HT942526TERPTRA_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

Toxic Exposures Research Program

Translational Research Award

Funding Opportunity Number: HT942526TERPTRA

Pre-Application Due: August 19, 2026

Application Due: November 19, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Toxic Exposures 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

Appendix 3 TERP Definitions

Appendix 4 Resources for Data and/or Previously Collected Biospecimens

FY26 Toxic Exposures 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 Toxic Exposures Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The intent of the fiscal year 2026 (FY26) Toxic Exposures Research Program (TERP) Translational Research Award (TRA) is to support translational research that will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications, including health care products, interventions, technologies and/or clinical practice guidelines. Translational research may be defined as an integration of basic science and clinical observations. New Approach Methodologies may also be used. Applications should provide evidence for the reciprocal transfer of information between basic and clinical science, or vice versa, in developing and implementing the research plan.

Distinctive Features: To encourage applications that include meaningful and productive collaborations, the FY26 TERP TRA includes a Partnering Principal Investigator Option (PPIO). One Principal Investigator (PI) is identified as the initiating PI, and an additional PI may be identified as a Partnering PI. If recommended for funding, each PI will be named on separate awards. The intent is to support interdisciplinary partnerships, such as those between clinicians and research scientists, that will accelerate the movement of promising ideas into clinical applications. Partnering should significantly advance the research beyond what would be possible through individual efforts.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $6.0M to fund approximately four Translational Research Award applications with total cost caps of $1.5M 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: October 1, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 19, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 24, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526TERPTRA

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 may be named by their organizations as the Principal Investigator (PI) or the partnering PI on the application.

Partnering PI Option (PPIO): One initiating PI and one partnering PI may collaborate on a single application, each of whom will be recognized as a PI and receive a separate award.

Individuals in a mentored position (e.g. postdoctoral fellows, clinical fellows) are not considered independent investigators.

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

An investigator may be named on only one TERP application as a 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or 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.

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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 Toxic Exposures Research Program (TERP). 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 TERP in 2022 to provide solutions toward the prevention, diagnosis, treatment, and mechanistic understanding of the adverse health outcomes associated with a broad range of military-related toxic exposures. Appropriations for the TERP from FY22 through FY25 totaled $105 million (M). The FY26 appropriation is $15M.

The vision of the TERP is to improve the health and quality of life and mitigate risks for those impacted by military-related toxic exposures. The mission of the TERP is to fund research to understand and provide solutions to prevent, diagnose, and treat the health outcomes associated with military-related toxic exposures impacting Service Members, Veterans, their Families and the public.

Impactful and highly relevant research will be hypothesis-driven and consider the health care needs of Service Members, their Families, Veterans, and/or the American public with symptoms, diseases, or conditions as a result of military-related toxic exposures and/or the need to minimize toxic exposures for military and civilian populations.

The TERP strongly encourages applicants to review Appendix 3, TERP Definitions, before writing and submitting their application.

The TERP encourages collaboration with DOW and/or U.S. Department of Veterans Affairs (VA) researchers and clinicians.

3.1. Award History

The TERP Translational Research Award (TRA) mechanism was first offered in FY22, with the Translational Research Partnership Award (which required partnership) being offered in FY25.

Since FY22, 189 TRA applications (representing 380 potential awards) were received, and 20 applications (representing 39 awards) were recommended for funding.

3.2. Intent of the Translational Research Award

The intent of the FY26 TERP TRA is to support translational research that will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications, including health care products, interventions, technologies, and/or clinical practice guidelines. Translational research may be defined as an integration of basic science and clinical observations. New Approach Methodologies may also be used. Applications should provide evidence for the reciprocal transfer of information between basic and clinical science or vice versa in developing and implementing the research plan.

3.2.1. TERP Program Goals and Topic Areas

To meet the intent of the award mechanism, applicants to the TRA are required to address at least one of the FY26 TERP program goals and at least one of the FY26 TERP topic areas.

Proposed research may be related to diseases, conditions, or symptoms supported by other

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CDMRP programs; however, TRA applications must be relevant to military-related toxic exposures. Selection of the program goal(s) and topic area(s) is the responsibility of the applicant. Selection must be made during the pre-application submission process and addressed in detail in the full application submission.

Program Goals: The FY26 TERP program goals are not listed in order of importance. The bulleted items are provided for additional context on current program priorities and, while encouraged, these are not the only items that can be addressed by applications.

Predict and Prevent: Identify strategies that can anticipate, identify, monitor, and prevent adverse effects of exposures to toxic substances.

• Understand the full range of effects from military-related environmental and toxic exposures to aid in predicting/preventing the effects.

• Understand the mechanisms of multigenerational effects of military-related toxic exposures and the impact of these exposures on reproductive health to aid in predicting/preventing the effects.

• Identify biological and/or psychosocial variables and risk factors that can impact disease outcomes from toxic exposures.

• Develop, adapt, validate, or optimize monitoring, for example, personal devices to detect and characterize individual environmental exposures.

Diagnose: Understand the clinical signs, symptoms, and outcomes associated with exposures;

and predict disease progression to develop specific or improved diagnostics.

• Understand complex, multi-exposure/physiological or nonchemical stressor (e.g., hormonal, sleep disorders, thermal stress) combinations, and how exposure impacts outcome.

• Identify behavioral factors (smoking, substance abuse, etc.), comorbidities, and pre-existing medical conditions that may impact exposure outcomes.

• Identify biomarkers of exposure to individual or multiple toxic substances alone or in combination with physiological/nonchemical stressors.

• Develop diagnostic screens/assays/devices for toxic exposures.

Treat: Minimize symptoms and disease progression associated with exposures.

• Develop new or improve existing therapeutics, treatments and strategies.

• Advance new therapeutics, treatments and strategies.

• Address the need for preclinical models that capture the adverse outcomes of human toxic exposures.

Topic Areas: Topic areas are not listed in order of importance.

• Neurotoxin Exposure

• Gulf War Illness (GWI) and Its Treatment

• Airborne Hazards and Burn Pits

• Other Military Service-Related Toxic Exposures in General, including Prophylactic Medications, Groundwater Contamination, Pesticides, Organophosphates, Toxic Industrial Chemicals, Materials, Metals and Minerals

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3.2.2. TERP Additional Guidance

Studies focused on the following areas do NOT meet the intent of the FY26 TERP:

• Research data that are classified and/or research in which the anticipated outcomes may be classified or deemed sensitive to national security concerns.

• Chemical warfare agents categorized as fourth-generation agents or non-traditional agents.

• Biological Select Agents or Toxins.

• Anomalous Health Incidents, commonly referred to as Havana Syndrome.

• Directed energy weapons.

• Development of medical countermeasures or devices intended to diagnose, detect, prevent, or treat the immediate (point of injury) health effects of chemical weapons, biological, radiological or nuclear threats.

• Treatments or therapeutics for the immediate, adverse health effects of any exposure that would be administered in an acute care setting, i.e., role of care (ROC) 1 or ROC 2.

○ In the military health echelon/ROC, this generally refers to ROC 1 and ROC 2 described below:

ROC 1: Unit-level medical care, ranging from point of injury through battalion aid station.

ROC 2: Advanced trauma management and emergency medical treatment.

For more information on the military roles of care, refer to Chapter 2, “Roles of Medical Care (United States),” Emergency War Surgery, Fifth United States Edition, 2018, Borden Institute.

Studies focused on the following areas ARE permitted. These examples are meant to inform prospective applicants in the context of the above exclusions and do not imply that these research areas are prioritized over any others within the scope of the FY26 TERP Program Goals and FY26 TERP Topic Areas.

• Evaluation/treatment of long-term or chronic health impacts of traditional chemical weapons, including but not limited to the long-term effects of sub-lethal doses of sarin, soman, and sulfur mustard and Gulf War illness.

• Other long-term/chronic effects of military-related exposures that would be diagnosed or treated at a ROC 3 (field hospital) or ROC 4 (definitive care; fixed medical treatment facility) or beyond.

3.2.3. Key Elements for the TRA

• Translational Potential: Projects should integrate basic science and clinical observations to accelerate the movement of promising ideas in military-related toxic exposure research toward clinical applications including health care products, interventions, technologies, or clinical practice guidelines that are relevant to Service Members, their Families, Veterans and/or the American public. The application should also demonstrate the reciprocal transfer of information between basic and clinical scientists.

Applications must clearly articulate three points along the translational research spectrum:

○ Where the field is now

○ Where the field will be after the successful completion of the proposed research project https://www.selectagents.gov/sat/list.htm https://medcoeckapwstorprd01.blob.core.usgovcloudapi.net/pfw-images/dbimages/Ch%202.pdf https://medcoeckapwstorprd01.blob.core.usgovcloudapi.net/pfw-images/dbimages/Ch%202.pdf https://medcoeckapwstorprd01.blob.core.usgovcloudapi.net/pfw-images/dbimages/Ch%202.pdf

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○ What the next step(s) will be after completion of the proposed project

• Impact: Applications should explain how the proposed research will have a significant impact on military-related toxic exposure research and/or patient care, with the intent to transition outcome(s)/product(s) (intellectual knowledge and/or tangible materiel) into clinical practice for Service Members, their Families, Veterans, and/or the American public who have been or could potentially be impacted by toxic exposures. Applications should demonstrate both the short- and long-term impacts, and how the successful completion of the proposed research will impact a critical problem or question in the field of research and/or patient care in at least one of the FY26 TERP Program Goals and at least one of the FY26 TERP Topic Areas.

• Preliminary Data are Required: Applications must include preliminary data (e.g., published works by the investigators, pilot data, peer-reviewed literature) to support feasibility of the study. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) and/or a member(s) of the research team.

• Partnering PI Option: The TRA includes an option for the Initiating PI to collaborate with one Partnering PI in order to encourage applications that include meaningful and productive collaborations between investigators. The intent of this option is to support new or existing interdisciplinary partnerships, such as those between clinicians and research scientists that will accelerate the movement of promising ideas into clinical applications.

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. Each PI is expected to bring a distinct contribution to the application, and the PIs’ unique expertise, when combined as a partnership, should address the research question better than any one investigator could individually. The PIs should have appropriately balanced intellectual input into the design and conduct of the 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 and Partnering PI, refer to Section 5.3, Submission Instructions.

3.2.4. Other Important Considerations for the TRA

Clinical trials are not allowed within this funding opportunity. TRA applications may include preclinical studies (including research involving animals) and/or clinical research involving human subjects, human anatomical substances, and human datasets, including correlative studies associated with an existing clinical trial.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research.

Applications proposing clinical trials may be submitted to the following FY26 TERP funding opportunity:

• Clinical Trial Award (Funding Opportunity Number HT942526TERPCTA)

It is the responsibility of the applicant to review the program announcement requirements and select the funding opportunity that aligns with the scope of the proposed research. Applications submitted under a mechanism that is not deemed appropriate for the type and scope of research requested will not be recommended for funding.

It is strongly encouraged that studies using human subjects, human anatomical substances, and/or datasets use relevant military and/or Veteran https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes

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FY26 Toxic Exposures Translational Research Award 10 populations/samples/datasets. Applicants are strongly encouraged to utilize objective data and measures to the maximum extent practicable. Applications not using military and/or Veteran populations/samples/datasets are strongly encouraged to provide justification for how the chosen populations/samples/datasets are relevant to military-related toxic exposures and will benefit Service Members, their Families and/or Veterans.

When applicable, the research team is encouraged to include both preclinical and clinical investigators.

Participation of at least one military or Veteran consumer as a member of the research team to contribute to the development of the research question, project design, oversight, and evaluation, as well as other significant aspects of the proposed project, is strongly encouraged.

• For the purposes of the FY26 TERP, a consumer is a person living with a disease, injury, or condition, or a family member or caregiver of a person impacted by a disease, injury, or condition associated with military-related toxic exposures. The consumer must be an active participant in an advocacy, outreach, or support organization; or, if military personnel on active duty, be approved to participate by their Commanding Officer.

Rigorous Study Design: 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.

Research Involving Animal Models: If the application proposes the use of animal models, consider the following:

• Pairing clinical populations to animal models in order to validate the clinical relevance and development of prevention, assessment, and treatment solutions is encouraged.

• For studies using animal models, the use of an established model is preferred unless there is a compelling scientific justification for the development or use of a new model.

• Proposed animal models should be well-justified, supported within the literature, and clearly align with clinical relevance.

• For studies proposing GWI research with animal models, a list of animal models funded by the former DOW CDMRP Gulf War Illness Research Program (GWIRP) is available at https://cdmrp.health.mil/gwirp/resources/amodels.

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.

Use of DOW or VA Resources: 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, datasets, 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.

Resources for Data and/or Previously Collected Biospecimens: The TERP has provided Appendix 4 as a reference, and it is not an exhaustive list of all resources that may be https://www.strobe-statement.org/ https://arriveguidelines.org/arrive-guidelines https://cdmrp.health.mil/gwirp/resources/amodels

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FY26 Toxic Exposures Translational Research Award 11 applicable to the proposed research. Researchers are not required to use any of the following limited examples provided or any one particular dataset. The TERP does not facilitate access to any of these resources and/or control the information presented on the websites.

Red Hill Health Impacts: Applications proposing epidemiological research on health outcomes that may be associated with the 2021 fuel release at Red Hill Bulk Fuel Storage Facility, or jet fuel exposures more broadly, are allowed under this mechanism.

In accordance with the National Defense Authorization Act for Fiscal Year 2024, Section 1092, the DOW conducted a feasibility assessment regarding potential Red Hill epidemiological health outcomes studies. This independent assessment emphasized that a variety of study scopes (i.e., population segments, types and pathways of exposure, health outcomes of interest) may be valuable and that the study design (i.e., cross-sectional or longitudinal; short-, medium-, or long-term; exposure-control or case-control) will depend on the associations being investigated.

The DOW encourages use of existing registries and expects that all studies will define and recruit appropriate comparison/control groups as well as account for potential confounding variables. Researchers can find additional resources related to the incident, including registry information and preliminary studies in Appendix 4.

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.

Single PI Option:

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.5M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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

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

Partnering PI Option:

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $1.5M. 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.

A separate award will be made to each PI’s organization.

The PIs are expected to be partners in the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

https://www.congress.gov/bill/118th-congress/house-bill/2670/text https://redhillregistry.org/wp-content/uploads/2025/12/Feasibility-Assessment-Report-to-Congress_Submitted_2024-09-22.pdf 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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Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator (Single PI Option) and/or for one investigator from each partnering application (PPIO) to attend one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 TERP TRA.

Must not be requested for:

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

• Clinical trial costs.

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4. Application Contents and Format

4.1. Application Overview

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

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

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

4.2. Pre-Application Components

The PI or Initiating PI 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 (three-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/Rationale:

– State the hypothesis of the proposed study and provide a brief explanation of the study rationale clearly articulating how the hypothesis and rationale are well-supported/justified.

○ Specific Aims and Study Design:

– Concisely state the specific aims of the proposed study.

– Briefly describe the experimental methods and approaches.

– As applicable, succinctly describe the proposed model system(s) (cellular, animal etc.), human samples, human datasets and/or human subjects.

▪ If the application will use human subjects, samples and/or datasets, indicate whether the proposed project will use military and/or Veteran populations/ samples/datasets OR how the chosen population/samples/datasets are relevant to military-related toxic exposures and will benefit Service Members, their Families and/or Veterans.

○ Alignment:

– Describe how the proposed project addresses at least one FY26 TERP Program Goal and at least one FY26 TERP Topic Area.

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○ Translational Potential:

– Describe how the proposed study will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications including health care products, interventions, technologies or clinical practice guidelines. Explain how the application will integrate basic science and clinical observations and allow for the reciprocal transfer of information between basic and clinical scientists.

– Clearly articulate the following three points along the translational research spectrum:

▪ Where the field is now.

▪ Where the field will be after the successful completion of the proposed research project.

▪ What the next step(s) will be after completion of the proposed project.

○ Impact and Military Relevance:

– State both the short- and long-term impacts and how the successful completion of the proposed research will advance the research field and ultimately lead to new treatments/therapeutics, diagnostic assays, or prevention strategies to improve the quality of life for those impacted by or likely to encounter toxic substances.

– State how the proposed research is responsive to the health care needs of Service Members, their Families, and/or Veterans that have been or could potentially be exposed to military-related toxic exposures.

– Describe how research findings could also benefit the general population.

o Partnership (only relevant for PPIO submissions):

Briefly describe the interdisciplinary partnership and how the collaborative efforts will better address the research question.

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

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

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

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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FY26 Toxic Exposures Translational Research Award 15

4.3. Full Application Components

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

Partnering PI Option: The CDMRP requires separate full application package submissions for 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 (15-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background/Rationale: Describe in detail the scientific rationale for the study.

Applications must include preliminary data (e.g., published works by the investigators, pilot data, peer-reviewed literature) to support the feasibility of the study. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) and/or a member(s) of the research team. The rationale should include a literature review that supports the development of the proposed project. The background section should clearly support the choice of the study variable and should explain the basis for the study questions and/or hypotheses.

Provide a summary of relevant prior preclinical and/or clinical work, and distinguish how the proposed study differs from other relevant or recently completed research.

State the relevance of the proposed research and the applicability of the anticipated findings to the intent of the mechanism and to at least one of the FY26 TERP Program Goals and at least one of the FY26 TERP Topic Areas.

– Hypothesis or Objective: Clearly state the hypothesis or the objective(s).

– Specific Aims: State and concisely explain the project’s specific aims. These aims should agree with the aims and associated tasks described in Attachment 5, Statement of Work. If the proposed research project is part of a larger study, present only tasks that this TERP award would fund.

– Research Strategy and Feasibility:

▪ Describe the experimental design, methods, and models, including appropriate controls, in sufficient detail to allow for their appropriateness and feasibility to be 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#_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

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FY26 Toxic Exposures Translational Research Award 16 assessed. Identify how the research strategy and approaches will meet the project’s goals and milestones.

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

Details of the strategy for how sex will be considered as a biological variable will be required in Attachment 2.

▪ Provide justification for the approach/model that will be used to support the proposed studies.

❖ If cell lines or animals are to be used, justify why the proposed cell line(s) or animal model(s) were chosen and discuss the model’s clinical relevance to human biology (including but not limited to routes of human exposures, exposure dose, outcomes [human symptoms, diseases/conditions] associated with exposures, and the types of exposures potentially encountered). For animal studies, full details will be required in the Animal Research Plan (Attachment 9).

❖ If proposing a correlative study, specify how the proposed project complements the existing research efforts and provides additional relevant insight beyond the initial study design.

❖ If human subjects, human biological samples, or datasets will be used, describe the study population and the appropriateness of the designated study population for the proposed study. Applicants are strongly encouraged to use relevant military and/or Veteran populations/ samples/datasets. Clearly state if studies will utilize human specimens or data that cannot be linked to a living individual and meet the requirements for exemption under 45 CFR 46.104(d)(4) of the Common Rule, Secondary Research for Which Consent is Not Required. For research involving human subjects, human biological samples, or datasets, full details will be required in the Human Subjects/Samples/Data Acquisition Plan (Attachment 10).

▪ Describe the statistical model and data analysis plan, as applicable.

❖ Provide a statistical sample size estimate and the method by which it was derived, including power analysis calculations, to demonstrate that the sample size is appropriate to meet the objectives of the study.

❖ Explain the statistical methods/model that will be used for data analysis.

❖ Describe how data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, and how outliers will be defined and managed, if applicable.

❖ Describe the randomization and blinding/masking procedures for the study, and any other measures to be taken to minimize the effects of subjective bias, if applicable.

▪ Describe how the proposed project is feasible and will be completed within the proposed performance period.

▪ Address potential research challenges and pitfalls, and provide alternative methods and approaches.

https://www.ecfr.gov/current/title-45/part-46/section-46.104#p-46.104(d)(4)

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FY26 Toxic Exposures Translational Research Award 17

▪ If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

○ 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.

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 any consumer(s) participating on the research team to demonstrate their commitment to the proposed project. 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): If applicable, 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, https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Toxic Exposures Translational Research Award 18 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, 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).