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

Program Announcement for the Defense Health Agency

Lupus Research Program

Impact Award

Funding Opportunity Number: HT942526LRPIPA

Pre-Application Due: July 29, 2026

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

FY26 Lupus Impact Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Impact 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 Lupus Impact Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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

eBRAP Help Desk

301-682-5507 help@eBRAP.org

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

Grants.gov Support Center

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

Questions regarding Grants.gov registration and Workspace.

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

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

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

FY26 Lupus Impact Award 4

1. Basic Information About the Funding Opportunity

Summary: This funding mechanism supports high-risk/high-reward research that has the potential to make a major impact in lupus research and/or lupus disease. The emphasis is on impact. Research must address at least one of the fiscal year 2026 (FY26) Lupus Research Program (LRP) Impact Award (IPA) focus areas. This funding mechanism does not allow clinical trials.

Distinctive Features: The FY26 LRP IPA encourages, but does not require, preliminary data.

An individual may be named as Principal Investigator (PI) on only one application per LRP award mechanism (Idea Award, IPA, Transformative Vision Development Award, Transformative Vision Award), for a maximum of four applications to the FY26 LRP.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $5M to fund approximately five Impact Award applications with total cost caps of $1M per award. The maximum period of performance is 4 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 29, 2026

• Application Submission Deadline: 11:59 p.m. ET, August 19, 2026

• End of Application Verification Period: 5:00 p.m. ET, August 24, 2026

• Peer Review: October 2026

• Programmatic Review: February 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526LRPIPA

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

FY26 Lupus Impact Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

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

2.1.2. Principal Investigator

Independent investigators (or equivalent) affiliated with an eligible organization are eligible to be named PI on the application, regardless of ethnicity, nationality or citizenship status. Individuals in mentored positions (e.g., postdoctoral fellows, clinical fellows, or equivalent) are not considered independent investigators and are not eligible.

An investigator may be named on only one FY26 LRP IPA application as a PI.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:~:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%201-,RECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0

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

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

FY26 Lupus Impact Award 6

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 LRP. 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 LRP in 2017 to provide support for lupus research with high potential impact and exceptional scientific merit. Appropriations for the LRP from FY17 through FY24 totaled $65 million (M). The FY26 appropriation is $10M.

The LRP’s vision is to cure lupus through partnership of scientists, clinicians, and persons affected by lupus. The LRP seeks to achieve this vision through its mission to fund research to understand, prevent, and diagnose lupus and to improve treatments and quality of life for patients, including Service Members and their Families, Veterans, and the general public.

Lupus is a complex disease that impacts multiple factors of an individual’s life. Because of this, the LRP retains a broad research scope to ensure funding opportunities exist for any promising avenues of research with the potential to lead to improvements in treatments, patient quality of life, or lessening the severity of symptoms. The LRP welcomes applicants new to the field of lupus research with novel and innovative ideas for interventions that have the potential to make a significant impact in the lives of individuals with lupus. Applications may address the LRP focus areas in lupus patients of any age, including but not limited to those with disproportionate health burdens. The LRP encourages the use of computational methodologies, data science, and innovative technologies for biological, clinical data, and health care delivery.

3.1. Award History

The LRP Impact Award mechanism was first offered in FY17. Since then, 318 Impact Award applications were received, and 47 were recommended for funding.

3.2. Intent of the Impact Award

The LRP IPA supports high-risk/high-reward research focused on scientific and clinical lupus issues that has the potential to make a major impact in lupus research and/or lupus disease.

Applications should include a well-formulated, testable hypothesis based on strong scientific rationale that is established through inferential reasoning and/or critical review and analysis of the literature. The LRP encourages preliminary data but it is not required.

3.2.1. Focus Areas for the IPA

The proposed research must address at least one of the following FY26 LRP IPA Focus Areas:

• Understanding how lupus disease heterogeneity impacts risk of disease, disease presentation, clinical course and outcomes using a diverse range of research disciplines including, but not limited to, biopsychosocial studies, personalized medicine, variation in treatment studies, health economics, socioeconomic studies, environmental studies, systems biology, maternal fetal health and epidemiological studies.

• Understanding the biological mechanisms of lupus disease including, but not limited to, studies of informative/rare patients.

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

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

FY26 Lupus Impact Award 7

• Determining the pathobiology of end organ injury related to lupus disease in target human tissues.

• Improving quality of life for individuals living with lupus including, but not limited to, addressing social determinants of health, nutrition, alternative therapies, access to health care resources, outcomes research, patient-reported outcomes, symptom and disease control, comparative effectiveness research, maternal fetal health and issues and challenges that, when addressed, make day-to-day living with lupus easier and life more fulfilling.

• Understanding the underlying genetic and epigenetic components and gene-environment interactions of lupus and how they may relate to clinical disease characteristics, variations, disparities and differences in response to therapies using functional genomic studies.

• Improving outcomes for lupus through innovative health care delivery models.

• Designing an intervention either at the individual and/or health care system level to improve the quality of life and mental health for individuals living with lupus. Example interventions include, but are not limited to, access to health care resources, outcomes research, symptom and disease control, comparative effectiveness research and issues and challenges that, when addressed, make day-to-day living with lupus easier and life more fulfilling.

3.2.2. Key Elements for the IPA

The following are important aspects of the LRP IPA:

• Impact: The proposed research should impact an area of importance in lupus disease. The application should clearly and explicitly describe the potential impact(s) of the proposed study for individuals living with lupus and convey its significance. The LRP IPA supports high-risk, high-reward studies that have the potential to make a significant advancement in lupus research and/or addressing lupus disease. The LRP does not consider research representing an incremental advance of previously funded research as impactful.

• Research Strategy: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of lupus. Applications may include experimental strategies that are novel or based on strong rationale derived from a literature review.

• Research Team: The research team’s background should be appropriate with respect to its ability to successfully complete the proposed work.

• Focus Areas: The proposed research must address at least one of the FY26 LRP IPA focus areas.

3.2.3. Other Important Considerations for the IPA

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. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the

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

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

FY26 Lupus Impact Award 8

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 4 years.

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

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 4 years.

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

Direct Cost Restrictions: For this award mechanism, direct costs must not be requested for:

• Clinical trial costs https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:~:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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

FY26 Lupus Impact Award 9

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 (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the FY26 LRP IPA focus area under which the application will be submitted.

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 (seven-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background/Rationale: Briefly describe the ideas and reasoning on which the proposed work is based. Demonstrate logical reasoning and provide a sound scientific rationale for the proposed project as established through a critical review and analysis of published literature. If proposing translational research, it is important to describe the studies showing proof of concept and clinical relevance. This award mechanism encourages, but does not require preliminary data. For applications providing preliminary data, it should support the feasibility of the proposed work.

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

– Specific Aims: Concisely explain the project’s specific aims proposed.

– Research Strategy:

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

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

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

FY26 Lupus Impact Award 10

▪ Explain how this research strategy will meet the research goals and objectives.

▪ Explain how the application develops and integrates the hypothesis(es) or objective(s), aims, experimental design, methods, statistical analysis plan and analyses into the project. The application should include the strategy for considering sex as a biological variable as part of the Supporting Documentation (Attachment 2).

▪ Describe how the experimental design and methodology are appropriate to address the stated objective(s). If the methodology is new or unusual, provide sufficient details for evaluation. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ Explain how the application acknowledges potential problems and addresses alternative approaches.

▪ For applications proposing non-exempt 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. Anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race and ethnicity should be provided as part of the application’s Supporting Documentation (Attachment 2). Refer to the CDMRP Directive on Inclusion of Women and Minorities as Subjects in Clinical Research for additional information.

▪ Describe the availability of the necessary resources, including human subjects or human anatomical substances, as applicable. If the proposed research involves access to military and/or U.S. Department of Veteran Affairs (VA) patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the General Application Instructions, Appendix 4, for additional considerations.

– Research Team:

▪ Discuss how the research team’s background is appropriate with respect to its ability to perform the proposed work, including evidence of sufficient clinical and/or statistical expertise (if applicable).

▪ Explain how the levels of effort are appropriate for successful completion of the proposed work.

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

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://cdmrp.health.mil/pubs/pdf/CDMRP%20IWAM%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20IWAM%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOD_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204%C2%A0%20Use%20of%20DOW%20or%20U.S.%20Department%20of%20Veterans%20Affairs%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOD_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204%C2%A0%20Use%20of%20DOW%20or%20U.S.%20Department%20of%20Veterans%20Affairs%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

FY26 Lupus Impact Award 11

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

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

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

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

Letters of Support (two-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

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

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

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

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

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

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a

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

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

FY26 Lupus Impact Award 12

Information regarding intellectual property can be found in the Code of Federal Regulations, Title 2, Part 200.315 (2 CFR 200.315), “Intangible Property.”

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

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

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

Focus Areas: State which FY26 LRP IPA focus area the application will address.

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

Specific Aims: State the specific aims of the study.

Research Strategy: Briefly describe the research strategy, including methodology, statistical analysis, and appropriate controls.

Impact: Summarize the impact of the proposed research on the quality of life for individuals living with lupus, on the understanding, prevention, diagnosis and/or treatment of lupus.

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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

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

FY26 Lupus Impact Award 13

Military Relevance: Describe how the study is relevant to military health, which includes Service Members, their Families, Veterans and/or other DOW beneficiaries.

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

– Describe the relationship of the proposed work to the specific FY26 LRP IPA focus area(s).

– Describe the ultimate applicability of the research.

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

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

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

▪ What is the likely impact of this study on the quality of life for individuals living with lupus, or the understanding, prevention, diagnosis and/or treatment of lupus?

– What is the potential benefit of the proposed study and the anticipated outcomes to Service Members, their Families, Veterans and/or other DOW beneficiaries?

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

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

Clearly describe, in a manner readily understood by readers without a background in science or medicine, to what extent the proposed research will, whether in the short-term or long-term, lead to an original and important contribution toward advancing lupus research or improving the quality of life for individuals living with lupus.

Describe how the proposed research moves beyond an incremental advancement compared to the current status of the field.

Describe how the proposed research addresses at least one of the FY26 LRP IPA Focus Areas.

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

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:~:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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

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

FY26 Lupus Impact Award 14

○ Attachment 7: Animal Research Plan (three-page limit): Upload as “AnimalResPlan.pdf”. (Attachment 7 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 8: Transition Plan (one-page limit): Upload as “Transition.pdf”.

Describe the planned immediate next steps to be taken by the research team upon successful completion of the project to bring the research outcome(s) to the next stage of development (e.g., next stage preclinical/clinical research, translational research, clinical trial). Discuss the methods and strategies necessary for the research outcome to impact patient care and outcomes and provide a realistic timeline. In addition, provide a plan to distribute the findings to the lupus community.

○ 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.

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

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=B.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Representations https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=Suggested%20Intragovernmental/Intramural%20Budget%20Form%2C%20if%20applicable%3A

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

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

FY26 Lupus Impact Award 15

(c) Additional Application Materials:

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

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

○ Biographical Sketch

○ Current/Pending Support

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

ii. Research & Related Budget

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.

External Link to the GAI

Grants.gov

External Link to the GAI eBRAP.org https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:~:text=C.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=B.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=E.-,DOW%20Data%20Management%20Plan,-If%20recommended%20for

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

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

FY26 Lupus Impact Award 16

5. Submission Requirements

5.1. Location of Application Package

Download the application package components for HT942526LRPIPA 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), https://grants.gov/ https://ebrap.org/eBRAP/public/Program.htm https://www.sam.gov/content/home https://ebrap.org/ https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=Obtain%20Unique%20Entity%20Identifier%20from%20System%20for%20Award%20Management https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_PreApp_Submission:~:text=III.-,PRE%2DAPPLICATION%20SUBMISSION,-General%20information%20about

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

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

FY26 Lupus Impact Award 17 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:~:text=IV.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:~:text=V.-,FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Applicant_Verification_Grants_Submission:~:text=E.-,Applicant%20Verification%20of%20Grants.gov%20Submission%20in%20eBRAP,-Once%20the%20full

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

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

FY26 Lupus Impact Award 18

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 LRP 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…