HT942526BMFRPIIRA_GG.pdf

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

Program Announcement for the Defense Health Agency

Bone Marrow Failure Research Program Investigator-Initiated Research Award

Funding Opportunity Number: HT942526BMFRPIIRA

Pre-Application Due: August 5, 2026

Application Due: November 4, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Bone Marrow Failure Investigator-Initiated Research Award 2

Content Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Investigator-Initiated Research Award;

provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Bone Marrow Failure Investigator-Initiated Research 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/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E: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 Bone Marrow Failure Investigator-Initiated Research Award 4

1. Basic Information About the Funding Opportunity

Summary: Supports studies that further develop mature ideas, expand upon key discoveries, and have the potential to make significant advances in bone marrow (BMF) failure research and/or patient care. Investigator-Initiated Research Award (IIRA) applications may involve translational and clinical research including studies in preclinical models, research with human data and/or anatomical substances, and research with human subjects, as well as correlative studies associated with a clinical trial(s); however, this award mechanism does not support clinical trials. IIRA applications may also support Investigational New Drug (IND)-enabling efforts such as lead compound characterization, and assessments of formulation and stability, absorption, distribution, metabolism and excretion, dose/response and toxicology.

Distinctive Features:

• This funding mechanism allows for a partnering Principal Investigator (PI). Only the initiating PI will submit a pre-application, but both PIs will need to submit full applications.

The partnering PI application is an abbreviated package specific to their distinct portion of the research project. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn.

• This award mechanism requires preliminary data relevant to the proposed project.

Applications can support clinical research studies; however, this mechanism does not allow clinical trials.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $1.25M to fund approximately one Investigator-Initiated Research Award application with total cost caps of $1.25M per award. The maximum period of performance is 3 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 (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 5, 2026

• Invitation to Submit an Application: September 16, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 4, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 12, 2026

• Peer Review: January 2027

• Programmatic Review: March 2026 Announcement Type: Initial Funding Opportunity Number: HT942526BMFRPIIRA 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 Bone Marrow Failure Investigator-Initiated Research 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 at all career levels affiliated with an eligible organization are eligible to be named PI or partnering PI on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may be named as a PI on a maximum of two applications to this program announcement. If an investigator is named as a PI on more than two BMFRP IIRA applications, only the first two applications received will be accepted; additional applications will be administratively withdrawn.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

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

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

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Bone Marrow Failure Research Program (BMFRP). 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 BMFRP in 2008 to provide support for research that has high potential impact and exceptional scientific merit in bone marrow failure.

Appropriations for the BMFRP from FY08 through FY24 totaled $71.55 million (M). The FY26 appropriation is $7.50M.

The vision of the BMFRP is to understand and cure BMF diseases. The program challenges the scientific community to design innovative research of inherited and acquired BMF diseases to improve understanding of the pathobiology and advance prevention and treatment. Through these efforts, the BMFRP seeks to improve the health of affected Service Members, Veterans and the general public, with the ultimate goal of cure.

BMFRP Objective The BMFRP objective is to fund research in the areas of inherited or acquired BMF. Studies focused on BMF syndromes and their progression to other malignancies, such as leukemia, are acceptable. However, the BMFRP will not consider research with a primary focus on myeloproliferative neoplasms, leukemia or other malignancies. Applications proposing stem cell biology studies and translational projects, including bone marrow transplantation studies and cellular therapies, should clearly relate to BMF diseases.

Projects related to Graft Versus Host Disease (GVHD) must explain how the issues the proposed research is investigating are specifically relevant to BMF, but not other stem cell transplant patients. Applications should describe the experimental design for using BMF models to directly test the proposed hypotheses. The BMFRP will not consider GVHD studies in other hematological disorders.

The BMFRP encourages research that improves the understanding and treatment of BMF diseases and conditions. To assist the application review process, applicants must specify the type(s) of disease or condition that will be the primary focus of the investigation. The following is a non-exhaustive list of diseases and conditions that are relevant to the objective of the BMFRP:

• Aplastic Anemia • Paroxysmal Nocturnal Hemoglobinuria

• Diamond-Blackfan Anemia • Pearson Syndrome

• Dyskeratosis Congenita/Telomere Biology

Disorders

• SAMD9/SAMD9L Germline Mutations

• Fanconi Anemia • Severe Congenital Neutropenia

• GATA2 Deficiency • Shwachman-Diamond Syndrome

• Induced BMF: Radiation/Chemical • VEXAS Syndrome

• Myelodysplastic Syndromes • Adenosine Deaminase 2 Deficiency

If the proposed research project focuses on a disease that is not listed, the application should clearly identify the disease or condition that is central to the study and provide justification that

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

FY26 Bone Marrow Failure Investigator-Initiated Research Award 7 the proposed research project meets the objective of the BMFRP. If the proposed research project is not specific for one disease or condition and will address multiple diseases or conditions, the application should clearly articulate the BMF communities that will benefit from the study.

3.1. Award History

The Investigator-Initiated Research Award mechanism was first offered in FY21. Since then, 38 Investigator-Initiated Research Award applications were received, and eight were recommended for funding.

3.2. Intent of the Investigator-Initiated Research Award

The BMFRP Investigator-Initiated Research Award (IIRA) is intended to support studies that further develop mature ideas, expand upon key discoveries, and advance research or patient care for individuals affected by BMF diseases. Applications may include translational and clinical research, such as studies in animal models, research using human data or anatomical substances, research involving human subjects, correlative studies linked to clinical trials, and Investigational New Drug (IND)-enabling efforts. However, this award does not support clinical trials.

Applications proposing correlative studies must have an associated clinical trial(s) with approval from relevant regulatory and ethical bodies and actively recruiting participants at the time of full application submission. The correlative research should address critical knowledge gaps, validate key findings, expand on transformative results or achieve other impactful outcomes.

For IND-enabling efforts, the research should focus on empirical, product-driven studies to generate data required for IND applications to the U.S. Food and Drug Administration (FDA).

This includes lead compound characterization, formulation and stability, absorption, distribution, metabolism, excretion, dose/response and toxicology.

Applications must include preliminary and/or published data that are relevant to BMF and the proposed research project.

3.2.1. Focus Areas for the IIRA

To meet the intent of the funding opportunity, applications must address at least one of the FY26 BMFRP focus areas listed below.

• Find effective BMF treatments and cures

• Understand the causes and progression of BMF diseases

3.2.2. Key Elements for the IIRA

The following are significant features of this award mechanism:

• Impact: Proposed research projects should address a central critical issue or question in

BMF disease research or patient care. High-impact research, if successful, will significantly advance current methods and concepts for the prevention, detection, diagnosis and/or treatment of BMF diseases.

• Translational Potential: The application should consider and describe the translational potential of the proposed project. The proposed study should support the reciprocal transfer

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

FY26 Bone Marrow Failure Investigator-Initiated Research Award 8 of information between basic and clinical science to further develop mature ideas and expand upon key discoveries. Applications should address how the research will translate findings into an understanding of causes or progression of BMF diseases, or strategies for treatment and/or a cure.

• Preliminary Data: Applications may derive observations driving the proposed research idea from laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients or anecdotal data. Applications must include preliminary and/or published data that are relevant to the mission of the BMFRP and support the proposed research project. Any unpublished preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team.

• Multidisciplinary Collaborations: The IIRA encourages applications with multidisciplinary team of investigators who bring specific skills that contribute to the successful completion of the project. This can include both intellectual input and research resources (e.g., supplies, reagents, equipment, personnel, services, tissue samples, access to patients or populations).

• Correlative Studies: The IIRA encourages applications proposing correlative studies of clinical trials to better characterize treatment response, validate key research results, expand upon potentially game-changing results or provide insights into disease biology, treatment mechanisms or other disease-related complications. The associated clinical trial(s) should be actively recruiting participants at the time of full application submission.

• IND-enabling Studies: Applications may propose studies that will enable empirical, product-driven, and focused accumulation of data to support an IND application to the U.S.

Food and Drug Administration (FDA).

• Partnering PI Option: The IIRA encourages applications that include meaningful and productive collaborations between investigators and includes an option for more than one PI. Electing to submit to the Partnering PI Option does not affect the total cost limit. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.2.3. Other Important Considerations for the IIRA

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, which is allowed.

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

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

3.3. Funding Instrument

The funding instrument for awards made under the program announcement will be grants (31

USC 6304).

3.4. Funding Details

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

Cost Cap:

The application’s total costs budgeted for the entire period of performance should not exceed $1.25M for single PI applications. For partnering PI applications, the combined total costs budgeted for the Initiating PI and Partnering PI should not exceed $1.25M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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

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

For Partnering PI Applications:

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

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

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 two investigators 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 BMFRP IIRA.

• Costs for correlative studies associated with a clinical trial(s), if applicable.

https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E: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:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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Must not be requested for:

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

• Clinical Trial Costs.

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

FY26 Bone Marrow Failure Investigator-Initiated Research Award 11

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.

The PI (Single PI application) or Initiating PI (Partnering PI application) must submit the following pre-application components.

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

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

The Preproposal Narrative should include the following:

○ Objective: Describe how the proposed research adheres to the intent of the FY26

BMFRP Objective. Identify the relevant BMF disease or condition and FY26 BMFRP Focus Area(s) it seeks to address.

○ Background/Research Problem: State the background and scientific rationale on which the proposed research project is based. Applications must include relevant literature citations and preliminary data. Clearly articulate how the research addresses a critical problem or question in BMF diseases. If proposing an IND-enabling study, identify the lead therapeutic candidate(s) and briefly justify readiness for the proposed IND-enabling effort.

○ Specific Aims and Study Design: Concisely state the project’s specific aims and describe the anticipated scientific approach. Include a description of controls, as appropriate.

– For project proposing correlative studies associated with clinical trial(s):

Specify how the proposed project complements or extends the existing research efforts.

Explain how the study advances the characterization of treatment response, validates key research results, expands upon potentially game-changing results, https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E: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:%7E: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 Bone Marrow Failure Investigator-Initiated Research Award 12 or provides insights into disease biology, treatment mechanisms or other disease-related complications.

Ensure that the associated clinical trial(s) will be active at the time of full application submission.

○ Impact: Explain the potential near- and long-term impact of the proposed research project and how it will move the research field toward achieving the BMFRP’s vision to understand and cure BMF diseases.

○ Personnel: Concisely describe how the research team’s combined expertise will better address the research question and lead to successful completion of the proposed research

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

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

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

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

4.3. Full Application Components for the PI or Initiating PI

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

Partnering PI Option: The CDMRP requires separate full application package submissions for the Initiating PI and Partnering PI, even if the PIs are located within the same organization. The application submission process for the Partnering PI uses an abbreviated full application package.

4.3.1. Full Application Components for the Initiating PI

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.

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

Describe the proposed project in detail using the outline below.

– Background: Present the ideas and reasoning behind the proposed research project and clearly demonstrate that there is sufficient scientific evidence to support the proposed stage of research, including preliminary, published and/or unpublished data. Cite relevant literature.

For IND-enabling studies, identify the lead therapeutic candidate(s) that are to be characterized in support of an IND application filing. Details for each lead therapeutic candidate should be described in Attachment 11: Lead Therapeutic Candidate(s) Statement.

– Objective: State the objectives of the study. State the FY26 BMFRP Focus Area(s) to be addressed by the proposed research.

– Specific Aims: Concisely explain the project’s specific aims. The aims should agree with the primary aims and associated tasks described in the SOW (Attachment 5). If this research project is part of a larger study, present only the tasks that this award would fund.

– Research Strategy:

Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for analysis of its appropriateness and feasibility.

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

Address potential problem areas and pitfalls, and present alternative methods and approaches.

If applicable, briefly describe the relevance of the chosen animal model to the BMF disease under investigation; full details will be required in the Animal Research Plan (Attachment 10).

If human subjects, anatomical samples or data will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples or data.

For all applications proposing 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).

If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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

FY26 Bone Marrow Failure Investigator-Initiated Research Award 14 access and publish data. Refer to the General Application Instructions, Appendix 4, for additional considerations.

If an IND-enabling study is proposed, describe how the data reporting and documentation are appropriate for a regulatory filing with the FDA, or international regulatory agency, if applicable.

– Correlative Study (if applicable):

Describe the clinical trial(s) the proposed study will correlate to and provide the clinicaltrials.gov ID number(s). Provide evidence that the associated clinical trial(s) will be active at the time of full application submission.

Specify how the proposed correlative study complements or extends the existing efforts and explain how the study advances the characterization of treatment response, validates key research results, expands upon potentially game-changing results or provides insights into disease biology, treatment mechanisms or other disease-related complications.

If the lead investigator of the clinical trial(s) is not the named PI or key personnel on this application, provide evidence of collaboration with the lead investigator of the clinical trial(s) and demonstrate access to the relevant patients, patient biological samples, patient data or other patient resources necessary to conduct the proposed correlative study.

Describe the outcome measures to be captured and plans for data analysis.

– Statistical Plan: Clearly describe the statistical plan and rationale for the statistical methodology and explain how it is appropriate for the proposed study. Provide a sample size estimate and the method by which it was derived, including power analysis calculation, as applicable. Include any plans for blinding and randomization.

○ 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Bone Marrow Failure Investigator-Initiated Research Award 15

Letters of Organizational Support: 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) meets the 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.

Letters of Access (if applicable): If access to patients, patient samples, patient datasets or other resources is necessary to conduct the study, and the PI or key personnel on this application does not own the resource, provide a letter of support signed by the appropriate authorizing individual confirming access to the resource.

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

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

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/datasets or resources that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from IRB review) are exempt from this requirement. If an application is adding an aim to conduct biosample collection and biomarker analysis to an existing clinical trial that is supported by a different source of funding, use of the patients enrolled in that trial is expected and the study potentially may not include diverse populations. These applications are exempt from this requirement.

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.

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 https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf

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FY26 Bone Marrow Failure Investigator-Initiated Research Award 16 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.

Include sufficient scientific evidence to support the proposed stage of research. If proposing a correlative study to a clinical trial(s), provide the clinicaltrials.gov ID number(s). If proposing an IND-enabling effort, identify the lead therapeutic candidate(s) that is to be studied in support of an IND application filing.

Objective: State the overall objective of the study.

Focus Area: State the FY26 BMFRP Focus Area(s) to be addressed by the proposed research.

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design, including appropriate controls.

Impact: Summarize how the proposed project is relevant to and will have near- and long-term impact on those affected by BMF and/or the understanding of BMF diseases. Identify the specific BMF disease that will be impacted by the research.

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

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

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

State the FY26 BMFRP Focus Area(s) to be addressed by the proposed research.

Describe the objectives and rationale for the proposed research.

Describe the ultimate applicability of the research.

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

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FY26 Bone Marrow Failure Investigator-Initiated Research Award 17

What bone marrow disease/syndrome is the study seeking to address and how will it help?

What are the potential clinical applications, benefits and risks?

If the research is too early for immediate clinical applicability, then describe the interim outcomes.

– What are the likely contributions of the proposed research project to advancing the field of BMF research and/or patient care among those with BMF diseases/syndromes?

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

– Identify the lead therapeutic candidate(s) that is to be studied in support of an IND application filing, if applicable.

○ Attachment 5: Statement of Work (five-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.

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

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”. The impact statement should be written with a broad audience in mind, including readers without a background in science or medicine.

– Describe how the proposed research project addresses the FY26 BMFRP Focus

Area(s) and is important to understanding the causes and progression of BMF diseases, realizing improvements in patient care and/or finding a cure.

– Describe the short-term impact: Detail the anticipated outcome(s)/product(s) (intellectual and/or tangible) that will directly result from the proposed research and explain how the outcomes will drive the BMF field forward and support new avenues for research or clinical care.

– Describe the long-term impact: Explain the potential long-term impact of this study on the field of BMF disease 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: Translation Potential Statement (one-page limit): Upload as “Translation.pdf”.

– Describe how the project is expected to translate promising research findings into advances in the understanding of BMF diseases or strategies for prevention and/or a cure and provide an anticipated timeline

– Explain how the proposed study will support the reciprocal transfer of information between basic and clinical science.

– Include a description of the next steps in the translation of the results of this research after the end of the project.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

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FY26 Bone Marrow Failure Investigator-Initiated Research Award 18

– Include a brief description of any collaborations with clinicians or physician-scientists for the proposed study.