HT9425-23-S-SOC1.pdf

FY23-FY28 DoD USSOCOM BAA for Extramural Biomedical & Human Performance Research and Development

I. OVERVIEW OF THE FUNDING OPPORTUNITY 1

United States Special Operations Command 2

Department of Defense 6

BROAD AGENCY ANNOUNCEMENT (BAA) 8

for Extramural Biomedical and Human Performance 9 Research and Development 10

Funding Opportunity Number: HT9425-23-S-SOC1 12

Announcement Type: Initial 13

Catalog of Federal Domestic Assistance Number: 12.420 14 Military Medical Research and Development 15

KEY DATES 17

Release/Posted Date: Initial 01 August, 2023 19 Closing Date: 31 July, 2028, 11:59 p.m. Eastern Time 21 This Funding Opportunity Announcement is a BAA. It is continuously open for a 5-year period, 23 from 1 August 2023 closing 31 July 2028, 11:59 p.m. Eastern Time. Note: This BAA will be 24 updated annually. 25

This Broad Agency Announcement must be read in conjunction with the General Submission 28

Instructions, which are available for downloading from Grants.gov. The General Submission 29 Instructions are located under the “package” tab and can be downloaded by selecting the 30 “Download Instructions” icon when previewing the submission package. 31

TABLE OF CONTENTS 34

I. OVERVIEW OF THE FUNDING OPPORTUNITY ....................................................... 1 35

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY ............... 3 36

II.A. Program Description ....................................................................................................... 3 37 II.A.1. Research Area of Interest .......................................................................................... 4 38

Develop improved pre-hospital canine combat casualty simulation training devices with an 39 emphasis on Special Operations Forces (SOF) pre-hospital providers. The proposed projects 40 must research and apply/or develop novel approaches for high-fidelity canine trauma training 41 simulation devices with physiologically relevant feedback to include temperature, pulse, lifelike 42 size and weight, realistic fur, active bleeding, anatomically accurate airways, and haptic 43 technology. Canine training devices should respond to medical treatments with little to no 44 operator/trainer intervention and capture and provide accurate casualty care feedback. All 45 simulators/simulations should meet Joint Airworthiness Standards........................................... 13 46 II.B. Federal Award Information .......................................................................................... 14 47 II.C. Eligibility Information ................................................................................................... 15 48 II.C.1. Eligible Applicants ................................................................................................... 15 49 II.C.2. Cost Sharing ............................................................................................................. 16 50 II.C.3. Other ......................................................................................................................... 16 51

II.D. Proposal/Application Submission Information ....................................................... 17 52 II.D.1. Where to Obtain the Proposal/Application Submission Package ............................ 17 53 II.D.2. Content and Form of the Proposal/Application Submission .................................... 18 54 II.D.3. Unique Entity Identifier (UEI) and System for Award Management (SAM) ........... 37 55 II.D.4. Submission Dates and Times ................................................................................... 39 56 II.D.5. Funding Restrictions ................................................................................................ 39 57 II.D.6. Other Submission Requirements .............................................................................. 41 58

II.E. Proposal/Application Review Information .................................................................... 41 59 II.E.1. Criteria ...................................................................................................................... 41 60 II.E.2. Proposal/Application Review and Selection Process ............................................... 42 61 II.E.3. Integrity and Performance Information .................................................................... 43 62 II.E.4. Anticipated Announcement and Federal Award Dates ............................................ 44 63

II.F. Federal Award Administration Information .................................................................. 44 64 II.F.1. Federal Award Notices ............................................................................................. 44 65 II.F.2. Administrative and National Policy Requirements .................................................. 44 66 II.F.3. Reporting .................................................................................................................. 45 67

II.G. Federal Awarding Agency Contacts ............................................................................. 46 68 II.G.1. eBRAP Help Desk.................................................................................................... 46 69 II.G.2. Grants.gov Contact Center ....................................................................................... 46 70

II.H. Other Information.......................................................................................................... 47 71 II.H.1. Administrative Actions ............................................................................................ 47 72 II.H.2. Proposal/Application Submission Checklist ............................................................ 49 73

APPENDIX 1: ACRONYM LIST ............................................................................................ 50 74

II. DETAILED INFORMATION ABOUT THE FUNDING 76

OPPORTUNITY 77

The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) United States Special Operations 78 Command (USSOCOM), BAA for Extramural 79 Biomedical and Human Performance Research and Development contains several changes from 80 previous USSOCOM BAAs. Read each section carefully. Note the following: 81

• The total individual project estimated cost ceiling has been increased from $4,000,000 to 83 $5,000,000, and generally anticipated project cost has been increased from $700,000 to 84 $1,500,000. 85

• The “Program Description” that describes the “Research Areas of Interest (RAIs)” have 86 been updated. 87

II.A. Program Description 88 This BAA is intended to solicit extramural research and development ideas using the authority 90 provided by United States Code, Title 10, Section 4001. This BAA is issued under the provisions 91 of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in Federal 92 Acquisition Regulation (FAR) 6.102(d)(2) and 35.016. In accordance with FAR 6.102, projects 93 funded under this BAA must be for basic and applied research to support scientific study and 94 experimentation directed toward advancing the state-of-the-art or increasing knowledge or 95 understanding rather than focusing on development of a specific system or hardware solution. 96 Research and development funding through this BAA is intended and expected to benefit and 97 inform both military and civilian medical practice and knowledge. 98 This BAA provides a general description of the USSOCOM’s research and development 100 programs, including RAIs, evaluation and selection criteria, pre-proposal/preapplication and full 101 proposal/application preparation instructions, and general administrative information. 102 Submission of a pre-proposal/pre-application is required. After review, if the USSOCOM is 103 interested in receiving a full proposal/application, the Applicant or Offeror will be invited to 104 submit a full proposal or full application. Specific submission information and additional 105 administrative requirements can be found in the document titled “General Submission 106 Instructions” available in Grants.gov along with this BAA. 107

The USSOCOM utilizes the tools and processes provided by the Congressionally Directed 109 Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical 110 Research Application Portal (eBRAP) system and retrieval and processing of full 111 proposal/application submissions from Grants.gov. Refer to Section II.G, Agency Contacts, for 112 additional information. 113 The USSOCOM’s supporting contracting office, the U.S. Army Medical Research Acquisition 115 Activity (USAMRAA) will be the awarding and administering office for proposals selected for 116 funding. 117

II.A.1. Research Area of Interest 118 A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research 120 Program is to identify and develop techniques, knowledge products, and materiel (medical devices, 121 drugs, and biologics) for early intervention in life-threatening injuries; prolonged field care (PFC); 122 human performance optimization; canine medicine/performance; brain health; immune response; 123 automation of systematic reviews and metanalysis; and novel post-traumatic stress, depression, and 124 anxiety treatment.. Special Operations Forces (SOF) medical personnel place a premium on medical 125 equipment that is small, lightweight, ruggedized, modular, multi-use, and designed for operation in 126 extreme environments. The equipment must be easy to use, require minimum maintenance, and have 127 low power consumption. Drugs and biologics should optimally not require refrigeration or other 128 special handling. All materiel and related techniques must be simple, effective, and easily modified 129 for commercialization. Research projects may apply existing scientific and technical knowledge for 130 which concept and/or patient care efficacy have already been demonstrated to meet SOF 131 requirements. The proposed research must be relevant to active-duty service members, veterans, 132 military beneficiaries, and/or the American public. Relevant research must be responsive to the 133 health care needs of the U.S. Armed Forces, family members of the U. S. Armed Forces, U.S. 134 Veterans, and civilian populations. Proposals must address a relevant health problem responsive to 135 one of the RAIs identified below. Additional RAIs may be added during the life of the BAA (FY23-136 FY28). The following RAIs are in no particular order: 137

1. Damage Control Resuscitation: 139 SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and 140 morbidity associated with critical wounds and injuries. The proposed research, application, and/or 141 development of medical techniques and materiel (medical devices and biologics) for optimal triage 142 and early intervention in critical life-threatening injuries when casualty evacuation is not possible or 143 is delayed. The project areas under “Damage Control Resuscitation” to which the USSOCOM will 144 give highest consideration are: 145

a. Global Treatment Strategies and Next Generation Wound Management: 147 The proposed project must research, apply, and/or develop effective treatment strategies that address 148 the following elements: hypotensive resuscitation, optimal fluid(s), uncomplicated shock, 149 noncompressible hemorrhaging, traumatic brain injuries, and austere damage control surgery. These 150 strategies must be optimized for medics in austere, far-forward areas, with minimal logistical or 151 specialty support, who must stabilize and treat patients for extended periods (days, not hours). 152 Projects that research and develop an all-in-one traumatic wound care treatment that can achieve 153 hemostasis, incorporate analgesia, deliver antibiotics, and start tissue regeneration are preferred. 154

b. Analgesia: 156 The proposed project must research, apply, and/or develop novel, safe, efficacious, peripherally, and 157 centrally acting analgesia that provide easy administration in the field, tolerance of extreme 158 environments, and effectiveness at the point of injury for a prolonged period of field care (days, not 159 hours) and does not sensitize the patient to topical analgesia. Maximum analgesia with minimal 160 sedation is preferred. 161

c. Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatics: 163 The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood 164 transfusions (i.e., person to person, pre-hospital blood banking, and blood substitutes) forward of 165 normal logistics support; (e.g., evaluating blood for type/cross matching and for the presence and/or 166 reduction of pathogens, leucocytes, and AB antibodies to improve safety of whole blood transfusion 167 at the point of injury). Projects that will be considered also include other blood components such as 168 freeze-dried plasma and platelets, cryoprecipitate, fibrinogen, prothrombin complex concentrate, and 169 injectable medications to address the coagulopathy of trauma such as Tranexamic acid. Research 170 should focus on extending shelf life of whole blood beyond current limitations. A long-term 171 objective is a blood substitute that is comparable in size, weight of traditional blood products, and 172 effectively functions like fresh whole blood without requiring refrigeration. Strategies to find the 173 delivery of these prototypes individually or in concert will also be considered. Priority will be given 174 towards projects that are oriented towards final solutions or prototypes that are shelf stable requiring 175 minimal to no refrigeration as well as those that can carry oxygen in quantities similar to healthy red 176 blood cells. 177

d. Austere Surgical Stabilization: 179 Future theatres where SOF personnel will operate are likely to be much less medically robust than 180 the past decade of fighting in our current theatres (this can translate to remote civilian areas). Rather 181 than sitting at hardened structures waiting on patients, surgical personnel may be increasingly asked 182 to go to the patient. Research should focus on mobility/portability of medical and surgical equipment, 183 including support equipment such as sterilization, with emphasis on equipment with greater 184 capabilities than currently fielded devices, smaller size and weight, low power demands, and 185 flexibility in power supplies. Additionally, research and development efforts should include 186 telehealth technologies linking forward surgical providers with higher medical authority consultation 187 and effective, relevant, and dynamic surgical training capabilities. Research may also include a 188 human systems approach to define limitations and mitigation strategies of surgical capability in 189 austere environments (i.e., low light, temperature variability, surgery in flight, etc.). 190

2. Prolonged Field Care (PFC): 192 SOF medical personnel require capabilities for far-forward medical care to reduce the mortality and 193 morbidity associated with critical wounds, injuries, diseases, and associated sepsis. PFC should focus 194 on novel treatments that support the ability to manage 3-5 patients across the spectrum of illness to 195 multi-system injury for a minimum of 5-7 days. Significant consideration will be given to proposals 196 focused on PFC that may also relate to Sections 1 (a-d) and 3(a) of this BAA. 197

a. Medical Sensors and Devices: 199 The primary emphasis is to research, apply and/or develop medical techniques, pharmaceuticals, 200 biologics, and field-sustainable, rapidly deployable medical sensors and/or devices for extended care 201 beyond initial trauma resuscitation, to include austere/forward surgery while operating in disease 202 endemic areas where casualty evacuation is delayed or unavailable. In addition, proposals that 203 investigate or develop wireless biosensors should demonstrate physiological monitoring capabilities 204 to include, but not limited to, heart rate, blood pressure, pulse oximetry, respiration rate, 205 capnography, core temperature, heart rate variability and compensatory reserve index (CRI). 206 Research and development of devices and sensors should include or plan for the capability to 207 transmit (Bluetooth) to Android handheld devices and tablets. (NOTE: Ideally, sensor and equipment 208 technologies should be electronically readable, scannable, or transmittable to the Battlefield Assisted 209 Trauma Distributed Observation Kit (BATDOK), an Android-driven, multi-patient, point of injury 210 casualty monitoring capability being fielded by the U.S. Air Force (USAF) Pararescuemen and other 211 SOF Medics. Novel devices are required which aid in measuring physiologic decompensation and/or 212 adequacy of treatment/resuscitation in the field environment and/or provide a trigger for a pre-213 hospital medical intervention (i.e., validation of tissue (muscle) oxygen saturation (StO2), CRI, 214 traumatic brain injury (TBI) measures, etc. 215

3. Portable Lab Assays and Diagnostics: 217 The proposed project must research, apply and/or develop novel concepts for portable and 218 environmentally stable far forward laboratory assays and diagnostics. Equipment should be 219 extremely portable, ruggedized, use limited or no external power, and any reagents should be self- 220 contained and stable in extreme environmental conditions. Preference will be given to proposals that 221 are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements. 222 Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or 223 other noninvasive technologies as described in paragraph 3.a. below are encouraged. 224

a. Occupational and Environmental Health (OEH) Hazards: 226 The proposed project must focus on development of novel methods and devices for rapid 227 identification and analysis of exposures to OEH hazards. Research must support the development 228 and analysis of handheld, field hardened, and environmentally stable analytical devices, monitoring 229 devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in 230 air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Such OEH 231 hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures, 232 food and water borne pathogens, toxins, biological agents, and radiological material exposures. 233 Research consideration should be given to development of small lightweight and programmable 234 unmanned underwater vehicles (UUV) and unmanned aerial vehicles (UAV) to conduct 235 environmental analysis of OEH hazards in water, air, and soil. UUVs and UAVs must be capable of 236 travel to designated locations, conduct point of collection analysis of OEH hazards, transmit data, 237 and return to originating base. 238

4. Force Health Protection and Environmental Medicine: 240 SOF personnel must often operate for extended periods of time in austere environments that expose 241 them to extremes in altitude, temperature, humidity, wind, kinetosis, infectious diseases, toxic 242 industrial chemicals, toxic industrial materials, and environmental hazards (including envenomation). 243 In addition, the environment may be compromised due to chemical, biological, and radiological 244 contamination. The primary emphasis of this research area is to research, apply, and develop 245 techniques, therapeutic measures, and materiel (personal protective equipment (PPE), medical 246 devices, drugs, and biologics) to ensure sustained human performance and effectiveness while 247 operating in harsh environmental conditions and/or wearing appropriate PPE. Additional research 248 opportunities include identification and characterization of specific risk profiles/threats associated 249 with the SOF unique mission sets. 250

a. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics, 252 Treatment, and Prophylaxis: 253 The proposed projects must research, apply, and/or develop novel approaches that will diagnose, 254 treat, and protect SOF personnel from exposure to chemical, biological, radiological, nuclear, and 255 high yield explosives in near real time. 256

b. Operational Monitoring: 258 The proposed project must seek to develop wireless biosensors for monitoring SOF personnel in 259 extreme environments (i.e., high altitude, whether in-flight or the environment itself, excessive heat 260 or cold, etc.), and potentially hazardous material exposure. Sensors should address physiological 261 measurements and/or chemical, biological and/or radiological hazards. For hazards monitoring, a 262 personal dosimetry device is desired that can detect and alarm based on radiation and chemical 263 presence. The alarming function can be pre-determined to account for known environmental 264 conditions (i.e., natural occurring radiation levels that are below threshold/detrimental health levels) 265 and Parts Per Million (PPM) counts that would trigger an alert. This detection device needs to be able 266 to alarm differently to identify the "type" of hazard(s), and to trigger a back-off and/or donning of 267 additional PPE. Monitoring should be capable of wirelessly communicating via Bluetooth to Android 268 handheld devices, tablets, or compatible wrist-mounted displays. 269

5. Brain Health: 271 Brain Health research efforts include, but are not limited to: development and validation of fieldable 272 Neurocognitive Assessment Tools (NCATs) and baseline testing, Comprehensive Symptom History 273 (CASH) collection, blast exposure and impact monitoring, determination of safe acceptable limits for 274 blast exposure, development and validation of capabilities to easily identify/diagnose mild, moderate, 275 and severe TBI, methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction, 276 methods to prevent TBI from impact and blast such as redesign of helmets, body armor, and 277 munitions, development of pharmaceuticals to prevent and/or treat brain injury, validation of brain 278 injury prevention strategies, and development of return to duty decision support tools. 279

a. Environmental Exposures: 281 Research that develops novel material and/or approaches to protect SOF personnel from the 282 neurological effects of single and repetitive auditory (impulse noise) and non- auditory 283

(overpressure) blast exposures and other environmental factors determined to affect nervous system 284 function. 285

b. Environmental Exposure Effects: 287 Research that determines the neurocognitive and nervous system effects from single and repetitive 288 blast exposures, impulse noise, and other potential hazardous environmental factors. 289

c. Biomarkers: 291 Research to determine which biomarkers are indicative of mild, moderate, and severe TBI; sequelae 292 from TBI causing further injury; recovery status; and recovery rate from TBI. Testing and validating 293 diagnostic biomarkers for TBI. Proposals should also consider incorporation of validated biomarkers 294 onto existing or future diagnostic platforms. Use of machine learning and/or model development to 295 interpret and report biomarkers that are indicative of TBI are of interest. 296

d. Genetic Factors: 298 Research to determine if there are genetic predispositions, epigenetic changes and/or, genomic 299 modulators that affect the susceptibility to and recovery from TBI and neurotrauma. 300

e. Neuropsychological Testing: 302 Research to validate Neurocognitive Assessment Tools (NCATs) to determine baseline 303 neurocognitive status, readiness, neurocognitive degradation, sensitivity to various exposures, TBI 304 and recovery status post injury. Proposals to improve the speed, accuracy, specificity, and proximity 305 to injury for the use of NCATs, as well as to compare new technologies and/or modalities (including 306 passive assessment of cognition) to existing NCATs. 307

f. Affect testing. Research to develop and validate baseline and transient affect testing or 309 assessment tools to measure emotion and/or mood, to monitor change in emotion and/or mood 310 after TBI, and to investigate the effects of emotion or mood status on functional performance. 311

g. Olfactory, Oculomotor, Auditory, Vestibular, Cranial Nerve, and Vocal-Acoustic 313 Performance: 314 Research and proposals to perform and validate oculomotor, auditory, vestibular, cranial nerve, and 315 vocal acoustic assessments. Research and proposals to assess the effect of nervous system injury to 316 oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance and strategies to 317 restore their performance after injury and prevent injury or further decline. 318

h. Postural Stability: 320 Research to assess the effects of blast exposure on postural stability including the proprioceptive 321 component. Novel treatment strategies, therapies, and therapeutics to prevent and/or correct 322 detriment to postural stability from TBI and neurotrauma caused by blast, impact, and/or other 323 environmental exposures. 324

i. Neuroendocrine Dysfunction: 326 Methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction. 327

j. Neuroimaging: 329 Research into novel imaging and imaging interpretation techniques including, but not limited to 330 Computed Axial Tomography (CAT), Magnetic Resonance Imaging (MRI), and Positron emission 331 tomography (PET) scans, to diagnose brain tissue pathologies including, but not limited to, axonal 332 injury, myelin injury, and astroglial scarring without the need for immunohistochemistry, 333 immunofluorescence, or histopathology testing. 334

k. Analytics: 336 Research into analysis including Machine Learning, Natural Language Processing, and Artificial 337 Intelligence enabled analysis of data including, but not limited to, NCATs; environmental exposures 338 likely to affect brain health; blast, impact, and noise exposures; auditory, vestibular, and vocal 339 acoustic assessments; postural stability assessments; and neuroimaging. 340

l. Neuromodulation: 342 Research into the use of neuromodulation techniques for treating TBI, neurotrauma, pain, restoring 343 and improving function, and improving behavioral health. 344

m. Brain Lymphatics and Glymphatics: 346 Research into measuring the fluid dynamics of the brain lymph system, diagnosing dysfunction, and 347 validation for tools or techniques to improve brain lymph clearance. 348

n. Pupillometry, Pupillary Response and Microsacaades: 350 Research into field capable pupillary response measurement capture and analysis, with or without the 351 ability to capture microsacaades in order to assess central nervous system loading and/or damage. 352

6. Immune Response: 354 The use of modified and novel strategies to cause, strengthen, or supplement immunity through the 355 use of, but not limited to mRNA vaccines, nanolipoprotein particles (NLPs), polyvalent vaccines, 356 and phages. 357

7. Chronic Pain: 359 The proposed research must address the development of novel, non-opioid treatments for chronic 360 pain with or without the presence of migraines, allodynia, or fibromyalgia; but not with 361 accompanying myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or cancer. 362

8. Automation of Systematic Reviews and Metanalysis: 364 Research into Automation of Systematic Reviews and Metanalysis using the Preferred Reporting 365 Items for Systematic Reviews and Meta Analyses (PRISMA) or a similar method. 366

9. Medical Simulation and Training Technologies: 368 The proposed project must research, apply and/or develop improved pre-hospital tactical combat 369 casualty care (TCCC) training with an emphasis on the SOF pre-hospital providers. Medical 370 simulations should replicate all phases of the pre-hospital combat environment, including care under 371 fire, tactical field care and casualty evacuation. Human-like simulators should bleed, breath, void, 372 have a physiologically relevant temperature, pulse, and response to medical care with little to no 373 operator/controller input, should be all-weather capable and should evoke an emotional response 374 from those with whom it interacts. Medical training simulations should capture and be capable of 375 providing a report on the timing, appropriateness, and effectiveness of medical treatment. All 376 material solutions should meet joint airworthiness standards. Additionally, there is interest in 377 research focused on validating or measuring the effectiveness of current medical simulation and 378 training technologies and in determining the best methods of acquiring and maintaining PFC skills as 379 well as the impact of these skills on patient outcomes. In addition, the proposed project must research 380 the efficacy of using stress inoculation training (vs traditional didactics or other instructional 381 methods) to teach key TCCC skills (e.g., tourniquets, IV placement, etc.). Of particular interest are 382 the effects on stress response, performance, and decision making of the student as well as best 383 methods for optimizing performance in high stress situations as well as mitigating negative aspects of 384 stress. 385

10. Human Performance Optimization: 387 USSOCOM requires SOF personnel to withstand extraordinary physical demands and psychological 388 stress to complete their missions. The optimization of SOF personnel’s ability to perform at very 389 high levels for long durations, in addition to processing information and making critical decisions in 390 a timely manner, while operating in extreme environments, will significantly improve their overall 391 operational effectiveness. This research area explores alternatives and/or new approaches to sustain 392 and optimize SOF human performance. 393

a. Improved Sleep: 395 The proposed project must research, apply and/or develop novel approaches to achieve the 396 restorative effects of sleep. This may include methods to induce, maintain, or improve the quality of 397 sleep throughout the entire night. Additionally, the ability to accelerate the effects of sleep through 398 methods requiring less time (e.g., the effects of sleeping eight hours are realized in four hours’ time) 399 or enabling the SOF personnel to quickly reach and adequately cycle through the stages of sleep 400 where the highest restorative effects occur (i.e., Stage 3/ deep sleep, and Stage 4/rapid eye movement 401 sleep). 402

b. Optimal Acclimatization Strategies: 404 The proposed project must research, apply, and/or develop novel approaches and/or technologies that 405 provide rapid and sustainable human acclimatization in austere environments, to include fatigue 406 countermeasure, extremes in temperature, extremes in altitude, and time-zone change (i.e., circadian 407 acclimatization). 408

c. Wearables: 410 The proposed project must research , apply, and/or develop novel approaches and/or wearable 411 technologies that will monitor physiological measures of human performance to include, but not 412 limited to, caloric expenditure, heart rate/heart rate response, heart rate variability, body fat 413 percentage, sleep hygiene (deep and REM sleep duration) in real-time. Measures should be accurate 414 with low fixed bias, wirelessly communicated via Bluetooth, Near Field Magnetic Induction or 415

Radio Frequency technology in real-time and provide the command the capability to utilize the data 416 for analysis of individuals and/or team performance via the USSOCOM Human Performance Data 417 Management System (i.e., Smartabase). The device should be able to be turned on/off and/or have an 418 inactive mode, provide real-time feedback on a display screen, be capable of displaying time, and be 419 adjustable to fit users of different statures. Of parallel interest to address is a proposed project to track 420 aircrew sleep, fatigue, and performance degradations through a wearable device that provides 421 quantitative data (rather than qualitative surveys often seen in USAF Fatigue Studies), that in turn 422 will be gathered and amalgamated from entire units, in order to track individual performance, unit 423 performance, mission impacts to performance levels, length of time for acclimatization (if it is ever 424 achieved), and potential risk of mishaps. 425

d. Diagnostics for Performance Sustainment: 427 The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to 428 provide actionable information on nutritional gaps, hormonal response to training, physiological 429 response to performance interventions and recovery, and epigenetic predictors of potential injury. 430

e. Performance Nutrition: 432 The proposed projects must research, apply and/or develop methods to accurately measure nutritional 433 status of SOF personnel. The proposed project should focus on cost effectiveness, accuracy, and 434 end-user compatibility (i.e., user friendly) methods or devices for identifying and optimizing an 435 individual’s nutrient status. Consideration of alternative fuel (energy) sources, dietary 436 supplementation, and nutrient volume/timing are specific areas of interest. 437

f. Pharmaceutical and Nutritional Supplement Interactions: 439 The proposed project must research, apply, and/or develop novel approaches to determining what, if 440 any, meaningful interactions occur between and among SOF-common medications (i.e., over-the- 441 counter (OTC) or prescription (Rx) and commonly ingested/commercially available nutritional 442 supplements). 443

g. Physiological Performance: 445 The proposed project must research, apply, and/or develop novel approaches and/or technologies to 446 maximize the physiological performance of SOF personnel in austere and/or training environments, 447 to include increased endurance, enhanced senses, tolerance to environmental extremes, and enhanced 448 overall fitness, in order to maintain operational posture/ability in high stress scenarios without 449 noticeable augmentation, and without hampering personnel mobility. 450

h. Cognitive Performance: 452 The proposed project must research, apply, and/or develop novel approaches and/or technology that 453 provide greater mental acuity or neuroenhancement (i.e., targeted enhancement and extension of 454 cognitive and affective abilities). Encompasses pharmacological and non-pharmacological methods 455 of improving cognitive, affective, motor functionality and performance, to include neuromodulation. 456

i. Psychological Performance and Suicide Prevention: 458

The proposed project must research, apply, and/or develop novel approaches to the assessment and 459 improvement of behavioral health within the force. Examples include but are not limited to, novel 460 approaches to treatment and rehabilitation from acute and/or chronic post-traumatic stress, 461 depression, and anxiety, improved emotional and nervous system self-regulation, digital/virtual 462 engagement strategies, methods to measure behavioral health performance over time, and improved 463 suicide prevention tools/strategies. 464

j. Family Readiness and Social Connectedness: 466 The proposed project must research, apply, and/or develop novel approaches to increase healthy SOF 467 family functioning. Family functioning includes positive interpersonal relationships, personal 468 resilience, self-efficacy, and the development of supportive social networks. Potential research could 469 determine what educational and didactic experiences best improve these factors of healthy SOF 470 family and relational functioning. 471

k. Spiritual Resilience: 473 The proposed project must research, apply, and/or develop innovative approaches to increase SOF 474 spiritual resilience or add scientific rigor to support current approaches. Spiritual resilience includes 475 religious practice, morals, ethics (such as just war tradition), connectedness, sense of purpose and 476 belonging. Potential research could determine what types of spiritual training or engagements best 477 improve these factors of spiritual resilience. 478

11. Canine Medicine and Performance: 480 SOF personnel rely on canines’ exceptional capabilities as combat multipliers. This research area 481 explores alternatives and/or new approaches to preserve and enhance SOF canine combat 482 performance. SOF medical personnel place a premium on canine-specific approaches that are 483 effective in extreme environments and do not require significant additional logistical support (i.e., 484 maximize use of available SOF Medic materiel). The eight “Canine Medicine and Performance” 485 project areas, to which SOF will give consideration, in priority order, are: 486

a. Trauma Resuscitation: 488 The proposed project must support development of innovative techniques/strategies for canine 489 trauma resuscitation (e.g., hypotensive resuscitation, whole blood/blood component replacement, and 490 non-compressible hemorrhaging), particularly to address ballistic projectile injuries, in 491 diverse/austere environments that lack immediately available medical evacuation or restorative 492 surgical capacity. 493 Note: Research should minimize or refrain from utilizing canine specific equipment or devices; this 494 will allow treatment from existing trauma kits fielded by SOF Medics. 495

b. Non-Traditional Anesthesia Protocols: 497 The proposed project must develop novel approaches for routine and emergency/post- traumatic 498 canine field sedation and/or anesthesia in diverse environments and, utilizing pharmaceuticals 499 available to SOF Medics. 500

c. Canine Performance Optimization 502

The proposed project must research, apply, and/or develop novel approaches and/or technologies that 503 address optimization of canine performance through improved physical conditioning programs, 504 enhanced nutrition, and genetics research. 505

d. Sensory Optimization and Protection: 507 Research must be oriented toward innovative methods that enhance or conserve SOF canine 508 olfactory, visual, and/or auditory performance during combat operations. 509

e. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Canine Decontamination, 511 Treatment, and PPE Against Possible Exposure: 512 The proposed projects must research, apply, and/or develop novel approaches that will diagnose, 513 treat, decontaminate, and protect canines from exposure to chemical, biological, radiological, 514 nuclear, and high yield explosives. 515

f. Environmental Extremes: 517 Project proposals must research, apply, and/or develop novel strategies that address acclimatization 518 to acute extremes in temperature, altitude, and/or time zone change (circadian acclimatization), 519 and/or prolonged marine environmental exposure in SOF canines. 520

g. Brain Health and TBI 522 Brain health research efforts include but are not limited to development and validation of NCATs, 523 blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure, 524 validation of neurocognitive baseline testing, capabilities to easily determine mild, moderate, and 525 severe TBI, pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment 526 strategies, and procedures to determine safe return to duty decisions for SOF canines. 527

h. Pre- and Post-Trauma Training / Behavioral Issues: 529 The proposed project must address unique approaches to diagnosing and treating SOF-peculiar 530 training and post-traumatic canine behavioral issues, in order to optimize pre-purchase selection and 531 post-purchase training strategies across the enterprise and restore performance in canines with 532 behavioral and/or post-trauma issues. 533

i. Canine Simulation Technologies: 535 Develop improved pre-hospital canine combat casualty simulation training devices with an emphasis 536 on Special Operations Forces (SOF) pre-hospital providers. The proposed projects must research and 537 apply/or develop novel approaches for high-fidelity canine trauma training simulation devices with 538 physiologically relevant feedback to include temperature, pulse, lifelike size and weight, realistic fur, 539 active bleeding, anatomically accurate airways, and haptic technology. Canine training devices 540 should respond to medical treatments with little to no operator/trainer intervention and capture and 541 provide accurate casualty care feedback. All simulators/simulations should meet Joint Airworthiness 542 Standards. 543

II.B. Federal Award Information 546 The Anticipated total costs budgeted for the entire period of performance inclusive of all contract 548 awards made in response to this BAA, will not exceed $10 Million annually. The number of 549 awards is indeterminate and contingent upon funding availability. Any funding that is received 550 by the USSOCOM that is appropriate for a research area described within this BAA may be 551 utilized to fund awards. Refer to Section II.D.5. Funding Restrictions, for detailed funding 552 information. 553 The USAMRAA will negotiate the contract awards for proposals selected for funding. A contract 555 is required when the principal purpose of the instrument is to acquire supplies or services for the 556 direct benefit or use of the U.S. Government. The contract type, along with the start date, will be 557 determined during the negotiation process. 558 Please see Appendix 2 of the General Submission Instructions for more information. 560 Research involving Human Anatomical Substances, Human Subjects, or Human Cadavers: 562 All DoD-funded research involving new and ongoing research with human anatomical 563 substances, human subjects, or human cadavers must be reviewed and approved by the 564 USAMRDC Office of Human Research Oversight (OHRO),, prior to research implementation. 565 This administrative review requirement is in addition to the local Institutional Review Board 566 (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is 567 not required. The OHRO Human Research Protections Offiical (HRPO) review is mandated to 568 comply with specific laws and requirements governing all research involving human anatomical 569 substances, human subjects, or human cadavers that is supported by the DoD. These laws and 570 requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a 571 minimum of 2 to 3 months for OHRO HRPO regulatory review and approval processes. 572 Additional time for regulatory reviews may be needed for clinical studies taking place in 573 international settings. When possible, protocols should be written for research with human 574 subjects and/or human anatomical substances that are specific to the DoD-supported effort 575 outlined in the submitted proposal/application as a stand-alone study. Submission to OHRO of 576 protocols involving more than the scope of work in the DoD-funded award will require review of 577 the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements 578 may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. 579 Refer to the General Submission Instructions, Appendix 1, and the Human Subject Resource 580 Document available on the eBRAP “Funding Opportunities & Forms” web page 581 (https://ebrap.org/eBRAP/public/Program.htm) for additional information. 582 Typically, a clinical trial is not associated with this BAA. A clinical trial is defined as a 584 prospective accrual of patients (human subjects) in which an intervention (e.g., device, drug, 585 biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested 586 for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome 587 represents a direct effect on the subject of that intervention or interaction. 588 https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/public/Program.htm

Research Involving Animals: All DoD-funded research involving new and ongoing research 590 with animals must be reviewed and approved by the USSOCOM Veterinarian Review Office 591 (VRO) which ensures that research conducted, contracted, sponsored, supported, or managed by 592 the DoD involving animal care are conducted in accordance with federal, DoD, Army, 593 USSOCOM VRO, and international regulatory requirements. The USSOCOM VRO is 594 responsible for administrative review, approval, and oversight of all animal research protocols, 595 including all changes made during the life of the protocol. 596

Specific documents relating to the use of animals in the proposed research will be requested if 597 the application is selected for funding. The VRO must review and approve all animal use prior 598 to the start of working with animals, including amendments to ongoing projects. PIs must 599 submit the institutional animal use protocol. Allow at least 1 to 2 months for regulatory review 600 and approval processes for animal studies. 601 Questions concerning animal use and review should be directed to the USSOCOM VRO: 603 Phone: 813-826-6031; Email: socom_vet@socom.mil. 604 Refer to the General Submission Instructions, Appendix 1, for additional information. 606 The USSOCOM intends that information, data, and research resources generated under awards 608 funded by this BAA be made available to the research community (which includes both 609 scientific and consumer advocacy communities) and to the public at large. 610

II.C. Eligibility Information 611

II.C.1. Eligible Applicants 612 II.C.1.a. Organizations: 614 Awards are made to organizations only. Organizations eligible to apply include national, 616 international, for-profit, non-profit, public, and private organizations. Refer to the General 617 Submission Instructions, Appendix 3.B, for general eligibility information. 618

NOTE: In accordance with FAR 35.017, Federally Funded Research and Development Centers 619 (FFRDCs) are not eligible to directly receive awards under this BAA. However, teaming 620 arrangements between FFRDCs and eligible organizations are allowed so long as they are 621 permitted under the sponsoring agreement between the Federal Government and the specific 622

FFRDC. 623

The USSOCOM is committed to supporting small businesses. Small business, Veteran-owned 624 small business, Service-disabled Veteran-owned small business, HUBZone small business, small 625 disadvantaged business, and woman-owned small business concerns must be given the 626 maximum practical opportunity to participate through subawards on research proposals 627 submitted through the BAA. 628

II.C.1.b. Eligible Investigators 629

Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship 631 status, who are employed by, or affiliated with, an eligible organization. 632 There are no limitations on the number of proposals for which an investigator may be named as a 634 Principal Investigator (PI). 635

The USAMRAA makes awards to eligible organizations, not to individuals. 636 In addition to other information provided herein, by submitting a proposal/application and 637 accepting an award, the organization is: (1) certifying that the investigators’ credentials have 638 been examined and; (2) verifying that the investigators are qualified to conduct the proposed 639 study and to use humans or animals as research subjects, if proposed. 640

II.C.2. Cost Sharing 641 Cost sharing/matching is not an eligibility requirement. 643

II.C.3. Other 644 Organizations must be able to access .gov and .mil websites in order to fulfill the financial and 646 technical deliverable requirements of the award and submit invoices for payment. 647

Refer to Section II.H.1, Administrative Actions, for a list of administrative actions that may be 648 taken if a pre-application or application does not meet the administrative, eligibility, or ethical 649 requirements defined in this BAA. 650

For general information on required qualifications for award recipients, refer to the General 651 Submission Instructions, Appendix 3. 652

Use of the System for Award Management (SAM) and the Responsibility/Qualification (R/Q): 653 To protect the public interest, the Federal Government ensures the integrity of Federal programs 654 by striving to conduct business only with responsible organizations. The USSOCOM uses the 655 “Exclusions” within the Performance Information functional area of the SAM and data from the 656 R/Q, a component within SAM, to verify that an organization is eligible to receive Federal 657 awards. More information about the SAM and the R/Q is available at https://www.sam.gov/. 658 Refer to the General Submission Instructions, Appendix 3, for additional information. 659

Conflicts of Interest: All awards must be free of conflicts of interest (COIs) that could bias the 660 research results. Prior to award of a contract, applicants will be required to disclose all potential 661 or actual COIs along with a plan to manage them. An award may not be made if it is determined 662 by the Contracting Officer that COIs cannot be adequately managed. Refer to the General 663 Submission Instructions, Appendix 3, for additional information. 664

Review of Risk: The following areas may be reviewed in evaluating the risk posed by an 665 applicant: Financial stability; quality of management systems and operational controls; history 666 of performance; reports and findings from audits; ability to effectively implement statutory, 667 regulatory, or other requirements imposed on non-Federal entities; degree of institutional 668 https://www.sam.gov/ https://www.sam.gov/ support; integrity; adequacy of facilities; and conformance with safety and environmental 669 statutes and regulations.