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 Focused Program Award – Rare Melanomas

Funding Opportunity Number: HT942526MRPFPARM

Pre-Application Due: July 13, 2026

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

FY26 Melanoma Focused Program Award – Rare Melanomas 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 Focused Program Award – Rare Melanomas; 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 Focused Program Award – Rare Melanomas 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/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E: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 Focused Program Award – Rare Melanomas 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Melanoma Research Program (MRP) Focused Program Award – Rare Melanomas, supports a multidisciplinary research program of at least two, but not more than three, distinct but complementary research projects addressing an overarching question relevant to rare melanomas.

Distinctive Features:

• *Updated for FY26* Investigators must include at least one rare melanoma survivor or patient advocate as part of the project team who will provide advice and consultation throughout planning, implementation, and results dissemination to maximize research impact.

• This is a partnering mechanism, requiring an Initiating Principal Investigator (PI) and at least one, but not more than two, Partnering PIs, see Figure 1.

○ Each named PI is expected to be a Project Leader for one of the proposed research projects. If recommended for funding, each PI will be named on separate awards to the recipient organization(s).

• After submitting the required pre-application, investigators must receive an invitation to submit a full application.

○ Only the Initiating PI will submit a pre-application. All PIs must submit full applications.

The Partnering PI(s)’s application is an abbreviated package specific to their proposed research project.

• Clinical trials are allowed.

Funding Details: The Congressionally Directed Medical Research Programs expects to allot roughly $5.6M to fund approximately two Focused Program Award – Rare Melanomas applications with total cost caps of $2.8M per award. The maximum period of performance is 4 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 (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), July 13, 2026

• Invitation to Submit an Application: August 19, 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: HT942526MRPFPARM Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Melanoma Focused Program Award – Rare Melanomas 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 Initiating PI must be an independent investigator at or above the level of Associate Professor (or equivalent).

The Initiating PI must devote a minimum of 10% effort to this award.

The Partnering PI(s) for the complementary and synergistic research project(s) must be an independent investigator at or above the level of Assistant Professor (or equivalent).

The investigators do not have to be at academic organizations.

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:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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:%7E:text=APPENDIX%201-,RECIPIENT%20QUALIFICATION%20AND%20RESTRICTION%20INFORMATION,-A.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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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: The widely accepted definition of cancer, and therefore melanoma, 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. For the purposes of the MRP, 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.” 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. Melanoma survivorship research covers a broad range of research areas that have the goal of improving the health and well-being of melanoma survivors and their families/care partners. 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

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Melanoma Focused Program Award – Rare Melanomas 7 outcomes, and support for psychological and social issues related to melanoma diagnosis, treatment and life post-treatment.

3.1. Award History

The Focused Program Award – Rare Melanomas (FPA-RM) mechanism was first offered in FY22. Since then, 52 FPA-RM applications were received and nine were recommended for funding.

3.2. Intent of the Focused Program Award – Rare Melanomas

The FY26 MRP FPA-RM supports a multidisciplinary research program of at least two, but not more than three, distinct but complementary projects addressing an overarching question relevant to rare melanomas (see Figure 1). Applications for the FPA-RM may propose projects across the entire research spectrum (biology, etiology, prevention, diagnosis and detection, prognosis, treatment and quality of life) and must address a critical unmet need relevant to rare melanomas. Although the FY26 MRP accepts applications addressing topics relevant to uveal melanoma, the MRP is particularly interested in receiving applications that address other uncommon presentations of melanoma, including but not limited to:

• Genetic (molecular subtypes).

• Histologic (desmoplastic and acral lentiginous).

• Tissue of origin (mucosal, acral).

• Clinical presentation (pediatric, leptomeningeal disease).

The FPA-RM requires more than one PI. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission.

The other PI(s) will be identified as a Partnering PI and will be the PI (i.e., Project Leader[s]) responsible for the other proposed research project(s). All PIs should contribute significantly to the development and execution of the proposed program. 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. Instructions regarding the unique full application components for the Initiating and Partnering PIs are located in Section 4.3. For individual submission requirements for the Initiating and Partnering PI(s), refer to Section 5.3, Submission Instructions.

3.2.1. Key Elements for the FPA-RM

Overarching Question: FPA-RM applications must describe a unifying, overarching question investigated by a set of research projects to address a critical unmet need relevant to rare melanoma research and/or patient care. The question may focus on one specific rare melanoma/uncommon feature, or the question may address a critical unmet need that is relevant to multiple rare melanomas/uncommon features.

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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Figure 1. For the FY26 FPA-RM, a research team, led by an Initiating PI and one or two Partnering PIs, (i.e., Project Leaders), will engage in at least two, but not more than three, distinct but complementary projects to answer an overarching question relevant to rare melanomas. The research team must include at least one rare melanoma consumer collaborator (e.g., patients, survivors, care partners who have lived rare melanoma experience) to maximize the impact and translatability of the research for the intended community(ies).

Research Team: The overall effort will be led by an Initiating PI with demonstrated success in leading large, focused projects. The Initiating PI is required to devote a minimum of 10% effort to this award and is expected to be the lead for one of the proposed research projects. The Initiating PI should create an environment that fosters and supports collaboration and innovation in a way that engages all members of the team, which includes the Partnering PI(s). The Initiating PI should assemble a highly qualified and multidisciplinary research team. The resources and expertise brought to the team by each PI should combine to create a robust collaboration. The Initiating PI and the Partnering PI(s) do not have to be at the same organization.

Research Projects: Applications should include multiple, distinct research projects that are each led by an individual PI and address complementary aspects of the overarching question.

Individual research projects may range from exploratory, hypothesis-developing studies through clinical trials. While individual projects should be capable of standing on their own high scientific merits, they should synergistically advance a solution beyond what would be possible through individual efforts. Each project, including hypothesis-developing studies, should propose a unique approach to addressing the overarching question capable of producing research findings with potential to advance the rare melanoma field and/or patient care. There should be a clear intent to progress toward translational/clinical work over the course of the effort. This award mechanism is not intended to support a series of research projects where the completion of one project is dependent on the success/completion of the other proposed project(s).

All research projects must be based on a strong scientific rationale and preliminary data, as appropriate, that supports the feasibility of the proposed approach(es). Clinical trials are allowed; a research project proposing a clinical trial must include preliminary data.

Initiating PI, Project #1

First Partnering

PI,

Project #2

Second Partnering PI, Project #3 (optional)

Rare Melanoma Consumer

Collaborator(s)

Overarching Question

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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Implementation Plan: An implementation plan that identifies critical milestones and outlines the knowledge, resources and/or technical innovations utilized to achieve the milestones should support the research strategy to address the overarching question. The implementation plan should include a plan for assessing individual project performance and progress toward addressing the overarching question. For multi-institutional collaborations, the application should discuss plans for communication and data transfer among the collaborating institutions, as well as plans to handle data, specimens and/or products obtained during the study.

Participating organizations should formalize an intellectual and material property plan.

Rare Melanoma Consumer Collaboration: For the purposes of the FPA-RM, a “rare melanoma consumer” is a rare melanoma survivor (active or post-treatment), family member or care partner who can provide lived experience expertise to the research project. Applicants to the FPA-RM must collaborate with the rare melanoma consumer community to maximize the impact and translatability of the research for the benefit of the intended community(ies).

Collaborative research approaches create partnerships between scientific researchers and rare melanoma consumers to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and rare melanoma consumers collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research/intervention design, implementation, evaluation and results dissemination.

Collaborative research approaches feature shared responsibility and ownership for the research projects to ensure non-tokenistic involvement of the rare melanoma consumers 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 rare melanoma consumer community may be established through integrating rare melanoma consumers into research teams as co-researchers, advisors and/or consultants; rare 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 rare melanoma consumer who will provide advice and consultation throughout the planning, implementation, and results dissemination of the research project.

The consumer(s) should speak to the needs of the rare melanoma consumer community, not just 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 rare melanoma consumer community.

• Assemble a rare melanoma consumer community advisory board. The advisory board may include rare 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 overall program and/or individual research projects.

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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• Patricial 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.

Milestone Meeting: The PIs are required to present an update on progress toward accomplishing the goals of the award at a Milestone Meeting held virtually after the conclusion of Year 2 of the period of performance. The intent of the Milestone Meeting is to assess research progress, address problems and define future directions. Research milestones to be accomplished by the end of Year 2 must be clearly defined in the Statement of Work (SOW) and will be finalized during award negotiations. Up to two additional members of the research team may be invited to the meeting; the rare melanoma consumer collaborator(s) should also attend the Milestone Meeting. Members of the MRP Programmatic Panel, CDMRP staff, the DHACA Grants Officer and other DOW stakeholders will attend the Milestone Meeting. Continued funding may be contingent upon the successful completion of specific research milestones and goals.

3.2.2. Other Important Considerations for the FPA-RM

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 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, provide appropriate letters of support, 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.

https://doi.org/10.2217/fon-2020-1198 https://pubmed.ncbi.nlm.nih.gov/34213358/ https://pubmed.ncbi.nlm.nih.gov/34213356/ 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:%7E:text=APPENDIX%204.%0AUSE%20OF%20DOW%20OR%20U.S.%20DEPARTMENT%20OF%20VETERANS%20AFFAIRS%20RESOURCES

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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.

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 4 years.

Cost Cap: The combined total costs budgeted for the entire period of performance in the applications of the Initiating PI and each Partnering PI should not exceed $2,800,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#DOW_AND_VA_WEBSITES:%7E:text=APPENDIX%2010.%0ADOW%20AND%20VA%20WEBSITES https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E: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 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E: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:%7E: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:%7E:text=in%20project%20activities.-,Cost%20Cap%3A,-The%20maximum%20cost https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#:%7E:text=and%20system%20accounts.-,Total%20Cost%3A,-The%20total%20costs

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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 4 years.

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

A separate award will be made to each PI’s organization.

The PIs are expected to be partners in the research, and direct cost funding should be divided accordingly unless otherwise warranted and clearly justified.

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 up to three research team members to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 MRP FPA-RM.

• Costs associated with rare 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.

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

Upload documents as individual PDF files unless otherwise noted. Files must comply with the formatting guidelines listed in the GAI.

• Preproposal Narrative (two-page limit): The Preproposal Narrative page limit applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs that provide additional information to expand the Preproposal Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the pre-application.

The Preproposal Narrative should provide the information outlined below.

NOTE: Recommended character limits do not supersede the maximum two-page limit for the preproposal narrative.

○ Overarching Question (Recommended 2,000-character limit):

– Describe the overarching question and justify how it addresses a critical unmet need relevant to rare melanoma research and/or patient care.

○ Proposed Research Projects (Recommended 1,600-character limit per research project):

– Provide the titles for at least two, but no more than three, independent research projects. Identify the PI (i.e., Project Leader) for each proposed research project.

– State the hypothesis to be evaluated/objective to be obtained for each research project and describe the specific aims that will be completed in support of the hypothesis/objective.

– Summarize how the proposed research projects will address the overarching question in unique but complementary ways. Explain how the completion of any one proposed research project will not depend on the completion of any other proposed research project(s).

– Describe the anticipated research outcomes or products that the research team expects to result from each proposed research project. Explain how the anticipated outcomes will advance rare melanoma research and/or improve patient care.

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#Appendix2:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E: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:%7E: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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○ Research Team (Recommended 2,000-character limit):

– Summarize how the resources and expertise brought to the team by each PI will combine to create a robust collaboration.

○ Rare Melanoma Consumer Collaboration (Recommended 500-character limit)

– Describe plans for incorporating rare melanoma consumer collaboration into the planning, execution and results dissemination of the proposed research. Identify the individual(s) and/or organization(s) of the proposed collaborator(s).

○ A figure may be included within the two-page limit illustrating the organization of the overall program but it is not required.

• Pre-Application Supporting Documentation: The items to be included as supporting documentation for the pre-application must be uploaded as individual files and are limited to the following:

○ References Cited (one-page limit): List the references cited (including URLs if available) in the Preproposal Narrative using a standard reference format that includes the full citation (i.e., author[s], year published, reference title and reference source, including volume, chapter, page numbers and publisher, as appropriate).

○ List of Abbreviations, Acronyms, and Symbols: Provide a list of abbreviations, acronyms and symbols used in the Preproposal Narrative.

○ Initiating and Partnering PI(s) Biographical Sketches: All PI biographical sketches should be combined and uploaded as a single combined file.

Biographical sketches should be used to demonstrate background and expertise through education, positions, publications and previous work accomplished. Biographical sketches for any other key personnel should not be provided with the pre-application.

4.3. Full Application Components

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

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

4.3.1. Full Application Components for the Initiating PI

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

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

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

(b) Attachments:

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

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E: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#_Content_Form_Full_App_Submission:%7E:text=eBRAP%20User%20Name-,Biographical%20Sketch,-%3A%20This%20file

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○ Attachment 1: Project Narrative (25-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Overall Program: Provide a brief summary of the comprehensive effort. Applicants should propose at least two, but no more than three research projects that address a critical unmet need relevant to rare melanoma research and/or patient care. Summarize the areas of synergy across the proposed research projects. A detailed description of the Overarching Question and each investigator’s roles and responsibilities will be included in Attachment 6: Overarching Question Statement.

Research Plan: Provide the following details for each proposed research project, organizing each project clearly and separately. Start each research project on a new page.

– Title: Provide a title for each research project. The titles of the research projects should remain unchanged from the pre-application to the full application.

– Project Leader: Identify the PI who will serve as Project Leader and any key personnel, as appropriate.

– Background: Present the scientific rationale to support the proposed research 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. As appropriate for the proposed research project, provide sufficient preliminary data to support the feasibility of work proposed. A research project 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 one of the PIs or another member of the FPA-RM research team.

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

– Specific Aims: State the specific aims of the research project. Only present tasks 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 problem areas and pitfalls, and present alternative methods and/or approaches.

Statistical considerations for research projects that DO NOT propose a clinical trial: If applicable, 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.) justify how analysis of the proposed sample size(s) will yield meaningful information.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative

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Statistical considerations for research projects 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 each proposed research project as part of Attachment 2.

Provide evidence that the research team will have access to, or be able to obtain during the period of performance, sufficient numbers of data sets, specimens, potential participants, etc. to derive meaningful conclusions from the proposed studies.

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 PDX 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 research projects proposing a clinical trial, provide this information within Attachment 10: Clinical Trial Strategy Statement rather than the Project Narrative.

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 one of the named PIs or key personnel on the application, applicants should provide 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 research projects 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.

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For research projects that propose using funds from this award for clinical research that involves prospective human participant enrollment, provide a mitigation plan for the estimated attrition of participants. For research projects proposing a clinical trial, this information should be provided within Attachment 10: 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 research projects 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 10.

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 10: Clinical Trial Strategy Statement.