HT942524BCRPCREA2-GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version 901. The General Application Instructions document is available for downloading from the Grants.gov funding opportunity announcement by selecting the “Package” tab, clicking “Preview,” and then selecting “Download Instructions.”

DOD FY24 Breast Cancer Clinical Research Extension Award 1

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Program Announcement for the Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Breast Cancer Research Program

Clinical Research Extension Award

Announcement Type: Initial

Funding Opportunity Number: HT942524BCRPCREA2

Assistance Listing Number: 12.420 Military Medical Research and Development

SUBMISSION AND REVIEW DATES AND TIMES

• Pre-Application (Letter of Intent Submission Deadline: 5:00 p.m. Eastern time (ET), September 12, 2024

• Application Submission Deadline: 11:59 p.m. ET, September 26, 2024

• End of Application Verification Period: 5:00 p.m. ET, October 1, 2024

• Peer Review: December 2024

• Programmatic Review: February 2025

DOD FY24 Breast Cancer Clinical Research Extension Award 2

TABLE OF CONTENTS

I. OVERVIEW OF THE FUNDING OPPORTUNITY

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Description II.A.1. The Breast Cancer Landscape II.A.2. FY24 BCRP Overarching Challenges

II.B. Award Information II.C. Eligibility Information

II.C.1. Eligible Applicants II.C.2. Cost Sharing II.C.3. Other

II.D. Application and Submission Information II.D.1. Location of Application Package II.D.2. Content and Form of the Application Submission

II.D.2.a. Step 1: Pre-Application Submission

II.D.2.b. Step 2: Full Application Submission

II.D.2.c. Applicant Verification of Full Application Submission in eBRAP

II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM) II.D.4. Submission Dates and Times II.D.5. Funding Restrictions II.D.6. Other Submission Requirements

II.E. Application Review Information II.E.1. Criteria II.E.2. Application Review and Selection Process II.E.3. Integrity and Performance Information

II.F. Federal Award Administration Information II.F.1. Federal Award Notices II.F.2. PI Changes and Award Transfers II.F.3. Administrative and National Policy Requirements II.F.4. Reporting

II.G. Federal Awarding Agency Contacts II.G.1. eBRAP Help Desk II.G.2. Grants.gov Contact Center

II.H. Other Information II.H.1. Program Announcement and General Application Instructions Versions II.H.2. Administrative Actions II.H.3. Full Application Submission Checklist

APPENDIX 1: ACRONYM LIST

DOD FY24 Breast Cancer Clinical Research Extension Award 3

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

II.A. Program Description

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the fiscal year 2024 (FY24) Breast Cancer Research Program (BCRP) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC) is the program management agent for this funding opportunity. The BCRP was initiated 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 FY23 totaled $4.24 billion.

The FY24 appropriation is $150 million (M).

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.

II.A.1. The Breast Cancer Landscape

The BCRP has prepared a brief overview, The Breast Cancer Landscape, that describes what is currently known about the most pertinent topics that are consistent with the BCRP’s mission of ending breast cancer. Applicants are strongly urged to read and consider The Breast Cancer Landscape before preparing their applications. The Breast Cancer Landscape may be found at https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2023.pdf.

II.A.2. FY24 BCRP Overarching Challenges

Considering the current breast cancer landscape and the BCRP’s mission, all FY24 BCRP Clinical Research Extension Award applications must address at least one of the following overarching challenges unless adequate justification for exception is provided.*

• 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 https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2023.pdf https://cdmrp.health.mil/bcrp/pdfs/BreastCancerLandscape2023.pdf

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• 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 are more effective, less toxic, and impact survival

• Eliminate the mortality associated with metastatic breast cancer

*Alternatively, with adequate justification, applications may identify and address another overarching challenge related to the breast cancer landscape. Justification must be provided in the application.

II.B. Award Information

The FY24 BCRP Clinical Research Extension Award aims to extend or expand the data collection, follow-up, and analysis of breast cancer clinical studies. The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research 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 mechanism to help ensure that science values those contributions with research that maximizes their impact.

The critical components of this award mechanism are:

Impact: Research supported by the FY24 BCRP Clinical Research Extension Award will have the potential to extend or affect the impact of the previously funded clinical trial or study or will result in new impact and accelerate progress toward ending breast cancer.

Research Scope: Although not all-inclusive, research proposed under the FY24 BCRP Clinical Research Extension Award may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients enrolled in an open/ongoing or completed clinical trial. 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 conduct clinical trials will not be supported.

Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. The applicant must demonstrate availability of, and accessibility to, the necessary resources or populations to accomplish the proposed research.

Data Evaluation and Sharing: Proposed research should be based on a study sample size that will ensure that 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 objectives and outline the statistical methods and considerations they will employ in their data analysis. The applicant must outline a data-sharing plan for the scientific

DOD FY24 Breast Cancer Clinical Research Extension Award 5 community to have access to the experimental platforms and molecular and other data generated from the proposed research.

Partnering PI Option: The FY24 BCRP Clinical Research Extension Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (PIs). One PI will be identified as the Initiating PI, who will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI.

The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring a distinct contribution to the application. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. The application is expected to 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 SOW, and why the work should be done together rather than through separate efforts. Applicants are discouraged from being named as a PI, Initiating PI, or Partnering PI on multiple Clinical Research Extension Award applications unless they are clearly addressing distinct research questions. 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 II.D.2, Content and Form of the Application Submission.

Personnel: Applications are expected to 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: Applications are required to include consumer advocate involvement.

The research team must include two or more breast cancer consumer advocates, and it is the applicant’s responsibility to outline the advocates’ role in the design and execution of the study.

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. Their role should be independent of their employment, and they may not be employees of any organizations 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. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.

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 recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research

DOD FY24 Breast Cancer Clinical Research Extension Award 6

Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women's health.

The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.

Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects that may or may not be considered a clinical trial. For this funding opportunity, research involving human subjects, human specimens, and data, including extended or expanded clinical follow-up of patients, is permitted; however, this award cannot be used to conduct clinical trials.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

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

USC 6304).

The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Clinical Research Extension Award should not exceed $5M for applications with a single PI or $6M if applying under the Partnering PI Option. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $9.3M to fund approximately one Clinical Research Extension Award application. Funding of applications received is contingent upon https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research

DOD FY24 Breast Cancer Clinical Research Extension Award 7 the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.1.a. Organization: Extramural and Intramural organizations are eligible to apply, including foreign or domestic organizations, for-profit and non-profit organizations, and public entities.

Extramural Organization: An eligible non-Department of Defense (DOD) organization.

Examples of extramural organizations include academic institutions, biotechnology companies, foundations, federal government organizations other than the DOD (i.e., intragovernmental organizations), and research institutes.

Intramural DOD Organization: Refers specifically to DOD organizations including DOD laboratories, DOD military treatment facilities, and/or DOD activities embedded within a civilian medical center.

Awards are made to eligible organizations, not to individuals. Refer to the General Application Instructions, Appendix 1, for additional recipient qualification requirements.

II.C.1.b. Principal Investigator

Independent Investigators at all academic levels (or equivalent) are eligible to be named as a PI, Initiating PI, or Partnering PI on an application.

There are no limitations on the number of applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI.

Investigators named on an application submitted under funding opportunity HT942524BCRPCREA are not eligible to submit a pre-application or full application for the same research project under the current funding opportunity.

Investigators are discouraged from being named as a PI, Initiating PI, or Partnering PI on multiple FY24 BCRP Clinical Research Extension Award applications unless they are clearly addressing distinct research questions.

An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization.

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II.C.2. Cost Sharing

Cost sharing/matching is not an eligibility requirement.

II.C.3. Other

Organizations must be able to access .gov and .mil websites to fulfill the financial and technical deliverable requirements of the award and submit invoices for payment.

Refer to Section II.H.2, Administrative Actions, for a list of administrative actions that may be taken if a pre-application or full application does not meet the administrative, eligibility, or ethical requirements defined in this program announcement.

II.D. Application and Submission Information

II.D.1. Location of Application Package

Submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP.org) and a full application (eBRAP.org or Grants.gov). Depending on the type of submission (i.e., extramural vs. intramural), certain aspects of the submission process will differ.

The CDMRP uses two portal systems to accept pre- and full application submissions.

eBRAP (https://ebrap.org) is a secure web-based system that allows PIs and/or organizational representatives from both extra- and intramural organizations to receive communications from the CDMRP and submit their pre-applications. Additionally, eBRAP allows extramural applicants to view and verify full applications submitted to Grants.gov and allows intramural DOD applicants to submit and verify full applications following their pre-application submission.

Grants.gov (https://grants.gov) is a federal system that must be used by funding agencies to announce extramural grant applications. Full applications for CDMRP funding opportunities can only be submitted to Grants.gov after submission of a pre-application through eBRAP.

https://ebrap.org/ https://grants.gov/

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Application Submission Workflow

Extramural Submission: An application submitted by an extramural organization for an extramural or intramural PI working within an extramural or intramural organization. For example, a research foundation submitting an application for a DOD employee working within a DOD organization would be considered an extramural submission and should follow instructions specific to extramural submissions. Download application package components for HT942524BCRPCREA2 from Grants.gov (https://grants.gov). Full applications from extramural organizations must be submitted through Grants.gov.

Intramural Submission: An application submitted by an intramural DOD organization for an investigator employed by that organization. Intramural DOD organizations may submit full applications to either eBRAP or Grants.gov. Download application package components for HT942524BCRPCREA2 from the anticipated submission portal eBRAP (https://ebrap.org) or Grants.gov.

The submission process should be started early to avoid missing deadlines. Regardless of submission type or portal used, all pre- and full application components must be submitted by the deadlines stipulated on the first page of this program announcement. There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The USAMRAA cannot make allowances/exceptions for submission problems encountered by the applicant organization using system-to-system interfaces with Grants.gov.

II.D.2. Content and Form of the Application Submission

Submitting applications that propose essentially the same research project to different funding opportunities within the same program and funding cycle is prohibited and will result in administrative withdrawal of the duplicative application(s).

https://grants.gov/ https://ebrap.org/

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Unnecessary duplication of funding, or accepting funding from more than one source for the same research, is prohibited. See the CDMRP’s full position on research duplication at https://cdmrp.health.mil/funding/researchDup.

Including classified research data within the application and/or proposing research that may produce classified outcomes, or outcomes deemed sensitive to national security concerns, may result in application withdrawal. Refer to the General Application Instructions, Appendix 7, Section B.

FY24 BCRP Programmatic Panel members should not be involved in any pre-application or full application. For questions related to panel members and pre-applications or applications, refer to Section II.H.2.c, Withdrawal, or contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507.

II.D.2.a. Step 1: Pre-Application Submission

Regardless of submission type (i.e., extramural or intramural), all pre-application components must be submitted by the PI or Initiating PI through eBRAP (https://eBRAP.org/), including the submission of contact information for the Partnering PI if exercising the Partnering PI Option.

During the pre-application process, eBRAP assigns each submission a unique log number. This unique log number is required during the full application submission process. The eBRAP log number, application title, and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire pre-application and full application submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify, and verify the application in eBRAP.

If any changes need to be made, the applicant should contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507 prior to the application submission deadline.

When starting the pre-application, applicants will be asked to select a “Mechanism Option.”

Please be sure to select the correct option appropriate to your pre-application:

Application Includes: Select Option:

Single PI No Option Initiating PI and Partnering PI Partnering PI Option

Partnering PI Option: After the Initiating PI confirms submission of the pre-application, the Partnering PI will be notified of the pre-application submission via an email from eBRAP. The Partnering PI must follow the link in the notification email to associate the partnering pre-application with their eBRAP account. If not previously registered, the Partnering PI must register in eBRAP.

After associating the pre-application with their eBRAP account, the Partnering PI should email the eBRAP Help Desk (help@ebrap.org) to have the desired contact information associated with their pre-application. The email should include the pre-application log number, the name of the Business Official, the name(s) of the Performing/Contracting Organization(s), and the submission-type for the pre-application (extramural or intramural).

https://cdmrp.health.mil/funding/researchDup mailto:help@eBRAP.org https://ebrap.org/ mailto:help@eBRAP.org mailto:help@ebrap.org

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Partnering PIs should not initiate a new pre-application based on the same research project submitted by the Initiating PI. Partnering PIs are urged to complete these steps as soon as possible. If they are not completed:

• The Partnering PI will not be able to view and modify their full application during the verification period in eBRAP.

• Any intramural Partnering PI will not be able to submit their full application package components to eBRAP.

II.D.2.a.i. Pre-Application Components

Pre-application submissions must include the following components (refer to the General Application Instructions, Section III.B, for detailed instructions regarding pre-application submission):

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

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.

II.D.2.b. Step 2: Full Application Submission

II.D.2.b.i. Full Application Submission Type

Extramural Submissions: Full applications from extramural organizations must be submitted through Grants.gov Workspace. Full applications from extramural organizations, including non- DOD federal organizations, received through eBRAP will be withdrawn. Refer to the General Application Instructions, Section IV, for considerations and detailed instructions regarding extramural full application submission.

Intramural Submissions: Intramural DOD organizations may submit full applications through either eBRAP or Grants.gov. There is no preference from the CDMRP for which submission portal is utilized; submission through one portal or the other does not provide the application any advantage during the review process. Intramural DOD organizations that choose to submit through Grants.gov should follow Extramural Submission instructions. Intramural DOD organizations that are unable to submit through Grants.gov should submit through eBRAP. For the remainder of this program announcement, it will be assumed intramural DOD submissions will proceed through eBRAP. Refer to the General Application Instructions, Section V, for considerations and detailed instructions regarding intramural DOD full application submission.

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II.D.2.b.ii. Full Application Submission Components for the PI or Initiating PI

Each application submission must include the completed full application package for this program announcement. See Section II.H.3 of this program announcement for a checklist of the required application components.

Partnering PI Option: The CDMRP requires separate full application package submissions for the Initiating PI and Partnering PI, even if the PIs are located within the same organization. Each full application package must be submitted using the unique eBRAP log number received by the Initiating and Partnering PIs during pre-application submission. All associated applications (the Initiating PI’s and the Partnering PI’s) must be submitted by the full application submission deadline.

(a) SF424 Research & Related Application for Federal Assistance Form (Extramural Submissions Only): Refer to the General Application Instructions, Section IV.B, for detailed information.

(b) Attachments:

Each attachment to the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines listed in the General Application Instructions, Appendix 2.

○ Attachment 1: Project Narrative (18-page limit): Upload as “ProjectNarrative.pdf”. The page limit of the Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.

Describe the proposed project in detail using the outline below.

– Background: Present the ideas and reasoning behind the proposed research and the FY24 BCRP Overarching Challenge that will be addressed. The application must provide a sound scientific rationale to support the proposed project and its feasibility as established through the demonstration of logical reasoning and a critical review and analysis of published literature; include relevant literature citations. Describe how the proposed work aims to extend or expand the data collection, follow-up, and/or analysis of a breast cancer trial or other clinical study. Include preliminary 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 project’s specific aims to be funded by this application.

DOD FY24 Breast Cancer Clinical Research Extension Award 13

– Research Strategy and Feasibility:

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

Describe the experimental design, methods, and analyses. Planned methods to address the proposed hypothesis/objective of the extension research should be provided in detail.

The proposed studies are expected to generate or test a hypothesis. Hence, it is essential that the data analysis plan, statistical methods, and considerations that will be employed to analyze the data and draw meaningful conclusions or generate hypotheses be outlined in detail. Include sample size projections and an appropriate power analysis, if applicable, to demonstrate that the sample size is appropriate to meet the objectives of the study.

Address potential problem areas and present alternative methods and approaches.

Provide information to support the availability of and access to the appropriate resources, data, patient population(s), and/or samples. See Attachment 10 for the required strategy for the inclusion of women and minorities appropriate to the objectives of the study. This award cannot be used to conduct clinical trials.

Briefly describe how data will be reported and shared. Details of data and resource sharing should be provided in Attachment 9, Data and Research Resources Sharing Plan.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”. Start each document on a new page. The Supporting Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures, or drawings. These items should be included in the Project Narrative.

There are no page limits for any of these components unless otherwise noted. Include only those 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 (including URLs, if available) in the Project Narrative using a standard reference format.

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

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Facilities, Existing Equipment, and Other Resources: Describe the facilities and equipment available for performance of the proposed project and 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 should be made to the original or present government award under which the facilities or equipment items are now accountable. There is no form for this information.

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

Letters of Organizational Support: Provide a letter (or letters, if applicable) signed by the Department Chair or appropriate organization official, confirming the laboratory space, equipment, and other resources available for the project. Letters of support not requested in the program announcement, such as those from members of Congress, do not impact application review or funding decisions.

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 DOD 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 DOD organization authorizing the collaborator’s involvement.

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

Letters of Support (if applicable): Provide a signed letter from any organizations providing resources, data, and/or biospecimens for the proposed study that will demonstrate that the PI has the support and access to resources necessary for the proposed work.

Intellectual Property: Information can be found in 2 CFR 200.315, “Intangible Property.”

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

Commercialization Strategy (if applicable): Describe the commercialization plan. The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors, and management team. Discuss the significance of this development effort, when it

DOD FY24 Breast Cancer Clinical Research Extension Award 15 can be anticipated, and the potential commercial use for the technology being developed.

DOD Data Management Plan (two-page limit is recommended): Describe the data management plan in accordance with Section 3.c, Enclosure 3, DoD Instructions

3200.12. Do not duplicate the Data and Research Resources Sharing Plan. Refer to General Application Instructions, Section IV.B, Attachments Form, Attachment:

Supporting Documentation, for detailed information regarding Data Management Plan content.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”. The technical abstract is used by all reviewers. Abstracts of all funded research projects will be posted publicly. Use only characters available on a standard QWERTY keyboard.

Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.

Technical abstracts should be written 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 will be addressed.

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

Specific Aims: State the specific aims of the study.

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

Impact: Briefly describe how the project will extend or expand 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.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”. The lay abstract is used by all reviewers, and addresses issues of particular interest to the affected community. Abstracts of all funded research projects will be posted publicly. Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed. Do not duplicate the technical abstract.

Lay abstracts should address the points outlined below in a manner that will be readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms, and abbreviations.

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

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423

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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 it help and how will it help them?

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

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

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

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”. Refer to the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for the suggested SOW format and recommended strategies for assembling the SOW.

For the Clinical Research Extension Award mechanism, 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 example is most appropriate for the proposed effort, for guidance on preparing the SOW. Use the “Suggested SOW Format” to develop the SOW for the proposed research. Submit as a PDF.

The SOW should indicate a feasible plan and timeline to conduct the research. The SOW must include specific research milestones to be accomplished by the end of each year in the period of performance.

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 recommended; 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.

DO NOT restate the research strategy as part of the Impact Statement.

– Articulate concisely how the proposed research will extend or expand 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 and justify how they would ultimately benefit from the proposed research.

https://ebrap.org/eBRAP/public/Program.htm

DOD FY24 Breast Cancer Clinical Research Extension Award 17

○ 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 SOW. Explain how the partnership will better address the research question and why the work should be done together rather than through separate individual efforts. Explain how both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. Explain how funding will be balanced between both PIs or otherwise provide appropriate justification.

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

Describe how the PIs’ and research teams’ 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 how the consumer advocates will be integrated into the design and execution of the study.

○ Attachment 9: Data and Research Resources Sharing Plan (two-page limit):

Upload as “Sharing.pdf”. Describe how data and resources generated during the performance of the proposed research project will be shared with the research community. This includes cases where pre-existing data or resources will be utilized and/or modified during the course of the proposed project. Specifically describe a plan to make experimental platforms, tissue samples, and other data and resources developed as a part of the proposed research projects available to the scientific community. 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 in the data and research resource sharing plan. Refer to the CDMRP Policy on Data & Resource Sharing located on the eBRAP “Funding Opportunities & Forms” web page https://ebrap.org/eBRAP/public/Program.htm for more information about the CDMRP’s expectations for making data and research resources publicly available.

○ Attachment 10: 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/gender, race, and ethnicity, 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 at https://ebrap.org/eBRAP/public/Program.htm. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex/gender, 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

DOD FY24 Breast Cancer Clinical Research Extension Award 18 pre-existing cohort is appropriate for the study objective with consideration of diversity.

Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, 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 11: Representations (Extramural Submissions Only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations template available on eBRAP (https://ebrap.org/eBRAP/ public/Program.htm). For more information, see the General Application Instructions, Appendix 8, Section B, Representations.

○ Attachment 12: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOD organization will be a collaborator in performance of the project, complete a separate budget using the “Suggested Intragovernmental/Intramural Budget Form”, available for download on the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). The budget should cover the entire period of performance for each intramural DOD site and include a budget justification as instructed. The total costs per year for each subaward (direct and indirect costs) should be included on the Grants.gov Research & Related Budget Form under subaward costs.

Refer to the General Application Instructions, Section V.A.(e), for additional information and considerations.

(c) Research & Related Personal Data: For extramural submissions, refer to the General Application Instructions, Section IV.B.(c), and for intramural submissions, refer to the General Application Instructions, Section V.A.(c), for detailed instructions.

(d) Research & Related Senior/Key Person Profile (Expanded): For extramural submissions, refer to the General Application Instructions, Section IV.B.(d), and for intramural submissions, refer to the General Application Instructions, Section V.A.(d), for detailed instructions.

○ PI Biographical Sketch (five-page limit): Upload as “Biosketch_LastName.pdf”.

○ PI Previous/Current/Pending Support (no page limit): Upload as “Support_LastName.pdf”.

○ Key Personnel Biographical Sketches (five-page limit each): Upload as “Biosketch_LastName.pdf”.

Include biographical sketches for team members, including consumer advocates.

○ Key Personnel Previous/Current/Pending Support (no page limit): Upload as “Support_LastName.pdf”.

https://ebrap.org/eBRAP/public/Program.htm

DOD FY24 Breast Cancer Clinical Research Extension Award 19

(e) Research & Related Budget: For extramural submissions, refer to the General Application Instructions, Section IV.B.(e), and for intramural submissions, refer to the General Application Instructions, Section V.A.(e), for detailed instructions.

○ Budget Justification (no page limit): For extramural submissions, refer to the General Application Instructions, Section IV.B.(e), Section L, for instructions. For intramural submissions, refer to General Application Instructions, Section V.A.(e), Budget Justification Instructions.

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 Partnering PI even if they are located within the same organization. Refer to Section II.D.5, Funding Restrictions, for detailed information.

(f) Project/Performance Site Location(s) Form: For extramural submissions, refer to the General Application Instructions, Section IV.B.(f), and for intramural submissions, refer to the General Application Instructions, Section V.A.(f), for detailed instructions.

(g) Research & Related Subaward Budget Attachment(s) Form (if applicable, Extramural Submissions Only): Refer to the General Application Instructions, Section IV.B.(g), for detailed instructions.

o Extramural Subaward: Complete the Research & Related Subaward Budget Form and upload through Grants.gov.

o Intramural DOD Subaward: Complete a separate “Suggested Intragovernmental/Intramural Budget Form” for each intramural DOD subaward and upload as a single document titled IGBudget.pdf to Grants.gov as Attachment 12.

II.D.2.b.iii. Full Application Submission Components for the Partnering PI

The application submission process for the Partnering PI uses an abbreviated full application package. Refer to the equivalent attachment above for details specific to each of the following application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Extramural Submissions Only): Refer to the General Application Instructions, Section IV.B.(a), for detailed information.

(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 (Extramural Submissions Only): Upload as “RequiredReps.pdf”.

DOD FY24 Breast Cancer Clinical Research Extension Award 20

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

(c) Research & Related Personal Data: For extramural submissions, refer to the General Application Instructions, Section IV.B.(c), and for intramural submissions, refer to the General Application Instructions, Section V.A.(c), for detailed information.

(d) Research & Related Senior/Key Person Profile (Expanded): For extramural submissions, refer to the General Application Instructions, Section IV.B.(d), and for intramural submissions, refer to the General Application Instructions, Section V.A.(d), for detailed information.

○ PI Biographical Sketch (five-page limit): Upload as “Biosketch_LastName.pdf”.

○ PI Previous/Current/Pending Support (no page limit): Upload as “Support_LastName.pdf”.

○ Key Personnel Biographical Sketches (five-page limit each): Upload as “Biosketch_LastName.pdf”.

Include biographical sketches for team members, including consumer advocates.

○ Key Personnel Previous/Current/Pending Support (no page limit): Upload as “Support_LastName.pdf”.