HT942526BMFRPIDA_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

Idea Development Award

Funding Opportunity Number: HT942526BMFRPIDA

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 Idea Development Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Idea Development Award; provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

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 Idea Development Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

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

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 Idea Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The BMFRP Idea Development Award (IDA) is intended to support innovative ideas and high-impact approaches based on scientifically sound evidence to move toward the BMFRP’s vision of understanding and curing BMF diseases.

Distinctive Features:

• This funding opportunity is open to Established Investigators (EIs) and Early-Career Investigators (ECIs). Reviewers will assess Principal Investigators (PIs) using distinct review criteria based on their eligibility as an EI or ECI.

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

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $4.0M to fund approximately five Idea Development Award applications with total cost caps of $0.8M 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 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526BMFRPIDA

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

An investigator may be named 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 IDA applications, only the first two applications received will be accepted; additional applications will be administratively withdrawn.

Established Investigators: Investigators who are 10 or more years from obtaining their first appointment as an independent investigator at the time of the application submission deadline are eligible to be named as the EI on the application. The EI should demonstrate BMF disease-related expertise and background through their funding and publication record. The EI should plan research collaborations and dedicate a level of effort that is appropriate for the successful conduct of the proposed work.

Early-Career Investigators: Investigators who are less than 10 years from obtaining their first appointment as an independent investigator at the time of the application submission deadline are eligible to be named as the ECI on the application. Time spent on extended family medical leave will not count against the 10-year eligibility restriction, and associated lapses in research time and appointments should be articulated in the application. The biographical sketch should clearly articulate the PI’s current appointment status and aggregate time from first appointment as an independent investigator. Postdoctoral or clinical fellows are not eligible for ECI designation. The ECI’s training should demonstrate the ability to accomplish the proposed work. The PI should demonstrate institutional commitment beyond financial backing such as, but not limited to, independent laboratory space, dedicated research time and potential collaborations. The ECI should propose to dedicate a level of effort for the proposed work that is appropriate to successfully conduct the research project.

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 Bone Marrow Failure Idea Development 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 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). 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 be clearly related 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 Idea Development 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 BMFRP Award mechanism was first offered in FY13. Since then, 367 Idea Development Award applications were received, and 72 were recommended for funding.

3.2. Intent of the Idea Development Award

The BMFRP Idea Development Award (IDA) is intended to support innovative ideas and high-impact approaches based on scientifically sound evidence to move toward the BMFRP’s vision of understanding and curing BMF diseases. The proposed research should include a well-formulated, testable hypothesis based on strong scientific rationale and a well-developed and articulated research approach. This award mechanism supports new ideas that are expected to generate data for future avenues of scientific investigation. Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data. This mechanism encourages hypothesis-driven correlative studies associated with clinical trials and/or clinical samples. Applications proposing correlative studies must have demonstrated access to samples and/or patient populations and the proposed study should represent new avenues of research that will advance the understanding of disease biology, treatment mechanisms or other innovative and impactful outcomes in BMF. Funding to conduct the clinical trial itself is outside the scope of this award mechanism.

3.2.1. Focus Areas for the IDA

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 IDA

The following are significant features of this award mechanism:

• Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, reveal new avenues of investigation or exhibit other creative qualities. This may include high-risk, potentially high-gain, approaches to BMF disease research. Research that is only an incremental advance is not considered innovative.

• Impact: Proposed research projects should address a central critical issue or question in BMF disease research and/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.

• Scientific Rationale and Feasibility: Projects must include a well-formulated, testable hypothesis based on strong scientific rationale and evidence that the applicant can complete the proposed work. Preliminary data is not required. While the inclusion of preliminary data

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 Idea Development Award 8 is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.

• Translational Potential: The application should consider the potential for translation of the project, even if the translational potential is long-term and anticipated to occur well beyond the end of the proposed project. Applications should describe how the research will translate findings into an understanding of causes or progression of BMF diseases, or strategies for prevention or a cure.

• Personnel: The application should demonstrate expertise in BMF diseases through the Principal Investigator’s (PI’s) background or that of the research team or through collaboration. The application should document all collaborations. ECIs must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the forefront of BMF research; however, the PI is not required to have previous BMF research experience.

3.2.3. Other Important Considerations for the IDA

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical trials are not allowed within this funding opportunity.

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

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 $800,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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://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

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 Idea Development Award 9

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.

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 IDA.

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

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 Idea Development Award 10

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.

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: State the objective of the proposed study. Identify the FY26 BMFRP Focus Area(s) the proposed research will address and describe how the study meets the intent of the award mechanism.

○ Research Idea: Briefly state the rationale, hypothesis/objective and specific aims of the proposed research. Present the ideas and reasoning behind the proposed study, while considering data/evidence to support its feasibility. Explain how the project addresses a critical problem in BMF research. For correlative studies linked to a clinical trial(s) and/or clinical samples, describe how the study generates new hypotheses or advances understanding of disease biology, treatment mechanisms or other impactful outcomes to enhance the trial's impact.

○ Innovation: Explain how the research introduces new paradigms, challenges existing ones, offers fresh perspectives on existing problems or demonstrates other creative qualities.

○ Impact: Describe the potential impact of the research and how it advances the BMFRP’s vision to understand and cure BMF diseases.

○ Personnel: Describe the BMF expertise of the PI and research team and its relevance to successfully completing the proposed research. Specify the PI's eligibility as an EI or ECI.

• 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:

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:~:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES 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 Bone Marrow Failure Idea Development Award 11

○ 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

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

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

○ Attachment 1: Project Narrative (10-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Present the rationale behind the proposed study and explain how this research demonstrates a critical understanding and in-depth analysis of BMF diseases. Highlight relevant prior experience. Include a well-formulated testable hypothesis based on strong scientific rationale and evidence that the proposed work can be completed. Preliminary data is not required. While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.

– Hypothesis or Objective: State the hypothesis to be tested or the objective to be reached. Identify the FY26 BMFRP Focus Area(s) the work seeks to address.

– Specific Aims: Concisely explain the project’s specific aims. If this research project is part of a larger study, present only the tasks that this award would fund.

– Research Strategy:

▪ Provide a detailed description of the experimental design, methods, analyses and appropriate controls to enable evaluation of their feasibility and appropriateness.

▪ If applicable, describe the prospective sample collection or ongoing clinical trial(s) the proposed study will correlate to and provide the clinicaltrials.gov ID number(s), if available.

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#_Content_Form_Full_App_Submission:~:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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 Idea Development Award 12

▪ Address potential problem areas and pitfalls, and present alternate methods and approaches.

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

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

▪ Describe the data reporting process and how documentation will support potential regulatory filings with the U.S. Food and Drug Administration (FDA) or international regulatory agencies, if applicable.

▪ Research projects may involve preclinical studies in animal models, human subjects or human anatomical substances. If using human data sets, specimens (e.g., blood, tumor tissue) or participants, provide evidence of availability and access to the required specimens or populations. Include a detailed plan for sample acquisition, participant recruitment and securing additional research resources. For projects utilizing data sets or specimens from biobanks, repositories or clinical trials, applicants must provide letter(s) of collaboration (see Attachment 2) from the manager or lead investigator confirming access and commitment to providing the data sets or specimens, if they are not named as the PI or key personnel on the application.

▪ 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).

– 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, 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 Bone Marrow Failure Idea Development Award 13 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 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 collaboration 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 200.1 (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.

▪ 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.

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 biospecimens/datasets or resources that cannot be linked to a specific individual, sex, ethnicity, or race 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

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 Idea Development Award 14 differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

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

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

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

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

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

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

If proposing a correlative study to an existing clinical trial(s), provide the clinicaltrials.gov ID number(s), if available.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached. Identify the FY26 BMFRP focus area(s) the work seeks to address.

Specific Aims: State the specific aims of the study.

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

Innovation: Briefly describe the novelty or paradigm shift proposed in the project and how it will yield critical discoveries, new avenues of investigation or major advancements to cure BMF diseases.

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

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/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 Bone Marrow Failure Idea Development Award 15

○ 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.

▪ What bone marrow disease or condition is the study seeking to address and how will it help?

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

– Describe the innovative aspects of the proposed research project.

– If the proposed 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/conditions?

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

○ Attachment 5: Statement of Work (four-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.

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

– Summarize how the proposed work is innovative.

– Describe how the proposed research project introduces a new paradigm or challenges existing paradigms in one or more of the following ways: concept or question, research methods or technologies, adaptations of existing methods or technologies, or looks at existing problems or issues from a new perspective.

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

– Explain how the potential level of gain for the research and/or patient community justifies the risk of the proposed research project.

– If a correlative study, explain how it will facilitate the generation of new hypotheses or advance the understanding of disease biology, treatment mechanisms or other innovative outcomes.

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 Bone Marrow Failure Idea Development Award 16 o Attachment 7: 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 8: Translation Potential Statement (one-page limit): Upload as “Translation.pdf”. The potential for translation of the project should be considered even if translation is considered a long-term goal and anticipated to occur well beyond the end of the proposed project.

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

– Include a brief description of any collaborations with clinicians or physician-scientists for the proposed study. Describe how the research team will leverage these relationships to ensure potential translation of study finding in the future.

○ Attachment 9: Early-Career Investigator Eligibility Statement, required for the ECI Option (one-page limit): Upload as “ECIeligibility.pdf”. Provide a letter signed by the PI and the Department Chair, or equivalent official to verify that the eligibility requirements have been met. The letter should verify that the PI is an independent investigator who is less than 10 years from obtaining their first faculty appointment (or equivalent) at the time of the application submission deadline. Include the organizational commitment for independent laboratory space and protection of dedicated research time to conduct the proposed project. A suggested Early-Career Investigator Eligibility Statement template is available for download on the Full Announcement page in Grants.gov. For more eligibility details, refer to Section 3.2.2., Key Elements for the Idea Development Award, and Section 2.1.2., Principal Investigator.

○ Attachment 10: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 11: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

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 Bone Marrow Failure Idea Development Award 17

(c) Additional Application Materials:

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

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

○ Biographical Sketch

○ Current/Pending Support

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

ii. Research & Related Budget

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…