HT942526BMFRPRDA_for 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

Resource Development Award

Funding Opportunity Number: HT942526BMFRPRDA

Pre-Application Due: October 7, 2026

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

FY26 Bone Marrow Failure Resource 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 Resource Development Award;

provides key award information and considerations; and outlines funding details

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Bone Marrow Failure Resource 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

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 Resource Development Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Bone Marrow Failure Research Program (BMFRP) Resource Development Award (RDA) supports the development of a multiomic atlas generated from well-annotated human bone marrow failure (BMF) samples, with omic data derived from marrow specimens. The resulting dataset should serve as an open-access, durable resource for the BMF research and clinical communities and is expected to facilitate key discoveries that advance the understanding of BMF diseases.

Distinctive Features: The application must include a robust Data Resource Sharing Plan that describes the means and timeline by which the fully developed resource will be made available to the scientific and clinical community.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $1.25M to fund approximately one Resource Development Award application with total cost caps of $1.25M per award. The maximum period of performance is 2 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), October 7, 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: HT942526BMFRPRDA

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 Resource 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 at all career levels affiliated with an eligible organization are eligible to be named Principal Investigator (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 Bone Marrow Failure Research Program (BMFRP) Resource Development Award (RDA) 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.

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 Resource 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 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 FY08 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 $7.5M.

The vision of the BMFRP is to understand and cure bone marrow failure (BMF) diseases. The program mission 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 focusing on BMF syndromes and their progression to other malignancies, such as leukemia, are eligible for funding. 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 the context of other hematological disorders.

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

BMFRP:

• Aplastic Anemia

• Diamond-Blackfan Anemia

• Dyskeratosis Congenita/Telomere Biology Disorders

• Fanconi Anemia

• GATA2 Deficiency

• Induced BMF: Radiation/Chemical

• Myelodysplastic Syndromes

• Paroxysmal Nocturnal Hemoglobinuria

• Pearson Syndrome

• SAMD9/SAMD9L Germline Mutations

• Severe Congenital Neutropenia

• Shwachman-Diamond Syndrome

• VEXAS Syndrome

• 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

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 Resource Development Award 7 demonstrating that the project aligns with the objective of the BMFRP. If the proposed research project is not specific to one disease or condition and addresses multiple BMF diseases or conditions, the application should clearly articulate the specific patient communities that will benefit from the study.

3.1. Award History

The BMFRP RDA mechanism was previously offered in FY11, when four applications were received and one was recommended for funding.

3.2. Intent of the Resource Development Award

The BMFRP RDA supports the development of a multiomic atlas generated from well-annotated human BMF samples, with omic data derived from marrow specimens. The resulting dataset should serve as an open-access, durable resource to be shared with the BMF research and clinical communities and is expected to facilitate further key discoveries that advance the understanding of BMF diseases.

This funding opportunity invites proposals that will utilize previously stored viable human marrow samples, and may include newly collected specimens, to generate comprehensive data resources, such as genomic, transcriptomic, proteomic, metabolomic, and epigenomic data.

Proposals must include single-cell omic analyses of human marrow specimens as a foundational component. Additional data types, such as serum metabolomic or other omic modalities, may be incorporated only if they are accompanied by single-cell transcriptomic data from the same specimens. Investigators are also encouraged to provide matched induced pluripotent stem cell (iPSC) lines that correspond to the single-cell omic captures of the original material, where available. Non-biospecimen data (such as patient reported outcomes) may be integrated to enrich the biospecimen data. The goal is to support the collection, processing, storage, and analysis of these biospecimens to create robust datasets for one or more BMF diseases, thereby advancing the understanding of disease mechanisms and enabling future research.

Award funds may be used for activities such as the collection and processing of biospecimens, quality control, and the generation of multiomic data from both new and existing samples. While the primary focus is on the creation of multiomic datasets, applicants are encouraged to propose additional relevant omic analyses of marrow cell data that are clearly justified and aligned with the needs of the BMF research community.

To maximize the impact and diversity of the resulting resource, multi-institutional collaborations are strongly encouraged, particularly those that broaden the range and depth of available patient samples. All supported projects are expected to maintain high standards of data quality, annotation, and ethical compliance, contributing generated datasets to an open-access, durable resource for the BMF research community.

The FY26 BMFRP RDA mechanism supports the development of a multiomic atlas of human BMF. Clinical trials or inclusion of animal data are NOT allowed under this award mechanism.

3.2.1. Focus Area for the RDA

Applications must address the following FY26 BMFRP focus area:

• Develop durable resources for the BMF research community https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in

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

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

FY26 Bone Marrow Failure Resource Development Award 8

3.2.2. Key Elements for the RDA

The following are significant features of this award mechanism:

• Multiomic Atlas Development: The key outcome of this funding opportunity will be the development of a comprehensive multiomic atlas from well-annotated bone marrow samples, aiming to establish a durable, open-access resource for the BMF research community. Public access may be through existing, well-annotated repositories or through the development of a new resource. Applications describing development of a new open-access resource must demonstrate the ability to host large datasets and perform data curation.

• Data Resource Sharing: This funding opportunity requires that all resulting data developed under this award mechanism be freely accessible to the BMF research, clinical and patient communities and made available to the general public.

• Impact: Proposed multiomic atlas projects should result in a high-quality, well-annotated dataset that captures the complexity of BMF syndromes and provides a basis for future studies that interrogate the data to better understand BMF disease mechanisms and potential treatment pathways.

• Preliminary Data: Applications must include preliminary and/or published data that are relevant to the mission of the BMFRP and support the proposed multiomic atlas project. Any unpublished preliminary data provided should originate from the laboratory of the PI or a member(s) of the research team.

• Personnel: The application should demonstrate expertise in BMF diseases and multiomic research, laboratory analyses, and data management through the combined background of the PI, project team, and any collaborations.

• Multidisciplinary Collaborations: Applicants are encouraged to form multidisciplinary teams of investigators who bring specific skills that contribute to the successful completion of the project. Such contributions can include both intellectual input and research resources (e.g., laboratory analyses, data annotation, and subsequent data recall, as well as biospecimens and/or access to patients and populations).

• Sustainment: The sustainability of the data resource is an essential component of the RDA, and plans should include the feasibility of future data expansion.

3.2.3. Other Important Considerations for the RDA

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).

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 Resource Development Award 9

3.4. Funding Details

Period of Performance: The maximum period of performance is 2 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance 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 2 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 FY26 BMFRP Resource Development Award.

Must not be requested for:

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

• Clinical trial costs.

• Animal studies costs.

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 Resource 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 component.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the proposed multiomic atlas resource, specifying the BMF patient population(s) and the biospecimens to be used (including the required bone marrow samples) from which the data will be derived.

LOIs are used for program planning purposes only (e.g., reviewer recruitment) and will not be reviewed during either the peer or programmatic review. An invitation to submit a full application is NOT provided after LOI submission. Applicants are encouraged to develop pre-application and full application components concurrently and submit a full application AFTER successful submission of the pre-application.

4.3. Full Application Components

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

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

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

(b) Attachments:

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

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

Describe the proposed project in detail using the outline below.

– BMFRP Objective: Describe how the proposed project adheres to the intent of the FY26 BMFRP Objective. Identify the relevant BMF disease(s) or condition(s), and explain how the proposed work addresses the FY26 BMFRP Focus Area.

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

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

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

FY26 Bone Marrow Failure Resource Development Award 11

– Background: Present the ideas and reasoning to support the proposed project.

Describe the multiomic data atlas to be developed and provide a rationale that supports the need for this resource. Clearly demonstrate a comprehensive understanding of critical barriers and gaps in BMF research that will be addressed with the resource. Cite relevant literature. The inclusion of preliminary data is required. Applicants must provide preliminary data that clearly demonstrate the unmet need in BMF research that their project aims to address. Data that exhibit proficiency with advanced single-cell omic technologies and/or the accompanying data collection scheme must be included. Proof-of-concept data from pilot, small-scale, multiomic analyses may be included to demonstrate the feasibility of developing the atlas.

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

– Project Design:

▪ Describe the study design, methods, and analyses, including relevant controls, in sufficient detail to allow assessment of their appropriateness and feasibility.

Provide a detailed description of the specific omic studies to be performed and the types of data to be collected. Specify whether each patient biospecimen is sufficient in size to support all planned omic analyses, or if separate biospecimens will be required for different studies. Additionally, indicate whether generating the multiomic dataset will deplete or destroy the available biospecimens.

▪ Briefly describe how the data will be collected, analyzed, annotated, organized, and stored in a manner that is consistent with the study objectives. More details will be required in the Data Management Plan (Attachment 7).

▪ Briefly describe how the multiomic atlas resource will be shared with the BMF research, clinical and patient communities, as well as the general public, and outline the strategy for maintaining it as a long-term durable resource. Additional details will be required in the Data Resource Sharing Plan (Attachment 8) and the Sustainment Plan (Attachment 9).

▪ Identify potential problem areas and present alternative methods and approaches to address them.

– Human Biospecimens:

▪ Identify the patient biospecimens available to the study, specifying disease types, biospecimen types (e.g., bone marrow, biopsy, iPSCs), the total number of biospecimens, the number of serial biospecimens, etc.

▪ Identify any control biospecimens to be included and describe the nature of the control (e.g., healthy control, family member control, patient pre-treatment control).

▪ Identify the source(s) of the biospecimens, how they are stored, who owns/controls them, how the study team will have access to them, and how they will be transported, if applicable. If the biospecimens are not owned/controlled by the PI, a letter confirming access must be uploaded under Supporting Documentation (Attachment 2).

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 Resource Development Award 12

– Military/VA Populations: 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 study. Also include a plan for obtaining any required data sharing agreements, memorandums of understanding, or other agreements necessary to access and publish the data. Refer to the GAI, Appendix 4, for additional considerations.

– Statistical Plan: Clearly describe the statistical plan and provide a rationale for the chosen statistical methodology, explaining its appropriateness for the proposed study. Given the importance of the number of patients sampled in evaluating the impact of the atlas, provide a sample-size estimate and the method by which it was derived, including a power analysis calculation, as applicable. Include any plans for blinding and randomization.

– Sex as a Biological Variable (SABV): Describe how sex as a biological variable will be considered, including the collection of data disaggregated by sex and a brief description of a sufficiently powered statistical analysis for sex differences. The SABV strategy should be provided as part of the application’s Supporting Documentation (Attachment 2).

– Women and Minorities in Research: For all applications proposing clinical research, including prospective specimen collection and/or the use of existing clinical samples for resource development, 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, race, 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. This award cannot be used to conduct clinical trials. 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).

○ 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:~:text=considered%20clinical%20trials.-,Clinical%20Research,-%3A%20For%20the 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 Resource Development Award 13

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

Letters of Support (two-page limit per letter): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the U.S. Department of Veterans Affairs (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 Collaboration (if applicable): Provide a signed letter from each collaborating individual and/or organization demonstrating that the PI has the support and resources necessary for the proposed work. If an investigator at an intramural DOW organization is named as a collaborator on a full application submitted through an extramural organization, the application must include a letter from the collaborator’s Commander or Commanding Officer at the intramural DOW organization authorizing the collaborator’s involvement.

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.

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

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

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

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

Use of DOW Resources (if applicable): Provide a letter of support signed by the lowest-ranking person with approval authority confirming access to active-duty military populations and/or DOW resources or databases.

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=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a

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

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

FY26 Bone Marrow Failure Resource Development Award 14

Use of VA Resources (if applicable): Provide a letter of support signed by the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief, confirming access to VA patients, resources, and/or VA research. If the VA-affiliated non-profit corporation is not identified as the applicant organization for administering the funds, include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research.

Intellectual Property: Information can be found in the 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.

○ 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 developing the proposed multiomic atlas resource, and its feasibility given the number, types, and quality of biospecimens available, including appropriate controls.

Objective: State the overall objective(s) of the study.

BMFRP RDA Focus Area: State whether the proposed project addresses the FY26 BMFRP Focus Area.

Specific Aims: State the specific aims of the study.

– Study Design: Briefly describe the study design, including the appropriate controls and the multiomic facilities.

– Impact: Summarize how the proposed multiomic atlas resource will benefit the BMF research, clinical and patient communities, as well as the general public, in the short-and long-term. Explain how this resource will advance the mission of the BMFRP to understand and cure BMF diseases. Identify the specific BMF disease(s) that will be particularly impacted by the research.

○ 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 how the proposed project addresses the FY26 BMFRP Focus Area.

– Summarize the objectives and rationale for the proposed study.

▪ Describe the ultimate applicability of the resource

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

▪ Summarize how the proposed resource will lead to new avenues of discovery or development.

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-,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 Resource Development Award 15

– If the project is too basic for immediate clinical applicability, then describe the interim outcomes.

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

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

○ 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.

○ 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 multiomic atlas resource addresses the FY26 BMFRP Focus Area, and how it will advance the mission of the BMFRP to understand and cure BMF diseases.

– Describe the short-term impact: Detail how the proposed multiomic atlas resource will benefit the BMF research, clinical and patient communities, as well as the general public in the near-term.

– Describe the long-term impact: Explain how the proposed multiomic atlas resource will drive the BMF field forward and support new avenues for research or clinical care.

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

○ Attachment 7: Data Management Plan (no page limit): Upload as “DataPlan.pdf”.

Provide a data management plan that includes:

– The types and formats of data to be collected and generated, including but not limited to genomic, transcriptomic, proteomic data, as well as clinical and demographic data, as available.

– The protocols for data acquisition, including the time and location of data acquisition where scientifically pertinent.

– The methods for data collection, including standard operating procedures for sample handling, data generation, and metadata annotation practices.

– A description of how the data will be processed, including the file formats and naming conventions that will be used. Include the approach for processing and aligning FASTQ files. Specify which reference clusters will be used, if de novo clustering is planned, and provide a justification for this choice.

– The quality assurance and quality control measures during collection, analysis, and processing, including data validation procedures.

– A description of the dataset origin when existing data resources are used, including the standards to be used for data and metadata formats and content.

– The data security measures appropriate for protecting data confidentiality, integrity, and availability.

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-,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 Resource Development Award 16

– The long-term data preservation strategies, including the appropriate timeframe for preservation, archiving in established BMF repositories (if applicable), backup procedures, and disaster recovery plans.

– The personnel responsible for data management, sharing, and oversight.

An additional Data Management Plan that conforms to the format established in Section 3.c, Enclosure 3, DoD Instructions 3200.12 will be requested only after a recommendation for funding is made.

Do not submit a copy of the National Institutes of Health (NIH) Data Management and Sharing Plan.

○ Attachment 8: Data Resource Sharing Plan (no page limit): Upload as “DataSharing.pdf”. Describe how data resources generated during the performance of the project will be shared with the research, clinical and patient communities. If applicable, detail how the cell barcodes will be linked to cluster annotations, and explain how the research community will be able to access and utilize these data. Describe whether the proposed plan for resource sharing includes existing publicly available BMF data repositories/platforms, or whether a new repository/platform will be created. Include strategies for making raw data and multiomic atlas(es) developed as part of the proposed project widely available to the research, clinical and patient communities.

Provide a milestone plan for data resource sharing, including the timeline and methods by which the research, clinical and patient communities will be informed of the availability and accessibility of the resource. Explain organizational and technical capabilities that support data resource sharing in a timely manner. The government reserves the right to identify repositories for submission of data for archive. Any costs associated with submission will be addressed during award negotiations. If there are limitations associated with a pre-existing agreement for the original data or research resources that preclude subsequent sharing, the applicant should explain this.

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.

Do not submit a copy of the NIH Data Management and Sharing Plan.

○ Attachment 9: Sustainment Plan (two-page limit): Upload as “Sustainment.pdf”.

Outline potential resources and plans for long-term sustained operations and improvements beyond the award period:

– Identify the individual(s) or organization responsible for maintaining the resource, including ensuring data security, integrity, and accessibility.

– Describe the methods by which questions, problems, or requests from the research, clinical and patient communities related to the resource will be received and addressed, including the communication channels (e.g., email, web portal, helpdesk).

– If maintenance will require financial support, estimate the annual maintenance cost and describe how it will be supported.

– Describe processes, partnerships, or agreements to secure ongoing support for sustainment of the data resource sharing effort.

– Provide plans for sustainable operations, including continued accrual and data curation for resource expansion to advance BMF research.

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources

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 Resource Development Award 17

○ Attachment 10: Project Team Statement (one-page limit): Upload as “Team.pdf”.

Describe how the team collectively possesses the necessary expertise in BMF disease, multiomic research, data management/security and resource sharing/dissemination.

Explain how the team’s expertise will support the successful development, management, and sustainment of the proposed resource. Highlight any collaborative arrangements or partnerships that enhance the team’s capabilities. Identify key team members, their roles, and relevant qualifications or experience. Clearly state whether key personnel are not receiving salary from the award. If applicable, provide assurances/letters of commitment that the unpaid personnel will contribute the required level of effort to complete the project. Describe the PI’s record of accomplishment and their ability to lead the team to accomplish the proposed project.

○ Attachment 11: Justification Statement (one-page limit): Upload as “Justification.pdf”. Describe how the quantity and type of biospecimens available and/or to be acquired are sufficient to support the proposed omic studies, and how the amount and type of data generated will be sufficient to support future research investigations and downstream interrogation. The samples may span different types of BMF diseases but must address the objective of the project.

○ Attachment 12: Regulatory Statement (for applications recruiting human subjects;

two-page limit): Upload as “RegState.pdf”. Outline the processes that will govern legal, ethical, and human subject issues, as well as the use of human biospecimens in the proposed research. Describe the appropriate plans for the coordination of regulatory submissions and approvals at participating sites. Discuss the plans for obtaining patient informed consent.

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

○ Attachment 13: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 14: 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…