Trauma Immunology Research Award

Trauma Immunology Research Award is sponsored by Department of Defense (DoD), Defense Medical Research and Development Program (DMRDP). The Trauma Immunology Research Award (TIRA) supports basic and applied research and early-stage development of materiel and knowledge products to address critical gaps in the understanding of the immune system, immune response, immune function, and other associated host response…

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 Defense Medical Research and Development Trauma Immunology Research Award 1 # I.

OVERVIEW OF THE FUNDING OPPORTUNITY Program Announcement for the Department of Defense Congressionally Directed Medical Research Programs # Defense Medical Research and Development Program (DMRDP) # Joint Program Committee-6/Combat Casualty Care Research Program # Trauma Immunology Research Award Announcement Type: Initial Funding Opportunity Number: HT9425-23-DMRDP-TIRA Assistance Listing Number: 12.

420 Military Medical Research and Development Pre-Application Submission Deadline: 5:00 p. m. Eastern time (ET), August 15, 2023 Invitation to Submit an Application: September 21, 2023 Application Submission Deadline: 11:59 p.

m. ET, November 9, 2023 End of Application Verification Period: 5:00 p. m.

ET, November 14, 2023 Peer Review: January 2024 Programmatic Review: March 2024 DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 2 I. OVERVIEW OF THE FUNDING OPPORTUNITY....................................................... 1 II.

DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ................. 3 II. A.

Program Description........................................................................................................ 3 II. A.

1. FY23 DMRDP TIRA Focus Areas .......................................................................... 4 II.

B. Award Information .......................................................................................................... 4 II.

C. Eligibility Information ..................................................................................................... 7 II.

C. 1. Eligible Applicants ..................................................................................................

7 II. C. 2.

Cost Sharing............................................................................................................. 7 II. C.

3. Other ........................................................................................................................ 7 II.

D. Application and Submission Information........................................................................ 8 II.

D. 1. eBRAP and Grants.

gov ........................................................................................... 8 II. D.

2. Content and Form of the Application Submission .................................................. 9 II.

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

24 II. D. 4.

Submission Dates and Times ................................................................................. 24 II. D.

5. Funding Restrictions .............................................................................................. 25 II.

D. 6. Other Submission Requirements ...........................................................................

26 II. E. Application Review Information ...................................................................................

27 II. E. 1.

Criteria ................................................................................................................... 27 II. E.

2. Application Review and Selection Process ............................................................ 29 II.

E. 3. Integrity and Performance Information..................................................................

30 II. E. 4.

Anticipated Announcement and Federal Award Dates .......................................... 30 II. F.

Federal Award Administration Information .................................................................. 31 II. F.

1. Federal Award Notices ........................................................................................... 31 II.

F. 2. Administrative and National Policy Requirements ................................................

31 II. F. 3.

Reporting ................................................................................................................ 32 II. G.

Federal Awarding Agency Contacts.............................................................................. 33 II. G.

1. eBRAP Help Desk ................................................................................................. 33 II.

G. 2. Grants.

gov Contact Center .................................................................................... 33 II. H.

Other Information .......................................................................................................... 33 II. H.

1. Program Announcement and General Application Instructions Versions............. 33 II.

H. 2. Administrative Actions ..........................................................................................

33 II. H. 3.

Application Submission Checklist ........................................................................ 36 APPENDIX 1: ACRONYM/TERM LIST ............................................................................... 38 DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 3 # II.

DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY # II. A.

Program Description Applications to the Fiscal Year 2023 (FY23) Joint Program Committee 6/Combat Casualty Care Research Program (JPC-6/CCCRP) are being solicited for the Defense Health Agency (DHA) J9, Research and Development Directorate, 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).

As directed by the Office of the Assistant Secretary of Defense for Health Affairs (OASD[HA]), the DHA manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.

The U.S. Army Medical Research and Development Command (USAMRDC) Congressionally Directed Medical Research Programs (CDMRP) provides DMRDP execution management support for DHP core research program areas, including the JPC-6/CCCRP. This funding opportunity announcement and subsequent awards will be managed and executed by CDMRP on behalf of the JPC-6/CCCRP.

The FY23 Consolidated Appropriations Act identified Trauma Immunology as an important research gap and included $10M in funding for research to address this gap. This Congressional Special Interest program area is administered by JPC-6/CCCRP with support from CDMRP. The JPC-6/CCCRP is a committee of Department of Defense (DOD) and non-DOD medical and military technical experts in combat casualty care-related program areas.

The Combat Casualty Care Research Program (CCCRP) seeks to drive medical innovation through development of knowledge and materiel solutions for the acute and early management of combat-related trauma, including point-of-injury, en route, and facility-based care in order to optimize survival and recovery from combat-related injury in current and future operational scenarios.

A primary emphasis of the CCCRP is to identify and develop medical techniques, knowledge products, and materiel (medical devices, drugs, and biologics) for early intervention in life-threatening battle injuries and prolonged care.

Development and validation of in vitro and in vivo assessment models that represent military-relevant conditions in wounded Service Members, as well as those that incorporate a systems biology approach, are of interest to the CCCRP when they can be used to identify and describe the safety and efficacy of novel technologies in patients in a predictable manner.

The immunological response to traumatic injuries has been studied over the years, but much remains unknown. Traumatic injuries initiate a chain of reactions with immune cells and modulators that, depending on various factors, could be advantageous or deleterious.

Traumatic injuries can affect multiple organ systems and cell types, trigger the release of damage-associated molecular patterns (DAMPs) and other sterile inflammatory responses to hemorrhage and tissue damage, and subsequent responses involving pathogen-associated molecular patterns (PAMPs) from infectious agents. Traumatic injuries lead to barrier dysfunction and other complex pathologies locally and systematically.

This Trauma Immunology program area seeks to advance military trauma research to address unsolved traumatic injury-associated immunology questions to include mechanisms and early-stage development of potential therapeutics. DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 4 The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and the American public.

II. A. 1.

FY23 DMRDP TIRA Focus Areas In order to meet the intent of the award mechanism, applications must address at least one of the following FY23 Trauma Immunology Research Award (TIRA) Focus Areas: Studies seeking to understand the initial inflammation and immune response profile to severe polytrauma that involves multiple organs at the molecular, cellular, tissue, and organ level.

Studies seeking to understand the post traumatic local and systemic immune responses and pathophysiological mechanisms. Of particular interest are studies that seek to understand how the immune response leads to secondary organ damage. Early-stage development of potential novel products and knowledge for treating severe polytrauma and associated deleterious immune responses.

Development and optimization of animal models that mimic the human trauma immunologic response, to improve the understanding of the human immune response and functions during and post severe polytrauma. # II. B.

Award Information The Trauma Immunology Research Award (TIRA) will support basic and applied research and early-stage development of materiel and knowledge products to address critical gaps in the understanding of immune system, immune response, immune function, and other associated host responses in combat injuries, in particular, severe polytrauma as encountered in the operational environment.

Polytrauma is defined as two or more injuries to physical regions or organ systems, one of which may be life-threatening, resulting in physical, cognitive, psychological, or psychosocial impairments and functional disability ( https://www. polytrauma. va.

gov/ understanding-tbi/definition-and-background. asp ). Specifically, the research that supports the understanding of inflammation, immune responses, and other host reactions at and post trauma as well as associated potential treatments represents key priorities for the CCCRP 1.

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 > 1U.

S. General Accounting Office. 2018.

New trauma care system: DOD should fully incorporate leading practices into its planning for effective implementation. GAO-18-300 Report. DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 5 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 total costs budgeted for the entire period of performance for an FY23 DMRDP Trauma Immunology Research Award should not exceed $2. 0M .

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 CCCRP expects to allot approximately $10. 0M to fund approximately five FY23 DMRDP TIRA 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 anticipated that awards made from this FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.

Research Involving Human Data, Human Anatomical Substances, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (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. Research involving animals, human anatomical substances, and human data is permitted; however, this award may not be used to conduct prospectively enrolled human subject clinical trials or clinical research. > Clinical trials are not allowed under this mechanism.

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. > Clinical research conducted with prospectively enrolled human subjects is not allowed under this mechanism.

Clinical research encompasses research with patient samples, data, and interaction DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 6 with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research .

Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research.

Patient-oriented research 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 study the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial. Excluded from the definition of clinical research are in vitro studies that utilize human tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.

104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required. Use of DOD or VA Resources: If the proposed research involves access to VA or DOD resources, or databases, the proposal/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.

Note, the CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOD or VA patient populations, resources, or databases.

Access to certain DOD or VA patient samples, resources, or databases may only be obtained by collaboration with a DOD or VA investigator who has a substantial role in the research and may not be available to a non-DOD or non-VA investigator if the resource is restricted to DOD or VA personnel.

Investigators should be aware of which resources are available to them if the proposed research involves a non-DOD or non-VA investigator collaborating with the DOD and/or VA. If the application is recommended for funding, the government reserves the right to withdraw or revoke funding until the Principal Investigator (PI) has demonstrated support for and access to the relevant population(s) and/or resource(s).

Research Involving Animals: All research funded by the FY23 DMRDP TIRA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC 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. DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 7 # 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 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/ . Cost sharing/matching is not an eligibility requirement. 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.

DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 8 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 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. Contact information for the eBRAP Help Desk and the Grants.

gov Contact Center can be found in Section II. G, Federal Awarding Agency Contacts . 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. DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 9 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 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. A change in PI or organization after submission of the pre-application may be allowed after review of a submitted written appeal (contact the eBRAP Help Desk at help@eBRAP.

org or 301-682-5507) and at the discretion of the USAMRAA Grants Officer. 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): DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 10 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 DMRDP TIRA 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. 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 (three-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 DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 11 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: Focus Area: Describe how the project addresses at least one of the FY23 DMRDP TIRA Focus Areas. Rationale: State the hypothesis and scientific rationale on which the proposed research project is based. Concisely describe how preliminary data and/or referenced literature support the research hypothesis and scientific rationale.

Specific Aims and Study Design: Concisely describe the project’s objectives, specific aims, and ultimate endpoints, and how they support the proposed research. If applicable, describe the animal models to be used and their relevance to human disease. Research Team: Provide a description of the PI and key personnel that clearly demonstrates the appropriate background and experience to accomplish the proposed work.

Impact and Military Benefit: Describe the potential near-term and long-term impact of the proposed research. Explain how the effort will advance military trauma research.

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.

DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 12 Pre-Application Screening Pre-Application Screening Criteria To determine the technical merits of the pre-application and the relevance to the mission of FY23 DMRDP, pre-applications will be screened based on the following criteria: Focus Area: How well the proposed study addresses at least one FY23 DMRDP TIRA Focus Areas.

Rationale: How well the hypothesis and scientific rationale are supported through preliminary data and/or referenced literature. Specific Aims and Study Design: To what degree the project’s objectives, specific aims, and ultimate endpoints support the proposed research. If applicable, how relevant the chosen animal model is to human disease.

Research Team: Whether the background and experience of the PI and key personnel are appropriate to perform the proposed research. Impact and Military Benefit: To what extent the proposed research will have potential near-term and long-term impact and advance military trauma research.

Notification of Pre-Application Screening Results Following the pre-application screening, Initiating PIs will be notified as to whether 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. DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 13 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. Table 1. Full Application Submission Guidelines Extramural Submissions Intramural DOD Submissions Application Package Location Download application package components for HT9425-23-DMRDP-TIRA 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-DMRDP-TIRA 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: Research & Related Personal Data Research & Related Senior/Key Person Profile (Expanded) Research & Related Budget 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: Budget DOD FY23 Defense Medical Research and Development Trauma Immunology Research Award 14 Extramural Submissions Intramural DOD Submissions Project/Performance Site Location(s) Form Research & Related Subaward Budget Attachment(s) Form 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 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. 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 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