HT942524SMBRP-TTDA-BAA_GG.pdf

This broad agency announcement must be read in conjunction with the General Submission Instructions, which are available for downloading from the Grants.gov funding opportunity announcement by selecting the “Package” tab, clicking “Preview,” and then selecting “Download Instructions.”

DOD FY24 MBRP Technology/Therapeutic Development Award 1

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Broad Agency Announcement for Extramural Research for the Department of Defense

Defense Health Program

Congressionally Directed Medical Research Programs

Military Burn Research Program

Technology/Therapeutic Development Award

Announcement Type: Initial

Funding Opportunity Number: HT942524SMBRP

Assistance Listing Number: 12.420 Military Medical Research and Development

SUBMISSION AND REVIEW DATES AND TIMES

• Pre-application (Preproposal) Submission Deadline: 5:00 p.m. Eastern time (ET), June 3, 2024

• Invitation to Submit an Application: July 21, 2024

• Application Submission Deadline: 11:59 p.m. ET, September 9, 2024

• End of Application Verification Period: 5:00 p.m. ET, September 16, 2024

• Peer Review: November 2024

• Programmatic Review: January 2025

DOD FY24 Military Burn Technology/Therapeutic Development Award 2

TABLE OF CONTENTS

I. OVERVIEW OF THE FUNDING OPPORTUNITY

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Description

II.A.1. FY24 MBRP Focus Areas

II.A.2. Award History

II.B. Award Information

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.2. Cost Sharing

II.C.3. Other

II.D. Application and Submission Information

II.D.1. Location of Application Package

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

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

II.D.4. Submission Dates and Times

II.D.5. Funding Restrictions

II.D.6. Other Submission Requirements

II.E. Application Review Information

II.E.1. Criteria

II.E.2. Application Review and Selection Process

II.E.3. Integrity and Performance Information

II.F. Federal Award Administration Information

II.F.1. Federal Award Notices

II.F.2. 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. Administrative Actions

II.H.2. Application Submission Checklist

APPENDIX I: ACRONYM LIST

APPENDIX II: TECHNOLOGY READINESS LEVELS AND KNOWLEDGE

READINESS LEVELS

APPENDIX III: DOD AND VA WEBSITES

APPENDIX IV: FAR/DFARS CLAUSES APPLICABLE TO CONTRACTS

REQUIREMENTS

DOD FY24 Military Burn Technology/Therapeutic Development Award 3

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

This funding opportunity announcement is a broad agency announcement (BAA) through the fiscal year 2024 (FY24) Military Burn Research Program (MBRP) for the Technology/Therapeutic Development Award (TTDA). For the remainder of the announcement, this BAA will be referenced as the MBRP TTDA. Specific submission information and additional administrative requirements can be found in the document titled “General Submission Instructions,” available in Grants.gov along with this BAA.

This BAA for MBRP is intended to solicit extramural research and development ideas using the authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). This BAA is issued under the provisions of the Competition in Contracting Act (CICA) of 1984 (Public Law 98-369), as implemented in Federal Acquisition Regulation (FAR) 6.102(d)(2) and

35.016 and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 35.016, projects funded under this BAA must be for applied research “not related to the development of a specific system or hardware procurement.” Research and development funded through this BAA is intended and expected to benefit and inform both military and civilian medical practice and knowledge.

This BAA is intended for extramural applicants only. For definitions and additional information, see Section II.C.1, Eligible Applicants. Intramural applicants applying through intramural organizations should use the separate funding opportunity announcement that is available through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org/ under funding opportunity number HT942524MBRPTTDA. The North American Industry Classification System (NAICS) code for contracts under this announcement is 541715 - Research and Development in the Physical, Engineering, and Life Science (except nanotechnology and Biotechnology) with a small business size standard of 1,000 employees.

II.A. Program Description

The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the fiscal year 2024 (FY24) MBRP using delegated authority provided by 10 USC 4001. The Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC) is the program management agent for this funding opportunity.

Congress initiated the MBRP in 2011 to address combat-related and trauma-induced burn injuries as well as to improve health and performance outcomes for burn-injured Service Members. Appropriations for the MBRP from FY11 through FY23 totaled $110 million (M).

The FY24 appropriation is $10M.

Burn injuries sustained by military Service Members while in the line of duty, whether on the battlefield or in a military training environment, represent a continuous health burden on both the injured Service Member and the Department of Defense health care systems in which they receive care. Historically, burn injuries afflicted some 5% to 20% of casualties during post-https://ebrap.org/

DOD FY24 Military Burn Technology/Therapeutic Development Award 4

World War II conflicts.1 In recent years, burns sustained during Operation Enduring Freedom/ Operation Iraqi Freedom affected nearly 9% of combat-related casualties.2 While thermal burns represent the most common mechanism of burn injury, other injurious mechanisms such as frostbite, high-voltage electrical, chemical, directed energy, and radiation/nuclear exposure represent an additional formidable threat to the health and well-being of Service Members. The Armed Forces Health Surveillance Division reports an increased number of cold-related injuries in recent years; high-voltage accidents occur on and off the battlefield; and the threat of chemical, nuclear, or directed energy weapons is an ever-present danger. Regardless of mechanism, combat-associated burn injuries are devastating due, in part, to the high incidence of concurrent severe traumatic injuries. In addition, burns sustained in a deployed environment more often lead to severe burns than those sustained in the civilian setting. The majority of combat burns sustained in recent conflicts resulted from explosive device detonation, leading to a greater Injury Severity Score, an increase in inhalation injuries, and a larger, full-thickness burn size.3 It is anticipated that in future conflicts the explosive weaponry used against U.S. forces will be more powerful than that seen in the past, likely resulting in a higher number of casualties with significant injuries and larger, more severe burns. Furthermore, the care provided to Service Members in a combat environment where evacuation may be significantly delayed may impact clinical outcomes. Irrespective of the injury mechanism, prolonged delay to definitive care renders assessment and treatment of burn wounds at or close to the point of injury challenging to medical and non-medical first responders alike. There is an urgent need to develop, refine, or test novel burn therapies or technologies that would allow for better provision of care, particularly in resource-limited settings, and to improve both short- and long-term patient outcomes.

II.A.1. FY24 MBRP Focus Areas

To meet the intent of the funding opportunity, the program seeks to fund research that enhances the ability to provide burn care in a resource-limited, austere setting such as a military operational environment. The program seeks to enhance the ability of medical and non-medical first responders and/or early-phase acute care medical providers to accurately assess burn severity, adequately treat burns, mitigate and/or treat burn-associated complications, and prevent progression of burn depth. Enhancing the ability to provide high-quality burn care at the point of injury and during the early, acute phase of care is expected to shorten the time to recovery and facilitate the physical and psychological health and well-being among burn-injured Service Members, with the potential for benefit among Veterans, military beneficiaries, and the American public. Within this context, the MBRP is interested in research proposals that address specific gaps in the area of military-relevant burns. Proposed research must address at least one of the following FY24 MBRP Focus Areas:

1 Kauvar DS, Wade CE, and Baer DG. 2009. Burn hazards of the deployed environment in wartime: Epidemiology of noncombat burns from ongoing United States military operations. Journal of the American College of Surgeons 209(4):453-460.

2 Escolas SM, Archuleta DJ, Orman JA, et al. 2015. Postdischarge cause-of-death analysis of combat-related burn patients. Journal of Burn Care and Research: Official Publication of the American Burn Care Association 38(1):e158-e164.

3 Kauver DS, Cancio LC, Wolf SE, et al. 2006. Comparison of combat and non-combat burns from ongoing U.S.

military operations. The Journal of Surgical Research 132:195-200.

DOD FY24 Military Burn Technology/Therapeutic Development Award 5

• Atypical Burns: Development and/or validation of methods to assess, treat, and/or prevent the progression of burns resulting from cold exposure, radiation, directed energy, chemical, or high voltage/combat-related electrical injuries.

• Burn Knowledge Products: Research to innovate best practices in the acute burn care continuum.

• Burn Injury-Related Complications: Development and/or validation of methods to prevent, assess, and/or treat burn injury-related complications including:

○ Over/under fluid resuscitation to include limited or low volume resuscitation

○ Acute respiratory distress syndrome (ARDS)

○ Sepsis

○ Inhalation injuries

○ Peripheral neuropathy

○ Chronification of pain (prevention only)

In order to meet the MBRP mission to “identify and close gaps in combat burn trauma care through military-focused research,” the program is providing a list of MBRP research priorities, herein referred to as Areas of Encouragement, to assist researchers in developing highly relevant proposals. The Areas of Encouragement were developed to complement the FY24 MBRP Focus Areas. The Areas of Encouragement were identified by the FY24 MBRP Programmatic Panel as high-priority capability and knowledge gaps. Although applicants are not required to address any Area of Encouragement from the list below, the program encourages applicants to read and consider the Areas of Encouragement before preparing their applications.

Areas of Encouragement:

• Development of a combination burn wound care product that prevents infection, burn progression, and pain; enhances healing through replacement or repair of the epidermis or dermis; is usable at the point-of-injury or soon thereafter.

• Development or refinement of point-of-injury and/or early acute burn wound care products that can be used in delayed care scenarios for at least 5 days.

• Expanded, novel indications for U.S. Food and Drug Administration (FDA)-approved medical products to achieve burn relevance.

• Development of therapeutics that mitigate burn-associated acute respiratory distress syndrome (ARDS) and/or refractory hypoxemia.

• Development of novel high fidelity burn simulation training aides.

DOD FY24 Military Burn Technology/Therapeutic Development Award 6

• Studies that test the safety and efficacy of frostbite treatment in a delayed evacuation field environment.

• Development of treatments for burn wounds and/or burn lung injury from closed-space fires.

• Development of medical countermeasures to prevent, or reduce the severity of, cold, steam, radiation, or directed energy burns (excludes clothing, or clothing-like products).

• Advanced, shelf-stable allografts for large surface area burns to be used and stored in austere conditions.

• Advanced allografts or skin substitutes that reduce immunogenicity to eliminate or reduce autograft need.

• Development of donor site sparing technologies for autografting.

• Development of a treatment or technology to repair burn-related peripheral nerve damage associated with neuropathy, neuralgia, and/or pruritis.

• Collaborative studies that align civilian and military burn research.

II.A.2. Award History

The MBRP TTDA mechanism was first offered in FY22. Since then, 60 Technology/ Therapeutic Development Award applications have been received, and five have been recommended for funding.

II.B. Award Information

The MBRP TTDA is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical application in resource-limited settings, particularly within the pre-hospital, or early, acute phase of care environments.

Applications must address one or more of the critical gaps included in the FY24 MBRP TTDA Focus Areas. Products under development must address the needs of military Service Members, Veterans, their beneficiaries, and the American public.

The product(s) to be developed may be a tangible item such as a medical device or pharmacologic agent (including, but not limited to, drugs or biologics). Knowledge products may be considered, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-materiel product that addresses an identified need in one or more of the FY24 MBRP TTDA Focus Areas. A knowledge product is based on current evidence, aims to transition clinical practice standards, training, or tools into clinical practice, or supports materiel solutions [systems to develop, acquire, provide, and sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.)

At the time of pre-application submission the proposed product must have achieved a minimum technology readiness level (TRL) or knowledge readiness level (KRL) of 3 (Appendix II).

DOD FY24 Military Burn Technology/Therapeutic Development Award 7

Proof-of-concept AND a prototype/preliminary version of the proposed product demonstrating its potential utility must be established at the time of pre-application submission. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.

This award mechanism is intended to facilitate progression of research that is supported by significant preliminary data but has not yet advanced to the level of clinical use. Examples of the types of research that may be supported include, but are not limited to:

• Testing new therapeutic or technologic modalities (e.g., agents, delivery systems, chemical modification of lead compounds, device testing and/or validation) using established or validated preclinical systems

• Designing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or technologies for use in advanced preclinical studies

• Developing pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity studies

• Investigational New Drug- or Investigational Device Exemption-enabling studies

Clinical trials and clinical research studies ARE NOT PERMITTED under this award mechanism. Projects involving limited use of commercially available human cells or anatomical specimens are permitted, provided that the use of such specimens is necessary for device or product development. Applicants interested in proposing clinical research should consider submitting to the FY24 MBRP Patient-Centered Research Award mechanism

(HT942524MBRPPCRA).

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

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

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

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease,

(b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and

(d) development of new technologies.

DOD FY24 Military Burn Technology/Therapeutic Development Award 8

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

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

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

Impact: The overall impact of the proposed research is a key component of this award mechanism. High-impact research will, if successful, lead to the development and translation of therapeutic or technologic advances for clinical application in the care of burn-injured casualties, such as detection, diagnosis, treatment, or burn complication prevention.

Relevance to Military Health: Relevance to the health care needs of burn-injured military Service Members is a key feature of this award.

Use of DOD or Department of Veterans Affairs (VA) Resources: Applications involving multidisciplinary collaborations among academia, industry, the military Services, the VA, and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix IV.

Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Projects that include research on animal models are required to submit Attachment 8, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.

The CDMRP expects to allot approximately $4.4M to fund approximately two MBRP Technology/Therapeutic Development Award applications. Funding of applications received https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104 http://www.nature.com/nature/journal/v490/n7419/full/nature11556.html https://arriveguidelines.org/arrive-guidelines

DOD FY24 Military Burn Technology/Therapeutic Development Award 9 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 FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

The funding instrument for awards made under the program announcement will be assistance agreements, contracts, or Other Transactions. The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. The USAMRDC will also consider the use of Other Transactions (OTs) as a vehicle for award, in accordance with the conditions in 10 USC 4021 and 10 USC 4022.

An assistance agreement can take the form of a grant or cooperative agreement. The level of government involvement during the project’s period of performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial government involvement” is anticipated, a grant will be made (31 USC 6304). Conversely, if “substantial government involvement” is anticipated, a cooperative agreement will be made (31 USC 6305).

Substantial involvement means that members of the U.S. government will assist, guide, coordinate, or participate in project activities.

A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government.

An “Other Transaction” will also be considered as a vehicle for award under this BAA, in accordance with 10 USC 4021 and 10 USC 4022. The OT authorities were created to give DOD the flexibility necessary to adopt and incorporate business practices that reflect commercial industry standards and best practices into its award instruments. When leveraged appropriately, OTs provide the government with access to state-of-the-art technology solutions from traditional and non-traditional defense contractors (NDCs), through a multitude of potential teaming arrangements tailored to the particular project and the needs of the participants. OTs can help to foster new relationships and practices involving traditional and NDCs, especially those that may not be interested in entering into FAR-based contracts with the government; broaden the industrial base available to government; support dual-use projects; encourage flexible, quicker, and cheaper project design and execution; leverage commercial industry investment in technology development and partner with industry to ensure DOD requirements are incorporated into future technologies and products; and collaborate in innovative arrangements. OTs are not FAR-based procurement contracts, grants, cooperative agreements, or cooperative research and development agreements.

The award type, along with the start date, will be determined during the negotiation process.

DOD FY24 Military Burn Technology/Therapeutic Development Award 10

The anticipated total costs budgeted for the entire period of performance for an FY24 MBRP Technology/Therapeutic Development Award should not exceed $2.2M. Refer to Section II.D.6, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025. For additional information refer to Section II.F.1, Federal Award Notices.

II.C. Eligibility Information

II.C.1. Eligible Applicants

II.C.1.a. Organization:

Applications for this BAA may only be submitted by extramural organizations, including foreign or domestic institutions, for-profit and non-profit organizations, and public entities.

Submissions from intramural DOD organizations to this BAA will be withdrawn.

Applications with Principal Investigators (PIs) employed by intramural DOD organizations may be submitted extramurally through a research foundation. It is also permissible for an intramural DOD investigator to be named as a collaborator on an application submitted through an extramural organization. In this case, the application must include a letter from the collaborator’s Commander or Commanding Officer at the intramural organization that authorizes the collaborator’s involvement.

In accordance with DoDI 5000.77 and FAR 35.017, Federally Funded Research and Development Centers (FFRDCs) are not eligible to directly receive awards under this BAA.

However, teaming arrangements between FFRDCs and eligible organizations are allowed as long as they are permitted under the sponsoring agreement between the federal government and the specific FFRDC.

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

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

Awards are made to eligible organizations, not to individuals.

II.C.1.b. Principal Investigator:

PIs at or above the level of Assistant Professor, or an independent investigator within the biomedical industry, may be named by the organization as the PI on the application.

There are no limitations on the number of applications for which an investigator may be named as a PI.

DOD FY24 Military Burn Technology/Therapeutic Development Award 11

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

II.C.2. Cost Sharing

Cost sharing/matching is not an eligibility requirement for contracts or assistance agreements but may exist if research OT or prototype OT is the selected funding instrument. Cost-sharing requirements for OTs are stated in 10 USC 4021 for Research OTs and 10 USC 4022 for Prototype OTs.

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.

Use of the System for Award Management (SAM): To protect the public interest, the federal government ensures the integrity of federal programs by striving to conduct business only with responsible organizations. The USAMRDC uses the “Exclusions” within the Performance Information functional area of the SAM and the “Responsibility and Qualifications” within the Entity Information functional area of the SAM to verify that an organization is eligible to receive federal awards. More information about SAM is available at https://sam.gov/SAM/. Refer to the General Submission Instructions, Section IV.A, for additional information.

Conflicts of Interest (COIs): Prior to award, applicants/offerors will be required to disclose all potential or actual COIs along with a plan to mitigate them. An award may not be made if it is determined by the USAMRAA Warranted Official that COIs cannot be adequately mitigated.

Refer to the General Submission Instructions, Appendix 1, for additional information.

Review of Risk: The following areas may be reviewed in evaluating the risk posed by an applicant: financial stability; quality of management systems and operational controls; history of performance; reports and findings from audits; ability to effectively implement statutory, regulatory, or other requirements imposed on non-federal entities; degree of institutional support;

integrity; adequacy of facilities; and conformance with safety and environmental.

For general information on required qualifications for award recipients, refer to the General Submission Instructions, Appendix 1.

Subcontracting Plan: If the resultant award is a contract that exceeds $750,000 and the offeror is other than a small business, the contractor will be required to submit a subcontracting plan for small business and small disadvantaged business concerns, in accordance with FAR 19.7, Defense Federal Acquisition Regulation Supplement (DFARS) 219.7. A mutually agreeable plan will be developed during the award negotiation process and incorporated as part of the resultant contract.

In addition to other information provided herein, by submitting an application and accepting an award, the organization is: (1) certifying that the applicants’ credentials have been examined and

(2) verifying that the applicants are qualified to conduct the proposed study and to use humans as research subjects, if proposed. Applicants include all individuals, regardless of ethnicity, https://sam.gov/SAM/

DOD FY24 Military Burn Technology/Therapeutic Development Award 12 nationality, or citizenship status, who are employed by, or affiliated with, an eligible organization.

Refer to Section II.H.1, 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 BAA.

II.D. Application and Submission Information

II.D.1. Location of Application Package

Submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP.org) and a full application (eBRAP.org or Grants.gov).

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

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

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

https://grants.gov/

DOD FY24 Military Burn Technology/Therapeutic Development Award 13

Application Submission Workflow

Extramural Submission: An application submitted by an extramural organization for an extramural or intramural PI working within an extramural or intramural organization. For example, a research foundation submitting an application for a DOD PI working within a DOD organization would be considered an extramural submission and should follow instructions specific to extramural submissions. Download application package components for HT942524SMBRP from Grants.gov (https://grants.gov). Full applications from extramural organizations must be submitted through Grants.gov.

The submission process should be started early to avoid missing deadlines. All pre- and full proposals/application components must be submitted by the deadlines stipulated on the first page of this BAA. There are no grace periods for deadlines; failure to meet submission deadlines will result in application rejection. The USAMRAA cannot make allowances/exceptions for submission problems encountered by the applicant organization using system-to-system interfaces with Grants.gov.

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

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

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

https://grants.gov/ https://cdmrp.health.mil/funding/researchDup

DOD FY24 Military Burn Technology/Therapeutic Development Award 14

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

FY24 MBRP Programmatic Panel members should not be involved in any pre-application or full application. For questions related to panel members and pre-applications or applications, refer to Section II.H.2.c, Withdrawal, or contact the eBRAP Help Desk at help@eBRAP.org or 301-682- 5507.

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

All pre-application components must be submitted through eBRAP (https://eBRAP.org/).

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

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

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

Pre-application submissions must include the following components (refer to the General Submission Instructions, Section III, for additional information on pre-application submission):

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

• 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 Idea: State the ideas and reasoning on which the proposed work is based.

State how the research addresses an important problem relevant to military burn injuries.

Describe the proposed product that will address an unmet need and briefly how the product advances upon existing technologies/therapeutics. Explain how the product meets the needs and requirements for the care of military-relevant burn injuries.

○ Research Strategy: State the hypothesis to be tested and/or the objective(s) to be reached. Briefly describe the study design and methodology to include animal models or human anatomical specimens to be used, if applicable. Concisely state the scientific mailto:help@eBRAP.org mailto:help@eBRAP.org

DOD FY24 Military Burn Technology/Therapeutic Development Award 15 rationale, the preliminary findings that support the continued development of the proposed product, and a description of how proof-of-concept has been demonstrated.

○ Focus Area: Describe how the proposed project addresses at least one of the FY24 MBRP Focus Areas and, if applicable, the Area(s) of Encouragement.

○ Transition Plan: Briefly describe how the anticipated outcomes will support the translation of promising preclinical findings into a product for clinical application.

○ Impact: The potential impact of the research, both short term and long term, in addressing one or more of the FY24 MBRP Focus Areas and Area of Encouragement (if applicable) should be clearly described. Describe how the research will result in the development and eventual translation of therapeutic or technologic advances for clinical application in the care of burn injuries, such as detection, diagnosis, treatment, or prevention of burn complications. Describe how the proposed project, if successful, will represent an improvement over currently available diagnostics, treatments, interventions, and/or standards of care.

○ Military Relevance: Describe (1) how the project addresses military-relevant burn injury; (2) how the therapy, technology, or knowledge gained from the proposed research could be implemented to address a military need; and (3) the role(s) of care within which the proposed study intervention or product is intended (e.g., prolonged field care, pre-hospital, emergency department, full-service hospital).

○ 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.

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

To determine the technical merits of the pre-application and the relevance to the mission of the MBRP, pre-applications will be screened based on the following criteria:

• Technology/Therapeutic Development Product: Whether the pre-application defines a product that will address an unmet need in burn care. Whether the proposed product

DOD FY24 Military Burn Technology/Therapeutic Development Award 16 addressed the care of military-relevant burn injuries in the early, acute phase of care.

Whether the proposed research is based on promising preclinical findings, sound scientific rationale, and demonstrated proof of concept.

• Research Strategy: How well the specific aims and proposed methodology support the research hypothesis and/or objectives and the development of the product.

• Impact: To what degree the research will result in a product for clinical application in the care of burn injuries, such as detection, diagnosis, treatment, or burn complication prevention. Whether the potential short-term and long-term outcomes (knowledge and/or materiel) of the proposed research, if successful, will impact a critical problem or question in the field of research and/or patient care within one or more of the FY24 MBRP Focus Areas.

• Military Relevance: How well the research will address military-relevant burn injuries;

how well the therapy, technology, or knowledge gained from the proposed research could be implemented to address a military need; and the ability to use the proposed product within a military care environment (e.g., prolonged field care, pre-hospital, emergency department, full-service hospital).

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

Following the pre-application screening, PIs will be notified as to whether they are invited to submit full applications. The estimated date when PIs can expect to receive notification of an invitation to submit a full application is indicated in Section I, Overview of the Funding Opportunity. No feedback (e.g., a critique of the pre-application’s strengths and weaknesses) is provided at this stage. Because the invitation to submit a full application is based on the contents of the pre-application, investigators should not change the title or research objectives after the pre-application is submitted.

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

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

Full applications from extramural organizations must be submitted through Grants.gov Workspace. Full applications from extramural organizations, including non-DOD federal organizations, received through eBRAP will be withdrawn. Refer to the General Submission Instructions, Section IV, for considerations and detailed instructions regarding extramural full application submission.

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

Each application submission must include the completed full application package for this BAA.

See Section II.H.2 of this BAA for a checklist of the required application components.

(a) SF424 Research & Related Application for Federal Assistance Form: Refer to the General Submission Instructions, Section IV.B, for detailed information.

DOD FY24 Military Burn Technology/Therapeutic Development Award 17

(b) Attachments:

Each attachment to the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines listed in the General Submission Instructions, Appendix 4.

○ 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 (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.

− Background: Describe how the proposed research project addresses at least one of the FY24 MBRP Focus Areas. Describe the product to be developed. Present the scientific rationale behind the proposed work. Cite relevant literature. Describe previous experience most pertinent to the project. Include relevant preliminary data and/or promising preclinical findings that demonstrate proof of concept of the product or prototype/preliminary version of the product; these data may be unpublished or from the published literature.

− Hypothesis/Objective: Clearly state the hypothesis to be tested (if applicable), a purpose statement, and/or the objective(s) to be reached.

− Specific Aims: Concisely explain the project’s specific aims. These aims should agree with the primary aims and associated tasks described in the Statement of Work (SOW). If the proposed work is part of a larger study, present only aims that this DOD award would fund.

− Research Strategy and Feasibility: Describe the proposed research strategy and feasibility of the approach, addressing the following:

Describe the study design (experimental, quasi-experimental, etc.), methods, and analyses, including appropriate controls, in sufficient detail for analysis and which support the specific aims.

Provide a well-developed, well-integrated research strategy that supports the translational feasibility, appropriateness, and promise of the approach.

Define the specific study outcomes and how they will be measured.

Describe the availability of and access to the necessary study resources.

Explain how the study is designed to achieve reproducible and rigorous results, including (if applicable) controls, sample size estimation, blinding, randomization, and data handling.

DOD FY24 Military Burn Technology/Therapeutic Development Award 18

Address potential problems and present alternative methods and approaches.

Describe data collection and handling, including rules for stopping data collection, criteria for inclusion and exclusion of data, how outliers will be defined and handled, and identification of primary endpoints/outcomes.

Clearly describe the statistical plan and the rationale for the statistical methodology, if applicable.

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

Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, or international regulatory agency, if applicable.

If animal studies are proposed, briefly describe the key elements of the study/studies as they relate to the overall project. Explain how and why the animal species, strain, and model(s) being used can address the scientific objectives and how it is optimal for addressing the study aims and facilitates rapid development and translation of solutions for the Warfighter. Describe how animal research will be conducted in accordance with the ARRIVE guidelines 2.0 (https://arriveguidelines.org/arrive-guidelines). Further details of research involving animals will be required in Attachment 8, Animal Research Plan, as applicable.

If human-derived biological specimens will be used, describe the sourcing and/or acquisition of samples. If human-derived specimens will be obtained from military Service Members, military families, and/or Veteran population(s) or datasets, describe the feasibility of accessing the samples/dataset(s). Clinical research (including Clinical Trials) is not allowed under the Technology/ Therapeutic Development Award.

If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to the General Submission Instructions, Appendix 4, for additional considerations.

Describe how the research project will be completed within the proposed period of performance.

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

https://arriveguidelines.org/arrive-guidelines

DOD FY24 Military Burn Technology/Therapeutic Development Award 19

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

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

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

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.

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

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

Supporting Documentation, for detailed information regarding Data Management Plan content.

Data and Research Resources Sharing Plan: Describe the type of data or research resource to be made publicly available as a result of the proposed work. Describe how data and resources generated during the performance of the project will be shared with the research community. Include the name of the repository(ies) where scientific data and resources arising from the project will be archived, if applicable.

If a public repository will not be used for data or resource sharing, provide justification. Provide a milestone plan for data/results dissemination including when data and resources will be made available to other users, including dissemination activities with a particular focus on feeding back the data to affected communities and/or research participants.