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

Program Announcement for the Defense Health Agency

Melanoma Research Program

Survivorship Research Award

Funding Opportunity Number: HT942526MRPSRA

Pre-Application Due: September 22, 2026

Application Due: October 14, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Melanoma Survivorship Research Award 2

Content

Before You Begin 3

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

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

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

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

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

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

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

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

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

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

Appendix 2 Acronym List

FY26 Melanoma Survivorship Research Award 3

Before You Begin

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

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

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

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

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:~: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 Melanoma Survivorship Research Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Melanoma Research Program (MRP) Survivorship Research Award addresses the relatively new and underfunded area of melanoma-specific survivorship by supporting a broad range of innovative and impactful research that has the intended outcome of improving the health and well-being of melanoma survivors, their families and/or their care partners in the near term. Proposed studies focusing exclusively on animal models or considering survival only without consideration of quality of life, overall health and/or function are not responsive to this funding opportunity.

Distinctive Features:

• The application must include at least one melanoma consumer collaborator, defined as a melanoma survivor, family member and/or care partner who can provide lived experience expertise to the research project team, or a melanoma-community supporting organization to support the planning, execution, and implementation of the proposed research.

• Clinical trials are allowed.

Funding Details: The Congressionally Directed Medical Research Programs expects to allot roughly $2.04M to fund approximately two Survivorship Research Award applications with total cost caps of $1.02M per award. The maximum period of performance is 3 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), September 22, 2026

• Application Submission Deadline: 11:59 p.m. ET, October 14, 2026

• End of Application Verification Period: 5:00 p.m. ET, October 20, 2026

• Peer Review: December 2026

• Programmatic Review: March 2027

Announcement Type: Initial

Funding Opportunity Number: HT942526MRPSRA

Assistance Listing Number: 12.420

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FY26 Melanoma Survivorship Research Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

The named Principal Investigator (PI) on the application must be an independent investigator at or above the level of Assistant Professor, or equivalent. The investigator does not have to be at an academic organization.

An investigator may be named on only one FY26 MRP full application as a PI.

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

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 Congressionally Directed Medical Research Programs (CDMRP) is the program office managing this FY26 funding opportunity as part of the Melanoma Research Program (MRP). 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 MRP in 2019 to provide support for research of high potential impact and exceptional scientific merit.

Appropriations for the MRP from FY19 through FY25 totaled $220 million (M). The FY26 appropriation is $40M.

The vision of the MRP is to prevent melanoma initiation and progression, and reduce hardship.

The mission is to support development of earlier interventions to enhance mission readiness, diminish melanoma burden, and improve quality of life for Service Members, Veterans, their Families and the American public.

Studies involving non-melanoma skin cancers are not allowed under the FY26 MRP.

The MRP identified three strategic priorities to ensure that funded research addresses unmet needs and/or underfunded areas of melanoma research and patient care. These three priorities are:

Prevention and Interception: Individuals diagnosed with melanoma have significantly improved prognoses when the disease is diagnosed and treated before it metastasizes.

Although primary prevention (use of sunscreen, sun avoidance, etc.) is critical, the MRP seeks to fund research that will lead to improved detection and monitoring capabilities (particularly for individuals at highest risk) as well as inhibition of melanoma initiation, early dissemination, emergence from tumor dormancy and metastases (i.e., interception).

With the exception of studies investigating rare melanomas, the FY26 MRP is not requesting research into established macrometastatic disease or developing treatments for macrometastatic disease.

Rare Melanomas: Rare melanoma subtypes can have distinct characteristics compared to cutaneous melanoma, which makes up the majority of melanoma diagnoses. Rare melanoma subtypes are typically less well-studied, and this has led to a variety of prevention, diagnosis and treatment challenges. The MRP seeks to fund research across the entire cancer research spectrum addressing unmet needs and knowledge gaps associated with rare melanomas.

Survivorship: With the increasing incidence of melanoma and the increased availability of effective treatment options for patients with melanoma, the number of melanoma survivors is also increasing. The MRP seeks to fund innovative and impactful research that advances studies in preservation of function (physical ability), quality of life improvement, symptom management, treatment outcomes and support for psychological and social issues related to melanoma diagnosis, treatment and life post-treatment.

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3.1. Award History

The MRP Survivorship Research Award (SRA) mechanism was first offered in FY24. Since then, 22 SRA applications were received and four were recommended for funding.

3.2. Intent of the Survivorship Research Award

Background:

The widely accepted definition of cancer survivorship spans the time from an individual receiving their initial diagnosis through the balance of their life. Under this definition, an individual is considered a melanoma survivor beginning at the time they receive their initial diagnosis.1 For the purposes of this award the needs and impact of a melanoma diagnosis on family members, friends and care partners of melanoma survivors are also included within the purview of “melanoma survivorship.”

The concept of melanoma survivorship is relatively new compared to other cancer types and the need for increased investment in melanoma-specific survivorship research is multi-faceted. The Surveillance, Epidemiology and End Results Program estimates that there were approximately

1.5 million people living with melanoma in the United States in 2022, with approximately 166,000 (~11%) of those individuals under 50 years old.2 Furthermore, the overall five-year survival rate of advanced, unresectable melanoma can be as high as 50%, due in large part to advancements in immuno- and targeted therapies; there is an increasing number of advanced stage melanoma survivors who are living over 10 years past their initial treatments. Because the incidence of melanoma continues to trend upward and melanoma survivors are living longer, the number of melanoma survivors will continue to increase.

The successes obtained in the advanced disease setting have led to use of immunotherapies at earlier stages (e.g., in melanoma patients with stage II and stage III disease). However, these newer therapies are known to carry risk of acute and long-term toxicities, including immune-related adverse events and cardiovascular and neurologic toxicities. This knowledge is driving the need to better understand and identify patients at risk for developing toxicities to allow for appropriate considerations for benefit versus toxicity risk when choosing treatment regimens.3

Intent of the SRA:

The needs of melanoma survivors are diverse, and no single discipline can address them all.

The intent of the SRA is to address the relatively new and underfunded area of melanoma-specific survivorship by supporting a broad range of innovative and impactful research that has the intended outcome of improving the health and well-being of melanoma survivors, their families and/or their care partners. Applications may propose development of evidence-based practices, behavioral health science, survivor and/or care partner well-being interventions and surveillance, and/or identification of psychosocial survivor outcomes. Clinical trials are allowed.

1 https://cancercontrol.cancer.gov/ocs/definitions 2 https://seer.cancer.gov/statistics-network/explorer/application.html?site=53&data_type=5&graph_type=11&compareBy=sex&chk_sex_3=3 &chk_sex_2=2&series=9&age_range=1&advopt_precision=1&hdn_view=1#resultsRegion1 3 Yen-Chou Chen et al., “A Brain, a Heart, and the Courage: Balancing Benefit and Toxicity of Immunotherapy in Melanoma,” American Society of Clinical Oncology Educ Book. 43:e390594 (2023).

doi: 10.1200/EDBK_390594. PMID: 37229626.

https://cancercontrol.cancer.gov/ocs/definitions https://seer.cancer.gov/statistics-network/explorer/application.html?site=53&data_type=5&graph_type=11&compareBy=sex&chk_sex_3=3&chk_sex_2=2&series=9&age_range=1&advopt_precision=1&hdn_view=1%23resultsRegion1 https://seer.cancer.gov/statistics-network/explorer/application.html?site=53&data_type=5&graph_type=11&compareBy=sex&chk_sex_3=3&chk_sex_2=2&series=9&age_range=1&advopt_precision=1&hdn_view=1%23resultsRegion1 https://seer.cancer.gov/statistics-network/explorer/application.html?site=53&data_type=5&graph_type=11&compareBy=sex&chk_sex_3=3&chk_sex_2=2&series=9&age_range=1&advopt_precision=1&hdn_view=1%23resultsRegion1 https://ascopubs.org/doi/10.1200/EDBK_390594?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed https://pubmed.ncbi.nlm.nih.gov/37229626/

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Examples of Allowable Research:

The following list outlines areas of survivorship research of interest to the MRP; it is not all inclusive. Applications may propose projects that address other areas of melanoma survivorship not listed below as long as the need for such research is clearly presented in the application materials.

• Preservation of function (physical ability) and symptom management throughout treatment and beyond

○ Understanding and preventing toxicities related to immunotherapies, including immune-related adverse events and cardiovascular and neurological toxicities.

○ Addressing reproductive and sexual health issues.

○ Reducing and preventing other major side-effects of treatment (e.g., lymphedema, fatigue).

○ Addressing physical issues/treatment effects that impact long-term (>5 years post-treatment) melanoma survivors.

• Psychological and social impacts of a melanoma diagnosis and treatment on melanoma survivors and care partners

○ Developing study methods and measures to improve quality of life and overall mental health (e.g., addressing depression, anxiety, “survivors’ guilt”).

○ Assessing the relationship(s) between behavioral and social functioning in relation to melanoma initiation, progression, detection, treatment and rehabilitation.

○ Addressing the psychological impact of fear of melanoma recurrence and multiple primary melanoma diagnoses.

• Treatment outcomes

○ Investigating the impact of alternative medicine, nutrition and lifestyle factors on treatment outcomes.

○ Developing melanoma-specific survivorship strategies and resources.

• Health care delivery

○ Addressing issues related to access to care, including follow-up care.

○ Improving prevention strategies, diagnosis, treatment and outcomes for melanoma survivors, including evidence-based underserved or under-represented populations.

○ Developing strategies to understand barriers to and improve communication amongst providers, patients and their care network.

Proposed studies focusing exclusively on animal models or considering survival only without consideration of quality of life, overall health and/or function are not responsive to this funding opportunity. Such types of studies may be better suited for submission to other FY26 MRP Funding Opportunities.

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

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3.2.1. Key Elements for the SRA

Impact: The SRA is intended to support research designed to have a major impact on the health and well-being of melanoma survivors, their families and/or care partners. Impactful research will accelerate the movement of promising ideas into clinical applications or other real-world applications and advance the field of melanoma-specific quality of life and survivorship.

Study Design: Applications should clearly articulate and justify the chosen study design.

Studies proposing retrospective analyses or prospective enrollment should clearly describe the architecture of the study (e.g., descriptive, correlational, field experimental, meta-analyses) and the study population(s). The study population(s) should be representative of the people who are anticipated to benefit from the research. If applicable, describe questionnaires in sufficient detail to justify interpretation of potential results.

Melanoma Consumer Collaboration: For the purposes of the SRA, a “melanoma consumer” is defined as a melanoma survivor, family member or care partner who can provide lived experience expertise to the research project team. Applicants to the SRA must collaborate with the melanoma consumer community to maximize the impact and translatability of the research for the benefit of the intended melanoma community(ies).

Collaborative research approaches create partnerships between scientific researchers and melanoma consumers to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and melanoma consumers collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research design, implementation, evaluation and results dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of the melanoma consumer community members within the research team. Research results are jointly interpreted, disseminated and fed back to affected communities and in some instances, translated into interventions or policy.

Collaborative relationships with the melanoma consumer community may be established through integrating community members into research teams as co-researchers, advisors and/or consultants; melanoma consumer collaborators should not be named as Initiating or Partnering PIs. Examples for implementing collaborative research approaches are listed below, but each research team may pursue other options as appropriate for the proposed research.

The research team may:

• Include at least one melanoma consumer who will provide advice and consultation throughout the planning, implementation and results dissemination of the research project.

The consumer(s) should be able to speak to the needs of the melanoma consumer community, not just speak to their own personal experiences.

• Establish partnerships with at least one community-supporting organization that provides advice and consultation throughout the planning, implementation and results dissemination of the research project. Community-supporting organizations may include advocacy groups or other formal organizational stakeholders that can speak to the needs of the melanoma consumer community.

• Assemble a melanoma consumer community advisory board. The advisory board may include melanoma consumers, a coalition of community-supporting organizations or any combination thereof that provides advice and consultation throughout the planning, implementation and results dissemination of the research project.

Additional information on collaborative research approaches can be found in:

• Cancer Research UK. Patient involvement toolkit for researchers.

https://www.cancerresearchuk.org/funding-for-researchers/patient-involvement-toolkit-for-researchers

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FY26 Melanoma Survivorship Research Award 10

• Patricia A. Spears, “Patient Engagement in Cancer Research From the Patient’s Perspective,” Future Oncology 17, no. 28 (2021): 3717–28. doi: 10.2217/fon-2020-1198.

Epub 2021 Jul 2. PMID: 34213358.

• Ann Tivey et al., “Patient Engagement in Melanoma Research: From Bench to Bedside,” Future Oncology 17, no. 28 (2021): 3705–16. doi: 10.2217/fon-2020-1165. Epub 2021 Jul 2.

PMID: 34213356.

• Jeannine M. Salamone, et al., “Promoting Scientist-Advocate Collaborations in Cancer Research: Why and How,” Cancer Research 78, no. 20 (2018): 5723–28. doi:

10.1158/0008-5472.CAN-18-1600.

• Food and Drug Administration. Center for Drug Evaluation and Research (CDER) Patient- Focused Drug Development.

3.2.2. Other Important Considerations for the SRA

Relevance to Military Health: Advancing knowledge in melanoma research, patient care and/or treatment options in the Military Health System is critical. Therefore, the MRP seeks to support research that is relevant to the health care needs of Service Members, Veterans and/or other their Families. The MRP encourages investigators to consider the following examples of how a project may demonstrate relevance to military health:

• Use of military or Veteran populations, biospecimens, data, databases or programs in the proposed research.

• Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, DOW, U.S. Department of Veterans Affairs (VA) and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans and/or their Families.

• Explanation of how the project addresses an aspect of melanoma that has relevance or is unique to Service Members, Veterans and/or their Families.

If the proposed research involves access to active-duty military and/or VA patient populations and/or DOW or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to the Full Application Submission Components, for detailed information. Refer to the GAI, Appendix 4, for additional information.

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.

Preclinical Research: 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 guidelines 2.0.

For Research Involving Animals: 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.

https://www.tandfonline.com/doi/full/10.2217/fon-2020-1198 https://pubmed.ncbi.nlm.nih.gov/34213358/ https://doi.org/10.2217/fon-2020-1198 https://pubmed.ncbi.nlm.nih.gov/34213356/ https://aacrjournals.org/cancerres/article/78/20/5723/631778/Promoting-Scientist-Advocate-Collaborations-in https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:~:text=APPENDIX%2010.%0ADOW%20AND%20VA%20WEBSITES 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://arriveguidelines.org/arrive-guidelines https://www.aphis.usda.gov/sites/default/files/ac-tech-note-categorizing-animal-pain-or-distress.pdf

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The MRP acknowledges that domestic dogs can spontaneously develop mucosal melanoma.

FY26 applications proposing mucosal melanoma studies involving pets that are voluntarily enrolled in studies at the owner’s discretion may be considered (e.g., a pet owner enrolling their domestic dog in a clinical trial administered in a veterinary hospital setting). Such studies, if recommended for funding, must obtain a waiver of National Defense Authorization Act for Fiscal Year 2026, Section 732 before initiating. Receipt of such a waiver is not guaranteed.

For Research Involving Human Data, Human Anatomical Substances, Human Subjects or Human Cadavers:

Clinical trials are allowed within this funding opportunity.

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

For more information, a Human Subject Research Resource is available on the CDMRP website.

Metastatic Cancer Task Force: 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, CDMRP encourages applicants to review the recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY26 MRP strategic priorities.

3.3. Funding Instrument

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

(31 USC 6304).

3.4. Funding Details

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

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $1.02M. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

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

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

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

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

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator 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 MRP SRA.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_20250328.pdf 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.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:~:text=and%20system%20accounts.-,Total%20Cost%3A,-The%20total%20costs

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• Costs associated with melanoma consumer collaboration (e.g., consultant costs, equitable participation training, capacity-building activities).

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

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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

Pre-application submissions must include the following components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Identify the melanoma consumer collaborator(s) that will serve as an advisor/consultant for the proposed research efforts (required).

4.3. Full Application Components

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

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

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

(b) Attachments:

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

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

Describe the proposed project in detail using the outline below.

– Background: Present the rationale to support the proposed research and its feasibility, as established through the demonstration of logical reasoning and a critical review and analysis of published literature; include relevant literature citations.

As appropriate for the proposed research, provide sufficient preliminary data to support the feasibility of work proposed. An application proposing a clinical trial must include sufficient preliminary data to justify the conduct of the trial. Any unpublished, preliminary data provided should originate from the laboratory of the PI or a member of the research team.

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

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

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FY26 Melanoma Survivorship Research Award 14

– Specific Aims: State the specific aims of the study. Only present aims that this award would fund.

– Research Strategy and Feasibility: Describe the experimental design, methodology and analyses, including appropriate controls, in sufficient detail for evaluation of their appropriateness and feasibility. Describe how the studies are designed to achieve reproducible and rigorous results that support successful completion of the project aims. Address potential problems and pitfalls and present alternative methods and/or approaches.

▪ Statistical considerations for applications that DO NOT propose a clinical trial: Clearly describe the statistical plan and the rationale for the statistical methodology. Describe an appropriate power analysis, how it supports the sample size and how it adequately represents an assessment of the population or subpopulation proposed. If a power analysis was not used to determine the proposed sample size, justify why a power analysis is not essential to the statistical evaluation. Ensure sufficient information is provided to allow thorough evaluation of all statistical calculations and/or the power of the proposed studies during review of the application. If there are sample size limitations (budget limitations, availability of specimens, etc.) explain how analysis of the proposed sample size(s) will yield meaningful information.

▪ Statistical considerations for applications that DO propose a clinical trial:

Describe the statistical model and data analysis plan with respect to the clinical trial objectives. Include a complete power analysis to demonstrate that the proposed clinical trial’s anticipated sample size is appropriate to meet the objectives of the study. Describe all clinical and statistical justifications and assumptions that support the sample size calculations. Explain any anticipated subgroup analyses and demonstrate that such analyses are appropriately powered. Ensure sufficient information is provided to allow thorough evaluation of all statistical calculations during review of the application.

▪ A separate Sex as a Biological Variable (SABV) Strategy is required for all applications as part of Attachment 2.

▪ If cell lines are to be used, justify why the proposed cell line(s) were chosen and clearly articulate the source(s) of the proposed cell line(s).

▪ If animal studies are proposed, including the use of patient-derived xenografts (PDXs) models, justify why the proposed animal model was chosen and clearly articulate the source of the model(s). Describe how the animal studies are conducted in accordance with the appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported.

▪ If human data sets, human anatomical substances (blood, tumor tissue, etc.), and/or human participants will be used, provide evidence supporting the availability of and access to the proposed specimens/populations required for the study. Include a detailed plan for the acquisition of samples or the recruitment of participants, and for acquiring any additional research resources necessary for conducting the proposed research project. For applications proposing a clinical trial, provide this information within Attachment 8: Clinical Trial Strategy Statement rather than the Project Narrative.

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For projects that propose using human data sets and/or specimens from biobank(s), biorepository(s) and/or ongoing or completed clinical trial(s), and if the manager or lead investigator is not the named PI or key personnel on the application, applicants should provide a letter(s) of collaboration within Attachment 2 from the manager or lead investigator for the source that details the applicant’s access to the data sets/specimens and confirms the manager/lead investigator’s commitment to provide the data sets/specimens.

▪ For applications that propose clinical research and/or a clinical trial, 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 specimens/participants. 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. See Attachment 2 for instructions regarding the Inclusion Enrollment Report that is required with all applications that propose clinical research/and or a clinical trial.

▪ For applications that propose using funds from this award for prospective human participant enrollment provide a mitigation plan for the estimated attrition of subjects. For applications proposing a clinical trial, this information should be provided within Attachment 8: Clinical Trial Strategy Statement rather than the Project Narrative.

▪ If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the General Application Instructions, Appendix 4, for additional considerations.

– Clinical Trial Information (if applicable): For applications that propose using funds from this award to conduct a clinical trial provide the following information within the Project Narrative:

▪ Identify the intervention. Briefly outline the primary – and secondary, if applicable

– endpoints of the trial and any relevant biomarkers. A thorough description of the endpoints will be requested in Attachment 8: Clinical Trial Strategy Statement.

▪ Describe the type of study to be performed (e.g., treatment, prevention, diagnostic), the study phase or class (if applicable), and the study model (e.g., single group, parallel, crossover). Explain how the chosen trial design is best suited to answer the proposed research question.

NOTE: Details regarding the Clinical Trial Strategy must be described in Attachment 8. Do not duplicate information from the Clinical Trial Strategy in the Project Narrative. The Project Narrative is not the formal clinical trial protocol. If recommended for funding, the clinical trial protocol will be requested during award negotiations.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:~:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Use_Of_DOW_Dept_Veterans_Affairs_Resource:~:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES

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○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

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

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

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

Letters of Support (two-page limit per letter is recommended): 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 meets 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.

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. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:~:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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

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FY26 Melanoma Survivorship Research Award 17 will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

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

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

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

○ 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 rationale behind the proposed research project.

Hypothesis/Objective(s): State the hypothesis to be tested or objective(s) to be reached.

Specific Aims: State the specific aims of the study.

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

Impact: Summarize how the outcomes of the proposed research will improve the health and well-being of melanoma survivors, their families…