HT9425FY26DMDRPIDA_for 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

Duchenne Muscular Dystrophy Research Program

Idea Development Award

Funding Opportunity Number: HT942526DMDRPIDA

Pre-Application Due: September 4, 2026

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Idea Development 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 Duchenne Muscular Dystrophy Idea Development 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 Duchenne Muscular Dystrophy Idea Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Duchenne Muscular Dystrophy Research Program (DMDRP) Idea Development Award (IDA) promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation.

This award supports impactful, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress in improving outcomes for individuals with Duchenne muscular dystrophy (DMD) in the near term. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale. The DMDRP strongly encourages research projects investigating therapies designed to demonstrate efficacy cross the life span, including infants, toddlers and nonambulatory individuals.

Distinctive Features: The FY26 DMDRP IDA mechanism offers three eligibility career categories:

• The Established Investigator category is for independent investigators at all academic levels, or equivalent

• The New Investigator – Early-Stage category is for independent investigators early in their careers (i.e., within 10 years of their first faculty appointment or equivalent). Applicants in this category will be reviewed separately from Established Investigators.

• The New Investigator – Transitioning category is for independent investigators at all academic levels, or equivalent, in an area other than muscular dystrophy who are seeking to transition to a career in DMD, thereby bringing their expertise to the field. Applicants in this category will be reviewed separately from Established Investigators.

Preliminary data relevant to DMD that supports the feasibility of the research hypotheses and research approaches are required for all applications. Clinical trials or clinical trial aims are not allowed.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.5M to fund approximately 5 Idea Development Award applications with total cost caps of $500,000 per award. The maximum period of performance is 2 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), September 4, 2026

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

• End of Application Verification Period: 5:00 p.m. ET, September 25, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526DMDRPIDA

Assistance Listing Number: 12.420

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

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

FY26 Duchenne Muscular Dystrophy Idea Development 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 affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

Only one PI career category may be chosen; the choice of application category is at the PI’s discretion, provided the eligibility criteria are met.

• Established Investigator

○ The PI must be an independent investigator at all academic levels, or equivalent.

• New Investigator – Early Stage

By the application submission deadline date, the PI must:

○ Be an independent investigator, or equivalent, who is within 10 years of their first faculty appointment, or equivalent, by the time of the application submission deadline.

Applicants may articulate lapses in research time or appointments denoted in the biographical sketch, in the application.

○ Not have previously received a Duchenne Muscular Dystrophy Research Program (DMDRP) Idea Development Award (IDA).

• New Investigator – Transitioning

By the application submission deadline date, the PI must:

○ Be an independent investigator at all academic levels, or equivalent, in an area other than muscular dystrophy who is seeking to transition to a career in Duchenne muscular dystrophy (DMD), thereby bringing their expertise to the field.

○ Investigators must pursue an active line of research in DMD and commit at least 10% minimum effort during each budget year toward the proposed DMD research project.

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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201-,RECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0

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

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

FY26 Duchenne Muscular Dystrophy Idea Development 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 Duchenne Muscular Dystrophy Research Program (DMDRP). 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 DMDRP in 2011 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the DMDRP from FY11 through FY25 totaled $92.1 million (M). The FY26 appropriation is $12.5M.

The vision of the FY26 DMDRP is to preserve and improve the function and quality of life across the lifespan of all individuals with DMD. As such, the DMDRP seeks to support discovery, development, and delivery of safe, effective therapeutics for DMD at all stages of the disease for the benefit of military Families and the general public. Additionally, the DMDRP supports the efforts of the National Institutes of Health (NIH) Muscular Dystrophy Coordinating Committee (MDCC) and the 2015 MDCC Action Plan for the Muscular Dystrophies, which prioritizes the need to improve treatments and reduce the disease burden for muscular dystrophies, including DMD.

The DMDRP seeks to support research that is relevant to the health care needs of Service Members, Veterans, and their Families, and/or Family readiness of Service Members. Musculoskeletal injuries and diseases are the third leading cause of medical encounters for active Service Members. Drug repurposing and development of novel advanced technologies to improve muscle strength and function after injury and disease are relevant to the support of Warfighter readiness and lethality. Additional information on relevance to military health can be found on the Program Summary Sheet on the DMDRP website.

3.1. Intent of the Idea Development Award

The FY26 DMDRP IDA promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports impactful, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress in improving outcomes for individuals with DMD in the near term. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.

Applications must include preliminary data relevant to DMD that supports the feasibility of the research hypotheses and research approaches. Preliminary data may include unpublished results from the laboratory of the PI, research team, or collaborators named on the application.

3.1.1. Focus Area for the IDA

To meet the intent of the funding opportunity, applications must address opportunities and challenges in the development of safe and effective therapies that focus on primary pathology of DMD. Therapies that will be efficacious for patients across the lifespan, including infants, toddlers and non-ambulatory individuals, are strongly encouraged.

https://mdcc.nih.gov/Action_Plan https://cdmrp.health.mil/dmdrp/pbks/DMDRP%20Program%20Summary_27June25.pdf https://cdmrp.health.mil/dmdrp/default

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 7

Studies proposed under this award mechanism may include:

• Research that will inform and improve therapy in individuals ineligible for currently approved therapies or in-development therapeutics (e.g., due to age, type of mutations, seropositivity, rare exons).

• Optimizing non-adeno-associated virus (AAV) or non-viral delivery to specific tissues or cell types, including targeting to skeletal muscle, heart, brain and muscle stem cells (e.g., ligand-assisted delivery, tissue-specific promoters, nanoparticles, alternative vectors, identification of biological barriers to delivery).

• Therapies that address muscle regeneration deficits.

• Strategies to overcome preexisting immunity and to facilitate repeat administration of biologic therapies (e.g., immune system modulation, vector modification).

• Repopulation of the muscle compartment using cell-based therapies, including, but not limited to, selection of novel cell types, expansion, cell delivery and homing, differentiation and integration.

• Non-genomic therapies that are downstream from the genetic defect to address disease pathogenesis (e.g., inflammation, fibrosis, fatty infiltration, mitochondrial dysfunction, etc.).

• Preclinical testing of therapies in combination with standard of care treatments or approved products.

• Discovery and validation of novel targets, including genetic modifiers and factors that determine the selective vulnerability/resistance of individual muscles, especially in humans.

• Validation of novel models to address human pathophysiology in DMD beyond skeletal muscle (e.g., smooth muscle, CNS).

• Identification of novel, minimally invasive biomarkers that allow evaluation of therapeutic effectiveness with strong potential for clinical translatability.

Studies in the following research areas will not be supported by this award mechanism:

• Testing the efficacy of candidate therapeutics without a strong mechanistic rationale.

• Evaluation of vectors or delivery technologies already prevalent in research studies (e.g., AAV9).

3.1.2. Key Elements for the IDA

• Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward improving outcomes for individuals with DMD.

The applicant should articulate the project’s near-term impact to both DMD research and individuals with DMD, even if clinical impact is not an immediate outcome. Applications that demonstrate exceptional scientific merit but lack high potential impact do not meet the intent of the IDA.

New Investigators: In addition to established DMD investigators, the FY26 DMDRP IDA mechanism encourages applications from independent investigators in the early stages of their careers (i.e., within 10 years of their first faculty appointment or equivalent) and applications from established investigators new to DMD research.

• The New Investigator – Early Stage category is designed to allow independent investigators early in their faculty appointments to be reviewed separately from established investigators.

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 8

• The New Investigator – Transitioning category is designed to allow independent investigators at all academic levels, or equivalent, in an area other than muscular dystrophy who are seeking to transition to a career in DMD, thereby bringing their expertise to the field.

Applications in this category will be reviewed separately from established DMD investigators.

The DMDRP strongly encourages PIs using the New Investigator – Early Stage category or New Investigator – Transitioning category to strengthen their applications by collaborating with investigators experienced in DMD research and/or possessing other relevant expertise. It is the responsibility of the applicant to describe how the included collaboration will augment the PI’s expertise to best address the research question. All applicants for the New Investigator categories must meet the specific eligibility criteria described in Section 2, Eligibility Information.

3.1.3. Other Important Considerations for the IDA

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, the 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; however, research involving human subjects and human anatomical substances is permitted.

Investigators wishing to apply for funding to support a clinical trial should consider submitting an application to the FY26 DMDRP Clinical/Translational Research Award, funding opportunity number HT942526DMDRPCTRA.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research.

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

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

3.2. Funding Instrument

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

(31 USC 6304).

3.3. Funding Details

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $500,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes 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

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 9 in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 2 years.

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

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

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. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 DMDRP IDA.

Must not be requested for:

• Clinical trial costs.

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

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

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

FY26 Duchenne Muscular Dystrophy Idea Development 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.

LOIs are used for program planning purposes only (e.g., reviewer recruitment) and will not be reviewed during either the peer or programmatic review. An invitation to submit a full application is NOT provided after LOI 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.

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: Present the ideas and reasoning behind the proposed research. The application must provide a sound scientific rationale to support the proposed project and its feasibility as established through the demonstration of logical reasoning and critical review and analysis of published literature; include relevant literature citations.

Include preliminary data to support the scientific rationale and feasibility of the research approaches. Applications are strongly encouraged to also include preliminary data to support the clinical relevance of the idea. Any unpublished 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

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 11 preliminary data provided should originate from the laboratory of the PI(s) or a member(s) of the research team.

– Hypothesis or Objective: State the hypothesis to be tested or the objective to be reached.

– Specific Aims: Concisely explain the project’s specific aims to be supported by this application. If the proposed research is part of a larger study, present only tasks that this award would fund.

– Research Strategy and Feasibility: Describe the experimental design, methods, and analyses including appropriate controls, in sufficient detail for evaluation. Clearly describe how data will be collected and analyzed in a manner that is consistent with the study objectives. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. Address potential limitations and present alternative methods and approaches. Describe availability of, access to, and quality control for all data and/or critical reagents, and/or cohorts, where relevant.

▪ If animal studies are proposed, describe how they will be conducted in accordance with the ARRIVE guidelines 2.0 to achieve reproducible and rigorous results, including the choice of model and the endpoint/outcomes to be measured.

▪ If human subjects or human biological samples will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples.

▪ For clinical research, describe the strategy for the inclusion of women and minorities in the clinical research appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, race, and/or ethnicity, and an accompanying rationale for the selection of subjects. This award cannot be used to support clinical trials.

▪ 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.

– Statistical Analysis Plan: Describe the statistical analysis plan for the resulting outcomes. If applicable, include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA), if applicable.

– Statement of Collaboration (optional; encouraged for applications submitting to a New Investigator eligibility criterion): Describe the composition of the study team, partners, or any collaborations in enough detail to determine whether the team includes relevant DMD subject matter or other relevant expertise to accomplish the proposed work as it relates to the study hypothesis or objective. Describe how the collaboration will augment the PI’s expertise to best address the research question.

https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOD_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204%0AUSE%20OF%20DOD%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOD_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204%0AUSE%20OF%20DOD%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 12

○ 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 (two-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.

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

Data and/or Research Sharing Plan: Describe the type of data and/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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 13 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 NIH 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.

− 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 Institutional Review Board [IRB] review) are exempt from this requirement.

○ 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: Present the scientific rationale behind the proposed research project.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached. Provide evidence or scientific rationale that supports the hypothesis/objective(s).

Specific Aims: State the specific aims of the study, ensuring they address opportunities and challenges in the development of safe and effective therapies that focus on primary pathology of DMD.

Study Design: Describe the study design, including appropriate controls.

Impact: Describe how the proposed project may lead to major advancements and significantly accelerate progress toward improving outcomes for individuals with

DMD.

Military Relevance: Describe how the study is relevant to military health.

○ 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.

What population will the research help, and how will it help them?

What are the potential applications, benefits and risks of the anticipated outcomes?

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/Program.htm#:~:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report 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 Duchenne Muscular Dystrophy Idea Development Award 14

What are the likely contributions of the proposed research project to advancing DMD research, patient care and/or quality of life?

What is the projected time anticipated to achieve a clinically relevant outcome?

What is the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families?

○ 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 the 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”. The Impact Statement should be written in plain language with a broad audience in mid, including readers without a background in science or medicine. The Impact Statement should articulate the project’s near-term impact to both DMD research and to individuals with DMD, even if clinical impact is not an immediate outcome.

– Describe how the proposed project is expected to make an important and original contribution to addressing opportunities and challenges in the development of safe and effective macromolecular and cellular therapies that address primary pathology of DMD. The relevance of all research, including basic, should relate to patient outcomes and how it benefits those affected by DMD.

– Explain how the proposed research will significantly accelerate progress towards improving outcomes for individuals with DMD.

– Explain briefly how the proposed research is relevant to the health care needs of Service Members, Veterans, their Families, and/or Family readiness of Service Members.

○ Attachment 7: Research Outcomes Plan: (one-page limit): Upload as “Outcomes.pdf”.

− Describe the anticipated research outcomes, including knowledge products, clinical products for development, etc.

− Describe the methods and strategies proposed to move the anticipated research outcomes to the next phase of development or clinical application after successful completion of the project.

− Detail the funding strategy to transition to the next level of investigation, development, and/or commercialization (e.g., partners, internal/external funding opportunities to be applied for).

− Demonstrate that a plan for management of intellectual property is in place.

○ 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 the ARRIVE guidelines

2.0 (Animal Research: Reporting In Vivo Experiments) 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 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://arriveguidelines.org/arrive-guidelines 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 Duchenne Muscular Dystrophy Idea Development Award 15

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:

− 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.

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

○ Attachment 10: 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.

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)

External Link to the GAI

Grants.gov

External Link to the GAI eBRAP.org 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#_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

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

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

FY26 Duchenne Muscular Dystrophy Idea Development Award 16

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.

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_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 Duchenne Muscular Dystrophy Idea Development Award 17

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526 DMDRPIDA 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 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 Duchenne Muscular Dystrophy Idea Development Award 18 pre-application and full application submission process. Inconsistencies may delay application 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.

When starting the pre-application, PIs should select a Mechanism Option appropriate to their pre-application:

Application Includes: Select Mechanism Option:

Established Investigator Idea Development Award – Established Investigator

New Investigator – Early Stage Idea Development Award – New Investigator – Early Stage

New Investigator – Transitioning Idea Development Award – New Investigator – Transitioning

5.3.2. Full Application Submission

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

eBRAP…