HT942525PRCRPIA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD25_01.

Program Announcement for the Department of Defense Defense Health Program

Peer Reviewed Cancer Research Program Idea Award

Funding Opportunity Number: HT942525PRCRPIA

Pre-Application Due: June 20, 2025

Application Due: September 25, 2025 https://ebrap.org/eBRAP/public/gai.htm?version=CD25_01

DOD FY25 Peer Reviewed Cancer Idea Award 2

Content

Before You Begin 3

Basic Information Contains a summary of the funding opportunity, funding details, and submission/review dates

Eligibility Details the factors that determine applicant organization and Principal Investigator eligibility

Program Description Describes the program mission and intent of the Idea Award, provides key award information and considerations, and outlines funding restrictions

Application Contents Introduces the two-step application process and provides 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 associated with application compliance review, pre-application and full application selection/notification, and risk assessment. Also details the complete review criteria for pre-application screening and both tiers of the CDMRP’s application review process, Peer Review and Programmatic Review

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

Post-Award Requirements References policy requirements for funded research, outlines reporting requirements, and restrictions related to Principal Investigator changes or 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

Appendix 3 DOD and VA Websites

DOD FY25 Peer Reviewed Cancer Idea 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 the 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 the funding opportunity and that all parties meet eligibility requirements.

Who to Contact for Support

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

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 Contact Center

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

Questions regarding Grants.gov registration and Workspace.

mailto:help@eBRAP.org mailto:support@grants.gov

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

DOD FY25 Peer Reviewed Cancer Idea Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2025 (FY25) Peer Reviewed Cancer Research Program (PRCRP) Idea Award (IA) supports innovative, untested, high-risk/potentially high-reward concepts, theories, paradigms, and/or basic cancer research. The advancement of knowledge in cancer research, patient care, and/or treatment options in the Military Health System (MHS) is critical to active-duty Service Members, Veterans, other military beneficiaries, and the American public.

Distinctive Features:

• The proposed project should demonstrate creative thinking and innovation.

• Incremental advances, the next logical step, or switching a model system from one cancer to another cancer are not appropriate for this award.

• Inclusion of preliminary data is not required; however, the project must be based on strong scientific rationale.

Funding Details: (New for FY25) Funding limits are now listed as total cost limits, which is the combination of both direct and indirect costs.

The Congressionally Directed Medical Research Programs (CDMRP) expects to allot approximately $14 million (M) to fund approximately 25 Idea Award applications with total cost caps of $560,000. The maximum period of performance is 2 years. It is anticipated that awards made from this FY25 funding opportunity will be funded with FY25 funds, which will expire for use on September 30, 2031. Awards supported with FY25 funds will be made no later than September 30, 2026.

Submission and Review Dates and Times

• Pre-Application (Preproposal) Submission Deadline: 5:00 p.m. Eastern Time (ET), June 20, 2025

• Invitation to Submit an Application: July 23, 2025

• Application Submission Deadline: 11:59 p.m. ET, September 25, 2025

• End of Application Verification Period: 5:00 p.m. ET, September 30, 2025

• Peer Review: November 2025

• Programmatic Review: February 2026 Announcement Type: Initial Funding Opportunity Number: HT942525PRCRPIA 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

DOD FY25 Peer Reviewed Cancer Idea Award 5

2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

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

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

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

2.1.2. Principal Investigator

To be named as the Principal Investigator (PI) on application, the PI must have a faculty-level appointment or equivalent. Industry titles may not be analogous to the faculty hierarchy in academia. For industry, investigators at or above an independent scientist level may be named by the company as the PI on the application.

Individuals affiliated with an eligible organization are eligible to be named as PI 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 General Application Instructions, Appendix 1, for additional recipient qualification requirements.

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

DOD FY25 Peer Reviewed Cancer Idea Award 6

3. Program Description

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC) is the program office managing this FY25 funding opportunity as part of the PRCRP. Congress initiated the PRCRP in 2009 to provide support for research of high potential impact and exceptional scientific merit. Appropriations for the PRCRP from FY09 through FY24 totaled $1.04 billion. The FY25 appropriation is $130M.

Congressional language stipulates the FY25 PRCRP must be relevant to Service Members, and address at least one of the congressionally directed FY25 PRCRP topic areas listed below.

• Bladder cancer

• Blood cancers

• Brain cancer

• Colorectal cancer

• Endometrial cancer

• Esophageal cancer

• Germ cell cancers

• Kidney cancer

• Liver cancer

• Lung cancer

• Lymphoma

• Mesothelioma

• Metastatic cancers

• Myeloma

• Neuroblastoma

• Neuroendocrine tumors

• Pancreatic cancer

• Pediatric, adolescent, and young adult cancers1

• Pediatric brain tumors

• Sarcoma

• Stomach cancer

• Thyroid cancer

Research proposed to the PRCRP must not address research in melanoma, or cancers originating in the breast, prostate, or ovary. In addition, FY25 PRCRP funds must not be used to study rare cancers except FY25 PRCRP topic area cancer types that are rare by definition.

FY25 PRCRP Portfolios and Strategic Goals

To meet the intent of the funding opportunity, all applications for FY25 PRCRP funding must specifically address one of the FY25 PRCRP topic areas as directed by the U.S. Congress and have direct relevance to military health. Additionally, the PRCRP implements a portfolio-driven approach by grouping related topic areas with strategic goals as a framework within which to address critical gaps in cancer research and patient care. All applications must address one of the FY25 PRCRP strategic goals as it relates to the portfolio-assigned FY25 PRCRP topic area. Topic areas may be included in more than one portfolio, but the application must be aligned to the strategic goals of the portfolio in which a topic area is included. If the proposed research does not specifically address one FY25 PRCRP topic area and one FY25 PRCRP strategic goal from a single portfolio, then the government reserves the right to administratively withdraw the application. The government reserves the right to reassign

1 The definition of adolescents and young adults is derived from the National Cancer Institute (https://www.cancer.gov/types/aya). Research should be targeted toward pediatric (ages 0-14 years), adolescents (ages 15-24 years), and/or young adults (ages 25-39 years).

https://www.cancer.gov/types/aya

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

DOD FY25 Peer Reviewed Cancer Idea Award 7 the application’s topic area if submitted to an incorrect topic area. The table below lists the FY25 PRCRP topic areas and strategic goals in each PRCRP portfolio category.

Portfolio: Blood Cancers All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Blood, Lymphoma, Myeloma Strategic Goals:

Prevention and Etiology

• Improve risk assessment of precancerous conditions

• Develop early intervention strategies to prevent initiation and/or progression

• Investigate autoimmune disorders as risk factors for lymphoma to inform surveillance strategies

• Understand the role of cancer stem cells and the tumor microenvironment in the development of blood cancers

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation, and/or therapeutic stratification

• Develop more cost-effective molecular diagnostics

• Identify biomarkers to predict progression from indolent disease

• Identify unique prognostic factors in pediatric, adolescent, and young adult malignancies

Treatment • Develop new, less toxic therapies

• Develop methods to predict therapeutic vulnerabilities

• Develop therapies that don’t require hospitalization

• Develop therapies employing gene editing technologies and cell therapies

• Identify contribution of immune niche to initial treatment response and relapse

• Develop therapeutic options for patients who fail last line therapies

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Identify long-term effects of gene editing and cell therapies and develop risk-based standards for surveillance of treated patients

• Improve understanding of the effects of long-term immunosuppression

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

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

DOD FY25 Peer Reviewed Cancer Idea Award 8

Portfolio: Gastroenterological Cancers All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Colorectal, Esophageal, Liver, Stomach, Pancreatic cancer Strategic Goals Prevention and Etiology

• Identify modifiable and non-modifiable risk factors to inform prevention strategies

• Identify factors driving the increasing rates of early-age onset disease

• Identify environmental and genetic factors associated with an increased cancer risk

• Identify key drivers of conversion from precancerous lesions into cancer

• Explore the interplay between the microbiome and infectious agents in cancer initiation and progression

• Conduct integrative studies that analyze stool, blood, and the microbiome as they impact disease onset and patient outcomes

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation, and/or therapeutic stratification

• Develop cost-effective and minimally invasive tools for early detection

• Develop preclinical models to study disease development

Treatment • Develop new, less toxic therapies

• Develop effective treatments for advanced disease

• Develop immunotherapies and novel targeting therapies

• Identify combination therapies to improve patient outcomes

• Identify predictive biomarkers to determine treatment response

• Develop integrated treatment plans to address short and long-term impacts of cancer

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Improve post treatment surveillance guidelines

• Develop validated tools to measure patient quality of life

Epidemiology • Design population-based studies to identify and characterize risk factors related to malignancy

• Implement systems to analyze disease patterns and track patient outcomes to inform best practices

• Examine the influence of familial genetics and geographic location on disease onset and treatment outcome

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

DOD FY25 Peer Reviewed Cancer Idea Award 9

Portfolio: Neurological Cancers All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Brain cancer, Pediatric Brain Tumors Strategic Goals:

Prevention and Etiology

• Identify biological and environmental exposures, including maternal exposures during pregnancy, that increase risk

Diagnosis and Prognosis

• Develop early detection methods that avoid diagnostic uncertainties

• Develop effective monitoring for recurrence/refractory disease

• Develop less invasive diagnostic procedures

Treatment • Develop new, less toxic therapies

• Prevent or overcome treatment resistance

• Develop personalized oncological care and synergistic multi-modal therapies

• Identify protective therapies to be used in conjunction with toxic therapies to reduce treatment-related damage

• Develop less invasive treatment options

• Develop therapies that cross the blood-brain-barrier

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Develop effective screening, monitoring, and provision of psychosocial support/care for the patient and family

• Develop care for patients as they transition from pediatric to adult survivors

Epidemiology • Analyze and assess the incidence/prevalence of brain tumors over time to identify changes in trends

Technology Development

• Advance the development or adoption of technologies in areas including artificial intelligence and machine learning, human microbiota, genomics, nanoparticles, and robotics

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

DOD FY25 Peer Reviewed Cancer Idea Award 10

Portfolio: Pediatric Adolescent and Young Adult Cancers (PAYAC) All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: PAYAC, Germ cell cancers, Neuroblastoma, Sarcoma, Thyroid cancer Strategic Goals:

Prevention and Etiology

• Determine the molecular basis of cancer predisposition syndromes

• Determine the extent to which development of disease is attributable to genetic versus environmental differences

• Increase understanding of epigenetic influences on cancer development and progression

• Identify biological and environmental exposures, including maternal exposures during pregnancy, that increase risk

• Investigate the role of microbiome composition in cancer risk and outcomes

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation, and/or therapeutic stratification

• Develop noninvasive techniques for monitoring progression and recurrence

• Identify biomarkers present in early-stage disease

• Develop preclinical models that accurately mimic disease

• Improve accurate and rapid diagnosis of sub-types of disease

Treatment • Develop new, less toxic therapies

• Develop treatments for relapse/recurrence, metastatic and advanced disease

• Increase the number of clinical trials, including ones that may not be curative but may improve the quality of life for terminal patients

• Generate evidence-based treatment and surveillance strategies to preserve fertility

• Reduce secondary cancers arising from treatment regimen

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

• Develop strategies to improve the full implementation of survivorship guidelines

• Develop survivorship guidelines based on current/modern therapeutic agents

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

DOD FY25 Peer Reviewed Cancer Idea Award 11

Portfolio: Solid Tumors All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Areas: Bladder cancer, Endometrial cancer, Mesothelioma, Sarcoma, Germ cell cancers, Thyroid cancer, Kidney cancer, Lung cancer, Neuroendocrine tumors Strategic Goals:

Prevention and Etiology

• Develop methods that mitigate or identify risk

• Develop prevention strategies

• Explore the mechanistic relationship between novel and known risk factors and oncogenesis

• Identify convergent etiologies underlining the development of malignancies

Diagnosis and Prognosis

• Improve methods for early detection, prognostic evaluation, and/or therapeutic stratification

• Investigate the interactions of pre-existing autoimmune disease and cancer

Treatment • Develop new, less toxic therapies

• Develop feasible precision medicine approaches

• Identify ways to tailor therapeutic strategies to minimize toxicity

Survivorship • Develop strategies to minimize and mitigate treatment toxicities

• Improve quality of life for survivors and/or caregivers

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

DOD FY25 Peer Reviewed Cancer Idea Award 12

Portfolio: Metastatic Disease All applications under this portfolio must address one topic area and one strategic goal listed below.

Topic Area: Metastatic Cancers, limited to PRCRP topic area cancers Strategic Goals:

Prevention and Etiology

• Identify biomarkers in primary disease that could predict metastatic potential

• Prevent immune evasion by circulating tumor cells

• Identify how dormant, disseminated tumor cells (DTCs) persist

• Identify drivers that initiate DTCs progression to metastatic colonies

• Prevent metastatic colonization by maintaining dormancy of DTCs

• Investigate clonal divergence of primary tumor cells between metastatic sites to immunological disease

Diagnosis and Prognosis

• Improve early detection of metastasis and dormant residual disease

• Develop biomarkers that predict and monitor treatment efficacy

Treatment • Develop new, less toxic therapies

• Revert metastatic cells to a dormant state

• Identify strategies to prevent or overcome treatment resistance

• Investigate abscopal effects of primary disease treatment

• Determine optimal sequencing of treatments

• Eliminate chemotherapy-induced metastasis

Survivorship • Develop strategies to alleviate treatment toxicities

• Improve quality of life for survivors and/or caregivers

Metastatic cancer is cancer that has spread from its original location to another place in the body, representing what are known as stage III and stage IV cancer diagnoses. While recent research has revealed that there is a genetic basis for susceptibility or resistance to metastasis, more research is needed to develop a comprehensive understanding of this complex process.

Applications submitted under any PRCRP topic area, including the Metastatic Cancers topic area, may not address or include research focused on melanoma or cancers that originate in the breast, prostate, or ovaries, or rare cancers (excluding relevant subtypes of the FY25 PRCRP topic areas) as part of the research study; such applications will be administratively withdrawn.

FY25 PRCRP Military Health Focus Areas

It is central to the Vision and Mission of the PRCRP that applications are related to military health and mission readiness, and investigators must demonstrate how the proposed research will decrease the burden of cancer on Service Members, their dependents, Veterans, and other military beneficiaries (i.e., Retirees and their Family members) (https://cdmrp.health.mil/pubs/video/prc/prcrp_vision_video).

https://cdmrp.health.mil/pubs/video/prc/prcrp_vision_video

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

DOD FY25 Peer Reviewed Cancer Idea Award 13

In addition to addressing at least one of the required FY25 PRCRP Topic Areas and FY25 Strategic Goals, applications for the FY25 Idea Award must define how the research is relevant to Service Members and their Families by addressing at least one of the FY25 PRCRP Military Health focus areas listed below.

FY25 PRCRP Military Health focus areas:

• Environmental exposure risk factors associated with cancer o Environmental and/or occupational risk factors should be relevant to activities specific to the military, such as assigned duties or deployments that may lead to exposures to potential carcinogens (ionizing radiation, chemicals, infectious agents, etc.). For more information on military-related exposures and risk factors for cancer, applicants should refer to Exposure-Related Health Concerns at https://www.publichealth.va.gov/exposures/health-concerns.asp or to the PRCRP website (https://cdmrp.health.mil/prcrp/default).

• Mission Readiness and Gaps in Cancer Research o Gaps in cancer prevention, early detection/diagnosis, prognosis, and/or treatment that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries and the general public.

o Gaps in quality of life and/or survivorship that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries, and the general public.

Mission readiness under the FY25 PRCRP Military Health focus areas refers to the impact of cancer on the Service Member. Decreasing the impact of cancer on active-duty Service Members and/or their Families protects the overall military missions. Some examples of relevant research to decrease the impact on mission readiness may include, but are not limited to:

• Studies on the improvement in survival while minimizing effects that would allow an active-duty Service Member to return to full duty;

• Treatments to minimize a cancer patient’s (either a Service Member’s or their Family member’s) time in the hospital, thus maximizing the time the Service Member is on duty;

• Effective ways to minimize cancer relapse for Service Members or their Families; and

• Research into improvements in cancer detection that would lead to earlier diagnosis, thus allowing for improved treatment of the Service Member and early return to duty.

For more information on military health and cancer:

• PRCRP Vision Video (https://cdmrp.health.mil/pubs/video/prc/prcrp_vision_video)

• PRCRP (https://cdmrp.health.mil/prcrp/default)

• MHS (https://www.health.mil)

• U.S. Department of Veterans Affairs (VA) (https://www.va.gov/) Investigators are strongly encouraged to collaborate, integrate, and/or align their research projects with DOD and/or VA research laboratories and programs (Refer to Appendix 3).

https://www.publichealth.va.gov/exposures/health-concerns.asp https://cdmrp.health.mil/prcrp/default https://cdmrp.health.mil/pubs/video/prc/prcrp_vision_video https://cdmrp.health.mil/prcrp/default https://www.health.mil/ https://www.va.gov/

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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3.1. Intent of the Idea Award

The FY25 PRCRP Idea Award supports innovative, untested, high-risk/potentially high-reward concepts, theories, paradigms, and/or basic cancer research.

The intention of the Idea Award is to fund innovative basic research that may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. The Idea Award is not intended to support a logical progression of an already established research project or line of research. Incremental advances, the next logical step, or switching a model system from one cancer to another cancer are not considered innovative. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design and generate robust preliminary data that can be used as a foundation for future research projects.

3.1.1. Key Elements for the IA

• Innovation is a key element of the Idea Award. Research deemed innovative may introduce a new paradigm, challenge current paradigms, look at existing problems from new perspectives or exhibit other uniquely creative qualities. This award is not intended to support advanced research.

• Relevance to Military Health: Relevance to the health care needs of military Service Members, Veterans, and their Families is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:

o Explanation of how the project addresses an aspect of the target disease that has direct relevance to the health of military Service Members, Veterans, and their Families.

o Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need.

o Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate.

o Collaboration with DOD or VA investigators or consultants. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration within the FY25 PRCRP topic areas can be found in Appendix 3.

It is the responsibility of the PI to select the funding opportunity that is most appropriate for the research proposed. Advanced research with robust preliminary data is more appropriate for the FY25 PRCRP Impact Award (HT942525PRCRPIPA).

3.1.2. Other Important Considerations for the IA

Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the 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. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

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

DOD FY25 Peer Reviewed Cancer Idea Award 15

Clinical trials are not allowed.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. An intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

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

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease; (b) diagnostic or detection studies (e.g., biomarker or imaging); (c) health disparity studies; and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

3.2. CDMRP-wide Encouragements

The following encouragements are broadly applicable across many CDMRP programs, including the PRCRP. Investigators are encouraged to consider addressing these areas in their applications if doing so is appropriate for their line of research and meets the intent of this funding opportunity.

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 FY25 PRCRP priorities.

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

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104 https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research

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

DOD FY25 Peer Reviewed Cancer Idea Award 16

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

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 2 years.

New for FY25: Funding limits are now listed as total cost limits, which is the combination of both direct and indirect costs. This is a change from prior years which listed funding limits for direct costs only.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $560,000. 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.

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

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 2 years.

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

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

May be requested for (not all-inclusive):

• 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 FY25 PRCRP Idea Award.

Must not be requested for:

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

• Clinical trial costs.

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

DOD FY25 Peer Reviewed Cancer Idea Award 17

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 DOD 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. Step 1: Pre-Application Components

Pre-application submissions must include the following components.

When starting the pre-application, applicants will be asked to select the following:

• Select the FY25 PRCRP portfolio addressed by the proposed research.

• Select the primary FY25 PRCRP topic area addressed by the proposed research.

• Select the FY25 portfolio classification and strategic goal to be studied.

• When applicable, a secondary FY25 PRCRP topic area should be selected. The secondary topic area may be any topic regardless of selected portfolio. Examples include, (not all-inclusive):

o Applications addressing more than one cancer type should select the two most applicable.

o Applications addressing a topic area that is the subtype of another topic area (e.g.

Lymphoma and Blood Cancers) should select both.

o Applications addressing a cancer type in PAYAC populations, should select both the cancer type and the PAYAC topic area.

o Applications addressing metastatic disease in a cancer type should select both the metastatic disease and cancer type category.

• Select the FY25 PRCRP Military Health Focus Area to be studied.

Note: Upload documents as individual PDF files unless otherwise noted.

• Preproposal Narrative (one-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 (uniform resource locators) 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 include the following:

o Background: State the FY25 PRCRP Topic Area(s) and FY25 PRCRP Strategic Goal to be studied.

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

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

DOD FY25 Peer Reviewed Cancer Idea Award 18 o Research Idea: Describe the rationale and hypothesis and how these support the study’s objectives and specific aims. Describe how the methodology and experimental design support the project’s goals.

o Innovation: Explain how the project is innovative (i.e., how it may lead to a new paradigm, challenge current paradigms, interrogates existing problems from new perspectives or exhibit other uniquely creative qualities).

o Impact: Describe how the research will lead to a breakthrough or make an impact in the FY25 PRCRP Topic Area to be addressed.

o Relevance to Military Health: Explain how the proposed research will lead to promising outcomes for one or more of the selected FY25 PRCRP Military Health Focus Area(s).

• 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:

o 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).

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

o Key Personnel Biographical Sketches: All biographical sketches should be uploaded as a single combined file. Biographical sketches should be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished.

4.3. Step 2: Full Application Components

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

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): Refer to the General Application Instructions, Section IV.B.(a), for detailed information.

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 listed in the General Application Instructions, Appendix 2.

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

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

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

DOD FY25 Peer Reviewed Cancer Idea Award 19

Describe the proposed project in detail using the outline below.

– Background: Describe how the proposed project addresses an FY25 PRCRP topic area and corresponding FY25 PRCRP strategic goal. Briefly state how the project addresses an FY25 PRCRP Military Health focus area(s). Additional Detail about the Military Health focus area must be described in Attachment 6.

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

– Rationale: State concisely the rationale for the proposed research. Preliminary data is not required.

– Specific Aims: State the specific aims of the study.

– Relevance to the Idea Award Intent: Describe how the research that may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives or exhibit other highly creative that may result in a new research avenue in the laboratory. Additional details on Innovation must be provided in Attachment 7.

– Research Strategy:

Describe the proposed study in sufficient detail to evaluate its appropriateness and feasibility to test the hypothesis and reach the final objective.

Articulate how the proposed research will have the potential to generate robust preliminary data that can be used as a foundation for future research projects.

Preliminary data is discouraged.

Describe all animal studies and how the studies are designed to achieve the objectives, including the choice of model and endpoints/outcome measures to be used, if applicable. Additional detail on animal studies must be described in Attachment 9.

Describe any human use. Demonstrate the availability of tissue, data, or human subjects for the collection of samples, if applicable. If human subjects or human anatomical samples will be used, include a plan for the recruitment of subjects or the acquisition of samples and document the experience of the PI(s) and/or key collaborators in recruiting human subjects for similar projects. This award may not be used to conduct clinical trials.

Describe potential problems and potential pitfalls and address alternative approaches.

Statistical Plan and Data Analysis must be submitted in Attachment 10.

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

There are no page limits for any of these components unless otherwise noted.

Include only those components described below; inclusion of items not requested or viewed as an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

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

DOD FY25 Peer Reviewed Cancer Idea Award 20

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

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

Facilities, Existing Equipment, and Other Resources: Describe the facilities and equipment available for performance of the proposed project and any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference should be made to the original or present government award under which the facilities or equipment items are now accountable. There is no form for this information.

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

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

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

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

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

Data and Research Resources 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 how data and resources generated during the period of performance will be shared with the https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sex%20as%20a%20Biological%20Variable%20in%20Research https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sex%20as%20a%20Biological%20Variable%20in%20Research https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Public%20Health%20Service%20Inclusion%20Enrollment%20Report

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

DOD FY25 Peer Reviewed Cancer Idea Award 21 research community and other affected communities. Include the name of the repository(ies) where scientific data and resources arising from the proposed clinical trial will be archived, if applicable. If a public repository will not be used for data or resource sharing, provide justification. Provide a milestone plan for data/results dissemination including when data and resources will be made available to other users, including dissemination activities with a particular focus on feeding back the data to affected communities and/or research participants. Refer to CDMRP’s Policy on Data & Resources Sharing for more information about CDMRP’s expectations for making data and research resources publicly available.

Use of DOD Resources or VA Resources (if applicable): If the proposed research involves access to military and/or VA patient populations and/or DOD 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.