HT9425_FY26_TSCRP_EHDA_GO Comments.docx

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

Program Announcement for the Defense Health Agency

Tuberous Sclerosis Complex Research Program Exploration-Hypothesis Development Award

Funding Opportunity Number: HT942526TSCRPEHDA

Pre-Application Due: July 9, 2026 Application Due: July 23, 2026 This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

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

Content

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 Exploration-Hypothesis 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

FY26 Tuberous Sclerosis Complex Exploration-Hypothesis Development 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 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.

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).

FY26 Tuberous Sclerosis Complex Exploration-Hypothesis Development Award 1

1. Basic Information About the Funding Opportunity Summary: The fiscal year 2026 (FY26) Tuberous Sclerosis Complex Research Program (TSCRP) Exploration-Hypothesis Development Award (EHDA) Ssupports the initial exploration of innovative, high-risk, high-gain and potentially groundbreaking concepts in the tuberous sclerosis complex (TSC) research field.

Distinctive Features: Preliminary Data is not required. Applications should demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $2.1M to fund approximately six Exploration-Hypothesis Development Award applications with total cost caps of $0.35M350,000 per award. The maximum period of performance is two 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 (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 9, 2026

· Application Submission Deadline: 11:59 p.m. ET, July 23, 2026

· End of Application Verification Period: 5:00 p.m. ET, July 30, 2026

· Peer Review: October 2026

· Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526TSCRPEHDA 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

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

Individuals affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

Independent investigators and postdoctoral fellow (or equivalent) are eligible to be named as the PI on this application. An investigator may be named on only one FY26 Tuberous Sclerosis Complex Research Program (TSCRP) EHDA application as a PI. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): Will CDMRP be capping TSCRP apps?

“An investigator may be named as PI on no more than three FY26 TSCRP applications across all award mechanisms, in any combination.”

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.

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

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 $121 million (M). The FY26 appropriation is $10M. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): TSCRP was not funded in FY25.

3.1. Award History

The TSCRP Exploration-Hypothesis Development Award mechanism was first offered in FY09. Since then, 307 Exploration-Hypothesis Development Award applications were received, and 72 were recommended for funding. The overall funding rate is 23.5%.

3.2. Intent of the Exploration-Hypothesis Development Award

The Exploration-Hypothesis Development Award (EHDA) supports the initial exploration of innovative, high-risk, high-gain and potentially groundbreaking concepts in the TSC research field. The studies supported by this award mechanism are expected to generate preliminary data for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on a strong scientific rationale and study design. Applications should demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis

3.2.1. Focus Areas for the EHDA

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

· 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 a fetuses or newborns with TSC. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): “care of fetuses” or “care of a fetus”

3.2.2. Key Elements for the EHDA

Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, examine existing problems from new perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative and is not consistent with the intent of the award mechanism.

Although not all-inclusive, the following examples are ways in which the proposed research project may be innovative:

· Explores a novel idea and/or research question in TSC research and/or patient care.

· Uses or develops novel methods or technologies to address a question in TSC research and/or patient care.

· Applies or adapts existing methods or technologies for novel TSC research or clinical purposes that differ fundamentally from those originally intended.

3.2.3. Other Important Considerations for the EHDA

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 not 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 two years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $350,000. 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 two 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 TSCRP Exploration-Hypothesis Development Award.

Must not be requested for:

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

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

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.

Letter of Intent (one-page limit): Provide a brief description of the research to be conducted. Include the FY26 TSCRP EHDA Focus Area(s) or another important problem or unmet need in TSC research and/or patient care to be addressed.

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.

(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 (four-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. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): Innovation is top scored criteria – should it possibly be mentioned in proposal narrative as well?

Describe the proposed project in detail using the outline below.

· Background/Scientific Rationale: Present the ideas and clearly articulate the scientific rationale for the proposed research project, including a well-formulated, testable hypothesis and a clear mechanistic underpinning. Include relevant literature citations. Describe previous experience and expertise most pertinent to the proposed research.

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

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

· Research Strategy and Feasibility:

· Describe the experimental design, methods and analyses, including appropriate controls, sample size estimation, blinding, randomization and power analysis, in sufficient detail for critical evaluation to .appropriately test the hypothesis and achieve reproducible and rigorous results.

· Describe the how the scientific rationale, including a well-formulated, testable hypothesis and clear mechanistic underpinning, supports the proposed research project.

· Describe the statistical analysis plan appropriate for the proposed research project and how the handling, collection and analysis of data is consistent with the study objectives..

· Address potential problem areas and present alternative methods and approaches.

· If animal studies are proposed, the applicant is required to submit an Animal Research Plan (Attachment 8).

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

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

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

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

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

· Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

· Letters of Support (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.

· 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 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.

· 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 EHDA Focus Areas. If the project does not address an FY26 TSCRP EHDA Focus Area, provide justification that the proposed research project addresses another important problem or unmet need in TSC research and/or patient care.

· 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 outcomes from the proposed research project, including how the new understanding may ultimately contribute to the goal of advancing TSC research and/or patient care.

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

· Attachment 7: Innovation Statement (one-page limit): Upload as “Innovation.pdf”.

· Describe how the proposed research project is innovative in the field of TSC.

· Describe how the proposed research project introduces a new paradigm, challenges existing paradigms, or looks at existing problems or issues from a new perspective.

· Describe how the research represents more than an incremental advance on published data or current work in the applicant’s laboratory.

· Attachment 8: Animal Research Plan (three-page limit): Upload as “AnimalPlan.pdf”. (Attachment 8 is only applicable and required for applications proposing animal studies) If the proposed study involves animals, a summary describing the animal research that will be conducted must be included in the application. Consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The Animal Research Plan may not be an exact replica of the protocol(s) submitted to the Institutional Animal Care and Use Committee (IACUC). The Animal Research Plan should address the following points to achieve reproducible and rigorous results for each proposed animal study:

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

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

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

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

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

· Attachment 9: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

· Attachment 10: 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.

(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.

eBRAP.org Grants.gov

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

· Biographical Sketch

· Current/Pending Support Intragovernmental applicants must include their internally supported research and development programs.

ii. Research & Related Budget

iii. Project/Performance Site Location(s)

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

4.4. Other Application Elements

If recommended for funding, a data management plan compliant with Section 3.c, Enclosure 3, DoD Instructions 3200.12 will be requested.

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

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

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526TSCRP from Grants.gov or eBRAP, depending on which submission portal will be used.

5.2. Unique Entity Identifier and System for Award Management The applicant organization must be registered as an entity in the System for Award Management (SAM), SAM.gov, and receive confirmation of an “Active” status before submitting an application through Grants.gov. Organizations must include the unique entity identifier (UEI) generated by the SAM in applications to this funding opportunity and maintain an active registration in the SAM at all times during which it has an active Federal award or an application under consideration.

5.3. Submission Instructions

The CDMRP uses two portal systems to accept pre- and full application submissions. The workflow below shows which portal system to use for pre- and full application submissions, respectively.

Application Submission Workflow

5.3.1. Pre-Application Submission

All pre-application components must be submitted by the PI through eBRAP.

During the pre-application process, eBRAP assigns each submission a unique log number. This unique log number is required during the full application submission process. The eBRAP log number, application title and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire pre-application and full application submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify and verify the application in eBRAP. Contact the eBRAP Help Desk if any changes need to be made.

5.3.2. Full Application Submission

Grants.gov Submissions: Full applications from extramural organizations must be submitted through the Grants.gov Workspace.

eBRAP Submissions: Only intramural DOW organizations may submit full applications through eBRAP.

5.3.3. Applicant Verification of Full Application Submission in eBRAP Independent of the submission portal, once the full application is submitted, it is transmitted to and processed in eBRAP; the transmission to eBRAP may take up to 48 hours. At this stage, the PI and organizational representatives will receive an email from eBRAP instructing them to log in to eBRAP to review, modify and verify the full application submission. The Project Narrative and Research & Related Budget Form cannot be changed after the application submission deadline. Other application components, including subaward budget(s) and subaward budget justification(s), may be changed until the application verification period ends. The full application cannot be modified once the application verification period ends.

5.4. Submission Dates and Times

The pre-application and full application submission process should be started early to avoid missing deadlines. Regardless of submission portal used, all pre- and full application components must be submitted by the deadlines stipulated in this program announcement. There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The DHACA cannot make allowances/exceptions for submission problems encountered by the applicant.

Submission dates and times are specified in Section 1, Basic Information.

5.5. Intergovernmental Review

Not applicable for this funding opportunity.

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

6. Application Review Information

6.1. Application Compliance Review

Submitting applications that propose essentially the same research project to different funding opportunities within the same program and fiscal year is prohibited and will result in administrative withdrawal of the duplicative application(s).

While it is allowable to propose similar research projects to different programs within the CDMRP or to other organizations, duplication of funding or accepting funding from more than one source for the same research is prohibited. See the CDMRP’s Directive on Research Duplication.

Including classified research data within the application and/or proposing research that may produce classified outcomes or outcomes deemed sensitive to national security concerns, may result in application withdrawal.

Members of the FY26 TSCRP Programmatic Panel must not be involved in any pre-application or full application including, but not limited to, concept design, application development, budget preparation and the development of any supporting documentation, including personal letters of support/recommendation for the research and/or PI. Programmatic panel members may provide letters to confirm PI eligibility and access to laboratory space, equipment and other resources necessary for the project if that is part of their regular roles and responsibilities (e.g., as Department Chair). A list of the FY26 TSCRP Programmatic Panel members can be found on the CDMRP website.

Additional restrictions and associated administrative responses are outlined in Section 9.2, Administrative Actions.

6.2. Review Criteria

6.2.1. Pre-Application Screening Criteria

Pre-applications submitted to this funding opportunity are used for program planning purposes only (e.g., reviewer recruitment) and will not be screened.

6.2.2. Peer Review Criteria

To determine technical merit, all applications will be evaluated individually according to the following scored criteria, where Innovation is ranked as most important, and other scored criteria are of equal importance. Preliminary data is allowed but not required.

· Innovation

· To what extent the proposed research project is innovative in the field of TSC.

· To what extent the proposed research project introduces a new paradigm, challenges existing paradigms, or looks at existing problems or issues from a new perspective.

· To what extent the proposed research project represents more than an incremental advance upon published data or current work in the applicant’s laboratory.

· Impact

· How well the proposed research project addresses one or more of the FY26 TSCRP EHDA Focus Areas or another important problem or unmet need in TSC research and/or patient care.

· Assuming the objectives/goals of the proposed research project are realized:

· To what extent the anticipated short-term outcomes will make an important contribution toward advancing TSC research.

· To what extent the anticipated long-term outcomes will make an important contribution toward the goal of advancing TSC research and/or patient care.

· To what extent the data and resources generated during the performance of the project will be shared with the research community.

· If applicable, to what extent the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

· Research Strategy and Feasibility

· How well the scientific rationale, including a well-formulated, testable hypothesis and clear mechanistic underpinning, supports the proposed research project.

· To what extent the experimental design and methods, including controls, sample size estimation, blinding, randomization and power analysis, are appropriate to test the hypothesis and achieve reproducible and rigorous results.

· How well the handling, collection and analysis of data are consistent with the study objectives.

· To what extent the proposed research project is feasible as described.

· How well the application identifies potential problems and addresses alternative approaches.

· If applicable, how well the proposed animal studies are designed to achieve the objectives, including the choice of model(s) and endpoints/outcome measures to be used.

· Whether the strategy for considering sex as a biological variable is appropriate to the objectives of the study, or whether the justification for a single-sex study is sufficiently strong.

In addition, the following criteria will also contribute to the overall evaluation of the application, but will not be individually scored and are therefore termed unscored criteria:

· Research Sharing Plan

· To what extent the plan for sharing of project data and research resources is appropriate and reasonable and includes dissemination to affected communities, study participants and/or the scientific community. If applicable, whether specific repository(ies) are named where data and research resources arising from the project will be stored.

· Personnel

· How appropriate the expertise and levels of effort are for successful conduct of the proposed work.

· Budget

· Whether the budget is appropriate for the proposed research.

· Environment

· To what extent the scientific environment and level of institutional support is appropriate for the proposed research project.

· How well the research requirements are supported by the availability of and accessibility to facilities and resources.

· Application Presentation

· To what extent the writing, clarity and presentation of the application components influence the review.

6.2.3. Programmatic Review

To make funding recommendations and select the application(s) that, individually or collectively, will best achieve the program objectives, the following criteria are used by programmatic reviewers:

· Ratings and evaluations of peer reviewers

· Relevance to the priorities of the FY26 TSCRP, as evidenced by the following:

· Adherence to the intent of the funding opportunity

· Program portfolio composition

· Relative innovation, impact and/or military benefit

6.3. Application Review and Selection Process

6.3.1. Pre-Application

There is no review and selection process for pre-applications submitted to this funding opportunity. CDMRP will NOT provide an invitation to submit a full application after pre-application 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.

6.3.2. Full Application

All applications are evaluated by scientists, clinicians and consumers in a two-tier review process. The first tier is peer review, the evaluation of applications against established criteria to determine technical merit, where each application is assessed for its own merit, independent of other applications. The second tier is programmatic review, a comparison-based process in which applications with high scientific and technical merit are further evaluated for programmatic relevance. Final recommendations for funding are subject to review and approval by a designated official. The highest-scoring applications from the first tier of review are not automatically recommended for funding. Funding recommendations depend on various factors as described in Section 6.2.3, Programmatic Review. Additional information about the two-tier process used by the CDMRP can be found on the CDMRP website.

Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds.

6.4. Risk, Integrity and Performance Information

Prior to making an assistance agreement award where the federal share is expected to exceed the simplified acquisition threshold, as defined in the Code of Federal Regulations, Title 2, Part 200.1 (2 CFR 200.1), over the period of performance, the federal awarding agency is required to review and consider any information about the applicant that is available in the SAM.

An applicant organization may review the SAM and submit comments on any information currently available about the organization that a federal awarding agency previously entered. The federal awarding agency will consider any comments by the applicant, in addition to other information in the designated integrity and performance system, in making a judgment about the applicant’s integrity, business ethics and record of performance under federal awards when determining a recipient’s qualification prior to award, according to the qualification standards of the Department of Defense Grant and Agreement Regulations (DoDGARs), Section 22.415.

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information In accordance with National Security Presidential Memorandum-33 and all associated laws, all fundamental research funded by the DOW must be evaluated for affiliations with foreign entities. All applicant organizations must disclose foreign affiliations of all key personnel named on applications. Failure to disclose foreign affiliations of key personnel shall lead to withdrawal of recommendations to fund applications. Applicant organizations may be presented with an opportunity to mitigate identified risks, particularly those pertaining to influence from foreign entities specified in law. Implementation of mitigation discussions and utilization of the DOD Component Decision Matrix must decrease risk of foreign influence in accordance with the above-mentioned laws and guidance prior to award.

7. Federal Award Notices For each compliant full application received, the organizational representative(s) and PI will receive email notification when the funding recommendations are posted to eBRAP, typically within 6 weeks after programmatic review. At this time, each PI will receive a peer review summary statement on the strengths and weaknesses of the application and an information paper describing the application receipt and review process for the TSCRP award mechanisms. The information papers and a list of organizations and PIs recommended for funding are also posted on the program’s page within the CDMRP website. After all awards are made, the CDMRP includes individual award information in a searchable database.

If an application is recommended for funding, after the email notification is posted to eBRAP, a government representative will contact the person authorized to negotiate on behalf of the recipient organization.

Only an appointed DHACA Grants Officer may obligate the government to the expenditure of funds to an extramural organization. No commitment on the part of the government should be inferred from discussions with any other individual. The award document signed by the Grants Officer is the official authorizing document (i.e., assistance agreement).

Intragovernmental obligations of funding will be made according to the terms of a negotiated Inter-Agency Agreement and managed by a CDMRP Science Officer.

Funding obligated to intragovernmental and intramural DOW organizations will be sent through the Military Interdepartmental Purchase Request (MIPR), Funding Authorization Document (FAD) or Direct Charge Work Breakdown Structure processes. Transfer of funds is contingent upon appropriate safety and administrative approvals. Intragovernmental and intramural DOW investigators and collaborators must coordinate receipt and commitment of funds through their respective Resource Manager/Task Area Manager/Comptroller or equivalent Business Official.

An organization may, at its own risk and without the government’s prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award.

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

8. Post-Award Requirements

8.1. Administrative and National Policy Requirements

Applicable requirements in the DoDGARs found in 32 CFR, Chapter I, Subchapter C, and 2 CFR, Chapter XI, apply to grants and cooperative agreements resulting from this program announcement.

The GAI contain information regarding administrative requirements and national policy requirements.

Refer to full text of the latest DoD R&D Terms and Conditions and the DHACA Research Terms and Conditions: Addendum to the DoD R&D Terms and Conditions for further information.

If there are delinquencies in technical reporting requirements for any existing DHA or U.S. Army Medical Research and Development Command awards at the applicant organization, DHACA will not issue any new awards to the applicant organization until all delinquent reports have been submitted.

Applications recommended for funding that involve animals, human data, human specimens, human subjects or human cadavers must be reviewed for compliance with federal animal and/or human subjects protection requirements and must be approved by the DHA R&D Office of Research and Regulatory Compliance (ORRC), prior to implementation. This administrative review requirement is in addition to the local IACUC, Institutional Review Board (IRB) or Ethics Committee (EC) review.

8.2. Reporting

Annual technical progress reports as well as a final technical progress report will be required. Annual and final technical progress reports must be prepared in accordance with the Research Performance Progress Report (RPPR).

The Award Terms and Conditions will specify whether additional and/or more frequent reporting is required.

Awards resulting from this program announcement may entail additional reporting requirements related to recipient integrity and performance matters. Recipient organizations that have federal contract, grant and cooperative agreement awards with a cumulative total value greater than $10M are required to provide information to the SAM about certain civil, criminal and administrative proceedings that reached final disposition within the most recent 5-year period and that were connected with their performance of a federal award. These recipients are required to disclose, semiannually, information about criminal, civil and administrative proceedings as specified in the applicable Representations.

8.3. Additional Requirements

Unless otherwise restricted, changes in the PI or organization will be allowed on a case-by-case basis, provided the intent of the award mechanism is met.

An organizational transfer of an award will not be allowed in the last year of the original period of performance or any extension thereof.

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

9. Other Information

9.1. Program Announcement Version

Questions related to this program announcement should refer to the program name, the program announcement name and the program announcement version code CD26_01d.

9.2. Administrative Actions

After receipt of full applications, the following administrative actions may occur.

9.2.1. Rejection

The following will result in administrative rejection of the full application:

· The Project Narrative is missing.

· The Budget is missing.

· Pre-application was not submitted.

9.2.2. Modification

· Pages exceeding the specified limits will be removed prior to reviewing all documents.

· Documents not requested will be removed.

9.2.3. Withdrawal

The following may result in administrative withdrawal of the full application:

· A member of the FY26 TSCRP Programmatic Panel is named as being involved in the development or execution of the research proposed or is found to have assisted in the pre-application or application processes.

· The application includes the name(s) of personnel from either of the CDMRP peer or programmatic review companies for which conflicts cannot be adequately mitigated. For FY26, the identities of the peer review contractor and the programmatic review contractor may be found on the CDMRP website.

· Personnel from applicant or collaborating organizations are found to have contacted persons involved in the review or approval process to gain protected evaluation information or to influence the evaluation process.

· The application from an extramural organization, including non-DOW federal agencies, is received through eBRAP.

· The federal government recipient organization (including an intramural DOW organization): (a) cannot accept and execute the entirety of the requested budget in FY26 funds; and/or (b) cannot coordinate the use of contractual, assistance or other appropriate agreements to provide funds to collaborators.

· The application fails to conform to this program announcement description.

· The application includes URLs, with the exception of links in the References Cited and Publication and/or Patent sections.

· The application includes research data that are classified and/or proposes research that may produce classified outcomes, or outcomes deemed sensitive to national security concerns.

· The same research…