HT9425-23-S-SOC1-0003.pdf

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

I. OVERVIEW OF THE FUNDING OPPORTUNITY

United States Special Operations Command

Department of Defense

BROAD AGENCY ANNOUNCEMENT (BAA)

for Extramural Biomedical and Human Performance

Funding Opportunity Number: HT9425-23-S-SOC1

Announcement Type: Revised-0003

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

KEY DATES

Release/Posted Date: Initial 27 July 2023. Revised -0001: 11 AUG 2023. Revised -0002: 29 APR 2024. Revised 0003: 23 July 2025.

Closing Date: 31 July, 2028, 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 2023 closing 31 July 2028, 11:59 p.m. Eastern Time. Note: This BAA will be updated annually.

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

I. OVERVIEW OF THE FUNDING OPPORTUNITY

II. DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY

II.A. Program Description II.A.1. Research Area of Interest

II.B. Federal Award Information II.C. Eligibility Information II.C.1. Eligible Applicants

II.C.2. Cost Sharing

II.C.3. Other

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

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

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

II.D.4. Submission Dates and Times

II.D.5. Funding Restrictions

II.D.6. Other Submission Requirements

II.E. Proposal/Application Review Information II.E.1. Criteria

II.E.2. Proposal/Application Review and Selection Process

II.E.3. Integrity and Performance Information

II.E.4. Anticipated Announcement and Federal Award Dates

II.F. Federal Award Administration Information II.F.1. Federal Award Notices

II.F.2. Administrative and National Policy Requirements

II.F.3. Reporting

II.G. Federal Awarding Agency Contacts II.G.1. eBRAP Help Desk

II.G.2. Grants.gov Contact Center

II.H. Other Information II.H.1. Administrative Actions

II.H.2. Proposal/Application Submission Checklist

APPENDIX 1: ACRONYM LIST

II. DETAILED INFORMATION ABOUT THE FUNDING

OPPORTUNITY

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

• The total individual project estimated cost ceiling has been increased from $4,000,000 to $5,000,000, and generally anticipated project cost has been increased from $700,000 to $2,000,000.

• The “Program Description” that describes the “Research Areas of Interest (RAIs)” 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 4001. 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 (FAR) 6.102(d)(2) and 35.016. 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 is intended and expected to benefit and inform both military and civilian medical practice and knowledge.

This BAA provides a general description of the USSOCOM’s research and development programs, including RAIs, 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.

The USSOCOM utilizes the tools and processes provided by the 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, the U.S. Army Medical Research Acquisition Activity (USAMRAA) will be the awarding and administering office for proposals 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) to support far-forward early intervention of life-threatening illnesses or injuries within an Irregular Warfare or asymmetric, multi-domain operational environment. 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 simple to employ, require minimum maintenance, and have low power consumption. Drugs and biologics should optimally not require refrigeration or other special handling. All materiel solutions must be capable of 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 U.S. Armed Forces, family members of the U. S. Armed Forces, and U.S. Veterans. Proposals must address a relevant health problem responsive to one of the RAIs identified below. Additional RAIs may be added during the life of the BAA (FY23-FY28). The following RAIs are in no particular order:

1. Damage Control Resuscitation (DCR):

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, drugs, 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 DCR to which the USSOCOM 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: resuscitation, optimal resuscitation fluid(s), uncomplicated shock, noncompressible 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, and incorporate analgesia 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 Hemostatics:

The proposed project must research novel strategies to increase the ease, efficacy, and safety of blood transfusions (i.e., person to person, pre-hospital blood banking, rolling blood banks, and 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 injectable medications to address the coagulopathy of trauma and novel strategies to improve tissue oxygenation.

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), and there will be a mismatch between capability and need. 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 linking forward surgical providers with higher medical authority consultation and effective, relevant, and dynamic surgical training capabilities. Lastly, research into future procedures and devices 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, improving surgical access in distributed maritime environment, surgery in flight, etc.) to bridge time to surgery when patient load exceeds surgical capability.

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. PFC 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. SOF medical personnel require capability to expedite evacuation and increase survivability with limited site of injury support in austere environments including: hyperbaric, mountainous, high-altitude, arctic, and distributed maritime operations. Significant consideration will be given to proposals focused on PCC that may also relate to Sections 1.a. through 1.d. and 5.b. of this BAA.

3. Medical Sensors and Devices:

The primary emphasis is to research, apply and/or develop field-sustainable, rapidly deployable medical sensors and/or devices for extended care beyond initial trauma resuscitation, to include austere/forward surgery while operating in 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 (CRI). Research and development of devices and sensors should include or plan for the capability to transmit (Bluetooth 4.2) to Android handheld devices and be designed with an open architecture to allow for sensors to be incorporated into a family of sensors that may or may not report to a central handheld device. (NOTE: Ideally, sensor and equipment technologies should be electronically readable, scannable, or transmittable to the Battlefield Assisted Trauma Distributed Observation Kit (BATDOK), an Android-driven, multi-patient, point of injury casualty monitoring capability being fielded by U.S. Air Force (USAF) Pararescuemen and other SOF Medics. 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), CRI, traumatic brain injury (TBI) measures, etc.

4. 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 that are field oriented, rugged, low weight/cube space and have little to no refrigeration requirements.

Additionally, novel wireless, transmittable or scannable solutions such as patches, scanner/readers or other noninvasive technologies as described in paragraph 5.a. below are encouraged.

5. 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 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.

a. 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 SOF personnel from exposure to chemical, biological, radiological, nuclear, and high yield explosives in near real time.

b. 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 handheld, 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.

c. Operational Exposure Monitoring:

The proposed project must seek to develop wireless biosensors for monitoring SOF personnel 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 4.2 to Android handheld devices, tablets, or compatible wrist-mounted displays.

6. Brain Health:

Brain Health research efforts include, but are not limited to: determining if repeated low-level blast exposure (rLLBE) causes brain injury or repeated blast brain injury (rBBI), 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 rBBI, methods to prevent, screen for, monitor, and correct neuroendocrine dysfunction. Additionally, Brain Health research efforts include, but are not limited to: 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 Protection:

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, nervous system, and auditory effects from single and repeated low- and high-level blast exposures, impulse noise, and other potential hazardous environmental factors.

c. Biomarkers:

Research to determine which biomarkers are indicative of rBBI; sequelae from rBBI causing further injury; recovery status; and recovery rate from rBBI. Testing and validating diagnostic biomarkers for rBBI. 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 rBBI are of interest.

d. Neuropsychological Testing:

Research to validate neurocognitive assessment tools (NCATs) to determine baseline neurocognitive status, readiness, neurocognitive degradation, sensitivity to various exposures, TBI and recovery status post injury. Proposals to improve the speed, accuracy, specificity, and proximity to injury for the use of NCATs, as well as to compare new technologies and/or modalities (including passive assessment of cognition) to existing NCATs.

e. 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.

f. 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.

g. Neuroendocrine Dysfunction:

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

h. 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 interface astroglial scarring without the need for immunohistochemistry, immunofluorescence, or histopathology testing.

i. 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.

j. Neuromodulation:

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

k. Brain Lymphatics and Glymphatics:

Research into measuring the fluid dynamics of the brain lymphatic system, diagnosing dysfunction, and validation for tools or techniques to improve brain lymphatic clearance.

l. Pupillometry, Pupillary Response, and Microsaccades:

Research into field capable pupillary response measurement capture and analysis, with or without the ability to capture Microsaccades to assess central nervous system loading and/or damage.

7. Automation of Systematic Reviews and Metanalysis:

Research into Automation of Systematic Reviews and Metanalysis using the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) or a similar method

8. Human Performance:

USSOCOM requires SOF personnel to withstand extraordinary physical demands and psychological stress to complete their missions. The optimization of SOF personnel’s 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 both to increase mission capability and to extend the career longevity of SOF personnel.

a. Improved 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 personnel 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. Optimal Acclimatization Strategies:

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

c. Wearables:

The proposed project must research, apply, and/or develop novel approaches and/or wearable technologies, and/or leverage commercial-off-the-shelf wearable technologies 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 utilize the data for analysis of individuals and/or team performance via the USSOCOM Human Performance Data Management System. 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 is a proposed project to track sleep, fatigue, and performance degradations through a wearable device that provides quantitative data (rather than qualitative surveys often seen in Fatigue Studies), that in turn will be gathered and amalgamated from entire units, in order to track individual performance, unit performance, mission impacts to performance levels, length of time for acclimatization (if it is ever achieved), and potential risk of mishaps.

d. 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.

e. Performance Nutrition:

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

f. Physiological Performance:

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

g. Cognitive Performance:

The proposed project must research, apply, and/or develop novel approaches and/or technology 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.

h. Psychological Performance and Suicide Prevention:

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

9. Canine Medicine and Performance:

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 and Performance” project areas, to which SOF will give consideration, in priority order, are:

a. Trauma Resuscitation:

The proposed project must support development of innovative techniques/strategies for canine trauma resuscitation (e.g., hypotensive resuscitation, whole blood/blood component replacement, and 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 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. Canine Performance:

The proposed project must research, apply, and/or develop novel approaches and/or technologies that address optimization of canine performance through improved physical conditioning programs, reduction of cognitive decline, 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 TBI Brain health research efforts include but are not limited to development and validation of 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 TBI, pharmaceuticals to prevent or treat brain injury, validation of brain injury treatment strategies, and procedures to determine safe return to duty decisions for SOF canines.

h. Pre- and Post-Trauma Training / Behavioral Issues:

The proposed project must address unique approaches to diagnosing and treating SOF-peculiar training and post-traumatic canine behavioral issues, 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.

10. Medical Sustainment SOF medical personnel require sustainment capabilities to support far-forward medical requirements to reduce the patient and supply risk associated with operational medicine. The proposed research, application, and/or development of medical sustainment techniques and materiel must address unique approaches to optimizing supply management and safeguarding equipment requirements. The project areas under “Medical Sustainment” to which the USSOCOM will give highest consideration are:

a. Power and Energy Project proposals must research, apply, and/or develop novel strategies that conserve or optimize medical equipment in-field use to reduce sustainment burden in prolonged, austere environments.

b. Austere Medical Logistics Procurement SOF personnel, operating in austere environments, may not have the ability to receive conventional resupply efforts. Project proposals must research, apply, and/or develop novel approaches to assist SOF personnel in developing and receiving medical resupplies or repair parts to meet their needs while in the field. These efforts must meet shipping and handling considerations (i.e. temperature control) for a wide range of medical products from batteries to blood. Efforts may include, but are not limited to, fabrication, improvisation, and/or delivery methods from sea, ground, air, or suborbital domains.

c. Equipment Protection Research that develops novel material and/or approaches to protect SOF medical equipment from environmental (i.e. CBRNE, freezing temperatures, etc.) and/or adversarial effects (i.e. jamming, electromagnetic pulse weapons, etc.).

d. Supply Monitoring Capability Project proposals must research, apply, and/or develop novel approaches to rapidly forecasting and calculating supply requirements based on patient treatment requirements, shelf-life, and storage considerations.

II.B. Federal Award Information

The Anticipated total costs budgeted for the entire period of performance inclusive of all contract awards made in response to this BAA, will not exceed $20 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 contract awards for proposals selected for funding. A contract is required when the principal purpose of the instrument is to acquire supplies or services for the direct benefit or use of the U.S. Government. The contract 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 Human Research Oversight (OHRO),, 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 OHRO Human Research Protections Official (HRPO) review 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 OHRO 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 OHRO of protocols involving more than the scope of work in the DoD-funded award will require 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 VRO, 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 https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/public/Program.htm 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, disadvantaged small business, and woman-owned small business concerns must be given the maximum practical opportunity to participate through subawards on research proposals 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.

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

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.

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 Responsibility/Qualification (R/Q):

To protect the public interest, the Federal Government ensures the integrity of Federal programs by striving to conduct business only with responsible organizations. The USSOCOM uses the “Exclusions” within the Performance Information functional area of the SAM and data from the R/Q, a component within SAM, to verify that an organization is eligible to receive Federal awards. More information about the SAM and the R/Q 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 a 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 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 $750,000 and the offeror is other than a small business, the contractor will be required to submit a subcontracting plan for small business and small disadvantaged business concerns, in accordance with FAR 19.704 and DFARS 219.704. A mutually agreeable plan will be incorporated as part of the resultant contract.

https://www.sam.gov/ https://www.sam.gov/

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 HT9425-23-S-SOC1.

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 DD Form 254, if issued.

Care must be exercised to ensure that classified, sensitive, and critical technologies are not included in a proposal/ application package. If such information is required, appropriate restrictive markings and procedures should be applied prior to submission of the proposal/ application package. Portions of the proposal/ application package 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 submission and full application submission 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 extramural organizations must be submitted through eBRAP (https://eBRAP.org/).

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

http://www.grants.gov/ http://www.grants.gov/ https://ebrap.org/ https://ebrap.org/ https://ebrap.org/ https://ebrap.org/ https://ebrap.org/

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 Officer. Change in Principal Investigator during contract performance unless otherwise restricted, will be allowed at the discretion of the USAMRAA Contracting Officer, provided that the intent of the award is met.

The organization, Business Official, and PI must register in eBRAP before submitting a pre-proposal/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. The organization, Business Officials, and PIs must all be registered and affiliated in eBRAP. (See eBRAP User Guide at https://ebrap.org/eBRAP/public/UserGuide.pdf.)

Pre-proposals may be submitted at any time prior to the BAA closing date. Pre-proposals should describe specific ideas or projects that pertain to any of the areas described under “Program Description” in this BAA. A pre-proposal/pre-application must include a brief description of the scientific methods and design to address the problem as described below. Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a pre-proposal/pre-application. DO NOT include any proprietary information in the pre-proposal/pre-application.

The pre-proposal/pre-application consists of the following components, which are organized in eBRAP by separate tabs. Refer to the General Submission Instructions, Section II, for additional information on the pre-proposal/pre-application submission.

• Tab 1 – Application Information: Enter the information as described in eBRAP before continuing the pre-proposal/pre-application.

• Tab 2 – Application Contacts: Enter contact information for the PI and the organization’s Business Official responsible for the sponsored program administration (or equivalent). This is the individual listed as “person to be contacted on matters involving this Application” in Block 5 of the Grants.gov SF424 form. The form is designed to fill in common required fields across other forms, such as the applicant's name, address, and Unique Entity Identifier (UEI) Number. Once it is completed, the information will transfer to the other forms.

The Business Official must either be named or invited in order for the pre-proposal/pre-application to be submitted. If the organization’s Business Official is not in eBRAP, an invitation to the Business Official to register in eBRAP must be sent. In addition, it is recommended that the applicant identify an Alternate Submitter in the event that assistance with pre- proposal/pre-application submission is needed.

NOTE: The eBRAP system does…