This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Vision Research Program

Clinical Trial Award

Funding Opportunity Number: HT942526VRPCTA

Pre-Application Due: July 28, 2026

Application Due: November 12, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Vision 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 Vision 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 Vision Clinical Trial Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Vision Research Program (VRP) 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 service-connected eye injury and visual dysfunction.

Research must align with at least one of the FY26 VRP Focus Areas.

Distinctive Features:

• For interventions that require Investigational New Drug (IND)/Investigational Device Exemption (IDE) or equivalent regulatory authorizations for clinical testing, the IND/IDE application or equivalent must be submitted to the relevant Regulatory Agency by the CTA application submission deadline. In addition, applicants must provide documentation of communication from the Regulatory Agency indicating that the IND/IDE or equivalent is active/safe to proceed by March 1, 2027, in order for the CTA application to be considered for funding. Refer to Attachment 7: Regulatory Strategy for further details.

• Scored peer review criteria include Clinical Impact; Research Strategy and Feasibility;

Recruitment, Accrual, Retention; Regulatory Strategy and Transition Plan; Statistical Plan and Data Analysis; Ethical Considerations; Personnel and Communication.

• Programmatic review criteria include adherence to the intent of the CTA, contribution to program portfolio, relative impact and relevance to military health.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.6 million (M) to fund approximately one Clinical Trial Award application with total cost caps of $2.6M. The maximum period of performance is 3 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 (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 28, 2026

• Invitation to Submit an Application: September 2026

• Application Submission Deadline: 11:59 p.m. ET, November 12, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 17, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526VRPCTA

Assistance Listing Number: 12.420 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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

FY26 Vision Clinical Trial Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

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#_Definition_List:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization,-%3AA%20foreign https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201.%0ARECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION

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

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

FY26 Vision Clinical Trial Award 6

3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Vision Research Program (VRP). 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 VRP in 2009 to target the various causes, effects and treatment of visual injury resulting from exposures to the elements during combat operations and damage from explosive devices. Appropriations for the VRP from FY09 through FY24 totaled $204.95 million (M). The FY26 appropriation is $10M.

The goal of the VRP is to transform visual system trauma care for our Armed Forces and the nation. Visual system trauma includes both injury of the ocular system and vision dysfunction as a result of traumatic brain injury (TBI).

The FY26 VRP challenges the scientific community to design innovative research that will significantly advance understanding, prevention, diagnosis, mitigation and/or treatment of eye injury or visual dysfunction associated with military exposure.

3.1. Award History

The VRP Clinical Trial Award (CTA) mechanism was first offered in FY17. Since then, 25 CTA applications were received, and 6 were recommended for funding.

3.2. Intent of the Clinical Trial Award

The VRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of service-connected eye injury and visual dysfunction. Clinical trials may be designed to 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 inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

3.2.1. Focus Areas for the CTA

To meet the intent of the funding opportunity, applications to the FY26 VRP CTA must address research in one or more of the following focus areas:

• Understand and treat eye injury or visual dysfunction as related to military exposure

• Diagnose, stabilize and treat eye injuries in austere environments and prolonged care settings

• Restore visual function after military exposure-related vision loss or severe visual impairment https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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

FY26 Vision Clinical Trial Award 7

3.2.2. Key Elements for the CTA

• Regulatory Agency: 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.

• If an IND/IDE or equivalent, is required, a regulatory application must be submitted to the relevant Regulatory Agency by the CTA application submission deadline. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

• Applicants must provide documentation of communication from the Regulatory Agency indicating that the IND/IDE or equivalent, is active/safe to proceed by March 1, 2027, in order for the CTA application to be considered for funding. Refer to Attachment 7:

Regulatory Strategy for further details.

• The proposed clinical trial is expected to begin no later than six months after the award date.

• When developing applications for the CTA, the VRP 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.

○ Statistical considerations, data management and analysis plans are appropriate for the proposed research.

3.2.3. Other Important Considerations for the CTA

Funding from this award mechanism must support a clinical trial. Preclinical research or non-trial clinical 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 VRP 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.

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).

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource

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

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

FY26 Vision Clinical Trial Award 8

3.4. Funding Details

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $2.6M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

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

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

Must be requested for:

• Travel costs for up to two investigators to present project information or disseminate results at one DOW-sponsored meeting to be specified by the program office during award negotiations (e.g., the Military Health System Research Symposium). For planning purposes, it should be assumed that the meeting will be held in the Central Florida Area.

Costs associated with travel to this meeting should be included in year 2 or 3 of the budget.

This is in addition to the scientific/technical meeting described below.

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year in addition to the required meeting described above to present project information or disseminate project results from the VRP CTA.

• 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.

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

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

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

FY26 Vision Clinical Trial Award 9

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.

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (two-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Objective/Rationale: Describe the objective and rationale of the proposed clinical trial, including background and key preliminary data. Specify the intervention to be investigated, the phase of the clinical trial and the primary and secondary outcomes.

Briefly describe the overall trial design. Clearly demonstrate that the proposed trial should be conducted, is ready to be initiated and is feasible.

○ Impact: Explain the potential of the proposed clinical trial to improve outcomes after vision injury. Be brief but as specific as possible.

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title, and reference source, including volume, chapter, page numbers and publisher, as appropriate).

○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

○ Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished.

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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

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

FY26 Vision Clinical Trial Award 10

4.3. Full Application Components

Applicants must receive an invitation to submit a full application. Uninvited full application submissions will be rejected.

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.

▪ 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.

▪ Describe how the intervention addresses current clinical needs, improves upon available interventions and/or standards of care, or addresses controversies and treatment issues within the field.

▪ 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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

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

FY26 Vision Clinical Trial Award 11

▪ 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.

– 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. 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 trials, such as those described in the CONSORT and SPIRIT guidelines.

▪ 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 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.

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

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

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

FY26 Vision Clinical Trial Award 12

▪ 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.

▪ For phase 3 clinical trials, describe plans for the valid and sufficiently powered analysis of group differences on the basis on sex, race and/or ethnicity as appropriate for the scientific goals of the study. Refer to the CDMRP Directive on the Inclusion of Women and Minorities as Subjects in Clinical Research for additional information on the requirements for phase 3 studies.

– 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.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work 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 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/Program.htm#:~:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

FY26 Vision Clinical Trial Award 13 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.

Commercial Entity Letters of Commitment (if applicable) (two-page limit per letter is recommended): If the proposed study involves use of a commercially produced investigational drug, device or biologic, provide a letter of commitment from the commercial entity indicating the availability of the product for the duration of the proposed clinical trial, support for the proposed phase of research and support for the indication to be tested.

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 (NIH) Data Management and Sharing Plan or duplicate the Data Management Plan, which will be requested only after a recommendation for funding is made.

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

Questionnaires and Other Research Data Collection Instruments (if applicable): 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.

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

Write the technical abstract using the outline below. Programmatic Reviewers rely on the technical abstract for appropriate description of the project’s key aspects. Clarity and completeness within the space limits are highly important.

– Background: 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.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~: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 Vision Clinical Trial Award 14

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

– Expected Outcome: Describe the expected outcome(s) of the proposed research.

○ 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. Why is it needed?

Describe the intervention(s).

Describe the phase of the trial and the projected timeline for achieving clinical applications.

Explain the expected outcome.

○ 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 Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work. Include milestones for data or research resource(s) sharing.

If conducting TBI-related research: The VRP requires that all TBI-related clinical research with at least 50 subjects funded by this program be shared through the jointly supported DOW-NIH Federal Interagency TBI Research Information System (FITBIR).

FITBIR-eligible research should include the following subtasks:

FITBIR investigator and study registration within the first 30 days of the award

Sharing of draft data collection forms with FITBIR

Annual FITBIR data submission

○ 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 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 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://fitbir.nih.gov/ 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-,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 Vision Clinical Trial Award 15 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 General Application Instructions, 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 General Application Instructions 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 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 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 Vision Clinical Trial Award 16 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 numbers and types of studies proposed to reach approval, licensure, or clearance, the types of Regulatory Agency meetings that will be held/planned and the submission filing 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. Indicate whether the proposed research involves a change that increases the risks associated with using the product. State whether the product is being promoted for off-label use (where promotion involves the sale of a marketed product).

If the product is not currently FDA-approved, -licensed, or -cleared, state the planned indication/use. Indicate whether the product would be classified as a drug, device, biologic or combination product. Indicate whether the FDA has confirmed the proposed classification. Identify the regulatory sponsor. Include a signed sponsor commitment letter acknowledging the regulatory sponsor’s understanding of all sponsor responsibilities and commitment to oversee execution of the study.

If an IND or IDE is required, the application must be submitted to the FDA prior to the FY26 VRP CTA 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. If there are any existing cross-references in place, provide the application number(s) and associated sponsor(s). Provide an explanation of the status of the application (e.g., past the critical 30-day period, pending response to questions raised by the FDA, on clinical hold, on partial clinical hold). If

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

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

FY26 Vision Clinical Trial Award 17 the IND or IDE application has been placed on clinical hold or partial hold, explain the conditions that must be met for release of the hold. Provide a summary of any previous meetings with the FDA on development of this product. A copy of the FDA meeting minutes should be included if available. Provide copies of communications from the FDA relevant to the most recent status of the IND or IDE application.

If available, provide a copy of the communication from the FDA indicating the IND or IDE application is active/safe to proceed. It not available at the time of application submission, applicants must submit it to the CDMRP Help Desk (help@eBRAP.org) by March 1, 2027, in order for the CTA application to be considered for funding.

If an active IND or IDE for the investigational product is in effect but an amendment is needed to include the proposed trial, describe the type and nature of the amendment(s) and the timeline for submission. Indicate whether the amendment increases the risk of the intervention.

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…