HT9425FY26DMDRPCTRA_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

Clinical/Translational Research Award

Funding Opportunity Number: HT942526DMDRPCTRA

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 Clinical/Translational Research Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Clinical/Translational Research Award;

provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:~:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:~:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

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

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

FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Duchenne Muscular Dystrophy Research Program (DMDRP) Clinical/Translational Research Award (CTRA) supports advanced translational research to accelerate promising ideas in Duchenne muscular dystrophy (DMD) research toward clinical applications. Research must address at least one of the FY26 CTRA Focus Areas. Research projects investigating therapies that will be efficacious across the life span are strongly encouraged.

Distinctive Features: The FY26 CTRA offers two funding levels:

• Funding Level 1 to support smaller, less complex preclinical and/or clinical research.

• Funding Level 2 to support larger, more complex preclinical and/or clinical research.

The FY26 CTRA also offers a Partnering PI Option (PPIO) to support meaningful and productive partnerships between two investigators collaborating on the proposed research project. The PPIO has two eligibility categories:

• Early-Career Partnering PI category for an independent, early-career investigator within 10 years of their first faculty appointment (or equivalent) by the time of application submission.

• Established Interdisciplinary Partnering PI for independent investigators at all academic levels, or equivalent, in an area other than muscular dystrophy, seeking to transition to a career in DMD, thereby bringing their expertise to the field.

Preliminary data are required for all applications. Pilot clinical trials and clinical trial readiness studies to better inform development of drugs, devices, and other interventions are allowed.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $8.46M to fund approximately 6 CTRA applications with total cost caps of $0.91M per award for Funding Level 1 with single PI; $1.0M per award for Funding Level 1 with PPIO; $1.75M per award for Funding Level 2 with single PI; and $1.90M per award for Funding Level 2 with PPIO. The maximum period of performance is 3 years for Funding Level 1. The maximum period of performance for Funding Level 2 is 4 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: HT942526DMDRPCTRA

Assistance Listing Number: 12.420

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

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

Partnering PI Option (PPIO): In order to be eligible for the PPIO option, the partnering PI must be in one of the two eligibility categories:

• Early-Career Partnering PI: An independent, early-career investigator within 10 years of their first faculty appointment (or equivalent) by the time of application submission. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application.

• Established Interdisciplinary Partnering PI: An independent investigator at all academic levels, or equivalent, in an area other than muscular dystrophy, seeking to transition to a career in Duchenne muscular dystrophy (DMD), thereby bringing their expertise to the field.

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 General Application Instructions (GAI) for additional recipient qualification requirements.

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the 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 Clinical/Translational Research Award

The FY26 DMDRP Clinical/Translational Research Award (CTRA) mechanism supports advanced translational research that will accelerate the movement of promising ideas in DMD research into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between applied and clinical research. As such, applications must include preliminary and/or published data relevant to DMD to support the proposed research project. Preliminary data may include unpublished results from the laboratory of the PI, research team, or collaborators named on the application.

This mechanism is intended to support established projects that have moved beyond the realm of basic research and proof-of-concept studies and have the potential to result in a near-term impact in clinical research or the clinic. Research projects investigating therapies that will be efficacious in patients across the lifespan, including infants, toddlers, and nonambulatory individuals, are strongly encouraged.

Pilot clinical trials and clinical trial readiness studies to better inform development of drugs, devices, and other interventions are allowed.

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

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 7

3.1.1. Focus Areas for the CTRA

To meet the intent of the funding opportunity, applications must address at least one of the following focus areas:

Preclinical Translational Research

• Extension or expansion of existing preclinical data in support of Investigational New Drug (IND) application-enabling studies. For example:

○ Optimizing therapeutic candidate or candidate delivery to target tissues (Funding Level 1 only)

○ Drug exposure

○ Independent replication

○ Comparative studies

○ Safety studies

○ Assay development, outcome measures and/or biomarkers (e.g., pharmacodynamic, prognostic, or predictive biomarkers, including potential surrogate markers)

Clinical Research

• Prospective/real world data/post-market studies for combination or sequential therapies, and/or long-term safety and efficacy studies

• Clinical studies designed to improve care and quality of life

• Assessment of clinical trial tools and outcome measures across the lifespan:

○ Discovery and qualification of pharmacodynamic, prognostic, and predictive biomarkers, including potential surrogate markers, with emphasis on minimally invasive approaches

○ Novel clinical outcome assessment

○ Patient-centered outcomes (e.g., quality of life, activities of daily living)

○ Secondary data analysis that helps to address clinical research tool validation

• Natural history studies in understudied systems (e.g., cognitive, gastrointestinal [GI], pulmonary, cardiac) or age ranges (e.g., infants, toddlers, and/or nonambulatory), with an aim toward clinical trial readiness

3.1.2. Key Elements for the CTRA

Funding Levels: The FY26 DMDRP CTRA offers two Funding Levels (refer to Section 3.4, Funding Details). Only one Funding Level category may be chosen per application, and the choice of application category is at the discretion of the applicant. The following are generalized descriptions of the scope of the research appropriate for each Funding Level:

• Funding Level 1: Intended to support smaller, less complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/application’s total costs budgeted for the entire period of performance should not exceed $0.91M for a single PI, or $1.0M for a

PPIO.

• Funding Level 2: Intended to support larger, more complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/application’s total costs budgeted for

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 Clinical/Translational Research Award 8 the entire period of performance should not exceed $1.75M for a single PI, or $1.90M for a

PPIO.

Partnering PI Option: The FY26 DMDRP encourages applications that include meaningful and productive collaborations between investigators. In an effort to promote enhanced research capacity within the DMD field, the FY26 CTRA includes an option to include a partnering PI. In order to be eligible for the PPIO, the partnering PI must meet one of the two eligibility categories:

• Early-Career Partnering PI: An independent, early-career investigator within 10 years of their first faculty appointment (or equivalent) by the time of application submission. Lapses in research time or appointments as denoted in the biographical sketch should be explained in the application.

• Established Interdisciplinary Partnering PI: An independent investigator at all academic levels, or equivalent, in an area other than muscular dystrophy, seeking to transition to a career in DMD, thereby bringing their expertise to the field.

The PPIO is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The Early-Career PI or the Established Interdisciplinary will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.1.3. Other Important Considerations for the CTRA

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 and clinical research are allowed within this funding opportunity.

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

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.

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%20For%20the 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

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 9

3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

CTRA Funding Level 1

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

Cost Caps:

Single PI: The application’s total costs budgeted for the entire period of performance should not exceed $0.91M.

PPIO: The combined total costs budgeted for the entire period of performance in the applications of the initiating PI and each Partnering PI should not exceed $1.0M.

CTRA Funding Level 2

Period of Performance: The maximum period of performance is 4 years.

Cost Caps:

Single PI: The application’s total costs budgeted for the entire period of performance should not exceed $1.75M.

PPIO: The combined total costs budgeted for the entire period of performance in the applications of the initiating PI and each Partnering PI should not exceed $1.90M.

All Funding Levels

If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years for Funding Level 1, or 4 years for Funding Level 2.

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 CTRA.

Must not be requested for:

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

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 10

4. Application Contents and Format

4.1. Application Overview

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

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

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

4.2. Pre-Application Components

The Initiating PI must submit the following pre-application 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

4.3.1. Full Application Components for the PI or Initiating PI

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.

Partnering PI Option: The CDMRP requires separate full application package submissions for the Initiating PI and each Partnering PI, even if the PIs are located within the same organization. The application submission process for the Partnering PI uses an abbreviated full application package.

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

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

(b) Attachments:

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

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

Describe the proposed project in detail using the outline below.

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– 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 must include preliminary data to support the clinical relevance of the idea. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) or a member(s) of the research team.

– Hypotheses/Objectives: State the hypotheses/study questions and overall objective(s) to be reached.

– Specific Aims: Concisely explain the project’s specific aims. If this application 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.

▪ 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.

▪ If funds for a clinical trial are requested, details regarding the Clinical Strategy Statement must be described in Attachment 9. Only those proposed studies measuring safety, effectiveness, and/or efficacy of an intervention are considered clinical trials and should submit a Clinical Strategy Statement.

– 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 https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=eBRAP.org.-,APPENDIX%204.,-USE%20OF%20DOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=eBRAP.org.-,APPENDIX%204.,-USE%20OF%20DOW

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 12 regulatory filing with the U.S. Food and Drug Administration (FDA), if applicable.

Ensure sufficient information is provided to allow thorough evaluation of all statistical calculations during review of the application.

– Statement of Collaboration (optional; encouraged for PPIO applications):

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.

○ 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 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 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 Duchenne Muscular Dystrophy Clinical/Translational Research Award 13 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 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 and/or a clinical trial 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 at least one of the FY26 CTRA Focus Areas.

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

Impact: Briefly describe how the proposed project will have an impact on preserving and improving the function and quality of life and extending the lifespan of all individuals with DMD. Describe how the project will translate promising, well-founded laboratory or clinical research findings into clinical applications for patients with or populations at risk for DMD.

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

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

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 14

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

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

– Summarize the objectives and rationale for the proposed research.

– State the FY26 CTRA Focus Area(s) the project addresses

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

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

– What is the projected time anticipated to achieve a clinically relevant outcome? What are the likely contributions of this study to advancing the field of DMD research and/or patient care?

– 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 either the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work or Example: Assembling a Generic Statement of Work, whichever is most appropriate for the proposed effort. Include milestones for data or research resource(s) sharing.

Each PI must submit an identical copy of a jointly created SOW. The specific contributions of the Initiating PI and the Partnering PI should be clearly noted for each task.

○ 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 mind, 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 research is relevant to at least one of the FY26 CTRA Focus Areas in a way that is consistent with the program’s goals. The relevance of all research should relate to patient outcomes and how it benefits those affected by DMD.

Describe how the project will translate promising, well-founded laboratory or clinical research findings into clinical applications for patients with or populations at risk for

DMD.

Explain how the proposed research will make a significant impact on DMD research and/or patient care, including how the new understanding may ultimately contribute to the goal of preserving and improving the function and quality of life, and extending the lifespan of all individuals with DMD.

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

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%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=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work 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-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 15

○ Attachment 7: Transition Plan (two-page limit): Upload as “Transition.pdf”. Provide information on potential methods and strategies to feasibly move the project’s findings to the next phase of development, clinical trials, and/or delivery to the commercial market after successful completion of the award. The transition plan should include the components listed below.

– A description of the scientific or technical requirements needed to advance the research findings.

– An assessment of the opportunities available and potential barriers that would impact the progress of commercializing and/or translating the study results into clinical practice.

– A timeline with defined milestones and deliverables describing the expected post-award progress of the results toward the next phase of development and eventual clinical impact.

– Details of the funding strategy that will be used to bring the outcomes to the next phase of development. Provide sufficient evidence that the PI has, or can secure, additional funding and describe potential options to secure the additional funding needed to bring the outcomes to the next phase of development (e.g., specific potential industry partners and/or specific funding opportunities to apply for).

– A description of collaborations and other resources that will be used to provide continuity of development.

– A plan to distribute the findings or intervention to the DMD community.

○ 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 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.

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FY26 Duchenne Muscular Dystrophy Clinical/Translational Research Award 16

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: Clinical Strategy Statement, if applicable (no page limit): Upload as “Clinical.pdf”. If funds for a clinical trial are requested, this attachment is required.

Only those proposed studies measuring safety, effectiveness, and/or efficacy of an intervention are considered clinical trials and should include a Clinical Strategy Statement.

− Describe the rationale for the proposed clinical trial. Provide a description of the intervention and the endpoints to be measured. Describe the type of clinical trial to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action. Describe potential challenges and alternative strategies where appropriate.

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

− Provide detailed plans for initiating the clinical study within the first year, including FDA IND/Investigational Device Exemption (IDE) application submission plans, prior to the FY26 DMDRP CTRA application submission deadline, if applicable.

Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, if applicable. The government reserves the right to withhold or withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA by the application submission deadline, or if documented status of the IND or IDE has not been obtained within nine months of the award date.

− Indicate the access to the study population, recruitment plans, and inclusion/exclusion criteria. Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects. Provide an anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity using the Public Health Service (PHS) Inclusion Enrollment Report, which is a three-page fillable PDF form that can be downloaded from eBRAP.

− Describe the type of clinical trial to be performed (e.g., prospective, randomized, cohort, case-control, cross-sectional) and outline the proposed methodology in sufficient detail to show a clear course of action. Describe potential challenges and alternative strategies where appropriate. Describe how the clinical trial will inform the correlative clinical research, if applicable.

− State how many months into the award the anticipated clinical trial would be initiated, taking into account any clinical trial preparation (IRB and DOW Office of Human Research Oversight [OHRO, previously Human Research Protection Office] approval). Note: The clinical trial must begin within the first year of the award.

− Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Specify the approximate number of human subjects to be enrolled.