HT942526ORPARA_GG.pdf

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

Program Announcement for the Defense Health Agency

Orthopaedic Research Program

Applied Research Award

Funding Opportunity Number: HT942526ORPARA

Pre-Application Due: August 19, 2026

Application Due: November 18, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Orthopaedic Applied 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 Applied 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

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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 Orthopaedic Applied Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The Orthopaedic Research Program (ORP) Applied Research Award (ARA) seeks applied research applications focused on advancing optimal treatment and restoration of function for individuals with orthopaedic injuries sustained during combat or service-related activities.

Distinctive Features:

• Applied research is defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new knowledge products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance and/or emerging approaches and technologies.

• Preliminary data is required.

• Military relevance: the ORP expects that research findings benefit Service Members, their families, Veterans and the general public.

• Clinical research is not allowed unless exempt under Title 32, Code of Federal Regulations, Part 219, Section 104(d) (32 CFR 219.104[d]) or eligible for expedited review under 32 CFR

219.110 or 21 CFR 56.110.

• Clinical trials are not allowed.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $3.8M to fund approximately four ARA applications with total cost caps of $950,000 per award. The maximum period of performance is 3 years. 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 (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 19, 2026

• Invitation to Submit an Application: September 25, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 18, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 23, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526ORPARA

Assistance Listing Number: 12.420

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

There is no limitation on the number of applications for which an investigator may be named PI.

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 Orthopaedic Research Program (ORP). 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 ORP in 2009 to provide support for research of high potential impact and exceptional scientific merit focused on optimizing recovery and restoration of function for military personnel with orthopaedic injuries sustained in combat or service-related duties. Appropriations for the ORP from FY09 through FY24 totaled $548.5 million (M). The FY26 appropriation is $20M.

The FY26 ORP challenges the scientific community to address the most significant gaps in care for the leading burden of injury and for facilitating return to duty. The program intends to support high-impact and clinically relevant research to advance treatment and rehabilitation from orthopaedic injuries (excluding spinal cord injuries) sustained during combat and service-related activities to maximize return to duty. It is expected that research findings would also benefit the general population. Applications involving interdisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA) and/or other federal agencies are highly encouraged.

FY26 congressional language for the Arthritis Research Program directed that arthritis research shall not be considered by other CDMRP peer reviewed programs such as ORP. The FY26 ORP will consider research that addresses conditions or health abnormalities related to arthritis.

3.1. Award History

The ORP Applied Research Award (ARA) mechanism was first offered in FY15. Since then, 485 ARA applications were received, and 81 were recommended for funding.

3.2. Intent of the Applied Research Award

The FY26 ORP ARA seeks applied research applications focused on advancing optimal treatment and restoration of function for individuals with orthopaedic injuries sustained during combat and service-related activities. The ORP encourages applicants to address how the proposed research will support patient care and allow patients to more quickly return to duty/work. The program expects that any research findings will also provide benefit to the general population.

The FY26 ORP ARA focuses on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new knowledge products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance and/or emerging approaches and technologies.

Research proposed under the FY26 ORP ARA may include small- to large-scale projects.

Studies allowed under the FY26 ORP ARA may include, but are not limited to:

• Evaluation, maturation and/or down-selection of potential product candidates (drugs, biologic constructs or devices/systems) in vitro and/or in vivo.

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• Preparation activities needed to support a future clinical trial or regulatory submission.

Awards may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind.

3.2.1. Focus Areas for the ARA

Applications submitted to the FY26 ORP ARA must address one or more of the following focus areas:

• Battlefield Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections on the battlefield, which may include prevention, early detection or improved eradication. The ORP encourages applications proposing alternatives to systemic antibiotic delivery. The ORP will not consider applications proposing strategies not feasible in a battlefield or combat environment.

• Composite Tissue Regeneration: Advanced tissue regeneration therapeutics in composite tissue for the restoration of traumatically injured extremities. The ORP encourages applications proposing techniques aimed at improving outcomes following high-energy extremity trauma, with a focus on improving wound healing and neuromuscular recovery following composite tissue loss and segmental bone loss. The ORP will not consider tissue engineering studies that solely address bone, cartilage, muscle or nerve.

• Limb Stabilization and Protection: Development and/or clinical evaluation of rapid limb stabilization and novel wound protectants for severely or critically wounded limbs to enable prolonged care and eventual transport to the point of definitive treatment. The ORP will not consider applications proposing interventions that solely address infection.

• Osteointegration Outcomes: Identification of best practices to optimize outcomes of patients who have percutaneous osseointegrated prosthetic limbs, e.g., infection, rejection, adapters and fail-safe devices, clinical outcomes.

• Return-to-Duty Strategies: Optimization and/or validation of decision-support tools, interventions and/or rehabilitation strategies that can retain a Service Member on duty, enable them to return to duty within one year of injury or avoid reinjury for common combat-related musculoskeletal injuries. Applications must describe the current standard of care and the proposed rehabilitation strategy, as applicable. The ORP encourages applications proposing treatment strategies for use along the continuum of care, capabilities for diagnosis of underlying pathology and efficacy of intervention measurements. The ORP will not consider applications proposing biomarker studies.

3.2.2. Key Elements for the ARA

• Impact: Upon successful completion, the proposed research is expected to yield knowledge products, approaches or technologies that have the potential to advance toward clinical translation. Strong transition plans are expected.

• Preliminary Data: Applications must include preliminary and/or published data relevant to the proposed research and demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of literature.

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• Military Benefit: Research outcomes must benefit Service Members, their families and Veterans, as well as the general public. PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. 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.

3.2.3. Other Important Considerations for the Applied Research Award

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 to the FY26 ORP ARA mechanism must support preclinical applied research.

Clinical research studies are not allowed within this funding opportunity unless exempt under 32 CFR 219.104[d] or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.

Clinical trials are not allowed within this funding opportunity.

Applicants seeking support for clinical trials and/or clinical research projects should consider the FY26 ORP Clinical Research Award (Funding Opportunity Number HT942526ORPCRA) mechanism.

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

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the 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 $950,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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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 the PI to present project information or disseminate project results at one DOW-sponsored meetings (e.g., the Military Health System Research Symposium) during Year 3 of the project’s period of performance. For planning purposes, it should be assumed that the meeting will be held in the National Capital or Central Florida areas. These travel costs are in addition to those allowed for annual scientific/technical meetings.

Must not be requested for:

• Clinical trial costs.

• Clinical research costs unless exempt under 32 CFR 219.104[d] or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.

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4. Application Contents and Format

4.1. Application Overview

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

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

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

4.2. Pre-Application Components

Pre-application submissions must include the following components.

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:

○ Background/Research Problem/Rationale: Describe the research problem to be addressed by the proposed study and the rationale on which it is based. State how the proposed research addresses the intent of the award mechanism.

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

○ Specific Aims and Study Design: Concisely state the specific aims of the study and describe the scientific approach and how it will accomplish the study aims. Include a description of controls, as appropriate.

○ Impact: State the FY26 ORP ARA Focus Area(s) addressed by the proposed research.

Briefly describe how the proposed project will have an impact on patient care for those who have sustained traumatic orthopaedic injuries, service-related or otherwise.

• 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.

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○ 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.

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.

Background: Establish the relevance of the study to an FY26 ORP ARA Focus Area. Describe in detail the rationale for the study questions and/or study hypotheses. Cite relevant literature. Include preliminary data that led to the development of the proposed project. State how the proposed work is a refinement or maturation of any existing work or research.

Objectives/Specific Aims/Hypotheses: State the hypotheses to be tested or the objectives to be reached. Concisely explain the specific aims of the proposed project.

Research Strategy and Feasibility:

▪ Describe the study design, methods and models, including appropriate controls, in sufficient detail for evaluation of appropriateness and feasibility.

▪ Explain how this research strategy will meet the research goals and milestones.

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

▪ Provide a well-developed, well-integrated and detailed research plan that supports the translational feasibility and promise of the approach.

▪ 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 handles, and identification of primary endpoints.

▪ If proposing development of a drug or device, describe how the study design and data reporting would support a regulatory filing with the U.S. Food and Drug Administration (FDA) or international equivalent, if applicable.

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▪ If the proposed research involves access to military and/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.

Technical Risks: Identify and describe potential problem areas in the proposed approach and alternative methods and approaches that will be employed to mitigate any risks that are identified. Provide evidence to support availability of and access to the animal model or human samples required for the study, as applicable.

Statistical and Data Analysis Plan: Describe the statistical model and data analysis plan with respect to the study objectives as appropriate to the type of study.

Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study.

▪ If any biological material will be used in the proposed studies, the name, definition, pathological classification and source of the material must be provided.

▪ If human anatomical samples will be used, include a detailed plan for the acquisition of samples.

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

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FY26 Orthopaedic Applied Research Award 13 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.

Letters of Commitment (if applicable) (one-page limit per letter is recommended): If the proposed study involves use of an investigational drug, device or biologic, provide a letter of commitment from the entity that holds the intellectual property rights indicating availability of the product for the duration of the study, support for the proposed phase of research and support for the indication to be tested.

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

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

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities. 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 attachment.

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

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

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

Background: State the FY26 ORP ARA Focus Area(s) addressed by the proposed research. State how the proposed research addresses the intent of the award mechanism. Present the scientific rationale behind the proposed research project.

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%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

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

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FY26 Orthopaedic Applied Research Award 14

Objective(s)/Hypothesis: State the hypothesis to be tested and/or objective(s) to be reached. Provide evidence or rationale that supports the objective/hypothesis.

Specific Aims: State the specific aims of the study.

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

Impact and Military Benefit: State explicitly how the proposed work may have a short- and/or long-term impact on patient care and/or restoration of function for those who have sustained traumatic orthopaedic injuries, combat-related or otherwise.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research. State the FY26 ORP ARA Focus Area(s) addressed by the proposed research.

– What are the potential applications, benefits and risks of the anticipated outcomes?

– What is the projected time it may take to achieve a clinically relevant outcome? If the research is far from clinical applicability, describe the interim outcomes.

– Describe how the proposed work may have a short- and/or long-term impact on patient care and/or restoration of function for those who have sustained traumatic orthopaedic injuries, combat-related or otherwise.

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

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to the Example: Assembling a Generic Statement of Work. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Impact Statement (two-page limit): Upload as “Impact.pdf”.

– Describe the short- and long-term impact of this study in a manner that will be readily understood by readers with and without a background in science or medicine.

– Discuss how the expected results of the proposed work will contribute to the goals of decreasing the clinical impact of traumatic orthopaedic injuries and provide better long-term outcomes for these patients.

– Provide information about the incidence and/or prevalence of the project-relevant orthopaedic injuries in Service Members and/or Veterans, as well as the incidence in the general population, if appropriate and available.

– Identify where along the military (and civilian) pathway of care the proposed product or intervention will be applied. Describe how the proposed study may impact unit readiness, point of injury care, service-associated trauma care and/or allow patients to more quickly return to duty/work.

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

○ Attachment 7: Transition Plan (two-page limit): Upload as “Transition.pdf”.

Describe/discuss the methods and strategies proposed to move the anticipated research outcomes to the next phase of development (e.g., clinical research trials, https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format 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://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

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

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

FY26 Orthopaedic Applied Research Award 15 commercialization, transition to industry and/or delivery to the civilian or military market) after successful completion of the award. Outline the regulatory strategy, as applicable.

Applicants are encouraged to work with their organization’s Technology Transfer Office (or equivalent) to develop the transition plan and description of the collaborations and resources that will be used to provide continuity of development. PIs are encouraged to explore developing relationships with industry and/or other funding agencies to facilitate moving the product into the next phase of development. The plan for post-award transition of the anticipated research outcome should include the components listed below, as appropriate and applicable to the research proposed:

– A brief schedule and milestones for transitioning the anticipated research outcomes to the next phase of development.

– Details of the funding strategy to transition to the next level of development and/or commercialization (e.g., partners, internal/external funding opportunities to be applied for). A description of collaborations and other resources that will be used to provide continuity of development.

– For knowledge products, the description of collaborations and other resources that will provide continuity of development may include proposed development or modification of Clinical Practice Guidelines and recommendations; provider training materials, patient brochures and other clinical support tools; scientific journal publications; models; simulations; and applications.

– The planned indication for the product label, if appropriate, and an outline of the development plan required to support that indication.

– A plan for resolving intellectual and material property issues among participating organizations.

– A description of ownership rights/access to the intellectual property necessary for the development and/or commercialization of products or technologies supported with this award and the government’s ability to access such products or technologies in the future.

– If applicable, address any real or perceived financial conflict of interests (COIs) or biases and briefly state how the COI or bias will be mitigated.

○ Attachment 8: Animal Research Plan (five-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:

– Briefly describe the research objective(s) of the animal study. Explain how and why the animal species, strain and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology.

– Summarize the procedures to be conducted. Describe how the study will be controlled.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=civilian%20medical%20center.-,Knowledge%20Product,-%3A%20A%20non https://arriveguidelines.org/arrive-guidelines https://arriveguidelines.org/arrive-guidelines

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

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

FY26 Orthopaedic Applied Research Award 16

– 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: Data Management (two-page limit): Upload as “DataManage.pdf”.

The Data Management attachment should describe all the methods used for data collection and should include the components listed below.

– Confidentiality: Address who will have access to study records, data and specimens, including an acknowledgement that representatives of DHACA are eligible to review study records. Address requirements for reporting sensitive information to state or local authorities.

– Data capture, verification and disposition: Describe the types of data, software and/or other materials to be produced. Describe how data will be captured and verified. If existing data resources are used, describe the dataset origin. Describe where data (both electronic and hard copy) will be stored, who will keep the data, how the data will be stored, the standards to be used for data and metadata format and content, and the length of time data will be stored.

– Data reporting: Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, if applicable.

– Storage: Describe specimen storage, to include location of storage, how long specimens have been or will be stored, any special conditions required, labeling and disposition. Outline the plan to store specimens for future use, if applicable.

– Laboratories performing evaluations and special precautions: Identify the laboratory performing each evaluation, as well as any special precautions that should be taken in handling the samples. Describe the quality assurance and quality control measures to be used during collection, analysis and processing. If transport of samples is required, describe provisions for ensuring proper storage during transport.

The Data Management attachment should not duplicate the Sharing Plan in Attachment 1: Project Narrative or the NIH Data Management and Sharing plan.

For more guidance on preparing the Data Management attachment, refer to the GAI DOW Data Management Plan. While the GAI instructions refer to applications recommended for funding, the specific basic requirements are the same for this attachment.

○ 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=E.-,DOW%20Data%20Management%20Plan,-If%20recommended%20for https://ebrap.org/eBRAP/public/Program.htm#:~:text=Required%20Representations 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=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:~: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 Orthopaedic Applied Research Award 17 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.

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

○ Biographical Sketch

○ Current/Pending Support

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

ii. Research & Related Budget

iii. Project/Performance Site Location(s)

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

4.4. Other Application Elements

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

External Link to the GAI

Grants.gov

External Link to the GAI eBRAP.org https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20Intragovernmental/Intramural%20Budget…