HT924524RCRPIDA_GG.pdf

This program announcement must be read in conjunction with the General Application

Instructions, version 901. The General Application Instructions document is available for downloading from the Grants.gov funding opportunity announcement by selecting the

“Package” tab, clicking “Preview,” and then selecting “Download Instructions.”

DOD FY24 Rare Cancers Idea Development Award 1

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Program Announcement for the Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Rare Cancers Research Program

Idea Development Award

Announcement Type: Initial

Funding Opportunity Number: HT942524RCRPIDA

Assistance Listing Number: 12.420 Military Medical

Research and Development

SUBMISSION AND REVIEW DATES AND TIMES

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

17, 2024

• Invitation to Submit an Application: July 26, 2024

• Application Submission Deadline: 11:59 p.m. ET, September 23, 2024

• End of Application Verification Period: 5:00 p.m. ET, September 26, 2024

• Peer Review: November/December 2024

• Programmatic Review: February 2025

DOD FY24 Rare Cancers Idea Development Award 2

TABLE OF CONTENTS

I. OVERVIEW OF THE FUNDING OPPORTUNITY

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Description

II.A.1. FY24 RCRP Focus Areas

II.A.2. Award History

II.B. Award Information

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.2. Cost Sharing

II.C.3. Other

II.D. Application and Submission Information

II.D.1. Location of Application Package

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

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

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

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

II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM)

II.D.4. Submission Dates and Times

II.D.5. Funding Restrictions

II.D.6. Other Submission Requirements

II.E. Application Review Information

II.E.1. Criteria

II.E.2. Application Review and Selection Process

II.E.3. Integrity and Performance Information

II.F. Federal Award Administration Information

II.F.1. Federal Award Notices

II.F.2. PI Changes and Award Transfers

II.F.3. Administrative and National Policy Requirements

II.F.4. Reporting

II.G. Federal Awarding Agency Contacts

II.G.1. eBRAP Help Desk

II.G.2. Grants.gov Contact Center

II.H. Other Information

II.H.1. Program Announcement and General Application Instructions Versions

II.H.2. Administrative Actions

II.H.3. Full Application Submission Checklist

APPENDIX 1: ACRONYM LIST

DOD FY24 Rare Cancers Idea Development Award 3

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

II.A. Program Description

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the fiscal year 2024 (FY24) Rare Cancers Research Program (RCRP) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The Congressionally

Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and

Development Command (USAMRDC) is the program management agent for this funding opportunity. Congress initiated the RCRP in 2020 to provide support for research of exceptional scientific merit in the area of rare cancers research. Appropriations for the RCRP from FY20 through FY23 totaled $60 million (M). The FY24 appropriation is $17.5M.

In FY20, the Defense Appropriations Act provided $7.5M to the Department of Defense (DOD) to support rare cancers research. The rare cancers research Topic Area was first introduced under the Peer Reviewed Cancer Research Program (PRCRP) in FY19. In FY20, the rare cancers Topic Area was excluded under PRCRP by Congress and RCRP was created as an individual program. In addition to the PRCRP, the CDMRP-managed cancer-specific research programs, such as breast, melanoma, glioblastoma and ovarian cancers have also funded rare cancer subtypes based on their site-specific origin classifications.

FY24 RCRP definition of rare cancers: Cancers affecting 6 or fewer persons per 100,000 per year in the United States. Applicants will be required to provide a justification statement explaining the relevance of the investigated cancer types/subtypes that fall under the RCRP’s definition of rare cancers.

The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

II.A.1. FY24 RCRP Focus Areas

To meet the intent of the funding opportunity, applications for the FY24 RCRP Idea

Development Award must address at least one of the three Focus Areas listed below:

• Biology: Identify disease-defining molecular pathways, cell context, and microenvironment.

• Research: Develop and validate rare tumor-specific models that can support clinical trial readiness.

• Therapy: Identify novel therapeutic strategies, including drug repurposing.

II.A.2. Award History

The RCRP Idea Development Award mechanism was first offered in FY20. Since then, 523

Idea Development Award applications have been received, and 59 have been recommended for funding.

DOD FY24 Rare Cancers Idea Development Award 4

II.B. Award Information

The FY24 RCRP Idea Development Award promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation.

This award supports research supported by preliminary data that could lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from rare cancers. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.

Preliminary data with disease-specific rationale (may include correlative studies to ongoing clinical research) to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study.

Key elements of the Idea Development Award are as follows:

• Impact: Research that has high potential impact may lead to major advancements and greatly improve outcomes for people with rare cancers.

• Research Idea: Although the proposed research must have direct relevance to rare cancers, the required preliminary data, which may include unpublished results from the laboratory of the Principal Investigator (PI), research team, or collaborators named on the application, or may be from outside the rare cancers research field. Research should also be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.

The application should clearly and explicitly articulate the project’s potential impact on rare cancers. Applications that demonstrate exceptional scientific merit but lack high potential impact do not meet the intent of the Idea Development Award.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service

Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

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

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

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

CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research

DOD FY24 Rare Cancers Idea Development Award 5 variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.

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. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191

(https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the 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. 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.

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.

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.

https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html

DOD FY24 Rare Cancers Idea Development Award 6

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.

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

USC 6304).

The anticipated direct costs budgeted for the entire period of performance for an FY24 RCRP

Idea Development Award should not exceed $350,000. Refer to Section II.D.5, Funding

Restrictions, for detailed funding information.

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

The CDMRP expects to allot approximately $6.16M to fund approximately 11 Idea

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

II.C. Eligibility Information

II.C.1. Eligible Applicants

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

Extramural Organization: An eligible non- DOD organization. Examples of extramural organizations include academic institutions, biotechnology companies, foundations, federal government organizations other than the DOD (i.e., intragovernmental organizations), and research institutes.

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

Awards are made to eligible organizations, not to individuals. Refer to the General Application

Instructions, Appendix 1, for additional recipient qualification requirements.

II.C.1.b. Principal Investigator

Independent investigators at or above the level of Assistant Professor (or equivalent) are eligible to be named as the PI on an RCRP Idea Development Award.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104

DOD FY24 Rare Cancers Idea Development Award 7

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

II.C.2. Cost Sharing

Cost sharing/matching is not an eligibility requirement.

II.C.3. Other

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

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

II.D. Application and Submission Information

II.D.1. Location of Application Package

Submission is a two-step process requiring both a pre-application submitted via the Electronic

Biomedical Research Application Portal (eBRAP.org) and a full application (eBRAP.org or

Grants.gov). Depending on the type of submission (i.e., extramural vs. intramural), certain aspects of the submission process will differ.

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

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

DOD applicants to submit and verify full applications following their pre-application submission.

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

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

DOD FY24 Rare Cancers Idea Development Award 8

Application Submission Workflow

Extramural Submission: An application submitted by an extramural organization for an extramural or intramural PI working within an extramural or intramural organization. For example, a research foundation submitting an application for a DOD employee working within a

DOD organization would be considered an extramural submission and should follow instructions specific to extramural submissions. Download application package components for

HT942524RCRPIDA from Grants.gov (https://grants.gov). Full applications from extramural organizations must be submitted through Grants.gov.

Intramural Submission: An application submitted by an intramural DOD organization for an investigator employed by that organization. Intramural DOD organizations may submit full applications to either eBRAP or Grants.gov. Download application package components for

HT942524RCRPIDA from the anticipated submission portal eBRAP (https://ebrap.org) or

Grants.gov.

The submission process should be started early to avoid missing deadlines. Regardless of submission type or portal used, all pre- and full application components must be submitted by the deadlines stipulated on the first page of this program announcement. There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The

USAMRAA cannot make allowances/exceptions for submission problems encountered by the applicant organization using system-to-system interfaces with Grants.gov.

https://grants.gov/

DOD FY24 Rare Cancers Idea Development Award 9

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

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

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

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

FY24 RCRP Programmatic Panel members should not be involved in any pre-application or full application. For questions related to panel members and pre-applications or applications, refer to

Section II.H.2.c, Withdrawal, or contact the eBRAP Help Desk at help@eBRAP.org or 301-682-

5507.

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

All pre-application components must be submitted by the PI through eBRAP

(https://eBRAP.org/).

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

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

When starting the pre-application, PIs should ensure that they have selected the appropriate “Cancer Type” category. After selecting one of the offered Cancer Types, a textbox will appear where the applicant should enter a specific name for the cancer that will be studied (60-character limit). PIs should also select “age groups”.

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

Pre-application submissions must include the following components (refer to the General

Application Instructions, Section III.B, for additional information on pre-application submission):

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

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

DOD FY24 Rare Cancers Idea Development Award 10

○ 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 (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:

– Justification: Explain how the study meets rare cancers research and how the cancer type, in the proposed study, falls under the RCRP rare cancers definition.

– Research: Describe the project’s hypothesis, objectives, rationale, and specific aims.

Describe the methodology and experimental design and explain how these will support the hypothesis and/or objectives of the project. Preliminary data with disease-specific rationale (may include correlative studies to ongoing clinical research) to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study.

– Focus Area relevance: Explain how the proposed research will lead to promising outcomes for one or more of the FY24 RCRP Focus Area(s).

– Impact: Describe how the novel idea will have a major impact on the outcomes of people with rare cancers, and the understanding of rare cancers.

○ 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.

– Key Personnel Biographical Sketches (five-page limit per individual): 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.

DOD FY24 Rare Cancers Idea Development Award 11

II.D.2.a.ii. Pre-Application Screening Criteria

To determine the technical merits of the pre-application and the relevance to the mission of the

Defense Health Program (DHP) and the RCRP, pre-applications will be screened based on the following criteria:

• Whether the proposed study falls under the definition of RCRP rare cancers research.

• How well the project’s hypothesis, objectives, rationale, and specific aims are described. To what extent the methodology and experimental design is shown to support the hypothesis and/or objectives of the project.

• Whether the proposed project addresses at least one of the FY24 RCRP Focus Areas. To what degree the proposed research may lead to promising outcomes for one or more of the selected FY24 RCRP Focus Areas.

• What potential impact these studies will have on the outcomes of people with rare cancers, and/or the understanding of rare cancers.

• Whether the project will lead to challenge current paradigms, look at existing problems from new perspectives, and/or exhibit other uniquely creative qualities.

II.D.2.a.iii. Notification of Pre-Application Screening Results

Following the pre-application screening, PIs will be notified as to whether they are invited to submit full applications. The estimated date when PIs can expect to receive notification of an invitation to submit a full application is indicated in Section I, Overview of the Funding

Opportunity. No feedback (e.g., a critique of the pre-application’s strengths and weaknesses) is provided at this stage. Because the invitation to submit a full application is based on the contents of the pre-application, investigators should not change the title or research objectives after the pre-application is submitted.

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

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

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

Extramural Submissions: Full applications from extramural organizations must be submitted through Grants.gov Workspace. Full applications from extramural organizations, including non-

DOD federal organizations, received through eBRAP will be withdrawn. Refer to the General

Application Instructions, Section IV, for considerations and detailed instructions regarding extramural full application submission.

Intramural Submissions: Intramural DOD organizations may submit full applications through either eBRAP or Grants.gov. There is no preference from the CDMRP for which submission portal is utilized; submission through one portal or the other does not provide the application any

DOD FY24 Rare Cancers Idea Development Award 12 advantage during the review process. Intramural DOD organizations that choose to submit through Grants.gov should follow Extramural Submission instructions. Intramural DOD organizations that are unable to submit through Grants.gov should submit through eBRAP. For the remainder of this program announcement, it will be assumed intramural DOD submissions will proceed through eBRAP. Refer to the General Application Instructions, Section V, for considerations and detailed instructions regarding intramural DOD full application submission.

II.D.2.b.ii. Full Application Submission Components

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

(a) SF424 Research & Related Application for Federal Assistance Form (Extramural

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

(b) Attachments:

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

Application Instructions, Appendix 2.

○ Attachment 1: Project Narrative (10-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.

Describe the proposed project in detail using the outline below. Preliminary data with disease-specific rationale (including correlative studies to existing clinical research) to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study.

– Background: Present the scientific rationale and feasibility behind the proposed research; include relevant literature citations and preliminary data that led to the development of the proposed study. Any preliminary data provided should be from the laboratory of the PI or member(s) of the collaborating team.

– Hypotheses/Objectives: State the hypotheses/study questions and overall objective(s) to be reached.

– Specific Aims: Concisely explain the project’s specific aims. If this application is part of a larger study, present only tasks that this award would fund.

DOD FY24 Rare Cancers Idea Development Award 13

– Research Strategy and Feasibility: Describe the experimental design, methods, and analyses, including appropriate controls, in sufficient detail for evaluation.

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

▪ If animal studies are proposed, describe how they will be conducted in accordance with the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo

Experiments) to achieve reproducible and rigorous results, including the choice of model and the endpoints/outcomes to be measured

(https://arriveguidelines.org/arrive-guidelines).

▪ If human subjects or human biological samples will be used, include a detailed plan for the recruitment of subjects or the acquisition of samples. This award cannot be used to conduct clinical trials.

▪ If applicable, describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex/gender, racial, and ethnic group, and an accompanying rationale for the selection of subjects.

– Data Collection and Statistical Analysis Plan: Describe how data will be collected and analyzed in a manner that is consistent with the study objectives.

▪ Detail a statistical analysis plan for the resulting outcomes.

▪ If applicable, include a complete power analysis to demonstrate that the sample size is appropriate.

▪ Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with Food and Drug

Administration (FDA) or international regulatory agency, if applicable.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”. Start each document on a new page. The Supporting

Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures, or drawings. These items should be included in the Project Narrative.

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

References Cited: List the references cited (including URLs, if available) in the

Project Narrative using a standard reference format.

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

https://arriveguidelines.org/arrive-guidelines

DOD FY24 Rare Cancers Idea Development Award 14

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

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

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

Congress, do not impact application review or funding decisions.

Letters of Collaboration (if applicable): Provide a signed letter from each collaborating individual and/or organization demonstrating that the PI has the support and resources necessary for the proposed work. If an investigator at an intramural

DOD organization is named as a collaborator on a full application submitted through an extramural organization, the application must include a letter from the collaborator’s Commander or Commanding Officer at the intramural DOD organization authorizing the collaborator’s involvement.

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

Property.”

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

▪ Commercialization Strategy (if applicable): Describe the commercialization plan. The plan should include intellectual property, market size, financial analysis, strengths and weaknesses, barriers to the market, competitors, and management team. Discuss the significance of this development effort, when it can be anticipated, and the potential commercial use for the technology being developed.

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

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

Supporting Documentation, for detailed information regarding Data Management

Plan content.

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

DOD FY24 Rare Cancers Idea Development Award 15

Data and Research Resources Sharing Plan: Describe the type of data or research resource to be made publicly available as a result of the proposed work. Describe how data and resources generated during the performance of the project will be shared with the research community. Include the name of the repository(ies) where scientific data and resources arising from the project 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 & Resource Sharing located on the eBRAP “Funding Opportunities & Forms” web page https://ebrap.org/eBRAP/public/Program.htm for more information about CDMRP’s expectations for making data and research resources publicly available.

Use of DOD Resources (if applicable): Provide a letter of support signed by the lowest-ranking person with approval authority confirming access to active-duty military populations and/or DOD resources or databases.

Use of VA Resources (if applicable): Provide a letter of support signed by the VA

Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical

Service Chief, confirming access to VA patients, resources, and/or VA research space. If the VA-affiliated non-profit corporation is not identified as the applicant organization for administering the funds, include a letter from the VA ACOS/R&D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research.

Inclusion of Women and Minorities (if applicable): Provide an anticipated enrollment table(s) for the inclusion of women and minorities appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex/gender, race, and ethnicity. The Public Health Service (PHS) Inclusion

Enrollment Report is a three-page fillable PDF form, which can be downloaded from eBRAP at https://ebrap.org/eBRAP/public/Program.htm.

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

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

Technical abstracts should be written using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the ideas and reasoning behind the proposed work.

Focus Area(s): State the FY24 RCRP Focus Area(s) that will be addressed.

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

DOD FY24 Rare Cancers Idea Development Award 16

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

Provide evidence or rationale that supports the objective/hypothesis.

Specific Aims: State the specific aims of the study.

Study Design: Briefly describe the study design, including appropriate controls.

Impact: Summarize the potential impact of the proposed project toward the goal of greatly improving outcomes for people with rare cancers.

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

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

– Describe the scientific objective and rationale for the proposed project in a manner that will be readily understood by readers without a background in science or medicine.

▪ State the FY24 RCRP Focus Area(s) in Section II.A.1 the project addresses.

– Describe the ultimate applicability of the research.

▪ What types of patients will it help and how will it help them?

▪ What are the potential clinical applications, benefits, and risks? If the research is too basic for clinical applicability, describe the interim outcomes expected and their applicability to the field.

▪ What is the projected time anticipated to achieve a clinically relevant outcome?

▪ What are the likely contributions of this study to advancing rare cancers research?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”. Refer to the eBRAP “Funding Opportunities & Forms” web page

(https://ebrap.org/eBRAP/public/Program.htm) for the suggested SOW format and recommended strategies for assembling the SOW.

For the Idea Development Award mechanism, refer the “Example: Assembling a Generic

Statement of Work”, for guidance on preparing the SOW. Use the “Suggested SOW

Format” to develop the SOW for the proposed research. Submit as a PDF.

DOD FY24 Rare Cancers Idea Development Award 17

– State explicitly how the proposed work addresses a critical component of at least one of the FY24 RCRP Focus Areas.

– Explain why the proposed research project is important to understanding the causes and progression of the rare cancer and/or to realizing improvements in outcomes for people with rare cancers.

– Describe how the proposed research will make an impact on cancer research and/or patient outcomes and how it benefits those affected by the cancer. The relevance of all research including basic research should relate to the outcomes.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”. The

Impact Statement should be written in plain language for lay persons. Explain in detail why the proposed research project is important, using the following headings:

– State explicitly how the proposed work addresses a critical component of at least one of the FY24 RCRP Focus Areas.

– Explain why the proposed research project is important to understanding the causes and progression of the rare cancer and/or to realizing improvements in outcomes for people with rare cancers.

– Describe how the proposed research will make an impact on cancer research and/or patient outcomes and how it benefits those affected by the cancer. The relevance of all research including basic research should relate to the outcomes.

○ Attachment 7: Justification Statement (one-page limit): Upload as

“Justification.pdf” (for programmatic review only). Describe how the cancer or cancer subtype is defined as rare under the definition of RCRP (incidence rate of 6 or fewer persons per 100,000 per year), including citations on incidence rates, mortality, and status of disease research.

○ Attachment 8: Representations (Extramural Submissions Only): Upload as

“RequiredReps.pdf”. All extramural applicants must complete and submit the Required

Representations template available on eBRAP (https://ebrap.org/eBRAP/ public/Program.htm). For more information, see the General Application Instructions, Appendix 8, Section B, Representations.

○ Attachment 9: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOD organization will be a collaborator in performance of the project, complete a separate budget using the

“Suggested Intragovernmental/Intramural Budget Form”, available for download on the eBRAP “Funding Opportunities & Forms” web page

(https://ebrap.org/eBRAP/public/Program.htm). The budget should cover the entire period of performance for each intramural DOD site and include a budget justification as instructed. The total costs per year for each subaward (direct and indirect costs) should be included on the Grants.gov Research & Related Budget Form under subaward costs.

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

DOD FY24 Rare Cancers Idea Development Award 18

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

(c) Research & Related Personal Data: For extramural submissions, refer to the General

Application Instructions, Section IV.B.(c), and for intramural submissions, refer to the

General Application Instructions, Section V.A.(c), for detailed instructions.

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

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

○ PI Previous/Current/Pending Support (no page limit): Upload as

“Support_LastName.pdf”.

○ Key Personnel Biographical Sketches (five-page limit each): Upload as

“Biosketch_LastName.pdf”.

○ Key Personnel Previous/Current/Pending Support (no page limit): Upload as

“Support_LastName.pdf”.

(e) Research & Related Budget: For extramural submissions, refer to the General Application

Instructions, Section IV.B.(e), and for intramural submissions, refer to the General

Application Instructions, Section V.A.(e), for detailed instructions.

○ Budget Justification (no page limit): For extramural submissions, refer to the General

Application Instructions, Section IV.B.(e), Section L, for instructions. For intramural submissions, refer to General Application Instructions, Section V.A.(e), Budget

Justification Instructions.

(f) Project/Performance Site Location(s) Form: For extramural submissions, refer to the

General Application Instructions, Section IV.B.(f), and for intramural submissions, refer to the General Application Instructions, Section V.A.(f), for detailed instructions.

(g) Research & Related Subaward Budget Attachment(s) Form (if applicable, Extramural

Submissions Only): Refer to the General Application Instructions, Section IV.B.(g), for detailed instructions.

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

o Intramural DOD Subaward: Complete a separate “Suggested

Intragovernmental/Intramural Budget Form” for each intramural DOD subaward and upload as a single document titled IGBudget.pdf to Grants.gov as Attachment 9.

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

Independent of submission type, once the full application is submitted it is transmitted to and processed in eBRAP. At this stage, the PI and organizational representatives will receive an email from eBRAP instructing them to log into eBRAP to review, modify, and verify the full application submission. Verification is strongly recommended but not required. eBRAP will validate full application files against the specific program announcement requirements, and discrepancies will be noted in the “Full Application Files” tab in eBRAP. However, eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to review all application components and ensure proper ordering as specified in the program announcement.

The Project Narrative and Research & Related Budget Form cannot be changed after the application submission deadline. If either the Project Narrative or the budget fails eBRAP validation or needs to be modified, an updated full application package must be submitted prior to the full application submission deadline. Other application components, including subaward budget(s) and subaward budget justification(s), may be changed until the end of the application verification period. The full application cannot be modified once the application verification period ends.

II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM)

The applicant organization must be registered as an entity in SAM

(https://www.sam.gov/content/home) and receive confirmation of an “Active” status before submitting an application through Grants.gov. Organizations must include the UEI generated by

SAM in applications to this funding opportunity.

II.D.4. Submission Dates and Times

The pre-application and application submission process should be started early to avoid missing deadlines. There are no grace periods. Failure to meet either of these deadlines will result in submission rejection.

All submission dates and times are indicated in Section I, Overview of the Funding Opportunity.

II.D.5. Funding Restrictions

The maximum period of performance is 3 years.

The application’s direct costs budgeted for the entire period of performance should not exceed

$350,000. 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 3 years.

https://www.sam.gov/content/home

DOD FY24 Rare Cancers Idea Development Award 20

For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY24 RCRP Idea Development Award.

Must not be requested for:

• Clinical trial costs

• Tuition

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

II.D.6. Other Submission Requirements

Refer to the General Application Instructions, Appendix 2, for detailed formatting guidelines.

II.E. Application Review Information

II.E.1. Criteria

II.E.1.a. Peer Review

To determine technical merit, all applications will be individually evaluated according to the following scored criteria, which are of equal importance:

• Research Strategy and Feasibility

○ How well the scientific rationale supports the project and its feasibility as demonstrated by a critical review and analysis of the literature, relevant preliminary data, and logical reasoning.

○ How well the hypotheses or objectives, aims, experimental design, methods, and analyses are developed.

○ How well the data collected is described and whether the analysis is consistent with the study objectives.

○ How well the data collection and statistical analysis plan, rationale for the statistical methodology, and power analysis (if applicable), are described.

○ If applicable, whether data will be appropriately reported and documented to support a regulatory filing with the FDA or international regulatory agency.

DOD FY24 Rare Cancers Idea Development Award 21

○ If animal studies are included, how well they are designed in accordance with the

ARRIVE guidelines 2.0 to achieve reproducible and rigorous results, including the choice of model and the endpoints/outcomes to be measured.

○ If human subjects or human biological samples will be used, how well the plan for the recruitment of subjects or the acquisition of samples is justified and appropriate to accomplish the proposed work.

○ If clinical research is proposed, whether the strategy for the inclusion of women and minorities and distribution of proposed enrollment are appropriate for the proposed research.

○ How well the application acknowledges potential problems and addresses alternative approaches.

• Impact

○ How explicitly the application stated the proposed work addresses a critical component in at least one of the FY24 RCRP Focus Areas.

○ How well the application clearly articulates the importance of understanding this research to the causes and progression of the…