Role 2) and combat support hospitals (Role 3), where medical assets and damage control capabilities could rapidly provide lifesaving treatment. Future combat scenarios may involve peer or near-peer adversaries in large-scale combat operations where evacuation capabilities are delayed or unavailable. Recent global military operations reflect combat operations in varied environments where medical and casualty care support is dispersed and sometimes isolated under difficult conditions (e.g., dense urban, subterranean, maritime, high-altitude, dust storm and extreme environments). When access to highly skilled providers under such conditions may be limited, the time-specific window of the golden hour may not be feasible. Therefore, it is essential to bring effective and efficient life-saving capabilities closer to the point of injury and sustain prolonged care (greater than 72 hours) where necessary. Innovations in technology and knowledge are critical to ensure front line provider skills sustainment to support rapid response in future operations. Advancement of clinical decision support tools and other automated technologies may support continued Force readiness and availability in combat environments and assist Warfighters in providing additional life-saving care where clinical capabilities are limited or non-existent. Casualty care must address not only the scope of these challenges, but also the scale of casualties projected. Mass casualty events that overwhelm immediately available medical capabilities, to include personnel, supplies, and/or equipment, present a significant obstacle to providing damage control interventions closer to the point of need.

3.1. FY26 CRRP Focus Areas

The program priorities described in past congressional intent for the CRRP are aligned to distinct focus areas that describe medical priorities to improve readiness and to deliver frontline care in combat situations. For FY26, the CRRP streamlined program research priorities into

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FY26 Combat Readiness – Medical Translational Research Award 7 three key focus areas aligned to distinct themes of medical readiness for the Warfighter.

Research supported by the FY26 CRRP must address at least one of the program focus areas listed below. Selection of the appropriate FY26 CRRP Focus Area is the responsibility of the applicant.

• Battlefield diagnostics, triage and decision aid tools: Solutions to enhance identification and management of trauma in point of injury, austere resuscitative and surgical care, prolonged casualty care and en route care environments

• Treatments: Solutions to enhance delivery of care in point of injury, austere resuscitative and surgical care, prolonged casualty care and en route care environments

• Battlefield readiness: Solutions to address readiness with a focus on prehospital and operational environments

3.2. Award History

The CRRP Translational Research Award mechanism was first offered in FY23. Since then, 135 Translational Research Award applications were received, and seven were recommended for funding.

3.3. Intent of the Translational Research Award

The FY26 CRRP TRA intends to support mature high-impact translational research that will accelerate innovative ideas into clinical applications, including health care products, technologies and/or practice guidelines. Research funded under this award mechanism will be hypothesis-driven, high-impact applied research that is relevant to Service Members, with the potential for benefit among Veterans, military beneficiaries and the American public.

Submissions that propose solutions to advance civilian trauma care are not precluded. Trauma care in complex and austere environments is not unique to military contexts. Civilian emergency medical care provided in rural settings or during natural disasters, public health crises and mass-casualty events draws on lessons learned in battlefield medicine. Solutions addressing medical challenges during combat operations have potential for integration into civilian-based practices to address health security threats and support a goal of zero preventable deaths, regardless of environment. The CRRP expects the innovative approaches and technologies developed with CRRP funding to improve survivability of injuries sustained in both combat and civilian settings.

Allowable Research: Applications to the FY26 CRRP TRA may include preclinical or clinical research. Proposal of animal studies is not a required element of this mechanism, but applications including animal studies must demonstrate the animal model is relevant and well-validated.

The FY26 CRRP TRA may support a small scale, pilot clinical trial only during an optional research effort (Option Phase). Applications that include a pilot clinical trial require additional submission requirements and review criteria.

Applicants are encouraged to leverage existing resources in translational research to address essential research ideas or unmet needs to enable the delivery of life-saving care to the Warfighter during prolonged and en route care in austere and combat environments. For this award mechanism, the definition of “leveraging” is as follows: an investigator basing a research project on existing resources in order to amplify potential gains in knowledge or accelerate technical maturity. Research of interest may include knowledge products, https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=Clinical%20Research%3A,-For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=Clinical%20Research%3A,-For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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FY26 Combat Readiness – Medical Translational Research Award 8

“knowledge resulting from research with the potential to improve individual or public health,”1 and solutions that can accelerate the introduction of military-relevant health products or technologies into clinical and/or operational use. Projects should take into consideration the varied expertise levels of targeted medical providers, available resources and the possible diverse environmental conditions in combat situations. Application submissions are encouraged to include characteristics relevant to military use in the prehospital, combat operational setting.

3.3.1. Key Elements for the TRA

Impact and military relevance: Research supported by the TRA seeks to accelerate translational research relevant to military trauma care closer to the point of injury and/or clinical implementation. Applications must clearly demonstrate innovative qualities that will lead to translation of advances for medical readiness and life-saving care for the Warfighter aligned to at least one of the FY26 CRRP Focus Areas.

Preliminary data: Applications must include preliminary data relevant to the proposed study.

Proposed research must clearly demonstrate a sound scientific approach based on the preliminary data and relevant scientific literature.

Research maturity: Research supported by the FY26 CRRP TRA must represent mature, translational research effort with a minimum biomedical TRL of 4 or KRL of 4. See Appendix 3 for more details.

3.3.2. Other Important Considerations for the TRA

Applications that consist of foundational research or a clinical trial during initial base award period of performance, or an advanced clinical trial in the Option Phase are not supported by the FY26 CRRP.

Funding from the FY26 CRRP may not be used to support studies requiring an exception from informed consent (EFIC).

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.

If the proposed research relies on access to unique resources, databases or populations, the application must describe access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research

1Charles C. Engel, Richard Silberglitt, Brain G. Chow, et al., "Development of a Knowledge Readiness Level Framework for Medical Research," 2019. Santa Monica, CA: RAND Corporation, RR-2127-OSD.

https://www.rand.org/pubs/research_reports/RR2127.html.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://www.rand.org/pubs/research_reports/RR2127.html

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FY26 Combat Readiness – Medical Translational Research Award 9 relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

3.4. Funding Instrument

The funding instrument for awards made under the program announcement will be assistance agreements. 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 to include but not limited to making recommendations for exercise of the Option Phase efforts based on: (a) overall study progress, including sufficient patient and/or data accrual; and/or (b) maintenance of a high quality of research.

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

3.5. Funding Details

3.5.1. Application Submissions to the CRRP TRA (no Option Phase)

Period of Performance: The maximum period of performance is 2 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.45M.

3.5.2. Application Submissions to the CRRP TRA With Option Phase

The CRRP TRA with Option Phase may be funded in two phases over the maximum period of performance listed below. Each phase must be a distinct but related research effort with a non-overlapping period of performance, research outcomes/milestones and budget. The Option Phase must clearly represent a follow-on effort stemming from the work completed during the base CRRP TRA. Research products from the CRRP TRA shall be leveraged in the subsequent Option Phase.

Period of Performance: The maximum period of performance for awards with an option phase is 3 years.

The first phase of performance of the CRRP TRA will be no greater than 2 years (base award).

The Option Phase will be no greater than 1 year, maximum of 3 years in total (base award plus Option Phase).

Cost Cap: The application’s total costs budgeted for the entire period of performance, including option period, should not exceed $2.45M.

The total costs budgeted for the first phase should not exceed $1.45M. Total costs budgeted for Option Phase year should not exceed $1.00M.

Awards funded under this mechanism may propose a base award, with a potential Option Phase (not required) to be considered for funding with a future appropriation, if available.

Applicants are required to select the appropriate funding option when applying.

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There is no guarantee of future appropriations for this program or that funds will be available in future years to implement the Option Phase of this award. The budget for the first phase should correspond to Budget Period 1 and 2 on the Research and Related Budget Attachment Form. The Option Phase should correspond to Budget Period 3 on the Research & Related Budget Attachment Form. The Budget Justification should clearly separate the first phase from the Option Phase and provide discrete totals for each phase.

Exercise of the Option Phase is contingent on the availability of sufficient future congressional appropriations to the CRRP, alignment of the proposed research during the Option Phase to that fiscal year’s congressional language, acceptable performance under the base award (first phase) by the recipients and relevance to current program priorities. Evaluation of progress against the Statement of Work (SOW) will be conducted during a virtual milestone review meeting to be conducted on or about Month 18 of the period of performance.

3.5.3. For Both Options Within This Mechanism

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 may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 2 years for the CRRP TRA and 3 years for the CRRP TRA with Option Phase.

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

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 a DOW-sponsored meeting (e.g., Military Health Systems Research Symposium) in Year 2 of the award. These travel costs are in addition to those allowed for annual scientific/technical meetings.

May be requested for (not all-inclusive):

• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving and resources/equipment to enable participation).

• Special purpose equipment.

• Costs for one investigator to travel to one scientific/technical meeting per year in addition to the required meeting described above. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 CRRP

TRA.

Must not be requested for:

• Costs for travel to scientific/technical meetings beyond the limits stated above.

• Equipment (general).

• Tuition.

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

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

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

4.2. Pre-Application Components

Pre-application 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 GAI.

• Preproposal Narrative: Provide responses in the appropriate data fields for the following:

○ Identify and explain how the proposed work will address at least one FY26 CRRP Focus Area. (750-character limit)

○ State the project’s hypotheses, objectives and specific aims, and briefly describe the experimental approach. Describe the maturity of approach, to include technology and/or knowledge readiness level. (2,000-character limit)

○ Concisely state the scientific rationale on which the proposed work is based. Describe relevant preliminary data to support the approach. If the work includes animal research, briefly describe which well-validated animal model will be used in the work. (1,000-character limit)

○ How will the proposed research lead to a major advancement for the focus area. Identify how the proposed work will address specific challenges encountered in priority environments identified by the DOW, i.e., frontline, prolonged and/or enroute care in austere and combat environments. (1,000-character limit)

○ Is the proposed research translational? How will the proposed work lead to translation of advances for improving medical readiness, mitigating fatalities and/or optimally treating life-threatening injuries. How well the proposed work promotes positive long-term outcomes for military health and medicine, as well as the general product. (1,000-character limit)

○ For CRRP TRA with Option Phase including a clinical trial: Will the proposed research include a clinical trial? If yes, briefly state the intervention, subject population(s) and how the trial meets the definition of a small-scale or pilot clinical trial. (750-character limit) https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ Additional information that the PI can use, at their discretion to provide supporting data, rationale and/or references for the pre-application (one page limit): References (including URLs if available) should be provided 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).

○ Key Personnel (one page limit): Provide a list of the PI and key personnel. Briefly describe roles, qualifications and expertise relevant to execution of the research project.

4.3. Full Application Components

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

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

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

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

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

Describe the proposed project in detail using one of the two outlines below, depending on whether or not a pilot clinical trial is included in the proposed research.

Outline for projects without a small-scale or pilot clinical trial:

– Background: Describe the problem, question, or knowledge gap related to at least one of the FY26 CRRP Focus Areas to be addressed by the proposed project.

Present the current state of the field and scientific rationale on which the proposed work is based. Describe the current state of the science, preliminary studies and/or preclinical data that supports the proposed research. These data may be unpublished or from the published literature. Describe any existing resources that the proposed project will leverage. If the project is part of a larger study, articulate the information that establishes a framework for this study. The application must demonstrate logical reasoning and provide a sound scientific rationale for the proposed project. Throughout the Project Narrative, describe how the proposed research is translational and has the potential for broadly applicable, cross-cutting advances that benefit military health and medicine as well as the general public.

– Hypothesis/Specific Aims/Hypotheses: State the hypothesis to be tested and/or the objective to be reached. Detail the project’s specific aims that will address the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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

FY26 Combat Readiness – Medical Translational Research Award 13 hypothesis and/or research objective. If the proposed work is part of a larger study, present only aims that this CRRP award would fund.

– For applications to the CRRP TRA with Option Phase: Each phase should reflect a distinct (i.e., severable) research effort with a non-overlapping period of performance and research outcomes/milestones. Clearly demonstrate how the Option Phase follows on from the CRRP TRA.

– Study Design and Feasibility: Describe the experimental design, methods and analyses, including appropriate controls, in sufficient detail for evaluation. Explain how the research strategy will meet the project’s goals and milestones within the proposed period(s) of performance. Provide a well-developed, well-integrated research strategy that supports the translational feasibility and promise of the approach. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ 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, is a well-validated animal model and how it is optimal for addressing the study aims and facilitates translation of solutions for the Warfighter. Describe how animal research will be conducted in accordance with appropriate preclinical research guidelines. Further details of research involving animals will be required in Attachment 8: Animal Research Plan, as applicable.

▪ Describe the data collection instruments (e.g., research questionnaires, assays, assessment measures) that will be used, and to what degree they are appropriate to support the proposed study. Define the specific study outcomes/endpoints and how they will be measured. Address potential problem areas and present alternative methods and approaches.

▪ If applicable, describe resources available for the development of sufficient quantities of critical reagents under Good Manufacturing Practice (GMP).

▪ If human subjects will be used, briefly describe the study population and include a detailed plan for the recruitment of human subjects. Further details of clinical research components will be required in Attachment 7: Human Subject Recruitment and Safety Procedures for Clinical Research, as applicable.

▪ If human-derived biological specimens or data 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).

▪ Provide information on the availability of, and access to, sufficient subjects to meet accrual goals for clinical studies. Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial and ethnic group, and an accompanying rationale for the selection of subjects. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of the application’s Supporting Documentation (Public Health Service [PHS] Inclusion Attachment in Attachment 2).

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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

FY26 Combat Readiness – Medical Translational Research Award 14

▪ 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 GAI, Appendix 4, for additional considerations.

– Statistical model and data analysis plan: Clearly describe the statistical model and data analysis plan with respect to the study objectives. Demonstrate the proposed research is designed to achieve reproducible and rigorous results. If applicable, include power analysis calculations. If applicable, describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA), or international regulatory agency. This is not the National Institutes of Health (NIH) Data Management and Sharing Plan. Further information describing the strategy for how sex will be considered as a biological variable will be requested in Attachment 2.

– Research Team: Describe how the background and expertise of the PI and other key personnel demonstrate their understanding of working in military populations or relevant trauma environments. Describe whether the composition of the research or study team is appropriate and complementary. If prospective clinical studies are included, the PI or research team must demonstrate appropriate expertise in conducting clinical studies.

Outline for projects with a small-scale or pilot clinical trial (CRRP TRA with Option Phase only):

– Background: Describe the problem, question or knowledge gap related to at least one of the FY26 CRRP Focus Areas to be addressed by the proposed project.

Present the current state of the field and scientific rationale on which the proposed work is based. Describe the current state of the science, preliminary studies and/or preclinical data that supports the proposed research. These data may be unpublished or from the published literature. Describe any existing resources that the proposed project will leverage. If the project is part of a larger study, articulate the information that establishes a framework for this study. The proposal/application must demonstrate logical reasoning and provide a sound scientific rationale for the proposed project. Throughout the Project Narrative, describe how the proposed research is translational and has the potential for broadly applicable, cross-cutting advances that benefit military health and medicine as well as the general public.

– Hypothesis/Specific Aims/Hypotheses: State the hypothesis to be tested and/or the objective to be reached. Detail the project’s specific aims that will address the hypothesis and/or research objective. If the proposed work is part of a larger study, present only aims that this CRRP award would fund.

For applications to the CRRP TRA with Option Phase: Each phase should reflect a distinct (i.e., severable) research effort with a non-overlapping period of performance and research outcomes/milestones. Clearly demonstrate how the Option follows on from the CRRP TRA.

– Study Design and Feasibility: Describe the experimental design, methods and analyses, including appropriate controls, in sufficient detail for evaluation. Explain how the research strategy will meet the project’s goals and milestones within the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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

FY26 Combat Readiness – Medical Translational Research Award 15 proposed period(s) of performance. Provide a well-developed, well-integrated research strategy that supports the translational feasibility and promise of the approach. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ 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, is a well-validated animal model and how it is optimal for addressing the study aims and facilitates translation of solutions for the Warfighter. Describe how animal research will be conducted in accordance with appropriate preclinical research guidelines. Further details of research involving animals will be required in Attachment 8: Animal Research Plan, as applicable.

▪ For clinical trials, describe the rationale for the proposed clinical trial during the Option Phase. Identify the intervention, technology, or approach to be investigated. Describe the clinical trial approach and outline the proposed methodology in sufficient detail to show a clear course of action. Demonstrate the availability of the intervention, technology or approach, including Investigational New Drug/Investigational Device Exemption (IND/IDE) status (or other relevant Regulatory Agency approvals), as applicable. Provide detailed plans for initiating the clinical study, including FDA IND/IDE application submission plans before Month 18 of the period of performance, if applicable.

Regulatory documentation should be provided as part of the application’s Supporting Documentation (Attachment 2). Indicate who holds the intellectual property rights for conduct of the study, if applicable. Describe how the study addresses clinical needs and how it compares with what is currently available and/or standards of care. Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, if applicable.

▪ Describe the data collection instruments (e.g., research questionnaires, assays, assessment measures) that will be used, and to what degree they are appropriate to support the proposed study. Define the specific study outcomes/endpoints and how they will be measured. Address potential problem areas and present alternative methods and approaches.

▪ If applicable, describe resources available for the development of sufficient quantities of critical reagents under GMP.

▪ If human subjects will be used, briefly describe the study population and include a detailed plan for the recruitment of human subjects. Further details of clinical research components will be required in in Attachment 7: Human Subject Recruitment and Safety Procedures for Clinical Research, as applicable.

▪ If human-derived biological specimens or data 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).

▪ Provide information on the availability of, and access to, sufficient subjects to meet accrual goals for clinical studies. Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements

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

FY26 Combat Readiness – Medical Translational Research Award 16 description of the composition of the proposed study population in terms of sex, racial and ethnic group, and an accompanying rationale for the selection of subjects. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of the application’s Supporting Documentation (PHS Inclusion Attachment in Attachment 2).

▪ 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 GAI, Appendix 4, for additional considerations.

▪ If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source of prior funding. Specifically, identify the portions of the study that would be supported with funds from this award.

– Statistical model and data analysis plan: Clearly describe the statistical model and data analysis plan with respect to the study objectives. Demonstrate the proposed research is designed to achieve reproducible and rigorous results. If applicable, include power analysis calculations. If applicable, describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, or international regulatory agency. This is not the NIH Data Management and Sharing Plan. Further information describing the strategy for how sex will be considered as a biological variable will be requested in Attachment 2.

– Research Team: Describe how the background and expertise of the…