HT942526TERPCTA_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

Clinical Trial Award

Funding Opportunity Number: HT942526TERPCTA

Pre-Application Due: August 19, 2026

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

FY26 Toxic Exposures Clinical Trial Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

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

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

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

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

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

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

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

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

Appendix 2 Acronym List

Appendix 3 TERP Definitions

Appendix 4 Resources for Data and/or Previously Collected Biospecimens

FY26 Toxic Exposures Clinical Trial Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

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

FY26 Toxic Exposures Clinical Trial Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Toxic Exposures Research Program (TERP) Clinical Trial Award (CTA) mechanism supports the advancement, execution, and analysis of clinical trials with the potential to have a significant impact on the prevention, treatment, or management of symptoms, diseases or conditions associated with or resulting from military-related toxic exposures. Proposed projects may range from small proof-of-concept clinical trials (e.g., pilot, first-in-human, phase 0) designed to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials (including pragmatic clinical trials) to determine efficacy in relevant patient populations.

Distinctive Features: To encourage applications that include meaningful and productive collaborations, the FY26 TERP CTA 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 interventions/knowledge products into clinical applications. Partnering should significantly advance the research beyond what would be possible through independent efforts.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.5M to fund approximately one Clinical Trial Award application with total cost caps of $4.5M per award. The maximum period of performance is 4 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: HT942526TERPCTA

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.

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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 Clinical Trial Award mechanism was first offered in FY22, with the Clinical Trial Partnership Award (which required partnership) being offered in FY25. Since FY22, 37 CTA applications (representing 72 potential awards) were received, and six applications (representing 12 awards) were recommended for funding.

3.2. Intent of the Clinical Trial Award

The TERP Clinical Trial Award (CTA) mechanism supports the advancement, execution, and analysis of clinical trials with the potential to have a significant impact on the prevention, treatment or management of symptoms, diseases, or conditions associated with or resulting from military-related toxic exposures.

Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), medical devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (i.e., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. It is anticipated that outcomes from studies funded by this award will follow a clinical development plan that advances the research to U.S. Food and Drug Administration (FDA) device or drug approval and/or the establishment of clinical practice guidelines, as applicable.

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3.2.1. TERP Program Goals and Topic Areas

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

The proposed research may be related to diseases, conditions, or symptoms supported by other CDMRP programs; however, CTA 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

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FY26 Toxic Exposures Clinical Trial Award 8

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

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 CTA

• Study Design: Applications should demonstrate the availability of, and access to, appropriate and well-justified study population(s) and the proposed intervention.

Applications should describe a study team with experience and expertise in all aspects of conducting clinical trials, including statistical analysis, knowledge of regulatory processes (if applicable), study coordination and data management. Applications should include plans for 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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FY26 Toxic Exposures Clinical Trial Award 9 appropriate statistical considerations, data management, analysis and interpretation.

Applicants are strongly encouraged to utilize objective data and measures to the maximum extent practicable.

• Clinical Impact: Applications should explain how the proposed research will have a significant impact on patient care for Service Members, their Families, Veterans, and/or the American public that have been or could potentially be impacted by the effects of military-related toxic exposures. Applications should demonstrate how the successful completion of the proposed research will have short- and long-term impacts, ultimately leading to new treatments/therapeutics/interventions and/or new outcomes (intellectual knowledge or clinical practice guidelines) that improve patient care and/or quality of life for those impacted by or likely to encounter toxic substances.

• Preliminary Data are Required: Applications must include preliminary data relevant to the proposed clinical trial. The proposed clinical trial must be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the relevant literature. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) and/or member(s) of the research team.

• Partnering PI Option: The CTA 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 interventions/knowledge products 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 CTA

Funding from this award mechanism must support a clinical trial. Preclinical and animal research is not supported in this funding opportunity.

Applicants seeking funding for research that does not meet the definition of a clinical trial should consider other FY26 TERP funding opportunities that may be more appropriate for such research. 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. CTA applications that do not describe a clinical trial will be administratively withdrawn.

An informational resource for preparing an application, the Human Subject Research Resource, is available on the CDMRP website.

Clinical Trial Start Date and Regulatory Submission: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for studies regulated by the Regulatory Agency. Unless otherwise noted, for the purposes of this https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://cdmrp.health.mil/#:~:text=Human%20Subject%20Research%20Resource

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FY26 Toxic Exposures Clinical Trial Award 10 funding opportunity, Regulatory Agency refers to the FDA or any equivalent international regulatory agency.

If an Investigational New Drug (IND) application, Investigational Device Exemption (IDE), or equivalent, is required, a regulatory application must be submitted to the relevant regulatory agency within six months of the award date. The regulatory application should be specific to the product and indication to be tested in the proposed clinical trial.

Study Population Considerations: The recruitment of relevant military and/or Veteran population(s) for the proposed clinical trial(s) is strongly encouraged. It is strongly encouraged that applications not using military and/or Veteran populations for the proposed studies provide justification for how the chosen population(s) is relevant to military-related toxic exposures and will benefit Service Members, their Families and/or Veterans.

Research Team Considerations: Inclusion of at least one clinician on the study team is strongly encouraged and may be necessary for specific interventions.

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, CONSORT, SPIRIT and ARRIVE guidelines 2.0.

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 applicable to the proposed research. Researchers are not required to use any of the 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.

3.3. Funding Instrument

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

(31 USC 6304).

https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines

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3.4. Funding Details

Period of Performance: The maximum period of performance is 4 years.

Single PI Option:

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $4.5M. 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 4 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 $4.5M. 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.

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 CTA.

• Research subject compensation and reimbursement for trial-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation).

Must not be requested for:

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

• Preclinical or animal research.

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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.

– Specify the intervention to be investigated and indicate the phase of the study and/or class of device, as appropriate.

○ Specific Aims and Study Design:

– Concisely state the specific aims of the proposed clinical trial and briefly describe the scientific approach to address them. Include a description of controls, as appropriate.

– Briefly describe the study population. The recruitment of relevant military and/or Veteran population(s) for the proposed clinical trial(s) is strongly encouraged.

Applications not using military and/or Veteran populations for the proposed studies are strongly encouraged to provide justification for how the chosen population(s) is relevant to military-related toxic exposures and will benefit Service Members, their Families and/or Veterans.

– Briefly describe the feasibility of the study including access to patient population(s), plans for recruitment and retention, and how the applicants will complete the study within the proposed period of performance.

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○ Alignment:

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

○ Clinical Impact and Military Relevance:

– State both the short- and long-term impacts and how the successful completion of the proposed research will ultimately lead to new treatments/therapeutics/ interventions and/or new outcomes (intellectual knowledge or clinical practice guidelines) that improve patient care and 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.

○ 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.

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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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

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

FY26 Toxic Exposures Clinical Trial Award 14

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

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (20-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below. It should be evident that the proposed study meets the definition of a clinical trial. Funding from this award mechanism must support a clinical trial and cannot be used for animal or other preclinical research studies.

– Background: Describe in detail the scientific rationale for the study. Provide a review and analysis of the available literature and completed/ongoing studies relevant to the proposed clinical trial.

▪ Describe the preliminary studies and published or unpublished clinical or preclinical data (required) that support the proposed clinical trial. Any unpublished preliminary data provided should originate from the laboratory of the PI(s) and/or a member(s) of the research team.

▪ Summarize key preclinical pharmacological findings, dosage studies, and other clinical studies (if applicable) that examine the safety and stability (as appropriate) of the intervention.

▪ Provide a summary of other relevant ongoing, planned, or completed clinical trials; and describe how the proposed study differs.

▪ State the relevance of the proposed research to at least one of the FY26 TERP Program Goals and at least one FY26 TERP Topic Area.

If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source(s) of prior funding. Identify the specific portions of the study that will be supported with funds from this award.

– Intervention: Identify the intervention to be tested. Include the following components, as applicable: intervention type (drug, device, behavioral, surgical, etc.), complete name and composition, source, general concept of design, administration route. Indicate who holds the intellectual property rights to the intervention, if applicable, and how the PI has obtained access to those rights, along with access to the intervention itself, for conduct of the clinical trial. As applicable, appropriate letters of commitment should be provided in Attachment 2: Supporting Documentation, demonstrating the study team’s access to the intervention(s) for the duration of the clinical trial. Describe how the intervention addresses current clinical needs and how it compares with currently available interventions and/or standards of care.

– Objectives, Specific Aims and Hypotheses: Describe the purpose of the proposed study with detailed objectives. State the hypothesis/research question to be tested in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Formatting_Guidelines:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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

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

FY26 Toxic Exposures Clinical Trial Award 15 the proposed clinical trial and detail the specific aims that will address the hypothesis/research question. Specific aims outlined here should be the same as those outlined in Attachment 5: Statement of Work.

– Study Design: Describe the proposed clinical trial in sufficient detail to evaluate its appropriateness and feasibility, relating to both the scientific success of the study and setting reasonable expectations of what study participants will experience.

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

▪ Describe the type of study to be performed (e.g., treatment, prevention, diagnostic), including study phase or class (if applicable) and study model (e.g., single group, parallel, crossover).

▪ Outline the proposed clinical trial methodology and study variables in sufficient detail to demonstrate a clear course of action and justification. Describe the interaction with the human subject, including the study intervention that they will experience, and include the dose and administration route. Provide sufficient detail in chronological order for a person not involved in the study to understand what the study participant will experience.

▪ Provide a schedule (e.g., flowchart or diagram) of study intervention(s), evaluation(s), and follow-up procedures, including, if applicable, the biospecimen that will be collected, the collection schedule and amount. Describe measures to ensure consistency of dosing (e.g., active ingredients for nutritional supplements, rehabilitation interventions). Define each arm/study group of the proposed trial, if applicable, and describe how group assignment will occur. Include a description of controls, as appropriate. Specify the approximate number of study participants to be enrolled. Indicate whether subjects, clinicians, data analysts and/or others will be blinded during the study. Describe any other measures to be taken to reduce bias.

▪ Define all endpoints/outcome measures relevant to the objectives of the study;

explain why they were chosen, and describe how, when and where they will be measured. Include all evaluations that will be made for study purposes. If questionnaires or other research data collection instruments will be used, include a copy of them in Attachment 2: Supporting Documentation. Describe the reliability and validity of the selected endpoints/outcome measures and evaluations, along with the applicable quality standards. Explain how the results of evaluations and/or data collection instruments will be used to meet the objectives of the study (or to monitor safety of human subjects). Describe potential limitations to datasets and/or data collection instruments and the impact on research endpoints.

If proposing clinical trials with Gulf War Veterans, the use of the Common Data Elements (CDEs) for GWI Clinical Research is strongly encouraged. If applicable, describe how the use of GWI CDEs was considered when developing the plans for the collection of clinical data and annotation of clinical samples.

▪ Briefly describe the study population and the inclusion and exclusion criteria that will be used to meet the needs of the proposed clinical trial. Additional details should be provided in Attachment 6: Study Population Recruitment and Safety Plan.

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

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

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– Statistical Plan and Data Analysis: Describe the statistical model and data analysis plan with respect to the study objectives. Ensure sufficient information is provided to allow for a thorough evaluation of statistical calculations during review of the application.

▪ 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. Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses will be appropriately powered.

▪ 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.

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

– Pitfalls and Mitigation Strategy: Describe potential challenges and discuss alternative methods/approaches that may be employed to overcome them.

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

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

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.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Inclusion%20of%20Women%20and%20Minorities%20as%20Subjects%20in%20Clinical%20Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

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Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work for the duration of the proposed clinical trial. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI meets the eligibility criteria.

As applicable, provide appropriate letters of commitment demonstrating the study team’s access to the intervention(s) for the duration of the clinical trial.

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, 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.