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

Clinical Trial Award

Funding Opportunity Number: HT942526MSRPCTA

Pre-Application Due: July 30, 2026

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

FY26 Multiple Sclerosis Clinical Trial 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 Trial 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 Clinical Trial 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 Multiple Sclerosis Clinical Trial Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of multiple sclerosis. All applications must address at least one of the FY26 MSRP CTA focus areas. Clinical trials may evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance and/or emerging approaches and technologies.

Distinctive Features: The FY26 CTA offers two funding levels. The following are generalized descriptions of the scope of research appropriate for each funding level:

• Funding Level 1 (CTA-FL1) supports small-scale, proof-of-principle clinical trials (e.g., pilot, first-in-human, phase 0) to demonstrate feasibility or inform the design of more advanced trials, or other clinical trials that are appropriate for this funding level. Preliminary data relevant to the proposed clinical trial are required.

• Funding Level 2 (CTA-FL2) supports larger-scale clinical trials at phase 1 or phase 2 that seek to show preliminary evidence of safety or efficacy (i.e., benefit of clinical or paraclinical outcomes) in relevant patient populations. Clear description and justification should be provided, which could include, but is not limited to, the intervention type, trial duration, sample size, outcome measures, assessment tools and frequency of assessment.

Preliminary data relevant to the proposed clinical trial in MS populations are required.

For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.0M to fund approximately two MSRP CTA-FL1 applications and one MSRP CTA-FL2 application with total cost caps of $1.0M for the CTA-FL1 and $2.0M for the CTA-FL2.

The maximum period of performance is 3 years for the CTA-FL1 and 4 years for the CTA-FL2. 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: HT942526MSRPCTA

Assistance Listing Number: 12.420

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

Independent investigators at all career levels are eligible to be named as a PI in a CTA-FL1 or CTA-FL2 application. Each investigator may be named as a PI on only one FY26 MSRP CTA-FL1 or CTA-FL2 application.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization,-%3AA%20foreign https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=federal%20government%20organization.-,Intramural%20DOW%20Organization%3A,-A%20subset%20of https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201.%0ARECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION

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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 a 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 MSRP did not receive appropriation in FY25. 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 CTA mechanism was first offered in FY20. Since then, 86 MSRP Clinical Trial Award applications were received, and 10 were recommended for funding.

3.2. Intent of the Clinical Trial Award

The MSRP Clinical Trial Award mechanism supports the rapid execution and analysis of clinical trials with the potential to have a significant impact on the treatment or management of multiple sclerosis (MS). Clinical trials may evaluate promising new products, pharmacologic agents (drugs, biologics, or medical devices), clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (i.e., pilot, first-in-human, phase 0) to demonstrate the feasibility or to inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

The FY26 CTA offers two funding levels. The following are generalized descriptions of the scope of research appropriate for each funding level:

• Funding Level 1 (CTA-FL1) supports small-scale, proof-of-principle clinical trials to demonstrate feasibility or inform the design of more advanced trials, or other clinical trials that are appropriate for this funding level. Preliminary data relevant to the proposed clinical trial are required.

• Funding Level 2 (CTA-FL2) supports larger-scale clinical trials at phase 1 or phase 2 that seek to show preliminary evidence of safety or efficacy (i.e., benefit of clinical or paraclinical outcomes) in relevant patient populations. Clear description and justification should be provided, which could include, but is not limited to, the intervention type, trial duration, sample size, outcome measures, assessment tools and frequency of assessment.

Preliminary data relevant to the proposed clinical trial in MS populations are required.

Only one funding level may be chosen per application, and the choice of application category is at the discretion of the applicant. The requested budget at each funding level must be justified and appropriate to the scope of the clinical trial proposed.

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3.2.1. Focus Areas for the CTA

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

• Promoting Repair, Neuroprotection and Remyelination in Multiple Sclerosis

○ Treatment may include, but is not limited to, drugs, biologics, devices, cell-based therapies, behavioral and lifestyle (e.g., exercise and diet) interventions.

○ Primary outcome measures should assess neuroprotection, regeneration or remyelination. Examples include, but are not limited to, neuroimaging and electrophysiology.

○ Additional outcome measures could include (as appropriate) clinical outcome measures, non-imaging biomarkers, markers of drug/biologic target engagement, pharmacokinetics/ pharmacodynamics, dose finding, safety, or other novel outcomes and biomarkers.

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

• Treatment of Multiple Sclerosis Symptoms

○ Interventions may include, but are not limited to, drugs and biologics; devices;

rehabilitation; behavioral and lifestyle (e.g., exercise and diet) strategies; bioengineering and neuroprosthetics.

○ Studies may address, but are not limited to, pain, fatigue, depression, anxiety, incontinence, impaired mobility, and cognitive, motor, visual or sexual dysfunction.

○ Outcome measures may include (as appropriate) clinical outcome measures;

neuroimaging, biomarkers; neurophysiologic measures; markers of target engagement;

pharmacokinetics/pharmacodynamics; dose finding; safety.

○ Careful consideration and description should be provided for all of the following:

population, intervention, controls, accurate measures of symptoms, statistical analysis and confounders.

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

3.2.2. Key Elements for the CTA

When developing applications for the MSRP CTA mechanism, the MSRP strongly encourages applicants to provide sufficient evidence to demonstrate the following key considerations:

• The availability of, and access to, the study population are sufficient.

• Intervention access and availability.

• The study team composition is appropriate for the proposed research.

• The statistical considerations, data management and analysis plans are appropriate for the proposed research.

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3.2.3. Other Important Considerations for the CTA

Funding from this award mechanism must support a clinical trial. Preclinical research is not supported in this funding opportunity.

Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other FY26 MSRP funding opportunities that may be more appropriate for such research.

An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency. Unless otherwise noted, for the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any equivalent international regulatory agency.

If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency by the Clinical Trial Award application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

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

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

3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is 3 years for the CTA-FL1 and 4 years for the CTA-FL2.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.0M for the CTA-FL1 and $2.0M for the CTA-FL2. 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost

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FY26 Multiple Sclerosis Clinical Trial Award 9

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 the CTA-FL1 and 4 years for the

CTA-FL2 .

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 Clinical Trial Award.

• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation).

Must not be requested for:

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

• Preclinical research costs.

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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 CTA 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 (20-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below. It should be evident that the proposed study meets the definition of a clinical trial.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical trial.

▪ Describe the preliminary studies and/or preclinical data that support the proposed clinical trial.

▪ Summarize key preclinical pharmacological findings, dosage studies and other clinical studies (if applicable) that examine the safety and stability (as appropriate) of the intervention.

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▪ Provide a summary of other relevant ongoing, planned or completed clinical trials, and describe how the proposed study differs.

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(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Intervention: Identify the intervention to be tested. Include the following components, as applicable: intervention type (drug, device, behavioral, surgical, etc.), complete name and composition, source, general concept of design, administration route. Description of devices should include general concepts of design, detailed operational instructions, any potential risks to users, and intended benefits. Other types of interventions should be fully described. Indicate who holds the intellectual property rights to the intervention, if applicable, and how the PI has obtained access to those rights, along with access to the intervention itself, for conduct of the clinical trial. As applicable, appropriate letters of commitment should be provided in Attachment 2: Supporting Documentation, demonstrating the study team’s access to the intervention(s) for the duration of the clinical trial. Describe how the intervention addresses current clinical needs and how it compares with currently available interventions and/or standards of care.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in the proposed clinical trial and detail the specific aims that will address the hypothesis/research question.

– Study Design: Describe the proposed clinical trial in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations of what study participants will experience.

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

▪ Describe the type of study to be performed. Outline the proposed clinical trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention that they will experience, and include the dose and administration route. Provide sufficient detail in chronological order for a person not involved in the study to understand what the study participant will experience.

▪ Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s), and follow-up procedures, including, if applicable, the biospecimen that will be collected, the collection schedule and amount. Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions). Define each arm/study group of the proposed trial, if applicable, and describe how group assignment will occur. Include a description of controls, as appropriate. Specify the approximate number of study participants to be enrolled. Indicate whether subjects, clinicians, data analysts and/or others will be blinded during the study. Describe any other measures to be taken to reduce bias.

▪ Define all endpoints/outcome measures relevant to the objectives of the study;

explain why they were chosen, and describe how, when and where they will be

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FY26 Multiple Sclerosis Clinical Trial Award 12 measured. Include all evaluations that will be made for study purposes. If questionnaires or other research data collection instruments will be used, include a copy of them in Attachment 2: Supporting Documentation. Describe the reliability and validity of the selected endpoints/outcome measures and evaluations, along with the applicable quality standards. Explain how the results of evaluations and/or data collection instruments will be used to meet the objectives of the study (or to monitor safety of human subjects).

▪ Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical trial. Additional details should be provided in Attachment 6: Study Population Recruitment and Safety Plan.

– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application.

▪ Include a complete power analysis to demonstrate that the proposed clinical trial’s anticipated sample size is appropriate to meet the objectives of the study.

Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

▪ 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. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

– Pitfalls and Mitigation Strategy: Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them.

○ 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.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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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 for the duration of the proposed clinical trial. 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.

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

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

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.

Questionnaires and Other Research Data Collection Instruments: Include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides or other instruments. This should include any drafts that are currently in use or underdevelopment.

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○ 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 CTA 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 rationale behind the proposed clinical trial.

– Hypothesis/Objective(s): State the objective of the proposed clinical trial and the hypothesis/research question to be addressed.

– Specific Aims: State the specific aims of the study.

– Study Design: Briefly describe the study design, including appropriate controls.

– Clinical Impact: Briefly describe how the proposed clinical trial will have a significant impact on the research field and/or treatment or management of multiple sclerosis.

– 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 clinical trial.

– Describe the intervention(s).

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

– What are the expected clinical applications and potential risks of the anticipated outcomes?

– Describe the ultimate applicability and impact of the proposed study and the anticipated outcomes to advancing research, patient care and/or quality of life?

– Describe the potential benefit of the proposed study and the anticipated outcomes to Service Members, Veterans and/or their Families.

○ Attachment 5: Statement of Work (five-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 Clinical Research and/or Clinical Trial Statement of Work. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Study Population Recruitment and Safety Plan (no page limit):

Upload as “StudyPopPlan.pdf”. Include the components listed below.

Enrollment Distribution: Provide 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. The enrollment table(s) should be appropriate to the objectives of the study.

Inclusion/Exclusion Criteria: List the inclusion and exclusion criteria for the proposed clinical trial. If limiting inclusion by age, race, ethnicity or sex, provide 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=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/Program.htm#:~:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~: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 Clinical Trial Award 15 strong rationale based on justification from scientific literature, preliminary data or other relevant considerations. List and describe any evaluations (e.g., laboratory procedures, history or physical examination) that are required to determine eligibility/ suitability for study participation and the diagnostic criteria for entry. Describe how the study population represents the population anticipated to benefit from the intervention.

Study Population Availability: Demonstrate that the research team has access to the proposed study population at each site. Describe the approximate number, pertinent demographic information and other relevant characteristics of the study population at each enrollment site. Indicate whether the actual size of available study population may be affected by ongoing clinical trials that compete for the same population. 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.

Recruitment and Retention Process: Explain methods for identification of potential study participants (e.g., medical record review, obtaining sampling lists, health care provider identification). Describe the recruitment process in detail; address who will identify potential study participants, who will recruit them, and what methods will be used to recruit them. Describe any special care (e.g., wound dressing assistance, transportation due to side effects of study intervention impairing ability to drive) or equipment (e.g., thermometers, telemedicine equipment) needed for human subjects enrolled in the study. If study participants will be compensated, include a detailed description of and justification for the compensation plan. Describe the methods that will be employed to retain participants within the study. Discuss past efforts in recruiting and retaining study participants for previous clinical trials (if applicable).

Address any potential barriers to accrual and plans for addressing unanticipated delays, including a mitigation plan for slow or low enrollment or poor retention.

Estimate the potential for participant loss to follow up and how such loss will be handled/mitigated. Indicate whether the study team has considered barriers to clinical trial participation and, if applicable, how the team aims to mitigate or overcome these barriers.

Women and Minorities Recruitment/Retention Strategy: Describe the strategy for recruitment, enrollment and retention specific to women and minorities in the clinical trial appropriate to the objectives of the study.

Informed Consent Process: Specifically describe the plan for obtaining informed consent from study participants; include information regarding the timing and location of the consent process. If minors or other populations that cannot provide informed consent are included in the proposed clinical trial, describe the plan to obtain assent (agreement) from those with capacity to provide it, or a justification for a waiver of assent. Appendix 6 of the GAI contains additional considerations unique to DOW-sponsored research.

Risks/Benefits Assessment:

▪ Foreseeable risks: Clearly identify all study risks, including potential safety concerns and adverse events. Address special precautions to be taken by the human subjects before, during and after the study (e.g., medication washout https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOD_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%206.%0ARESEARCH%20PROTECTIONS%20REVIEW%20REQUIREMENTS

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 Clinical Trial Award 16 periods, dietary restrictions, hydration, fasting, pregnancy prevention). If applicable, identify any potential risk to the study personnel.

▪ Risk management and emergency response: Appropriate to the study’s level of risk, describe how safety monitoring and reporting to the Institutional Review Board (IRB) and Regulatory Agency (if applicable) will be managed and conducted. Describe all safety measures to minimize and/or eliminate risks to human subjects and study personnel or to manage unpreventable risks. Discuss the overall plan for provision of emergency care or treatment for an adverse event for study-related injuries, including who will be responsible for the costs of such care.

▪ Potential benefits: Describe known and potential benefits of the study to the human subjects who will participate in the study. Articulate the importance of the knowledge to be gained as a result of the proposed research. Discuss why the potential risks to human subjects are reasonable in relation to the anticipated benefits to the human subjects and others that may be expected to result.

○ Attachment 7: Regulatory Strategy (no page limit): If submitting multiple documents, start each document on a new page. Combine and upload as a single file named “Regulatory.pdf”. Answer the following questions and provide supporting documentation as applicable.

State the product/intervention name.

For products/interventions that do not require regulation by a Regulatory Agency:

Provide evidence that the clinical trial does not require regulation by a Regulatory Agency. Submissions providing “not applicable,” “none,” or similar responses do not satisfy this request. No further information about this attachment is required.

For products that require regulation by a Regulatory Agency:

Describe the overall regulatory strategy and product development plan that will be performed during the project’s period of performance to support the planned product indication/label. Include, as appropriate, a description of the regulatory application submission strategy.

▪ State whether the product is FDA-approved, -licensed, or -cleared, and marketed in the United States. If the product is marketed in the United States, state the product label indication. State whether the proposed research involves a change to the approved label indication.

▪ If the product is not currently FDA-approved, -licensed, or -cleared, state the planned indication/use and whether an IND or IDE application was submitted. If an IND or IDE is required, the application must be submitted to the FDA prior to the FY26 MSRP Clinical Trial Award application submission deadline. The IND or IDE should be specific for the investigational product (i.e., not a derivative or alternate version of the product) and include an indication to be tested in the proposed clinical trial. Provide the date of submission, the application number and a copy of the FDA letter acknowledging the submission.

▪ Provide a summary of any meetings the research team had with regulatory agencies or consultants regarding the proposed research; include key outcomes, action items and recommendations. If available, provide a copy of the

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 Clinical Trial Award 17 communication from the FDA indicating the IND or IDE application is active/safe to proceed.

▪ If the clinical trial will be conducted at international sites, provide equivalent information and supporting documentation relevant to the product indication/label and regulatory approval and/or filings in the host country(ies).

○ Attachment 8: Study Personnel and Organization (no page limit): Start each document on a new page. Combine into one document and upload as “Personnel.pdf”. The Study Personnel and Organization attachment should include the components listed below.

Organizational Chart: Provide an organizational chart that identifies key members of the study team and an outline of the governing structure for multi-institutional studies. Identify collaborating organizations, centers, and/or departments, and name each person’s position on the project; include any separate laboratory or testing centers. Identify the data and clinical coordinating center(s) and note any involvement from Contract Research Organizations, as appropriate, including the location of the organization. If applicable, identify the Regulatory Agency sponsor and any external consultants or other experts who will assist with Regulatory Agency sponsor applications. While there is no specified format for this information, a table(s) or diagram is recommended.

Study Personnel Description: Describe the composition of the study team in enough detail to determine whether the team includes relevant subject matter expertise to accomplish the proposed work. Include the roles of individuals named in the organizational chart along with any external consultants or advisors who will provide critical guidance and input to the study team (e.g., statistician, regulatory expert, commercialization consultant, clinical ethicist, patient advocate). Study coordinator(s) should be included. Describe how the levels of effort for each individual are appropriate to successfully support the proposed clinical trial.

– Study Management Plan: Describe the day-to-day management of the proposed clinical trial. Provide a plan for ensuring the standardization of procedures among staff and across sites (if applicable). If the proposed clinical trial involves more than one institution, clearly describe the multi-institutional structure governing the research protocol(s) across all participating institutions. If applicable, describe how communication and data transfer between/among the collaborating institutions will occur, as well as how data, specimens and/or imaging products obtained during the study will be handled and shared. Provide a plan for resolving intellectual and material property issues among participating organizations.

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