HT942526MSRPEHDA_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

Multiple Sclerosis Research Program Exploration – Hypothesis Development Award

Funding Opportunity Number: HT942526MSRPEHDA

Pre-Application Due: July 30, 2026

Application Due: August 13, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Multiple Sclerosis Exploration – Hypothesis 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 Exploration – Hypothesis 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 Multiple Sclerosis Exploration – Hypothesis 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/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Multiple Sclerosis Research Program (MSRP) Exploration – Hypothesis Development Award (EHDA) supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the Multiple Sclerosis (MS) research field. The studies supported by this award mechanism are expected to lay the groundwork for future avenues of scientific investigation. All applications must address at least one of the FY26 MSRP EHDA focus areas. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design.

The presentation of preliminary and/or published data is not required.

Distinctive Features: This funding mechanism includes two options: Established Investigator and New Investigator. The New Investigator option supports applicants early in their faculty appointments.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.00M to fund approximately eight MSRP Exploration – Hypothesis Development Award applications with total cost caps of $0.25M per award. The maximum period of performance is 2 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032.

Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 30, 2026

• Application Submission Deadline: 11:59 p.m. ET, August 13, 2026

• End of Application Verification Period: 5:00 p.m. ET, August 20, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027 Announcement Type: Initial Funding Opportunity Number: HT942526MSRPEHDA 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 Multiple Sclerosis Exploration – Hypothesis 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

Although a Principal Investigator (PI) may be eligible for both the Established Investigator and New Investigator options, only one may be chosen at the time of pre-application submission; the choice is at the PI’s discretion.

• Established Investigator

○ The PI must be an independent investigator at all career levels.

• New Investigator

○ At the application submission deadline, the PI must be an independent investigator within no more than five years from the start of their non-mentored position; and must not have received more than $300,000 in total direct costs for previous or concurrent MS research as a PI of one or more non-mentored, peer-reviewed grant(s) from any agency.

Independent investigators affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status. An investigator may be named on only one FY26 Multiple Sclerosis Research Program (MSRP) Exploration – Hypothesis Development Award (EHDA) application as an Established Investigator or New Investigator.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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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 MSRP. The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the MSRP in 2009 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the MSRP from FY09 through FY24 totaled $153.1 million (M). The FY26 appropriation is $15.0M.

The vision of the MSRP is to prevent, cure, reverse, or slow the progression and lessen the personal and societal impact of multiple sclerosis. The mission is to support pioneering concepts and high-impact research relevant to the prevention, etiology, pathogenesis, assessment, treatment, and ultimate cure of multiple sclerosis for the benefit of Service Members and their Families, Veterans and the American public.

3.1. Award History

The MSRP EHDA mechanism was first offered in FY16. Since then, 280 EHDA applications were received, and 64 were recommended for funding. The overall funding rate is 22.9%.

3.2. Intent of the Exploration – Hypothesis Development Award

The MSRP EHDA supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in the MS research field. The studies supported by this award mechanism are expected to lay the groundwork for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design. The presentation of preliminary and/or published data is not required.

The proposed research project must be innovative. Innovative research may examine a novel paradigm, challenge current paradigms, look at existing problems from novel perspectives or exhibit other highly creative qualities. Research that is an incremental advance beyond ongoing research or published data is not considered innovative and is not consistent with the intent of this award mechanism. It is the responsibility of the PI to clearly and explicitly articulate how the proposed research project is innovative in the field of MS research.

3.2.1. Focus Areas for the EHDA

To meet the intent of the funding opportunity, all applications submitted to the FY26 MSRP EHDA program announcement must address one or more of the following focus areas:

• Central Nervous System Repair, Protection and Regenerative Potential in MS Supports innovative mechanistic studies and translational approaches to promote axonal protection, regeneration, or remyelination in MS and/or relevant experimental models of demyelination. Examples of acceptable studies include, but are not limited to:

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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○ Obstacles to repair and approaches to overcome and achieve remyelination. Factors to be considered include extrinsic or intrinsic factors (e.g., mechanical, sex, aging, inhibitory signaling), trophic and inhibitory factors, and lifestyle factors.

○ Cell-cell interactions within the central nervous system.

○ Epigenetic regulation of cells within the central nervous system.

○ Drugs, biologics, and cell-based therapies that target the central nervous system.

○ Identification of factors that promote protection and repair.

○ Innate immune-mediated mechanisms within the central nervous system.

○ Development of imaging and non-imaging outcome measures of repair.

○ Development of new models that reflect disease progression.

Note: Will not support studies solely addressing developmental myelination, dysmyelination, basic mechanisms of demyelination, or peripheral immunomodulatory therapeutic strategies that limit tissue injury secondarily.

• Correlates of Disease Activity and Progression in MS Supports studies to identify and/or validate correlates of disease activity and progression using pre-existing specimens and/or data acquired from well-characterized, adequately controlled, and sufficiently powered patient cohorts.

○ Examples of acceptable cohorts for study include controlled clinical trials, observational studies and registries.

○ Analyses may utilize existing clinical data and outcome measures, specimens and/or imaging data.

○ Correlates include clinical outcome measures, patient self-reported measures, and imaging and non-imaging biomarkers.

○ Careful consideration should be given to potential confounders in the study population

(e.g., disease-modifying therapies).

Inclusion of information regarding the quality of the specimens, replication plan, assay validation, or context of use will be given special consideration.

Note: The study must leverage pre-existing specimens and/or data that are available at the time of application submission. The collection of new specimens and/or data is not permitted.

• Biology and Measurement of MS Symptoms Supports studies of MS symptoms, which may include pain, fatigue, depression, anxiety, incontinence, impaired mobility, and cognitive, motor, visual or sexual dysfunction, etc.

Examples of acceptable studies include, but are not limited to, the following:

○ Mechanisms underlying symptoms of MS.

○ Development of measurements for future interventional studies to alleviate symptoms.

○ Development and/or validation of outcome measures and tools for symptoms including wearables and/or remote data capture.

○ Observational studies on the prevalence or significance of symptoms including the contribution of comorbidities, lifestyle behaviors and high-risk populations. Careful

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Multiple Sclerosis Exploration – Hypothesis Development Award 8 consideration should be given to potential confounders in the study population (e.g., disease-modifying therapies), controls and/or accurate measures of symptoms.

Note: Will not support studies of disease-modifying therapies that secondarily impact MS symptoms.

• Mechanisms Contributing to, or Associated With, MS Etiology, Prodrome, Onset and Disease Course Supports studies to identify various factors and their roles in MS etiology, prodrome, onset, activity, disease worsening and progression. Examples of factors include, but are not limited to, the following:

○ Infections (such as Epstein-Barr Virus and SARS-CoV-2) and/or vaccines

○ CNS innate immunity and compliment activation

○ Genetics and/or epigenetics

○ Environment (such as toxins and military exposures)

○ Comorbidities

○ Health behaviors

○ Demographics (including, but not limited to, sex, race, ethnicity, age)

3.2.2. Key Elements for the EHDA

New Investigator Option: The FY26 MSRP EHDA mechanism encourages applications from investigators in the early stages of their MS research career. The New Investigator option is designed to support the continued development of promising independent investigators that are early in their faculty appointments. Applications from Established Investigators and New Investigators will be peer- and programmatically reviewed in separate groups. PIs applying under the New Investigator option are encouraged to strengthen their applications through collaboration with investigators experienced in MS research and/or possess other relevant expertise as demonstrated by a record of funding and publications.

For the “Correlates of Disease Activity and Progression in MS” focus area, applications must demonstrate access to the relevant specimens and/or data of the proposed cohort. Refer to Attachment 9: Letter(s) Confirming Access to Specimens and/or Data for more details.

Note for projects involving animal models of MS: Applicants should be prudent in the choice of animal model(s) for their proposed research project. Applicants must justify the relevance of their proposed animal model(s) to the specific aspect of human MS to be studied.

3.2.3. Other Important Considerations for the EHDA

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical trials are not allowed within this funding opportunity.

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 9

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $250,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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

Must not be requested for:

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

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FY26 Multiple Sclerosis Exploration – Hypothesis 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. Include the FY26 MSRP EHDA Focus Area under which the application will be submitted.

4.3. Full Application Components

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

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

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

(b) Attachments:

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

○ Attachment 1: Project Narrative (five-page limit): Upload as

“ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Describe the problem, question, or knowledge gap related to one or more of the FY26 MSRP EHDA Focus Areas the proposed research will address.

Clearly describe how the proposed research project directly addresses one or more of the focus areas. Present the ideas and scientific rationale behind the proposed research project, including relevant citations. Preliminary data is not required.

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

– Specific Aims: Concisely explain the proposed research project’s specific aims.

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E: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:%7E: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:%7E: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:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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FY26 Multiple Sclerosis Exploration – Hypothesis Development Award 11

– Research Strategy and Feasibility:

For all focus areas, the following criteria apply:

Describe the experimental design, methods, and analyses, including appropriate controls; and how they will achieve reproducible and rigorous results.

Describe the statistical analysis plan appropriate for the proposed research project.

If applicable, submit an Animal Research Plan (Attachment 8) and justify the relevance of the proposed animal model(s) to MS in humans.

If applicable, describe how the analysis will account for potential confounding factors in the study population (e.g., disease-modifying treatments).

Address potential problem areas and present alternative methods and approaches.

In addition, for research addressing the “Correlates of Disease Activity and Progression in MS” focus area:

Describe the proposed pre-existing cohort, including the type of specimens and/or data available.

Describe the size of the pre-existing cohort, including the intervention and control groups; and the expected statistical power of the study.

Explain how the cohort is appropriate for the study objective.

Outline plans and opportunities for eventual validation or independent replication of results in follow-up studies.

New Investigator Option: Collaboration with investigators experienced in MS research and/or possessing other relevant expertise is encouraged. If applicable, describe the specific contributions of the collaborator(s) to the research project. The application should describe how the collaboration(s) will augment the PI’s expertise to best address the research question. All New Investigator option applicants must meet specific eligibility criteria as described in Section 2.1.2, Principal Investigator.

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

If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding, or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

○ 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.

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FY26 Multiple Sclerosis Exploration – Hypothesis Development Award 12

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 (five-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.

Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g., for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Multiple Sclerosis Exploration – Hypothesis 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 National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

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

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

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

Background: State the FY26 MSRP EHDA Focus Area(s) to be addressed.

Describe how the proposed research project directly addresses one or more of the FY26 EHDA focus areas. Present the ideas and reasoning behind the proposed research project.

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

Specific Aims: State the specific aims of the study.

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

Innovation: Describe how the proposed research project is innovative in the field of

MS.

Impact: Explain how the proposed research project will produce results that are likely to translate, whether in the short term or long term, into advancing MS research, patient care and/or quality of life.

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?

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

– What is the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E: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:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 14

○ 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”.

Explain why the proposed research project is important and the impact it will have on one or more of the FY26 MSRP EHDA Focus Areas. Describe the potential impact(s) under two separate headings:

– Short-term impact: Detail the anticipated outcome(s) that will be directly attributed to the results of the proposed research project related to one or more of the FY26 MSRP EHDA focus areas.

– Long-term impact: Explain the anticipated long-term gains from the proposed research project, including how the new understanding will ultimately contribute toward the goal of advancing MS research, patient care, and/or quality of life related to one or more of the FY26 MSRP EHDA focus areas.

– If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

○ Attachment 7: Innovation Statement (one-page limit): Upload as “Innovation.pdf”.

– Describe how the proposed research project is innovative in the field of MS.

– Describe how the proposed research project introduces a new paradigm, challenges existing paradigms, or looks at existing problems or issues from a new perspective.

– Describe how the research represents more than an incremental advance on published data, ongoing research or current work in the applicant’s laboratory.

○ Attachment 8: Animal Research Plan (three-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 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.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E: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:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 15

– 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: Letter(s) Confirming Access to Specimens and/or Data: Upload as “Access.pdf”. (Attachment 9 is only applicable and required for applications addressing the “Correlates of Disease Activity and Progression in MS” focus area.)

If the application addresses the focus area “Correlates of Disease Activity and Progression in MS,” or if the application addresses more than one focus area and one of them is “Correlates of Disease Activity and Progression in MS,” provide a confirmation letter signed by the appropriate Institution Official who has the authority to confirm access to the proposed cohort specimens and/or data necessary to carry out the study.

The study must leverage pre-existing specimens and/or data that are available at the time of application submission. The collection of new sets of specimens and/or data is not permitted.

○ Attachment 10: Eligibility Statement (one-page limit): Upload as “Eligibility.pdf”.

(Attachment 10 is only applicable and required for applications to the New Investigator option.)

Provide a letter signed by the Department Chair, Division Chief, or equivalent official, verifying that the eligibility requirements will be met on the application submission deadline. The letter should verify that the PI is an independent investigator at the level of Assistant Professor (or equivalent), with no more than 5 years from the start of his/her independent faculty position (excluding time spent in residency, fellowship, or on family medical leave), and has not received more than $300,000 in total direct costs for previous or concurrent MS research as a PI of one or more non-mentored, peer-reviewed grant(s) from any agency. (Refer to Section 2.1, Eligible Applicants, for eligibility information.)

○ Attachment 11: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 12: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Required%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=federal%20government%20organization.-,Intramural%20DOW%20Organization%3A,-A%20subset%20of https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E: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:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Multiple Sclerosis Exploration – Hypothesis Development Award 16

(c) Additional Application Materials:

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

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

○ Biographical Sketch

○ Current/Pending Support

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

ii. Research & Related Budget

iii. Project/Performance Site Location(s)

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

4.4. Other Application Elements

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

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

External Link to the GAI

Grants.gov xternal ink to the GAI eBRAP.org https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:%7E:text=C.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E:text=B.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 17

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526MSRPEHDA 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 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:%7E:text=Obtain%20Unique%20Entity%20Identifier%20from%20System%20for%20Award%20Management https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_PreApp_Submission:%7E: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 Multiple Sclerosis Exploration – Hypothesis Development Award 18 eBRAP log number, application title and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire pre-application and full application submission process. Inconsistencies may delay application 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 Exploration – Hypothesis Development Award – Established Investigator (EHDA-EI)

New Investigator Exploration – Hypothesis Development Award – New Investigator (EHDA-NI)

5.3.2. Full Application Submission

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

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

5.3.3. Applicant Verification of Full Application Submission in eBRAP

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

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

5.4. Submission Dates and Times

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

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

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

5.5. Intergovernmental Review

Not applicable for this funding opportunity.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=federal%20government%20organization.-,Intramural%20DOW%20Organization%3A,-A%20subset%20of…