HT942526BCRPCREA2_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

Breast Cancer Research Program

Clinical Research Extension Award

Funding Opportunity Number: HT942526BCRPCREA2

Pre-Application Due: November 4, 2026

Application Due: November 18, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Breast Cancer Clinical Research Extension 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 Clinical Research Extension 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 Breast Cancer Clinical Research Extension 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 Breast Cancer Clinical Research Extension Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Breast Cancer Research Program (BCRP) Clinical Research Extension Award supports research that extends the data collection, follow-up, and analysis of breast cancer clinical studies. The intent of this award mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical studies by addressing the knowledge lost due to early trial termination, limited patient follow-up, or suboptimal sample and/or data collection and analysis. All applications must address at least one of the FY26 BCRP overarching challenges or provide adequate justification for exception.

Distinctive Features:

• The research team must include two or more breast cancer consumer advocates.

• This funding mechanism allows for a single Principal Investigator (PI), or two partnering PIs referred to as the Initiating PI and the Partnering PI. For the Partnering PI Option (PPIO), only the Initiating PI will submit a pre-application, but both PIs will need to submit at the full application stage. Be advised, failure to submit all associated (Initiating and Partnering PI) applications by the deadline may result in administrative withdrawal.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $8.4 million (M) to fund approximately one Clinical Research Extension Award application with total cost caps of $7M for applications with a single PI or $8.4M if applying under the PPIO. The maximum period of performance is four 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), November 4, 2026

• Application Submission Deadline: 11:59 p.m. ET, November 18, 2026

• End of Application Verification Period: 5:00 p.m. ET, November 25, 2026

• Peer Review: January 2027

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526BCRPCREA2

Assistance Listing Number: 12.420

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FY26 Breast Cancer Clinical Research Extension 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, Initiating PI, or Partnering PI on the application, regardless of ethnicity, nationality or citizenship status.

An investigator may only be named as a PI, Initiating PI, or Partnering PI on a single application for this Clinical Research Extension Award program announcement.

Investigators named as PI, Initiating PI or Partnering PI on an application submitted under funding opportunity HT942526BCRPCREA are not eligible to submit a pre-application or full application for the same research project under this current funding opportunity.

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

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the BCRP. 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 BCRP in FY92 to support innovative, high-impact research, with a mission of ending breast cancer for Service Members and their Families, Veterans, and the general public. Appropriations for the BCRP from FY92 through FY25 totaled $4.52 billion. The FY26 appropriation is $145M.

The BCRP challenges the scientific community to design research that will address the urgency of ending breast cancer. Specifically, the BCRP seeks to accelerate high-impact research with clinical relevance, encourage innovation and stimulate creativity, and facilitate productive collaborations.

The BCRP brief overview, called The Breast Cancer Landscape describes what is currently known about the most pertinent topics that are consistent with the BCRP’s mission of ending breast cancer. Considering the current breast cancer landscape and the program’s mission, the BCRP seeks to invest in research that addresses the following FY26 BCRP overarching challenges:

• Prevent breast cancer (primary prevention)

• Identify determinants of breast cancer initiation, risk, or susceptibility

• Distinguish deadly from non-deadly breast cancers

• Conquer the problems of overdiagnosis and overtreatment

• Identify what drives breast cancer growth; determine how to stop it

• Identify why some breast cancers become metastatic

• Determine why/how breast cancer cells lie dormant for years and then re-emerge; determine how to prevent lethal recurrence

• Revolutionize treatment regimens by replacing them with ones that do all of the following:

improve survival, are more effective, and are less toxic

• Eliminate the mortality associated with metastatic breast cancer

3.1. Intent of the Clinical Research Extension Award

The FY26 BCRP Clinical Research Extension Award supports research that extends the data collection, follow-up, and analysis of breast cancer clinical studies. The intent of this award mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical studies by addressing the knowledge lost due to early trial termination, limited patient follow-up, or suboptimal sample and/or data collection and analysis. Patients’ contributions of tissue, serum, and other biologic specimens and their data are invaluable to saving lives. The BCRP has created this award mechanism to help ensure that science values those contributions with research that maximizes their impact.

Although not all-inclusive, the scope of research that this award mechanism supports includes projects entailing a deeper molecular analysis of clinical samples, initiation of https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2025.pdf

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FY26 Breast Cancer Clinical Research Extension Award 7 new correlative studies, biomarker validation, or continuing clinical follow-up of patients enrolled in an open/ongoing or completed clinical trial or study. The proposed research may be hypothesis-testing or -generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. Innovation is not a criterion for this award mechanism.

Projects proposing to initiate a new clinical trial or study, or enroll new patients in an open/ongoing clinical trial or study do not meet the intent of this program announcement.

3.1.1. Key Elements for the Clinical Research Extension Award

Impact: Proposed research must have the potential to extend the impact of the previously funded clinical trial or study, or result in new impact and accelerate progress toward ending breast cancer.

Overarching Challenges: Considering the current breast cancer landscape and the BCRP’s mission, all applications must address at least one of the above overarching challenges or provide adequate justification for exception.1 The BCRP strongly urges applicants to read and consider The Breast Cancer Landscape before preparing their applications.

Feasibility: Applications must provide preliminary data to support the scientific rationale and feasibility of the research approaches. The application must demonstrate availability of, and access to, the necessary resources and/or populations to accomplish the proposed research.

Data Evaluation and Sharing: Applications should base the proposed research on a study sample size that will ensure the results support valid conclusions or will generate a meaningful hypothesis. It is the applicant’s responsibility to provide sufficient evidence that the sample size is appropriate to meet the study’s objective and to outline the statistical methods and considerations they will employ in their data analysis. The applicant must outline a data sharing plan for the scientific community to have access to the experimental platforms and molecular and other data generated from the proposed research.

Personnel: Applications must include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.

Consumer Advocates: The research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. They must perform their role independently of their employment and cannot be employees of any organization participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. The consumer advocates’ role should focus on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.

Partnering PI Option: The Clinical Research Extension Award PPIO encourages applications that include meaningful and productive partnerships between two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. The

1 With adequate justification, applications may identify and address another overarching challenge related to The Breast Cancer Landscape. Investigators must provide justification in the application.

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PIs may have expertise in similar or disparate scientific disciplines, but each PI must bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar levels of effort to the conduct of the project. The application should balance funding between both PIs unless appropriately justified. The PPIO encourages, but does not require, new partnerships. The application should describe how the PIs’ unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the proposed project, and why the work should be done together rather than through separate efforts. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section 5.3, Submission Instructions.

3.1.2. Other Important Considerations for the Clinical Research Extension Award

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.

Research involving human data, human anatomical substances and/or interaction with human subjects, including extended clinical follow-up of previously enrolled patients, is permitted.

However, this award cannot be used to initiate a new clinical trial or study, or enroll new patients in an open/ongoing clinical trial or study.

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.

The proposed research must be relevant to Service Members, Veterans, their Families, and/or the American Public. PIs are encouraged to integrate and/or align their research projects with DOW and/or VA research laboratories and programs. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 10 of the GAI.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the task force recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and align with the FY26 BCRP priorities.

3.2. Funding Instrument

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

(31 USC 6304).

3.3. Funding Details

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in 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#DOW_AND_VA_WEBSITES https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research 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.

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Cost Cap: For applications with a single PI, the application’s total costs budgeted for the entire period of performance should not exceed $7.0M. For PPIO applications, the combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and the Partnering PI should not exceed $8.4M. 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(s) may request the entire maximum funding amount for a project that may have a period of performance less than the maximum four years.

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

For Partnering PI Option Applications: A separate award will be made to each PI’s organization.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Research subject compensation and reimbursement for study-related out-of-pocket costs (e.g., travel, lodging, parking, costs associated with caregiving, and resources/equipment to enable participation), if applicable.

• Costs for three 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 BCRP Clinical Research Extension Award.

Must not be requested for:

• Costs to initiate a new clinical trial or study, or enroll new patients in an open/ongoing clinical trial or study.

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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

The Initiating PI must submit the following pre-application components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the overarching challenge(s) under which the application will be submitted.

4.3. Full Application Components

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

4.3.1. Full Application Components for the PI or Initiating PI

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

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

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

(b) Attachments:

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

○ Attachment 1: Project Narrative (18-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

– Background: Present the ideas and reasoning behind the proposed research and identify the overarching challenge(s) that the study will address. The application must demonstrate logical reasoning and provide sound scientific rationale for the proposed project as established through a critical review and analysis of published literature.

Describe how the proposed work will extend the data collection, follow-up, and/or analysis of a breast cancer clinical trial or other clinical study. Include preliminary https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01#_Recipient_Qualification_Restriction_Info:~: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 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

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FY26 Breast Cancer Clinical Research Extension Award 11 data to support the scientific rationale and feasibility of the research approaches.

– Hypothesis or Objective: State the hypothesis to be tested or generated, or the objective to be reached.

– Specific Aims: Concisely explain the specific aims of the study.

– Research Strategy and Feasibility:

▪ Provide a detailed description of the database, specimens, other resource, or clinical trial(s) or study the proposed project will extend. Include, if relevant, the National Clinical Trial (NCT) number, funding source, design, number of patients enrolled, relevant results to date, and location and quantity of data/specimens that are available from the trial(s) or study.

▪ Describe the experimental design, methods and analyses. Provide a detailed description of planned methods to address the hypothesis/objective of the extension research. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ The proposed studies should generate or test a hypothesis. Hence, it is essential that the application outlines in detail the data analysis plan, statistical methods, and considerations that the investigators will employ to analyze the data and draw meaningful conclusions or generate hypotheses. Include sample size projections and an appropriate power analysis, if applicable, to demonstrate that the sample size is appropriate to meet the objective.

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

▪ Describe the availability of and access to the appropriate resources, data, cohort(s), and/or human samples, and provide appropriate letters of support in Attachment 2: Supporting Documentation. See Attachment 9: Inclusion of Women and Minorities for the required strategy for the inclusion of women and minorities appropriate to the objectives of the study. Projects proposing to initiate a new clinical trial or study, or enroll new patients in an open/ongoing clinical trial or study do not meet the intent of this program announcement.

▪ Briefly describe data reporting and sharing procedures. Provide details of data and resource sharing in Attachment 10: Research Sharing Plan.

○ 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.

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=CD25_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20Attachment%3A-,Supporting%20Documentation%3A%20Combine%20and%20attach%20as%20a%20single%20PDF%20file%20named%20%E2%80%9CSupport.pdf%E2%80%9D,-.%20Submitting%20material https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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

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

Consumer Advocate Letters of Commitment: Provide a letter signed by each consumer advocate confirming their commitment to participate in the proposed project.

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

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

○ 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.

Overarching Challenge(s): State the overarching challenge(s) that the proposed research will address.

Hypothesis/Objective(s): State the hypothesis to be tested or generated, or the objective to be reached. Provide evidence or rationale that supports the hypothesis/objective.

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

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Impact: Briefly describe how the project will extend the impact of the previously funded clinical trial or study, or will result in new impact. Describe how the proposed project will have an impact on at least one of the overarching challenges and accelerate progress toward ending breast cancer.

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

○ 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.

– Clearly describe the scientific rationale, objective, and aims of the application.

Describe the ultimate applicability and impact of the research.

▪ Which overarching challenge(s) does the research address?

▪ What types of patients or at-risk individuals will the research help and how will it help them?

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

▪ What is the projected time for achieving a patient-related outcome?

▪ What is the likely impact of this study on the BCRP’s mission of ending breast cancer?

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

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested Statement of Work (SOW) Format.

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

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

○ Attachment 6: Impact Statement (300 words or less is recommended; one-page limit): Upload as “Impact.pdf”.

The statement should address the points outlined below written in a manner that is readily understood by readers without a background in science or medicine. DO NOT restate the research strategy as part of the Impact Statement.

– Articulate concisely how the proposed research will extend the impact of the previously funded clinical trial or study, or will result in new impact.

– Explain how the proposed research will have an impact on at least one of the overarching challenges and accelerate progress toward ending breast cancer.

– Identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Justify how these individuals would benefit from the project.

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 Breast Cancer Clinical Research Extension Award 14

– Explain briefly how the proposed research is relevant to Service Members, Veterans and their Families.

○ Attachment 7: Partnership Statement (one-page limit): Upload as “Partnership.pdf”. (Attachment 7 is only applicable and required for applications submitted under the Partnering PI Option.)

Describe the partnership and combined expertise of the Initiating and Partnering PI that are critical for the research strategy and completion of the proposed work. Explain how the partnership will better address the research question and why the work should be done together rather than through separate efforts. Explain how both PIs have equal intellectual input into the design of the project and will devote similar levels of effort to the conduct of the project. Explain the plan to balance funding between both PIs, or otherwise provide appropriate justification.

○ Attachment 8: Research Team Statement (one-page limit): Upload as “Team.pdf”.

Describe how the PI’s and research team’s combined backgrounds and breast cancer-related expertise will contribute to accomplishing the research goals. Provide the names of at least two consumer advocates and their affiliation with a breast cancer advocacy organization(s). Describe how the consumer advocates’ knowledge of current breast cancer issues and how their background and/or training in breast cancer research will contribute to the proposed research. Explain the integration of the consumer advocates into the planning, design, implementation, and evaluation of the research

○ Attachment 9: Inclusion of Women and Minorities (four-page limit): Upload as “Inclusion.pdf”.

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. 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. For research extending or expanding an existing clinical trial or study to conduct additional patient follow-up, sample collection, or analyses, use of the patients enrolled in that trial or study is expected and the study potentially may not include diverse populations. Explain how the pre-existing cohort is appropriate for the study objectives. 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 and may submit N/A for this statement.

○ Attachment 10: Research Sharing Plan (two-page limit): Upload as “Sharing.pdf”.

Describe the type of data or research resources 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. This includes cases where pre-existing data or resources will be utilized and/or modified during the course of the proposed project. If applicable, include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived. Specifically describe a plan to make experimental platforms, tissue samples and other data and resources developed as a part of the https://ebrap.org/eBRAP/public/Program.htm#:~:text=Statement%20of%20Work-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report,-n/a 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 Breast Cancer Clinical Research Extension Award 15 proposed research project available to the scientific community. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, pre-existing agreements for the original data or research resources that preclude subsequent sharing, 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 11: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 12: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

(c) Additional Application Materials:

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

https://ebrap.org/eBRAP/public/Program.htm#:~:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources 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 Breast Cancer Clinical Research Extension Award 16

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

○ Biographical Sketch

Biographical sketches or equivalent must be submitted for the breast cancer consumer advocates.

○ Current/Pending Support

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

ii. Research & Related Budget

Partnering PI Option: Initiating and Partnering PIs must have a separate budget and justification specific to their distinct portions of the effort that the applicant organization will submit as separate Grants.gov or eBRAP application packages. The Initiating PI should not include budget information for the Partnering PI, or vice versa, even if they are located within the same organization. Refer to Section 3.3, Funding Details, for detailed budget information.

iii. Project/Performance Site Location(s)

iv. Research & Related Subaward Budget Attachment(s) (if applicable, Grants.gov submissions only)

4.3.2. Full Application Components for the Partnering PI

Refer to the equivalent attachment above for details specific to each of the following application components. See Appendix 1 for a checklist of the full application components required for the Partnering PI.

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

(b) Attachments:

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”. Each PI must submit an identical copy of a jointly created SOW.

○ Attachment 11: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”.

○ Attachment 12: Suggested Intragovernmental/Intramural Budget Form: Upload as “IGBudget.pdf”.

(c) Additional Application Materials:

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

External Link to the GAI

Grants.gov

External Link to the GAI eBRAP.org https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_IV:~:text=C.-,Additional%20Application%20Materials,-The%20following%20are https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Additional_App_Materials_V:~:text=B.-,Additional%20Application%20Materials,-The%20following%20are

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

FY26 Breast Cancer Clinical Research Extension Award 17

i. Research & Related Senior/Key Person Profile

○ Biographical Sketch

Biographical sketches or equivalent must be submitted for the breast cancer consumer advocates.

○ Current/Pending Support

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

ii. Research & Related Budget

Initiating and Partnering PIs must have a separate budget and justification specific to their distinct portions of the effort that the applicant organization will submit as separate Grants.gov or eBRAP application packages. The Partnering PI should not include budget information for the Initiating PI, or vice versa, even if they are located within the same organization. Refer to Section 3.3, Funding Details, for detailed budget information.

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…