HT942526RTRPIIRA_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

Reconstructive Transplant Research Program

Investigator-Initiated Research Award

Funding Opportunity Number: HT942526RTRPIIRA

Pre-Application Due: October 21, 2026

Application Due: November 4, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Reconstructive Transplant Investigator-Initiated 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 Investigator-Initiated 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 location of 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

FY26 Reconstructive Transplant Investigator-Initiated 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 Reconstructive Transplant Investigator-Initiated Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Reconstructive Transplant Research Program (RTRP) Investigator-Initiated Research Award supports studies that have the potential to make an important contribution to reconstructive transplant research, patient care, and/or quality of life.

All projects must demonstrate solid scientific rationale with military-relevant utility. The Investigator-Initiated Research Award does not support clinical trials.

Distinctive Features:

• Scope: Applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, and clinical research in human subjects or human anatomical substances.

• Study Design and Feasibility: The study design should be rigorous and support maximal reproducibility and translational feasibility. A strong statistical plan with appropriate power analysis is important.

• Impact: Project results should have the potential for long- and short-term impact on the reconstructive transplant research field and/or patient community. Projects should address at least one of the FY26 RTRP Focus Areas.

• Preliminary Data: Preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed research must be included.

• Military Relevance: All projects must be responsive to the health care needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their Family members, caregivers, or clinicians, as well as the general public. Collaboration with military researchers and clinicians is encouraged but not required.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $8.0 million (M) to fund approximately eight Investigator-Initiated Research Award applications with total cost caps of $1.0M per award. The maximum period of performance is 3 years. It is anticipated that awards made from this fiscal year 2026 (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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), October 21, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 4, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 9, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526RTRPIIRA

Assistance Listing Number: 12.420 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 Reconstructive Transplant Investigator-Initiated Research Award 5

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 Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named on only two FY26 RTRP Investigator-Initiated Research Award applications as PI.

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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 6

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 Reconstructive Transplant Research Program (RTRP). 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 RTRP in 2012 to provide support for research of high potential impact and exceptional scientific merit to refine approaches for, and increase access to, reconstructive transplants and state-of-the-art immunotherapy. Appropriations for the RTRP from FY12 through FY24 totaled $153M. The FY26 appropriation is $12M.

The RTRP challenges the scientific community to design innovative research that will advance science and clinical practice of vascularized composite allotransplantation (VCA) to improve access, safety and quality of life for catastrophically injured Service Members, Veterans and the American public. VCA refers to the transplantation of multiple tissues such as muscle, bone, nerve and skin as a functional unit (e.g., a hand or face) from a deceased donor to a recipient with a severe injury. The ultimate goal is to return injured Service Members to duty and restore their quality of life.

3.1. Award History

The RTRP Investigator-Initiated Research Award mechanism was first offered in FY16. Since then, the program received 253 Investigator-Initiated Research Award applications and 43 were recommended for funding.

3.2. Intent of the Investigator-Initiated Research Award

The Investigator-Initiated Research Award is intended to support studies that have the potential to make an important contribution to reconstructive transplant research, patient care and/or quality of life. Though the RTRP Investigator-Initiated Research Award supports groundbreaking research, all projects must demonstrate solid scientific rationale with military-relevant utility.

Investigator-Initiated Research Award applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, and clinical research in human subjects or human anatomical substances, as well as correlative studies associated with an existing clinical trial.

The RTRP allows for the leveraging of novel findings from solid organ transplant research for testing in a VCA setting, so long as the rationale and benefits for doing so are appropriately explained and justified. For example, the proposed research should clearly explain why the anticipated result might be different in VCA, or why it is important to confirm that the result is the same in VCA, or why repeating the study in a VCA setting could lead to new mechanistic insights or a better understanding of the unique aspects of VCA.

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 7

3.2.1. Focus Areas the Investigator-Initiated Research Award

To meet the intent of the FY26 RTRP Investigator-Initiated Research Award mechanism, applicants must address at least one of the focus areas listed below with an accompanying sub bullet:

• Improve or optimize VCA immunosuppression

○ Define the unique targets and/or mechanisms of VCA immunogenicity and its regulation

○ Develop novel tolerogenic agents or approaches for VCA immunosuppression

○ Develop less toxic and/or personalized regimens for maintenance immunosuppression

• Identify and/or validate reliable prognostic or diagnostic biomarkers, methods, or tools for monitoring the specific needs of VCA graft rejection and immunosuppression

○ Identify and/or validate reliable biomarkers for predicting and monitoring acute and chronic VCA rejection in the clinic (i.e., human clinical samples)

○ Develop assays, devices or technology for clinical graft monitoring utilizing biomarkers;

proposed devices should consider human use factors unique to VCA recipients

○ Identify and/or validate reliable approaches to measuring and monitoring in vivo or clinical immunosuppression levels

• Advance VCA preservation strategies

○ Develop promising static preservation strategies, active perfusion modalities or other technologies for translation to the clinic

○ Develop mitigation strategies for preservation-mediated injury, including immune activation or ischemia reperfusion injury

• Develop tools for measuring VCA outcomes including

○ Performance (functional)-based

○ Patient-reported

○ Neurocognitive

3.2.2. Key Elements for the Investigator-Initiated Research Award

• Study Design and Feasibility: The proposed study design should be clearly described, rigorous, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, as applicable. If a model system is included in the research it should be appropriate for the study and applicable to VCA.

• Impact: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY26 RTRP Investigator-Initiated Research Award Focus Areas.

• Military Relevance: All projects must be responsive to the health care needs of military Service Members and/or Veterans recovering from catastrophic injury and/or their Family members, caregivers or clinicians, as well as the American public.

• Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients, or

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

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 8 anecdotal data. Preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed project must be included.

3.2.3. Other Important Considerations for the Investigator-Initiated Research Award

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 trials are not allowed within this funding opportunity.

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 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.

3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants (31

USC 6304).

3.4. Funding Details

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1M. 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 3 years.

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 one DOW-sponsored meeting (e.g., the Military Health System Research Symposium) during the period of performance. For planning purposes, it should be assumed that the meeting will be 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://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 9 held in the Central Florida area. For budgetary purposes, it should be assumed that this will occur in Year 2. The travel costs are in addition to those allowed for annual scientific/technical meetings.

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• 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 RTRP Investigator-Initiated Research Award.

Must not be requested for:

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

• Clinical trial costs.

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 10

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.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the FY26 RTRP Investigator-Initiated Research Award Focus Area under which the application will be submitted.

4.3. Full Application Components

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 (10-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Background/Rationale/Readiness: Describe the research problem, question, or knowledge gap related to at least one of the FY26 RTRP Investigator-Initiated Research Award Focus Areas to be addressed by the proposed research. Present the ideas and scientific rationale behind the proposed project and clearly demonstrate that there is sufficient evidence to support the proposed stage of research. If leveraging findings from solid organ transplant research for testing in a VCA setting, explain the rationale and benefits for doing so. If utilizing a model system, explain how the model is appropriate for the study and applicable to VCA.

Preliminary and/or published data that are relevant to reconstructive transplantation and support the rationale for the proposed research must be https://ebrap.org/eBRAP/public/index.htm 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#_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 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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FY26 Reconstructive Transplant Investigator-Initiated Research Award 11 included in the application. Describe how the previous experience of the PI and research team relates to the proposed research project.

Hypothesis and Objective: State the hypothesis to be tested and the objective(s) to be reached.

Specific Aims: Concisely explain the project’s specific aims to be funded by this application. If the proposed work is part of a larger study, then present only tasks that would be funded under this FY26 RTRP award.

Study Design and Feasibility:

▪ Describe the study design, methods and analyses, including appropriate controls, in sufficient detail for evaluation of appropriateness and feasibility.

▪ Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ If proposing development of a device, describe how the design would support a regulatory filing with the Food and Drug Administration (FDA) or international equivalent.

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

▪ Describe how data will be reported and how it will be ensured that the documentation will support a regulatory filing with the FDA or international equivalent, if applicable.

▪ Describe the statistical plan and rationale for the statistical methodology. Provide a sample size estimate and the method by which it was derived, including power analysis calculation, as applicable. Include any plans for blinding and randomization. Explain how this plan is appropriate for the proposed study, and how the study is designed to achieve reproducible and rigorous results.

▪ Address potential problem areas and present alternative methods and approaches.

▪ If animal studies are proposed, briefly describe the key elements of the study/studies as they relate to the overall project; detailed information is required in Attachment 8: Animal Research Plan. Describe the availability of and access to the animal model proposed. New: Include a letter of support from the animal vendor/provider in Attachment 2: Supporting Documentation indicating the cost and timeline for availability.

▪ If human subjects or human anatomical substances will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples. The plan should include a description of how the samples and any associated data will be stored during and after the study, including compliance with relevant laws and regulations for human subjects research. Consent forms for all samples collected under this project should include permission for the samples to be used in future studies without the need for re-consent. Describe the availability of and access to the proposed study population and past successes in recruiting similar populations. If an active-duty military, Veteran or military Family member or caregiver population will be used in the proposed research project, include the

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 12 details in Attachment 7: Military Relevance Statement. This award may not be used to conduct clinical trials.

▪ For all applications proposing clinical research, 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. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement. 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 (Attachment 2).

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

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. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. 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. New: If applicable, provide a letter signed by the animal vendor/provider describing the cost and timeline of availability for the animal model proposed.

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=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 13

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.

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

▪ Address any impact of intellectual property issues on product development and subsequent government access to products supported by this program announcement.

▪ Commercialization Strategy (if applicable): Describe the commercialization plan. The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors and management team. Discuss the significance of this development effort, when it can be anticipated, and the potential commercial use for the technology being developed.

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. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Inclusion Enrollment Report (only required if clinical research is proposed):

Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the “Public Health Service (PHS) Inclusion Enrollment Report”, a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race and ethnicity. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from IRB review) are exempt from this requirement.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a

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FY26 Reconstructive Transplant Investigator-Initiated Research Award 14

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background/Rationale/Readiness: Describe the research problem, question, or knowledge gap related to at least one of the FY26 RTRP Investigator-Initiated Research Award Focus Areas to be addressed by the proposed research. Present the ideas and scientific rationale behind the proposed project. If leveraging findings from solid organ transplant research for testing in a VCA setting, briefly explain the rationale and benefits of doing so. If utilizing a model system, explain how the model system is appropriate for the study and applicable to VCA.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached.

Specific Aims/Study Design: State the specific aims of the proposed research project, and briefly describe the study design, including appropriate controls.

Impact: Briefly describe the short- and long-term impact of this study on reconstructive transplant research, patient care, and/or quality of life, including the impact on at least one of the FY26 RTRP Investigator-Initiated Research Award Focus Areas.

Military Relevance: Briefly explain how the proposed project will have immediate or potential long-term benefit for the health care needs of military Service Members and/or Veterans recovering from catastrophic injury, and/or their Family members, caregivers, or clinicians, as well as the American public.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

Summarize the objectives and rationale for the proposed research.

State the FY26 RTRP Investigator-Initiated Research Award Focus Area(s) addressed by the proposed research.

Describe the ultimate applicability and impact of the research.

▪ What types of patients will the research help, and how will it help them? Include the current available statistics for the related injury/condition.

▪ What are the potential clinical applications, benefits and risks?

▪ What is the projected time it may take to achieve a patient-related outcome? If the research is far from clinical applicability, describe the interim outcomes.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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

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

FY26 Reconstructive Transplant Investigator-Initiated Research Award 15

Briefly explain how the proposed project will have immediate or potential long-term benefit for the health care needs of military Service Members and/or Veterans recovering from catastrophic injury, and/or their Family members, caregivers, or clinicians, as well as the American public.

What are the likely contributions of the proposed research to advancing the field of reconstructive transplant research?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to Example: Assembling a Generic Statement of Work. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”.

Describe how the proposed research addresses a critical problem in and will make an important contribution (both short-term and long-term) to the field of reconstructive transplant research, patient care and/or quality of life, including an assessment of the likelihood that a successful outcome of the proposed project will lead to a practical application in individuals recovering from traumatic injury. Address the impact on at least one of the FY26 RTRP Investigator-Initiated Research Award Focus Areas. Although not all-inclusive, the following are examples of ways in which research projects may have an impact, if successful:

Has the potential to advance the field of reconstructive transplant research.

Has the potential to change the standard of care.

Contributes to the development or validation of evidence-based policy or guidelines for patient evaluation and care.

○ Attachment 7: Military Relevance Statement (one-page limit): Upload as “MilRel.pdf”. Demonstrate how the proposed research is responsive to the health care needs and quality of life of military Service Members and/or Veterans recovering from catastrophic injury, and/or their Family members, caregivers, or clinicians, as well as the American public. 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 General Application Instructions, Appendix 4, for additional considerations.

○ Attachment 8: Animal Research Plan (five-page limit): Upload as “AnimalResPlan.pdf”. (Attachment 8 is only applicable and required for applications proposing animal studies.)

If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application. Consult ARRIVE 2.0 guidelines to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve reproducible and rigorous results for each proposed animal study:

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work 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://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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

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

FY26 Reconstructive Transplant Investigator-Initiated Research Award 16

Briefly describe the research objective(s) of the animal study. Explain how and why the animal species, strain and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology.

Describe and confirm the availability of and access to the animal model proposed.

Include alternate strategies should access to the animal model become restricted.

Summarize the procedures to be conducted. Describe how the study will be controlled.

Describe the randomization and blinding procedures for the study, and any other measures to be taken to minimize the effects of subjective bias during animal treatment and assessment of results. If randomization and/or blinding will not be utilized, provide justification.

Provide a sample size estimate for each study arm and the method by which it was derived, including power analysis calculations.

Describe how data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, statistical methods for data analysis and identification of the primary endpoint(s).

○ Attachment 9: Post-Award Transition Plan (one-page limit): Upload as “Transition.pdf”.

The Post-Award Transition Plan should:

Identify the project’s anticipated research outcomes including knowledge products and/or clinical products for development. A “knowledge product” is a non-materiel product that aims to transition into medical practice, training, tools or to support materiel solutions; and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.

Provide an overview of the next phase of development and the anticipated methods and strategies to be employed.

Include a timeline for development and describe potential collaborations, resources, and funding required. Indicate whether any of these are already in place.

As appropriate, discuss ownership rights/access to the intellectual property necessary for the development.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

(c) Additional Application Materials:

The following are additional forms for application submission. Follow the instructions specific to the submission portal, as found within the GAI.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Required%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

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

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

FY26 Reconstructive Transplant Investigator-Initiated Research Award 17

i. Research & Related Senior/Key Person Profile (Expanded)

○ Biographical Sketch

○ Current/Pending Support

Intragovernmental applicants must include their internally supported research and development programs.

ii. Research & Related Budget

iii. Project/Performance Site Location(s)

iv. Research & Related Subaward Budget Attachment(s) (if applicable, Grants.gov submissions only)

4.4. Other Application Elements

If recommended for funding, a data management plan compliant with Section 3.c, Enclosure 3, DoD Instructions 3200.12 will be requested.

The government reserves the right to request a revised budget, budget justification and/or additional information for applications recommended for funding.

External Link to the GAI

Grants.gov

External Link to the GAI eBRAP.org https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:~:text=C.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=B.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=E.-,DOW%20Data%20Management%20Plan,-If%20recommended%20for

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

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

FY26 Reconstructive Transplant Investigator-Initiated Research Award 18

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526RTRPIIRA from Grants.gov or eBRAP, depending on which submission portal will be used.

5.2. Unique Entity Identifier and System for Award Management

The applicant organization must be registered as an entity in the System for Award Management (SAM), SAM.gov, and receive confirmation of an “Active” status before submitting an application through Grants.gov. Organizations must include the unique entity identifier (UEI) generated by the SAM in applications to this funding opportunity and maintain an active registration in the SAM at all times during which it has an active Federal award or an application under consideration.

5.3. Submission Instructions

The CDMRP uses two portal systems to accept pre- and full application submissions. The workflow below shows which portal system to use for pre- and full application submissions, respectively.

Application Submission Workflow

5.3.1. Pre-Application Submission

All pre-application components…