FY21 DMRDP JPC6 ERCA PA_GG.pdf

This Program Announcement must be read in conjunction with the General Application Instructions, version 601. 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 FY21 DMRDP JPC-6/CCCRP ERC Award 1

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Program Announcement for the Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Defense Medical Research and Development Program (DMRDP)

Joint Program Committee 6 (JPC-6)/

Combat Casualty Care Research Program (CCCRP)

En Route Care Award

Announcement Type: Initial

Funding Opportunity Number: W81XWH-21-DMRDP-ERCA

Catalog of Federal Domestic Assistance 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), March 31, 2021

• Invitation to Submit an Application: May 13, 2021

• Application Submission Deadline: 11:59 p.m. ET, June 23, 2021

• End of Application Verification Period: 5:00 p.m. ET, June 28, 2021

• Peer Review: August 2021

• Programmatic Review: October 2021

DoD FY21 DMRDP JPC-6/CCCRP ERC 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. FY21 DMRDP JPC-6/CCCRP ERCA Focus Areas

II.A.2. Award Background

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. Address to Request Application Package

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

II.D.3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number 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. CDMRP 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

APPENDIX 2: TECHNOLOGY READINESS LEVELS AND KNOWLEDGE

READINESS LEVELS

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II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

II.A. Program Description

Applications to the Fiscal Year 2021 (FY21) 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 2358 (10 USC 2358). 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 US Army Medical Research and Development Command (USAMRDC) Congressionally Directed Medical Research Programs (CDMRP) provides Defense Medical Research and Development Program (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 the CDMRP with strategic oversight from the JPC-6/CCCRP.

The JPC-6/CCCRP is one of five core research program areas within the DHP. 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 JPC-6/CCCRP strives to optimize survival and recovery from combat-related or trauma-induced injury in current and future operational scenarios. This is being accomplished through the development of knowledge and materiel products for the acute and early management of combat-related or trauma-induced injury, including point-of-injury, en route, and forward surgical care. Products developed by JPC-6/CCCRP-supported research are applied in-theatre and within the clinical facilities of the Military Health System (MHS). These solutions not only minimize the morbidity and mortality of combat-related injuries in Service members, they also are often translatable to the civilian healthcare system.

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

II.A.1. FY21 DMRDP JPC-6/CCCRP ERCA Focus Areas

The JPC-6/CCCRP En Route Care (ERC) portfolio seeks to provide materiel and knowledge solutions to enable increased levels of care en route, mitigate negative effects of transportation or environmental extremes, provide patient care for longer time periods when delayed evacuation exceeds available capability and/or capacity, and extend provider capabilities in order to care for larger numbers of casualties.

The JPC-6/CCCRP has identified the following Focus Areas for funding under the FY21 DMRDP JPC-6/CCCRP ERCA. To meet the intent of the award mechanism, applications MUST specifically address at least one ERCA Focus Area. Research not aligned to at least one Focus Area will not be considered for funding. The ERCA Focus Areas are:

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• Patient movement (e.g., ground, air, and sea transport) o Improved understanding of factors that influence clinical outcomes o Knowledge and materiel solutions to mitigate the negative impacts of patient movement

Areas of interest include evidence-based safe transport and patient hand-off guidelines for critically injured patients (e.g., optimal altitude to prevent/ reduce secondary trauma following hemorrhagic shock or traumatic brain injury, or vibration restrictions in post-operative patients) during and following a prolonged care scenario and documentation to improve outcomes and injury characteristics.

• ERC in extreme cold environments (-25°F to -40°F or -32°C to -40°C) o Improved understanding of the factors that influence ERC performance and patient clinical outcomes o Knowledge and materiel solutions to improve ERC performance and patient outcomes in extreme cold environments

Areas of interest include care provider cognitive and physical performance, durability and efficacy of ERC tools and materials, and environmental constraints imposed.

• Mode, timing, and regulation of movement for ill, injured, resuscitated, and post-operative patients using manned or unmanned systems o Improved understanding of factors that influence clinical outcomes o Knowledge and material solutions to improve patient outcomes

II.A.2. Award Background

As the DoD prepares to address future battlefield, the outlook is framed in the recognition that the return of great power competition and multiplication of emerging threats portends changes in the pace, place, and complexity of war. Increased competition from technologically advanced and well-resourced peer and near-peer states, as well as global technological advances that enable emerging small- and non-state actors to generate threats, increasingly challenge United States deterrence, which is being contested in all domains.(References [Ref.] 1,2 below)

Simultaneously, changes in the Arctic landscape have exposed previously unreachable natural resources, increasing competition between Arctic nations, here in relatively close proximity, in a vast and inhospitable environment above latitude 66° 34' North.(Ref. 3, below) Consequently, the DoD’s strategic approach is to build Arctic awareness, enhance Arctic operations, and strengthen rules-based order in the region by re-invigorating Arctic warfighting capability through training exercises, strengthen regional partnerships, military capability gap

DoD FY21 DMRDP JPC-6/CCCRP ERC Award 5 identification, and Arctic equipment testing to signal commitment to the Arctic region.(Ref. 3-5, below)

Decay of Arctic fighting acumen since the cold war has left a number of knowledge gaps currently being filled in a number of joint exercises in the region,(Ref. 6, below) but with a number of questions remaining for how best to provide combat casualty care and patient movement to support the Warfighter. Extreme Arctic conditions produce multitudinous challenges for flight operations,(Ref. 7, below) but patient care capability will also be severely impacted. For example, self-aid and buddy care will be complicated by the necessity for and presence of Arctic-wear. Moreover, tactical field care will necessarily include moving the casualty to a sheltered environment to mitigate a very rapid onset of hypothermia. Consequently, combat vehicles will likely become the first shelters of opportunity but with very limited space for the provision of critical care. As a consequence, hypothermia mitigation and treatment merit very high consideration.

Unfortunately, existing hypothermia prevention devices have limited ability to maintain core temperature at 37°C (98.6°F) for 2 hours at ambient temperatures of 22.5°C (72.5°F).(Ref. 8, below) It is unknown if these products will function or be completely ineffectual at maintaining body core temperature in lower ambient temperatures. Moreover, these products will likely be unable to restore body core temperature in casualties already suffering from marked hypothermia, particularly against frigid temperatures. Such equipment limitation is not restricted to temperature management devices; it remains unknown how extreme cold regions will affect function and employment of all en route care tools and supplies.

Beyond challenges imposed by extreme cold, locating and retrieving casualties is further complicated by Arctic topology and vast distances, much over the semi-frozen seas. Opening of sea lanes as a consequence of thinning sea ice has seen a remarkable increase in ship casualties, placing an extraordinary burden on search and rescue (SAR) capability. Between 2005 and 2019, the rate of casualties in Arctic circle waters for commercial ships with gross weight meeting or exceeding 100 tons increased 1366%; “Given the location of current U.S. Coast Guard operating bases, it could take Coast Guard aircraft several hours, and Coast Guard cutters days or even weeks, to reach a ship in distress or a downed aircraft in Arctic waters.”(Ref. 3, below) Constrained to providing care solely within the confines of the evacuation platform, en route care providers most often become task-saturated with very low numbers of casualties.(Ref. 9, below)

Patient movement by unmanned systems (ground, sea, and air) is of tremendous interest as a means to increase patient movement capability in hazardous and austere conditions if these systems can be made to sustain casualties during patient movement.

Automating patient movement and en route care is a research and development priority for all the services.(Ref. 10-12, below) Generally, the pathway includes: machine perception, reasoning, and intelligence; human-autonomous system interaction and collaboration; scalable teaming of autonomous systems; and testing, evaluation, validation, and verification.(Ref. 13, below) While great strides have been made toward increasing closed-loop systems to automate specific tasks much work remains to be accomplished toward coordinating and integrating multiple closed-loop systems.

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References:

1. Mattis J. 2018. Summary of the 2018 National Defense Strategy of the United States of America. Department of Defense, Washington.

2. U.S. Army Training and Doctrine Command. 2018. The U.S. Army in Multi- Domain Operations 2028. Department of the Army. Retrieved from:

https://www.tradoc.army.mil/Portals/14/Documents/MDO/TP525-3- 1_30Nov2018.pdf.

3. O’Rourke R, Comay LB, Folger P, et al. 2020. Changes in the Arctic: Background and Issues for Congress. Retrieved November 4, 2020 from https://crsreports.congress.gov/product/pdf/R/R41153.

4. Statement for the Record before the Senate Armed Services Committee, Subcommittee on Readiness and Management Support, on U.S. Policy and Posture in Support of Arctic Readiness, March 3, 2020, pp. 2-4.

5. Office of the Under Secretary of Defense for Policy. Report to Congress Department of Defense Arctic Strategy. June 2019. Retrieved November 18, 2020 from https://media.defense.gov/2019/Jun/06/2002141657/-1/-1/1/2019-DOD-ARCTIC- STRATEGY.pdf.

6. Marine Corps Forces Europe. 2020. U.S. forces to hone Arctic warfare skills in Norway’s high North in exercise Cold Response 20. Retrieved November 18, 2020 from https://www.marines.mil/News/News-Display/Article/2100494/us-forces-to-hone-arctic-warfare-skills-in-norways-high-north-in-exercise-cold/.

7. Defense Systems Information Analysis Center. 2019. 2d Marine Aircraft Wing (MAW) Aviation Operations in Amphibious Environments Study.

8. Allen PB, Salyer SW, Dubick MA, et al. Preventing hypothermia: Comparison of current devices used by the US Army with an in vitro warmed crystalloid fluid model. J Trauma 69 Suppl 1:S154-S161.

9. Conti S, Lloyd A, Kinsler R, et al. 2019. A Novel Test of Define Task Saturation Limits of U.S. Army Critical Care Flight Paramedics. USAARL Enroute Care Research Group.

10. States Air Force. 2020. Air Force Surgeon General Medical Modernization Priorities for Fiscal Year 22-26 Program Objective Memorandum.

11. Office of Naval Research. 2015. Naval S&T Strategy. Retrieved November 20, 2020 from https://defenseinnovationmarketplace.dtic.mil/wp-content/uploads/2018/02/NavalSTStrategy2015_Final_01-26-15.pdf.

12. U. S. Army. 2017. The US Army Robotic and Autonomous Systems Strategy. Internet) available at: www.arcic.army.mil/App_Documents/RAS_Strategy.pdf.

http://www.tradoc.army.mil/Portals/14/Documents/MDO/TP525-3-1_30Nov2018.pdf https://crsreports.congress.gov/product/pdf/R/R41153 https://media.defense.gov/2019/Jun/06/2002141657/-1/-1/1/2019-DOD-ARCTIC-STRATEGY.PDF https://media.defense.gov/2019/Jun/06/2002141657/-1/-1/1/2019-DOD-ARCTIC-STRATEGY.PDF https://www.marines.mil/News/News-Display/Article/2100494/us-forces-to-hone-arctic-warfare-skills-in-norways-high-north-in-exercise-cold/ https://www.marines.mil/News/News-Display/Article/2100494/us-forces-to-hone-arctic-warfare-skills-in-norways-high-north-in-exercise-cold/ https://defenseinnovationmarketplace.dtic.mil/wp-content/uploads/2018/02/NavalSTStrategy2015_Final_01-26-15.pdf https://defenseinnovationmarketplace.dtic.mil/wp-content/uploads/2018/02/NavalSTStrategy2015_Final_01-26-15.pdf

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13. Conway III JL. 2017. Toward a US Air Force Arctic strategy. Air & Space Power Journal 31.2:68. Bornstein, J.2015. DOD autonomy roadmap: Autonomy community of interest. Army Research Laboratory Aberdeen Proving Ground United States.

14. Hatzfeld J, Hildebrandt G, Maddry J, et al. 2021. Top 10 research priorities for United States Military en route combat casualty care. Mil Med doi: 10.1093/milmed/usaa480 [online ahead of print].

II.B. Award Information

The intent of this award mechanism is to support development of highly innovative materiel and knowledge products to drive critical combat casualty care capabilities to the Warfighter in highly mobile, austere, and extreme environments where evacuation capabilities may be significantly delayed or unavailable.(Ref. 2, above) This Funding Opportunity aligns with the recently published Committee on En Route Combat Casualty Care (CoERCCC) top 10 research priorities including: medical documentation, clinical decision support, patient monitoring, transfer of care, transport physiology, maintenance of normothermia, transport timing, intelligent tasking, commanders’ decision support, and unmanned transport,(Ref. 14, above) and focuses on research to knowledge and materiel to improve the en route care and patient movement from point of injury to definitive care by ground, air, and sea.

The solutions under this Funding Opportunity will not be limited to military use. Knowledge and materiel products developed will have applications in civilian environments as well. Natural disasters, explosive events, accidents, and mass shootings can generate a surge of casualties and complex injuries that can mirror those seen on the battlefield. Additionally, civilians, particularly those in rural areas, face challenges with delayed access to hospital-based care.

While only 20% of all Americans live in rural areas, they account for more than 50% of all trauma-related fatalities. The majority of these individuals do not live within an hour of a Level I or II trauma center and could benefit from improvements in ERC. Solutions generated by this work will be applicable in civilian settings where mode of patient movement, environmental conditions, or traumatic condition are similar to the military use case.

We anticipate that projects funded under this award mechanism, as systematic application of knowledge or understanding, directed toward the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements, will increase survivability from both combat-related and trauma-induced injuries.

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

DoD FY21 DMRDP JPC-6/CCCRP ERC Award 8 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 FY21 DMRDP JPC-6/CCCRP ERCA will not exceed $1.4 million (M). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $1.8M of the FY21, $1.8M of the FY22, and $1.8M of the FY23 DHP RDT&E appropriations to fund approximately three or four (3 or 4) FY21 DMRDP JPC_6/CCCRP ERC Award 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 FY21 funding opportunity will be funded with FY21, FY22, and FY23 funds, which will expire for use on September 30, 2027, September 30, 2028, and September 30, 2029, respectively.

Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the U.S. Army Medical Research and Development Command (USAMRDC) Office of Research Protections (ORP), Human Research Protection Office (HRPO), 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 submission is not required. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

If the proposed research is cooperative (i.e., involving more than one 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.

This Funding Opportunity may support applied or clinical research; however, clinical trials are not allowed under this Funding Opportunity. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions https://ebrap.org/eBRAP/public/Program.htm

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(which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Clinical Research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research. Note: Studies that meet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.

Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active duty military 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.

Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC ORP 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.

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 organization other than the DoD, and research institutes.

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Intramural DoD Organization: A DoD laboratory, DoD military treatment facility, and/or DoD activity embedded within a civilian medical center. Intramural Submission: 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.

USAMRAA makes awards to eligible organizations, not to individuals.

II.C.1.b. Principal Investigator

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

The CDMRP 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/.

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).

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.

https://orcid.org/ https://ebrap.org/

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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.1. Address to Request Application Package eBRAP is a multifunctional web-based system that allows PIs to submit their pre-applications electronically through a secure connection, to view and edit the content of their pre-applications and full applications, to receive communications from the CDMRP, and to submit documentation during award negotiations and period of performance.

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

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 CDMRP 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 CDMRP Help Desk at help@eBRAP.org or 301-682-5507 to request a change in designation.

https://ebrap.org/ https://ebrap.org/ mailto:help@eBRAP.org

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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 PIs 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 CDMRP 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.

FY21 DMRDP JPC-6/CCCRP ERCA Programmatic Panel members should not be involved in any pre-application or application. For questions related to panel members and pre-https://ebrap.org/ mailto:help@eBRAP.org https://ebrap.org/eBRAP/public/Program.htm https://cdmrp.army.mil/dmrdp/panels/21jpc_6_erca

DoD FY21 DMRDP JPC-6/CCCRP ERC Award 13 applications or applications, refer to Section II.H.2.c, Withdrawal, or contact the CDMRP 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 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 Plan: Concisely state the ideas and rationale on which the proposed work is based. State the project’s hypotheses, objectives, and specific aims, and briefly describe the experimental approach.

– Personnel: Briefly state the qualifications of the PI and key personnel to perform the described research project.

– Innovation, Impact and Relevance: State explicitly how the proposed work is innovative and may improve trauma care. Describe the potential impact of this application to directly or indirectly benefit military Service members during multi-domain operations (MDO) and the public.

– Alignment with Focus Areas: Identify and explain how the proposed work addresses at least one of the FY21 DMRDP JPC-6/CCCRP ERCA Focus Areas.

○ 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).

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– 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.

– Budget Summary: Upload as “BudgetSummary.pdf”. Complete the two-page Pre- Application Budget Summary Form (available for download in eBRAP) as instructed.

– Quad Chart: Upload as “QuadChart.pdf”. Complete the Quad Chart template, a one-page PowerPoint file that must be downloaded from the CDMRP eBRAP System at https://ebrap.org/eBRAP/public/Program.htm, and save, using Adobe Acrobat Reader, as a PDF file.

• 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 DHP and the JPC-6/CCCRP, pre-applications will be screened based on the following criteria:

○ Research Plan: How well the rationale, hypotheses, objectives, specific aims, and experimental approach support the research idea(s).

○ Alignment with Focus Areas: To what extent the proposed work addresses at least one of the FY21 JPC-6/CCCRP ERCA Focus Areas.

○ Innovation, Impact and Relevance: To what extent the study outcomes could improve trauma care. How well the proposed study is innovative and will directly or indirectly benefit military Service members during MDO and the public.

○ Personnel: To what extent the qualifications of the PI and key personnel are appropriate to perform the proposed research project.

• 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

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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://www.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.

Table 1. Full Application Submission Guidelines

Extramural Submissions Intramural DoD Submissions

Application Package Location Download application package components for W81XWH-21-DMRDP-ERCA from Grants.gov (https://www.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 W81XWH-21-DMRDP-ERCA from eBRAP (https://ebrap.org).

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

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Extramural Submissions Intramural DoD Submissions

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.

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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 if the Project Narrative or the budget 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 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.

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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.

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 MB, and the file size for the entire full application package may not exceed 200 MB.

○ Attachment 1: Project Narrative (15-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 to expand 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.

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– Background: Describe in detail the scientific rationale for the proposed study.

Include a literature review and, if applicable, provide preliminary studies and/or data that support the scientific rationale and led to the development of the research project.

The background section should clearly support the choice of study variables and should explain the basis for the study questions and/or study hypotheses. Establish the relevance and applicability of the proposed study and findings to the intent of the mechanism and address at least one of the FY21 JPC-6/CCCRP ERCA Focus Areas.

– Objectives/Specific Aims/Hypothesis: Provide a description of the purpose and objectives of the study with detailed specific aims and hypotheses.

All proposed research:

Describe the experimental design, controls, methods, and analyses, and their integration into the project and how they will generate rigorous and reproducible results.

Define the study variables and describe how they will be measured. Include a description of appropriate controls, endpoints to be used, and analyses to be performed and how they function to achieve the research objectives and the anticipated outcomes of the study.

Describe the statistical plan as appropriate for the proposed research.

Identify and describe potential problem areas in the proposed approach and alternative methods and approaches that will be employed to mitigate any risks that are identified.

Applications that include research on animal models are also required to submit Attachment 8, Animal Research Plan.

For research involving human subjects:

Describe the population(s) of interest and how they relate to the research objectives.

Describe the methods that will be used to recruit a sample of human subjects from the accessible population (e.g., convenience, simple random, stratified random).

Describe the human subject-to-group assignment process (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group, or other procedures), if applicable. Explain the specific actions to accomplish the group assignment (e.g., computer assignment, use of table of random numbers).

Specify the approximate number of human subjects that will be enrolled. If multiple study sites are involved, state the approximate number to be enrolled

DoD FY21 DMRDP JPC-6/CCCRP ERC Award 20 at each site. Include a complete power analysis to demonstrate that the sample size is appropriate to meet the objectives of the study. If a subpopulation of a recruited sample population will be used for analysis, complete a statistical analysis to ensure appropriate power can be achieved within the subpopulation study.

– Personnel: Describe how the composition, background, expertise, levels of effort, and record of success of the research/study team personnel (e.g., study coordinator, statistician, etc.) are appropriate to ensure success of the proposed research.

○ 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,…