HT942526TBDRPTDRA_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

Tick-Borne Disease Research Program

Therapeutic/Diagnostic Research Award

Funding Opportunity Number: HT942526TBDRPTDRA

Pre-Application Due: July 22, 2026

Application Due: October 22, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

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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 Therapeutic/Diagnostic Research Award; provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

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Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

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

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1. Basic Information About the Funding Opportunity

Summary: The intent of the fiscal year 2026 (FY26) Tick-Borne Disease Research Program (TBDRP) Therapeutic/Diagnostic Research Award (TDRA) is to support product-driven therapeutic and diagnostic development research aimed at reducing the burden of Lyme disease and/or other tick-borne diseases and conditions, and improving patient care and/or quality of life. Treatment-focused applications should be therapeutic evaluation studies designed to advance new ideas aimed at drug or treatment discovery that are still in the early/preclinical stages of development. Diagnosis-focused applications should propose diagnostic approaches that will be readily integrated into clinical settings.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.65M to fund approximately two Therapeutic/Diagnostic Research Award applications with total cost caps of $1.325M per award. The maximum period of performance is 3 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 22, 2026

• Invitation to Submit an Application: September 3, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 22, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 27, 2026

• Peer Review: December 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526TBDRPTDRA

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) on the application.

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 PI on the application, regardless of ethnicity, nationality or citizenship status.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

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 Tick-Borne Disease Research Program (TBDRP). 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 TBDRP in 2016 to support innovative and impactful research that addresses fundamental issues and gaps in knowledge of tick-borne diseases. Appropriations for the TBDRP from FY16 through FY24 totaled $55 million (M). The FY26 appropriation is $7M.

The TBDRP’s vision is to eliminate the health burden of tick-borne diseases. The TBDRP’s mission is to fund innovative research to understand and provide solutions to prevent, detect, and resolve Lyme disease and other tick-borne diseases and conditions for the benefit of Service Members, Veterans, their Families and the American public.

3.1. Award History

The TBDRP Therapeutic/Diagnostic Research Award (TDRA) mechanism was first offered in FY22. Since then, 50 TDRA applications were received, and 10 were recommended for funding.

3.2. Intent of the Therapeutic/Diagnostic Research Award

The intent of the FY26 TBDRP TDRA is to support product-driven therapeutic and diagnostic development research aimed at reducing the burden of Lyme disease and/or other tick-borne diseases and conditions and improving patient care and/or quality of life. Treatment-focused applications should be therapeutic evaluation studies designed to advance new ideas aimed at drug or treatment discovery that are still in the early/preclinical stages of development.

Diagnosis-focused applications should propose diagnostic approaches that will be readily integrated into clinical settings.

All research projects must have translational potential and aim to improve patient care and/or quality of life for military Service Members, Veterans, and their Families, as well as the American public living with Lyme disease and/or other tick-borne diseases and conditions.

3.2.1. Focus Areas for the TDRA

TDRA applications must be focused on Lyme disease and/or other tick-borne diseases with emphasis on reducing the public health burden of these illnesses.

Applications focused on persistent Lyme disease, and other tick-borne diseases and conditions endemic to the United States are particularly encouraged.

TDRA applications must respond to at least one of the following specific focus areas:

• Treatment

○ Evaluation of novel therapeutics or repurposed compounds for treatment of tick-borne diseases

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○ Extensive refinement of therapeutic candidates in a drug development program, including, but not limited to, structure/activity relationships, and pharmacokinetic/ pharmacodynamic and toxicologic studies

• Diagnosis

○ Evaluation/validation of approaches that provide diagnostic advantages for single or multiple tick-borne pathogens, with priority given to direct detection of Borrelia burgdorferi or tests that detect multiple tick-borne pathogens or diseases

○ Evaluation/validation of more accurate or novel approaches capable of distinguishing active Lyme infection from previous exposure and/or resolution of infection

○ Evaluation/validation of approaches for the detection/diagnosis of maternal-to-fetal transmission of Lyme disease and/or other tick-borne infections

Applications proposing screening of publicly available compound libraries for Lyme disease therapeutics will be considered non-responsive to this mechanism.

Applications proposing studies focused on tick-borne disease pathogenesis and discovery/initial development of relevant therapeutics and diagnostics are not within the scope of this funding opportunity; applicants should consider submitting to the TBDRP Idea Development Award under funding opportunity number HT942526TBDRPIDA.

3.2.2. Key Elements for the TDRA

Impact: Applications should address how the successful completion of the proposed research will significantly impact a critical problem or question in the field of Lyme disease and/or other tick-borne disease research and/or patient care. Applications should explain how both the anticipated immediate and long-range outcomes of the proposed research will advance knowledge and/or technology toward improved patient care and/or the quality of life for individuals with Lyme disease and/or other tick-borne diseases/conditions. Applications should describe how the proposed research will advance the potential evidence-based treatment, therapeutic or diagnostic toward dissemination and clinical implementation for Service Members, their Families and the American public.

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

3.2.3. Other Important Considerations for the TDRA

Applicants with limited tick-borne disease experience are strongly encouraged to collaborate with experienced tick-borne disease investigators. Applicants with substantial tick-borne disease experience are strongly encouraged to partner with experts in therapeutic and diagnostic assay development and transition, particularly those from the commercial sector.

The proposed studies are expected to be experimental in nature and product-driven. Examples of the types of research that may be supported by this award include, but are not limited to:

• Testing new therapeutic modalities (agents, delivery mechanisms) using established and accepted preclinical models

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• Optimization and improvement of potential treatments or therapeutics for easy administration outside of a clinical setting

• Investigational New Drug application-enabling studies leading to the development of pharmacologic agents, including compound characterization, absorption, distribution, metabolism, and excretion studies, and dose/response and toxicology studies to demonstrate safety and efficacy in relevant model systems

• Evaluation of potential diagnostic assays or devices using in vitro or ex vivo samples

• Studies aimed at improving diagnostic assay sensitivity, specificity, and/or implementation in standard clinical settings

Leveraging existing resources, maximizing statistical power, and using validated biospecimens and data from Lyme and other tick-borne disease biorepositories and databases are encouraged, but not required. Investigators are strongly encouraged to incorporate the following components into their study design where appropriate: authentication of proposed cell lines; statistical rigor of in vitro cellular studies and preclinical animal experiments; and validation in well-characterized cohorts of patients. Studies utilizing data derived from large patient studies that include long-term health records, biospecimen repositories, pre-existing research and/or studies that apply state-of-the art genomic and/or proteomic analysis, bioinformatics, and/or mathematical models to such data are also encouraged. The criteria defining the inclusion/exclusion of curated biospecimens or data in biorepositories or databases must be described to demonstrate the validity of their use in the proposed studies.

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) are permitted; however, clinical trials are not allowed within this funding opportunity.

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.

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 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:~:text=APPENDIX%2010.%0ADOW%20AND%20VA%20WEBSITES

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3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

Period of Performance: The maximum period of performance is 3 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1,325,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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

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

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to 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 TBDRP TDRA.

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

Pre-application submissions must include the following components.

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

• Preproposal Narrative (two-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should include the following:

○ Research: State a clear hypothesis for the project that is supported through a strong scientific rationale, referenced literature, and preliminary data. Describe the study type (e.g., concept development, animal validation, human validation), project specific aims, and scientific approach.

○ Relevance: Summarize the relevance of the proposed project to the TDRA Focus Areas.

○ Impact: Describe the immediate and long-range outcomes of the proposed study and their impact on Lyme disease and/or other tick-borne disease research, patient care, and morbidity and/or mortality for military Service Members, their Families and the American public. Describe how the proposed research will advance the potential evidence-based treatment, therapeutic, or diagnostic toward dissemination and clinical implementation.

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

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

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

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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

4.3. Full Application Components

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

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

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

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

(b) Attachments:

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

○ Attachment 1: Project Narrative (12-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Background/Rationale: Describe the problem, question, or gap in an area of patient care that is related to at least one of the TDRA Focus Areas and that will be addressed by the proposed research. Present a strong scientific rationale behind the proposed work. Describe previous experience most pertinent to the proposed research. Preliminary data are required. Include relevant literature citations and/or preliminary data to support the study’s feasibility. Any unpublished preliminary data provided should be from the laboratory of the PI or member(s) of the collaborating team.

Hypotheses/Objectives: State the hypotheses/study questions and/or overall objective(s) to be reached.

Specific Aims: Concisely explain the project’s specific aims in support of the hypothesis/objectives. If this application is part of a larger study, present only tasks that this award would fund. Avoid interdependency of specific aims. Proposed studies should not be dependent upon the successful outcomes, products, or samples from other ongoing research efforts.

Research Strategy and Feasibility:

Describe the experimental design, methods, and analyses, including appropriate controls, blinding/masking, and randomization. Provide sufficient detail so that the appropriateness and feasibility of the research strategy can be fully evaluated.

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.

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▪ Describe the features of any novel screening assay, experimental model, or other tools that will be used to evaluate the putative therapeutic or diagnostic, describing appropriate controls and providing justification for why this is the most appropriate approach/model to support the proposed studies.

❖ If cell lines or animals are to be used, describe how the choice of proposed cell line(s) or animal model(s) is justified and relevant to human biology and natural tick-borne disease transmission. Include relevant preliminary data to support testing the study hypothesis using this approach/model. Include information about authentication of proposed cell lines. For animal studies, full details will be required in Attachment 8.

❖ For research involving human subjects, human biological samples, or datasets, full details will be required in Attachment 9. 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.

▪ 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.

▪ Address potential challenges/pitfalls and provide alternative methods/approaches to mitigate these concerns, including interdependency of aims or dependency on successful outcomes, products, or samples from other ongoing research efforts.

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

▪ 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 or may result in administrative withdrawal of the application.

https://www.ecfr.gov/current/title-45/part-46/section-46.104#p-46.104(d)(4) https://www.ecfr.gov/current/title-45/part-46/section-46.104#p-46.104(d)(4) 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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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(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

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

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

Intellectual and Material Property Plan: Provide a plan for resolving intellectual and material property issues among participating organizations.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf

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FY26 Tick-Borne Disease Therapeutic/Diagnostic Research Award 14 milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

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

Inclusion Enrollment Report (only required if clinical research is proposed):

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

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

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

Background: Present the ideas and logical reasoning behind the proposed research project as it relates to the TDRA Focus Areas.

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

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design, including appropriate controls, and describe how it is novel and/or an improvement over current approaches.

Impact: Describe the impact of the proposed study on Lyme disease and/or other tick-borne diseases/conditions research, and on patient care and quality of life for military Service Members and the American public.

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

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

– State the TDRA Focus Area(s) the project addresses.

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

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FY26 Tick-Borne Disease Therapeutic/Diagnostic Research Award 15

– Describe the ultimate applicability of the research:

▪ What is the project’s potential impact on reducing the public health burden of tick-borne diseases/conditions, including the potential effect of the proposed research on the health and welfare of military Service Members and the American public?

▪ What are the potential clinical applications, benefits, and risks?

▪ What is the projected time it may take to achieve a patient-related outcome?

▪ If the research is not yet ready for immediate clinical applicability, describe the interim outcomes.

▪ What are the likely contributions of the study to advancing the field of Lyme disease and/or other tick-borne disease research?

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

Refer to eBRAP for the Suggested SOW Format.

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

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

Explain in detail how the proposed project will address a critical problem in Lyme disease and/or other tick-borne diseases/conditions and/or will impact the TDRA Focus Area(s) being addressed as follows:

Public Health Burden: Describe the burden of illness for the disease(s) or condition(s) to be studied, including current evidence-based public health information on mortality, morbidity, and economic impact. Describe in detail how the proposed research will ultimately reduce the burden of Lyme disease and/or other tick-borne illnesses and their effect on public health. If the study is focused on a tick-borne disease with low incidence or on a subpopulation affected by tick-borne diseases, then provide details on how the proposed research will have an impact on that disease and subpopulation. Describe how the research is focused on tick-borne diseases and conditions endemic to the United States, and/or involves persistent Lyme disease.

Military Relevance: Describe how the proposed research is relevant to and will specifically impact the health care needs and welfare of military Service Members, Veterans and their Families in a way that is consistent with the program’s goals.

The following resources include data on tick-borne diseases in the military and can be used in developing the Impact Statement:

▪ Medical Surveillance Monthly Report Feb 2021 (Vol 28, No. 2)

▪ Medical Surveillance Monthly Report May 2022 (Vol 29, No. 5)

▪ Medical Surveillance Monthly Report Jan 2024 (Vol 31, No. 1)

▪ Medical Surveillance Monthly Report Mar 2025 (Vol 32, No. 3)

▪ Medical Surveillance Monthly Report Nov 2025 (Vol 32, No.11)

Short-Term Impact: Detail the anticipated short-term outcome(s)/product(s) (intellectual and/or tangible) that can be directly attributed to the proposed research.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://health.mil/Reference-Center/Reports/2021/02/01/Medical-Surveillance-Monthly-Report-Volume-28-Number-02 https://health.mil/Reference-Center/Reports/2022/05/01/Medical-Surveillance-Monthly-Report-Volume-29-Number-05 https://health.mil/Reference-Center/Reports/2024/01/01/MSMR-January-2024-vol-31-no-1 https://health.mil/Reference-Center/Reports/2025/03/01/MSMR-Vol-32-No-3-Mar-2025 https://health.mil/Reference-Center/Reports/2025/11/01/MSMR-Vol-32-No-11-Nov-2025 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Tick-Borne Disease Therapeutic/Diagnostic Research Award 16

Long-Term Impact: Explain the anticipated long-term advancements over current knowledge, technology, and/or practice, ultimately contributing to the field of Lyme disease and/or other tick-borne diseases/conditions research, patient care, and morbidity and/or mortality. Describe how the proposed treatment/therapeutic offers advancement beyond the current standard of care or provides a potential treatment/ therapy where one does not currently exist (if applicable). Describe how the proposed diagnostic approach offers more sensitivity and specificity than current assays, helps define patient populations, differentiates disease states, and/or assesses efficacy of potential therapeutics (if applicable). Describe how the proposed research will advance the potential evidence-based treatment, therapeutic, or diagnostic toward dissemination and clinical implementation.

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

○ Attachment 7: Post-Award Transition Plan (three-page limit): Upload as “Transition.pdf”. Describe the methods and strategies proposed to advance the anticipated research outcomes/products (intellectual knowledge and/or tangible materiel) to the next phase of development (clinical trials, commercialization, and/or delivery to the civilian or military market) after successful completion of the proposed effort. Applicants are encouraged to work with their organization’s Technology Transfer Office (or equivalent) to develop the post-award transition plan.

The post-award transition plan should include the components listed below, as appropriate and applicable to the research proposed.

A description of the anticipated outcomes/products expected upon completion of the proposed research efforts. Outcomes should be relevant, measurable and include the intended end-user.

Provide a description of how the anticipated outcomes/products of the proposed research will be disseminated to both the scientific and consumer/stakeholder communities.

Details of the funding strategy that will be used to advance the outcomes to the next phase of development, commercialization (e.g., partners, funding opportunities to be applied for), and/or incorporation into patient care.

Provide a brief schedule and milestones for bringing the outcomes/products to the next phase of development (e.g., further research, clinical trials, commercialization/ transition to industry, delivery to the military or civilian market, incorporation into clinical practice, clearance/approval by a Regulatory Agency).

For knowledge products, include the development or modification of clinical practice guidelines/recommendations, provider training materials, patient brochures, clinical support tools, scientific journal publications, models, simulations, and other applications. (A “knowledge product” is a non-materiel product that aims to transition into medical practice, training, tools or to support materiel solutions; and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.)

As appropriate, discuss ownership rights/access to the intellectual property necessary for the development and/or commercialization of products or technologies supported with this award. Include a plan for resolving intellectual and material property issues among participating organizations. If the intellectual property rights

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FY26 Tick-Borne Disease Therapeutic/Diagnostic Research Award 17 are not owned by the applicant, PI or a member of the study team, describe the planned next steps necessary to make the product available to the target population.

○ Attachment 8: Animal Research Plan (three-page limit): Upload as “AnimalResPlan.pdf”. (Attachment 8 is only applicable and required for applications proposing animal studies.)

If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application.

Proposed studies should not rely on samples, reagents, or tools that are contingent upon completion of other ongoing efforts outside the scope of this proposal.

Consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve rigorous and reproducible results for each proposed animal study:

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

Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology and natural tick-borne disease transmission.

Include relevant preliminary data to support testing the study…