W81XWH-18-S-SOC1_0004.docx

I. OVERVIEW OF THE FUNDING OPPORTUNITY

United States Special Operations Command

Department of Defense

BROAD AGENCY ANNOUNCEMENT (BAA)

for Extramural Biomedical Research and Development

Funding Opportunity Number: W81XWH-18-S-SOC1 Announcement Type: Modified-0004 Catalog of Federal Domestic Assistance Number: 12.420 Military Medical Research and Development

KEY DATES

Release/Posted Date: Initial 1 August, 2018, Revised 14 July 2020, Revised 26 October 2020, Revised/Annual Posting 23 June 2021. Revised 18 March 2022.

Closing Date: 31 July, 2023, 11:59 p.m. Eastern Time

This Funding Opportunity Announcement is a BAA. It is continuously open for a 5-year period, from 1 August 2018 closing 31 July 2023, 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.

TABLE OF CONTENTS

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

New for 2018: The Fiscal Year 2018 – Fiscal Year 2023 (FY18-FY23) United States Special Operations Command (USSOCOM), BAA for Extramural Biological Research and Development contains several changes from previous USSOCOM BAAs. Read each section carefully. Note the following:

· 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 open period of the BAA has been extended to 5 years and will be amended annually with any updates.

· The “Program Description” that describes the “Research Areas of Interest” have been updated.

II.A. Program Description

This BAA is intended to solicit extramural research and development ideas using the authority provided by United States Code, Title 10, Section 2358. This BAA is issued under the provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in Federal Acquisition Regulation 6.102(d) (2) and 35.016 and in DoD Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 6.102, 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 funding through this BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge.

This BAA provides a general description of USSOCOM’s research and development programs, including research areas of interest, evaluation and selection criteria, pre-proposal/preapplication and full proposal/application preparation instructions, and general administrative information. Submission of a pre-proposal/pre-application is required. After review, if the USSOCOM is interested in receiving a full proposal/application, the Applicant or Offeror will be invited to submit a full proposal or full application. Specific submission information and additional administrative requirements can be found in the document titled “General Submission Instructions” available in Grants.gov along with this BAA.

USSOCOM utilizes the tools and processes provided by Congressionally Directed Medical Research Programs (CDMRP). The CDMRP manages the electronic Biomedical Research Application Portal (eBRAP) system and retrieval and processing of full proposal/application submissions from Grants.gov. Refer to Section II.G, Agency Contacts, for additional information.

The USSOCOM’s supporting contracting office, U.S. Army Medical Research Acquisition Activity (USAMRAA) will be the awarding and administering office for proposals/applications selected for funding.

II.A.1. Research Area of Interest

A primary emphasis of the USSOCOM Biomedical, Human Performance, and Canine Research Program is to identify and develop techniques, knowledge products, and materiel (medical devices, drugs, and biologics) for early intervention in life-threatening injuries, prolonged field care (PFC), human performance optimization, canine medicine/performance, brain health, and immune response. Special Operations Forces (SOF) medical personnel place a premium on medical equipment that is small, lightweight, ruggedized, modular, multi-use, and designed for operation in extreme environments. The equipment must be easy to use, require minimum maintenance, and have low power consumption. Drugs and biologics should optimally not require refrigeration or other special handling. All materiel and related techniques must be simple and effective, and easily modified for commercialization. Research projects may apply existing scientific and technical knowledge for which concept and/or patient care efficacy have already been demonstrated to meet SOF requirements.

The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. Relevant research must be responsive to the health care needs of the Armed Forces, family members of the Armed Forces, the U.S. Veterans and civilian populations. Proposals/applications must address a relevant health problem responsive to one of the Research Areas of Interest (RAI) identified below. Additional RAI’s may be added during the life of the BAA (FY18-FY23). The following RAIs are in no particular order:

1. Damage Control Resuscitation:

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

a. Global Treatment Strategies and Next Generation Wound Management:

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

b. Analgesia:

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

c. Far Forward Blood, Blood Components, Blood Substitute, & Injectable Hemostatic:

The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood transfusion (i.e. person to person, pre-hospital blood banking, blood substitutes) forward of normal logistics support; (e.g., evaluating blood for type/cross matching and for the presence and/or reduction of pathogens, leucocytes and AB Antibodies to improve safety of whole blood transfusion at the point of injury). Projects that will be considered also include other blood components such as freeze-dried plasma and platelets, cryoprecipitate, fibrinogen, prothrombin complex concentrate and injectable medications to address the coagulopathy of trauma such as Tranexamic acid. Research should focus on extending shelf life of whole blood beyond current limitations. A long-term objective is a blood substitute that is comparable in size, weight of traditional blood products, and effectively functions like fresh whole blood without requiring refrigeration. Strategies to find the delivery of these prototypes individually or in concert will also be considered. Priority will be given towards projects that are oriented towards final solutions or prototypes that are shelf stable requiring minimal to no refrigeration as well as those that are capable of carrying oxygen.

d. Austere Surgical Stabilization:

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

2. Prolonged Field Care (PFC):

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

a. Medical Sensors and Devices:

The primary emphasis is to research, apply and/or develop medical techniques, pharmaceuticals, biologics and field-sustainable, rapidly deployable medical sensors and/or devices for extended care beyond initial trauma resuscitation, to include austere/forward surgery while operating in disease endemic areas where casualty evacuation is delayed or unavailable. In addition, proposals that investigate or develop wireless biosensors should demonstrate physiological monitoring capabilities to include, but not limited to, heart rate, blood pressure, pulse oximetry, respiration rate, capnography, core temperature, heart rate variability and compensatory reserve index. Research and development of devices and sensors should include or plan for the capability to transmit (Bluetooth) to Droid-type handheld devices and tablets. (NOTE: Ideally, sensor and equipment technologies should be electronically readable, scan-able, or transmittable to the Battlefield Assisted Trauma Distributed Observation Kit (BATDOK), a droid driven, multi-patient, point of injury casualty monitoring capability being fielded by U.S. Air Force (USAF) Pararescuemen and other SOF medics. Specifications can be preproposal if selected for full proposal submission. Novel devices are required which aid in measuring physiologic decompensation and/or adequacy of treatment/resuscitation in the field environment and/or provide a trigger for a pre-hospital medical intervention (i.e., validation of tissue (muscle) oxygen saturation (StO2), cardiac risk index (CRI), traumatic brain injury (TBI) measures, etc.

3. Portable Lab Assays and Diagnostics:

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

a. Occupational and Environmental Health (OEH) Hazards:

The proposed project must focus on development of novel methods and devices for rapid identification and analysis of exposures to OEH hazards. Research must support the development and analysis of hand held field hardened and environmentally stable analytical devices, monitoring devices, dosimetry, assays for rapid on-site identification, and real-time analysis of OEH hazards in air, water, and soil that could pose an acute or chronic health hazard to SOF personnel. Such OEH hazards include toxic industrial chemicals/toxic industrial materials (TICs/TIMs), lead exposures, food and water borne pathogens, toxins, biological agents, and radiological material exposures. Research consideration should be given to development of small lightweight programmable submersible unmanned aerial vehicles (UAV) to conduct environmental analysis of OEH hazards in water, air and soil. UAVs must be capable of travel to designated locations, conduct point of collection analysis of OEH hazards, transmit data and return to originating base.

4. Force Health Protection and Environmental Medicine:

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

a. Optimal Acclimatization Strategy:

The proposed project must research, apply and/or develop novel approaches that provide rapid and sustainable human acclimatization, to include fatigue counter actions, for extremes in temperature, altitude, and time-zone change (circadian acclimatization).

b. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Rapid Diagnostics, Treatment, and Prophylaxis:

The proposed projects must research, apply, and/or develop novel approaches that will diagnose, treat, and protect human exposure to chemical, biological, radiological, nuclear, and high yield explosives in near real time.

c. Operational Monitoring:

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

5. Medical Simulation and Training Technologies:

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

6. Human Performance Optimization:

USSOCOM requires SOF Operators to withstand extraordinary physical demands and psychological stress to complete their missions. The optimization of SOF Operators ability to perform at very high levels for long durations, in addition to processing information and making critical decisions in a timely manner, while operating in extreme environments, will significantly improve their overall operational effectiveness. This research area explores alternatives and/or new approaches to sustain and optimize SOF human performance.

a. Improve Sleep:

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

b. Diagnostics for Performance Sustainment:

The proposed project must research, apply, and/or develop minimally invasive diagnostic devices to provide actionable information on nutritional gaps, hormonal response to training, physiological response to performance interventions and recovery, and epigenetic predictors of potential injury.

c. Nutritional Status:

The proposed projects must research and/or apply methods to accurately measure nutritional status in SOF operators. The proposed project should focus on cost effectiveness, accuracy, and end-user compatibility (i.e., user friendly) methods or devices for identifying an individual’s nutrient status, as well as effective means for improving a less than optimal status.

d. Enhanced Physiological Performance:

Develop technologies to maximize the physiological performance of SOF Operators, including increased endurance, enhanced senses, tolerance to environmental extremes, and enhanced overall fitness in order to maintain operational posture/ability in high stress scenarios without noticeable augmentation, and without hampering personnel mobility.

e. Enhanced Mental Performance:

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

f. Optimal Performance Strategy:

The proposed project must research, apply and/or develop novel approaches that provide rapid and sustainable human performance for austere environments and/or the SOF training/operational calendar. Consideration of alternative fuel (energy) sources, dietary supplementation, and nutrient volume/timing are specific areas of interest.

g. Pharmaceutical and Nutritional Supplement interactions:

The proposed project must research, apply and/or develop novel approaches to determining what, if any meaningful interactions occur between and among SOF-common medications (Over-The-Counter (OTC) or Prescription (Rx) and commonly ingested/commercially available nutritional supplements.

h. Wearable Devices:

The proposed project must develop wearable technology(ies) that will monitor physiological measures of human performance to include, but not limited to, caloric expenditure, heart rate/heart rate response, heart rate variability, body fat percentage, sleep hygiene (deep and REM sleep duration) in real-time. Measures should be accurate with low fixed bias, wirelessly communicated via Bluetooth, Near Field Magnetic Induction or Radio Frequency technology in real-time, and provide the command the capability to manipulate the data for analysis of individuals and/or team performance. The device should be able to be turned on/off and/or have an inactive mode, provide real-time feedback on a display screen, be capable of displaying time, and be adjustable to fit users of different statures. Of parallel interest to address, a proposed project to track aircrew sleep, fatigue, and performance degradations through a wearable device that provides quantitative data (rather than qualitative surveys often seen in USAF Fatigue Studies), that in turn will be gathered and amalgamated from entire squadrons, in order to track individual performance, squadron performance, mission impacts to performance levels, length of time for acclimatization (if it is ever achieved), and potential risk of mishaps.

7. Canine Medicine:

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

a. Trauma Resuscitation:

The proposed project must provide research supporting development of innovative techniques/strategies for canine trauma resuscitation (e.g. hypotensive resuscitation, whole blood/blood component replacement, non-compressible hemorrhaging), particularly to address ballistic projectile injuries, in diverse/austere environments that lack immediately available medical evacuation or restorative surgical capacity.

Note: Research should minimize or refrain from utilizing canine specific equipment or devices; this will allow treatment from existing trauma kits fielded by SOF medics.

b. Non-Traditional Anesthesia Protocols:

The proposed project must seek to develop novel approaches for routine and emergency/post-traumatic canine field sedation and/or anesthesia in diverse environments and, utilizing pharmaceuticals available to SOF Medics.

c. Optimizing Canine Performance and Nutrition:

The proposed project must provide research and apply and/or develop novel strategies that address optimization of canine performance through improved physical conditioning programs, enhanced nutrition, and genetics research.

d. Sensory Optimization and Protection:

Research must be oriented toward innovative methods that enhance or conserve SOF canine olfactory, visual, and/or auditory performance during combat operations.

e. Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Canine Decontamination, Treatment, and PPE against possible exposure:

The proposed projects must research, apply, and/or develop novel approaches that will diagnose, treat, decontaminate, and protect canines from exposure to chemical, biological, radiological, nuclear, and high yield explosives.

f. Environmental Extremes:

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

g. Brain Health and Traumatic Brain Injury Brain health research efforts include, but are not limited to: development and validation of Neurocognitive Assessment Tools (NCATs), blast exposure and impact monitoring, determination of safe acceptable limits for blast exposure, validation of neurocognitive baseline testing, capabilities to easily determine mild, moderate, and severe Traumatic Brain Injury (TBI), pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment strategies, and procedures to determine safe return to duty decisions.

h. Pre and Post Trauma Training / Behavioral Issues:

The proposed project must provide research addressing unique approaches to diagnosing and treating SOF-peculiar training and post-traumatic canine behavioral issues, in order to optimize pre-purchase selection and post-purchase training strategies across the enterprise and restore performance in canines with behavioral and/or post-trauma issues.

i. Canine Simulation Technologies:

Develop improved pre-hospital canine combat casualty simulation training devices with an emphasis on the SOF pre-hospital providers. The proposed projects must research and apply /or develop novel approaches for high-fidelity canine trauma training simulation devices with physiologically relevant feedback to include temperature, pulse, lifelike size and weight, realistic fur, active bleeding, anatomically accurate airways and haptic technology. Canine training devices should response to medical treatments with little to no operator/trainer intervention, and capture and provide accurate casualty care feedback. All simulators/simulations should meet Joint airworthiness standards.

8. Brain Health

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

a. Environmental exposures. Research that develops novel material and/or approaches to protect SOF personnel from the neurological effects of single and repetitive auditory (impulse noise) and non-auditory (overpressure) blast exposures and other environmental factors determined to affect nervous system function.

b. Environmental exposure effects. Research that determines the neurocognitive and nervous system effects from single and repetitive blast exposures, impulse noise, and other potential hazardous environmental factors.

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

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

e. Neuropsychological testing. Research to validate Neurocognitive Assessment Tools (NCATs) to determine baseline neurocognitive status, neurocognitive degradation, TBI and recovery status post injury. Proposals to improve the speed, accuracy, specificity, and proximity to injury for the use of NCATs.

f. Olfactory, Oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance. Research and proposals to perform and validate oculomotor, auditory, vestibular, cranial nerve, and vocal acoustic assessments. Research and proposals to assess the effect of nervous system injury to oculomotor, auditory, vestibular, cranial nerve, and vocal-acoustic performance and strategies to restore their performance after injury and prevent injury or further decline.

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

h. Neuroendocrine Dysfunction. Methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction.

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

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

k. Neuromodulation. Research into the use of neuromodulation techniques for treating TBI, neurotrauma, pain, restoring and improving function, and improving behavioral health.

l. Brain lymphatics and glymphatics. Research into measuring the fluid dynamics of the brain lymph system, diagnosing dysfunction, and validation for tools or techniques to improve brain lymph clearance.

m. Pupillary response and microsacaades. Research into field capable pupillary response measurements with the ability to capture microsacaades in order to assess central nervous system loading and/or damage.

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

II.B. Federal Award Information

The Anticipated total costs budgeted for the entire period of performance will not exceed $10 Million annually. The number of awards is indeterminate and contingent upon funding availability. Any funding that is received by the USSOCOM that is appropriate for a research area described within this BAA may be utilized to fund awards. Refer to Section II.D.5. Funding Restrictions, for detailed funding information.

The USAMRAA will negotiate the award types consisting of either contracts, grants or, cooperative agreements for proposals/applications selected for funding. The Federal Grant and Cooperative Agreement Act of 1977, United States Code, Title 31, Sections 6301-6308 (31 USC 6301-6308), provides the legal criteria to select a procurement contract or an assistance agreement.

An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. Government.

An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award. A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. Government. The award type, along with the start date, will be determined during the negotiation process.

Please see Appendix 2 of the General Submission Instructions for more information.

Research involving Human Anatomical Substances, Human Subjects, or Human Cadavers:

All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted proposal/application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Refer to the General Submission Instructions, Appendix 1, and the Human Subject Resource Document available on the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

Typically, a clinical trial is not associated with this BAA. A clinical trial is defined as a prospective accrual of patients (human subjects) in which an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction.

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

Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The VRO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol. Allow at least 1 to 2 months for regulatory review and approval processes for animal studies.

Questions concerning animal use and review should be directed to the USSOCOM VRO: Phone: 813-826-6031; Email: socom_vet@socom.mil

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

The USSOCOM intends that information, data, and research resources generated under awards funded by this BAA be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large.

II.C. Eligibility Information II.C.1. Eligible Applicants

II.C.1.a. Organizations:

Awards are made to organizations only. Organizations eligible to apply include national, international, for-profit, non-profit, public, and private organizations. Refer to the General Submission Instructions, Appendix 3.B, for general eligibility information.

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

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

II.C.1.b. Eligible Investigators

Eligible investigators include all individuals, regardless of ethnicity, nationality, or citizenship status, who are employed by, or affiliated with, an eligible organization.

The USAMRAA makes awards to eligible organizations, not to individuals.

In addition to other information provided herein, by submitting a proposal/application and accepting an award, the organization is: (1) certifying that the investigators’ credentials have been examined and; (2) verifying that the investigators are qualified to conduct the proposed study and to use humans or animals as research subjects, if proposed.

II.C.2. Cost Sharing

Cost sharing/matching is not an eligibility requirement.

II.C.3. Other

Organizations must be able to access .gov and .mil websites in order to fulfill the financial and technical deliverable requirements of the award and submit invoices for payment.

There are no limitations on the number of proposals for which an investigator may be named as a Principal Investigator (PI).

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

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

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

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

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

Subcontracting Plan: If the resultant award is a contract that exceeds $700,000 and the offeror is other than a small business, the contractor will be required to submit a subcontracting plan for small business and small disadvantaged business concerns, in accordance with FAR 19.704 and DFARS 219.704. A mutually agreeable plan will be incorporated as part of the resultant contract.

II.D. Proposal/Application Submission Information

II.D.1. Where to Obtain the Proposal/Application Submission Package

To obtain the complete Grants.gov proposal/application package (hereinafter, submission package), including all required forms, perform a Grants.gov (http://www.grants.gov/) basic search using the Funding Opportunity Number W81XWH18SSOC1.

Submission is a two-step process requiring both (1) pre-proposal/pre-application submission through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through Grants.gov or eBRAP, depending on the type of application being submitted.

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

Classified Submissions: Classified proposals are not expected. However, in an unusual circumstance the applicant may be notified that access to classified information and/or controlled unclassified information will occur under the work proposed. In those instances where a contract is awarded requiring access to classified information and/or controlled unclassified information, clause FAR 52.204-2 shall be in effect, as well as a DD254, if issued. For questions regarding the potential for access to classified information and/or controlled unclassified information, please coordinate with the TPOC for that topic area prior to proposal submission.

Care must be exercised to ensure that classified, sensitive, and critical technologies are not included in a whitepaper. If such information is required, appropriate restrictive markings and procedures should be applied prior to submission of the whitepaper. Portions of the whitepapers may be subject to release under terms of the Freedom of Information Act, 5 U.S.C. 552, as amended.

Pre-application content and forms must be accessed and submitted at eBRAP.org. Full application packages must be accessed and submitted at Grants.gov.

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

II.D.2. Content and Form of the Proposal/Application Submission Submission is a two-step process requiring both pre-application and full application as indicated below. The submission process should be started early to avoid missing deadlines. There are no grace periods.

Pre-Application Submission: All pre-applications for both extramural and intramural organizations must be submitted through eBRAP (https://eBRAP.org/).

Full Application Submission: Full applications must be submitted through the online portals as described below.

Submitting Organizations: Full applications from extramural organizations must be submitted through a Grants.gov Workspace. Applications submitted by extramural organizations (e.g., research foundations) on behalf of intramural DoD or other Federal organizations or investigators will be considered extramural submissions. Applications from extramural organizations, including non-DoD Federal organizations, received through eBRAP will be withdrawn. See definitions in Section II.C.1, Eligible Applicants.

A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and modify the full application submissions associated with them. eBRAP will validate full application files against the specific BAA requirements, and discrepancies will be noted in an email to the PI in the “Full Application Files” tab in eBRAP. It is the applicant’s responsibility to review all application components for accuracy as well as ensure proper ordering as specified in this BAA.

The application title, eBRAP log number, and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent throughout the entire pre-application and full application submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify, and verify the application in eBRAP. If any changes need to be made, the applicant should contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507 prior to the application submission deadline.

II.D.2.a. Step 1: Pre-Proposal/Pre-Application Submission Content Submission of a pre-proposal/pre-application is required and must be submitted through eBRAP (https://eBRAP.org/). If the USSOCOM is interested in receiving a full proposal/application, the PI will be sent an invitation to submit via eBRAP.

During the pre-proposal/pre-application process, each submission is assigned a unique log number by eBRAP. This unique eBRAP log number is required during the full application submission process. To begin the pre-application process, first select whether the submitting organization is extramural or intramural, then confirm your selection or cancel. Incorrect selection of extramural or intramural submission type will delay processing.

If an error has been made in the selection of extramural versus intramural and the pre-application submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk at help@eBRAP.org or 301-682-5507 to request a change in designation.

Because the invitation to submit a proposal/application is based on the contents of the pre- proposal/pre-application, a PI should not change the title or research objectives after the pre- proposal/pre-application is submitted. A PI and organization identified in the pre-proposal/pre- application should be the same as those intended for the full proposal/application submission. If any changes are necessary after submission of the pre-proposal/pre-application, the PI must contact the eBRAP Help Desk via email at help@eBRAP.org or 301-682-5507. A change in PI or organization after submission of the pre-proposal/pre-application will be allowed only at the discretion of the USAMRAA Contracting or Grants Officer.

The organization, Business Official, and PI must register in eBRAP before submitting a preproposal/pre-application. Upon completion of an organization’s registration in eBRAP and approval by the eBRAP Help Desk, the organization name will be displayed in eBRAP to assist the organization’s Business Officials and PIs as they register.