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

Program Announcement for the Defense Health Agency

Hearing Restoration Research Program Focused Research Award

Funding Opportunity Number: HT942526HRRPFRA

Pre-Application Due: August 25, 2026

Application Due: September 10, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Hearing Restoration Focused 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 Focused 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 Hearing Restoration Focused 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.

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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 Hearing Restoration Focused Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Hearing Restoration Research Program (HRRP) Focused Research Award (FRA) supports promising research that accelerates drug discovery and therapeutic development for hearing restoration after military-relevant auditory system injury. The FRA may be used to support preclinical studies and/or clinical research. Research must align with at least one of the FY26 HRRP Focus Areas. The FRA cannot be used to support clinical trials, tinnitus research or vestibular research.

Distinctive Features:

• The FRA offers two Funding Levels to support research at different stages and the exploration/development of ideas of different maturity levels.

• Funding Level 2 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, and Personnel.

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

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $400K to fund approximately one FRA – Funding Level 1 application with a total cost cap of $400K and approximately $2.4M to fund approximately two FRA – Funding Level 2 applications with total cost caps of $1.2M per award. The maximum period of performance is 2 years for FRA – Funding Level 1 and 3 years for FRA – Funding Level 2. It is anticipated that awards made from this fiscal year 2026 (FY26) funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 25, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 10, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 15, 2026

• Peer Review: November 2026

• Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526HRRPFRA Assistance Listing Number: 12.420 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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 Hearing Restoration Research Program (HRRP). 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 HRRP in 2017 to provide support for hearing restoration research with the goal of reducing the burden of hearing loss on Service Members.

Appropriations for the HRRP from FY17 through FY24 totaled $70.0 million (M). The FY26 appropriation is $5.0M.

The HRRP aims to deliver groundbreaking solutions for hearing restoration by advancing the understanding, diagnosis, repair and regeneration of the auditory system.

Program priorities: There are no U.S. Food and Drug Administration (FDA)-approved drugs to treat hearing loss associated with sensory, neural, synaptic or central auditory dysfunction.

Although significant progress has been made in the molecular and cellular understanding of hearing loss and regeneration mechanisms in the inner ear, the majority of research is preclinical. The unique anatomical features of the inner ear render it difficult to access and not amenable for biopsy, creating a major hurdle for the clinical validation and translation of preclinical findings. Furthermore, it severely hinders the advancement of diagnostic capabilities beyond behavioral functional tests. As potential therapeutics to treat sensory, neural, synaptic or central auditory dysfunction are discovered, the ability to correctly match patient populations to appropriate interventions and accurately measure outcomes will be crucial for the success of clinical trials. The HRRP challenges the scientific community to design innovative research to overcome these major obstacles to hearing restoration.

3.1. Award History

The HRRP FRA mechanism was first offered in FY19. Since then, 241 FRA applications were received, and 53 were recommended for funding.

3.2. Intent of the FRA

The FRA supports promising basic through translational research that accelerates drug discovery and therapeutic development for hearing restoration after military-relevant auditory system injury.

The FRA may be used to support preclinical studies and/or clinical research. However, the FRA may not be used to conduct clinical trials.

Tinnitus or vestibular-related research is excluded.

3.2.1. Focus Areas

To meet the intent of the funding opportunity, applications to the FY26 HRRP FRA must address research in one or more of the following Focus Areas:

• Improve and accelerate the translation of biological regeneration/repair mechanisms into clinical applications. Research addressing the damage, repair and regeneration of the auditory system after military-relevant injuries is strongly encouraged.

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• Develop diagnostic tests that differentiate sensory, neural, synaptic and central processing disorders, that may inform applicability and outcomes for current or future hearing restoration therapeutics.

• Develop reliable in-vitro human models to facilitate the understanding, derivation and characterization of human auditory cells, and/or to facilitate the evaluation of hearing restoration therapies.

3.2.2. Key Elements for the FRA

• Experimental design requirements for studies that aim to develop therapeutic interventions:

○ If the therapeutic intervention aims to restore hearing after established hearing loss, the experimental design must enable or facilitate the eventual connection of the intervention to specific pathology (e.g., sensory, neural, synaptic or central auditory) and the application of the intervention to real-world injuries.

○ If the therapeutic intervention aims to preserve cells/synapses after acute auditory injury, to be administered soon after or even before the injury, the experimental design must demonstrate sufficient consideration of safety criteria that the intervention will have to meet in order for it to be given to people at risk of, but have not yet been diagnosed with, hearing loss.

Refer to Attachment 1, Project Narrative, for additional details on these requirements.

• Funding Levels: The FY26 HRRP FRA offers two Funding Levels to support research at different stages and the exploration/development of ideas of different maturity levels. The applicant will select the funding level during pre-application submission. The funding level should be selected based on the stage and maturity level of the research project, rather than the amount of the budget.

○ Funding Level 1 supports exploratory, high-risk/high-reward research that is in the earliest stages of idea development. Research must have the potential to yield new avenues of investigation, such as new approaches, new research tools or new paradigms.

– Preliminary data are allowed but not required. Applicants must provide solid rationale of the research idea, supported by literature.

– Investigators without prior experience with the auditory system are welcome to submit research ideas to Funding Level 1, provided that the investigating team has sufficient expertise to test the research idea.

○ Funding Level 2 supports the advancement of more mature research toward clinical translation.

– Funding Level 2 applications may focus on any phase of research from basic through translational.

– Preliminary data supporting the readiness and feasibility of the proposed research are required.

– PPIO: The FY26 HRRP FRA Funding Level 2 includes an option for two PIs. One

PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the

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

FY26 Hearing Restoration Focused Research Award 8 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 FRA

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. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants (31

USC 6304).

3.4. Funding Details

• Funding Level 1:

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $400,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 2 years.

• Funding Level 2:

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 $1,200,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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.

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Both PIs should contribute significantly to the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

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.

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

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

Direct Cost Restrictions: For the FRA, direct costs:

Must be requested for, if applying for Funding Level 2:

• 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), regardless of funding level:

• 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 HRRP FRA.

• 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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FY26 Hearing Restoration Focused Research Award 10

4. Application Contents and Format

4.1. Application Overview

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

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

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

4.2. Pre-Application Components

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

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted.

4.3. Full Application Components

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.

4.3.1. Full Application Components for the PI or Initiating PI

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

(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: Upload as “ProjectNarrative.pdf”.

Page Limit:

– Funding Level 1: six-page limit

– Funding Level 2: 12-page limit Describe the proposed project in detail using the outline below.

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FY26 Hearing Restoration Focused Research Award 11

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 is innovative, addresses an important need, and is supported by rationale, critical analysis of the literature, and as applicable, preliminary data. If proposing to develop an intervention, clearly state whether the intervention is for restoring hearing after established hearing loss or for preserving cells/synapses after acute auditory injury, to be administered soon after the injury.

Specific Aims: Describe the project’s specific aims.

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. 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 and ARRIVE guidelines 2.0. As applicable, include measures to be taken to reduce bias and achieve reproducible and rigorous results to facilitate evaluation.

If the intervention aims to restore hearing after established hearing loss, describe how the experimental design will enable or facilitate the eventual connection of a therapeutic intervention to specific pathology (e.g., sensory, neural, synaptic or central auditory) and the application of the intervention to real-world injuries. Describe plans to examine, document and interpret both auditory system pathology (e.g., damage to hair cells and/or synapses) and auditory function.

If the intervention aims to preserve cells/synapses after acute auditory injury, to be administered soon after or even before the injury, describe the safety criteria that the intervention will meet in order for it to be given to people at risk of, but have not yet been diagnosed with, hearing loss. Explain the rationale used to develop the criteria and describe any known side effects. Explain why the criteria will likely be accepted by the Regulatory Agency and potential users.

For the purposes of this funding opportunity, Regulatory Agency refers to the

FDA or any relevant international regulatory agency unless otherwise noted.

If the applicant has engaged the Regulatory Agency and received guidance on the acceptability of the proposed criteria, please include that information in the application.

If the applicant has engaged potential users to estimate/predict the level of user acceptance, please include that information in the application.

Research involving in vivo or in vitro models, including but not limited to cell lines, animals, organoids and other New Approach Methodologies (NAMs): Justify the selection of the proposed model(s). Explain why it was chosen over other models and how it is appropriate for addressing the study aims. As appropriate, consider including in vitro human models or other NAMs to accelerate clinical translation. For research involving animals, further details will be required in Attachment 8, Animal Research Plan, as applicable.

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 https://www.strobe-statement.org/ https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:%7E:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the

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FY26 Hearing Restoration Focused Research Award 12 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.

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.

Research involving 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=eBRAP.org.-,APPENDIX%204,-.%0AUSE%20OF https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Hearing Restoration Focused Research Award 13 published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

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

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.

Inclusion Enrollment Report (only required if clinical research 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.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a

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

FY26 Hearing Restoration Focused Research Award 14

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 ideas and scientific rationale behind the proposed research.

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

Specific Aims: State the specific aims of the study.

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

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 idea 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.

– The HRRP requires that all traumatic brain injury (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:

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://fitbir.nih.gov/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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

FY26 Hearing Restoration Focused Research Award 15

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 hearing restoration 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 the 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 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 (Audiology & Otolaryngology) 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.

https://cdmrp.health.mil/hrrp/pdfs/A%20Beginners%20Guide%20to%20Military%20Health%20Care%20(Audiology%20&%20Otolaryngology).pdf https://cdmrp.health.mil/hrrp/pdfs/A%20Beginners%20Guide%20to%20Military%20Health%20Care%20(Audiology%20&%20Otolaryngology).pdf

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

FY26 Hearing Restoration Focused Research Award 16

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

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: Partnership Statement (one-page limit): Upload as “Partnership.pdf”. (Attachment 9 is only applicable and required for applications choosing the PPIO.)

Describe how the partners’ combined experience will better address the research question and explain why the work should be done together rather than through separate efforts.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

(c) Additional Application Materials:

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

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Required%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=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/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

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

FY26 Hearing Restoration Focused Research Award 17

i. Research & Related Senior/Key Person Profile (Expanded) o Biographical Sketch o Current/Pending Support

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

ii. Research & Related Budget Initiating and Partnering PIs must have a separate budget and justification specific to their distinct portions of the effort that the applicant organization will submit as separate Grants.gov or eBRAP application packages. The Partnering PI should not include budget information for the Initiating PI, or vice versa, even if they are located within the same organization. Refer to Section 3.4, Funding Details, for detailed budget information.

iii. Project/Performance Site Location(s)

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

4.3.2. Full Application Components for the Partnering PI

Refer to the equivalent attachment above for details specific to each of the following application components. See Appendix 1 for a checklist of the full application components required for the Partnering PI.

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

(b) Attachments:

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”. Each PI must submit an identical copy of a jointly created SOW.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as

“RequiredReps.pdf”.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form: Upload as

“IGBudget.pdf”.

(c) Additional Application Materials:

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

xternal ink to the GAI

Grants.gov

External Link to the GAI eBRAP.org https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:%7E:text=C.-,Additional%20Application%20Materials,-The%20following%20are…