HT942526RTRPCA_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

Concept Award

Funding Opportunity Number: HT942526RTRPCA

Pre-Application Due: September 2, 2026

Application Due: September 16, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Reconstructive Transplant Concept 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 Concept 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

FY26 Reconstructive Transplant Concept 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 Concept Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Reconstructive Transplant Research Program (RTRP) Concept Award supports the exploration of highly innovative new concepts or untested theories that address an important problem relevant to reconstructive transplantation. The Concept Award does not support clinical trials.

Distinctive Features:

• Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, examine existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative.

• Relevance: Projects should address at least one of the FY26 RTRP Focus Areas.

• Preliminary Data: Presentation of preliminary data is not allowed; however, applications should demonstrate the ability to achieve interpretable results. A rationale for the proposed work must be provided.

• Early-Career Investigators: Early-career investigators are encouraged to apply.

Investigators at or above the level of postdoctoral fellow are eligible to apply.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $0.6 million (M) to fund approximately three Concept Award applications with total cost caps of $200,000 per award. The maximum period of performance is 18 months. 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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), September 2, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 16, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 21, 2026

• Peer Review: November 2026

• Programmatic Review: January 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526RTRPCA

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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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

Investigators at or above the level of postdoctoral fellow affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status. The investigators do not have to be from academic organizations.

An investigator may be named on only two FY26 RTRP Concept Award applications as a 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 Concept 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 first offered the Concept Award in FY15. Since then, the program received 196 Concept Award applications and 26 were recommended for funding.

3.2. Intent of the Concept Award

The Concept Award supports the exploration of highly innovative new concepts or untested theories that address an important problem relevant to reconstructive transplantation. The purpose of the Concept Award is to support high-risk studies with the potential to reveal new avenues of investigation, not the logical progression of an established research project.

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.

3.2.1. Focus Areas for the Concept Award

To meet the intent of the FY26 RTRP Concept 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

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FY26 Reconstructive Transplant Concept Award 7

• 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 Concept Award

• Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, examine existing problems from new perspectives or exhibit highly creative qualities.

• Relevance: All projects must be responsive to at least one of the FY26 RTRP Focus Areas and 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: Inclusion of preliminary data is not allowed; however, applications should provide a clear rationale and demonstrate the ability to achieve interpretable results.

• Young/early-career investigators are encouraged to apply.

3.2.3. Other Important Considerations for the Concept 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.

Because the FY26 RTRP Concept Award is designed for preliminary investigations, projects involving human subjects or anatomical substances will not be supported unless they are exempt under Title 32, Code of Federal Regulations, Part 219, Section 104(d) (32 CFR 219.104[d]) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.

Studies that do not qualify for exempt status or expedited review will be administratively withdrawn and will not be funded.

Clinical trials are not allowed within this funding opportunity.

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 Concept Award 8

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 18 months.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $200,000. 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 18 months.

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 projects 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 held in the Central Florida area. 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 Concept Award.

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.

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

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FY26 Reconstructive Transplant Concept Award 9

Must not be requested for:

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

• Clinical trial costs.

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

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FY26 Reconstructive Transplant Concept 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 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 (two-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Innovation: Describe how the proposed research is innovative and has the potential to reveal new avenues for investigation in reconstructive transplantation. Innovation should be the primary feature of the proposed study.

Hypothesis/Rationale/Purpose: Concisely state the hypothesis/purpose of the proposed research and provide the rationale. If leveraging findings from solid organ transplant research for testing in a VCA study, briefly explain the rationale and benefits of doing so. Preliminary data are not allowed.

Aims/Objectives: Concisely state the project’s specific aims and objectives. Do not request funding as part of a larger study.

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 Concept Award 11

Research Strategy: Describe the experimental design and methodology, including plans for analyses. If the methodology is new or unusual, describe it in sufficient detail for evaluation. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

If the proposed research involves human subjects or specimens, provide evidence that the study is either exempt under 32 CFR 219.104(d) or eligible for expedited review under 21 CFR 56.110. 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.

Relevance: Provide a brief statement, in non-technical terms, describing the importance of this research to at least one of the FY26 RTRP Focus Areas. Clearly and explicitly state 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, clinicians, as well as the American public. If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

○ 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 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#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Reconstructive Transplant Concept Award 12 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.

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.

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.

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

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FY26 Reconstructive Transplant Concept Award 13

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: 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 the Example: Assembling a Generic Statement of Work. Include milestones for data or research resource(s) sharing.

○ Attachment 4: Innovation Statement (one-page limit): Upload as “Innovation.pdf”.

Describe how the proposed research is innovative in one or more of the following ways:

concept or question, research methods or technologies, adaptations of existing methods or technologies or other ways. Explain how exploring the concept may lead to new areas of research. Describe how the proposed research represents more than an incremental advance beyond ongoing research and published data and will move research in a new direction. If leveraging findings from solid organ transplant research for testing in a VCA setting, briefly explain the rationale and benefits of doing so.

○ Attachment 5: 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 6: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 7: 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.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources 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/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 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 Concept Award 14

(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.

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.

If recommended for funding, applicants will be requested to provide a Technical Abstract prior to award.

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

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5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526RTRPCA 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 must be submitted by the PI through eBRAP.

During the pre-application process, eBRAP assigns each submission a unique log number. This unique log number is required during the full application submission process. The eBRAP log number, application title and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire pre-application and full application submission process. Inconsistencies may delay application https://grants.gov/ https://ebrap.org/eBRAP/public/Program.htm https://www.sam.gov/content/home https://ebrap.org/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=Obtain%20Unique%20Entity%20Identifier%20from%20System%20for%20Award%20Management https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_PreApp_Submission:~:text=III.-,PRE%2DAPPLICATION%20SUBMISSION,-General%20information%20about

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 Concept Award 16 processing and limit or negate the ability to view, modify and verify the application in eBRAP.

Contact the eBRAP Help Desk if any changes need to be made.

5.3.2. Full Application Submission

Grants.gov Submissions: Full applications from extramural organizations must be submitted through the Grants.gov Workspace.

eBRAP Submissions: Only intramural DOW organizations may submit full applications through eBRAP.

5.3.3. Applicant Verification of Full Application Submission in eBRAP

Independent of the submission portal, once the full application is submitted, it is transmitted to and processed in eBRAP; the transmission to eBRAP may take up to 48 hours. At this stage, the PI and organizational representatives will receive an email from eBRAP instructing them to log in to eBRAP to review, modify and verify the full application submission.

The Project Narrative and Research & Related Budget Form cannot be changed after the application submission deadline. Other application components, including subaward budget(s) and subaward budget justification(s), may be changed until the application verification period ends. The full application cannot be modified once the application verification period ends.

5.4. Submission Dates and Times

The pre-application and full application submission process should be started early to avoid missing deadlines. Regardless of submission portal used, all pre- and full application components must be submitted by the deadlines stipulated in this program announcement.

There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The DHACA cannot make allowances/exceptions for submission problems encountered by the applicant.

Submission dates and times are specified in Section 1, Basic Information.

5.5. Intergovernmental Review

Not applicable for this funding opportunity.

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/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Applicant_Verification_Grants_Submission:~:text=E.-,Applicant%20Verification%20of%20Grants.gov%20Submission%20in%20eBRAP,-Once%20the%20full

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 Concept Award 17

6. Application Review Information

6.1. Application Compliance Review

Submitting applications that propose essentially the same research project to different funding opportunities within the same program and fiscal year is prohibited and will result in administrative withdrawal of the duplicative application(s).

While it is allowable to propose similar research projects to different programs within the CDMRP or to other organizations, duplication of funding or accepting funding from more than one source for the same research is prohibited. See the CDMRP’s Directive on Research Duplication.

Including classified research data within the application and/or proposing research that may produce classified outcomes or outcomes deemed sensitive to national security concerns may result in application withdrawal.

Members of the FY26 RTRP Programmatic Panel must not be involved in any pre-application or full application including, but not limited to, concept design, application development, budget preparation and the development of any supporting documentation, including personal letters of support/recommendation for the research and/or PI. Programmatic panel members may provide letters to confirm PI eligibility and access to laboratory space, equipment and other resources necessary for the project if that is part of their regular roles and responsibilities (e.g., as Department Chair). A list of the FY26 RTRP Programmatic Panel members can be found on the CDMRP website.

Additional restrictions and associated administrative responses are outlined in Section 9.2, Administrative Actions.

6.2. Review Criteria

6.2.1. Pre-Application Screening Criteria

Pre-applications submitted to this funding opportunity are used for program planning purposes only (e.g., reviewer recruitment) and will not be screened.

6.2.2. Peer Review Criteria

To determine technical merit, all applications will be evaluated individually according to the following criteria, which are listed in decreasing order of importance. These criteria will contribute to the overall score and evaluation of the application, but will not be individually scored.

• Innovation

○ To what extent the proposed research is innovative for the reconstructive transplant field (e.g., concept or question, research methods or technologies, adaptations of existing methods or technologies from other fields or other ways).

○ To what extent exploring the concept may lead to new avenues of reconstructive transplant research.

https://cdmrp.health.mil/funding/researchDup https://cdmrp.health.mil/funding/researchDup https://cdmrp.health.mil/rtrp/panels/RTRP%20FY26%20Programmatic%20Panel%20List.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Applicant_Verification_Grants_Submission:~:text=Classified%20Information%2C%20Data%20or%20Outcomes

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 Concept Award 18

○ How well the proposed research represents more than incremental advance beyond ongoing research of published data and will move reconstructive transplant research in a new direction (preliminary data are not allowed).

○ If leveraging findings from solid organ transplant research, to what extent the rationale and benefits of doing so support testing in a VCA setting.

• Relevance

○ To what extent the proposed research project addresses an important scientific question relevant to at least one of the FY26 RTRP Focus Areas.

○ To what extent the proposed research project is 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.

○ If applicable, to what extent the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

• Research Strategy and Feasibility

○ To what extent the proposed research is supported by sound scientific rationale.

○ To what extent the specific aims, research strategy and methods are appropriate to address the stated objectives.

○ How well studies are designed to achieve reproducible and rigorous results, including the choice of model and the endpoints/outcomes to be measured.

○ If applicable, whether sufficient evidence is provided to support that the study is either exempt under 32 CFR 219.104(d) or eligible for expedited review under 21 CFR 56.110.

○ Whether the strategy for considering sex as a biological variable is appropriate to the objectives of the study or whether the justification for a single-sex study is sufficiently strong.

• Personnel

○ How appropriate the expertise and levels of effort are for successful conduct of the proposed work.

• Transition Plan

○ Whether the identified next level of development, including anticipated methods and strategies, is described and appropriate.

○ Whether an anticipated timeline for development, as well as potential collaborations, resources, funding and intellectual property rights, have been considered.

• Research Sharing Plan

○ To what extent the plan for sharing of project data and research resources is appropriate and reasonable and includes dissemination to affected communities, study participants and/or the scientific community.

○ If applicable, whether specific repository(ies) are named where data and research resources arising from the project will be stored.

• Budget

○ Whether the budget is appropriate for the proposed research.

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 Concept Award 19

• Environment

○ To what extent the scientific environment and level of institutional support is appropriate for the proposed research project.

○ How well the research requirements are supported by the availability of and accessibility to facilities and resources.

• Application Presentation

○ To what extent the writing, clarity and presentation of the application components influence the review.

6.2.3. Programmatic Review

To make funding recommendations and select the application(s) that, individually or collectively, will best achieve the program objectives, the following criteria are used by programmatic reviewers:

• Ratings and evaluations of peer reviewers

• Relevance to the priorities of the FY26 RTRP, as evidenced by the following:

○ Adherence to the intent of the funding opportunity

○ Program portfolio composition

○ Programmatic relevance to military health and at least one of the FY26 RTRP Focus Areas

○ Relative innovation

6.3. Application Review and Selection Process

6.3.1. Pre-Application

There is no review and selection process for pre-applications submitted to this funding opportunity. The CDMRP will NOT provide an invitation to submit a full application after pre-application submission. Applicants are encouraged to develop pre-application and full application components concurrently and submit a full application AFTER successful submission of the pre-application.

6.3.2. Full Application

All applications are evaluated by scientists, clinicians and consumers in a two-tier review process. The first tier is peer review, the evaluation of applications against established criteria to determine technical merit, where each application is assessed for its own merit, independent of other applications. The second tier is programmatic review, a comparison-based process in which applications with high scientific and technical merit are further evaluated for programmatic relevance. Final recommendations for funding are subject to review and approval by a designated official.