HT9425_FY26_TSCRP_IDA_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 Idea Development Award

Funding Opportunity Number: HT942526 TSCRPIDA

Pre-Application Due: July 9, 2026 Application Due: July 23, 2026

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

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

DOD FY25 Tuberous Sclerosis Complex Exploration-Hypothesis Development Award

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 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

DOW FY26 Tuberous Sclerosis Complex Idea 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).

DOW FY26 Tuberous Sclerosis Complex Idea Development Award 1

1. Basic Information About the Funding Opportunity Summary: The fiscal year 2026 (FY26) Tuberous Sclerosis Complex Research Program (TSCRP) Idea Development Award (IDA) Supports conceptually innovative and high-impact research that could ultimately lead to critical discoveries in tuberous sclerosis complex (TSC) research and/or improvements in patient care.

Distinctive Features: This funding mechanism allows for established and new-to-the-field investigators. New-to-the-field investigators are independent investigators that are early in their faculty appointments and/or established investigators transitioned from other research fields into TSC research. Applications to the New-to-the-Field option will compete separately from the Established Investigators submitting to the regular Idea Development Award (IDA).

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $3.2M to fund approximately four IDA applications with total cost caps of $0.80M per award. The maximum period of performance is three 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: HT942526TSCRPIDA 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

Although a Principal Investigator (PI) may be eligible for both the Established Investigator and New-to-the-Field Investigator categories, only one category may be chosen at the time of pre-application submission; the choice of application category is at the PI’s discretion.

Established Investigator

· The PI must be an independent investigator at all career levels.

New-to-the-Field Investigator

· By the application submission deadline, the PI must be either:

· An independent investigator at the level of instructor or staff scientist, Assistant Professor (or equivalent), or above; or

· An established independent investigator in an area other than TSC at all career levels seeking to transition to a career in TSC thereby bringing their expertise to the field.

· Must not have received more than $300,000 in total direct costs for previous or concurrent TSC research as a PI of one or more federally funded, non-mentored peer-reviewed grants. (National Institutes of Health K Awardees are eligible to apply.)

· Must not have received a New Investigator Award previously from any program within the CDMRP.

· The PI must commit at least 10% of their effort toward the proposed TSC research project. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): Is this for both PI options or just NFI? Recommend making this more clear if for both.

· Graduate students, postdoctoral fellows, and other “mentored” researchers are not eligible for this award.

Investigators affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status. An investigator may be named on only one FY26 Tuberous Sclerosis Complex Research Program (TSCRP) IDA application as a PI. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): Is CDMRP limiting the number of applications a PI can be named on for all of TSCRP? Possibly add language “and may be named on only X TSCRP applications as 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.

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): I know TSCRP was not funded in FY25 but wondering if maybe this should speak to that?

3.1. Award History

The TSCRP Idea Development Award mechanism was first offered in FY02. Since then, 516 Idea Development Award applications were received, and 101 were recommended for funding. The overall funding rate is 20%.

3.2. Intent of the Idea Development Award

The IDA promotes ideas that have the potential to yield high-impact findings and new avenues of investigation. This award mechanism supports conceptually innovative research that could ultimately lead to critical discoveries in TSC research and/or improvements in patient care. Research projects should include a well-formulated, testable hypothesis based on strong preliminary data and scientific rationale.

3.2.1. Focus Areas for the IDA

The FY26 TSCRP IDA 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.

3.2.2. Key Elements for the IDA

Impact: Applications should articulate both the short- and long-term impact of the proposed research. High-impact research will, if successful, significantly advance TSC research and/or patient care.

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

New-to-the-Field Investigator (NFI): The FY26 TSCRP IDA mechanism encourages applications from investigators in the early stages of their TSC research career. The NFI Option is designed to support the continued development of promising independent investigators that are early in their faculty appointments and/or the transition of established investigators from other research fields into TSC research. Applications to the NFI Option will compete separately from Established Investigators submitting to the regular IDA. PIs applying under the NFI Option are strongly encouraged to strengthen their applications through collaboration with investigators experienced in TSC research and/or possessing other relevant expertise as demonstrated by a record of funding and publications. See Attachment 8: Eligibility Statement.

3.2.3. Other Important Considerations for the IDA

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 three years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $800,000. 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 three 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 Idea Development Award].

Must not be requested for:

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

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

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 IDA 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 (10-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. Include preliminary and/or published data that are relevant to TSC and the proposed research project.

· 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. If this research project is part of a larger study, present only tasks that this award would fund.

· 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. If any biological material will be used, the name, definition, pathological classification and source of the material must be provided.

· Describe how data will be collected, handled and analyzed in a manner that is 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.

· If animal studies are proposed, the applicant is required to submit an Animal Research Plan (Attachment 9).

· If human subjects or human anatomical samples will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples. For clinical research, 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 Policy on Inclusion of Women and Minorities, and Frequently Asked Questions for the policy may be downloaded from eBRAP under “Resources and Reference Material” at https://ebrap.org/eBRAP/public/Program.htm.

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

· NFI Investigators: Collaboration with investigators experienced in TSC research and/or possessing other relevant expertise is encouraged. If applicable, describe the specific contributions of the collaborator(s) to the research project. The application should describe how the collaboration(s) will augment the PI’s expertise to best address the research question. All NFI Investigator applicants must meet specific eligibility criteria as described in Section 2.1.2, Principal Investigator. Comment by Martin, JoAnn L CIV DHA DHA CONTRACTING ACT (USA): NFI stands for New to Field Investigator (NFI) – technically this says New to Field Investigator Investigator.

Possibly change to NFI Option or Spell out New-to-the Field Investigators:

· 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.

· Impact: Briefly describe how the proposed research project will have a short- and long-term impact on TSC research and/or patient.

· Innovation: Briefly describe how the proposed research project is innovative in the field of TSC

· 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 IDA Focus Areas. If the project does not address an FY26 TSCRP IDA 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 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.

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

· Attachment 8: Eligibility Statement (one-page limit): Upload as “Eligibility.pdf”. (Attachment 8 is only applicable and required for applications to the NFI Option.)

Provide a letter, signed by the PI and the Department Chair, Dean, or equivalent official, verifying that the eligibility requirements will be met by the application submission deadline. The letter should verify that the PI is an independent investigator at or above the level of Assistant Professor (or equivalent), or an established independent investigator in an area other than TSC at or above the level of Assistant Professor seeking to transition to a career in TSC thereby bringing their expertise to the field; that the PI has not received more than $300,000 in total direct costs for previous or concurrent TSC research as a PI of one or more federally funded, non-mentored peer-reviewed grants. (Refer to Section 2.1.2, Principal Investigator, for eligibility information.)

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

· Attachment 11: 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.

When starting the pre-application, PIs should select a Mechanism Option appropriate to their pre-application:

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 Impact and Research Strategy and Feasibility are ranked as most important, and all other score criteria are of equal importance:

· Impact

· How well the proposed research project addresses one or more of the FY26 TSCRP IDA 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.

· How well the statistical analysis plan was described and considered appropriate for the proposed research project.

· 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 animal study (or studies) is designed to achieve the objectives, including the choice of model and endpoints/outcome measures to be used.

· If applicable, how well the study (or studies) is designed to achieve reproducible and rigorous results, including controls, sample size estimation, blinding, randomization and data handling.

· If applicable, whether the strategy for the inclusion of women and minorities, and the distribution of proposed enrollment, are appropriate for the proposed research.

· 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.

· 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.

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

· Personnel

· To what extent the levels of effort by the PI and other key personnel are appropriate to ensure success of the proposed research project.

· To what degree the PI and research team’s experience, expertise and record of accomplishments demonstrate their ability to successfully complete the proposed research project.

· In addition, for NFI:

· To what degree the PI’s record of accomplishments demonstrates their potential for contributing to the field of TSC research and completing the proposed work.

· If applicable, to what extent the specific contributions of the collaborator(s) will augment the PI’s expertise to best address the research question.

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

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.

· 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 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. The 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.