HT942523SBAA1_27Jan2026.pdf

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 1 for Extramural Medical Research

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Defense Health Agency Research & Development

BROAD AGENCY ANNOUNCEMENT

Funding Opportunity Number: HT942523SBAA1

Announcement Type: Initial

Assistance Listing Number: 12.420 Military Medical Research and Development

KEY DATES

Release/Posted Date: October 1, 2022

Closing Date: September 30, 2027, 11:59 p.m. Eastern Time

This funding opportunity announcement is a broad agency announcement (BAA). It is continuously open for a 5-year period, from October 1, 2022, through September 30, 2027, 11:59 p.m. Eastern Time.

This broad agency announcement must be read in conjunction with the General Submission Instructions, which are available for downloading from Grants.gov. The General Submission Instructions are located under the “package tab” and can be downloaded by selecting the “Download Instructions” icon when previewing the submission package.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 2

Table of Contents

I. OVERVIEW OF THE FUNDING OPPORTUNITY

I.A. New for Fiscal Year 2023 – Fiscal Year 2027

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Descriptions

II.A.1. Military Infectious Diseases II.A.2. Combat Casualty Care II.A.3. Traumatic Brain Injury II.A.4. Psychological Health II.A.5. Sensory Systems II.A.6. Musculoskeletal Injury II.A.7. Environmental Exposures II.A.8. Directed Energy/Radiation Health II.A.9. DOD Working Dogs

II.B. Award Information II.B.1. Clinical Trial Support II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources ...19 II.B.3. Technology Requirements and Standards II.B.4. Data Sharing II.B.5. Funds Available and Anticipated Number of Awards II.B.6. Award Amounts and Periods of Performance II.B.7. Mechanisms of Support

II.C. Eligibility Information II.C.1. Eligible Applicants II.C.2. Cost-Sharing II.C.3. Other

II.D. Proposal/Application Submission Information II.D.1. Where to Obtain the Proposal/Application Submission Package II.D.2. Content and Form of Proposal/Application Submission II.D.3. Unique Entity Identifier (UEI) and System for Award Management II.D.4. Submission Dates and Times II.D.5. Intergovernmental Review II.D.6. Funding Restrictions II.D.7. Other Submission Requirements

II.E. Proposal/Application Review and Selection Information II.E.1. Criteria for Research Proposals/Applications Without a Clinical Trial

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II.E.2. Proposal/Application Selection Process II.E.3. Integrity and Performance Information II.E.4. Notification of Proposal/Application Review Results

II.F. Federal Award Administration Information II.F.1. Federal Award Notices II.F.2. Administrative and National Policy Requirements II.F.3. Reporting Requirements

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. Contractor/Recipient Qualification II.H.2. Proprietary Information II.H.3. Administrative Actions

II.I. Checklist for Research Proposal/Application Submission Without a Clinical Trial

APPENDIX I. RESEARCH AREAS OF INTEREST

I. Military Infectious Diseases II. Combat Casualty Care III. Traumatic Brain Injury IV. Psychological Health V. Sensory Systems VI. Musculoskeletal Injury VII. Environmental Exposures VIII. Directed Energy/Radiation Health IX. DOD Working Dogs

APPENDIX II. CLINICAL TRIALS

I. Important Aspects of Clinical Trials II. Full Proposal/Application Submission Components for Studies with a Clinical Trial ...77 III. Review Criteria for Research Proposals/Applications with a Clinical Trial IV. Checklist for Research Proposal/Application Submission with a Clinical Trial

APPENDIX III. DOD AND VA WEBSITES

APPENDIX IV. PROCEDURES FOR ACQUISITION, PROCESSING, STORAGE,

AND SHIPMENT OF BIO-FLUIDS

APPENDIX V. NATIONAL INSTITUTE OF MENTAL HEALTH DATA ARCHIVE –

INFORMED CONSENT

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APPENDIX VI. TECHNOLOGY READINESS LEVELS AND KNOWLEDGE

READINESS LEVELS

APPENDIX VII. ACRONYMS AND ABBREVIATIONS

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I.A. New for Fiscal Year 2023 – Fiscal Year 2027 The fiscal year 2023 – 2027 (FY23 – FY27) U.S. Army Medical Research and Development Command’s (USAMRDC) BAA for Extramural Medical Research contains several changes from previous USAMRDC BAAs. Read each section carefully. Note the following:

• The open period of the BAA is 5 years and will be amended annually with any updates.

• The “Research Areas of Interest” can be found in Appendix I.

• 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, United States Code, Title 31, Sections 6301-6308 (31 USC 6301-6308), which provides the legal criteria to select a procurement contract or an assistance agreement. The award type, along with the start date, will be determined during the negotiation process.

• For assistance agreements:

○ The total period of performance may be proposed for up to a maximum of 4 years in length; additional periods may be considered.

○ Any assistance agreement (grant or cooperative agreement) awarded under this BAA will be governed by the award terms and conditions that conform to the Department of Defense’s (DOD) implementation of Office of Management and Budget guidance in Code of Federal Regulations, Title 2, Part 200 (2 CFR 200), “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.” DOD implementation is located in Chapter XI of 2 CFR.

• For contract awards:

○ The total period of performance may be proposed for up to 5 years in length; additional periods may be considered.

○ Any contract awarded under this BAA will be governed by the various provisions of the Federal Acquisition Regulation (FAR) and the Defense Federal Acquisition Regulation Supplement (DFARS).

• For other transactions:

○ Regarding Other Transaction Agreements (OTAs) that utilize the authority within 10 USC 4021 or 4022, the period of performance will be dependent upon each specific award made.

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II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

The USAMRDC’s mission is to provide solutions to medical problems of importance to the American Service Member at home and abroad, as well as to the general public at large. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology (S&T), operational requirements, military threat assessments, and national defense strategies. Extramural research and development programs play a vital role in the fulfillment of the objectives established by the USAMRDC.

General information on the USAMRDC can be obtained at https://mrdc.health.mil/.

This BAA is intended to solicit extramural research and development ideas using the authority provided by 10 USC 4001. The BAA is issued under the provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in 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 basic and applied research to support scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on development of a specific system or hardware solution. Research and development funded through this BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge. This BAA utilizes competitive procedures in accordance with 10 USC 3012 for the selection for award of S&T proposals/applications. For the purposes of this BAA, S&T includes activities involving basic research, applied research, advanced technology development, and, under certain conditions, may include activities involving advanced component development and prototypes.

The selection process is highly competitive, and the quantity of meaningful submissions (both pre-proposals/pre-applications and full proposals/applications) received typically exceeds the number of awards that available funding can support.

This BAA provides a general description of USAMRDC’s research and development programs, including Research Areas of Interest, evaluation and selection criteria, pre-proposal/pre-application and full proposal/application preparation instructions, and general administrative information. Specific submission information and additional administrative requirements can be found in the document titled, “General Submission Instructions,” which is available on Grants.gov along with this BAA.

Proposal/application submission by extramural organizations through Grants.gov requires use of the Workspace interface, which separates the proposal/application package into individual forms. Applicants must create a Workspace in Grants.gov, complete the required forms, and submit their proposal/application Workspace package.

The management agent for this BAA is the Congressionally Directed Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical Research Application Portal (eBRAP) system, pre-proposal/pre-application and full proposal/application receipt and review, and other key process oversight. Refer to Section II.G, Federal Awarding Agency Contacts, for additional information.

https://mrdc.health.mil/

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The USAMRDC’s supporting acquisition office, the U.S. Army Medical Research Acquisition Activity (USAMRAA), will be the awarding and administering office for proposals/applications selected for funding, unless approval is obtained from the USAMRAA Senior Contracting Official to allow another federal acquisition office to execute and administer an award.

II.A. Program Descriptions

II.A.1. Military Infectious Diseases

The Joint Force operates in areas of the world where endemic and emerging infectious diseases present substantial and immediate health risks to U.S. personnel. Future operational scenarios, to include large scale combat operations (LSCOs), pose an increased risk of infectious diseases due to degraded natural environmental disease barriers and public health infrastructure, as well as the potential for delayed evacuation times. Current national, military, and biodefense strategies and subsequent requirements documents specify a worldwide force protection capability to prevent, diagnose, and treat endemic and emerging infectious disease threats to protect the Joint Force.

Likewise, wound infection resulting from complex traumatic injuries in a prolonged care environment poses a substantial threat to the operational effectiveness of deployed forces.

During prolonged care scenarios to include LSCO environments, infection and complications secondary to injury will develop in the prehospital setting through Role 3. While recent conflicts typically managed infection at higher roles of care, future conflicts in contested environments with near-peer adversaries will require management in-theater due to delayed casualty evacuation and/or treatment. While most infected wounds during insurgency operations over the last 20 years were not initially colonized with multidrug-resistant organisms (MDROs), the prevalence of MDRO infections significantly increased as casualties moved through higher roles of care. The inability to prevent, delay, or treat wound infections in a prolonged care environment will increase the prevalence and severity of infected wounds. Similarly, a concomitant increase in MDRO wound infections will occur across the continuum of care.

Therefore, closing the gap on the impact of wound infections on the Joint Force requires countermeasures to prevent, diagnose, and treat both initial wound infections and MDRO infections across the continuum of care.

The scope of the DHA Military Infectious Diseases (MID) portfolio relates to the prevention, diagnosis, and treatment of military relevant infectious diseases, to include combat-associated wound infections to serve the overall goal of maintaining unit and individual readiness, preserving operational effectiveness, and accelerating return to duty following infection.

The MID portfolio priority research areas are organized into the following capability areas:

• Prevent: Develop solutions to prevent endemic and emerging infectious diseases, to include combat-associated wound infections, to maintain readiness and preserve operational effectiveness. Prevention is the most desirable infectious disease countermeasure because it prevents disease from occurring (versus treatment post-infection), is the most cost-effective approach, and reduces unit loss rate.

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• Diagnose: Develop solutions to diagnose endemic and emerging infectious diseases, to include combat-associated wound infections, to maintain readiness, preserve operational effectiveness, and accelerate return to duty.

• Treat: Develop solutions to treat endemic and emerging infectious diseases, to include combat-associated wound infections, to maintain readiness, preserve operational effectiveness, and accelerate return to duty.

Research Areas of Interest for the MID portfolio are found in Appendix I.I. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.2. Combat Casualty Care

Combat Casualty Care (CCC) encompasses the assessment, diagnosis, treatment, stabilization, and disposition (return to duty or evacuation) of Service Members at point of need (PON), including far-forward, en route, and extended pre-hospital environments. The scope of the CCC portfolio includes capability requirements that will optimize recovery from combat-related injuries to decrease the burden of survivorship, reduce morbidity and mortality across the continuum of CCC, and accelerate return to duty, when possible. Capability requirements within the CCC portfolio focus on Immediate Casualty Care, Medical Care in Operational Environments, Patient Movement, and Enabling Medical System Technologies.

The CCC portfolio offers a plan for identifying, developing (when necessary), evaluating, transitioning methods, therapeutics and technologies aimed at improving acute and early combat-related trauma management solutions. The continuum of care is defined as an integrated system that guides care at PON and tracks wounded, ill, or injured (WII) Service Members through the various roles of care (ROC; 1, 2, and 3) by facilitating seamless movement using comprehensive health service through discharge from definitive care.

The capability requirements have been identified based on assessment of the current and future medical and operational needs and/or existing research gaps of the military medical community.

The CCC portfolio places an emphasis on the following capability requirements:

• Tactical Combat Casualty Care (TCCC): TCCC encompasses advanced medical solutions to assess, treat, and stabilize combat-related injuries needed at PON through ROC 1, and the ability to hold patients longer when evacuation is challenged. Future large-scale, multi-domain combat operations will significantly contest the military’s “Golden Hour” or “Golden Day” paradigm used to date. Responding to this challenge and taking measures to maintain high rates of survival and recovery among wounded Service Members will require innovative solutions that sustain/build medical capabilities as far forward as possible to support and immediately stabilize the injured Service Member in addition to continuing that care when evacuation is delayed or unavailable.

• Resuscitative Strategies and Care: Advanced resuscitative care is paramount for battlefield survivability at PON and anywhere along the continuum of care. Delays in evacuation and high casualty rates in the future battlespace will place further demands on advanced trauma care if casualties deteriorate and need to be resuscitated again anywhere in the evacuation

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 9 chain. Effective hemorrhage control and replacement of lost blood volume are the lifesaving, battle-proven treatments most likely to mitigate hemorrhagic shock and blood failure. The ability to provide enough resuscitative products, such as whole blood, at the point of need in the future battlespace for large numbers of casualties remains a critical medical challenge for operational forces. The Resuscitative Strategies and Care capability requirement outlines forward resuscitative and augmenting solutions (blood, blood products, and substitutes) to wounded Service Members experiencing complications from trauma, shock, or other life-threatening conditions in austere and resource-limited environments.

• Care of Complex Injuries and Organ Support: Providers in the future battlespace will be challenged with managing large casualty volumes with a need for high acuity care with limited resources. Across the continuum of care, far forward providers will need to have adaptable medical solutions to help manage complex injuries and further address the respiratory, cardiovascular, metabolic, and immunologic consequences of trauma, shock, organ failure, and burn in contested and isolated environments. Prolonged and resource-limited settings further drive the need to develop tools that support the wounded across various operational platforms in diverse environments of the future battlespace. Activities within this Care of Complex Injuries and Organ Support capability requirement seek to resolve critically identified Joint deficiencies associated with casualty care for WII Service Members in a complex and resource-limited operational environment.

• Forward Surgical Care: In the future battlespace, contested and resource-limiting environments will hinder evacuation and access to larger medical elements closest to PON. It will be incumbent upon medical, evacuation, and logistics elements to position surgical assets further forward and in greater isolation than in recent theaters. Forward surgical care, also known as damage control surgery (DCS), is a principal component of military medicine, enabling medical personnel to provide lifesaving surgical interventions to injured Service Members. Activities within the Forward Surgical Care capability requirement include identifying and developing new or leveraging existing knowledge and materiel solutions needed to surgically stabilize life-threatening injuries closest to PON. Performance of these critical surgical interventions promotes survivability of injured Service Members and helps to further prevent or mitigate a casualty's irreversible physiologic deterioration. As we prepare for the future fight without the benefits of the “Golden Hour,” the battlefield medical system must be modernized to maximize the further-forward surgery paradigm and bring with it medical solutions that will ensure expeditious surgical care to wounded Service Members in theatre.

• Functional Recovery from Traumatic Wound and Burn Injuries: Significant increases to the frequency and severity of traumatic wound and burn injuries are predicted to challenge capability and capacity in a future battlespace. Urban dense terrain and multi-domain operations of the future are expected to generate complex wounds and burn injuries that will require advanced prolonged care and stabilization when tactical evacuations to robust rear element medical care infrastructures are delayed. Under current doctrine, these wound and burn casualties will quickly overwhelm providers and available resources in an already strained and complex operational environment. Moreover, the specialized care needed for burn patients comes with significant challenges as even a small number of burn casualties can deplete a large number of resources quickly. As a result, the need for aggressive

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 10 battlefield wound and burn care technologies are paramount to providing advanced care to wounded Service Members. Activities within the Functional Recovery from Traumatic Wound and Burn Injuries capability requirement focus on yielding knowledge and advanced materiel solutions needed to assess, treat, and manage complex wounds and burn injuries in any pre-hospital, resource-limited battlespace environment.

• Effects of Transport on Complex Injuries: As the military engages in future multi-domain operations, contested air, land, and sea superiority will result in significantly extended evacuation times for WII Service Members. Distinct from previous research and development efforts, the future battlespace will require military en route care research to focus on the intersection of the patient, their injury or illness, the stresses of transport, and the environment of care in addition to the multimodal transport platform that may be used.

Casualty care providers will need to better understand the effects of prolonged transport time, mode(s) of transport, and environmental factors that can negatively impact Service Members with complex/polytraumatic injuries under these extended and diverse conditions. Activities within the Effects of Transport on Complex Injuries capability requirement focus on understanding and advancing knowledge to better enable effective casualty support and treatment during transportation from PON to more advanced ROCs, in between ROCs via various evacuation platforms, and scalability. Understanding the physiological response to transport is not only needed to inform future practice guidelines and policy decisions for anticipated conflicts, but provides necessary operational and medical data, highlights important deficiencies in the current system, and offers information that can be used to create robust solutions for medical evacuation support in the future battlespace.

• En Route Care: According to military doctrine, patient movement throughout the continuum of medical care is termed “en route care,” an important element of which is providing the appropriate medical capability during the transport so that the patient’s clinical condition is not compromised. In this SRP, en route care includes (1) ground transport at point of injury through both unregulated and regulated means; (2) ground, maritime, and rotary and fixed-wing tactical transport; (3) strategic intercontinental air transport; (4) maritime transport from surface and underwater ships out at sea; and (5) nontraditional space medical mobility systems. Effective en route care throughout the continuum is a critical element needed during combat operations to ensure optimal patient outcomes and maintain operational advantage.

Activities within the En Route Care capability requirement include focus on modalities to increase care provider capability and capacity during transportation of casualties and solutions that enhance patient movement efforts in pre-hospital and mass evacuations scenarios. A Joint approach to research efforts will be key to advancing solutions with a consideration that each Service has distinct needs within their respective domain of operations that will continue to be discussed and deconflicted as necessary.

• Virtual Health and Monitoring: To meet the challenges of the future battlespace, the DOD will need technological advancements that will enhance provider capabilities that decrease cognitive load, aid decision-making through artificial intelligence (AI), or offer telementoring/telemedicine support to improve patient outcomes and enhance the combat health system across the continuum of care. The Virtual Health and Monitoring capability requirement focuses on decision support tools that assist care providers in providing enhanced assessment, diagnosis, intervention, treatment, and continued monitoring of a

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 11 patient’s physiological and injury status. Furthermore, these Joint capabilities will target enabling critical care expertise earlier into far forward environments and interfacing seamlessly with Joint tactical networks in denied, degraded, intermittent, and limited environments (DDIL). Each of the services and their respective cyber security offices have operational requirements for implementation of virtual medical systems that will continue to be discussed and deconflicted as necessary to develop Joint capabilities.

• Scalable Triage: Optimizing casualty care requires a coordinated, real-time, common operating platform to extend the capacity of the MHS to multi-domain operations.

Developing a Joint, forward-deployed intelligent trauma system is needed to support the medical care team’s ability to efficiently triage, communicate, and care for wounded Service Members across ROCs; improve operational planning efforts for evacuation; and promote overall survivability in the future battlespace. Moreover, these force-multiplying capabilities are crucial for mitigating resource and medical team constraints experienced during mass casualty events. This Scalable Triage capability requirement seeks to resolve deficiencies for effective triage through the use of fast and accurate screening, diagnostic, and communication tools that can be used across the Services; and effective protocols suited for the tactical environment that adapt to the limitations of the operational environment, the mission, and available resources (e.g., time, equipment, supplies, personnel, and evacuation capabilities).

• Autonomous Systems: As the military prepares for a future conflict where air superiority and freedom of movement is limited or contested across an active battlespace, access to advanced systems that utilize clinical decision support through AI, autonomous medical technologies, and robotics to enhance casualty care and evacuation, when necessary, will be vital. Autonomous systems have the potential to provide the medical support needed in contested environments at the PON and during transport across the operational continuum of care; but must be further developed in order to create an unmanned evacuation capability that can reliably care for combat casualties in the future. These solutions must include biosensors, AI, and machine learning (ML) to enable the development of closed-loop/autonomous medical systems capable of providing critical care. The Autonomous System capability requirement seeks to resolve deficiencies in knowledge and materiel solutions associated with integrated/interfaced medical system technologies using semi-autonomous, autonomous, and unmanned capabilities to help augment medical providers in operational environments, reducing task saturation, and to perform care and evacuation needs in situations that are unsafe.

The Research Areas of Interest for the CCC portfolio are found in Appendix I.II. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.3. Traumatic Brain Injury

Traumatic Brain Injury (TBI) is a collective term used for multiple different physiological states that are consequences of physical damage to the brain. This type of damage typically arises from an external force and can be penetrating, contact non-penetrating closed-head, effects from blast and blast overpressure, as well as other energies and forces; TBI is also seen with polytrauma.

The human brain is among the most heterogeneous organs in the body, and trauma can cause the

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 12 most varying source of disease, making brain injury a very complex medical issue to solve, especially rapidly. The earlier brain injury can be addressed, the better outcome is expected of the patient. The two main overarching gaps existing with TBI in combat and early management are objective diagnosis/prognosis and treatment. Both of these can vary depending on the injury types; however, it may be possible that the diverse types of injuries share common objectives, rapid biomarkers, and treatment interventions. Some injuries are quite different from others; for instance, mild TBI (mTBI) in theater may yield no physical impairments yet lead to cognitive and psychological issues which can greatly reduce unit readiness and combat effectiveness.

The scope of the DHA TBI program relates to the diagnosis and treatment of military-relevant brain injury, to include combat-associated TBI, polytrauma, blast and blast overpressure, recognizing the vast diversity of the injury types. Both early diagnosis/prognosis and treatment can serve to prevent further damage seen in repetitive mTBI and blast overpressure, and more severe injuries.

Focus areas for the TBI program are:

• TBI assessment and diagnosis:

o Development of noninvasive far forward TBI assessment tools o Fluid-based biomarker tools to identify and assess TBI far forward o Advanced analytic tools for TBI management and diagnosis

• TBI point-of-injury stabilization:

o Minimally invasive intracranial access for Role 2 and mobile medical care o Therapeutic interventions to treat/stabilize penetrating and severe TBI o Therapeutic interventions to treat mild/moderate TBI

• TBI countermeasures to prevent adverse brain health effects and performance degradation resulting from hazardous/injurious exposures:

o Modulating concussion dosimetry health performance criteria, particularly for blast injuries o Modulating concussion dosimetry health performance criteria, particularly for impact injuries

• TBI monitoring and return-to-duty:

o Biomarkers to detect long-term effects o Validation and implementation of clinical findings related to return-to-duty

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 13 o Targeted strategies to prevent/treat TBI o TBI contributions to other injuries that prolong recovery and return-to-duty (e.g., musculoskeletal injury) o Models to predict health problems associated with mTBI

Out-of-scope areas include training for forward responders, management of chronic effects of TBI, neurodegenerative disease, epilepsy, and spinal cord injuries.

Diagnose/prognose and monitor: Develop solutions to objectively diagnose the injury, prognose and monitor to inform treatment options and to maintain readiness, preserve operational effectiveness, and accelerate return to duty.

Treat: Develop solutions to initiate early treatment for the spectrum of TBI categories including interventions for milder injuries to maintain readiness, preserve operational effectiveness, and accelerate return to duty. Interventions for more moderate and severe injuries at Roles 1 and 2 to improve outcomes in prolong care scenarios.

Prevent: Develop capabilities to prevent further brain damage by providing early warnings and management of potential injury arising from blast overpressure in training and combat, and combat environments.

This DOD funded program requires that all TBI-related clinical research data with at least 50 subjects funded by this program be shared through the jointly supported DOD-National Institutes of Health (NIH) Federal Interagency TBI Research (FITBIR) Informatics System.

Recipients will be required to upload study data annually and in accordance with the FITBIR data submission policies. There is no fee to use the FITBIR, and detailed guidance and policies, including a cost estimator tool for budgeting considerations, can be found at the FITBIR website.

The Research Areas of Interest for the Traumatic Brain Injury portfolio are found in Appendix I.III. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.4. Psychological Health

The mission of the Psychological Health (PH) portfolio is to assess, protect, sustain, and optimize the readiness and performance of Service Members, their Families, and the military community by developing effective biomedical countermeasures against operational stressors, as well as to prevent and mitigate physical and psychological injuries and threats during training and operations. This mission is made up of seven capability requirements relating to the advancement of psychological health research for the military community. Psychological health encompasses multiple domains including clinical conditions and psychological readiness, and therefore these capability requirements capture psychological health across domains that are not necessarily targeting a specific psychological health clinical condition.

https://fitbir.nih.gov/

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The PH portfolio places an emphasis on the following capability requirements:1

• Development of Assessment Tools: Identify objective non-self-report factors that can provide the basis for the development of tools that assess, monitor, and document an individual’s current psychological state which would provide a comparison across relevant time points and enable decision-support interventions.

• Countermeasures for Military Community Needs and Vulnerabilities: Develop psychological health support and prevention solutions for Service Members, their Families, and the military community that match their needs; and enable the scaling up and adoption of these solutions.

• Countermeasures Against Current and Emerging Threats: Identify evidence-based prevention strategies and develop prevention services that protect Service Member psychological health, readiness, and performance.

• Models of Care for Efficient Interventions: Develop recognition, triage, and referral protocols, effective psychological health models, and/or models incorporating non-specialty medical personnel for early intervention of psychological health conditions.

• Models of Care for Tailored Intervention: Deliver tailored psychological health care for Service Members, their Families, and the military community which would restore and maintain psychological health, readiness, and performance across their lifecycle.

• Medically Appropriate Return-to-Duty Guidelines: Develop and validate core elements of Joint Services return to duty criteria.

• Solutions to Optimize Psychological Readiness: Develop Service Member, unit, and leadership tools to improve and maximize psychological readiness and performance.

The Research Areas of Interest for the Psychological Health portfolio are found in Appendix I.IV. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.5. Sensory Systems

The Sensory Systems program focuses on military-related injuries and illnesses to sensory modalities, such as pain, ocular, auditory, and vestibular. The program is structured into modalities to cover a range of distinct research areas within medical S&T research. Capability requirements within the Sensory Systems Program focus to characterize basic mechanisms and advance assessment, diagnosing, monitoring, and treatment of sensory injuries, dysfunctions, or illnesses.

The capability requirements have been identified based on assessment of the current and future medical and operational needs and/or existing research gaps of the military medical community.

The Sensory Systems program places an emphasis on the following capability requirements:

1 Capability requirements are not listed in order of priority

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• Mechanistic Characterization: Develop improved models of sensory injury or illness, describing the etiology, mechanism(s), progression, and potential targets for prevention.

• Assessment Tool Development: Develop knowledge and materiel solutions for diagnosing and quantifying sensory injury or illness (in clinical testing and operationally relevant function).

• Stabilization Took Development: Optimize stabilization solutions and point-of-injury care of sensory injury to preserve function and readiness.

• Treatment Tool Development: Develop knowledge and materiel solutions for the repair or mitigation of sensory injury or illness.

Focus areas for the Sensory Systems program are:

• Improved pain control or anesthesia o Stabilization and treatment tool development to improve pain control or anesthesia (e.g., reduce care demand) o Development of therapeutics with minimal impairment of Service Member operational capabilities

• Ocular injury stabilization o Temporary corneal repair

• Auditory injury assessment o Tool development and mechanistic characterization for the assessment of auditory injury

• Ocular injury assessment o Tool development for assessment of ocular injuries and associated operational performance effects

Out of scope areas include: polymorbidities and injury associated with TBI; training medical providers to examine, assess, and treat injuries/illness; regenerative, restorative, and transplant capabilities; enhancing sensory system capabilities; longitudinal care for sensory injury/illness;

peripheral nerve and spinal cord damage; chronic pain.

The Research Areas of Interest for the Sensory Systems portfolio are found in Appendix I.V.

Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.6. Musculoskeletal Injury

The Musculoskeletal Injury program advances medical solutions to prevent, diagnose, treat, and rehabilitate musculoskeletal injuries (MSKI). By addressing critical research gaps, it develops innovative, data-driven strategies to reduce injury risk, enhance recovery, and improve long-term

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 16 outcomes, ensuring Service Member readiness and resilience. The program delivers scalable solutions that support rapid assessment, effective treatment, and seamless reintegration into active duty. Through cutting-edge medical technologies, regenerative medicine, and comprehensive rehabilitation approaches, the Musculoskeletal Injury program empowers military healthcare providers and operational leaders to enhance force readiness and sustain the health of the Joint Force.

Capability requirements within the Musculoskeletal Injury program focus to reduce the risk of injury while advancing the diagnosing, monitoring, and treatment of musculoskeletal injuries, and optimizing return-to-duty decisions.

The Capability requirements have been identified based on assessment of the current and future medical and operational needs and/or existing research gaps of the military medical community.

• Assess and Diagnose Musculoskeletal Injuries

• Musculoskeletal Injury Risk Mitigation: Musculoskeletal injury risk mitigation programs

• Return to Duty and Reintegration: Solutions to determine fitness for duty following musculoskeletal injury.

Focus areas for the MSKI program are:

• MSKI rehabilitation interventions, technologies, and techniques to treat MSKI in pre-hospital interventions

• Therapeutic interventions to accelerate recovery from MSKI

• Preservation of musculoskeletal health

Out of scope areas include: treatment of spinal cord injury.

The Research Areas of Interest for the Musculoskeletal Injury portfolio are found in Appendix I.VI. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.7. Environmental Exposures

The purpose of the Environmental Exposures program is to counter health threats, disease, and non-battle injury through prevention, assessment, and treatment of military relevant environmental exposures. The following environmental exposures are included in the scope of the overall program: extreme heat, cold, high terrestrial altitude, military diving, toxic exposures, aviation medicine, and vibration/acceleration. Weaponized chemical, biological radiological and nuclear (CBRN), blast, infectious disease, and noise are not within the program’s scope. The program supports basic (6.1), applied (6.2), and advanced technology development (6.3) research efforts.

The Research Areas of Interest for the Environmental Exposures portfolio are found in Appendix

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 17

I.VII. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.8. Directed Energy/Radiation Health

Directed Energy and Radiation Health address injuries and adverse health effects from exposure to non-ionizing radiation and ionizing radiation.

Directed Energy: The term directed energy is defined for military applications as the ability to project non-ionizing electromagnetic energy either broadly for communication and surveillance or in a focused manner to produce defensive or offensive effect(s) at militarily relevant distances.

Given the non-kinetic nature of directed energy threats, the elicitation of a bioeffect may compromise well-being resulting in an adverse health effect, prompting healthcare assessment and treatment. This area of research should add clarity to discriminators in which bioeffects become health effects following radiofrequency, optical, or acoustic exposures in an operational environment. The overarching focus is to improve capabilities and knowledge available to distinguish between a “bioeffect” and injurious “adverse health effect” resulting from directed energy exposures via established mechanisms. Research deliverables should have direct applications to relevant directed energy safety standards and/or clinical practice guidelines.

Radiation Health: Radiation health promotes warfighter health and readiness through activities that support the discovery and development of medical capabilities to counter threats from acute ionizing radiation exposure. Research efforts to be considered include discovery and development of: radiation pre-exposure prophylaxis candidates; biomarkers to support diagnosis or to inform effective treatment modalities; characterization of the mechanism(s) of radiation injury and/or the mechanism(s) of action of medical countermeasures; and characterization of combined injuries resulting from CBRN exposures in the presence of trauma injuries (e.g., hemorrhage, severe burn). Capabilities are intended to be for use in operational military environments, including Roles of Care 1 through 3.

The Research Areas of Interest for the Directed Energy/Radiation Health portfolio are found in Appendix I.VIII. Applicants are urged to read and consider these before preparing their proposals/applications.

II.A.9. DOD Working Dogs

The DoD Working Dog portfolio supports the development of health readiness solutions for canine injury prevention, wound recovery, therapeutics, and pain management emphasizing return to duty. Injury prevention research identifies and characterizes occupational risk factors for MSKI and probability of MSKI occurrence based on breed, genetics, or body conformation.

Wound recovery and therapeutics research delivers optimal protocols and therapies for injuries and return-to-duty plans for military working dogs (MWD)s. Pain management research leads to solutions that effectively recognize, prevent, and treat pain in MWDs, including acute and chronic pain, field analgesia, and sedation/anesthesia and their associated effects.

The Research Areas of Interest for the DOD Working Dog portfolio are found in Appendix I.IX.

Applicants are urged to read and consider these before preparing their proposals/applications.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 18

II.B. Award Information This BAA may be used to support applied research, preclinical research, clinical research, and clinical trials/testing (or equivalent). BAA proposals/applications that include a clinical trial have additional proposal/application and review requirements (see Appendix II). The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

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. (3) Outcomes research and health services research.

A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 219. Note: A Food and Drug Administration (FDA)-regulated clinical investigation is always a clinical trial, but not all clinical trials are FDA-regulated clinical investigations.

Research Involving Human Anatomical Substances, Human Data, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human data human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow up to 3 months to complete the OHRO regulatory review and approval processes following submission of all required and complete documents to the OHRO. Refer to the General Submission Instructions, Appendix 1, and the Office for Human Research Protections Office Resources and Overview document available on the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

If the proposed research involves more than one institution, plans for the multi-institutional structure governing the research protocol(s) should be outlined. In addition, a written plan for single IRB review arrangements must be provided for research conducted in the United States involving more than one institution. 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. Communication and data transfer between or among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the https://ebrap.org/eBRAP/public/Program.htm

FY23 – FY27 DOD USAMRDC Broad Agency Announcement 19 application. A separate intellectual and material property plan agreed on by all participating institutions is also required for multi-institutional clinical research/trials.

Research Involving Animals: All research funded by the BAA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.

Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in S.C. Landis et al., “A call for transparent reporting to optimize the predictive value of preclinical research,” Nature 2012, 490:187-191 (https://www.nature.com/articles/nature11556). 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. Applicants should consult the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 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.

II.B.1. Clinical Trial Support

Investigator(s) proposing a clinical trial should refer to Appendix II for a detailed description of the requirements for such a proposal/application. The pre-proposal/pre-application submission process should be performed as described in Section II.D.2.a. Full proposal/application submission is described in Appendix II. Refer to Appendix II, Section IV, Checklist for Research Proposal/Application Submission With a Clinical Trial, in preparing the full proposal/application.

For projects proposing a clinical trial:

• If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required for the study, the IND/IDE application must be submitted to the FDA by the proposal/application submission. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND/IDE is not required. Refer to Attachment 12, Regulatory Strategy (Appendix II), for further details.

• If the clinical trial of an investigational product will be conducted at international sites, evidence that an application has been submitted to the relevant national regulatory agency of the host country(ies) is required by the above deadlines.

• Clinical trials must be initiated no later than 12 months after the award date.

Note: The government reserves the right to withhold or withdraw funding if an IND or IDE is necessary to conduct the study…