HT942526TSCRPCTRA_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

Tuberous Sclerosis Complex Research Program Clinical Translational Research Award

Funding Opportunity Number: HT942526TSCRPCTRA

Pre-Application Due: July 23, 2026

Application Due: August 6, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Idea Development 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.

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

FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Tuberous Sclerosis Complex Research Program (TSCRP) Clinical Translational Research Award (CTRA) supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis or treatment of tuberous sclerosis complex (TSC).

Distinctive Features: This funding mechanism allows for multiple Principal Investigators (PIs). Only the initiating PI will submit a pre-application, but all PIs will need to submit full applications. The partnering PI(s) application is an abbreviated package specific to their distinct portion of the research project. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $3.50 million (M) to fund approximately two Clinical Translational Research Award applications with total cost caps of $1.60M for single PI applications and $1.90M for partnering PI applications. 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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 23, 2026

• Application Submission Deadline: 11:59 p.m. ET, August 6, 2026

• End of Application Verification Period: 5:00 p.m. ET, August 13, 2026

• Peer Review: November 2026

• Programmatic Review: February 2027 Announcement Type: Initial Funding Opportunity Number: HT942526TSCRPCTRA Assistance Listing Number: 12.420

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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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

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

Independent investigators at all career levels are eligible to be named as a PI, Initiating PI or Partnering PI.

Each investigator may be named on only one FY26 Tuberous Sclerosis Complex Research Program (TSCRP) CTRA application as a PI, Initiating PI or Partnering PI.

For studies that address improving clinical care of TSC, advanced practice providers, genetic counselors or nurses are eligible to be named as a PI, Initiating PI or Partnering 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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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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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 Tuberous Sclerosis Complex Research Program (TSCRP). 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 TSCRP in 2002 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the TSCRP from FY02 through FY24 totaled $121M. The TSCRP did not receive appropriation in FY25. The FY26 appropriation is $10M.

3.1. Award History

The TSCRP Clinical Translational Research Award mechanism was first offered in FY17. Since then, 36 Clinical Translational Research Award applications were received, and 13 were recommended for funding.

3.2. Intent of the CTRA

The CTRA supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis or treatment of TSC. Projects supported by this award mechanism may include, but are not limited to:

• Studies moving from preclinical to clinical research and/or the reverse; or analyzing human anatomical substances and/or data associated with completed clinical trials to understand the mechanism of action, or to improve diagnosis, prognosis or treatment.

• Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints and validation of pharmacokinetics/pharmacodynamics.

• Pilot clinical trials, where limited clinical testing (e.g., small sample size) of a novel intervention to produce information on diagnostic or therapeutic effectiveness, safety, tolerability or mechanisms of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions with the potential to improve TSC outcomes.

• New studies improving clinical care of TSC encompassing the analysis of existing real-world clinical practice data to develop/improve guidelines for better outcomes in defined areas relevant to the FY26 TSCRP CTRA Focus Areas, include but are not limited to epilepsy surgery, tumor resection, reproductive health, perinatal surveillance and care, etc.

Preclinical studies may be appropriate but must include a clinical component. Projects that are strictly animal research will not be considered for CTRA funding and should consider other FY26 TSCRP funding opportunities.

3.2.1. Focus Areas for the CTRA

The FY26 TSCRP CTRA encourages applications in mechanistic studies, animal model development, biomarkers, therapeutics and patient-centered studies that address one or more of the following focus areas:

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• Understanding, preventing and treating the features of TSC-Associated Neuropsychiatric Disorders and reducing their impact, including pharmacological, behavioral and surgical interventions.

• Strategies for preventing and eradicating tumors and cysts associated with TSC, such as angiomyolipomas, subependymal giant cell astrocytoma and lymphangioleiomyomatosis (LAM), including gaining a deeper mechanistic understanding of tumor microenvironment, TSC signaling and m-TOR independent pathways.

• Preventing epilepsy, improving treatment and mitigating neurodevelopmental and adverse outcomes associated with TSC-related seizures.

• Developing, assessing and testing emerging diagnostic and therapeutic technologies to improve outcomes in TSC.

• Understanding potential pathogenic mechanisms or improving outcomes of maternal-fetal and reproductive health of women with TSC or LAM and the perinatal care of fetuses or newborns with TSC.

3.2.2. Key Elements for the CTRA

The following are important aspects of the CTRA:

• Translation: The application should clearly state how the proposed research project will expand upon promising preclinical and/or clinical research findings to move the field closer to a clinical application by the end of the study.

• Impact: Proposed studies should have the potential to improve the diagnosis, prognosis, treatment of TSC or to improve clinical care of TSC by:

○ Likely having a major impact on TSC patients by applying promising and well-founded laboratory or other preclinical or clinical research findings to the care of patients.

○ Leveraging information from completed clinical trials to address knowledge gaps in resulting outcomes, validate key research findings and expand upon potentially transformative results, or investigate novel findings.

○ Developing or improving clinical care guidelines for better outcomes.

• Feasibility: The application should demonstrate that the investigators have access to the necessary specimens, data, intervention and patient population. If the application requires access to critical specimen or data, or if the application involves a pilot clinical trial, see Attachment 10, Letter(s) Confirming Access to Essential Resources.

• Preliminary Data: Unpublished results from the laboratory of the PI or collaborators named on the application, and/or data from the published literature that are relevant to TSC and the proposed research project, are required.

• Partnering PI Option: The TSCRP CTRA includes an option for more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI, refer to Section 5.3, Submission Instructions.

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3.2.3. Other Important Considerations for the CTRA

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.

Clinical trials are allowed within this funding opportunity.

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

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the 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.

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 $1.60M for single PI applications and $1.90M for partnering PI applications. 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.

Application Submissions With the Partnering PI Option: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI(s) should not exceed $1,900,000. 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.

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The applicants may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years. The duration of the period of performance for the Initiating PI and Partnering PI should be the same.

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

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

Any application that requests the higher level of funding but does not include a collaborative PI will have its budget reduced as appropriate.

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 TSCRP Clinical Translational Research Award.

Must not be requested for:

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

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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 initiating PI must submit the following pre-application components:

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

Include the FY26 TSCRP CTRA Focus Area(s) or another important problem or unmet need in TSC research and/or patient care to be addressed.

Letters of intent (LOIs) are used for program planning purposes only (e.g., reviewer recruitment) and will not be reviewed during either the peer or programmatic review. An invitation to submit a full application is NOT required after LOI submission. Applicants are encouraged to develop pre-application and full application components concurrently and submit a full application AFTER successful submission of the pre-application.

4.3. Full Application Components

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.

Application submissions with the Partnering PI Option: The CDMRP requires separate full application package submissions for the Initiating PI and each 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:

(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.

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○ Attachment 1: Project Narrative (15-page limit): Upload as “ProjectNarrative.pdf”.

The page limit of the Project Narrative 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 (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.

Describe the proposed project in detail using the outline below.

‒ Background/Scientific Rationale: Present the ideas and rationale behind the proposed research project, including a well-formulated, testable hypothesis, and clear mechanistic underpinning. Include relevant literature citations. Describe previous experience and expertise most pertinent to the proposed research project. Inclusion of preliminary and/or published data that are relevant to TSC and the proposed research project are required.

‒ Hypothesis/Objective: State the hypothesis to be tested or the objective to be reached.

‒ Specific Aims: Concisely explain the project’s specific aims to be funded by this award.

‒ Research Strategy and Feasibility:

Describe the experimental design and methods, including controls, sample size estimation, blinding, randomization and power analysis to achieve reproducible and rigorous results.

Address potential problem areas and present alternative methods and approaches.

Describe the handling, collection and analysis of data and ensure they are consistent with the study objectives.

Describe the statistical analysis plan appropriate for the proposed research project.

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

Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the U.S. Food and Drug Administration (FDA), if applicable.

For applications proposing animal studies, describe how the animal studies are designed to achieve the objectives, including the choice of model(s) and endpoints/outcome measures to be used. Submission of Attachment 9, Animal Research Plan is required.

For clinical research or pilot clinical trial, describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial and ethnic group, and an accompanying rationale for the selection of subjects. 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. The inclusion strategy should agree with the enrollment table(s) provided in Attachment 2, Supporting Documentation: Inclusion Enrollment Report.

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In addition, for applications involving data analysis and/or specimens from completed clinical trial(s) (including correlative studies):

Describe the proposed pre-existing cohort and its relevance to TSC, including the type of the data and/or specimens, and the size of the cohort. Submission of Attachment 10 is required to confirm the access to the necessary data and/or specimens.

In addition, for applications involving a pilot clinical trial: (Note: The Project Narrative is not the formal clinical trial protocol. If recommended for funding, the clinical trial protocol will be requested.)

Describe the type of pilot clinical trial to be performed, the intervention to be tested, human subject population to be recruited, outcome measures, ethical consideration, recruitment strategy and regulatory strategy, as appropriate.

Submission of Attachment 10 is required to confirm the access to the intervention and patient population.

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

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 General Application Instructions, Appendix 4, for additional considerations.

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

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

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Inclusion Enrollment Report (only required if clinical research and/or a clinical trial 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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a https://ebrap.org/eBRAP/public/Program.htm#:%7E: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:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 13 individual, ethnicity, or race (typically classified as exempt from IRB review) are exempt from this requirement.

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 (five-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 (SABV) 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 (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

Commercialization Strategy (if applicable): Describe the commercialization plan.

The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors, and management team. Discuss the significance of this development effort, when it can be anticipated, and the potential commercial use for the technology being developed.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g., for intellectual property, feasibility, cost, or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or 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 Tuberous Sclerosis Complex Clinical Translational Research Award 14 their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

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

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

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

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

Background: Present the scientific rationale behind the proposed research project.

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

Specific Aims: State the specific aims of the study.

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

Military Relevance: Describe how the study is relevant to military health.

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

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

– Summarize the objectives and rationale for the proposed research.

– What population will the research help, and how will it help them?

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

– What are the likely contributions of the proposed research project to advancing research, patient care and/or quality of life?

– What is the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families.

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

Refer to eBRAP for the Suggested SOW Format.

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

Partnering PI Option:

Each PI must submit an identical copy of a jointly created SOW. The specific contributions of the Initiating PI and [each or the] Partnering PI should be clearly noted for each task.

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

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FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 15

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

Explain why the proposed research is important and the impact that it will have on one or more of the FY26 TSCRP CTRA Focus Areas. If the project does not address an FY26 TSCRP CTRA Focus Area, provide justification that the proposed research project addresses another important problem or unmet need in TSC research and/or patient care Explain the proposed research project’s potential to improve the diagnosis, prognosis, or treatment of TSC by applying promising and well-founded laboratory or other preclinical or clinical research findings to the care of patients, and/or leveraging information from completed clinical trials to address knowledge gaps or investigate novel findings.

– Short-Term Impact: Detail the anticipated outcome(s) that make an important contribution toward advancing TSC research.

– Long-Term Impact: Explain the anticipated long-term gains from the proposed research project, including how the new understanding may ultimately contribute to the goal of advancing TSC research and/or patient care and make a significant contribution toward improving the diagnosis, prognosis or treatment of TSC.

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

○ Attachment 7: Clinical Translation Statement (one-page limit): Upload as “Translation.pdf”.

Describe the translational aspects of the proposed research. The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the introduction of health care products, technologies or practice guidelines for clinical use. State explicitly how the proposed research project is translational in nature and describe how it will help to move an observation forward into clinical practice.

If the proposed research includes both preclinical research and a pilot clinical trial, explain how the preclinical research and pilot clinical trial aims are connected and necessary to advance the research toward clinical implementation. Include a clear description of the next step in the translation of the results of this research after the end of the project.

○ Attachment 8: Partnership Statement (one-page limit): Upload as “Partnership.pdf” (Attachment 8 is only applicable and required for applications submitted under the Partnering PI Option).

Describe the expertise of the Initiating and Partnering PIs and how each will bring different strengths to the proposed project. Describe the unique expertise that each PI brings to the project, how each is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts.

Outline the contribution and time commitment of each partner and how each will have significant intellectual input on the design, conduct and analysis of the project. Describe how the PIs will manage the collaboration and workflow to optimize research efforts.

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

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

FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 16

○ Attachment 9: Animal Research Plan (three-page limit): Upload as “AnimalPlan.pdf”. (Attachment 9 is only applicable and required for applications proposing animal studies.)

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

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

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

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

– Describe the randomization and blinding procedures for the study, and any other measures to be taken to minimize the effects of subjective bias during animal treatment and assessment of results. If randomization and/or blinding will not be utilized, provide justification.

– Provide a sample size estimate for each study arm and the method by which it was derived, including power analysis calculations.

– Describe how data will be handled, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, statistical methods for data analysis, and identification of the primary endpoint(s).

○ Attachment 10: Letter(s) Confirming Access to Essential Resources: Upload as “Access.pdf”. (Attachment 10 is only applicable and required for applications involving data analysis and/or specimens or involving in a pilot clinical trial).

If applications are involved in analyzing data and/or specimens from completed clinical trials, provide a letter of support signed by the appropriate institution official who has the authority to confirm access to the proposed cohort data and/or specimens. If applications are involved in conducting a pilot clinical trial, provide a letter of support signed by the appropriate institution official who has the authority to confirm access to the proposed intervention and patient population.

○ Attachment 11: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 12: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

https://arriveguidelines.org/arrive-guidelines https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Required%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

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FY26 Tuberous Sclerosis Complex Clinical Translational Research Award 17

(c) Additional Application Materials:

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

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

○ Biographical Sketch

○ Current/Pending Support

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

ii. Research & Related Budget Initiating and Partnering PIs must have a separate budget and justification specific to their distinct portions of the effort that the applicant organization…