HT942523SBAA1_30Oct2026.pdf

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

I. OVERVIEW OF THE FUNDING OPPORTUNITY

Defense Health Agency Science & Technology

BROAD AGENCY ANNOUNCEMENT

for Extramural Medical Research

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 DHA Broad Agency Announcement for Extramural Medical Research 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. Strategic Research Plan 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.B. Award Information

II.B.1. Clinical Trial Support

II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources ...18

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 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

II.E.2. Proposal/Application Selection Process

II.E.3. Risk, Integrity and Performance Information

FY23–FY27 DOD DHA Broad Agency Announcement for Extramural Medical Research 3

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

APPENDIX II. CLINICAL TRIALS

I. Important Aspects of Clinical Trials

II. Full Proposal/Application Submission Components for Studies With a Clinical Trial ..76

III. Review Criteria for Research Proposals/Applications With a Clinical Trial

IV. Checklist for Research Proposal/Application Submission With a Clinical Trial

APPENDIX III. DOW AND VA WEBSITES

APPENDIX IV. PROCEDURES FOR ACQUISITION, PROCESSING, STORAGE,

AND SHIPMENT OF BIOFLUIDS

APPENDIX V. NATIONAL INSTITUTE OF MENTAL HEALTH DATA ARCHIVE –

INFORMED CONSENT

APPENDIX VI. TECHNOLOGY READINESS LEVELS AND KNOWLEDGE

READINESS LEVELS

APPENDIX VII: FY23–FY27 DHA S&T BAA ADDENDUM –FY26 NEW PROGRAM

FY23–FY27 DOD DHA Broad Agency Announcement for Extramural Medical Research 4

INCREASES

APPENDIX VIII. ACRONYMS AND ABBREVIATIONS

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 5

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

The fiscal year 2023–2027 (FY23–FY27) Defense Health Agency (DHA) BAA for Extramural

Medical Research contains several changes from previous versions. 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 War’s

(DOW) 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.” DOW 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.

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 6

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

The DHA strives 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 DHA. General information on the DHA can be obtained from health.mil/STPMD. The publicly releasable DHA Strategic

Research Plans (SRPs) described in this document (except Directed Energy/Radiation Health) can be obtained from health.mil/STPMD.

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 DHA’s Science and Technology (S&T) SRPs, 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 Defense Health Agency Science & Technology.

(DHA S&T) The DHA S&T coordinates the management of the Electronic Biomedical Research

Application Portal (eBRAP) system, pre-proposal/pre-application and full proposal/application https://health.mil/STPMD https://health.mil/STPMD

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 7 receipt and review, and other key process oversight. Refer to Section II.G, Federal Awarding

Agency Contacts, for additional information.

The DHA S&T’s supporting acquisition office, the Defense Health Agency Contracting Activity

(DHACA), will be the awarding and administering office for proposals/applications selected for funding, unless approval is obtained from the DHACA Senior Contracting Official to allow another federal acquisition office to execute and administer an award.

II.A. Strategic Research Plan Descriptions

The scope of research priorities included in this funding opportunity are limited to research that is approved for funding and not the full scope of the respective SRPs. Priorities listed are not in order of importance. Priorities support basic (6.1), applied (6.2), and advanced technology development (6.3) research efforts.

The following DHA S&T criteria apply to scope for inclusion in an SRP and associated SRP-based S&T program planning:

• Medical research providing knowledge or materiel products relating to preventing, stabilizing, preserving, repairing, and/or resolving diseases or injuries affecting Service

Members across military operational environments

• Medical research addressing Joint Military Health System (MHS) capability requirements or gaps

• Research that is operationally relevant, transition-oriented, traceable to clinical practice, informs military doctrine, and/or informs health or product development

Research areas that do not meet these criteria, and are excluded from SRPs and this funding opportunity, include:

• Human performance enhancement (beyond baseline)

• Medical surveillance

• Non-research infrastructure maintenance

• Healthcare policy assessments

• Personal protective equipment/weapon systems evaluation

• Non-medical Military Occupational Series (MOS) training

• Clinical practice implementation science

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

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 8 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 funded research in the DHA Military Infectious Diseases (MID) SRP relates to the prevention, diagnosis, and treatment of military-relevant infectious diseases, including 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.

Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The MID

SRP places an emphasis on the following:

• Prevent: Develop solutions to prevent endemic and emerging infectious diseases, including 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.

• Diagnose: Develop solutions to diagnose endemic and emerging infectious diseases, with a specific focus on diagnosing combat-associated wound infections and predicting wound-infection-associated sepsis, in order to maintain readiness, preserve operational effectiveness, and accelerate return to duty.

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

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

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 9

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. Care provided at the point of need (PON) includes: far-forward at point of injury, en route, and within extended pre-hospital environments. The scope of funded research in the CCC SRP includes solutions for the acute and early management of combat-related trauma, including point of injury, prolonged and en route care.

The CCC SRP prioritizes identifying, developing (when necessary), evaluating, and 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 operational medicine.

Priorities are identified based on an assessment of current and future medical and operational needs and/or existing research gaps validated by the military medical community. The CCC SRP places an emphasis on the following:

• Tactical Combat Casualty Care (TCCC): TCCC encompasses advanced medical solutions to assess, treat, and stabilize combat-related injuries at PON through ROC 1, and the having 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. 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. This priority focuses on solutions to support PON to immediately stabilize injured Service Members and continuation of care for return to duty or evacuation.

• 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 chain. Effective hemorrhage control and replacement of lost blood volume are the lifesaving, battle-proven treatments most likely to mitigate hemorrhagic shock and blood loss. The ability to provide enough resuscitative products, including whole blood, at the point of need in the future battlespace for large numbers of casualties remains a critical medical challenge.

This priority focuses on 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, high acuity care, and limited resources.

Across the continuum of care, far forward providers need adaptable medical solutions to manage complex injuries and address respiratory, cardiovascular, metabolic, and immunologic consequences of trauma, shock, organ failure, and burn. Prolonged and

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 10 resource-limited settings further drive the need to develop tools that support the wounded across various operational platforms in diverse and isolated environments. This priority focuses on activities that 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: Contested and resource-limiting environments will limit evacuation and PON support from larger medical elements. It will be incumbent upon medical, evacuation, and logistics elements to position surgical assets farther 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 this priority 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 physiological 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 in 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 (MDOs) 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 battlefield wound and burn care technologies are paramount to providing advanced care to wounded Service Members. Activities within this priority 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 MDOs, 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

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 11 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: Patient movement throughout the continuum of care is termed “en route care,” which provides medical capability during patient transport to preserve clinical conditions. En route care is transport by regulated or unregulated vehicles or platforms from the point of injury through definitive care by (1) ground transport; (2) rotary or fixed-wing transport; (3) maritime transport from surface and underwater; and (4) nontraditional space medical mobility systems. Effective en route care is critical to ensure optimal medical outcomes and maintain operational advantage. Activities within this priority include modalities to increase care provider capability and capacity during cognitive overload, and mass evacuation scenarios with Service-specific platforms.

The Research Areas of Interest for the CCC SRP 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 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 funded research in the TBI SRP relates to the diagnosis and treatment of military-relevant brain injuries, including combat-associated TBI, polytrauma, blast, and blast overpressure, while recognizing the vast diversity of the injury types. Early diagnosis, prognosis, and treatment can serve to prevent further damage seen in repetitive mTBI, blast overpressure, and more severe injuries.

Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The TBI

SRP places an emphasis on the following:

Diagnose/prognose and monitor: Develop solutions to objectively diagnose the injury, FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 12 prognosticate outcomes, and monitor recovery to inform treatment options, 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. This includes developing interventions for moderate and severe injuries at ROC 1 and 2 to improve outcomes in prolonged care scenarios.

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

Focus areas include:

• 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 pre-hospital and deployed treatment:

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

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

The Research Areas of Interest for the TBI SRP are found in Appendix I.III. Applicants are urged to read and consider these before preparing their proposal and applications.

II.A.4. Psychological Health

The scope of funded research in the Psychological Health SRP includes developing solutions to maintain Service Member readiness, improve behavioral health diagnoses, and provide behavioral health interventions that enable rapid return to duty. Priorities focus on advancing

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 13 psychological health research for the military community and encompass multiple domains, including clinical conditions and psychological readiness.

Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The

Psychological Health SRP places an emphasis on the following:

• Development of Assessment Tools: Identify objective, non-self-report factors to inform the development of tools that assess, monitor, and document Service Members’ current psychological states, enabling comparison across relevant time points and supporting decision-making interventions.

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

Service Members.

• 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 SRP 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 SRP is structured into modalities to cover a range of distinct research areas within medical S&T research, and priorities focus to characterize basic mechanisms and advance assessment, diagnosing, monitoring, and treatment of sensory injuries, dysfunctions, or illnesses.

The scope of funded research in the Sensory Systems SRP focuses on developing improved pain and anesthesia techniques for use in the battlefield and medical treatment facilities resulting in solutions for improving pain treatment and promising early-stage products with enhanced efficacy/safety profiles.

Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The Sensory

Systems SRP places an emphasis on the following:

• Stabilization Tool 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 include:

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 14

• Improved pain control o Development of stabilization and treatment tools to improve pain control (e.g., reducing care demand, repurposing existing compounds) o Development of therapeutics with minimal impairment of Service Member operational capabilities o Identification of acute risk factors associated with the development of chronic pain (the chronicity of pain)

• Battlefield anesthesia and advanced sedation o Development of novel hemo-stable anesthetic agents with minimal impact on blood pressure and cardiovascular function o Development of long-lasting, reversible sedatives for prolonged care and transport o Development of vaporizor-free, operationally relevant delivery techniques

Out-of-scope areas include: polymorbidities and injuries associated with TBI; training medical providers to examine, assess, and treat injuries or illnesses; regenerative, restorative, and transplant capabilities; sensory system capability enhancements; longitudinal care for sensory injuries and illnesses; peripheral nerve and spinal cord damage; and chronic pain.

The Research Areas of Interest for the Sensory Systems SRP 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 scope of funded research in the Musculoskeletal Injury (MSKI) SRP focuses on developing treatment strategies, technologies, and techniques to address musculoskeletal injuries close to the point of injury in pre-hospital environments. Additionally, it supports solutions that provide initial in-theater protection and preservation while facilitating later aspects of care, including reconstruction, long-term rehabilitation, and recovery.

Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The MSKI

SRP places an emphasis on the following:

• Initial Care for Musculoskeletal Injuries: Develop treatment strategies, technologies, and techniques to mitigate sequelae and optimize outcomes for Service Members in garrison and forward-deployed settings.

Focus areas include:

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

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 15

• Therapeutic interventions to accelerate recovery from MSKIs

• Solutions for the preservation of musculoskeletal health

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

The Research Areas of Interest for the MSKI SRP are found in Appendix I.VI. Applicants are urged to read and consider these before preparing their proposal and applications.

II.A.7. Environmental Exposures

The Environmental Exposures SRP includes priorities to counter health threats, disease, and non-battle injury through the prevention, assessment, and treatment of military-relevant environmental exposures. Priorities are identified based on an assessment of current and future medical and operational needs, existing research gaps validated by the military medical community, or both. The Environmental Exposures SRP places an emphasis on the following:

• Environmental Exposure and Health Risk Prevention: Develop mechanisms and/or countermeasures to prevent health threats associated with environmental exposures.

• Environmental Exposures Treatment: Develop means to treat the harmful effects of extreme environmental exposures

The scope of funded research in the Environmental Exposures SRP focuses on developing objective physiological and functional measures to reliably determine when Service Members can safely return-to-duty following a frostbite injury, providing next-generation guidelines and treatments for exertional heat illness, and providing Maximum Exposure Guidelines (MEGs) for combustion products by developing assessment methodologies and vulnerability factors of key hazards.

Focus areas include:

• Extreme heat

• Cold

• Toxic exposures

Out-of-scope areas include: weaponized chemical, biological, radiological and nuclear (CBRN), blast, infectious disease, and noise.

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

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

II.A.8. Directed Energy/Radiation Health

The Directed Energy and Radiation Health SRP address injuries and adverse health effects from exposure to non-ionizing radiation and ionizing radiation. Priorities are identified based on an

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 16 assessment of current and future medical and operational needs and/or existing research gaps validated by the military medical community. The Directed Energy and Radiation Health SRP places an emphasis on the following:

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 that prompts healthcare assessment and treatment. This area of research should add clarity to discriminators in which bioeffects become adverse 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 an 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

(CPGs).

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 radiation exposures in the presence of trauma injuries (e.g., hemorrhage, severe burn). Capabilities are intended for use in operational military environments, including ROC 1 through 3.

The Research Areas of Interest for the Directed Energy/Radiation Health SRP are found in

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

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.

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 17

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 DOW-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 DHA Office of Research and Regulatory Compliance (ORRC), 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 (ebrap.org) 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 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 DHA ORRC 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

(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 https://ebrap.org/eBRAP/public/Program.htm https://www.nature.com/articles/nature11556

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 18

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 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 but has not been obtained within 6 months of the award date.

II.B.2. Use of Military and Department of Veterans Affairs Populations or Resources

Principal Investigators (PIs) are encouraged to integrate and/or align their research projects with

DOW and/or Department of Veterans Affairs (VA) research laboratories and programs and existing clinical trial networks. Collaboration with the DOW and/or VA is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOW and VA areas of research interest or potential opportunities for collaboration can be found in Appendix III.

Use of DOW or VA Resources: If the proposed research involves access to active-duty military and/or Veteran patient populations and/or DOW or VA resources or databases, the proposal/ application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Use Attachment 2: Supporting

Documentation, to provide relevant documentation to demonstrate access to DOW and/or VA populations or resources. Refer to the General Submission Instructions, Appendix 1, for additional information.

45 CFR Section 46.114 (Cooperative Research) of the Common Rule requires any institution located in the United States that is engaged in cooperative research to rely upon approval by a https://arriveguidelines.org/arrive-guidelines

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 19 single IRB for that portion of the research that is conducted in the United States. For multi-site studies with collaborating VA institutions engaged in non-exempt human subjects research, and for which the use of a single IRB is determined to be not appropriate for the particular research context, a memorandum from the VA Office of Research and Development approving exception of the single IRB requirement must be sought and provided to the OHARO OHRO during the human research protection official review of the project.

Access to certain DOW or VA patient populations, resources, or databases may only be obtained by collaboration with a DOW or VA investigator who has a substantial role in the research and may not be available to a non-DOW or non-VA investigator if the resource is restricted to DOW or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DOW or non-VA investigator collaborating with the DOW and/or VA. If the proposal/application is recommended for funding, the government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s).

Conducting DOW-Funded Human Research with Military Populations: There are unique requirements and limitations for compensating DOW-affiliated personnel for study participation and for conducting research with military Service Members or their Families/children and research with populations from U.S. Special Operations Command may require additional reviews and approvals. Additional information regarding conducting DOW-funded human research with military populations can be found in the Conducting Research with Military

Populations Guide.

II.B.3. Technology Requirements and Standards

Any technology-based research products/prototypes (such as devices, mobile apps, software, information technology (IT) infrastructure, etc.) that expect to interact with military health IT systems should conform with accepted industry and DOW Information Management/IT standards for interoperability, cybersecurity, as well as the DOW Architecture Framework

(DOWAF) and viewpoints, as follows:

a. DOWAF and viewpoints

b. DOD Instruction (DoDI) 8500.01 March, 14, 2014, “Cybersecurity”

c. DoDI 8510.01 July 19, 2022, “Risk Management Framework (RMF) for DoD Systems”

d. Any products expected to provide data to MHS Genesis, the DOW Military Electronic Health

Record system (which is the military version of Cerner Millennium commercial-off-the-shelf electronic health record), should be aimed toward meeting the Health Level 7 and Fast

Healthcare Interoperability Resources standards in order to ultimately provide integration with MHS Genesis.

e. All software-based research products, including computer code, software code, data, and metadata, should be provided as deliverables, and electronic versions need to be able to be uploaded to standards-based electronic repositories. Metadata (i.e., the data dictionary and data model) as well as data (i.e., cases) generated in the research should be provided in an https://mrdc.health.mil/index.cfm/resources/research_protections/ohro https://mrdc.health.mil/index.cfm/resources/research_protections/ohro

FY23–FY27 DOW DHA Broad Agency Announcement for Extramural Medical Research 20 industry-standard format for access by the government in an open-source data repository of electronic deliverables.

f. Any information systems that are owned or operated by the contractor, and that process, store, or transmit Federal contract information not intended for public release,…