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

Translational Research Award

Funding Opportunity Number: HT942526VRPTRA

Pre-Application Due: July 28, 2026

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

FY26 Vision Translational Research Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Translational Research Award; provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Vision Translational Research Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

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

FY26 Vision Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Vision Research Program (VRP) Translational Research Award (TRA) supports translational research that transforms a promising discovery into new drugs, devices or clinical practice guidelines that are ready for definitive testing in clinical trials during or by the end of the period of performance. The TRA may be used to support preclinical studies, clinical research or a pilot clinical trial, but not a full-scale clinical trial. Research must align with at least one of the FY26 VRP Focus Areas.

Distinctive Features:

• If developing new drugs or device(s), the research team must include expertise in the regulatory approval process.

• The TRA includes a Partnering Principal Investigator (PI) Option (PPIO) for two PIs, an Initiating PI and a Partnering PI.

• Scored peer review criteria include Research Idea/Rationale, Research Strategy and Feasibility, Impact, Personnel and Post-Award Transition Plan.

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

• The VRP may share FY26 TRA applications and reviews with the National Eye Institute (NEI) for independent funding consideration.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $1.6 million (M) to fund approximately one Translational Research Award application with a total cost cap of $1.6M. 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: HT942526VRPTRA

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

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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 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.

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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 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 $204.95M.

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 Translational Research Award (TRA) mechanism was first offered in FY13. Since then, 125 TRA applications were received, and 30 were recommended for funding.

3.2. Intent of the Translational Research Award

The VRP TRA supports translational research that transforms a promising discovery into new drugs, devices or clinical practice guidelines that are ready for definitive testing in clinical trials during or by the end of the period of performance.

The TRA may be used to support preclinical studies, clinical research or a pilot clinical trial (PCT). Applications proposing a PCT must also include non-PCT, translational research component(s) (e.g., preclinical studies, clinical research).

The TRA may not be used to support full-scale clinical trials.

3.2.1. Focus Areas for the TRA

To meet the intent of the funding opportunity, applications to the FY26 VRP TRA 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=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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3.2.2. Key Elements for the TRA

• If developing new drugs or device(s), the research team must include expertise in the regulatory approval process.

• If applicable, the proposed research should enable the submission of an Investigational New Drug (IND)/Investigational Device Exemption (IDE) application or international equivalent to a Regulatory Agency during or by the end of the period of performance. 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.

• Pilot Clinical Trial: The VRP defines a PCT as a limited clinical testing of a novel intervention that is designed to inform the feasibility, rationale and design of full-scale clinical trials. Applications that propose PCTs will have additional submission requirements and review criteria.

• PPIO: The FY26 VRP TRA includes an option for two Principal Investigators (PIs). One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory and administrative requirements. For individual submission requirements for the Initiating PI and Partnering PI, refer to Section 5.3, Submission Instructions.

3.2.3. Other Important Considerations for the TRA

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

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.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.6M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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FY26 Vision Translational Research Award 8 accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

If choosing the PPIO, the cost cap applies to the combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI. A separate award will be made to each PI’s organization. Both PIs should contribute significantly to the research, and funding should be divided accordingly unless otherwise warranted and clearly justified.

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 or, if choosing the PPIO, up to one investigator per award, 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 or, if choosing the PPIO, one investigator per award, to travel to one scientific/technical meeting per year to present project information or disseminate project results from the VRP TRA.

• Research subject compensation and reimbursement for study-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.

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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

The PI, or Initiating PI, if choosing the PPIO, must submit the following pre-application components.

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

• Preproposal Narrative (one-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 rationale of the proposed research including key preliminary data if applicable. Concisely state the project’s objective(s)/hypothesis(es) and specific aims. Do not go into details of experimental design.

○ Impact: Explain the anticipated impact of the proposed research on vision injury research or patient care. Be brief but as specific as possible.

○ Adherence to the Intent of the TRA: Explain how the proposed research transforms a promising discovery into new drugs, devices or clinical practice guidelines that are ready for definitive testing in clinical trials. As applicable, explain how the proposed research will support the submission of an IND/IDE application during or by the end of the period of performance.

• 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.

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

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FY26 Vision Translational Research Award 10

○ 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.

4.3. Full Application Components

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

4.3.1. Full Application Components for the PI or (if choosing the PPIO) Initiating PI

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

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

Describe the proposed project in detail using the outline below.

− Research Idea/Rationale: Explain the research idea. Clearly state the objective(s) to be reached and/or the hypothesis(es) to be tested. Explain how the proposed research transforms a promising discovery into new drugs, devices or clinical practice guidelines that are ready for definitive testing in clinical trials during or by the end of the period of performance. Explain how the proposed research is supported by rationale, critical analysis of the literature and preliminary data. Describe any element(s) of the proposed research that is innovative or offers significant improvement over existing ideas or solutions.

− Specific Aims: Describe the project’s specific aims. As applicable, clearly identify which aim involves a PCT. Applications proposing a PCT must also have non-PCT translational research component(s) (e.g., preclinical studies, clinical research).

− Research Strategy: Describe the experimental design, methods and analyses, including controls, in sufficient detail so that the appropriateness and feasibility of the research strategy can be fully evaluated. Demonstrate sufficient understanding and consideration of regulatory approval requirements and process. 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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FY26 Vision Translational Research Award 11 guidelines 2.0. As applicable, include measures to be taken to reduce bias and achieve reproducible and rigorous results to facilitate evaluation.

▪ Research involving in vivo or in vitro models, including but not limited to cell lines, animals, organoids and other New Approach Methodologies:

Justify the selection of the proposed model(s). Explain why it was chosen over other models, how it is appropriate for addressing the study aims. For research involving animals, further details will be required in Attachment 8, Animal Research Plan.

▪ If proposing clinical research:

❖ Describe the study population. Describe the rationale for the selection of subjects/samples/data. Explain how the selection is appropriate for addressing the study aims. Provide a detailed plan for the recruitment of human subjects or the acquisition of samples, including evidence that the research team has access to subjects, samples and/or data.

❖ Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial and ethnic group. If limiting inclusion of any group by sex, race or ethnicity, provide justification related to the scientific goals. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of Attachment 2: Supporting Documentation.

▪ If proposing a PCT:

❖ Describe the design of the PCT and outline the proposed methodology in sufficient detail to show a clear course of action. Explain how the PCT will inform the feasibility, rationale and design of full-scale clinical trials. Identify the intervention(s) to be tested, projected outcomes, study variables, controls and endpoints. Demonstrate the availability of, and access to, the intervention to be tested.

❖ Applications proposing a PCT must also submit Attachment 9, Human Subjects/Samples Acquisition and Safety Procedures and Attachment 10, Regulatory Strategy. Do not duplicate information from Attachments 9 and 10 in the Project Narrative.

❖ The Project Narrative is not the formal clinical trial protocol. If recommended for funding, the clinical trial protocol will be requested during award negotiations.

▪ Statistical Plan: Describe the statistical plan, including power analysis, and the rationale for the statistical methodology.

▪ Address potential pitfalls and problem areas, and present alternative methods and approaches.

▪ Explain how the research can be completed within the proposed period of performance.

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▪ 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.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

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

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI meets the eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

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

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

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FY26 Vision Translational Research Award 13

Inclusion Enrollment Report (only required if clinical research or a pilot clinical trial is proposed): Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the “Public Health Service (PHS) Inclusion Enrollment Report”, a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race and ethnicity. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from IRB review) are exempt from this requirement.

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

○ 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.

Research Idea/Rationale: Present the idea and scientific rationale behind the proposed research. Clearly explain what promising discovery is being translated and how the proposed research will ready the discovery for definitive clinical testing.

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

Specific Aims: State the specific aims of the study. As applicable, clearly identify which aim involves a PCT.

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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FY26 Vision Translational Research Award 14

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

Be as specific as possible.

○ 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 ideas and rationale for the proposed research. Why is it needed?

– Explain the objective(s) and study design of the proposed research. What questions will it answer, and how will it answer them?

– Explain the expected outcome. At the end of the project, what new knowledge or new capability will have been gained?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

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

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

– 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: Impact Statement (one-page limit): Upload as “Impact.pdf”.

Describe the anticipated impact of the proposed work on vision injury research and/or patient care. Be as specific as possible. Write with a broad audience in mind, including readers without a background in science or medicine.

– Explain who will benefit from the proposed research and how they will benefit.

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

○ Attachment 7: Relevance to Military Health Statement (one-page limit): Upload as “Military.pdf”. Explain how the proposed research and anticipated outcomes will benefit Service Members, Veterans and/or their Families. Discuss how the proposed research is applicable to operational performance, medical readiness and/or quality of life.

As applicable, include the elements below:

− If active-duty military, Veteran or military Family member population(s) will be used in the proposed research project, describe the population(s), the appropriateness of the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://fitbir.nih.gov/ https://fitbir.nih.gov/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Vision Translational Research Award 15 population(s) for the proposed research, and the feasibility of using the population. If a non-military population will be used for the proposed research project, explain how the population simulates the targeted population.

− If applicable, provide a description of how the knowledge, information, products or technologies gained from the research could be implemented in a dual-use capacity to both benefit the civilian population and address a military need.

− If the ultimate outcome of the research is intended to be applicable in the military operational environment (e.g., battlefield, Battalion Aid Stations, Forward Support Medical Battalions), identify any element(s) or special consideration(s) related to the intended applicability. Applicants may consult A Beginner’s Guide to Military Healthcare System for descriptions of the range of military operational environment and types of care provided.

○ Attachment 8: Animal Research Plan (no page limit): Upload as “AnimalResPlan.pdf”. (Attachment 8 is only applicable and required for applications proposing animal studies.) If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application. Consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve reproducible and rigorous results for each proposed animal study; do not duplicate information from the Project Narrative:

− Briefly describe the research objective(s) of the animal study.

− Summarize the animal species, strains and model(s) to be used. Identify the ages, sex and total number of animals by species to be used.

− Summarize the procedures to be conducted, the endpoints and outcome measures.

− Describe how the study will be controlled.

− Describe the randomization and blinding procedures for the study, and any other measures to be taken to minimize the effects of subjective bias during animal treatment and assessment of results. If randomization and/or blinding will not be utilized, provide justification.

− Provide a sample size estimate for each study arm and the method by which it was derived, including power analysis calculations.

− Describe how data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, statistical methods for data analysis and identification of the primary endpoint(s).

○ Attachment 9: Human Subjects/Samples Acquisition and Safety Procedures (no page limit): Upload as “HumProc.pdf”. (Attachment 9 is only applicable and required for applications proposing a PCT.)

Include the components listed below as applicable. Do not duplicate information from the Project Narrative.

https://cdmrp.health.mil/vrp/pdf/A%20Beginner's%20Guide%20to%20Army%20Healthcare%20System.pdf https://cdmrp.health.mil/vrp/pdf/A%20Beginner's%20Guide%20to%20Army%20Healthcare%20System.pdf https://arriveguidelines.org/arrive-guidelines

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FY26 Vision Translational Research Award 16

– Study Population and Recruitment Process: Describe the study population, criteria for inclusion/exclusion and the methods that will be used for recruitment/accrual/retention of human subjects.

▪ Demonstrate that the research team has access to the proposed study population. If applicable, discuss past efforts in recruiting human subjects from the target population for previous clinical studies. Address any potential barriers to accrual and plans for addressing unanticipated delays.

▪ Describe how the subject-to-group assignments process will be conducted (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group or other procedures), if applicable.

▪ Include a detailed description of and justification for the compensation plan if the human subjects will be compensated for participation in the study.

▪ For clinical studies proposing to recruit military or VA personnel, refer to the General Application Instructions, Appendix 4, for more information on recruitment process and considerations, payment and confidentiality. If a non-military non-VA population will be used for the proposed clinical study, explain how results obtained will be applicable to military or VA personnel.

– Informed Consent Process: Describe the plan for obtaining informed consent from human subjects. Include relevant draft process documents. Provide a draft, in English, of the Informed Consent Form.

– Screening Procedures: List and describe any evaluations that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry.

– Risks/Benefits Assessment: Identify all foreseeable study risks (physical, psychological, social, legal and other). Discuss the importance of the knowledge to be gained in relation to the risks to subjects. Clearly describe measures of risk management and plans for emergency response. Describe known and potential benefits, which may or may not be direct to subjects, in relation to risks.

Note: Payment and/or other compensation for participation are not considered benefits and must be addressed in Study Population and Recruitment Process.

– Human Samples: Describe the types and source(s) of specimens, records or data to be collected and evaluated. Include information about specimen storage (i.e., location, duration, special handling conditions). Describe the identifiers that will be associated with the human specimens and data and provide a list of who has access to subjects’ identities. Describe how individually identifiable private information will be protected.

○ Attachment 10: Regulatory Strategy (no page limit): Upload as “Regulatory.pdf”.

(Attachment 10 is only applicable and required for applications proposing a PCT) If submitting multiple documents, start each document on a new page. Combine and upload as a single file. Answer the following questions and provide supporting documentation as applicable.

– State the product/intervention name.

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

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FY26 Vision Translational Research Award 17

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:

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 or a change that increases the risks…