HT9425-23-VRP-IIRA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version 803. 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 FY23 Vision Investigator-Initiated Research Award 1

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Program Announcement for the Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Vision Research Program

Investigator-Initiated Research Award

Announcement Type: Initial

Funding Opportunity Number: HT9425-23-VRP-IIRA

Assistance Listing Number: 12.420 Military Medical Research and Development

SUBMISSION AND REVIEW DATES AND TIMES

• Pre-Application Submission Deadline: 5:00 p.m. Eastern time (ET), July 14, 2023

• Invitation to Submit an Application: September 2023

• Application Submission Deadline: 11:59 p.m. ET, November 8, 2023

• End of Application Verification Period: 5:00 p.m. ET, November 13, 2023

• Peer Review: January 2024

• Programmatic Review: March 2024

DOD FY23 Vision Investigator-Initiated Research 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. FY23 VRP 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. eBRAP and Grants.gov

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

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.E.4. Anticipated Announcement and Federal Award Dates

II.F. Federal Award Administration Information

II.F.1. Federal Award Notices

II.F.2. Administrative and National Policy Requirements

II.F.3. 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. Application Submission Checklist

APPENDIX 1: ACRONYM LIST

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II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

II.A. Program Description

Applications to the Fiscal Year 2023 (FY23) Vision Research Program (VRP) are being solicited by the U.S. Army Medical Research Acquisition Activity (USAMRAA) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The execution management agent for this program announcement is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC). The VRP was initiated in 2009 to fund impactful military-relevant vision research that has the potential to significantly improve the healthcare and well-being of military Service Members, Veterans, their family members and caregivers, and the American public.

Appropriations for the VRP from FY09 through FY22 totaled $164.95 million (M). The FY23 appropriation is $20M.

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

The goal of the VRP is to transform visual system trauma care for our Armed Forces and the nation. Eye injury accounted for approximately 15% of all injuries from battlefield trauma sustained during the wars in Afghanistan and Iraq. Surveillance data from the Department of Defense (DOD) showed more than 275,000 eye injuries in the U.S. Armed Forces between 2000 and 2017. More than 6,000 of the injuries were categorized as having a high risk of blindness.

In addition, statistics from the Traumatic Brain Injury Center of Excellence show that, through the third quarter of 2022, more than 468,000 Service Members have been diagnosed with traumatic brain injury (TBI), which can have significant impact on vision even when there is no injury to the eye.

The FY23 VRP challenges the scientific community to design innovative research that will significantly advance the understanding, prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure. Research outcomes are expected to ultimately improve the care of Service Members and Veterans as well as the American public.

II.A.1. FY23 VRP Focus Areas

To meet the intent of the award mechanism, applications to the FY23 VRP Investigator-Initiated Research Award (IIRA) must address research in one or more of the following Focus Areas:

• Understanding and treatment of eye injury or visual dysfunction as related to military exposure.

• Diagnosis, stabilization, and treatment of eye injuries in austere environments and prolonged field care settings

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• Restoration of visual function after military exposure-related vision loss or severe visual impairment

II.A.2. Award History

The VRP IIRA mechanism was first offered in FY18. Since then, 265 IIRA applications have been received, and 59 have been recommended for funding.

II.B. Award Information

The FY23 VRP IIRA is intended to support studies that will yield highly impactful discoveries or major advancements in the research and/or patient care of eye injury and/or visual dysfunction as related to military exposure.

Applications involving multidisciplinary collaborations among academia, industry, the military services, the Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged.

To support research projects at different stages and the exploration/development of ideas of different maturity levels, two different funding levels are available under this program announcement. When submitting the pre-application, it is the responsibility of the applicant organization to select the funding level that is most appropriate for the research proposed.

The funding level should be selected based on the stage and maturity level of the research project, rather than the amount of the budget.

• Funding Level 1 supports exploratory, innovative, high-risk/high-reward research that is in the earliest stages of idea development. Research must have the potential to yield new avenues of investigation, such as new approaches, new research tools, or new paradigms.

○ Preliminary data are not required. However, applicants must provide solid rationale for the research idea, supported by literature.

○ The investigating team must have sufficient expertise to test the research idea.

• Funding Level 2 supports the advancement of more mature research toward clinical translation. The research idea or solution should be innovative or novel, or offer significant refinements, improvements, or new applications of existing ideas or solutions, as applicable.

○ Funding Level 2 applications may focus on any phase of research from basic through translational.

○ Preliminary data supporting the readiness and feasibility of the proposed research are required.

Research involving human subjects and human anatomical substances is permitted; however, the IIRA may not be used to conduct clinical trials.

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A clinical trial is defined 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.

Applicants may consult the following resource documents as applicable:

• Blast Term Dictionary and Guidance Documents for Blast Injury Research

• A Primer for Conducting Department of Defense (DOD) Funded Human Research with Military Populations

• A Beginner’s Guide to Army Healthcare System

A description of health services across the range of military operations can be found in the Joint Health Services Joint Publication 4-02.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the DOD during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.

The anticipated direct costs budgeted for the entire period of performance for an FY23 VRP IIRA-Funding Level 1 should not exceed $260,000. The anticipated direct costs budgeted for the entire period of performance for an FY23 VRP IIRA-Funding Level 2 should not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $0.832M to fund approximately two VRP IIRA- Funding Level 1 applications, and $6M to fund approximately five VRP IIRA-Funding Level 2 applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific 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 https://cdmrp.health.mil/vrp/pdf/Blast%20Term%20Dictionary%20and%20Guidance%20Documents%20for%20Blast%20Injury%20Research%20k.._.pdf https://cdmrp.health.mil/pubs/pdf/Conducting%20Research%20Military%20Pop%20DoD_funded_7NOV2022.pdf https://cdmrp.health.mil/pubs/pdf/Conducting%20Research%20Military%20Pop%20DoD_funded_7NOV2022.pdf https://cdmrp.health.mil/vrp/pdf/A%20Beginner's%20Guide%20to%20Army%20Healthcare%20System.pdf https://cdmrp.health.mil/pubs/pdf/Joint%20Health%20Services%20Publication%20JP%204-02.pdf

DOD FY23 Vision Investigator-Initiated Research Award 6 anticipated that awards made from this FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.

Following selection of projects for VRP funding, the VRP may share FY23 IIRA applications and reviews with the National Eye Institute (NEI) of the National Institutes of Health (NIH) for independent funding consideration. Additional or separate application information may be required by the NEI. The number of applications to be considered for funding by the NEI is indeterminate and contingent upon NEI’s determination of the quality of applications and funding availability.

Research Involving Animals: All research funded by the FY23 VRP IIRA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO) Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information..

Research Involving Human Data, Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC OHARO, Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO.

Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo for additional information.

As of January 20, 2020, U.S. institutions engaged in non-exempt cooperative research must rely on a single IRB to review and approve the portion of the research conducted at domestic sites in accordance with Code of Federal Regulations, Title 45, Part 46.114(b) (45 CFR 46.114[b]). If the proposed, non-exempt research involves more than one U.S.-based institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.

Use of DOD or VA Resources: If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.

https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo

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Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in Landis, SC, 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 were written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in research and should be applied consistently across basic and translational studies.

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.1.a. Organization: All organizations, including foreign organizations, foreign public entities, and international organizations, are eligible to apply.

Government Agencies Within the United States: Local, state, and federal government agencies are eligible to the extent that applications do not overlap with their fully funded internal programs. Such agencies are required to explain how their applications do not overlap with their internal programs.

As applications for this program announcement may be submitted by extramural and intramural organizations, these terms are defined below.

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

Intramural DOD Organization: A DOD laboratory, DOD military treatment facility, and/or DOD activity embedded within a civilian medical center. Intramural Submission: An application submitted by a DOD organization for an intramural investigator working within a DOD laboratory or military treatment facility or in a DOD activity embedded within a civilian medical center.

The USAMRAA makes awards to eligible organizations, not to individuals.

II.C.1.b. Principal Investigator

Independent investigators at all academic levels (or equivalent) may be named by the organization as the Principal Investigator (PI) on the application.

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

The CDMRP strongly encourages all PIs to participate in a digital identifier initiative through Open Researcher and Contributor ID, Inc. (ORCID). Registration for a unique ORCID identifier can be done online at https://orcid.org/.

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

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II.C.2. Cost Sharing

Cost sharing/matching is not an eligibility requirement.

II.C.3. Other

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

For general information on required qualifications for award recipients, refer to the General Application Instructions, Appendix 3.

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

II.D. Application and Submission Information

Submission of applications that are essentially identical or 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).

Exception: Applicants to the FY23 VRP IIRA - Funding Level 2 are permitted to simultaneously submit the same project as part of an application to the FY23 VRP Focused Translational Team Science Award (FTTSA) (Funding Opportunity Number: HT9425-23-VRP-FTTSA). The scope and budget of the IIRA - Funding Level 2 and the FTTSA applications must be appropriate for the respective award mechanism. Accepting multiple awards to support the same project will not be allowed.

Inclusion of classified research data within the application and/or proposing research of which the anticipated outcomes may be classified or deemed sensitive to national security concerns may result in application withdrawal. Refer to the General Application Instructions Appendix 2, Section E.

II.D.1. eBRAP and Grants.gov

The electronic Biomedical Research Application Portal (eBRAP) (https://ebrap.org) is a secure web-based system that allows PIs to submit their pre-applications, view and verify extramural full applications submitted to Grants.gov (https://grants.gov), receive communications from the CDMRP, and submit documentation during award negotiations and throughout the period of performance. eBRAP also allows intramural organizations to submit full applications following pre-application submission.

Grants.gov is a federal system required to be utilized by agencies to receive and process extramural grant applications. Full applications may only be submitted to Grants.gov after submission of a pre-application through eBRAP.

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

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Contact information for the eBRAP Help Desk and the Grants.gov Contact Center can be found in Section II.G, Federal Awarding Agency Contacts.

Extramural Submission:

• Pre-application content and forms must be accessed and submitted at eBRAP.org.

• Full application packages must be accessed and submitted at Grants.gov.

Intramural DOD Submission:

• Pre-application content and forms must be accessed and submitted at eBRAP.org.

• Full application packages must be accessed and submitted at eBRAP.org.

Note: Applications from an intramural DOD organization or from an extramural federal government organization may be submitted to Grants.gov through a research foundation.

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

Submission is a two-step process requiring both pre-application (eBRAP.org) and full application (eBRAP.org or Grants.gov) as indicated below. The submission process should be started early to avoid missing deadlines. There are no grace periods. Full application submission guidelines differ for extramural (Grants.gov) and intramural (eBRAP.org) organizations (refer to Table 1, Full Application Guidelines).

The application title, eBRAP log number, 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.

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

During the pre-application process, eBRAP assigns each submission a unique log number.

This unique eBRAP log number is required during the full application submission process.

To begin the pre-application process, first select whether the submitting organization is extramural or intramural, then confirm your selection or cancel. Incorrect selection of extramural or intramural submission type will delay processing.

If an error has been made in the selection of extramural versus intramural and the pre-application submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507 to request a change in designation.

All pre-application components must be submitted by the PI through eBRAP (https://eBRAP.org/). Because the invitation to submit an application is based on the contents of mailto:help@eBRAP.org mailto:help@eBRAP.org

DOD FY23 Vision Investigator-Initiated Research Award 10 the pre-application, investigators should not change the title or research objectives after the pre-application is submitted.

The applicant organization and associated PI identified in the pre-application should be the same as those intended for the subsequent application submission. If any changes are necessary after submission of the pre-application, the applicant must contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507.

PIs with an ORCID identifier should enter that information in the appropriate field in the “My Profile” tab in the “Account Information” section of eBRAP.

The pre-application consists of the following components, which are organized in eBRAP by separate tabs (refer to the General Application Instructions, Section II.B, for additional information on pre-application submission):

• Tab 1 – Application Information

Submission of application information includes assignment of primary and secondary research classification codes, which may be found at https://ebrap.org/eBRAP/public/ Program.htm. Applicants are strongly encouraged to review and confirm the codes prior to making their selection.

• Tab 2 – Application Contacts

Enter contact information for the PI. Enter the organization’s Business Official responsible for sponsored program administration (the “person to be contacted on matters involving this application” in Block 5 of the Grants.gov SF424 Research & Related Form). The Business Official must be either selected from the eBRAP list or invited in order for the pre-application to be submitted.

Select the performing organization (site at which the PI will perform the proposed work) and the contracting organization (organization submitting on behalf of the PI, which corresponds to Block 5 on the Grants.gov SF424 Research & Related Form) and click on “Add Organizations to this Pre-application.” The organization(s) must be either selected from the eBRAP drop-down list or invited in order for the pre-application to be submitted.

It is recommended that PIs identify an Alternate Submitter in the event that assistance with pre-application submission is needed.

• Tab 3 – Collaborators and Key Personnel

Enter the name, organization, and role of all collaborators and key personnel associated with the application.

FY23 VRP Programmatic Panel members should not be involved in any pre-application or 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.

mailto:help@eBRAP.org https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/public/Program.htm https://cdmrp.health.mil/vrp/panels/panels23

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• Tab 4 – Conflicts of Interest

List all individuals other than collaborators and key personnel who may have a conflict of interest in the review of the application (including those with whom the PI has a personal or professional relationship).

• Tab 5 – Pre-Application Files

Note: Upload documents as individual PDF files unless otherwise noted. eBRAP will not allow a file to be uploaded if the number of pages exceeds the limit specified below.

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

The Preproposal Narrative should include the following:

– Research Idea/Rationale:

Funding Level 1: Describe the research idea to be explored and the rationale.

Concisely explain how the idea may yield new avenues of investigation, such as new approaches, new research tools, or new paradigms.

Funding Level 2: Describe the proposed research, rationale, and the preliminary data supporting its readiness and feasibility. Concisely explain how it is designed to advance a line of research toward clinical translation.

Both Funding Levels: Explain how the research idea meets the intent of the FY23 VRP IIRA and aligns with one or more of the FY23 VRP Focus Areas.

– Objective(s)/Hypothesis(es), Specific Aims, and Approaches: Concisely state the project’s objective(s)/hypothesis(es), specific aims, and describe the scientific approaches. Include a description of controls, as appropriate. As applicable, identify the animal models to be studied, the data to be analyzed, and/or the human subject population to be engaged during the study.

– Impact: Describe the anticipated short- and long-term impact of this study on the field of visual system trauma research and/or care.

– Personnel: Briefly state the qualifications of the PI and key personnel. Clearly demonstrate that the investigating team has sufficient expertise that is appropriate for the research idea and the proposed phase/type of study.

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○ 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 (six-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.

• Tab 6 – Submit Pre-Application

This tab must be completed for the pre-application to be accepted and processed.

Pre-Application Screening

• 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 VRP, pre-applications will be screened based on the following criteria:

○ Research Idea/Rationale:

– Funding Level 1: How well the research idea is supported by a rationale. To what extent it is designed to yield new avenues of investigation.

– Funding Level 2: How well the proposed research is supported by preliminary data and a rationale. To what extent it is designed to advance a line of research toward clinical translation.

– Both Funding Levels: How well the research idea meets the intent of the FY23 VRP IIRA and aligns with one or more of the FY23 VRP Focus Areas.

○ Objective(s)/Hypothesis(es), Specific Aims, and Approaches: Whether the proposed research has clear objective(s)/hypothesis(es). To what extent the specific aims and approaches form a coherent research plan to address the objective(s)/hypothesis(es).

○ Impact: To what extent the short- and long-term outcomes of the proposed study, if successful, will impact the field of visual system trauma research and/or care.

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○ Personnel: To what extent the investigating team has sufficient qualification and expertise to perform the proposed research.

• Notification of Pre-Application Screening Results

Following the pre-application screening, PIs will be notified as to whether or not they are invited to submit applications; however, they will not receive feedback (e.g., a critique of strengths and weaknesses) on their pre-application. The estimated timeframe for notification of invitation to submit an application is indicated in Section I, Overview of the Funding Opportunity. Invitations to submit a full application are based on the Pre-Application Screening Criteria listed above.

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

Applications will not be accepted unless notification of invitation has been received.

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

Each application submission must include the completed full application package for this program announcement. The full application package is submitted by the Authorized Organizational Representative through Grants.gov (https://grants.gov/) for extramural organizations or through eBRAP (https://ebrap.org/) for intramural organizations. See Table 1 below for more specific guidelines.

II.D.2.b.i. Full Application Guidelines

Extramural organizations must submit full applications through Grants.gov. Applicants must create a Grants.gov Workspace for submission, which allows the application components to be completed online and routed through the applicant organization for review prior to submission.

Applicants may choose to download and save individual PDF forms rather than filling out webforms in Workspace. A compatible version of Adobe Reader must be used to view, complete, and submit an application package consisting of PDF forms. If more than one person is entering text into an application package, the same version of Adobe Reader software should be used by each person. Check the version number of the Adobe software on each user’s computer to make sure the versions match. Using different versions of Adobe Reader may cause submission and/or save errors – even if each version is individually compatible with Grants.gov.

Refer to the General Application Instructions, Section III, and the “Apply For Grants” page of Grants.gov (https://www.grants.gov/web/grants/applicants/apply-for-grants.html) for further information about the Grants.gov Workspace submission process. Submissions of extramural applications through eBRAP may be withdrawn.

Do not password protect any files of the application package, including the Project Narrative.

https://www.grants.gov/ https://www.grants.gov/web/grants/applicants/apply-for-grants.html

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Table 1. Full Application Submission Guidelines

Extramural Submissions Intramural DOD Submissions Application Package Location

Download application package components for HT9425-23-VRP-IIRA from Grants.gov (https://grants.gov) and create a Grants.gov Workspace. Workspace allows online completion of the application components and routing of the application package through the applicant organization for review prior to submission.

Download application package components for HT9425-23-VRP-IIRA from eBRAP (https://ebrap.org).

Full Application Package Components SF424 Research & Related Application for Federal Assistance Form: Refer to the General Application Instructions, Section III.A.1, for detailed information.

Tab 1 – Summary: Provide a summary of the application information.

Tab 2 – Application Contacts: This tab will be pre-populated by eBRAP; add Authorized Organizational Representative.

Descriptions of each required file can be found under Full Application Submission Components:

• Attachments

• Research & Related Personal Data

• Research & Related Senior/Key Person

Profile (Expanded)

• Research & Related Budget

• Project/Performance Site Location(s)

Form

• Research & Related Subaward Budget

Attachment(s) Form

Tab 3 – Full Application Files: Upload files under each Application Component in eBRAP.

Descriptions of each required file can be found under Full Application Submission Components:

• Attachments

• Key Personnel

• Budget

• Performance Sites

Tab 4 – Application and Budget Data:

Review and edit proposed project start date, proposed end date, and budget data pre-populated from the Budget Form.

Application Package Submission Create a Grants.gov Workspace.

Add participants (investigators and Business Officials) to Workspace, complete all required forms, and check for errors before submission.

Submit a Grants.gov Workspace Package.

An application may be submitted through Workspace by clicking the “Sign and Submit” button on the “Manage Workspace” page, under the “Forms” tab. Grants.gov

Submit package components to eBRAP (https://ebrap.org).

Tab 5 – Submit/Request Approval Full Application: After all components are uploaded and prior to the full application submission deadline, enter your password in the space provided next to “Enter Your Password Here” and press the “Submit Full Application” button. eBRAP will notify your Resource https://grants.gov/

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Extramural Submissions Intramural DOD Submissions recommends submission of the application package at least 24-48 hours prior to the close date to allow time to correct any potential technical issues that may disrupt the application submission.

Note: If either the Project Narrative or the budget fails eBRAP validation or needs to be modified, an updated Grants.gov application package must be submitted via Grants.gov as a “Changed/Corrected Application” with the previous Grants.gov Tracking ID prior to the application submission deadline. Do not password protect any files of the application package, including the Project Narrative.

Manager/Comptroller/Task Area Manager or equivalent Business Official by email. Do not password protect any files of the application package, including the Project Narrative.

Application Verification Period The full application package submitted to Grants.gov may be viewed and modified in eBRAP until the end of the application verification period. During the application verification period, the full application package may be modified with the exception of the Project Narrative and Research & Related Budget Form.

After eBRAP has processed the full application, the organizational Resource Manager/ Comptroller/Task Area Manager or equivalent Business Official and PI will receive email notification of this status and will be able to view and modify application components in eBRAP. During the application verification period, the full application package may be modified with the exception of the Project Narrative and Research & Related Budget Form. Your Resource Manager/Comptroller/ Task Area Manager or equivalent Business Official should log into eBRAP to review and to approve prior to the application verification deadline.

Further Information Tracking a Grants.gov Workspace Package.

After successfully submitting a Workspace package, a Grants.gov Tracking Number is automatically assigned to the package. The number will be listed on the “Confirmation” page that is generated after submission.

Refer to the General Application Instructions, Section III, for further information regarding Grants.gov requirements.

Refer to the General Application Instructions, Section IV, for further information regarding eBRAP requirements.

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The full application package must be submitted using the unique eBRAP log number to avoid delays in application processing.

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

• Extramural Applications Only

SF424 Research & Related Application for Federal Assistance Form: Refer to the General Application Instructions, Section III.A.1, for detailed information.

• Extramural and Intramural Applications

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 4.

For all attachments, ensure that the file names are consistent with the guidance. Attachments will be rejected if the file names are longer than 50 characters or have incorrect file names that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space, and period. In addition, there are file size limits that may apply in some circumstances.

Individual attachments may not exceed 20 megabytes (MB), and the file size for the entire full application package may not exceed 200 MB.

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

– Page Limit: Page limits for the Project Narrative are correlated with the application’s funding level:

Funding Level 1: 6-page limit

Funding Level 2: 12-page limit

Describe the proposed project in detail using the outline below:

– Background/Rationale: Provide a sound scientific rationale for the proposed research.

Funding Level 1: Describe the idea that the proposed research will explore and develop, clearly stating the objective(s) to be reached and/or the hypothesis(es) to be tested. Present sufficient literature to support the rationale for testing the idea.

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Explain how the proposed research has the potential to yield new avenues of investigation, such as new approaches, new research tools, or new paradigms.

Preliminary data are allowed but not required.

Funding Level 2: Describe the proof-of-concept finding(s) that the proposed research aims to move forward to the next phase of development, clearly stating the objective(s) to be reached and/or the hypothesis(es) to be tested. Present sufficient preliminary data and critical analysis of literature to support the readiness of the objective(s), the soundness of the hypothesis(es), and the feasibility of the approach(es). Explain how the proposed research is innovative or novel or offers significant refinements, improvements, or new applications of existing ideas or solutions.

– Specific Aims: Concisely explain the project’s specific aims. Explain how the aims address the objective(s) and/or hypothesis(es) of the proposed research.

– Research Strategy: Describe the experimental design, methods, and analyses, including appropriate randomization, blinding/masking, and controls. Provide sufficient detail so that the appropriateness and feasibility of the research strategy can be fully evaluated.

If cell lines or animals are to be used, justify the selection of the proposed cell line(s) or animal model(s). Be specific as to why the cell line or animal model was chosen over other cell lines or models, how it is appropriate for addressing the study aims, and how it is relevant to human visual biology and/or injury.

Further details of research involving animals will be required in Attachment 8:

Animal Research Plan, as applicable.

If human subjects or human biological samples will be used, describe the study population and include a detailed plan for the recruitment and retention of subjects or the acquisition of samples. Further details of research involving human subjects or human biological substances will be required in Attachment 9:

Human Subjects/Samples Acquisition and Safety Procedures, as applicable. This award may not be used to conduct clinical trials.

Describe the statistical plan and the rationale for the statistical methodology.

Provide a sample size estimate and the method by which it was derived, including power analysis calculation, if applicable.

Describe measures to be taken to reduce bias and achieve reproducible and rigorous results, including controls, blinding, randomization, and data handling, as applicable.

Address potential problems that may arise and present alternative methods and approaches.

Explain how the research can be completed within the proposed period of performance.

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○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”. Start each document on a new page. If documents are scanned to PDF, the lowest resolution (100 to 150 dpi) should be used. 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 that includes the full citation (i.e., author[s], year published, title of reference, source of reference, volume, chapter, page numbers, and publisher, as appropriate).

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 Organizational Support (two-page limit per letter is recommended):

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) (two-page limit per letter is recommended): Provide a signed letter from each collaborating individual or organization demonstrating that the PI has the support or resources necessary for the proposed work. If an investigator at an intramural organization is named as a collaborator on an application submitted through an extramural organization, the application must include a letter from the collaborator’s Commander or Commanding Officer at the intramural organization that authorizes the collaborator’s involvement.

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Letter of Commitment (if applicable) (two-page limit per letter is recommended): If the proposed study involves use of a commercially produced investigational drug, device, or biologic, provide a letter of commitment from the commercial entity indicating the availability of the product for the duration of the study, support for the proposed phase of research, and support for the indication to be tested.

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.

Data and Research Resources Sharing Plan: Describe how data and resources generated during the performance of the project will be shared with the research community. Refer to the General Application Instructions, Appendix 2, Section K, for more information about the CDMRP expectations for making data and research resources publicly available.

All TBI clinical research projects are required to report data to the Federal Interagency TBI Research (FITBIR) informatics system (https://fitbir.nih.gov/) on a quarterly basis. There is no direct charge to users of the FITBIR Informatics System. A project estimation tool (https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp) is available to help estimate costs and manpower needs that may be associated with data submission.

Data Management Plan (two-page limit): Describe the data management plan in accordance with Section 3.c Enclosure 3, DoD Instructions 3200.12.

For Extramural Applications: Refer to General Application Instructions, Section III.A.2, Attachments Form, Attachment 2, Supporting Documentation, for more detailed information.

For Intramural Applications: Refer to General Application Instructions, Section IV.A.1, Application Component – Attachments, Attachment 2, Supporting Documentation, for more detailed information

Quad Chart: Provide a Quad Chart for the proposed project. The format for the quad chart is available on the eBRAP “Funding Opportunities & Forms” web page at https://ebrap.org/eBRAP/public/Program.htm.

https://fitbir.nih.gov/ https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/320012p.pdf?ver=2018-12-17-130508-423 https://ebrap.org/eBRAP/public/Program.htm

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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 from 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. For VA PIs, if the VA non-profit corporation is not identified as the applicant institution 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.

○ 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. Do not include proprietary or confidential information. Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.

Programmatic Reviewers rely on the technical abstract for appropriate description of the project’s key…