ERDC BAA - ARMY

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The U.S. Army Corps of Engineers’ Engineer Research and Development Center (ERDC) is issuing a continuously open Broad Agency Announcement to fund basic, applied, and advanced research across a wide range of engineering, environmental, and defense-relevant technology areas. Awards are made on a rolling basis through cooperative agreements, subject to the availability of funds so interested companies should submit as soon as possible.

How much funding would I receive?

ERDC does not specify a standard award size. Individual awards may range from small research efforts to very large, multi-year programs, with an overall program ceiling of $1 billion. Funding levels are determined based on technical scope, relevance, and available funding within the sponsoring ERDC laboratory.

What could I use the funding for?

To be eligible for consideration and possible contract award, the technology or methodology shall be either basic research, applied research, advanced technology development not for a specific system/hardware, or demonstration and validation.

If your technology is novel and fits into one of the following Areas of Interest, you could potentially be funded:

Coastal and Hydraulics Laboratory (CHL)

• Overview

  Research is performed in the areas of hydraulic structures such as locks, dams, outlet works, control gates, stilling basins, spillways, channels, fish handling systems, and pumping stations, flood control channels, navigation channels, riverine and estuarine hydrodynamics and transport processes, groundwater, hydrology; dredgingrelated equipment, and on coastal problems related to coastal storm hazards and risk management, beach erosion, navigation, sedimentation, Regional Sediment Management, inlet stabilization, and construction, operation and maintenance of coastal structures (breakwater, jetties, groins, seawalls, etc.). Major areas of interest include coastal hydrodynamics (wind waves, tides, currents, wind related water levels); coastal sedimentation (longshore transport, inlet sedimentation); coastal geology and geomorphology; design and stability of coastal structures; erosion and storm reduction potential and life-cycle performance of natural and nature-based features; system optimization methods and performance metrics for coastal operations; coastal resiliency; and interaction of structures and coastal processes. Other activities include descriptions of coastal processes; theoretical studies; watershed and regional sediment and water systems studies; numerical and physical model techniques; data collection and analysis techniques; and development of laboratory and prototype instrumentation and equipment. The following sections contain information on these research areas and specific research thrusts.

• A. Physical Processes in Estuaries (CHL-1)

  Research in estuarine physical processes deals with the hydrodynamic and transport characteristics of water bodies located between the sea and the upland limit of tidal effects. Research is directed toward knowledge that will improve field measurements and predictions of these processes. Specific areas of required research include the following physical processes in estuaries and other tidal waters. Specific areas of required research include the following physical processes in estuaries and other tidal waters. a. The propagation of tides. b. Transport of salinity, mixing processes, stratified flows. c. Transport, erosion, and deposition of sediments, including settling velocity, aggregation of sediment, consolidation of sediment. d. Behavior and characteristics of sediment beds, including movement, consolidation, armoring, bonding, physical chemical characteristics, density, erodibility. e. Flow between aquifers and surface waters.

  Specific areas of required research include the following activities with respect to the physical processes listed. a. The effect of human activities, including dredging construction, vessel traffic, flow diversion, training, structures, and protective structures. b. Measurements of parameters that are indicative or descriptive of the processes listed in the 2nd paragraph by in-situ and remote methods in the lab and field. c. Prediction of processes listed in the 2nd paragraph by analytical methods, physical models, numerical models, and other techniques. d. Conceptual and mathematical descriptions of the processes listed in the 2nd paragraph. e. Development of materials, equipment, and methods that potentially lead to applied research that would make human activities listed safer, more economical, or more effective. f. Development of methods, techniques, and procedures that enable the treatment of an estuary as a system.

• B. Inland Hydraulic Structures (CHL-2)

  Research in hydraulic structures is related to the hydraulic performance of locks, dams, outlet works, control gates, stilling basins, spillways, channels, bank protection, riprap stability, pumping plants and other hydraulic structures, and with physical and/or numerical model studies to predict and analyze the physical water quality aspects of water resources projects. Specific areas of required research include the following: a. Conduct physical and numerical hydraulic model investigations of a wide variety of hydraulic structures to verify proposed designs and develop more effective and economical designs. b. Analyze model and prototype data and inspection of field installations to develop design criteria for hydraulic structures. c. Develop methods of correlating theoretical and experimental information with design methods used by the Corps of Engineers to improve existing procedures and provide material for inclusion in appropriate manuals. d. Develop physical and/or numerical models to predict and analyze the water quality aspects of water resources projects and design appropriate hydraulic structures to control water as well as water quantity while satisfying the desired objectives. e. Conduct research and/or develop numerical codes to advance techniques for analyzing physical aspects of water quality in lakes and rivers through a better understanding of the hydrodynamics in density-stratified environments and for improving water quality within and downstream of density-stratified reservoirs and to investigate the ability of existing and proposed water resources projects to satisfy established water quality standards. f. Conduct basic studies for development of hydraulic design and operation guidance for hydraulic structures used in inland waterways for navigation and flood control purposes, including wave forces/loads on gates (tainter, miter, etc.). g. Conduct/analyze tests, both model and prototype, of the performance of hydraulic appurtenances to flood control and navigation dams such as spillways, outlet works, energy dissipaters, and approach and exit channels, to develop design guidance that will provide structures of maximum efficiency and reliability with minimum maintenance. h. Develop innovative methods to prepare and revise engineering manuals for hydraulic design of various hydraulic structures. i. Develop innovative methods to conduct training courses on design of various hydraulic structures. j. Develop innovative methods to prepare technical reports of all work conducted.

• C. Open Channel Flow and Sedimentation (CHL-3)

  Research in open channel flow and sedimentation includes basic studies related to development of hydraulic design guidance for designing modifications to natural stream channels to provide for local flood risk reduction. Emphasis is placed on channel stability as well as channel flow capacity. Specific areas of required research include the following: a. Studies related to the development of effective methods to analyze a natural stream's response to modifications made for flood control purposes. b. Studies applicable to development of stream bank and streambed protection methods where channel instability exists. c. Studies applicable to development of sediment transport, local scour, and stream form relationships for a broad range of stream types, bed and bank materials, and meteorological and hydrological conditions. d. Collection and analysis of data that aid in evaluating existing methods and/or developing new methods to analyze channel stability for the variety of channel flow conditions and stream types existing in natural stream systems.

• D. Dredging Research (CHL-4)

  Protection and enhancement of the environment associated with operation and maintenance of navigable U.S. waterway infrastructure through dredging activities is a national priority. Dredging operations and environmental requirements of navigation projects are inseparable. Research is required to predict the time-dependent movement of non- contaminated sand and sand/silt mixtures of dredged materials placed in the nearshore zone, and all materials placed in the offshore region. The cost of dredging operations attributable to compliance with environmental windows that are determined to be over-restrictive, inconsistent, or technically unjustified can be reduced. More effective contaminated sediment characterization and management will reduce costs and enhance the reliability of methods associated with the assessment, dredging, placement, and control of sediments from navigation projects. Better instrumentation for dredge and site monitoring is required to implement automated dredge inspection and payment methods and accurately monitor placement of contaminated materials. Emerging technologies regarding innovative equipment and processes should be expeditiously introduced into the dredging arena. Enhanced ecological risk management for dredging and disposal projects through technically sound approaches for characterizing, managing, and conducting risk-based evaluations are required for expanding options regarding both contaminated and non-contaminated dredged materials.

• E. Navigation Channel Design (CHL-5)

  Research in navigation channel design involves basic research to develop design guidance for the design of new channels and modifications of existing waterways. It involves identifying maneuvering requirements in restricted waterways that affect the channel dimensions, alignment, and location of appurtenances in the navigation channel under various environmental and vessel traffic conditions. It also involves identifying the stability of the channel, maintenance requirements and designing structures that reduce or eliminate the maintenance requirements. Finally, it involves quantifying the flow and pressure fields generated by a tow or ship passing through a waterway and the related impacts on the sediment resuspension in the channel, channel border, and side channel/backwater areas. Studies involve deep and shallow draft navigation channels and physical and mathematical models. Human factors are included in research and project studies using a ship and tow simulator.

  Specific areas of required research include the following: a. Physical model investigations of a wide variety of navigation channel configurations in many environments with different type vessels to verify proposed designs and to develop more efficient and safe designs and to lower environmental impacts. b. Development and enhancement of mathematical models of vessels, both ships and push-tows, for use on the simulator to add vessel types not available or to increase the accuracy with which the model reproduces the vessels response. c. Development of methods and modeling techniques to predict the currents and sediment transport characteristics of various channel designs and integrate this with the navigation model studies, including those generated by the vessel movement. d. Development of methods and modeling techniques to predict the currents and sediment transport characteristics of various channel designs and integrate this with the navigation model studies. e. Development of methods and techniques to prepare and display visual information for the pilot on the simulator projection system. f. Development of methods and measurement equipment, techniques for measuring scale model performance in physical model navigation studies. g. Development of methods and techniques to improve the ship simulator and increase reliability of design estimates, including data and tools for ship motions, draw down, squat, ship-generated waves, and ship maneuvering. h. Development of methods and techniques for the analysis and evaluation of model results to optimize the channel design and to determine the level of safety, or conversely, risk involved with the various designs and ship transits.

• F. Computer-Aided Hydraulic Engineering (CHL-6)

  Research in this topic area develops computer-aided design tools that can be used by hydraulic engineers in planning, design, construction, operation, and maintenance of navigation and flood control projects. The scope includes open channel and closed conduit flows, equipment, structures, and sediment transport analysis and modeling.

• G. Groundwater (CHL-7)

  Research in groundwater is structured to enhance understanding and prediction of the flow of water and various transported constituents through the environment, including groundwater issues from contaminant remediation to levee erosion as well as surface water problems from flash flooding to nearshore coastal flows. Primary tools are computer models that solve (approximately) conservation equations for mass, momentum, and energy in various physical systems. Work includes developing the numerical methods for solving these equations, writing the computer code to implement the approximations in desktop and high-performance computing environments, and applying the models as part of engineering studies to investigate processes like levee erosion and overtopping, seawater intrusion, and flow through vegetation.

• H. Hydrology (CHL-8)

  Research in this area primarily addresses military applications related to mobility, counter mobility, and water supply. Specific research involves the following areas: a. Large-scale hydrologic modeling. b. Rapid procedures for flood forecasting. c. Groundwater-surface water interaction processes. d. Multi-scale, multi-physics hydrologic modeling. e. Remote sensing and quantification of precipitation. f. Development of spatially varying precipitation hydrology models. g. Visualization of results for hydrology and dam break models. h. Interfacing with existing and new hydrology models. i. Interfacing watershed models with water quality and other environmental models.

• I. H&H GIS/Database Development (CHL-9)

  Research involves the following areas: a. Electronic Navigation Charting. b. Integration of GIS/Database and H&H models. c. Watershed management for erosion control. d. Larger River System management for flood control navigation. e. Visualization Techniques

• J. Coastal Hydrodynamics, Coastal Processes (CHL-10)

  Research in this area includes: shallow water wave estimation; forecasting and hindcasting of wind generated waves for oceanic to local regions; wave theory; statistical distribution of wave parameters; simulation of spectral and phase resolved conditions in wave basins; infragravity (free and bound) waves; nearshore currents; wave breaking; wave/current and wave structure interactions; wave and sediment interactions with natural and nature-based features; long and short waves in ports and harbors; tsunami modeling; wind generated currents; storm surge; tidal circulation; twoand three dimensional numerical simulation models (including finite difference, finite element, finite volume and curvilinear coordinate techniques); coastal meteorology; explosion generated waves; ship response to winds, currents and waves; moored ship response; mooring design and analysis, ribbon bridge hydrodynamics and turbulence.

• K. Coastal Inlets, Navigation Channels (CHL-11)

  Research includes sediment shoaling in coastal inlet channels; stability and performance of inlet channels; scour at structures; sediment transport modeling; influence of structures such as jetties and breakwaters on wave, current, and sedimentation processes. Numerical modeling of inlet hydrodynamics and sedimenttransport processes, including long-term geomorphologic evolution of inlet channels, shoals, and adjacent beaches, and the interaction with navigation structures. Nearshore placement of dredged sediment to foster wave reduction and sediment supply to adjacent beaches. Short- and long-term dune evolution in vicinity of coastal inlets. Shoreline evolution modeling and storm erosion of beaches, particularly concerning over wash and breaching near inlets; wind and wave generated sediment transport; sediment budget analysis; coastal and inlet geomorphology; and PC-, workstation-, and mainframe-based automated coastal engineering software (including relational and GIS data bases)

• L. Coastal Structure and Facility Design (CHL-12)

  Research includes development of functional and stability design criteria for coastal structures and facilities (breakwaters, seawalls, jetties, groins, harbors, marinas, etc.); wave run-up, over-topping, refraction, diffraction, transmission, reflection, etc.; design of floating breakwaters; breakwater stability; application of spectral wave conditions to coastal engineering; stability of riprap to irregular wave attack; stability and functional design of overtopped rubble mound breakwaters; scale modeling of armor unit strength; analysis of structural data for floating breakwaters; investigation of numerical structural models for floating breakwaters; development of wave run-up gage for rough and porous slopes; investigation of attenuation/mooring force models of floating breakwaters; development of materials and techniques to produce high quality breakwater model armor units; analysis of wave run-up overtopping, refraction, diffraction, transmission and/or reflection data on coastal structures and beaches and design of structures for Logistics-Over-The-Shore (LOTS) operations.

• M. Field and Laboratory Measurements, Data Collection, and Analysis (CHL13)

  This topic area includes research in technologies, instrumentation, and monitoring systems in coastal and riverine settings for collecting, analyzing, and disseminating data related to measurements of coastal waves, surface currents, water levels, water quality, sediment, and wind, primarily in the field, but also in a sediment laboratory; advanced data analysis (spectral and non-spectral) techniques; remote sensing techniques; bedload and suspended sediment transport; monitoring and evaluating technical and structural stability of coastal projects; advanced hydrographic survey techniques, field measurement of coastal processes; bathymetric survey systems.

• N. Experimental Coastal Model Equipment, Operation and Analysis (CHL-14)

  Research includes development of equipment and techniques for specialized model construction, experimental wave generation equipment, specialized data acquisition and analysis systems, advanced model operations techniques, and laboratory and scale effects in movable bed model studies.

• O. General Coastal Engineering, Coastal Geology, Dredging Investigations CHL-15)

  This topic area includes topics such as sand bypassing systems and equipment; beach fill design; coastal geology and geomorphology; functional design and evaluation of coastal works and coastal structures; methodologies to assess and track coastal resilience performance; littoral transport; coastal and offshore dredging studies; agitation dredging systems and equipment; physical monitoring of dredged material; physical processes in coastal wetlands; application of Geographic Information Systems; design of nearshore and offshore dredged material placement; evaluation of dredged material disposal sites; analysis of dredging operations management.

• P. Regional and Watershed Sediment Management (CHL-16)

  Regional Sediment Management (RSM) research is intended to provide knowledge and tools that the Corps and the Nation need for effective water resource projects. RSM implies the holistic management of sediment within systems or regions to produce environmentally and economically sustainable projects. Goals include improved project design, operation, and maintenance methods, minimized disruption of natural sediment pathways and processes, and mediation of natural processes that have adverse environmental or economic impact. The approach of the Corps research is to produce targeted R&D serving multiple Corps business areas; to employ ongoing projects’ experience (including Demonstration Projects) to provide data and lessons learned; to use enabling technologies of localscale products and tools, including those generated by other R&D programs within and outside the Corps; to generate technologies that integrate the best available knowledge on sediment behavior and regional morphology into management decision support tools for a) regional and basin scale analyses and b) evaluation of the impacts of projects and management decisions on and by long-term, large-scale sedimentation processes. A key element in ERDC research is full coordination with other organizations with sediment management or monitoring expertise.

• Q. Marine Transportation Technologies (CHL-17)

  Research in this topic area serves one of the USACE’s primary missions, to provide safe, reliable, efficient, effective, and environmentally sustainable waterborne transportation systems for movement of commerce, national security needs, and recreation. To accomplish this mission, the USACE requires R&D to facilitate tracking of vessels on inland waterways (shallow draft) and coastal ports (deep draft). Knowing what vessels are arriving, when, the commodities being carried, etc., will provide lock operators and operations project managers valuable tools to improve safety, efficiency, asset management, and help to make decisions on performance-based funding for navigation project maintenance and improvements. Work in this area focuses on software that uses the United States Coast Guard’s (USCG) Automated Identification Systems (AIS) vessel mounted transmitters which broadcasts a radio signal with the vessels name, position, heading, velocity, and a wide range of other information. Proposals are sought for developing the following: a. Capability that will take the full suite of standard CG AIS messages and provide them in near real time to the Corps facilities in the immediate area of the vessel. b. Capability to allow collection of the full suite of standard AIS messages simultaneously at all pertinent Corps Inland and Deep Draft facilities. c. Capability to customize user interface to allow the Corps operations staff to view vessels in the vicinity of the Corps facilities to make decisions on the order in which to allow commercial tows to pass through lock. d. Provide the capability for Corps facilities to transmit pertinent information to the vessels in the immediate vicinity of the Corps facilities via AIS. e. System optimization methods and performance metrics for vessel operations. Special Considerations: The level of understanding of AIS technology and signal processing, the number of successful installations of similar AIS software processing capabilities; experience with USCG staff, facilities, regulations, and procedures.

• R. Post-Wildfire Hydrologic, Sediment, and Geomorphologic Management (CHL-18)

  Post-Wildfire research is focused on improving understanding of post-fire impacts through exploitation of affordable data acquisition methods and enhancement of numerical modeling capabilities to assist with planning, management, and mitigation in post-wildfire environments. Immediately following a wildfire, vegetation is removed, organic soil horizons are reduced to ash, and hydrophobic soils combine to result in increased water and sediment discharge and debris, mud, and hyper concentrated flows. In the years following a wildfire, ecotone shifts, gully formation, and channel incision alter the hydrologic system response, resulting in dramatic changes in hydraulic and sediment impacts down system. Wildfires represent a significant perturbation to natural systems that dramatically alter the morphologic, hydrologic, and sediment regimes of impacted watersheds. The overall purpose of this area of research and development is to investigate post-wildfire impacts on hydrologic and hydraulic response, geomorphic evolution, and sedimentation, with specific research needed in the following areas: a. Studies related to cost-effective (in situ and remotely sensed) data acquisition and processing methods. b. Studies related to better understanding the longer-term geomorphic impacts and subsequent recovery processes in post-fire environments. c. Studies related to hydrological physical processes, empirical approaches, and numerical modeling. d. Studies related to hydraulics and sediment transport physical processes and numerical modeling.

• S. Nearshore Coastal Research in Support of the U.S. Coastal Research Program (CHL- 19)

  Proposals are invited to address nearshore coastal research needs within three broad research themes as identified by the U.S. Coastal Research Program (USCRP) (see Nearshore Process Community, 2015 for more details). Nearshore systems include the complex interactions of physical, biological, chemical, and human influences within the transition region across the land and the continental shelf, spanning (from onshore to offshore) coastal plains, wetlands, estuaries, coastal cliffs, dunes, beaches, surf zones, and the inner shelf. Worldwide, nearly 1 billion people live at elevations within 10 m of present sea level, an elevation zone in need of engineering solutions that reduce risks to life and property produced by various extreme events. The nearshore is a societally relevant region that requires and improved understanding of the feedbacks and couplings that shape, sustain, and alter coastal landscapes. The three broad research themes include a need to understand, better predict, and respond to (1) Long-term coastal evolution due to natural and anthropogenic processes; (2) Extreme Events including: flooding, erosion, and the subsequent recovery; and (3) The physical biological and chemical processes impacting human and ecosystem health. Each is detailed below a. Long-term coastal evolution due to natural and anthropogenic processes: As storms impact increasingly urbanized coastal communities, an understanding of long-term coastal evolution is critical. Improved knowledge of long-term morphological, ecological, and societal processes and their interactions will result in an improved ability to simulate coastal change and develop proactive solutions for resilient coasts and better guidance for reducing coastal vulnerability. b. Extreme Events including flooding, erosion, and the subsequent recovery: U.S. coastal extreme event related economic losses have increased substantially over the past decades. Addressing this research theme will result in an improved understanding of the physical processes during extreme events, leading to improved models of flooding, erosion, and recovery. Utilization and application of the improved models will produce societal benefit in the form of more resilient coastal communities. c. The physical, biological, and chemical processes impacting human and ecosystem health: Nearshore regions are used for recreation, tourism, human habitation, and provide habitat and valuable ecosystem services. These areas must be sustained for future generations, however overall coastal water quality is declining due to microbial pathogens, fertilizers, pesticides, and heavy metal contamination, threatening ecosystem and human health. To ensure sustainable nearshore regions, predictive real-time water- and sediment-based pollutant modeling capabilities must be developed, which requires expanding our knowledge of the physics, chemistry, and biology of the nearshore. The resulting societal benefits will include better beach safety, healthier ecosystems, and improved mitigation and regulatory policies.

• T. Comprehensive Water Risk Management (CWRM) (CHL- 20)

  Proposals are invited to develop and explore the application of next generation technologies, methods and approaches that lead to the creation of a seamless national hydro-terrestrial capability within the USACE and partner agencies. CWRM includes advanced data collection, prediction and management technologies that can provide water managers the tools required to minimize, mitigate, and better manage water hazards under present and future design requirements. Proposals for research in the following specific areas are needed: a. Inland and Coastal Compound Flooding: Research to support the inclusion of inland and coastal compound flooding in the reduction of comprehensive flood risk from riverine flows, precipitation, coastal storms, groundwater emergence, sea level change, snowmelt, wildfires, subsidence, and other natural as well as anthropogenic events. b. Data Collection: Research to support the collection and analysis of water data through in-situ and standoff measurements including satellite, and various uncrewed systems (UxS). For UxS this includes sensing, perception, control, and data process techniques. Needs include data collection techniques for snowpack analysis, soil-moisture determination, wave environment, estimation of under-water bathymetry, reservoir capacity, etc. c. Probabilistic Modeling – Uncertainty quantification and Data Assimilation: Research to support development of methodology for quantifying numerical uncertainty and forward propagation of that uncertainty into numerical prediction. Additionally, research to develop methods for assimilating observations into probabilistic numerical methods to refine predictions for wave, circulation, and morphologic models. d. Artificial Intelligence and Machine Learning (AI/ML) Technologies: Research to support the use AI/ML technologies to increase the accuracy and efficiency of hydrologic and hydraulic numerical models. Capabilities include advanced data assimilation technologies for error reduction and longer forecasts. e. Flash Flooding: Research to improve the technologies to predict and mitigate water hazards due to flash flooding. Research requirements include downscaling of weather forecasts including precipitation, wind speeds, atmospheric pressure, etc. f. Cold Weather Water Hazards: Research to improve the performance of predictive techniques in cold regions including the arctic. Research requirements include the effects of ice cover on wave and storm mitigation, the effects of the permafrost on hydrologic processes, the effects of flood risk mitigation features on freshwater sources, etc. g. Arid Region Water Hazards: Research to improve the performance of predictive techniques in arid regions. Research requirements include infiltration processes, groundwater and surface water interaction, aquifer recharge, wildfire hydrology, etc. h. Numerical Model Coupling Techniques: Research to improve the performance of numerical model coupling methods. Research requirements include inter and intra-model communication for inter-agency model collaboration.

• U. Innovations in Sediment Management (CHL- 21)

  Proposals are invited to develop leap-ahead innovative and sustainable dredging and sediment management solutions to dramatically reduce costs, increase channel/infrastructure reliability, and add significant economic, environmental, and social value to the Nation. Proposals for research in the following specific areas are requested: a. Coastal/ Hydrodynamic Engineering Nature-Based Solutions (NBS) and Hybrid Solutions: Research to inform the development of tools, techniques and guidance behind designing and engineering nature-based solutions (NBS) and hybrid solutions. This R&D will help in the development of methods and standards which support effective planning, designing, construction, and O&M of NBS/hybrid solutions to support the reduction of coastal and inland flooding risks. This research should focus on exploring the potential for integrating NBS/hybrid solutions within existing hydrodynamic engineering and land use planning practices. b. Innovative Dredging Technologies/ Autonomous Methods: Research to develop technologies and techniques for improved dredging operations. R&D can address evaluating next-generation technologies and dredging operations (e.g., hydrodynamic dredging), real-time dredge position and bottom mapping techniques, autonomous dredging to reduce costs, increase beneficial use of dredged material, sediment transfer and placement equipment to facilitate more beneficial uses (e.g., thin layer placement, strategic placement), reduce channel and reservoir infilling to reduce dredging need, or renewing reservoir capacity through application of technologies developed for navigation channel maintenance. Proposals are invited to develop leap-ahead innovative and sustainable dredging and sediment management solutions to dramatically reduce costs, increase channel/infrastructure reliability, and add significant economic, environmental, and social value to the Nation. Proposals for research in the following specific areas are requested: a. Coastal/ Hydrodynamic Engineering Nature-Based Solutions (NBS) and Hybrid Solutions: Research to inform the development of tools, techniques and guidance behind designing and engineering nature-based solutions (NBS) and hybrid solutions. This R&D will help in the development of methods and standards which support effective planning, designing, construction, and O&M of NBS/hybrid solutions to support the reduction of coastal and inland flooding risks. This research should focus on exploring the potential for integrating NBS/hybrid solutions within existing hydrodynamic engineering and land use planning practices. b. Innovative Dredging Technologies/ Autonomous Methods: Research to develop technologies and techniques for improved dredging operations. R&D can address evaluating next-generation technologies and dredging operations (e.g., hydrodynamic dredging), real-time dredge position and bottom mapping techniques, autonomous dredging to reduce costs, increase beneficial use of dredged material, sediment transfer and placement equipment to facilitate more beneficial uses (e.g., thin layer placement, strategic placement), reduce channel and reservoir infilling to reduce dredging need, or renewing reservoir capacity through application of technologies developed for navigation channel maintenance. c. Hydrodynamic and Geomorphologic Response of Biomaterials: Research into the use of bio-based materials, such as biopolymers, to enhance and increase the resiliency of NBS, including earthen levees, coastal dunes, and dam embankments. This research should focus on the hydrodynamic and geomorphologic response of biomaterials to the impacts of hydrological and meteorological extremes. Considering the performance and sustainability of biobased materials, we seek to understand the potential of bio-based materials to reduce the risk and cost of rehabilitating and maintaining these structures and increase their resiliency against potential threats. We invite research that furthers our understanding and application of bio-based materials for this purpose, as a component of comprehensive water risk management and abilities to adapt to dynamic environmental forcing requirements. The research should be designed to provide evidence and support decision making. It should be based on research available at existing open-source platforms, or data that is proposed to be collected for the research. d. Monitoring of NBS and Beneficial Use of Dredged Sediment Projects: Research to improve the understanding of the performance of NBS and beneficial use of dredged sediment projects through monitoring. Monitoring could include the project’s response to storm events and the post-storm recovery. Monitoring techniques will vary based on the project but may be comprised of satellite data, remote sensing measurements, in-situ measurements, or engaging the public to crowdsource data collection. The monitoring research may also include the development or testing of innovative sensors or monitoring techniques.

• V. Next Generation Water Management (CHL-22)

  Proposals are invited to explore the application of next generation technologies, methods and approaches that are aimed at improving water management practice within the USACE and partner agencies, including efforts that support research, development and implementation of capabilities to support Forecast Informed Reservoir Operations (FIRO). FIRO is a management approach that seeks to improve water supply, enhance flood risk reduction and achieve additional ecosystem benefits through application of advanced weather and watershed forecast capabilities in water management practice.

  FIRO envisions advanced observation and prediction technology that can provide water managers more lead time to selectively retain or release water from reservoirs based on longer- term forecasts. When storms cause moderate-to-high reservoir levels, normal operation is to release water to re-establish flood control space. FIRO pilot studies have demonstrated that some of that water can be retained for future supply as long as no major precipitation is expected and it can be shown that the retained water can be released past downstream flood prone areas prior to the arrival of the next storm. This strategy permits earlier supply capture in some years, improving supply reliability for downstream water users and improving the timing and volume of releases to protect water quality and provide flows needed for ecosystem benefits. Proposals for research in the following specific areas are needed: a. Improvement of forecast skill to support advanced water management, including meteorological phenomena that are major drivers for floods in various regions across the country including atmospheric rivers, tropical storms/hurricanes, clusters of long-lived thunderstorms and Nor’Easters. This can also include improvements in weather observations and numerical weather forecasting models that result in improved forecasting lead times for water management decision-making.

  b. Improvements in data synthesis, decision support systems and data visualization capabilities to enhance water management decision-making.

  c. Hydrologic and reservoir model development and application, including improvements in watershed monitoring to enhance hydrologic and reservoir models.

  d. Application of FIRO screening process tools to regions of the United States where FIRO has not previously been applied or tested.

  e. Application of FIRO viability assessment processes to systems of dams where multiple dams are operated within a watershed to achieve overall system water management objectives.

  f. Research to support updates to USACE Water Control Manuals (WCMs) using FIRO approaches, scenarios and principles. Updates to WCMs require numerous studies in areas of meteorology, hydrology, hydraulics, ecology and economics. Incorporation of next generation approaches such as FIRO require research efforts to identify best management practices on how to safely and effectively incorporate these new approaches into water management practice as defined in WCMs.

Geotechnical & Structures Laboratory (CHL)

• Overview

  Research performed by the Geotechnical and Structures Laboratory’s (GSL) eight branches consists of investigations in the areas of soil mechanics, engineering geology, geophysics and seismology, earthquake engineering, pavements (both expedient and permanent), mobility and traffic ability of military vehicles, structural design and performance of structures under both static and dynamic loadings, earth dynamics, and the uses and performance of concrete, cement, and other construction materials. Research areas also include measurement and analysis of seismic and acoustic signals to locate airborne and ground military targets and buried objects (including unexploded ordnance) and to characterize earth media. Research on concrete and cement is predominantly related to current recognized needs, both civil and military. Military expediency focuses additional attention on ease and speed of concrete placement, development of very high-strength materials, and use of non-traditional, indigenous, and other special materials in concrete construction. Civil works research focuses primarily on the need to improve the performance of both new and old concrete structures. Structures research involves development, testing, and evaluation of a broad class of structures to resist the effects of static and dynamic loads induced by earthquakes and other sources. The Geotechnical and Structures Laboratory also conducts research involving all aspects for improving the survivability of fixed installations.

• A. Earthquake Engineering (GSL-1)

  Research areas of interest include the dynamic behavior of soil and rock; liquefaction of soils, including coarse-grained and fine-grained soils; in-situ testing to evaluate properties related to dynamic behavior; centrifuge scale-model testing using a multi-waveform shake table; in-situ testing to evaluate susceptibility to liquefaction; methods of analysis of dynamic behavior of earth materials; methods of analysis of dynamic soil- structure interaction; risk-based and probability-based methods of analysis; seismic wave propagation in earth materials; seismically induced settlements in soils and remedial treatment of soils potentially susceptible to earthquake-induced instability or strength loss; computer visualization and dynamic simulation; site response analysis; and strong motion instrumentation.

• B. Geophysics (GSL-2)

  ERDC supports research in the development of land, air, or waterborne geophysical methods to be used for characterization of hazardous waste sites, detection and monitoring of seepage, nondestructive investigation of archeological sites, location of groundwater, and detection of buried objects; analytical and data-processing techniques, borehole surveys, cross hole seismic imaging, electromagnetic detection of anomalies, seismic surveys, sub bottom profiling, and acoustic impedance surveys; and uses of microgravity.

• C. Mobility of Vehicles (GSL-3)

  The Mobility Systems Branch addresses engineering research on the performance of vehicles operating cross country and on-road, and/or in negotiating dry and wet obstacles in worldwide terrains. This is a highly specialized technical area involving engineering mechanics, vehicle dynamics, mathematics, statistics, computer specialties, geology, and soil mechanics. Research in this area includes developing fundamental relations between soil and vehicle running gear; improving criteria concerning the effects of vehicle vibration and ride shock on sensors and data streams from rapidly moving sensors over rough terrain; developing algorithms describing weather effects on terrain, multi-vehicle movements along road nets, stochastic processes describing influence of uncertainties of data elements, and developing modeling and simulation capabilities for near real-time assessments of mobility and counter mobility for battlefield operations and operations other than war.

• D. Pavement Technology (GSL-4)

  Research in this area is conducted in support of the Corps mission to design and construct roads and airfields worldwide and other related engineering functions. This research includes the development of engineering criteria for the design, construction, evaluation, maintenance, and rehabilitation of permanent and expedient airfields, pavements, and ports. Research areas of interest include improved design procedures, structural performance modeling, material characterization and evaluation, nondestructive testing, rapid repair of structures, expedient surfacing (to include novel, composite, and metallic systems), aircraft and vehicular ground flotation, access/egress systems, gravel surfaced and non-surfaced areas, the use of geotextiles and geomembranes, grid-confining systems, soil stabilization, dust-control materials and techniques, advanced binder systems, remote assessment, earth anchoring, pavement evaluation, and advanced testing, monitoring, and evaluation equipment, software, and methods to support pavement and pavement related functions.

• E. Soil and Rock Mechanics (GSL-5)

  Research is needed to: (a) improve methods for prediction and control of erosion of unlined spillway channels during uncontrolled releases; (b) develop innovative methods for flood protection and flood fighting, including field evaluations of promising technologies; (c) develop guidance for applications of trenchless technology (e.g., micro tunneling, horizontal directional drilling, pipe ramming, pipe jacking, auger boring, etc.) on Corps structures, including measures to ensure safety and stability of Corps structures when trenchless technology is used to install pipelines, cables, or conduits through or beneath levees and other structures;(d) develop improved methods, including risk-based methods for analyzing earth and rock fill dams and other water control structures for both static- and earthquake-induced stresses; (e) improve the state of knowledge of physical and engineering properties of soil, rock, and clay shales; earth-rock mixtures, granular filters, cohesive and non-cohesive fine- grained soils susceptible to liquefaction; and soils susceptible to drastic volume changes (collapse, consolidation, swell); (f) develop rational analytical procedures and more reliable prediction of behavior of partially saturated soils; (g) determine the response of soils in situ to static and dynamic loading and unloading; (h) determine the susceptibility of earth dams to cracking, hydraulic fracturing, and internal erosion; (i) evaluate improved defensive design measures in use of materials, particularly in filter and transition zones and impervious barriers; (j) improve procedures for monitoring and analysis of the performance of new and existing structures, particularly the use and interpretation of observations and data from specialized instrumentation, and expedient systems for rapid inspection and evaluation of the integrity of dams; (k) improve the understanding of the aging processes in dams and the influence of aging (particularly deterioration of safety-related features) on long-term maintenance and/or rehabilitation requirements for dams; (l) develop a better understanding of failure mechanisms to improve design of defensive measures, to provide information for remedial repairs, to assess potential damages resulting from failure, and to provide a basis for emergency actions; (m) develop expedient remedial measures when hazardous conditions are identified and, thus, reduce the damages and catastrophic potential of dam failures; (n) develop methodology to evaluate forces exerted on structural elements by adjacent soil masses that result from long- term variation in soil properties; (o) develop improved methodology for design and construction procedures for shallow and deep foundations, including mats, footings, piers, and piles for buildings, hydraulic structures and waterfront structures; (p) large-scale physical and numerical modeling of deep underground structures (tunnels, shafts, chambers, and intersections); (q) predictions of rock mass dredgability; (r) acoustic emission (micro-seismic) applications in geotechnical engineering; (s) geotechnical aspects of hazardous and low-level radioactive waste disposal; (t) evaluation of rock for use as riprap; (u) grouting of soil and rock masses; (v) sliding stability of gravity structures, and (w) centrifuge modeling of structures founded on or in rock.

• F. Dam Research (GSL-6)

  Research is conducted in support of the Army’s Dams and Transportation Infrastructure Program, specifically the Dam Safety subcomponents. Research covers design, construction, maintenance, repair, and inspection procedures of Army dams as well as other engineering functions as they relate to transportation structures. This involves the formulation of engineering criteria for the design, construction, evaluation, maintenance, and rehabilitation of dams. Research areas of interest include improved inspection procedures, material characterization and evaluation, nondestructive testing, rapid repair, scour, unknown material properties, unknown foundations, and underwater inspection.

• G. Engineering Geology (GSL-7)

  The GSL conducts a broad range of research in the field of engineering geology in support of federal or other Government technical missions. Specific areas of interest within this field include application of remote sensing to geologic and geomorphic assessments; geo-archeological investigations; applied and numerical geomorphic analysis; computer applications in geotechnical engineering; 3-D visualization systems; uses of geographic information systems; geo hydrology in military and civil applications; including water quality and supply issues; geologic mapping; geologic applications of mathematical techniques and geo statistics; groundwater monitoring, including well installation and design; geologic application of groundwater models; integration of geological and geophysical subsurface exploration techniques; land-loss studies; remedial measures at groundwater contamination sites; seismic hazard characterization and evaluation; subsurface exploration methods (drilling and sampling techniques); test site selection; conceptual and geologic and hydro geologic models.

• H. Excavation, Structural Demolition, and Obstacle Creation (GSL-8)

  Current criteria for improved demolitions call for significantly reduced manning levels and preparation times to accomplish assigned missions. Cost effectiveness, versatility, and safety are also of great importance. Current efforts involve technologies for the standoff creation and reduction of all types of battlefield obstacles, and the excavation of fighting positions. A prime consideration is the development of more efficient means for the application of various types of energetic materials to targets of interest. In addition, modern materials and design principles used in typical target structures must be incorporated into future plans and guidelines for demolitions. Typical missions of interest are road cratering, anti-tank ditching, bridge and tunnel demolition, and the breaching of walls, bunkers, levees, and dams.

• I. Ammunition Storage Safety (GSL-9)

  The military services must store large amounts of munitions, both for war reserves and for training purposes. New conceptual designs for components or systems for storage are needed to reduce the likelihood of an accidental detonation of stored munitions, limit the propagation of air blast and fragments, or mitigate the safety hazards produced by an accidental detonation. In addition, test data and simulation techniques are needed to aid in the definition of the safety hazards from such detonations, and the mechanics of blast propagation among munition stores. Obsolete munitions are often disposed of by deliberate, controlled detonation. Research is needed on new methods for safe, efficient, and environmentally acceptable methods for deactivation of a wide variety of munition types.

• J. Physical Simulation of Munition Phenomenology (GSL-10)

  The mechanical effects induced by munition detonations are physically simulated using a variety of energy sources. Simulations are performed at full- and small (1/2 to 1/10) scale. The mechanical effects from conventional energetic materials are normally performed at small scale. These studies could benefit from improved (better fidelity, less expensive) simulators and simulation techniques. They could also enhance the development of test methodology for micro-scale (1/100 to 1/10) testing including centrifuge testing. Micro-scale test methodology includes the miniature high- fidelity energy sources, miniature sensors, advanced optical techniques, high-fidelity construction techniques for miniature structures, and theoretical developments in the scaling of material behavior.

• K. Geophysical Phenomenology - Multi-Modal Geophysical Phenomenology, Modeling, Data Processing, and Data Management (GSL-11)

  The objectives include detecting, classifying, and locating airborne and ground military targets and buried objects using geophysical methods for homeland defense and homeland security applications. Also included are invasive and non-invasive approaches for measuring and quantifying the geophysical/geologic signatures of diverse geo-environments. This can include the development of new and/or improved analytical and numerical models, rapid data- processing techniques, and new subsurface imaging techniques that include active and passive sensor modalities in a variety of rural and urban terrains.

  Of particular interest is the broadband propagation of energy including, but not limited to seismic/acoustic/infrasonic/electromagnetic/ thermal/chemical, under variable conditions using a variety of sensing platforms (fixed, mobile, airborne, space). The development of new tactics, techniques, and procedures for the employment of novel sensing methods as well as the development and/or verification of empirical testing and evaluation techniques is also desirable. Data management and multi-mode integration techniques and platforms are also of interest.

• L. Laboratory Tests and Constitutive Model Development for Geologic Materials (GSL-12)

  This research requires the formulation of mathematical constitutive models to simulate the mechanical behavior of geological and structural materials and incorporation of models into application-oriented prediction/analysis techniques. Also of interest are the development of dynamic test equipment and techniques and the experimental evaluation of geological and structural material response to high-pressure transient loadings.

• M. Projectile Penetration (GSL-13)

  Theoretical and experimental studies of projectile stresses and trajectories due to impact and penetration into geologic and man-made targets and development of design criteria for shield systems include development of equipment and diagnostic techniques to examine the response of targets to low- and high-velocity impact of penetrators, rods, etc.

• N. Computational Structural Mechanics for DOD Applications (GSL-14)

  The efficient use of scalable computers will require fundamentally new concepts in computational mechanics algorithms. Research includes mathematical formulations and development of scalable computational mechanics algorithms in the areas of structural response, penetration, contact impact, structure-medium interaction, multi-scale, multi-physics, and interdisciplinary flow-thermal-structural interactions. This research area also includes development of computational models for new materials and composite construction (consisting of concrete, composite, and/or geologic materials), as well as the behavior and control of structures composed of such composite construction for military applications.

• O. Concrete Materials (GSL-15)

  Research in this area includes improving the performance of concrete materials and systems. Performance could include very high tensile or compressive strength, high ductility, high fracture toughness, low shrinkage, rapid hardening, very low permeability, resistance to abrasion and erosion durability, chemical resistance, shock-attenuating properties, ultra-low density, thermal insulation properties, workability, and other unique attributes. This includes improvements in the materials typically used in a concrete mixture such as aggregate, cement, supplementary cementitious materials, and chemical admixtures. Aggregates could include waste and/or manmade materials such as fly ash (traditional, blended, or reclaimed), silica fume, ground granulated blast-furnace slag, recycled concrete, lightweight aggregates other potentially low cost and/or green materials. Micro- and Nanoscale aggregates, inclusions, pozzolans, cements and reinforcements such as microspheres, nanosilicates, microfibers and low-cost nanotubes or nanofibers would also be included in this research area. Chemical admixtures such as water reducers, set retarders, set accelerators, air-entraining admixtures, and foaming and defoaming agents that lend unique properties would also be considered in this research area. Since reinforcement is a critical element to the ductility and durability of concrete materials, advanced reinforcement materials that enhance these properties fall under this research area. Additionally, this topic area would include research involving nontraditional cement binders including polymer- impregnated concrete, polymer or resin concrete, polymer Portland-cement concrete and geopolymer concretes.

• P. Concrete Properties and Analysis (GSL-16)

  Research in this area if focused on the development of new nondestructive and destructive test methods and analysis techniques to better characterize the properties and performance of concretes and the constituents that they are composed of at scales ranging from the nano-level to the macro-level. There are a vast number of topics in testing and analysis that could be included in this area as related to the physical and chemical properties of aggregates, cements, pozzolans, admixtures, fibers, and their interaction during the mixing, placing, curing, and service phases of a concrete. This could include but is not limited to: 1. Developing test methods and analysis techniques to better quantify material properties at aggregate-paste and fiber-paste transition zones.

  2. Developing tools, test methods and analysis techniques to non-destructively define the spatial distribution of components in a concrete specimen.

  3. Developing better assessment tools and criteria for predicting durability and longevity of concrete and grout.

  4. Developing better methods to define and classify chemical admixtures by chemical composition and mechanism of performance.

  5. Developing innovative systems to construct concrete materials and structures more economically.

  6. Developing theoretical, computational, and experimental methods for effectively characterizing stress, strain, progressive damage, and fracture of engineering materials subjected to static and dynamic loads.

• Q. Maintenance, Repair, and Rehabilitation of Concrete (GSL-17)

  Forensic analyses such as assessment of remaining life, maintenance and minor remedial measures, repair and rehabilitation, and surveillance and monitoring are topics of interest. Structures of interest include concrete locks and dams and appurtenant concrete and steel structures (outlet works, retaining walls, gates, piles, bulkheads, tunnels, intakes, etc.), other horizontal and vertical concrete infrastructure, and metals and polymer systems related to those concrete components.

• R. Other Areas of Materials Research (GSL-18)

  Research is needed in the development, properties, and performance of a range of materials for military and civil applications. Needed materials research for concrete applications includes such materials as: curing compounds, coatings, and overlays; polymers or other agents for improving bond between old and new concrete; water stop materials for use in hydraulic structures, and methods for characterizing and testing such materials; grouts for injection underground in very fine fracture systems or porous media; organic and inorganic composites that are used in construction; and grout materials and technologies for waste-disposal and containment such as for both commercial and defense-related low-level and high-level radioactive wastes.

  Other materials research needs include the development, testing, and prototyping of metals, composites, or other novel materials exhibiting advanced mechanical, thermal, rheological, chemical, electrical, and multi-functional properties, and performances. Research is performed on energy absorbing materials for impact, ballistic and blast resistance; hierarchical, multi- layered, and functionally graded material systems; multi-scale reinforcement for macro performance; self-sensing and self-healing materials; and materials demonstrating advancements in durability, high strength-to-weight, fatigue resistance, and ease of application.

• S. Bridge Research (GSL-19)

  Research is conducted in support of the Army’s Dams and Transportation Infrastructure Program, specifically the Bridge Safety and Waterfront Facilities subcomponents. Research covers design, construction, maintenance, repair and inspection procedures of Army bridges and waterfront facilities worldwide as well as other engineering functions as they relate to transportation structures. This involves the formulation of engineering criteria for the design, construction, evaluation, maintenance, and rehabilitation of permanent and expedient bridge and port facilities. Research areas of interest include improved inspection procedures, material characterization and evaluation, nondestructive testing, rapid repair, scour, unknown material properties, unknown foundations, traffic safety, underwater inspection, fracture critical and fatigue evaluations, load capacity, load testing, and load ratings.

• T. Structures Research (Civil Works) (GSL-20)

  Research is conducted in assessing the performance of critical structures to extreme loads, such as those resulting from seismic, terrorist attack, and storm events, as well as the effects of flow-induced vibrations. Efforts include assessing sensitivity of structural design and analysis procedures, vulnerability of structures, and critical design parameters to develop appropriate load-resistance factors. Techniques for retrofit, including use of new and innovative materials, of structures to resist extreme loads is of interest. Also, a better understanding of long-term behavior and deterioration of civil structures is needed, including factors such as material interactions, thermal stresses, and any issues affecting design of new structures and operation and maintenance of existing structures.

  Nonlinear and linear system identification research includes vibration testing, data acquisition, data processing, and analysis techniques for determining linear and nonlinear dynamic and static response properties of structures and structural systems subjected to earthquakes, blast effects from mining (or other) operations, other transient random, harmonic dynamic loads, and static or pseudo static loads.

• U. Structures Research (Military) (GSL-21)

  1. Research is needed on the response of aboveground and shallow-buried structures subjected to military dynamic loads; specifically, the prediction of the load and response to failure of aboveground and shallow-buried structures. This effort will involve the following research:

  a. Development of techniques to simulate military dynamic loads on aboveground and mounded structures.

  b. Development of design procedures for components in semihardened and protected facilities.

  c. Analysis of structural loading and damage resulting from internal or external detonations.

  d. Development of fast-running models for PC based applications to predict the response of structures, both hardened and unhardened, to single and multiple explosive detonations.

  2. Research on deeply based structures and hardened existing systems involving the following:

  a. Development of comprehensive structural design for deeply buried and surface-buried structures subjected to air blast-induced and direct-induced ground shock from surface and shallow earth-penetrating high-energy sources.

  b. Formulation of computer models for SSI and pre- and post-test analysis of structural response to include correlation and comparison with experimental data.

  3. Research on surveillance and intrusion detection sensors involves the constraints of the environment on sensor systems used to detect intruders and placed along the perimeter of high-value military installations. Improved methods for rapid and accurate measurement of predetermined influential environmental parameters must be developed. Analytical techniques relating to specific sensing phenomenology’s and target/nontarget-generated signatures and signature wave interactions to variations in environmental characteristics are required. Of particular interest is the integration of multiple sensor systems (both detection-type and environmental/background monitoring transducers) that use various sensing phenomena for enhanced target detection and classification and increase nuisance and background signature rejection. Research studies are required in the determination of automated techniques for monitoring sensor system response and sensitivity to provide optimum and consistent performance as a function of time varying changes of influential environmental characteristics.

  4. The Corps of Engineers is involved with research on the design of military facilities for protection from high-energy sources. These efforts include the following research:

  a. Prediction of the response of structural elements common to conventional or expedient construction to military loads.

  b. Methods of retrofitting conventional buildings to harden them against nearby military high-energy sources.

  c. Development of innovative design of structural components, such as windows and doors, subject to high-energy sources.

  d. Development of analytical methods for predicting the effects of forced entry devices on structural components.

  e. Development of innovative designs using low-density materials for expedient protection of troops and equipment from the effects of military high- energy sources.

  f. Development of microprocessor-based software/hardware and supporting documentation to aid in the assessment of structural survivability to the effects of conventional and advanced weapons systems. The software will address the integration of databases, weapons effects calculations, and operational factors associated with engineer survivability missions.

  g. Development of a procedure to ensure robust codes, user-friendly interfaces, and supporting documentation for use in the testing and development of microprocessor-based survivability and structural assessment software/hardware.

  5. Composite Materials for Force Protection-Research in this area includes developing, characterizing, modeling, and testing of layered composite materials for protection against air blast and penetration/fragmentation. These materials are intended for use in lightweight expedient protective systems to protect against improvised explosive devices and conventional weapons such as small arms, standoff weapons, fragmenting weapons, and shape charges. It is envisioned that panels of these materials could be incorporated into protective structure designs to increase survivability of personnel or to protect mission-critical assets. Performance measures include such attributes as build time, low mass, cost, penetration resistance, ductility, and environmental durability. Additionally, this topic area includes methods to develop appropriate material anisotropic and or non-homogeneous material models for incorporation into advanced computational models such as Abaqus, LS-DYNA, and EPIC. Protocols for evaluation and performance testing of composite materials subjected to energetic, high-strain rate events are desired.

  6. Worldwide Construction Practices- This research includes capturing typical construction practices and construction material properties worldwide. Information of interest is material properties of structural components, building types and construction techniques, building footprints, construction timeframe/era of buildings, and location of the building (country, world region, urban terrain zone).

• V. Multispectral Camouflage Research (GSL-22)

  This research area involves all aspects of fixed-facility survivability incorporating signature management and other technical effects. Fixed facilities include stationary and relocatable high-value targets. The general goal is to directly and indirectly increase the survivability of U.S. and Allied facilities and improve the U.S. and allied counterintelligence, Surveillance, and Reconnaissance (counter-ISR) capability against adversaries. Multispectral refers to those areas of the electromagnetic spectrum used by the United States and potential adversaries in reconnaissance and surveillance and in attack platform target acquisition and detection. Major objectives include: quantifying or otherwise evaluating counter-ISR technology effectiveness; investigating materials and techniques for signature modification; developing technical effects and physical countermeasures, procedures, and applications; developing computer-based analytical procedures for simulating scenes; developing instrumentation for and conducting target/background signature measurements; assessing the United States and threat operations and sensor capabilities with both currently fielded and new design reconnaissance and surveillance and attack platform sensors and systems; developing applications for intelligence information for military missions; providing guidance to field commanders and information for the RDT&E community; and studies of the interaction of camouflage technology with other operational factors, particularly in determining operational supportability, costs and manpower, interoperability, and joint interoperability requirements.

• W. Advanced Maneuver Technologies (GSL-23)

  This research addresses ground vehicle maneuver in urban environments which poses many new operational and tactical challenges for the Army and Joint Forces. While many improvements have been made in protecting ground vehicles in the last decade, these improvements come with a cost, namely limited situational awareness due to reduced visibility and limited maneuverability in tight spaces because of larger vehicle size. Both of these constraints seriously reduce the mobility of ground vehicles in urban environments. To address these constraints, research is needed to develop technologies to identify nearby dynamic hazards for ground vehicles in urban environments and provide early warning to ground vehicle operators or autonomous driving systems. Specifically, this research will address methods and procedures to develop advanced technologies that will be used for detecting dynamic hazards in urban environments such as traffic flow rates and congestion, pedestrians, buried threats, constricted roads, and other obstacles or anomalous objects in real-time. In addition, further research is needed to develop technologies that will deliver the information in a consolidated or data excerpt manner and report the locations of interest and concern to the driver and or operator. The performance of emerging technologies in sensors and data processing to provide better situational awareness in near real-time to ground vehicle operators maneuvering in dynamic urban terrain is also of interest.

• X. Railroad Technology (GSL-24)

  Research in this area is conducted in support of the Corps mission to design, construct, and operate railroad systems worldwide. This research includes railroad design, construction, inspection, evaluation, maintenance, and rehabilitation. Research areas of interest include advanced and composite materials, rapid repair, non-destructive evaluation, geotextile use in construction, in-situ additive manufacturing of components, soil stabilization, GIS, and remote assessment.

Environmental Sensing

• Overview

  Current research is in the acquisition of information by remote sensor systems, the impact of the environment on imaging and other sensor systems, and advanced signal processing. Sensors using electromagnetic, seismic, and acoustic energy forms are of interest. In addition, work is conducted to determine terrain and other environmental effects on high- technology sensor systems. Sensor systems include optical and infrared millimeter wave (active and passive). Briefly described below are specific research areas.

• A. Sensing (EL-1)

  The EL has an ongoing program to develop and demonstrate advanced technologies that support the Army’s requirements for improved detection and discrimination of unexploded ordnance (UXO), depleted uranium (DU) munitions, radiological threats, and deployment platforms. Additional research work is needed for subsurface (land-based) and underwater (proud and buried) UXO sensing, data analysis, display, and platform navigation/positioning. Special areas of interest include novel sensing concepts for the detection and relocation of buried objects (DU, metallic, and nonmetallic targets) using magnetic, electromagnetic induction, ground penetrating radar, seismic/acoustic, chemical, and/or radiological methods or a combination thereof. Fundamental measurements and models that define/predict the performance of these sensing methodologies in varying environmental conditions for UXO, DU and radiological targets are also of interest. Research is also needed to develop advanced data analysis techniques that can significantly reduce the number of false positives arising from natural anomalies and man-made sources.

• B. Environmental and Military Sensing (EL-2)

  1. Research in this area includes basic and applied research to develop environmental sensing, characterization, and monitoring capabilities necessary to quantify environmental site conditions and trends at local and regional scales. In the military area, research is conducted on basic signature research, to better understand target and environmental background signature characteristics.

  2. Specific areas of required research include:

  a. Development, integration, and application of remote sensing technologies and the use of these data in geospatial models to characterize site conditions over large areas.

  b. Development of innovative data fusion approaches, particularly the combined use of hyper spectral and bathymetric and/or topographic LIDAR data for the extraction of environmental information.

  c. Research to identify, model, and mitigate the effects of the environment on novel sensing techniques that address environmental and military requirements.

  d. Development of ground-based and airborne remote sensing approaches, and associated modeling, for unexploded ordnance detection, minefield detection, military targets and vehicles, and smart weapons development.

  e. Rapid collection, analysis, and visualization of sensor data for environmental quality and military applications.

• C. Environmental, Sensing, Characterization, and Modeling (EL-3)

  There is growing need to utilize and develop artificial intelligence (AI) and machine learning (ML) technologies for enhanced characterization of forested environments. Novel technologies should leverage remotely sensed and high fidelity in-situ data to improve understanding of complex forest conditions. Numerous benefits for military defense, environmental stewardship, forest resource monitoring and evaluation, and military readiness exist from identifying, quantifying, visualizing, and understanding forest data. Research is needed to capitalize on recent developments in AI-based big data analytics to characterize forests and forest-dwelling species and habitats data to better understand vegetated ecosystems that is traditionally obtained through in situ sampling. Research is needed to capitalize on recent developments in AI based big data analytics to characterize forests and other ecosystems.

  Specific areas of required research include:

  a. Developing novel forest modeling frameworks that utilize remote-sensing and in-situ field data to inform and validate forest characterization—to include vertical stratification.

  b. Quantifying forest characteristics and associated forest-dwelling fauna—to include threatened and endangered species. Provide specialized expertise in the application and deployment of advanced environmental sensors to detect and monitor rare and sensitive species—particularly focused in tropical forested habitats.

  c. Demonstrated experience deploying, managing, and analyzing data from remotely deployed autonomous environmental sensor platforms, including paired acoustic/visual monitoring systems such as Autonomous Recording Units (ARUs), omnidirectional microphones, trail cameras, and related technologies to document rare and sensitive species presence, behavior, and responses to anthropogenic noise disturbances and military training activities.

  d. Tailoring sensor arrays to rapidly detect, evaluate, and quantify both acoustic and visual data in Pacific Island forested ecosystems.

• D. Environmental Instrumentation (EL-4)

  1. Research and development in this area includes basic and applied research and technology demonstrations that support rapid measurement of biological and chemical hazards of the environment.

  2. Specific areas of required research include:

  a. The integration and interoperability of environmental instrumentation with future and existing military robotic systems: this includes unmanned aerial systems, ground robotics, autonomous submersibles, and robotic surface watercraft.

  b. Provide new applications that support faster processing on small low-power hardware to triage environmental measurements to immediately identify biological and chemical hazards.

  c. Techniques that support biomimicry in robotic systems and the differentiation of biotic from abiotic systems. Instruments that are low-power, small, and compact to assess the biological and chemical characteristics of water, soil, and air, in surface and subterranean environments.

  d. Research into sensing of aerosols and/or plumes from either ground or airborne platforms.

  e. Research into novel uses of unmanned aerial systems for environmental characterization and change detection - including fusion of active and passive modalities.

Contaminated Site Characterization, Assessment & Remediation

• Overview

  An extensive research and development program is being conducted by the Department of Defense to assist in the cleanup of contamination at military installations. The EL is developing technologies for characterizing, monitoring, and applying physical, chemical, and biological treatment of toxic and hazardous waste in contaminated surface and ground waters and soils. The EL is also developing, evaluating, and verifying numerical models and guidance for solid waste disposal systems.

• A. Innovative Technology for Environmental Sensors and Tools. (EL-5)

  The EL has an ongoing research program to develop advanced technologies for environmental sensing, characterization, and monitoring in order to quantify environmental conditions at sites of interest. The program is actively developing field-based tools and sensors to conduct rapid site characterization/screening for environmental contaminants. Additional research is needed in the areas of novel sensing technologies for detection of chemical and biological contaminants allowing for rapid field-based data acquisition. Also, research is needed to develop technologies and platforms allowing for rapid data analysis/interpretation/reporting. Fundamental measurements and models that define/predict the performance of new sensing methods in soil, water and air are also of interest.

• B. Innovative Technologies for Treating Contaminated, Sediment, Soil, Surface Water, Ground Water, and Hazardous Waste (EL-6)

  Presently, EL is continuing to conduct research, develop technologies and apply strategies to treat complex organic- and metal-contaminated hazardous liquids, off-gases, soils, sludges, sediments, and residuals from past disposal practices. Research is divided into two major categories: technologies for treating contaminated soils and sediments, and innovative technologies for treating contaminated surface and ground waters. Areas of R&D include: (1) physical and chemical technologies to destroy/detoxify or reduce the quantity and/or toxicity of the contaminated materials, (2) biological processes and methods to detoxify/destroy hazardous waste constituents, (3) techniques for in situ treatment of groundwater aquifers, (4) laboratory design criteria for and field implementation of piloting equipment for promising technologies, (5) computer-based techniques to assess operational performance of various treatment processes/systems and (6) improved analytical chemistry techniques and methodology to assess treatment technologies.

• C. Design, Evaluation, Verification and Modeling of Solid and Hazardous Wastes and Contaminated Sediments (EL-7)

  Efforts are continuing to develop water balance and leachate models for solid waste disposal systems and dredged material disposal facilities. Additional work is needed to model innovative designs, nonsoil surface materials, cobbled surfaces, preferential flow through heterogeneous waste materials and other layers, and effects of complex mixtures of vegetation including trees. Similarly, additional work is needed to verify the existing models.

Sediment Geochemistry and Biological Effects

• Overview

  Potential adverse environmental impacts of disposal of contaminated sediments must be assessed prior to permitting operations. This includes the determination of the impacts that contaminated dredged materials exert on the environment prior to dredging.

• A. Environmental Risk Assessment (EL-8)

  Current research on the fate and effects of environmental contaminants occurs under the general paradigm of Environmental Risk Assessment. Specific studies fall into one or more of the following areas:

  1. Hazard Identification. This is the process of showing causality (i.e., a chemical or complex mixture can cause some adverse effect). If this causality can be demonstrated, the chemical is referred to as a "hazard." If there is no causal link, risk need not be quantified. Important target receptors are also identified by this stage (for example, humans, endangered species, and ecologically or economically important species). Research is conducted to develop the technology for hazard identification and the establishment of causality.

  2. Effects Assessment. While Hazard Identification decides if a chemical or complex mixture is toxic; Effects Assessment establishes the relationship of the toxicant dose and associated biological response. This is accomplished via experimental research in which surrogate species are exposed to gradients (spatial, concentration, etc.) of the hazard in question, and biological effects are monitored. Biologically important endpoints measured include survival, growth, reproduction, and population-level parameters. These endpoints must be accompanied by technically sound interpretive guidance. Results are expressed in dose- response or exposure-response relationships. Research is conducted to develop the necessary experimental/statistical designs, technically sound tests (for example, chronic sub lethal sediment bioassays) and appropriate extrapolations (for example, high dose to low environmentally realistic exposures, and surrogate test species to receptor of interest). Analysis of the uncertainty associated with these effects assessments is also conducted.

  3. Exposure Assessment. In Exposure Assessment, the magnitude, frequency, and duration of contaminant exposure relative to the target receptor(s) are determined. This research is model-intensive, with both descriptive and quantitative models being used to evaluate pathways and routes. A pathway exists if the hazard travels between the initial source of contamination and the ultimate biological receptor. An exposure route is pathway that the chemical contacts the receptor (for example, ingestion, inhalation, dermal absorption, bioaccumulation, trophic transfer). Analysis of the uncertainty associated with these exposure assessments is also conducted.

  4. Risk Characterization, Management, Communication, and Analysis. Outputs from the Effects Assessment and Exposure Assessments are joined in Risk Characterization to yield an estimate of risk. Research is conducted to determine the best ways to characterize risk both numerically and descriptively. Also, uncertainty analysis is undertaken to identify the qualitative and quantitative important sources of uncertainty. Techniques employed include error propagation, probability distributions, sensitivity analysis, Monte Carlo simulation and others. Once environmental risk has been quantified, management action may be required.

  5. Research is conducted to develop management alternatives, which range from no action to extensive (and expensive) remediation. Results of the Environmental Risk Assessment are weighed and balanced with other factors such as applicable laws and regulations, engineering feasibility, potential benefits, costs, economic impacts, and the socio-political decision environment.

  Risk Communication is a dialogue that occurs at two levels: between the risk assessor and the risk manager, and between the risk manager and the public. Research is conducted to identify optimal procedures for communicating environmental risks, including an appreciation for the limits and uncertainties of the numerical results. Risk Analysis is a broad, inclusive term encompassing the processes of Risk Assessment, Risk Management, and Risk Communication as well as any field verification or monitoring activities. Field verification is a study or studies carried out to determine the accuracy of laboratory observations and predictions. Field monitoring (in the context of Risk Assessment) is undertaken to ensure that steps taken to manage the chemical risks were successful. Field research studies are carried out for both verification and monitoring purposes.

  6. Engineering With Nature® (EWN®) Research Supporting Innovative Field Sampling Practices, Natural Infrastructure (NI) Construction/Deployment and Related Technologies. Conduct a broad array of EWN research and development that may include, but is not limited to: research pertaining to placement of scientific instruments and/or pursuit of novel experiments that advance field-based sampling and laboratory practices for the purpose of measuring and archiving the performance of natural infrastructure (NI); conduct research and/or test innovative instrumentation that records/monitors natural and engineering processes resulting from the placement of NI and/or hybrid infrastructure; conduct research and test new technologies that result in accelerated construction/placement of natural and nature based features and/or improved placement strategies for dredged sediment used to construct EWN projects.

  7. Technology Transfer Development for Engineering With Nature® (EWN®) Research Areas. Research, develop and analyze technology transfer concepts; analyze target audiences for technical information; test innovative methods of transferring EWN research results and technology to supplement conventional technology transfer. Included may be such items as interactive internet and PC technology applied to training and general information transfer; technology applications of electronic media using the Internet; and innovative public information systems/products. Audiences include Corps of Engineers and the Department of Defense; Congress and other Federal, State, and local agencies; port and transportation authorities; universities; environmentalists and other public interest groups; and the general public.

• B. Sediment Water Interactions (EL-9)

  Sediment/Soil Water Properties. Current research encompasses a wide range of investigations designed to increase understanding of sediment-water interactions. Emphasis is on conduct of investigations for determining the impacts that sediment/soil properties have on sorption and transformation of explosives and release of semi-volatile contaminants to the atmosphere. Factors responsible for sorption and transformation of explosives include redox potential, pH, and the geochemical characteristics of the soil or sediment. Factors affecting the release of semi volatile contaminants from soil or sediment to the atmosphere include relative humidity, wind speed, contaminant concentration, moisture content, porosity, and organic carbon content. Research is also conducted on colloidal system contaminant transport, accelerated sediment oxidation, and the role of solution chemistry in contaminant partitioning between sediment and water.

  Diverse research activities focused on characterizing microorganisms and microbial communities in natural and engineered environments relevant to contaminant transformations, biogeochemical cycling, host-microbiome-contaminant interactions, bio- enabled materials, synthetic biology, and environmental biological threats are currently underway.

  1. Biodegradation of Contaminants. Studies in the biodegradation area emphasize destruction of organic contaminants for remediation purposes. Emphasis is on (1) bioinformatics of microbial community diversity and activities in various ecosystems; (2) delineating biodegradation pathways, enzymes, and genes; (3) determining intermediate and final end- products; (4) assessing the role of environmental and genetic factors regulating the pathways utilized and the rate and extent of destruction of the parent compound; (5) determining the survival and activity of microorganisms added to ecosystems, and biotreatment systems; and (6) enhancing biodegradation to obtain the maximum destruction of organic contaminants within a soil, sediment, or treatment system.

  2. Microbial Sensing. Novel microbial, cellular, molecular and/or genomic approaches are sought and developed for the rapid functional and DNA-based identification, detection, and monitoring of microorganisms in various environmental matrices including soils, sediments, and surface waters. Novel ecological approaches to detect, monitor and predict prokaryotic/eukaryotic microbes are sought that combine physiology, molecular tools, biochemistry, modeling, and remote sensing for the management of high biomass events and environmental toxins.

  3. Biomaterials and Composite Structures. Novel biological materials and/or techniques are sought to manipulate bioprocesses and biomineralization pathways as additives to aggregate and composite products. These products will support advancements in material structural properties that support civil works and military operations.

  4. Insect and plant field collections, insect husbandry, plant maintenance with greenhouse access is sought for various microbiome projects. Needs will be seasonal and very specific to limited insect or plant systems as dictated by internal projects.

  5. Soil, Sediment and Environmental Chemistry. Research interests broadly center on deciphering environmental processes that shape the emergent chemical, physical and biological properties of soils and sediments in natural and built environments. Studies aim to bridge the gap between fundamental science and practical engineering solutions to enhance understanding of environmental processes, improve infrastructure resilience, and promote sustainable practices in soil and sediment management.

  a. Geochemistry of Soils and Sediments. Topics of interest include understanding i) the cycling of nutrients, metal(loid)s, and radionuclides in soils and sediments, ii) the impact of dynamic chemical conditions on soil physical properties, and iii) complex interactions between chemical reactions and dynamic fluid flow (reactive transport). Of particular interest are soil systems impacted by seawater inundation, wildfire, and other natural and anthropogenic disturbances, which alter the productivity, erodibility and trafficability of soils, and soil characteristics that influence military operations and natural disasters. Studies employ the use of novel field measurements, laboratory experiments, and advanced methods of soil analysis, such as synchrotron-based X-ray absorption spectroscopy, -X-ray diffraction, and X-ray fluorescence microprobe analysis. Molecular to field-scale processes occurring in soils and sediments are modeled using computational tools such as geochemical and reactive transport modeling.

  b. Soils and Sediments in the Built Environment. Research broadly focuses on the function and characteristics of soil and sediment within built environments, including dynamic urban coastal zones. In the built environment, soils and sediments are altered by human activities and/or derived from human-transported materials. Anthropogenic impacts on soil may be intentional (e.g., engineered for a specific purpose) or unintentional (e.g., accidental release of waste). Our research aims to decipher both intentional and unintentional consequences of anthropogenic activities on the health and function of soils and sediments. Focus area includes (1) standardizing approaches to soil health assessment (2) methods to enhance soil functions in nature-based features such as carbon sequestration and water retention, and (3) fate of legacy contaminants such as lead.

• C. Techniques for Contaminated Dredged Material Disposal and Treatment (EL-10)

  1. Development/implementation of innovative technologies to reduce or eliminate contamination present in surface sediment and/or dredged materials. Research to include 1) technologies for cost effective in situ treatment of surface sediments to reduce bioavailability/toxicity; 2) ex situ treatment technologies to reduce contamination and facilitate expanded opportunities for beneficial use of treated material.

  2. Development or enhancement of computer models to be included in the Automated Dredging and Disposal Alternatives Modeling System (ADDAMS) to evaluate the environmental impacts of dredged material disposal. Evaluations include water quality impacts of initial release in open water, effluent discharge, runoff and leachate, benthic impacts, plant and animal uptake, and volatilization.

  3. Development and/or application of new or improved environmental chemistry methodologies to assess contaminant concentrations of dredged material and other complex matrices (e.g., elutriates, bioaccumulation tissues, etc.) focusing on specific compounds or classes, cost effectiveness, quality assurance, lower detection limits, and removal/reduction of challenging matrix interferences.

• D. EMERGING CONTAMINANTS IN THE ENVIRONMENT (EL-11)

  1. Presently, EL is continuing to conduct research, develop technologies and apply strategies to address emerging contaminants (ECs) in the environment. Research falls into for 5 broad categories:

  a. Detection and Measurement:

  b. Development and application of technologies for the detection and measurement of ECs in environmental media at environmentally relevant concentrations.

  c. Application of innovative technologies to discern source of EC contamination.

  d. Screening level methodologies to facilitate near real time detection and measurement of ECs in the field.

  e. Development of forensic methodologies and computational approaches for detection, measurement, prediction of EC precursors and/or degradation products in environmental media.

  2. Exposure Assessment:

  Development and application of technologies for measuring/predicting the movement and fate of ECs in the environment.

  3. Effects Assessment:

  Development and/or application of technologies for establishing the effects of ECs on important ecological and human health receptors/endpoints.

  4. Risk Characterization/Management:

  a. Development and/or application of innovative technologies for characterizing risk of ECs in environmental media. Development and/or application of decision-making tools to support EC related risk management decision-making.

  b. Development and/or application of innovative technologies to remove, concentrate, and/or destroy ECs in environmental media.

  c. Development and/or application of innovative technologies to assist in identification of safer alternatives.

Environmental and Water Quality Modeling

• Overview

  The Corps of Engineers is involved in research and development related to water quality and contaminant fate/transport modeling for surface water, watersheds, and the subsurface, or groundwater. This encompasses a wide range of environmental issues, such as water quality and ecosystem linkages, contaminant transport and fate, eutrophication, effects of land use/management on watershed runoff quality, total maximum daily loads (TMDLs), and ecological and human health risk assessment as related to contaminants in the environment. Research may include model development and field and laboratory investigations to improve model descriptions and to provide required data for model validation.

• A. Numerical Water Quality and Contaminant Modeling (EL-12)

  This area of work is oriented toward development and application of water quality and contaminant fate/transport models for surface water and the subsurface, or groundwater. Surface water modeling includes watersheds and receiving waters, e.g., riverine, reservoir, wetland, estuarine, and coastal water bodies. Groundwater modeling includes modeling both the unsaturated and saturated zones, as well as multi-component flow and transport. Models are utilized for conventional water quality (e.g., nitrogen, phosphorus, carbon, dissolved oxygen, etc.) and contaminants, i.e., toxic substances, such as organic chemicals, trace metals, radionuclides, explosives, and other military unique compounds. Emphasis includes the following: formulation of appropriated physical, chemical, and biological algorithms; improvement of mathematical and numerical methods; collection and assemblage of data for model evaluation; conduct of field and laboratory process investigations designed to develop/improve model descriptions, dynamic linkage of water quality and biological models, including biomass-based, individual-based, and population- based biological models; integration of contaminant exposure models with biological effects data or models to quantify risk; incorporation of uncertainty analysis into modeling; linkage of physical/chemical models with biological population models; linkage of cross- domain models for system wide modeling; development of routines/linkages to include the effects on water quality of watershed landscape features (e.g., buffer zones) and vegetation management; development of a risk assessment modeling system; and development of software to provide graphical user interfaces and modeling environments to enhance model utility and ease of application.

• B. Complex Adaptive Systems (EL-13)

  The central goal of this effort is to identify the rules and feedback processes that govern how interactions between modular components in natural system shape important holistic properties, like the global resiliency to disturbances, and, invariably, the fate of the individual components themselves. These tasks are central to basic research efforts in Complex Adaptive Systems (CAS); an area that impacts a wide range of critical needs in both military and civil works (e.g., immune system responses, decision-making, social feedbacks, and ecosystem management). Current research focuses on ecological systems in which the use of different species and study systems is encouraged to provide diverse and novel solutions to understanding, predicting, or improving the resiliency of complex systems. Recent case studies range from a contaminant’s (e.g., altered water quality, noise, chemical) impacts on individual development and performance, the social roots of information cascades in social vertebrates (spanning from fish and humans), to overall ecosystem functioning based on infrastructure design, overharvesting, or mismanagement. This topic area is inherently interdisciplinary and emphasizes team efforts in the combination of analytical, numerical, and laboratory experiments to test competing hypotheses.

• C. Water Quality and Behavior Modeling (EL-14)

  This research topic focuses on developing early warning indicators to demonstrate how changes in water quality can affect critical ecological processes, thereby raising the subsequent risks imposed on animal populations. We focus on demonstrating when environmental quality is not merely a potential hazard, but how it elicits a functional (e.g., physiological) change during early exposure stages that can impact future performance and, invariably, population survival. Anthropogenic disturbances would include sediment plumes, temperature spikes, or contaminants. Animals typically display stable and, generally, predictable physiological and behavioral patterns in non-stressful conditions.

  However, sub- lethal (including chronic) or acute environmental changes can drastically alter behavior and activity, remain undetected, and invariably introduce unacceptable levels of error in model predictions. Current methodologies range from simple bioassays to more complex physiological consequences at the individual level, to long-term costs/benefits at higher ecological levels (i.e., habitat use, populations, and communities). Hypothesis testing based on a combination of laboratory and modeling is encouraged, along with field data when possible. Findings from these efforts play an important role in both civil works and military activities.

Environmental Impact Prediction, Assessment and Management

• Overview

  This research program addresses environmental impact prediction, assessment, and remediation and is intended to provide Corps, Army, and other field operating elements with techniques and methodologies for environmental assessments and EIS preparation, guidance on selecting appropriate planning, design, construction, and operation alternatives, and implementation of the planning function pursuant to NEPA and other legislation and guidance. Specific objectives include:

  A. Developing, verifying, and demonstrating practical prediction and assessment techniques including applying and refining habitat-based evaluation methods, evaluating mitigation measures, developing streamlined frameworks for environmental monitoring, applying ecosystem simulation principles to environmental analysis, and estimating future habitat quality.

  B. Documenting and quantifying environmental effects associated with various types of Corps, Army, and other activities. Research has included the effects of aquatic habitat modification on anadromous fishes, the effects of selective clearing and snagging on in stream habitat, and t h e benefits of channel modification for aquatic habitat in reservoir tail waters and local flood control channels.

  C. Developing and demonstrating design, construction, and management alternatives that will minimize adverse effects and protect natural and cultural resources. Research has included techniques for managing wildlife habitats, preserving archeological sites, and stabilizing eroding shorelines.

  D. Developing, validating, and demonstrating novel systems biology-, computational biology- or bioinformatics-based approaches to understanding and quantifying toxicological impacts of environmental contaminants in environmentally relevant organisms.

• A. Biotechnical Shore Stabilization (EL-15)

  Biotechnical (sometimes called bioengineering) shore stabilization is the use of a combination of live vegetation and structural materials (for example, breakwaters, geotextiles, erosion control fabrics/mats, building materials) for erosion control of shores. Shores of particular interest are those of streams, lakes, or dredged material deposits and subject to erosion from waves, surface runoff, and wind. Research is needed to determine the causes and amounts of erosion and to identify and assess cost-effective biotechnical erosion control methods. Studies may include, but are not limited to, identifying, developing, and cultivating appropriate flood- tolerant plants and varieties or cultivars and cost-effective installation procedures of biotechnical techniques.

• B. Freshwater Fishery Investigations (EL-16)

  Primary areas of research are predicting environmental impacts of navigation and flood control projects on fishes, freshwater mussels, and other aquatic fauna; benefits of restoring aquatic habitat including environmental flows; conservation of endangered fish and mussel species; evaluating freshwater and coastal wetland fish communities; management of invasive species movement and colonization including Asian Carp; and fishery management in vegetated waterbodies. New and innovative approaches to determine physiological, behavioral, population and community level responses of fishes to habitat variables are of interest, along with technological advancements in sampling and multivariate data analysis capabilities. Demographic and landscape habitat models are anticipated products of this research.

• C. Freshwater Macro invertebrate Investigations (EL-17)

  Research focuses on assessment of aquatic and terrestrial invertebrate communities, with emphasis on insects and mussels. Studies include stream and river biotic assessments, terrestrial and aquatic insect surveys, assessment of threatened and endangered invertebrate populations, feeding ecology of fishes, and evaluation of stream and river food webs and energetics. Assessments of environmental effects of USACE activities, including stream and river impoundments and structural changes, are also performed using naturally occurring macroinvertebrate and mussel communities as indicators of current and past ecological shifts. Restoration and management recommendations are also made through the analysis of these invertebrate communities in both freshwater and terrestrial ecosystems. Technical and analytical advancements, including sampling and data analysis are of interest.

• D. Mitigation (EL-18)

  An avoidance, minimization, and/or compensation process is required for impacts from water resources projects on ecological resources (fish, wildlife, habitat, or installation activities). Planning and implementing mitigation are a complex process, and new ideas that contribute to success of mitigation are invited. Subjects such as Best Management Practices for avoiding or minimizing impacts, planning for mitigation based on impact analysis, incremental analysis to justify mitigation, mitigation banking, future predictions, and mitigation for indirect or cumulative impacts are included.

• E. In Stream Flow Requirements for Aquatic Biota (EL-19)

  Research focuses on development and application of fish habitat assessment methods. Currently, the most widely used system, the Physical Habitat Simulation System (PHABSIM), is used to assess the effects of reservoir operations on downstream fish habitat. Research is needed to better quantify the relationships for fish preference and flow conditions, as well as habitat requirements for aquatic invertebrates. When appropriate, laboratory-based studies can support field-based modelling efforts. Verification studies of these models will be required as development continues. Assessment methods must be able to evaluate the impacts of a variety of reservoir operations such as base load or peaking hydropower releases and at multiple scales from single project to basin – wide studies.

• F. Behavioral and Structural Fish Barriers (EL-20)

  Entrainment of fish at Corps hydropower projects may result in passage of fish through turbines with attendant death or injury from impact with runner blades, pressure changes, or shear forces. Evaluations of a number of behaviorally based technologies and structural barrier designs conducted under laboratory and field conditions have yielded results that are generally inconsistent. Consequently, there currently exist no consistent guidelines for selection of appropriate technology for site-specific applications at Corps dams. Research is required to relate effectiveness of different technologies to size and species of fish, dam design, operations, season, and other site-specific conditions. The information produced by this research will be used to develop specifications and guidelines for fish protection technologies at Corps dams to reduce entrainment and mortality. This effort may involve literature synthesis, laboratory research, design and fabrication of prototype systems, or field studies as well as simulation analysis of fish movement/passage patterns.

• G. Fish Guidance and Bypass Systems (EL-21)

  CE water resource activities may result in blockage of historical fish migration routes through waterways. These blockages, with associated fragmentation of habitats, may have severe impacts on anadromous and catadromous fish populations. A variety of bypass system technologies are available to guide fish around dams. However, many of these systems operate at reduced efficiencies because they damage fish, fish are unable to locate entrances to the systems, or because fish become disoriented and "fall back" after an initial successful passage. Research is required to better understand the hydraulic and behavioral characteristics of fish bypass systems, including the use of behavioral technologies to guide fishes towards these systems and to successfully orient them within the system.

• H. Coastal Ecology (EL-22)

  Research topics in coastal ecology include multidisciplinary investigations of the environmental impacts of engineering activities in the coastal zone, such as dredging, dredged material disposal, and construction of coastal structures (e.g., jetties, breakwaters, groins, seawalls, marinas). Emphasis is placed on improved technologies for assessment, protection, and management of fish and shellfish resources and their habitats. Of particular relevance are proposals dealing with endangered species (e.g., sea turtles, marine mammals), beneficial uses of dredged material and habitat restoration in the coastal zone (e.g., marsh, oyster reef or mudflat creation), and application of population dynamics and ecological models for impact prediction and assessment at population/community/ecosystem/watershed levels. Other areas of interest include effects of beach nourishment and use of offshore borrows areas, seasonal restrictions on dredging and disposal operations, artificial reef technologies, and cumulative impact determination and mitigation techniques.

  Other focus areas include:

  a. Effects of beach nourishment on benthic communities and surf-zone (near- shore) fishes,

  b. Active and passive fisheries acoustics to assess fish migratory patterns, spawning habitat, fish density and spatial distribution patterns near dredging operations and placement sites.

  c. Essential Fish Habitat (EFH) protection from increases in turbidities and suspended sediments.

  d. Fish entrainment

  e. Behavioral changes to marine organisms (e.g., migratory blockage of migratory fishes due to the presence of the dredge, particularly in narrow or constricted waterways).

  f. Underwater noise impacts to aquatic species due to dredging and disposal operations.

  g. Ecosystem restoration (e.g., filling offshore/near-shore borrow areas to natural bathymetry).

  h. Artificial reef creation using dredged rock and other suitable material to enhance fisheries and shell fisheries resources.

  i. Thin-layer placement, re-contouring natural bathymetries. Increased costs associated due to compliance with environmental windows/seasonal restrictions imposed on dredging and disposal operations, and cumulative impact determination and mitigation techniques.

• I. Techniques for Designing, Operating and Managing Dredged Material Disposal Facilities and Beneficial Use Projects (EL-23)

  1. Refinement and verification of techniques for designing, operating, and managing dredged material disposal areas.

  2. Development of a computerized economic database for costs associated with dredging sediments; disposing of dredged material; and constructing, rehabilitating, and operating and managing dredged material disposal areas.

  3. Development and refinement of computer models for dredged material management and beneficial use to be included in the ADDAMS.

• J. Systems Biology, Computational Biology, and Bioinformatics for Environmental Impact Assessment (EL-24)

  A wide spectrum of research in systems toxicology, biological networks, synthetic biology, predictive toxicology, genomics, bioinformatic data mining of next-generation sequencing data, adverse outcome pathway development, toxicological modes of action discovery, herbicide resistance mechanisms, structural biology, chemoinformatics, and molecular modeling is currently underway. Proposed research in mechanistic/predictive toxicology, structural biology, bioinformatics, or computational biology would complement current research areas.

  1. Novel genomics, epigenetics and synthetic biology approaches are sought and developed to assess biochemical, physiological, or other toxicological (adverse) effects on the biota at molecular, cellular, tissue/organ, individual, population, community, or ecosystems levels.

  2. Novel in silico modeling and data mining approaches that are based on computational biology, biophysical or bioinformatics principles and techniques are sought and developed to systematically analyze and interpret big data generated using cutting-edge and high- dimensional biotechnologies such as next-generation DNA sequencing, hybridization-based microarray, proteomics, and metabolomics technologies. Novel mathematical approaches and analysis methodologies are also sought to interpret or describe data generated using novel experimental protocols, and which may account for internal forces, energy and information flows that regulate biological, biophysical, or bioenvironmental processes.

  3. Tools for assessing environmental impacts of synthetic biology. This work involves identifying synthetic biology technologies and understand their current state of use, development, technology readiness, as well as their potential environmental impact. This includes hazard identification, effects assessment, fate, transport, and transferability of various technologies. Moreover, the work entails quantifying environmental impacts of synthetic biological technologies through experimental and modeling approaches. This includes establishing screening mechanisms for genetic and physiological traits for synthetically derived systems, microcosm experiments with tractable organisms to assess potential for spread/transfer of synthetic constructs.

Environmental Criteria for Stream Channel Alteration Projects

• Overview

  The Corps of Engineers is involved in the alteration of stream channels for flood damage reduction, navigation, channel stabilization, and ecosystem restoration, as well as alterations performed by others as part of the Clean Water Act. Modifications to channels include removal of snags and vegetation, channel alignment (straightening), channel enlargement, construction of levees, stream bank protection, and grade control. The Corps is also involved in regulating and furnishing technical assistance to States in regard to other types of channel alterations such as gravel mining. Work at the US Army Engineer Research and Development Center’s Environmental Laboratory (EL) and elsewhere has generated environmental design criteria for stream channel alterations to improve the net effect of these projects. Examples of environmental design features include low-flow channels, combinations of structure and vegetation, management of cutoff bend ways and other backwater areas, and recreational trails.

• A. Riparian and In Stream Habitat Restoration (EL-25)

  Current research includes formulating guidelines for stream restoration and environmental enhancement of flood control and aquatic ecosystem restoration projects. Among the general issues addressed are, in-stream and riparian habitat assessment; benefits of habitat improvement, structures, and techniques; impacts of vegetation on flow conveyance and/or sustainability, channel stability, and sediment transport; construction practices; and monitoring and maintenance. Proposals are invited in these general areas and related efforts. In addition, specific needs include the following: (1) Techniques to quantify habitat and other environmental benefits of restoration efforts, as well as quantification of adverse impacts to the aquatic environment, (2) Algorithms that account for momentum losses at vegetated floodplain/channel interfaces, (3) Data supporting evaluations of the hydraulic impacts of in-stream structures, (4) Development and refinement of related computerized databases and models, and (5) Calculating impacts to and identifying vulnerabilities of riparian systems.

• B. Assessing Benefits of Channel Modifications (EL-26)

  Dams and local flood control structures may degrade aquatic habitat conditions in tail waters and streams. In some cases, habitat degradation can be eliminated, stabilized, or reversed through channel modification for aquatic habitat (i.e., construction of low-cost, low head weirs to create pools) with minimal changes in dam operation or flood channel design. However, there are no widely accepted methods available to incrementally relate in stream aquatic habitat value, channel modifications, and in stream flows to allow trade-off analyses among cost, design, and habitat benefits. It is desirable to modify existing in stream flow methods or develop new methods that will allow incremental assessment of habitat values, alternative flows, and different channel designs. This work may involve data collection, analysis, interpretation, and software development.

More topics in progress (see solicitation for all topics).

Are there any additional benefits I would receive?

Beyond the direct funding, ERDC awards provide meaningful strategic advantages:

Government Validation and Technical Credibility:
Selection by ERDC signals strong alignment with U.S. Army and national infrastructure priorities, which can materially strengthen your credibility with customers, primes, and investors.

Non-Dilutive Technology Maturation:
Companies can advance core technology without equity dilution, preserving ownership while increasing enterprise value.

Long-Term Government Relationship Building:
ERDC BAAs are often a gateway into follow-on DoD contracts, reimbursable work, and sole-source opportunities.

Increased Visibility Across DoD and Civil Works:
Successful projects frequently expand beyond a single lab, creating exposure across USACE, DoD, and federal infrastructure stakeholders.

What is the timeline to apply and when would I receive funding?

This BAA is continuously open until January 1, 2027, and all submissions initially enter the process as pre-proposals. Pre-proposals may be submitted at any time through the ERDCWERX portal and are limited to five pages, plus a one-page executive summary.

ERDC conducts a preliminary technical review of pre-proposals as they are received. Offerors can expect a response within 60 days of submission, either encouraging submission of a full proposal or advising that the pre-proposal was not favorably reviewed.

If a pre-proposal receives a favorable review, ERDC will issue a formal invitation from the Contracting Office to submit a full proposal. Full proposals then undergo scientific peer review, cost evaluation, and funding availability assessment.

There is no fixed award cycle or batch deadline. Awards may be made at any time following successful evaluation and are subject to availability of funds.

Where does this funding come from?

Funding is provided by the U.S. Army Corps of Engineers (USACE) through its Engineer Research and Development Center (ERDC) and supported DoD research programs.

Who is eligible to apply?

Eligibility is unrestricted, meaning any qualified U.S. or international entity may apply, subject to statutory and regulatory requirements. This includes:

• For-profit companies

• Startups and small businesses

• Universities and nonprofit research organizations

What companies and projects are likely to win?

ERDC evaluates proposals based on:

• Clear alignment with ERDC mission and stated research areas

• Strong scientific or technical merit

• Demonstrated capability of the proposing team

• Practical relevance to military or civil works challenges

• Realistic scope and cost relative to expected outcomes

Are there any restrictions I should know about?

• ERDC may limit awards based on funding availability in specific technical areas

• Some projects may be subject to export control, security, or publication restrictions

• Proposals must clearly identify whether research is considered “fundamental”

• Full proposals must be submitted only through designated laboratory channels, not directly to technical staff

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive pre-proposal under this BAA will likely take 20–40 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 for the Pre-Proposal Submission.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

See solicitation on sam.gov

Parkinson’s Disease Therapeutics Pipeline Program (MJFF)

Below is a brief summary. Please check the full RFA before applying (link in resources section).

Executive Summary:

The Parkinson’s Disease Therapeutics Pipeline Program is a rolling funding program run by the Michael J. Fox Foundation (MJFF) that provides $250,000 to over $2 million in nondilutive funding to industry and industry-academia teams advancing Parkinson’s disease therapeutics. Funding supports pre-clinical and early clinical development of pharmacological, biological, and non-pharmacological interventions with clear potential to slow, stop, or delay disease progression or meaningfully reduce symptom burden. Companies can submit pre-proposals at any time, with reviews typically completed within three weeks, and invited full proposals reviewed on a quarterly cycle.

How much funding would I receive?

Award amounts typically range from $250,000 for smaller, targeted projects to upwards of $2 million for larger, multi-stage pre-clinical or clinical development programs. Final award size is determined in consultation with MJFF based on project scope, stage of development, novelty, and unmet patient need.

What could I use the funding for?

MJFF prioritizes pre-clinical and clinical programs that may slow, stop, or prevent disease progression, efforts that address moderate-to-advanced motor or non-motor symptoms of Parkinson’s not well-managed by current treatments such as advanced gait disturbances (e.g., balance issues linked to falls, freezing) and cognitive changes. Activities within scope of this program include:

• Pre-Clinical: Identifying, validating and/or developing novel pharmacological and non- pharmacological interventions through pre-clinical development from early screening topre-clinical characterization and testing.

• Clinical: Progressing promising interventions with strong preclinical packages into/through initial clinical assessment exploring pharmacokinetics and pharmacodynamics, safety/tolerability, or early proof of biology and/or clinical efficacy.For novel targets, MJFF is particularly interested in de-risking programs by supporting early proof of concept in patients to gain insight into the therapeutic potential, including exploration of biomarker-based or clinical endpoint-based efficacy.

Any intervention may be considered based on clear patient need, rationale and strong mechanism-of-action understanding. Interventions may be pharmacological (small molecules), biological (biologic, gene therapy) or non-pharmacological including surgical approaches, technology-enabled therapeutics and neuromodulation approaches. Competitive non- pharmacologic proposals will have compelling, existing data from human studies with strong potential for clinical adoption. Applicants may also propose testing of repurposed or repositioned therapies but should propose clear and robust biomarker-enabled testing strategies.

Are there any additional benefits I would receive?

Beyond direct funding, MJFF awards offer meaningful strategic advantages:

• Strong Scientific and Patient-Centered Validation: Selection by MJFF signals rigorous scientific merit and strong alignment with patient-driven therapeutic priorities in Parkinson’s disease.

• De-Risking for Follow-On Capital: MJFF explicitly positions this program to de-risk therapeutic programs and catalyze follow-on investment from venture capital, strategic partners, and other funders.

• Access to MJFF’s Ecosystem: Awardees gain access to MJFF’s extensive network of clinicians, researchers, industry partners, patient advisors, and proprietary research tools, datasets, and biosample repositories.

• Enhanced Exit and Commercialization Potential: Government- and foundation-validated programs often command higher valuations during licensing, acquisition, or later-stage financing due to reduced technical and clinical risk.

What is the timeline to apply and when would I receive funding?

Pre-proposals may be submitted at any time and are typically reviewed within three weeks. If invited, full proposals are submitted during one of five annual review cycles. Funding decisions are communicated within three months of full proposal submission.

Upcoming full proposal deadlines include:

• February 22, 2026 → Funding decision May 2026

• April 23, 2026 → Funding decision July 2026

• June 25, 2026 → Funding decision September 2026

Where does this funding come from?

Funding is provided directly by the Michael J. Fox Foundation for Parkinson’s Research, a nonprofit organization dedicated to accelerating cures and better treatments for Parkinson’s disease through aggressively funded translational research.

Who is eligible to apply?

Eligibility is limited to:

• Industry applicants (biotechnology, pharmaceutical, medical device, or other for-profit companies), or

• Academic teams partnered with an industry collaborator capable of commercial development.

Both U.S. and non-U.S. entities are eligible. The for-profit entity is expected to serve as the primary grantee and commercialization lead.

What companies and projects are likely to win?

Successful applications typically demonstrate:

• A strong biological rationale for the therapeutic target, supported by genetic or in vitro/in vivo validation data.

• A clearly differentiated therapeutic approach believed to be superior to existing or pipeline therapies.

• Robust translational biomarker strategies to measure target engagement and mechanism of action.

• Clear preclinical-to-clinical translation potential with a realistic commercialization pathway.

• For clinical programs, a patient-centered development plan incorporating patient input.

Are there any restrictions I should know about?

MJFF will not fund:

• Large-scale target discovery efforts (e.g., genomic or transcriptomic screening).

• Target validation using only tool compounds with no path to drug development.

• Reformulation of commercially available drugs via new routes of administration.

• Studies evaluating dietary supplements.

MJFF does not intend to serve as the sole funder and expects applicants to pursue complementary funding sources.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive pre-proposal for this opportunity will likely take 20–40 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Fractional support is $300 per hour, with most pre-proposal projects requiring 10-20 hours of expert support from strategy through submission of full proposal.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

See Request for Applications Here.

Army Medical Operational Capabilities for 2040 BAA

Executive Summary:

The MED CDID Broad Agency Announcement (BAA) invites industry and other performers to propose innovative medical concepts and technologies that support tactical Army medical units in the 2040 Future Operational Environment. The program is open through December 31, 2030, using a multi-step process: submission of a Vulcan Scout Card, followed—if selected for further interest—by a white paper and then a full technical and cost proposal. Companies should plan their internal timelines to first shape a high-impact Scout Card aligned to MED CDID’s three imperatives: clearing the battlefield, maximizing return to duty, and overcoming contested logistics.

How much funding would I receive?

The MED CDID BAA does not specify individual award ceilings or a total program funding limit. Instead, offerors must propose a Rough Order of Magnitude (ROM) total cost (including any fee) that is consistent with the scope of work, period of performance, and any dollar ranges specified in the announcement or follow-on calls. Common costs range from $500K to $5M.

What could I use the funding for?

Proposals should address at least one problem associated with the following aspects of the future operational environment (FOE):

a. Enemy action (through fires, maneuver, electronic warfare, etc.) will inhibit evacuation and medical resupply operations. Slow, reduced, or ineffective evacuation or medical resupply delays the Soldier’s treatment at the proper medical treatment facility. When evacuation slows, the consumption of medical treatment items increases, thus compounding the resupply problem. The cumulative effects of inadequate evacuation and medical resupply will reduce the return to duty rate and increase the number of preventable deaths.

b. The proliferation of drones, sensors, and other advanced technologies has made the modern battlefield more transparent than ever before. This transparency, coupled with long range precision and massed fires, requires Army forces to be distributed across a wider area and to displace frequently. Enemy precision and massed fires will result in more frequent mass casualty incidents, which will likely occur in support areas rather than near the front lines. Future medical forces must therefore be highly mobile to conduct survivability moves, to support widely distributed units, and to respond quickly to the point of need with both medical personnel and supplies (Class VIII).

c. The future battlefield will likely have a broad range of man-made and naturally occurring chemical and biological threats. These threats may be varied and difficult to detect and prevent, making early warning systems crucial. Toxic industrial chemicals and toxic industrial materials in urban areas pose additional threats. Directed energy and other new weapons may cause novel wound patterns that require new training and treatments.

d. When operating in urban areas, challenges include moving through routes blocked by rubble, craters, and other obstacles. Medical units must plan to extract patients from collapsed buildings, interaction with civil medical infrastructure, and potentially large numbers of injured civilians and enemy prisoners.

e. An increasingly transparent and lethal battlefield with chem-bio threats and new weapons systems will create continuous physiological and psychological stressors. These stressors will lead to a decline in the cognitive, physical, and emotional aspects of Soldier performance, and thus a decline in unit combat effectiveness. Army medical units must expand capacity to build and restore individual resiliency, to reduce disease non-battle injury (DNBI) losses, and increase return to duty (RTD).

AREAS OF INTEREST

The Army is looking for solutions in the following categories. Please note that these categories are not comprehensive, but rather to provide context. Categories may be created or removed as time progresses:

• Clear the Battlefield

  Future wars will produce dramatically higher casualty numbers that will stress patient evacuation systems and restrict freedom of maneuver. Minimizing preventable death requires a multi-modal medical evacuation (MEDEVAC) system with advanced enroute care from the point of injury (POI) to the appropriate medical treatment facility at echelon. This MEDEVAC system must be mobile, survivable, and sustainable. It will leverage manned as well as autonomous and semi-autonomous platforms, integrate with casualty evacuation (CASEVAC) capabilities, and be synchronized to maximize efficiency.

  a. Autonomous / semi-autonomous platforms. Manned evacuation platforms areexpected to be insufficient for future combat operations with peer adversaries or in non-permissive environments. The Army's Robotics and Autonomous System (RAS) Strategy leverages systems to increase reach, capacity, and protection in high-risk areas. Unmanned aerial systems (UAS) and unmanned ground vehicles (UGVs) can be staged with support units to provide delivery of critical medical supplies when evacuation is not possible (i.e., prolonged care). A versatile unmanned system (UMS) with casualty evacuation capability would serve as a valuable tool for medical missions.

  b. CASEVAC. CASEVAC complements MEDEVAC by providing additional evacuation capacity when the number of casualties (workload) or mandated reaction time exceeds the capabilities or capacity of MEDEVAC assets. Casualty evacuation is often the first step in moving patients from the point of injury to the appropriate medical facility. Self-aid and buddy-aid are critical. Effective operational planning and a C2 system that integrates non-standard platforms maximizes the commander’s freedom of action and ensures efficient use of evacuation assets. Augmentation of medical personnel and equipment onboard dedicated CASEVAC platforms will increase survivability.

  c. Multimodal evacuation. Multimodal evacuation capabilities meet FOE challenges by using multiple modes of transportation (e.g. boats, buses, trains, etc.) to fulfill evacuation capability and capacity shortfalls. Future evacuation capabilities involve the seamless integration of land, air, and maritime (sea and river) transportation to ensure an efficient and effective evacuation system. Leveraging different modes of transportation optimizes mobility and flexibility, enhances response capabilities, and enables swift evacuation in a variety of operational environments.
  
  d. Prolonged Care. The FOE may not allow evacuation of patients at a time and place of our choosing, due to unavailability of assets or enemy action. Prolonged care is necessary to provide patient care for extended periods when evacuation is not available. Currently, the Prolonged Care Augmentation Detachment (PCAD) is designed to operate forward of definitive care capabilities in support of medical units, such as Battalion Aid Stations (BAS), medical companies, and Forward Resuscitation and Surgical Detachments (FRSD) to manage patients in a prolonged care setting. Further study is needed to determine if this capability can be significantly improved.

  e. Integrated and synchronized C2 of patient movement capabilities. C2 systems facilitate seamless communication and information sharing among healthcare providers, commanders, evacuation elements, and other stakeholders involved in patient movement. These systems enable real-time coordination, synchronization, and decision-making, ensuring efficient and effective allocation of resources for patient movement. An integrated C2 system incorporates AI-enabled real-time data analysis, predictive modeling, and adaptive learning to enable the following: mission requests management, treatment and evacuation capability tracking and two-way communication, intelligent tasking (dispatching), data management, and telemedicine and telehealth technologies to facilitate remote consultations, triage, and medical guidance during patient movement. These solutions enable evacuation mission and system management and enable healthcare providers to remotely assess and manage patients. They also allow optimization of medical personnel, equipment, supplies, and evacuation resources based on patient needs, urgency, and available capacity.

• Maximizing Return to Duty (RTD)

  Maximizing RTD allows for experienced Soldiers to return to the fight as quickly as possible after becoming wounded, injured, or ill. It includes prevention—minimizing disease and nonbattle injury (DNBI).

  a. Holistic resiliency. Commanders in conjunction with their medical staff will maximize preparedness through a holistic approach prior to and during deployment. This will serve to help minimize DNBI and battle injuries (BI). A holistic approach includes cognitive, physical, and emotional well-being, emphasizing proper nutrition, sleep, and social and environmental factors to navigate the rigors of combat operations. Advances in areas such as body-worn sensors, stress inoculation, and medical cognitive enhancements will further increase Soldiers’ capabilities in austere environments while decreasing the likelihood of becoming a casualty. Advanced biomedical engineering can create vaccines and individualized treatments to address emerging health threats before deployment to preserve the force.

  b. Theater Convalescence. In the theater of operations, convalescence capability is essential to maximizing RTD rates. Soldiers who are unlikely to RTD within the prescribed period (theater evacuation policy) will be evacuated out of theater with the first suitable transportation asset. Establishing in-theater convalescence serves to simultaneously decrease the logistical burden on theater transportation assets while decreasing the burden on replacement operations. Rehabilitation support encompasses cognitive and emotional healing as well as physical recovery (e.g., physical therapy with combat and operational stress control). Advanced prosthetics, exoskeletons, and robotic rehabilitation systems can assist Soldiers in regaining mobility and functionality after injury.

  c. Operational Public Health (OPH). OPH is a critical enabler for commanders to maintain maximum strength on the battlefield. OPH minimizes casualties through full spectrum surveillance, monitoring, and testing activities against environmental, biological, and chemical threats. Equipped and trained field sanitation and CBRN elements will establish tailored active and passive protection measures, resulting in more survivable formations. Army medical formations must integrate manned and unmanned air and surface systems to improve detection, diagnostics, and treatment. These formations must share information with all partners through a single, data-centric C2 system empowering both timely operational decisions and timely medical responses.

  d. Healthcare Training and Education. Medical education and training must align with combat demands. This comprehensive approach will encompass all medical specialties, using advanced training methodologies like virtual reality, haptic feedback systems, and AI-driven simulations to develop and maintain skills. These technologies will provide realistic and repeatable opportunities for personnel to practice high-stress and complex scenarios, like trauma triage or prolonged care.

  e. Advanced Diagnostics. In a combat environment, where split-second decisions can mean the difference between life and death, the benefits of advanced diagnostics are immeasurable. By incorporating cutting-edge technologies such as precision medicine, nanomedicine, robotics, telemedicine, and gene editing technology, Soldiers can experience optimized health and improved combat performance. Additionally, advanced diagnostics enable early detection of internal injuries, such as internal bleeding or organ damage, which may not be immediately evident. Swift identification of these hidden injuries allows medical personnel to intervene promptly and prevent further harm. Moreover, advanced diagnostics aid in identifying infectious diseases or exposure to hazardous agents (e.g., CBRN), thereby preventing outbreaks. Ultimately, the integration of advanced diagnostics in combat empowers medical teams to deliver timely and accurate care, leading to improved outcomes for wounded, injured, or ill Soldiers and enhanced operational efficiency.
  
  f. Advanced Therapeutic Technology (ATT). ATT will play a critical role in supporting commanders and Army Medicine. In austere and contested environments, ATT will enhance Army Medicine's ability to rapidly triage and assess injuries, leveraging portable diagnostic devices and advanced imaging systems to determine the severity of injuries and provide timely treatment. The ability of ATT to track Soldiers' exposure to hazardous conditions, such as chemical agents or extreme temperatures, will also be crucial in protecting personnel from emerging threats.

  g. Advanced Treatment Modalities (ATMs). The integration of ATMs will revolutionize the way combat commanders operate in future operational environments. With the advent of cutting-edge technologies such as robotic surgery and portable diagnostic equipment, commanders will be empowered to make informed decisions that prioritize the health and safety of their troops. ATMs such as bioengineered skin substitutes and negative pressure wound therapy will be particularly critical in managing complex battlefield injuries, promoting faster wound healing, reducing infection risk, and enhancing long-term recovery. The combination of these advanced medical capabilities and technologies, including artificial intelligence, machine learning, and data analytics, will enable rapid and effective treatment of wounded personnel, reduce the risk of mortality and morbidity, and facilitate their swift return to duty.

• Overcoming Contested Logistics

  Future supply lines will likely be disrupted, congested, and under constant threat. Predicted high casualty rates in future warfare requires Army medical forces to have predictable and reliable delivery of Class VIII at the point of need (PON). This will enable clearing the battlefield and maximizing RTD while facilitating expanded maneuver and survivable formations. In the FOE, the threat will likely target sustainment nodes from the homeland (industrial base) to the operational area, cutting off access to sustainment capabilities and resources. Compounding this problem is the demand to support widely distributed friendly forces.

  a. Advanced Manufacturing. Advanced manufacturing can revolutionize logistics by enabling the production of essential supplies at or near the PON. This includes the production of Class VIII A/B medical supplies through synthetic biology and biomedical manufacturing.

  b. Predictive medical logistics (MEDLOG). This capability uses advanced analysis to predict where and when medical supplies will be needed. It allows for the optimization of Class VIII supplies, which include medical materiel and equipment, across all echelons. By analyzing expected casualty rates and injury mechanisms, predictive MEDLOG enables planning and allocation of resources. Integration with partners and allies will additionally enhance this capability by using standardized equipment, supplies, and data-sharing protocols, ensuring that medical logistics systems work seamlessly across different military forces. At higher echelons, persistent assessment of the supply chain (from rare earth metals and active pharmaceutical ingredients to industrial-based capacity) must be conducted through the lens of risk to mission and risk to force.

  c. Multimodal resupply. Multimodal resupply combines air, land, and maritime transportation with manned and unmanned systems to enhance resupply capabilities and reduce reliance on a single mode of transport. Air transport provides speed and agility for time-sensitive items, while land transport offers flexibility in various terrains. Maritime transport (both sea and river, surface and subsurface) handles larger quantities over longer distances. Manned systems provide adaptability, while unmanned and autonomous systems offer speed, precision, and reduced risk. This multimodal approach optimizes logistics operations, ensures timely supply delivery, and overcomes challenges in contested environments.

  d. Distributed supply nodes. These nodes are strategically positioned throughout the operational area to ensure effective resupply. This approach offers several advantages, including reduced vulnerability to disruptions, resupply redundancy, and enhanced operational coordination. By having multiple supply nodes, military forces can mitigate disruptions in one area by relying on alternative nodes (to include those of partners and allies). Supplies can be sourced from the nearest available node, reducing transportation time and costs, and ensuring critical supplies reach the PON in a timely manner. Additionally, strategically positioned supply nodes enable better coordination and synchronization of logistics activities, optimizing resource distribution, and enhancing overall operational effectiveness while reducing strain on logistics capabilities. Robots and autonomous platforms specifically designed to operate in these supply nodes allow for additional flexibility.

  e. Autonomous and semi-autonomous resupply systems. Autonomous and semi- autonomous resupply systems enhance logistics capabilities by reducing reliance on human intervention in contested logistics. These systems leverage advanced technologies to automate and streamline the resupply process, resulting in increased efficiency and flexibility while reducing risk. In addition, these systems can serve to enhance situational awareness by having their sensors gather data from their surroundings.

  f. Tele-maintenance and remote diagnostics. These capabilities will enable medical logisticians to provide guidance and consultation from afar, minimizing the need for physical transportation of personnel and materiel. Advanced diagnostic tools and predictive maintenance algorithms can identify potential equipment failures before they occur, ensuring the highest levels of readiness.

• Cross-cutting Components

  There are functions that support two or more of the three medical imperatives outlined above.

  a. Artificial Intelligence and Machine Learning. By using AI and ML to analyze vast amounts of data, patterns can be detected, outcomes can be more accurately predicted, and sound recommendations can be quickly developed for commanders. This allows medical personnel at all echelons and across all medical functions to act more quickly and decisively, ultimately reducing preventable deaths.

  b. Human-machine teaming. This teaming involves leveraging the unique strengths of both humans and machines to achieve operational goals. Machines, equipped with AI and machine learning, can process, and analyze vast amounts of data at speeds far beyond human capabilities. This allows for real-time analytics of supply chain needs and predictive modeling for medical supply, evacuation, and treatment. The integration of human capabilities with advanced technological systems represents a transformative shift towards more efficient, responsive, and adaptive medical support on the battlefield.

  c. Scalable, highly mobile multifunctional organizations. The FOE demands that medical units at all echelons be as mobile as the maneuver units they support to keep up with the rapid pace of military operations and to better ensure survivability. Medical organizations that are scalable and multifunctional will allow maneuver commanders increased flexibility in rapidly changing situations. In addition, medical units must decrease their signature (physical, electronic, etc.) to avoid enemy detection.

  d. Interoperability with the Combined Joint Force. Interoperability with partners and allies is crucial for achieving success. It ensures that different medical forces can work together seamlessly, share information, and support each other's operations. This capability enhances mission success by leveraging the strengths and resources of multiple Services and nations, fostering mutual trust and cooperation. Moreover, interoperability helps in responding swiftly to global crises, maintaining regional stability, and deterring potential threats through a unified front. Ultimately, it strengthens collective defense and augments the Army's medical capabilities.

  e. Health Engagement. Health engagement plays a significant role in winning in competition and being prepared for crisis and conflict. Through engagement with international health organizations, foreign militaries, and local healthcare systems, Army medical forces can foster collaboration, build trust, and promote a shared understanding of health security threats and responses. This, in turn, enhances interoperability with partners and allies, allowing for more effective coordination and cooperation in response to health crises and other operational challenges. Health engagement also allows for enhancing situational awareness.

  f. Reach back. Reach back is an essential component for enhancing battlefield capability, capacity, and operational readiness. This approach will use advanced telepresence and telemedicine technologies, along with integrated data systems, to conserve a commander's fighting strength. Reach back improves real-time diagnostics and remote treatment, allowing medical personnel real-time remote access to specialized care. Furthermore, in an environment characterized by contested logistics, reach back can provide a lifeline, using virtual platforms to maintain continuity of care and resource allocation.

  g. Operate in a CBRN environment. The best way to deter enemy CBRN use is to demonstrate that Army forces can effectively operate in a CBRN environment. The ability to rapidly assess threats, evacuate and treat patients, and resupply in contaminated areas is crucial to minimize preventable death and maximize RTD. Additionally, continued development of advanced deployable sensors that can observe current and emerging CBRN threats can help decrease those threats.

  h. Medical Modeling and Simulations. Incorporating medical modeling and simulation in both training and in operational settings is crucial. By using advanced modeling techniques, medical professionals can simulate diverse medical scenarios, thereby optimizing treatment plans, forecast the spread of diseases, and evaluate casualties in complex operational environments. These simulations facilitate the development medical resource allocation plans, identifying potential bottlenecks in the treatment and evacuation process, and enhance preparedness in large-scale conflicts. Furthermore, modeling and simulation allows testing of various prevention and intervention strategies, aiding in the identification of the most efficient approaches to minimize casualties and improve overall outcomes.

Are there any additional benefits I would receive?

Beyond the direct award, MED CDID funding offers significant strategic advantages for companies operating in defense, medical technology, logistics, AI/ML, and dual-use innovation:

Government Validation and Credibility:
Being selected by the U.S. Army Medical Capability Development Integration Directorate demonstrates strong technical merit and alignment with Army 2040 operational needs. This validation can accelerate engagement with primes, program offices, integrators, and investors who prioritize government-vetted technologies.

Enhanced Visibility and Notoriety:
Although the BAA does not explicitly promise publicity, MED CDID-aligned innovations often surface in Army medical modernization discussions, technical exchanges, and defense-sector forums—raising your company’s profile across DoD medical, logistics, and capability development communities.

Ecosystem Access and Collaboration Opportunities:
Awardees gain direct interaction with MED CDID, Army Futures Command stakeholders, and operational medical units. These touchpoints can open pathways to experimentation events, requirements discussions, field evaluations, and future contracting opportunities with Army, Joint, and SOF medical acquisition organizations.

Stronger Exit and Acquisition Potential:
Nondilutive DoD funding that advances medical, logistics, or autonomy technologies—combined with Army validation—typically increases a company’s valuation and attractiveness to acquirers in defense, biotech, medtech, autonomy, and advanced manufacturing. Government-backed maturity substantially strengthens both commercial and dual-use exit potential.

What is the timeline to apply and when would I receive funding?

Open period: The announcement is open from its posting date through December 31, 2030, as an open-ended BAA.

• Submission cadence: Vulcan Scout Cards may be submitted at any time during the open period, subject to the process in the BAA. The government may also issue separate, focused calls for follow-on white papers at any time while the BAA is active.

• Multi-step process:

  1. Vulcan Scout Card submission.

  2. If of interest, MED CDID may request a white paper and/or

  3. A formal technical and cost proposal.

The BAA does not specify review cycle timing or when funds would be awarded after a proposal is submitted. Actual award timing will depend on when MED CDID issues a request for proposal, internal evaluations, and contracting timelines.

Where does this funding come from?

This opportunity is issued by the U.S. Army Medical Capability Development Integration Directorate (MED CDID), which is responsible for enabling the Army Health System and developing future medical concepts and requirements for the Army and Joint Force

Who is eligible to apply?

The BAA does not restrict eligibility. Typical BAAs accept proposals from:

• U.S. businesses of any size

• Universities

• Nonprofits

• Federally-funded research and development centers (with limitations)

Foreign entities may be subject to additional restrictions depending on classification and export-control considerations.

What companies and projects are likely to win?

Based on the BAA’s emphasis, competitive projects are likely to:

• Directly address one or more of the three MED CDID imperatives:

  • Clearing the battlefield (evacuation, prolonged care, integrated patient-movement C2).

  • Maximizing return to duty (resiliency, OPH, advanced diagnostics and treatment, training).

  • Overcoming contested logistics (advanced manufacturing, predictive MEDLOG, multimodal resupply).

• Provide innovative, future-oriented solutions for the 2040 operational environment, not just incremental improvements to current practice.

• Show clear relevance to the described FOE challenges (distributed forces, mass casualties, CBRN threats, urban operations, contested logistics).

• Leverage cross-cutting enablers such as AI/ML, human-machine teaming, interoperability with joint and allied forces, and medical modeling and simulation to materially improve outcomes (reduced preventable deaths, higher RTD rates, more resilient logistics).

In short, teams that tightly map their concept to these problem statements and demonstrate operational impact for Corps-and-below medical units are best aligned with the BAA.

Are there any restrictions I should know about?

• Tactical level focus: The BAA is focused on tactical-level (Army Corps and below) medical units, not broader health systems in isolation.

• Targeted white papers: White papers should address only the specific portion of the BAA the offeror intends to accomplish. Submitting a single white paper that tries to cover the entire scope of the BAA is “most likely” to be rejected.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive scout card under this BAA will likely take 20–30 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available to submit a scout card for a flat fee of $2,500.

Fractional support is $300 per hour, with most scout card projects requiring 10-12 hours of work.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

See solicitation on Vulcan

ARPA-H BioStabilization Systems (BoSS)

Executive Summary:

The ARPA-H BioStabilization Systems (BoSS) program provides multi-year support for teams developing ambient-temperature cell stabilization and scalable bioprocessing systems. Performer Solution Summaries are due February 19, 2026.

How much funding would I receive?

ARPA-H anticipates multiple OT awards, with the expectation that Performer teams will be funded through multi-phase development (up to 48 months). While specific award ceilings aren't stated, ARPA-H OT programs typically support multi-million-dollar development efforts and note that several teams may be funded initially with down-selects in later phases.

What could I use the funding for?

The BioStabilization Systems (BoSS) program aims to transform how live cell-based therapies are stabilized, manufactured, and distributed. At its core, BoSS addresses a foundational bottleneck in the delivery of advanced cell and gene therapies (CGTs): the critical dependence on ultra-cold conditions (-80 to -196˚C) for storage and transport. BoSS will yield a bioprocessing system that enables scalable production of thermally stable cells, paving the way for a new era of efficient and resilient manufacturing and distribution of biologics without any need for cold storage. BoSS-developed technologies will also accelerate many other avenues in biotechnology that directly impact healthcare, including bio-surveillance, regenerative medicine, large-scale genetic testing, blood product supply, and wound repair, in addition to improving access to a wide range of existing biotherapeutics.

This ISO is intended to solicit:

1) Performer teams that can pioneer breakthrough cell stabilization technologies and integrate these technologies into a commercially viable system for producing cell therapy products at scale. Strategic partnerships are encouraged to best position technologies for commercialization success, such as assembling multidisciplinary teams that may include experts from academic, industry, regulatory, commercialization, and non-traditional backgrounds.

2) An Independent Verification and Validation (IV&V) partner to reliably provide well-characterized, clinically relevant, government-selected cells to Technical Area Performers. This partner will also assess cell viability and system performance at critical junctures throughout the program.

• Background

  This year approximately 150 million Americans will use at least one thermally unstable biologic, such as a monoclonal antibody, vaccine, or cell therapy. The instability of these medicines necessitates a reliance on cold chain, which jeopardizes product effectiveness, escalates costs, and limits access due to complex, temperature-dependent manufacturing and distribution schemes. Furthermore, costly ultra-cold cryopreservation is the standard approach to extending shelf-life stability for life saving biologics such as CGTs. However, demand for CGTs continues to surge, powered by their transformative impact on healthcare and reflected in rapid market expansion. Globally, there are now >3000 CGTs in the development pipeline, ranging from pre-clinical through pre-registration phases. Innovative solutions that relieve cold chain requirements while preserving shelf-life stability are crucial to meeting this rising demand, as FDA approval and widespread patient access to CGTs rely on maintaining product quality throughout storage and distribution.

  BoSS aims to develop innovative technologies that preserve cells at ambient temperatures, a breakthrough approach we will subsequently refer to as biostabilization. Achieving biostabilization remains a two-fold challenge that has yet to be overcome. The first challenge requires cellular interventions to preserve the integrity and function of vital elements prior to undergoing stabilization, enabling cells to withstand physical changes that would otherwise cause irreversible damage. This could include delivering protectants into cells and/or altering cells in other ways to improve processing and storage resilience. To maintain the clinical utility of cell products, cellular interventions to prepare and deploy biostabilization must be both biocompatible and reversible. The second challenge involves implementing aseptic, cell-friendly handling instrumentation to deploy stabilization techniques across various production scales.
  
  One approach to address the first challenge is to adopt nature’s strategies to accomplish biostabilization. For example, ‘anhydrobiotes’ can tolerate extreme loss of water and persist in a dehydrated state for years (e.g., tardigrades, rotifers, brine shrimp), quickly regaining full function after rehydration. Molecular contributors to this resilience have been elucidated such as amorphous trehalose glass and special classes of intrinsically disordered proteins (IDPs). Recent studies have revealed cell structure re-arrangements and stress-induced formation of molecular condensates that may be essential for surviving the stresses of dry processing. Other discoveries from the genomic to the organismal scale form the natural basis of desiccation tolerance and may be adapted or improved upon for biostabilization. Solutions inspired by chemistry and materials science advances are also encouraged along with approaches that employ biocompatible polymers, scaffolds, multi-organic frameworks, or cell encapsulation to protect and stabilize cells.

  Addressing the second challenge requires development of new processing approaches and potentially new instrumentation that can yield products suitable for ambient storage. Current gold standard methods for batch processing like lyophilization (freeze-drying) are energy-intensive, slow, and challenging to apply to complex biologics. While appropriate for proteins, antibodies, and even some vaccines, lyophilization is a risky and unproven approach for high-value cell products that are widely used in the biopharma industry as starting materials, manufacturing intermediates, host cells, and cell-based therapies. Nascent technologies like microwave-assisted vacuum foam-drying, thin film freeze-drying, and polymerization gelation exhibit potential for processing complex biologics but remain at a low manufacturing readiness level (MRL), i.e., early-stage development and requires significant development to establish full-scale production. Established technologies with high MRL, such as spray-drying, commonly used for food production, offer the advantage of continuous processing and may have potential for adaptation to biologics.
  

  Successful completion of BoSS will yield a bioprocessing system designed as a platform technology for stabilizing cell biologics capable of easy integration into biomanufacturing pipelines. The bioprocessing system will enable scalable production and distribution of thermally stable cells benefiting the biopharmaceutical ecosystem that uses cells as starting materials, manufacturing intermediates, and CGTs. Breakthroughs from BoSS are expected to yield biostabilization innovations including intracellular and extracellular protectants and stabilizers, enabling bioprocessing technologies, and re-animation products. Together, BoSS bioprocessing system and biostabilization technologies will be commercially viable solutions that will establish a new paradigm for biomanufacturing designed to reduce costs and ensure that biological medicines are accessible to patients, including those living in the most remote and resource-limited communities.

• Technical Areas

  BoSS envisions that successful solutions will converge from extremophile biology, biomaterials science, biomanufacturing, pharmaceutical formulation, process engineering, and device development to unlock new bioprocessing and biostabilization solutions, bridging historical silos in biostasis science and advancing biological medicines. Proposals are required to address solutions to both technical areas:
  
  Technical Area 1 (TA1): BioPrep

  Approaches to BioPrep include preparing, protecting, and other methods of intervention to allow cells to endure and recover from biostabilization at room temperature. BioPrep solutions should be reversible interventions that support the suspension of biological activity while ensuring cellular health and integrity upon reanimation. BioPrep solutions may also include the development of re-animation techniques and solutions that rapidly restore biological activities after biostabilization.
  
  Technical Area 2 (TA2): Bioprocessing

  Bioprocessing technologies (e.g., instruments, devices) should enable the deployment of biostabilization concepts at scale. Activities may include the scale-up of an early MRL, cell-friendly processing technology, or the adaptation of scaled systems that can be re-designed to safely and gently handle cells. The proposed solution should mitigate stress on cells while achieving biostabilization with preserved quality and function for extended durations at ambient temperatures.
  
  Proposers must submit proposals to both TAs. A conforming proposal will account for all program requirements outlined in this ISO, both TA-specific and overall program milestones and metrics.

• Program Overview

  Technology commercialization is a critical part of achieving the ARPA-H mission to improve health outcomes for all Americans. To support this goal, progress will be measured by strategic metrics and milestones that must be met to advance through subsequent phases. Technologies will advance across three integrated phases designed to drive both technical advancement and commercial translation:

  •

  Phase 1 focuses on establishing the scientific feasibility of ambient biostabilization. This proof-of-concept stage includes developing innovative cell preparation approaches with enabling instrumentation that, together, are capable of inducing biostabilization as well as re-animation methods to restore function after biostabilization.

  •

  Phase 2 emphasizes integrated capability demonstrations, converging biological and manufacturing innovations into a cohesive bioprocessing system that can produce stabilized cells under simulated commercial conditions.

  •

  Phase 3 advances to scaled solution development and industry transition, preparing the bioprocessing system for market entry through GMP-compliant production, strategic industry partnerships, and validation in real-world use cases.

  Performer teams must meet increasingly stringent technological capability requirements and stabilized cell quality metrics during each phase to demonstrate progress on biostabilization technology development. Performers will choose cells used for end of phase demonstrations from a list of government-selected cell types, which will be identified at the start of the performance period. Sub-phase milestones may be demonstrated on cell types chosen by the Performer, with consideration to the restrictions identified in Table 1. In later stages, end of phase demonstrations will be permitted on cells that are aligned with Phase 3 transition partners. Ideal transitional partners for Performers are organizations equipped with established distribution networks to seamlessly integrate the developed bioprocessing system into their existing biomanufacturing pipelines for cell biologics, accelerating the path from innovation to implementation.

  At the end of the program, biostabilization technologies will demonstrate capability, scalability, and applicability of commercially viable platform technologies that enable room temperature storage and distribution of stabilized cells agnostic of cell type, supporting widespread access to biologic medicines. The ideal bioprocessing system will integrate seamlessly with biomanufacturing and fill-finish systems. Ultimately, partnerships will culminate into early adoption of a new commercially viable bioprocessing system capable of scalable production of stabilized cell products that meet Good Laboratory Practice (GLP) and GMP standards with a path paved for commercialization to support broad industry adoption.

Are there any additional benefits I would receive?

Beyond the primary funding, BoSS awardees gain several indirect strategic advantages:

Government Validation & Credibility
Selection by ARPA-H establishes strong scientific legitimacy and positions your technology as a potential national-level biomanufacturing platform.

Enhanced Visibility & Notoriety
Awardees are featured through ARPA-H communications, Proposers’ Day events, and industry engagement, increasing recognition among biotech investors, health systems, and biopharma manufacturers.

Access to a National Innovation Network
BoSS includes structured engagement with an Independent Verification & Validation (IV&V) partner, FDA interactions, and optional commercialization support—creating opportunities for partnerships, pilot studies, and eventual technology adoption.

Stronger Exit, Growth, and Acquisition Potential
Nondilutive development of platform technologies can significantly improve valuation, especially for companies working in CGT manufacturing, biosurveillance platforms, or enabling bioprocessing technologies. Government validation reduces perceived technical risk for acquirers and later-stage investors.

What is the timeline to apply and when would I receive funding?

Key dates:

• Proposers’ Day: January 29, 2026

• Performer Solution Summary: February 19, 2026

• Performer Pitch: March 26, 2026

• IV&V Solution Summary: April 17, 2026

• IV&V Pitch: May 15, 2026

Where does this funding come from?

Funding is issued through the Advanced Research Projects Agency for Health (ARPA-H), under the Scalable Solutions Office, using Other Transaction (OT) authority for high-risk, high-impact biomedical innovation.

Who is eligible to apply?

Universities, Nonprofits, Small and large commercial businesses, Non-U.S. entities (with restrictions; must not be from foreign entities of concern), Must conduct work in the U.S., FFRDCs and U.S. Government entities cannot participate as Performers.

What companies and projects are likely to win?

See full solicitation for details. Strong candidates include companies with capabilities in:

• Cell & gene therapy engineering

• Bioprocessing & biomanufacturing instrumentation

• Biomaterials, polymers, encapsulation, or intracellular protectants

• Cell preservation technologies (cryopreservation alternatives, desiccation biology)

• Microfluidics, closed-system processing, or continuous manufacturing

• Regulatory-ready biologics or device development expertise

• Advanced analytical platforms (cell viability, potency, functional assays)

Winning projects will propose integrated TA1 + TA2 solutions capable of achieving:

• Room-temperature stability (14 days → 3 months)

• Reanimation <1 hour by Phase 3

• High viability, function, and potency metrics across multiple cell types

Are there any restrictions I should know about?

Key restrictions include:

• No genetic manipulation of cells

• No dangerous gain-of-function research (per EO 14292)

• No demonstrations on RBCs or microbial species

• No slow (>4 hr prep or >1 day processing) methods

• No methods that cannot scale or meet GMP requirements

• No traditional lyophilization

• Teams must maintain SAM.gov registration for Step 2

How long will it take me to prepare an application?

For a first-time applicant, preparing a solution summary under this opportunity will likely take 50-70 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Resources

See the full solicitation here.

Autonomous Interventions and Robotics (AIR) – ARPA-H-SOL-26-146

Below is a summary. Please see the official solicitation on sam.gov for details (link in Resources Section).

Executive Summary:

The AIR program will award multiple OT agreements to teams developing autonomous endovascular robotic systems and interventional microbots that can perform key parts of surgical and interventional procedures without direct human control. The program runs for five years (two-year Phase 1 and three-year Phase 2). Companies must submit a Solution Summary by January 26, 2026 and a Full Proposal by March 30, 2026.

How much funding would I receive?

The ISO does not specify a minimum or maximum award amount. ARPA-H states only that it expects to make multiple OT awards under this opportunity; budgets will be driven by the scope, risk, and duration of each proposed 5-year effort (2-year Phase 1 + 3-year Phase 2).

What could I use the funding for?

The Autonomous Interventions and Robotics (AIR) program aims to catalyze the development of autonomous robotic surgery—an intervention during which a robot performs part, or all, of the procedure without direct human input. AIR encompasses two (2) technical areas: Technical Area 1 (TA1)—endovascular robotics, and Technical Area 2 (TA2)—microbots. Technical Area 1 comprises sub-areas TA1-A—endovascular robotic systems and TA1-B—endovascular simulation environment.

• Background

  During an endovascular procedure, the surgeon reviews the pre-operative CT of the patient’s vasculature, makes a small incision in the patient’s skin, then manually navigates guidewires and catheters from the femoral or radial artery up into the patient’s brain, using occasional guidance from intra-operative 2D fluoroscopy images. The surgeon steers the distal tip of the catheter around tortuous anatomy by pushing, pulling, and twisting the catheter at the entry point—a challenging process requiring dexterity, mental mapping, and an understanding of the physical properties of catheters. Often, the surgeon must try multiple types of catheters, restarting the navigation from the beginning and losing precious time in the process. Once the target is reached, additional challenges await. For example, during a mechanical thrombectomy—the removal of a stroke-inducing blood clot from the brain—once the catheter reaches the clot, there is ambiguity around contact and suction; with little tactile feedback beyond translated resistance, the surgeon needs to make a seal and suction the clot. In addition, endovascular surgeons receive high yearly doses of radiation during procedures, increasing their risk of cancer and other sequelae such as cataracts1.

  Thrombectomies are a critical unmet need in the United States and worldwide. Every year, approximately 335,000 Americans experience an ischemic stroke caused by a large vessel occlusion (LVO), a situation in which a major blood vessel in the brain is blocked by a clot. The standard of care is to mechanically remove the clot via thrombectomy; unfortunately, only ~40,000 Americans per year—about 10% of the patients with LVOs—receive thrombectomies2. There are only 311 thrombectomy-capable centers in the United States as of 20223, and they are unevenly distributed, with 50% of Americans living more than one hour away from one. Time to procedure is crucial; every 10-minute delay in revascularization lowers a patient’s disability-free lifetime by ~40 days and increases health care costs by $10,0004. While thrombectomies are currently recommended for patients within six hours from stroke onset, recent clinical studies have shown benefit to 24 hours and beyond5.

  More broadly, other specialized or highly invasive procedures are often the only way to obtain disease diagnostics and treat pathological conditions. These include biopsies of suspicious tissue, ablations of uterine fibroids, and destruction of kidney stones, among numerous others. Overall, surgery remains dangerous: more than one in three patients experience adverse events during surgical care. Furthermore, surgery requires specialist care, which can involve extensive travel and waiting times.

  Automated systems such as microbots (small, mechanical, electronic or hybrid devices) have the potential to dramatically increase access to interventions. However, surgical microrobot research and development is largely at an early stage and mostly devoted to biosensing and microrobot motion; the smaller the entity, the more difficult it is for the entity to propel itself directionally. Implementation of end-to-end clinical solutions is notional at best, except for pill-sized gastro-intestinal (GI) imaging devices, which are specifically excluded from accepted AIR solutions. Autonomous endovascular systems also currently do not exist; although complex robotics elements have been developed in industry and academia, autonomous navigation and control algorithms are still in their infancy.

• Program Goals

  AIR aims to make endovascular procedures available at hospitals everywhere through autonomous robotic systems; it is understood, though, that the transition from the current state of clinical care to this audacious goal is likely to involve multiple practical evolutionary steps. They will likely include: a) clinical trials during which endovascular surgeons present in the room will be ready to take over at any moment from the autonomous endovascular robotic system; b) a first deployment phase, in which local general surgeons and remote endovascular surgeons will oversee the procedure; and ultimately, c) a phase in which only local general surgeons (or other medical professionals) will oversee the operation of thoroughly validated autonomous systems.

  AIR microbots are intended to create a paradigm shift in interventional procedures, transforming these invasive procedures—currently performed in advanced care settings and requiring skilled practitioners—into minimally invasive procedures performed in a general practitioner’s office. Microbots are expected to simplify existing procedures, enable completely new procedures, reduce complications rates and costs, and increase procedure availability.

• Technical Area 1

  Technical Area 1 (TA1) of AIR aims to develop fully autonomous robotic endovascular intervention systems. After a medical professional inserts the catheter system into the femoral or radial artery, the robot will complete an endovascular procedure without human intervention. The system capabilities will be demonstrated in several procedures, including 3D rotational angiogram imaging, vascular embolization, and, most importantly, thrombectomy. Autonomous endovascular systems developed in TA1-A will encompass:

  1) Robotic control systems that can manipulate catheters and guidewires

  2) Navigation algorithms based on pre-operative imaging and real-time sensing

  3) Steerable catheters and guidewires (if required)

  4) Solutions for autonomous clot removal and vascular embolization

  In addition, TA1-B will develop an in silico testing and validation environment for these robots, an activity that will include the collection of fluoroscopic videos of endovascular procedures, CT angiograms, and other imaging modalities as needed for training.

  Note that autonomous blood vessel access is out of scope for the AIR program; a surgeon or surgical technician will obtain vessel access.
  
  Additional details are available in the solicitation.

• Technical Area 2

  Technical Area 2 (TA2) of AIR aims to develop a set of interventional microbots. Performers will specify a target clinical indication and develop microbots that move, sense, and act to diagnose or treat this condition by means of more precise targeting and/or less invasive access. TA2 teams will address:

  a. Microbot locomotion

  b. Anatomy/pathology targeting methods

  c. Miniaturization or externalization of power supplies and computational processing

  d. Autonomous or automated action

  e. Microbot removal or deactivation

  Gastrointestinal/ingestible pill microbots that only image, stimulate, and/or deliver cargo are out of scope for the AIR program.

  Although the technologies for both TAs are developed and validated for a target indication, it is expected that they will serve as platforms for multiple interventions and procedures.
  
  Additional details are available in the solicitation.

Are there any additional benefits I would receive?

Beyond direct funding, AIR awards can provide strategic benefits typical of ARPA-style programs:

• Government technical validation: Being selected by ARPA-H signals that your approach is technically ambitious and nationally relevant in health innovation and surgical autonomy, which can help in discussions with strategics, hospital systems, and investors.

• Positioning for regulatory and ecosystem engagement: AIR is structured with parallel FDA collaboration (for TA1) and explicit regulatory milestones (e.g., simulation frameworks, Q-submissions) that can de-risk later clinical and commercialization steps.

• Access to a high-end performer network: Performers will interact with other top robotics, imaging, and microbotics teams, plus FDA scientific collaborators and ARPA-H program staff—often leading to follow-on partnerships and future solicitations.

• Nondilutive growth capital: Because funding is nondilutive, successful teams can mature high-capex platforms (robotics, microfabrication, imaging) while preserving equity and potentially driving higher valuations and stronger exit options down the line.

What is the timeline to apply and when would I receive funding?

1. Proposer’s Day: December 16, 2025

2. Q&A deadline: January 20, 2026, 5:00 PM ET

3. Solution Summaries due: January 26, 2026, 5:00 PM ET

4. Full Proposals due: March 30, 2026, 5:00 PM ET

Where does this funding come from?

The Advanced Research Projects Agency for Health (ARPA-H), a federal R&D agency within HHS, issuing awards under the authority of 42 U.S.C. § 290c(g)(1)(D) via OT agreements.

Who is eligible to apply?

• Universities and other educational institutions

• Non-profit organizations

• Small businesses

• Other-than-small businesses

What companies and projects are likely to win?

1. Overall Scientific & Technical Merit:
   Companies proposing highly innovative, technically rigorous, and fully executable plans with well-defined milestones, clear risk-mitigation strategies, and IP structures that enable commercialization are most competitive. Winning projects will demonstrate a credible path to achieving AIR’s demanding 5-year technical milestones.

2. Proposer’s Capabilities & Related Experience:
   Teams with deep, directly relevant expertise—including experienced robotics engineers, imaging specialists, microbot developers, and required clinicians (e.g., an endovascular neurosurgeon for TA1-A)—are most likely to win. Prior success delivering complex R&D programs on time and on budget is a major advantage.

3. Assessment of Proposed Cost/Price:
   ARPA-H will favor proposers who submit realistic, well-justified budgets that reflect the true complexity of autonomous surgical robotics or microbot development. Costs must align with the technical plan, leverage past research efficiently, and avoid artificially low budgets or staffing junior personnel simply to reduce cost.

Are there any restrictions I should know about?

• Key restrictions from the ISO include:

  • Scope restrictions

    • TA1 excludes autonomous vascular access and closure; a human must obtain vessel access.

    • GI “pill camera–only” devices and ingestible microbots that only image, stimulate, or deliver cargo are out of scope; GI microbots must at least sense and biopsy, or sense/biopsy/ablate, to qualify.

    • Purely biological, purely chemical, or chem-bio-only delivery concepts (no mechanical/electronic component) are not acceptable microbots. Nanoparticles alone are out of scope.

  • Team composition and application rules

    • TA1-A teams must include at least one endovascular neurosurgeon.

    • A given team may propose to either TA1-A or TA1-B, but not both

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive solutions summary under this BAA will likely take 40–60 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Check the full solicitation here.

DARPA Strategic Technology Office-Wide Broad Agency Announcement (BAA)

Executive Summary:

DARPA’s Strategic Technology Office (STO) BAA is soliciting breakthrough research concepts that create new mission-level capabilities beyond the current state of practice. The agency will fund a limited number of high-risk, high-reward proposals across a broad range of defense and national-security technical domains. Applications are due December 19, 2025.

How much funding would I receive?

DARPA does not publish fixed award amounts for this BAA. STO funds a limited number of proposals, and budgets are determined by the technical approach, the scope of work, and alignment with STO priorities.

What could I use the funding for?

DARPA's STO seeks innovative ideas and disruptive technologies that provide the U.S. military and national security leaders with trusted, disruptive capabilities across all physical domains (Air, Space, Sea, and Land) and across the spectrum of competition. STO programs deliver solutions at speed and scale for today's warfighters while developing the resilient "breakthrough" systems and technologies needed for future battlespaces. STO does not focus on one area of responsibility or phenomenology. Rather, STO programs capture the strategic, logistical, and tactical complexity of today's national security environments. STO is a "systems office" seeking to create new "proof-of-concept" mission systems. Its goals are to develop and demonstrate new capabilities that expand what is technically possible.

Research areas of current interest to STO include, but are not limited to, the following topics:

•  Acoustic communication and sensing

•  Adaptability

•  Advanced computing

•  Additive manufacturing

•  Architecture and advanced systems engineering

•  Artificial intelligence

•  Autonomy and control algorithms

•  "Big data" analytics

•  Combat identification

•  Command and control (C2)

•  Communications and networking, virtual and adaptive

•  Complexity management

•  Critical infrastructure defense

•  Decision aids and C2 technology

•  DevOps and novel software development and integration

•  Directed energy (DE)

•  Distributed autonomy and teaming (machine-machine, human-machine)

•  Economic security

•  Effects chain functions (disaggregated find, fix, finish, target, engage, assess)

•  Electro-optic/infrared sensors

•  Electromagnetic warfare (EW)

•  High-frequency (HF) communications and sensing

•  High voltage electric power systems and architecture

•  Human behavior modeling

•  Human-machine symbiosis

•  Industrial engineering

•  Integration and reliability technologies

•  Interoperability

•  Logistics

•  Modeling and simulation

•  Microwave and millimeter wave communications and sensing

•  Novel kinetic effects

•  Non-kinetic effects (EW, DE, cyber)

•  Optical technologies

•  Photonics

•  Radio technologies (especially software-defined and novel waveforms and processing)

•  Radar and adaptive arrays

•  Resilient systems

•  Robotics

•  Seekers and other expendable sensors and processing

•  Sensors and analytics

•  Signal processing

•  Space sensors, communications, autonomy, and architectures (especially supporting proliferated low earth orbit constellations)

•  Strategy analysis technology

•  Supply chain analytics

•  System of systems

•  Undersea and seabed technology

•  Tactics development technology

•  Testing and data collection

•  Very low earth orbit (VLEO) technology

•  Very low frequency (VLF) technology

Are there any additional benefits I would receive?

Beyond the direct award, DARPA funding offers significant strategic advantages:

Government Validation and Credibility:
Receiving a DARPA award signals exceptional scientific and engineering merit, which accelerates engagement with primes, integrators, strategic partners, and investors.

Enhanced Visibility and Notoriety:
DARPA programs are frequently highlighted in federal communications, technical conferences, and defense media—boosting your company’s profile across the national security sector.

Ecosystem Access and Collaboration Opportunities:
Awardees gain access to DARPA program managers, government labs, test ranges, and a high-level innovation network—opening doors to future contracts and partnerships.

Stronger Exit and Acquisition Potential:
Nondilutive funding that matures breakthrough technology, combined with the DARPA “stamp,” often increases valuation and attractiveness to large defense, aerospace, semiconductor, and AI-focused acquirers.

What is the timeline to apply and when would I receive funding?

Applications are due December 19, 2025.

DARPA does not publish a fixed award timeline.

Where does this funding come from?

Funding comes from the Defense Advanced Research Projects Agency (DARPA) under the Strategic Technology Office (STO), a DoD organization responsible for advanced mission-level systems and emerging technologies.

Who is eligible to apply?

The BAA does not restrict eligibility. Typical DARPA BAAs accept proposals from:

• U.S. businesses of any size

• Universities

• Nonprofits

• Federally-funded research and development centers (with limitations)

Foreign entities may be subject to additional restrictions depending on classification and export-control considerations.

What companies and projects are likely to win?

DARPA will select proposals that score highly on scientific merit, mission relevance, and cost realism.

• High Scientific & Technical Merit: Innovative, feasible, and well-justified approaches with clear deliverables, identified risks and credible mitigations, and a team with the expertise to execute.

• Strong Contribution to DARPA’s Mission: Efforts that meaningfully advance U.S. national security capabilities, show a credible transition path to U.S. defense applications, and include an IP strategy that does not hinder government use.

• Realistic, Well-Substantiated Costs: Budgets that accurately reflect the level of effort, materials, labor, and technical scope—avoiding artificially low estimates and demonstrating efficient use of prior research and existing capabilities.

Are there any restrictions I should know about?

• Proposals must not duplicate existing STO programs or other active STO BAAs.

• Research that yields incremental or “evolutionary” improvements is specifically excluded.

• Offerors are strongly encouraged to review current STO programs and speak with program managers before applying.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $15,000 Project + a 5% Success Fee.

Fractional support is $300 per hour, with most DARPA proposal projects requiring 80–100 hours of expert support from strategy through submission of full proposal.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

See solicitation on sam.gov

CIRM CLIN2: Funding Opportunity for Clinical Trials

Executive Summary:

CIRM’s CLIN2 program provides up to $15M to advance interventional Phase 1–3 clinical trials for stem cell–based and genetic therapies addressing serious unmet needs. Applications are accepted quarterly, with 2026 deadlines falling on the last business day of January, April, July, and October at 2:00 PM PST.

How much funding would I receive?

Funding depends on the stage of your clinical trial:

• First-in-Human: Up to $8M (for-profit) / $12M (non-profit)

• Phase 2/Subsequent Phase 1: Up to $15M

• Phase 3/Pivotal: Up to $15M

What could I use the funding for?

The CLIN2 award supports completion of an interventional phase 1, 2 or 3 clinical trial for a stem-cell based or genetic therapeutic candidate and may also fund an associated natural-history comparator or lead-in normal healthy volunteer study. Applicants are encouraged to use accelerating trial designs where appropriate, such as basket trials or adaptive design dose-escalation protocols.

The CLIN2 Program aims to advance clinical candidates that have the potential for transformative patient impact and that address barriers to access and affordability. To support this goal, align with Proposition 14’s mandate, and remain responsive to an evolving scientific and regulatory landscape, funding preferences will be set on an annual basis. These preferences will be guided by portfolio analyses and other strategic considerations in a cyclical manner.

For fiscal year 2025-2026 CLIN2 cycles, the following modalities and project features will be prioritized:

• Pluripotent stem cell-derived therapies

• In vivo genetic therapies

• Therapies using non-viral nucleic acid delivery

• Projects addressing diseases of the brain and CNS

• Applications from California organizations

• Projects progressing from CIRM-funded IND-enabling or earlier phase clinical trial awards

• Projects with Fast Track, RMAT or Breakthrough designations

• Projects proposing pivotal clinical trials (as agreed-to by the FDA)

• Required Activities

  • All clinical operations activities needed to complete the trial according to the proposed timeline

  • Outreach, enrollment, and retention activities to achieve trial enrollment demographics reflecting the target patient population

  • Treatment of patients with the therapeutic candidate (or control) and follow-up visits per the clinical protocol

  • Sharing of any non-clinical as well as clinical data per the CIRM data sharing requirements

  • Establishment and regular convening of a Strategic Planning Committee (SPC) with clinical development expertise to provide forward-looking strategic advice

  • Activities associated with managing, preserving, and sharing data and knowledge from the study

  • Activities associated with access and affordability planning for the therapeutic candidate in the proposed indication

• Allowable Activities

  • Natural history studies needed for baseline or control data for the interventional trial

  • Lead-in studies in normal healthy volunteers for the interventional trial

  • Studies to develop biomarkers, understand mechanisms of action and develop a potency assay

  • Regulatory activities including FDA interactions and requests for designations

  • Non-clinical studies required by the FDA (FDA documentation required)

  • Strategic planning activities

  • Manufacturing activities to supply the current clinical trial, including technology transfer and FDA-approved comparability studies, if needed

• Conditionally Allowable Activity

  Manufacturing for the next phase trial. Funding of that activity will be conditioned on 1) an interim evaluation by CIRM and a panel of independent experts of the clinical trial data to date, and 2) provision of 50% co-funding for this activity, if co-funding is required as specified in “Award Amount and Duration” below

• Unallowable Activities

  • Costs incurred on or before the date of ICOC approval

  • Discovery or translational research

  • Activities already budgeted or paid for under a prior, existing or future CIRM award

  • The costs of activities performed by a separate out-of-state organization that retains intellectual property or independent publication rights in any intellectual property (e.g., invention, technology, data) arising out of the CIRM-funded project

Are there any additional benefits I would receive?

Government Validation and Credibility
CIRM’s rigorous review provides a powerful credibility signal to investors, strategic partners, and clinical collaborators.

Enhanced Visibility and Notoriety
Awardees benefit from increased recognition through CIRM communications and visibility across the state’s stem cell and gene therapy ecosystem.

Access to CIRM’s Specialized Infrastructure

• Alpha Clinics Network for trial acceleration and patient access

• GMP Manufacturing Network for cell and gene therapy manufacturing

• Industry Resource Partners including preferred CROs and CDMOs

Stronger Exit and Valuation Potential
Nondilutive capital allows companies to advance high-value programs without dilution, often increasing valuation and improving partnership or acquisition outcomes.

What is the timeline to apply and when would I receive funding?

Applications Accepted: Quarterly

• 2026 Deadlines: Last business day of January, April, July, October at 2:00 PM PST

• GWG Scientific Review: ~90 days after deadline

• Board Approval: ~60 days after review

• Project Start: Within 60 days of approval

Total time from submission to project kickoff: ~6 months.

Where does this funding come from?

Funding is provided by the California Institute for Regenerative Medicine (CIRM) through Proposition 14, which supports the advancement of stem cell and genetic medicine programs statewide.

Who is eligible to apply?

For-profit or non-profit organizations

1. FDA-cleared IND (or submitted IND for CIRM-funded programs with clearance within 30 days)

2. PI with ≥15% effort

3. Project Manager with ≥50% effort

4. Data Project Manager

5. Applicant must be the IND sponsor

6. At least one California trial site

7. Must begin work within 60 days of board approval

8. Must meet co-funding and solvency requirements

What companies and projects are likely to win?

CIRM scores applications across five scientific merit categories:

1. Value Proposition – Whether the therapy offers meaningful clinical improvement over existing options, addresses unmet need, and is practical for real-world uptake by patients, providers, and payors.

2. Scientific Rationale – Strength of the biological justification, robustness of supporting data, and evidence of disease-modifying activity from relevant models or prior clinical studies.

3. Project Plan & Design – Whether proposed activities efficiently advance development, enable clear go/no-go decisions, support timely enrollment, include appropriate manufacturing plans, and can be delivered within the proposed budget, timeline, and risk-mitigation strategy.

4. Team & Resources – Expertise and coordination of the project team, access to required facilities (including manufacturing), and track record with stem cell or gene therapy programs.

5. Population Impact – Understanding of the affected population and strength of plans for representative outreach, enrollment, and retention.

Are there any restrictions I should know about?

No funding for discovery or early translational research:

1. No pre-approval costs

2. No out-of-state work where the external organization retains IP/publication rights

3. Co-funding required for for-profits (30–50%)

4. Only one CLIN2 application per PI per cycle

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive proposal will likely take 150–250 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for $15000 Initial Fee + a 3% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the Funding Announcement Here.

CIRM DISC5 Awards: Funding Opportunity for Discovery Stage Research

Executive Summary:

CIRM’s DISC5 Awards fund up to $2.5 million per project for small, collaborative teams to run high-risk, exploratory discovery research in stem cell biology, genetic research, and regenerative medicine. Each project must be co-led by a California-based Principal Investigator and Co-Investigator from different labs, with human stem cells or genetic research central to the approach. Applications for the current cycle open November 14, 2025 and are due January 30, 2026 at 2:00 pm PT.

How much funding would I receive?

Each DISC5 award can request up to $2,500,000 in total project costs (including direct, facilities, and indirect costs) for a project lasting up to 3 years. Budgets at or above $900,000 in any single project year require additional justification and may be adjusted during review and negotiation.

What could I use the funding for?

The DISC5 Awards will support exploratory and innovative foundational research led by pairs of interdisciplinary investigators applying a range of technologies and approaches to address fundamental knowledge gaps or bottlenecks in stem cell biology and/or regenerative medicine. Proposals should aim to achieve one or more of the following outcomes:

• Advancing fundamental understanding of human stem and progenitor cells as they pertain to human health and disease.

• Advancing the use of stem cells to interrogate disease mechanisms to uncover biological insights thatcould enable therapeutic target and/or biomarker discovery.

• Gaining mechanistic insights to address key scientific or technical bottlenecks in stem cell, genetherapy, and/or other regenerative medicine approaches.

• Advancing applicability of stem cells, gene therapies, and/or other regenerative medicine approaches to all affected populations.

Proposals focused on validating or optimizing a therapeutic approach or candidate are not aligned with this program’s focus on foundational discovery.

Required Activities: Activities associated with managing, preserving, and sharing data and knowledge from the study

Allowable Activities:

• Any basic research activities that meet the DISC5 objective to address knowledge gaps or bottlenecks in stem cell biology with relevance to human biology and disease, where human stem cells or genetic research is part of the central approach or hypothesis, and that seek to achieve one or more of the outcomes listed in “Scope and Structure.”

• Partnering activities with patient-centered organizations or other project-relevant community groups.

• Travel and accommodation expenditures associated with attendance of CIRM organized meetings and conferences. See additional details in Discovery Program Meetings and Conferences, pg. 13.

• Activities to support outreach or communication of research plans or outcomes with the wider public.

• Engagement activities with trainees supported through CIRM’s EDUC or INFR programs

Unallowable Activities:

• Therapeutic or other commercial development activities including lead optimization, manufacturing, pre-clinical toxicology and pharmacology studies and other activities targeted by CIRM’s PDEV and CLIN programs.

• Costs of activities performed by a separate out-of-state organization that retains intellectual property or independent publication rights in any intellectual property (e.g., invention, technology, data) arising out of the CIRM-funded project.

• Costs incurred on or before the date of ICOC approval.

• Activities already budgeted or paid for under a prior, existing or pending CIRM award or which are already supported by another funder.

Are there any additional benefits I would receive?

Beyond the direct funding, DISC5 awardees benefit from:

Visibility and credibility: CIRM is one of the nation’s most recognized regenerative medicine funders. A DISC5 award strengthens credibility with partners, investors, and follow-on funders.

Positioning for future non-dilutive funding: DISC5 supports early high-risk data generation, enabling teams to later apply for CIRM’s translational and clinical programs or alternative funding sources.

What is the timeline to apply and when would I receive funding?

For the current cycle:

• Application deadline: January 30, 2026 at 2:00 pm PT

• Grants Working Group (GWG) review: ~60–90 days after the deadline

• Board approval and Notice of Award: ~150 days after the deadline

• Project start: Must begin within 90 days of award approval

  Most awardees can expect to start work approximately 6–8 months after the application deadline.

Where does this funding come from?

The DISC5 Awards are funded by the California Institute for Regenerative Medicine (CIRM), a voter-created state agency dedicated to accelerating stem cell, genetic, and regenerative medicine research. DISC5 is part of CIRM’s Discovery Program under its 2024 Strategic Allocation Framework.

Who is eligible to apply?

Eligible organizations:
Must be a California Organization (non-profit or for-profit) as defined by CIRM. More than 50% of W-2 employees must be full-time California residents paying CA income tax. The PI must be located in California. California subsidiaries must retain IP rights from the project.

Eligible teams:
• Exactly one PI and one Co-Investigator (Co-I).
• Both must be employed by California Organizations.
• Each must commit at least 5% effort.
• PI and Co-I must be from different labs.
• The team must include an experienced Data Project Manager.

Project requirements:
• Must include human stem cell and/or genetic research as a central component.
• Any non-human models must be strongly justified and validated with human models when possible.
• Applications must be complete, accurate, and non-duplicative across CIRM programs.

Application limits:
• An individual may serve as PI on only one DISC5 application per cycle.
• An individual may serve on no more than two DISC5 applications total per cycle (as PI or Co-I).
• Co-funding is not required.

What companies and projects are likely to win?

CIRM funds projects that score highly across five criteria:
• Significance: Advance foundational stem cell or regenerative medicine knowledge with broad impact.
• Innovation: Use novel approaches or cross-disciplinary methods.
• Rationale: Present a sound scientific basis and justified experimental models.
• Plan & Design: Offer a clear, feasible research plan with strong team coordination and realistic budgets/timelines.
• Population Impact: Consider genetic, environmental, and community factors to ensure findings apply across diverse California populations

Are there any restrictions I should know about?

Key restrictions include:

• No therapeutic development (manufacturing, lead optimization, preclinical tox/pharm, IND-enabling studies).
• Out-of-state organizations cannot retain IP or publication rights for any CIRM-funded work.
• No costs incurred prior to ICOC approval.
• Applications must be complete, accurate, and not duplicative with other pending CIRM submissions.
• Projects must start within 90 days of award approval.
• Only one no-cost extension (max 6 months) may be requested—and approval is not guaranteed.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive proposal will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for $13000 Initial Fee + a 5% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the Funding Announcement Here.

Making Obstetrics Care Smart (MOCS) – ARPA-H

Executive Summary:

ARPA-H’s Making Obstetrics Care Smart (MOCS) program, run by the Scalable Solutions Office (SSO), is soliciting proposals under ISO ARPA-H-SOL-26-143 to develop new placenta health tests and noninvasive, wireless, AI-backed monitoring tools that can better predict fetal oxygen status and guide intervention during labor and delivery. Pre-proposal discussions are required between December 15–19, 2025, and full proposals are due by 12:00 PM ET on January 21, 2026 via the ARPA-H Solutions Portal.

How much funding would I receive?

Specific funding amounts are not listed so practically, you should assume that budgets must be tailored to the technical scope required to:

• Develop and validate placenta risk-stratification tools, and/or

• Design, build, and test noninvasive, wireless fetal monitoring technologies integrated with AI/ML decision support.

What could I use the funding for?

Based on the stated technical objectives, allowable work is expected to focus on R&D activities according to these guidelines:

The Problem

• The United States has the highest rate of maternal and infant morbidity and mortality of any wealthy country, despite spending more per capita on maternal care.

• This unacceptable status quo is largely the result of a 50-year-old, imprecise tool used during labor and delivery to monitor babies and determine whether they are getting enough oxygen—a tool called the fetal electronic monitor.  

• Without reliable data, confusion prevails and it’s tough to make smart, informed decisions. Women end up having unnecessary cesarean sections and babies are born with low oxygen levels, which sometimes cause lifelong complications.  

• This confusion leads to the dissolution of trust between patients and the medical system, massive lawsuits, and ultimately can cause medical providers to quit obstetrics, exacerbating the healthcare provider shortage.   

The Solution

• The Making Obstetrics Care Smart (MOCS) program aims to address this combination of problems by developing technology to help families and care teams plan for and have safe deliveries.  

• Our goal is ambitious: use advanced diagnostics and smart technology to make births safe. The program seeks to generate tools to predict both chronic and acute fetal status and provide the best recommendations for intervention, giving peace of mind to the care providers, mothers, and families making choices for critical labor and delivery care.

• MOCS will develop better ways to track a baby’s status during labor. First, developing a new test that will assess the health of the placenta to understand which patients are at high risk for complications during labor. Second, designing new types of noninvasive, wireless sensors and AI-backed technology to gain real-time information about a baby’s oxygen levels and make smart decisions during delivery.  

• If successful, MOCS will enable safe deliveries for all, drastically improving the health of women and children.

Are there any additional benefits I would receive?

Beyond direct funding, competitive ARPA-H programs like MOCS typically create several strategic benefits for companies and teams:

• Government validation and credibility
  Being selected by ARPA-H signals strong technical merit and alignment with high-priority national health goals in maternal and infant outcomes. That endorsement can de-risk you in the eyes of hospitals, payers, strategic partners, and investors.

• Visibility in a critical health domain
  MOCS targets one of the most pressing and visible failures in U.S. healthcare: maternal and infant morbidity and mortality tied to inadequate fetal monitoring. Demonstrated progress here can drive significant attention from media, advocacy groups, and professional societies.

• Access to a curated ecosystem
  The program explicitly aims to convene “the best researchers and collaborators in labor and delivery, including healthcare providers, hospitals, payers, attorneys, and families,” creating a structured network of stakeholders that can accelerate pilots, studies, and adoption.

• Non-dilutive capital to mature your product
  ARPA-H support is non-dilutive, enabling you to build and validate high-risk capabilities—advanced diagnostics, sensors, and AI—without giving up equity. That can translate into stronger valuations in later private rounds or at exit.

• Stronger exit and partnership potential
  A validated, government-funded platform for safer labor and delivery can be attractive to medical device manufacturers, hospital system partners, payers, and women’s health platforms looking to expand into perinatal safety and monitoring.

These strategic benefits are not guaranteed, but they are typical of successful participation in high-profile federal health R&D programs.

What is the timeline to apply and when would I receive funding?

From the publicly available materials:

• Proposers’ Day: December 11, 2025 (hybrid; Washington, DC + virtual).

• Required pre-proposal discussions: December 15–19, 2025 (request via ARPA-H Solutions Portal).

• Full Proposal Due: January 21, 2026 at 12:00 PM ET (submitted via ARPA-H Solutions Portal).

The documents provided do not specify:

• Exact dates for selection decisions,

• Award announcement dates, or

• When funds will be obligated or projects will start.

Where does this funding come from?

Funding is provided by the Advanced Research Projects Agency for Health (ARPA-H), specifically through its Scalable Solutions Office (SSO), under ISO ARPA-H-SOL-26-143 for the Making Obstetric Care Smart (MOCS) program.

Who is eligible to apply?

Academia, non-profit organizations, for-profit entities, hospitals, community health centers, and non-federal research centers. Non-U.S. entities may participate if compliant with all applicable laws.

What companies and projects are likely to win?

Official scoring criteria have not been released but typical criteria for ARPA-H opportunities are below (in descending importance):

1. Scientific/technical merit—innovative, complete plans with clear deliverables, risks, and mitigations;

2. Contribution & relevance to ARPA-H’s mission—transformative potential, unmet need, commercialization/transition thinking, and IP/software approaches that enable adoption (preference for open standards/OSS where appropriate);

3. Team capabilities/experience—track record delivering similar efforts on budget/schedule;

4. Cost/budget alignment with the technical approach. ARPA-H encourages proposing the best technical solution over low-risk/minimal-uncertainty concepts.

Are there any restrictions I should know about?

• Attendance at Proposers’ Day is optional.
  It is not required for submission or selection, though ARPA-H notes it may help with teaming.

• Pre-proposal discussions are required.
  Pre-proposal discussions between December 15–19, 2025 must be scheduled via the ARPA-H Solutions Portal and are a required step before full proposal submission.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive full proposal will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our support is available for $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

The AFWERX & SpaceWERX Open Topic Small Business Innovation Research (SBIR) Program

Executive Summary:

AFWERX & SpaceWERX’s Open Topic provides SBIR/STTR awards to small businesses to validate feasibility (Phase I) and build prototypes with Air Force or Space Force partners (Phase II or D2P2). Any technology could potentially be funded if it provides real value to the military. Phase I awards are up to $75K/$110K for 3 months; Phase II up to $1.25M/$1.8M; Direct to Phase II up to $1.25M. The next deadlines are estimated to be Q4 of 2025 or Q1 of 2026.

How much funding would I receive?

1. Phase I (Feasibility Study): Up to $75K (SBIR) or $110K (STTR) for a 3-month effort.

2. Phase II (Prototype Development): Up to $1.25M (SBIR) or $1.8M (STTR) for up to 21 months.

3. Direct to Phase II (D2P2): Up to $1.25M (SBIR) for up to 21 months, available to companies that can skip Phase I by providing prior feasibility evidence and a signed Customer Memorandum.

What could I use the funding for?

• Phase I funds a feasibility study and/or customer discovery to identify an Air Force or Space Force end user and customer, culminating in a preliminary and final report.

• Phase II/D2P2 funds R&D to adapt and prototype your dual-use solution with an Air Force or Space Force Technical Point of Contact and the Customer/End User who signed the Customer Memorandum.

See sample projects here.

Are there any additional benefits I would receive?

Beyond the formal funding award, AFWERX/SpaceWERX Open Topic participants gain several strategic advantages:

• Government Validation and Credibility: Selection for an AFWERX or SpaceWERX SBIR/STTR award demonstrates strong technical merit and alignment with Department of the Air Force priorities. This validation builds trust among primes, defense customers, and private investors.

• Enhanced Visibility and Market Recognition: Awardees are often highlighted in AFWERX communications, SpaceWERX showcases, and federal innovation reports—raising profile across defense, aerospace, and venture communities.

• Access to the National Defense Innovation Network: Recipients gain entry into the AFVentures ecosystem, connecting with Air and Space Force end users, program offices, and transition partners to accelerate dual-use commercialization and follow-on contracting opportunities.

• Stronger Commercial and Exit Potential: By advancing technology with nondilutive funding and government-backed validation, companies enhance valuation, de-risk product development, and increase attractiveness for acquisition or follow-on investment

What is the timeline to apply and when would I receive funding?

The next deadlines are expected to be Q4 of 2025 and Q1 of 2026. Funding is generally received 4-5 months after the deadline.

Where does this funding come from?

Awards are made under the Department of the Air Force SBIR/STTR program via AFWERX/AFVentures and the Air Force Research Laboratory.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Proposals are evaluated based on three primary criteria:

• Technical Approach: The soundness, feasibility, and innovation of your proposed solution—how effectively it addresses the problem and advances the state of the art.

• Defense Need: The strength of alignment between your technology and an identified Air Force or Space Force capability gap, as demonstrated through end-user engagement or a signed Customer Memorandum.

• Commercialization Potential: The dual-use viability and market readiness of your solution—its potential to scale in both defense and commercial sectors.

Strong applications clearly articulate all three dimensions, showing technical excellence, a validated Air Force or Space Force use case, and a credible path to commercial success.

Are there any restrictions I should know about?

• Proposal Template Compliance: You must use the required proposal template; any content placed outside designated pages will not be evaluated.

• U.S.-Based R/R&D Requirement: All research and development activities funded under the award must be conducted within the United States.

• ITAR Restrictions: Projects involving ITAR-controlled materials limit the participation of foreign nationals.

• Customer Memorandum Requirement: A signed Customer Memorandum is mandatory for all Phase II and Direct to Phase II (D2P2) submissions.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for

• Phase I: $9,000 Flat Fee + a 5% Success Fee.

• Phase II/D2P2: $15,000 Flat Fee + a 5% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Access the AFWERX Website here.

USSOCOM BAA for Extramural Biomedical and Human Performance Research and Development

Executive Summary:

United States Special Operations Command (USSOCOM) is awarding $2,000,000 to $10,000,000 for projects across defined Research Areas of Interest (RAIs) to advance biomedical, human performance, and canine medicine relevant to Special Operations Forces. This BAA is open continuously through 31 July 2028; applicants must first submit a pre-proposal via eBRAP and, if invited, a full application (generally within 60 days of invitation).

How much funding would I receive?

1. Typical project size: $2 Million to $10 Million

2. Program capacity: “Anticipated total costs… will not exceed $20 Million annually” across all awards funded under this BAA.

What could I use the funding for?

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 Research Areas of Interest below (Clinical trials are normally not funded by this BAA):

• 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:

  • 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.

  • 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.

  • 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.

  • 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.

• 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.

• 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.

• 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 are encouraged.

• 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.

  • 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.

  • 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.

  • 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.

• 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

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

  • 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.

  • 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.

• 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

• 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.

  • 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).

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

• 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:

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

• 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:

  • 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.

  • 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.

  • 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.).

  • 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.

Are there any additional benefits I would receive?

Beyond direct funding, participation under the USSOCOM Biomedical and Human Performance BAA offers significant strategic advantages:

Government Validation and Credibility:
Being selected for funding by USSOCOM demonstrates exceptional technical capability and mission relevance to U.S. Special Operations Forces. This validation enhances your organization’s credibility with DoD program managers, defense primes, and dual-use technology investors seeking field-proven innovation.

Enhanced Market Visibility and Notoriety:
Awardees often gain visibility through federal award announcements, DoD communications, and defense medical research forums—positioning your company as a recognized contributor to national security and elite force readiness.

Ecosystem Access and Collaboration Opportunities:
Projects funded under this BAA operate within the broader military biomedical and human performance ecosystem, connecting recipients with military laboratories, medical R&D commands, and operational units. This access frequently leads to additional collaboration, follow-on funding, and contracting opportunities.

Stronger Exit and Acquisition Potential:
Advancing your technology with nondilutive government support and demonstrating validation in demanding SOF environments can significantly increase company valuation and strategic attractiveness for acquisition or investment by defense, medical, and performance technology leaders.

What is the timeline to apply and when would I receive funding?

• Open period: Continuously open through 31 July 2028.

• Two-step submission: Pre-proposal via eBRAP; if invited, submit the full application (generally within 60 days).

• Review & notice: Applicants should receive disposition within ~180 days of submission; awards may be made any time throughout the year and are contingent on funding and successful negotiations.

• Regulatory lead times: Allow 2–3 months for DoD human-subjects review (OHRO/HRPO) and 1–2 months for animal research review (VRO), as applicable.

Where does this funding come from?

Funding is provided by the Department of Defense (USSOCOM) and administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA); the program leverages CDMRP/eBRAP systems. Any funds received by USSOCOM appropriate to the BAA’s research areas may be used, up to a program total of $20M annually.

Who is eligible to apply?

Organizations only: national/international, for-profit, non-profit, public, and private. FFRDCs are not eligible for direct awards but may team under their sponsoring agreements. Eligible investigators are individuals employed by/affiliated with eligible organizations. No cost sharing is required.

What companies and projects are likely to win?

Winning projects consistently score high on USSOCOM’s evaluation factors, which include:

• Technical Merit and Scientific Rigor: The proposed approach must be well-founded, methodologically sound, and clearly linked to measurable outcomes.

• Innovation and Impact: Reviewers favor projects that introduce novel methods, materials, or technologies capable of significantly improving SOF medical or performance capabilities. Incremental improvements without clear operational relevance tend to score poorly.

• SOF Relevance: Proposals must explicitly tie their work to unique SOF operational needs—such as portability, durability, limited logistics support, or extreme-environment applicability.

• Feasible Study Design and Realistic Execution Plan: Reviewers expect achievable milestones, well-defined deliverables, and credible transition pathways for eventual use by operational forces or integration into DoD systems.

• Qualified Team and Institutional Capability: Teams with demonstrated expertise in biomedical R&D, human performance, or defense health technology—and with access to appropriate facilities and regulatory infrastructure—are prioritized.

• Appropriate and Realistic Budget: Budgets should align with the scope and complexity of work, typically falling between $2 million and $10 million total costs for projects up to five years in duration.

Companies that combine strong technical innovation, credible execution capability, and a direct line of sight to SOF mission impact are most likely to be selected for funding.

Are there any restrictions I should know about?

• Project length: Up to 5 years.

• Pre-proposal required; unsolicited full proposals without invitation are rejected.

• Clinical trials are typically not associated with this BAA.

• Human/animal research approvals required.

• Administrative pitfalls leading to rejection/withdrawal include: missing/over-limit narratives, missing budget, inclusion of URLs in prohibited sections, and inconsistencies between pre-proposal and full application.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive pre-proposal will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for the pre-proposal for $7000. Full proposal quoted upon invitation.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the Funding Announcement: HT9425-23-S-SOC1 BROAD AGENCY ANNOUNCEMENT (BAA) for Extramural Biomedical and Human Performance Research and Development Department of Defense

NIH STTR RFA-DA-25-047: Seeking Products to Address Social Needs Impacting Substance Use Disorders (SUD)

Executive Summary:

The National Institute on Drug Abuse (NIDA) is awarding up to $2.0 million per project for U.S. small businesses to develop technologies addressing social needs that impact substance use disorders (SUD), excluding alcohol use disorder. Applications are due March 13, 2026. Companies should start preparing at least 16 weeks prior to ensure registration and submission compliance. Partnership with a research organization is required.

How much funding would I receive?

$314,363 for Phase I projects (up to 6 months).

What could I use the funding for?

A variety of products addressing the individual-level factors of health-related social needs (HRSN) should be considered to confront SUD. Additionally, technology, such as telemedicine and mobile health applications, provide an opportunity to address HRSN with the ability to provide tested, accessible, and ongoing solutions for individuals who are the most at-risk for these risk factors that impact SUD. According to the Substance Abuse and Mental Health Services Administratio (SAMHSA), technology has several advantages in addressing SUD including decreased waiting periods, decreased stigma impact and increased privacy. The advantages of technology are also exhibited in its capability to make treatment services more accessible and convenient, which can aid to improve SUD outcomes and reduce disparities.

Regarding this NOFO, a product is any source of value for the end-users and customers. A product can be a physical/tangible device as well as digital services, software as a service, or non-physical/non-tangible products (including but not limited to digital applications, digital platforms, or service models). These and other comparable examples could be considered eligible products. Products can be the result of original scientific research, recycled existing technology for SUD, extension of an observation into SUD area, development of a new business model or distribution/delivery channel that reveals currently unseen value, or the delivery of a product or service to disregarded consumers.

The National Institute on Drug Abuse (NIDA) supports the development of evidence-based SUD care and treatment technology from multiple funding opportunities published elsewhere. The eligible small businesses can submit applications focusing on products that reduce costs, time, and/or increase access in addressing HRSN including, but not limited to, housing instability, non-medical transportation, food insecurity, utility needs, and personal safety. The products should provide the best feasible and accessible opportunities for the intended end-users to measurably improve their HRSN and SUD. Products of interest that address, but are not limited to, the following HRSN include:

• Access to housing services.

• Soft skills development and/or job training (e.g., in entrepreneurship, literacy, financial literacy, IT skills) for employment.

• Stigma and nurture compassion.

• Family healthy behaviors, social skills, community opportunities, and productive social involvement.

• Social stability (community, tradition, faith, family), self-regulation, and resilience.

• Well-being (mental, physical, spiritual), communal belonging, and positive productivity.

• Social support networks for recovery, engagement with care, and/or access to needed services.

• Successful community reintegration for formerly incarcerated people.

• Social needs service engagement and coordination among justice-involved organizations.

• Employer education to hire, retain, and facilitate treatment for employees seeking help for SUD.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed STTR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

• Next Application Deadlines: March 13, 2026

• Scientific Review: July following submission

• Council Review: October

• Earliest Start Date: December of the same year

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

• Must partner with a nonprofit research institution.

What companies and projects are likely to win?

Projects that demonstrate:

• Measurable improvement in one or more social determinants of health affecting SUD outcomes.

• Use technology (digital, AI-enabled, or connected health tools) to reduce costs, stigma, or access barriers.

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Align with NIDA’s goals to integrate behavioral health and social needs solutions into recovery ecosystems

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must partner with a research institution who performs a minimum of 30% and maximum of 60% of the work.

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for

• Phase I: $9,000 Flat Fee + a 5% Success Fee.

• Phase II: $13,000 Flat Fee + a 5% Success Fee.

• Fast-Track: $13,000 Flat Fee + a 5% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the RFA Here

ARPA-H Scalable Solutions Office (SSO) BAA

Executive Summary:

ARPA-H’s Scalable Solutions Office (SSO) has an open “Mission Office Innovative Solutions Opening (ISO)” to fund revolutionary solutions that expand access, affordability, manufacturing, and distribution of health technologies across the U.S. healthcare system. The ISO accepts Solution Summaries and, if encouraged, full proposals; it anticipates multiple awards made as Other Transactions (OTs). The solicitation is open now and remains open until March 5, 2029.

How much funding would I receive?

The solicitation does not specify dollar amounts or funding ceilings. Awards are made as Other Transaction (OT) agreements at the government’s discretion, with specific payment structures negotiated individually. As a rule of thumb, companies should request only what they need to reach a meaningful technical or commercialization milestone—a concrete point that clearly demonstrates feasibility, enables transition, or unlocks follow-on investment.

What could I use the funding for?

This ISO seeks solution summaries and proposals for projects that fall within the general scope of the ARPA-H Scalable Solutions Office (SSO). The SSO seeks to improve health care access and affordability through revolutionary technical innovations that address the challenges of geography, distribution, manufacturing, and data- and information management. Many communities and remote areas in the United States lack access to timely and quality health care, which leads to disparities in health outcomes for those populations. Bottlenecks during the manufacturing processes of products and health technologies also lead to delays and limited availability, preventing effective distribution of health care solutions to areas of need, especially in emergencies.

Funded SSO health innovation projects will improve the readiness of technologies and medical capabilities to be rapidly, broadly, and affordably adopted by patients, providers, and payers throughout the healthcare ecosystem and improve the patient experience. Manufacturing and supply chain focused SSO projects will lower the bar to entry for new developers, accelerate the rate of development, reduce development and product costs, and improve reliability and agility in manufacturing and product distribution.

Solutions should focus on rapid innovation and the use of partnerships, as well as flexible distribution networks and streamlined manufacturing processes. The following SSO interest areas categorize the ground-breaking solutions we seek to support:

• Health Technologies and Interventions:

  • Approaches to improve affordability and access to health care that are adaptable to various geographic, demographic, economic contexts and can be rapidly and broadly deployed (e.g., drug-repurposing, point-of-care diagnostics, and modular health care infrastructure).

  • Tailored solutions that provide the pediatric population parity with the adult population with respect to access to treatments and other health care interventions, and that adapt to the pediatric patient’s changing physiology and developmental status over the course of years.

  • Transformational approaches to reduce or eliminate health disparities, including leap-ahead technologies that scale novel approaches in human factors, and human-centered design to respond to full diversity of patients in varied geographic settings. Tools to enable expansion of capacities, capabilities, and reach of individual and institutional healthcare providers (e.g., school nurses and schools, walk-in clinics, homesteading care) to address unmet health care access needs and expand availability of critical services.

  • Foundational capabilities to accelerate diagnoses of rare diseases and reduce the cost and increase the availability rare disease treatments wherever patients are, without the need for specialized facilities or healthcare expertise.

  • Novel materials and technologies to not only return autonomy to limited mobility and/or home bound patients.

• Advanced Technologies for Medical Product and Capability Distribution:

  • Methods for standardization, automation, and broad distribution of complex procedures including, but not limited to, histopathology, rare disease diagnosis and treatment, and surgical interventions to ensure access and delivery to all populations.

  • Technical approaches to enhance delivery of effective healthcare solutions, to include dentistry, in rural or low resource settings, including but not limited to "last mile delivery”, at-home monitoring and diagnosis, imaging, drug delivery, telehealth augmentation, and support for remote medical procedures with limited need for specialized training.

  • Technologies to enable the deployment of critical healthcare resources rapidly and securely at scale to the point of need in permissive and non-permissive (i.e., damaged infrastructure, cyberdenied) environments during a public health crisis or natural disaster.

  • Innovative information technology, data and analytic products and technologies to enable ordering, inventory management, situational awareness, allocation planning and demand forecasting of critical healthcare resources during a public health crisis or natural disaster.

• Biomanufacturing Innovations:

  • Innovative manufacturing technologies

    • Approaches that reduce costs; improve access; expedite production timelines; and strengthen domestic competitiveness for biologics, pharmaceuticals, medical devices and personalprotective equipment (PPE). These innovations aim to mitigate supply chain risks through:

      • Novel solutions to minimize the reliance on cold chain management and specialized handling of pharmaceuticals and biologics.

      • Scalable solutions to strengthen biomanufacturing supplychains, resolve bottlenecks, and enable domestic production, such as:

        • Improved production of active pharmaceutical ingredients, process consumables, and other critical materials (e.g., enzymes, cell lines, etc.).

        • Data-driven models to optimize bioprocessing, enhance process control, and bolster supply chain visibility.

        • Development of alternative materials and innovative methods for PPE manufacturing.

        • Improvement of capabilities to sustainably re-shore manufacturing and utilize readily accessible, cost-efficient feedstocks to strengthen the local and national industry bases.

  • Predictable, programable biological production

    • Advanced analytical technologies designed to improve product knowledge, accelerate release, and/or significantly improve analytical figures of merit.

    • Novel sensor systems, process analytical technologies, and associated process models to precisely manage bioproduction management, including:

      • Process control and monitoring systems.

      • Real-time release assays for rapid product validation.

      • Predictive capabilities to inform process development and enable efficient and effective scale-up of manufacturing to industrial scale.

Are there any additional benefits I would receive?

Beyond the formal funding award, there are significant indirect benefits to receiving an ARPA-H Scalable Solutions Office (SSO) agreement:

• Government Validation and Credibility:
  Being selected by ARPA-H—the nation’s newest high-impact biomedical research agency—signals exceptional scientific credibility and alignment with the federal government’s most forward-leaning health innovation priorities. This “ARPA-H validation” often accelerates partnerships with major healthcare systems, research institutions, and investors who recognize the rigor and selectivity of government-vetted innovation.

• Enhanced Market Visibility and Notoriety:
  Award recipients are frequently featured in ARPA-H announcements, federal health innovation communications, and national press coverage. This visibility positions your company as a recognized leader in translational health technology and attracts new collaborators, talent, and private-sector investment.

• Ecosystem Access and Collaboration Opportunities:
  ARPA-H performers gain access to a broad innovation ecosystem spanning federal health agencies, academic research centers, and industry partners. These relationships foster collaboration, facilitate regulatory readiness, and open pathways to follow-on contracts, pilot deployments, and commercialization opportunities within the U.S. health system.

• Nondilutive Growth and Strategic Leverage:
  Because funding is nondilutive, companies can scale and validate core technologies without giving up equity. This validation and maturity achieved under government sponsorship often lead to higher valuations and greater leverage in future fundraising or acquisition discussions.

What is the timeline to apply and when would I receive funding?

Open period: now through March 5, 2029.

• Step 1 (required): Submit a Solution Summary via the ARPA-H Solution Submission Portal. ARPA-H strives to provide written feedback within 30 business days of submission.

• Step 2: If encouraged, you’ll generally have 45 calendar days from feedback to submit a full proposal (unless ARPA-H specifies otherwise).

• Review cadence: ARPA-H reviews proposals on a rolling basis and strives to issue a decision within 60 calendar days of receiving a full proposal.

• Award timing: After selection, final negotiations for an Other Transaction (OT) award are completed rapidly, and invoicing is handled through Payment Management Services.

Because of this streamlined process, most ARPA-H applicants move from initial Solution Summary to award decision in approximately 4–5 months—making ARPA-H one of the fastest federal funders for high-impact health innovation projects.

Where does this funding come from?

The Advanced Research Projects Agency for Health (ARPA-H), a federal R&D agency within HHS, issuing awards under the authority of 42 U.S.C. § 290c(g)(1)(D) via OT agreements.

Who is eligible to apply?

Academia, non-profit organizations, for-profit entities, hospitals, community health centers, and non-federal research centers. Non-U.S. entities may participate if compliant with all applicable laws.

What companies and projects are likely to win?

Reviewers assess (in descending importance):

1. Scientific/technical merit—innovative, complete plans with clear deliverables, risks, and mitigations;

2. Contribution & relevance to ARPA-H’s mission—transformative potential, unmet need, commercialization/transition thinking, and IP/software approaches that enable adoption (preference for open standards/OSS where appropriate);

3. Team capabilities/experience—track record delivering similar efforts on budget/schedule;

4. Cost/budget alignment with the technical approach. ARPA-H encourages proposing the best technical solution over low-risk/minimal-uncertainty concepts.

Are there any restrictions I should know about?

• Standards & IP: strong preference for open, consensus-based standards (e.g., FHIR/TEFCA, DICOM) and commercial-friendly open-source licenses when feasible; proposals must justify any deviations/standard extensions and may need a pre-submission meeting for exceptions. Provide good-faith IP rights representations; pre-publication review may be required when sensitive info could be disclosed.

• Compliance: Human Subjects (IRB), Animal Subjects (IACUC), NIH Genomic Data Sharing (if applicable), CUI handling, research security disclosures (including CHIPS/NPSM-33 requirements), and OCI disclosures/mitigation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive full proposal under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

ARPA-H Resilient Systems Office (RSO) BAA

Executive Summary:

ARPA-H’s Resilient Systems Office (RSO) is accepting innovative Solution Summaries and full proposals—on a rolling basis—aimed at strengthening the adaptability, reliability, and interoperability of the U.S. health ecosystem. Multiple awards are anticipated under flexible Other Transaction (OT) agreements. The ISO is open now and remains open until March 5, 2029.

How much funding would I receive?

The solicitation does not specify dollar amounts or funding ceilings. Awards are made as Other Transaction (OT) agreements at the government’s discretion, with specific payment structures negotiated individually. As a rule of thumb, companies should request only what they need to reach a meaningful technical or commercialization milestone—a concrete point that clearly demonstrates feasibility, enables transition, or unlocks follow-on investment.

What could I use the funding for?

The Resilient Systems Office (RSO), one of ARPA-H’s mission offices, seeks project proposals that drive innovations to enhance the adaptability, reliability, and interoperability of the health ecosystem. Submissions should aim for groundbreaking ideas that solve systemic challenges across the health landscape, leveraging cutting-edge technologies that address long-standing gaps in the quality, consistency, personalization, and efficacy of care.

RSO is interested in innovations that take a systems level approach in areas including, but not limited to, systems biology, data systems, biophysical systems, health IT systems, sociotechnical systems, health-related systems engineering, and other systems with the potential to improve health outcomes. While RSO welcomes “out of the box” ideas to address the above gaps, the mission office encourages proposals that address the following areas:

• Fortifying systems to improve robustness:

  Novel system designs and modular capabilities that extend the shelf-life of systems, ensuring peak performance across a broad range of healthcare environments and use cases. Applications of interest include, but are not limited to, the adaptability and robustness of biological systems; digital platforms for secure and efficient management of information; and socio-technical systems to maintain access to care and critical information.

• Removing barriers to enhance system efficiency and efficacy:

  Approaches that provide paradigm shifts in system dynamics to improve health outcomes. This includes improvements to system interoperability, process, and transparency; foundational capabilities to enable integration of emerging technology solutions; overcoming systemic barriers driven by misaligned incentives; user-centric tools that improve patient care coordination and user experience; and clinical and research solutions to boost efficiency, reduce cognitive load, and accelerate scientific discovery and its application.

• Early detection and interventions to mitigate disruptions to the healthcare ecosystem:

  Agile interventions to reduce the impact of disruptions and enhance readiness to manage and recover from large-scale health events. This spans the entire health system, including supply chains, manufacturing, and logistics.

Are there any additional benefits I would receive?

Beyond the formal funding award, there are significant indirect benefits to receiving an ARPA-H Resilient Systems Office (RSO) agreement:

• Government Validation and Credibility:
  Being selected by ARPA-H—the nation’s newest high-impact biomedical research agency—signals exceptional scientific credibility and alignment with the federal government’s most forward-leaning health innovation priorities. This “ARPA-H validation” often accelerates partnerships with major healthcare systems, research institutions, and investors who recognize the rigor and selectivity of government-vetted innovation.

• Enhanced Market Visibility and Notoriety:
  Award recipients are frequently featured in ARPA-H announcements, federal health innovation communications, and national press coverage. This visibility positions your company as a recognized leader in translational health technology and attracts new collaborators, talent, and private-sector investment.

• Ecosystem Access and Collaboration Opportunities:
  ARPA-H performers gain access to a broad innovation ecosystem spanning federal health agencies, academic research centers, and industry partners. These relationships foster collaboration, facilitate regulatory readiness, and open pathways to follow-on contracts, pilot deployments, and commercialization opportunities within the U.S. health system.

• Nondilutive Growth and Strategic Leverage:
  Because funding is nondilutive, companies can scale and validate core technologies without giving up equity. This validation and maturity achieved under government sponsorship often lead to higher valuations and greater leverage in future fundraising or acquisition discussions.

What is the timeline to apply and when would I receive funding?

Open period: now through March 5, 2029.

• Step 1 (required): Submit a Solution Summary via the ARPA-H Solution Submission Portal. ARPA-H strives to provide written feedback within 30 business days of submission.

• Step 2: If encouraged, you’ll generally have 45 calendar days from feedback to submit a full proposal (unless ARPA-H specifies otherwise).

• Review cadence: ARPA-H reviews proposals on a rolling basis and strives to issue a decision within 60 calendar days of receiving a full proposal.

• Award timing: After selection, final negotiations for an Other Transaction (OT) award are completed rapidly, and invoicing is handled through Payment Management Services.

Because of this streamlined process, most ARPA-H applicants move from initial Solution Summary to award decision in approximately 4–5 months—making ARPA-H one of the fastest federal funders for high-impact health innovation projects.

Where does this funding come from?

The Advanced Research Projects Agency for Health (ARPA-H), a federal R&D agency within HHS, issuing awards under the authority of 42 U.S.C. § 290c(g)(1)(D) via OT agreements.

Who is eligible to apply?

Academia, non-profit organizations, for-profit entities, hospitals, community health centers, and non-federal research centers. Non-U.S. entities may participate if compliant with all applicable laws.

What companies and projects are likely to win?

Reviewers assess (in descending importance):

1. Scientific/technical merit—innovative, complete plans with clear deliverables, risks, and mitigations;

2. Contribution & relevance to ARPA-H’s mission—transformative potential, unmet need, commercialization/transition thinking, and IP/software approaches that enable adoption (preference for open standards/OSS where appropriate);

3. Team capabilities/experience—track record delivering similar efforts on budget/schedule;

4. Cost/budget alignment with the technical approach. ARPA-H encourages proposing the best technical solution over low-risk/minimal-uncertainty concepts.

Are there any restrictions I should know about?

• Standards & IP: strong preference for open, consensus-based standards (e.g., FHIR/TEFCA, DICOM) and commercial-friendly open-source licenses when feasible; proposals must justify any deviations/standard extensions and may need a pre-submission meeting for exceptions. Provide good-faith IP rights representations; pre-publication review may be required when sensitive info could be disclosed.

• Compliance: Human Subjects (IRB), Animal Subjects (IACUC), NIH Genomic Data Sharing (if applicable), CUI handling, research security disclosures (including CHIPS/NPSM-33 requirements), and OCI disclosures/mitigation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive full proposal under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

ARPA-H Proactive Health Office (PHO) BAA

Executive Summary:

ARPA-H’s Proactive Health Office (PHO) has an open Innovative Solutions Opening (ISO) to fund high-impact R&D that improves health span and health outcomes before disease onset. The ISO accepts Solution Summaries now through March 5, 2029, with multiple awards anticipated under Other Transactions (OTs). Eligible proposers include for-profit companies, non-profits, and academia. Solutions must be novel (not incremental) and align with PHO interests in prevention, early detection, behavior change, and system-level innovations.

How much funding would I receive?

The solicitation does not specify dollar amounts or funding ceilings. Awards are made as Other Transaction (OT) agreements at the government’s discretion, with specific payment structures negotiated individually. As a rule of thumb, companies should request only what they need to reach a meaningful technical or commercialization milestone—a concrete point that clearly demonstrates feasibility, enables transition, or unlocks follow-on investment.

What could I use the funding for?

The Proactive Health Office (PHO), one of ARPA-H’s mission offices, is seeking solutions to improve the health spans and health outcomes of Americans prior to the onset of disease and/or the development of diminished quality of life from illness. Specifically, PHO hypothesizes that: 1) the development of novel early detection methods and prophylactic interventions could drastically improve the health of American throughout their lives; 2) population-level improvements in access to and uptake of disease increase prevention- and wellness-promoting behaviors; and 3) system-level innovations are required to deliver proactive health measures effectively.

Specific PHO interest areas include:

• Novel prevention, detection, and prophylactic treatment methods for disease, including:

  i. Prophylactic approaches to prevention of diseases and harmfuldisease outcomes.

  ii. Methods for continuous and widespread sensing of health-state, and early disease indicators that can be deployed at population-scales.

  iii. Novel and scalable methods for early detection of disease and illness that include the use of low/no-cost sensing modalities.

• Population-level approaches to increase the adoption of prevention- and wellness behaviors:

  i. Methods to inform and educate individuals about healthy behaviors, including lifestyle and preventative medical measures.

  ii. Methods that incentivize individuals to adopt and maintain healthy behaviors.

  iii. Novel approaches to increasing individual health spans and independence even in the absence of disease.

  iv. Early indicators of both disease- and pre-disease states, and measures associated with proactive health outcomes that are both inexpensive and effective. Low-cost, high-uptake mental health resiliency and mindfulness-building methods for individuals.

• System innovation for the delivery of proactive health outcomes:

  i. Novel, robust, and predictive surrogates for long-term health outcomes with associated epidemiological models.

  ii. Valuation models for long-term treatment effects for vaccination, screening, and other public health interventions.

  iii. New funding and delivery models for preventative interventions.

• Other Topics

  High-quality submissions that propose revolutionary technologies that meet the goals of PHO will be considered even if they do not address the areas of interest listed above.

Are there any additional benefits I would receive?

Beyond the formal funding award, there are significant indirect benefits to receiving an ARPA-H Proactive Health Office (PHO) agreement:

• Government Validation and Credibility:
  Being selected by ARPA-H—the nation’s newest high-impact biomedical research agency—signals exceptional scientific credibility and alignment with the federal government’s most forward-leaning health innovation priorities. This “ARPA-H validation” often accelerates partnerships with major healthcare systems, research institutions, and investors who recognize the rigor and selectivity of government-vetted innovation.

• Enhanced Market Visibility and Notoriety:
  Award recipients are frequently featured in ARPA-H announcements, federal health innovation communications, and national press coverage. This visibility positions your company as a recognized leader in translational health technology and attracts new collaborators, talent, and private-sector investment.

• Ecosystem Access and Collaboration Opportunities:
  ARPA-H performers gain access to a broad innovation ecosystem spanning federal health agencies, academic research centers, and industry partners. These relationships foster collaboration, facilitate regulatory readiness, and open pathways to follow-on contracts, pilot deployments, and commercialization opportunities within the U.S. health system.

• Nondilutive Growth and Strategic Leverage:
  Because funding is nondilutive, companies can scale and validate core technologies without giving up equity. This validation and maturity achieved under government sponsorship often lead to higher valuations and greater leverage in future fundraising or acquisition discussions.

What is the timeline to apply and when would I receive funding?

Open period: now through March 5, 2029.

• Step 1 (required): Submit a Solution Summary via the ARPA-H Solution Submission Portal. ARPA-H strives to provide written feedback within 30 business days of submission.

• Step 2: If encouraged, you’ll generally have 45 calendar days from feedback to submit a full proposal (unless ARPA-H specifies otherwise).

• Review cadence: ARPA-H reviews proposals on a rolling basis and strives to issue a decision within 60 calendar days of receiving a full proposal.

• Award timing: After selection, final negotiations for an Other Transaction (OT) award are completed rapidly, and invoicing is handled through Payment Management Services.

Because of this streamlined process, most ARPA-H applicants move from initial Solution Summary to award decision in approximately 4–5 months—making ARPA-H one of the fastest federal funders for high-impact health innovation projects.

Where does this funding come from?

The Advanced Research Projects Agency for Health (ARPA-H), a federal R&D agency within HHS, issuing awards under the authority of 42 U.S.C. § 290c(g)(1)(D) via OT agreements.

Who is eligible to apply?

Academia, non-profit organizations, for-profit entities, hospitals, community health centers, and non-federal research centers. Non-U.S. entities may participate if compliant with all applicable laws.

What companies and projects are likely to win?

Reviewers assess (in descending importance):

1. Scientific/technical merit—innovative, complete plans with clear deliverables, risks, and mitigations;

2. Contribution & relevance to ARPA-H’s mission—transformative potential, unmet need, commercialization/transition thinking, and IP/software approaches that enable adoption (preference for open standards/OSS where appropriate);

3. Team capabilities/experience—track record delivering similar efforts on budget/schedule;

4. Cost/budget alignment with the technical approach. ARPA-H encourages proposing the best technical solution over low-risk/minimal-uncertainty concepts.

Are there any restrictions I should know about?

• Standards & IP: strong preference for open, consensus-based standards (e.g., FHIR/TEFCA, DICOM) and commercial-friendly open-source licenses when feasible; proposals must justify any deviations/standard extensions and may need a pre-submission meeting for exceptions. Provide good-faith IP rights representations; pre-publication review may be required when sensitive info could be disclosed.

• Compliance: Human Subjects (IRB), Animal Subjects (IACUC), NIH Genomic Data Sharing (if applicable), CUI handling, research security disclosures (including CHIPS/NPSM-33 requirements), and OCI disclosures/mitigation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive full proposal under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

ARPA-H Health Science Futures (HSF) Mission Office BAA

Executive Summary:

The ARPA-H Health Science Futures (HSF) Mission Office is accepting Solution Summaries and full proposals for revolutionary health R&D under its Innovative Solutions Opening (ISO), ARPA-H-SOL-24-104. Multiple awards are anticipated via Other Transaction (OT) agreements. The ISO remains open through March 5, 2029, and you must submit a short Solution Summary and receive written feedback before a full proposal. Submissions must align with HSF focus areas (e.g., breakthrough technologies, transformative tools, and adaptable platform systems) and are expected to be high-risk, high-impact—incremental or clinical-trial-stage efforts are out of scope.

How much funding would I receive?

The solicitation does not specify dollar amounts or funding ceilings. Awards are made as Other Transaction (OT) agreements at the government’s discretion, with specific payment structures negotiated individually. As a rule of thumb, companies should request only what they need to reach a meaningful technical or commercialization milestone—a concrete point that clearly demonstrates feasibility, enables transition, or unlocks follow-on investment.

What could I use the funding for?

This ISO seeks solution summaries and proposal submissions for projects that fall within the general scope of the ARPA-H Health Science Futures (HSF) mission office. The HSF mission office expands what is technically possible by developing approaches that will remove the scientific and technological limitations that stymie progress towards the healthcare of the future. The HSF mission office
supports cutting-edge, often disease-agnostic research programs that have the potential for translational real-world change. Specifically excluded from consideration are proposals that represent an evolutionary or incremental advance in the current state of the art, or technology that has reached the clinical trial stage. An example of this type of proposal might include the request to fund clinical trials of an otherwise developed product. Additionally, proposals directed toward policy changes; traditional education and training; center coordination, formation, or development; and construction of physical infrastructure are outside the scope of the ARPA-H mission.

The following areas define the ground-breaking research that HSF seeks to support:

• Breakthrough Technologies

  Paradigm shifting technologies that will change how we approach the diagnosis, treatment, and impact of diseases and conditions.

  • Novel approaches to improve maternal and fetal medicine, decrease maternal morbidity and mortality during birth, and the post-partum period. Efforts should include new technology to monitor, detect, and/or treat maternal and/or fetal complications with less invasive and traumatic methods.

  • Foundational advances in genetic, epigenetic, cellular, tissue, and organ replacement therapies that enable personalized medical interventions at scale in a manner that is accessible, cost-effective, and designed to impact the communities of greatest need.

  • Interventions that target and reverse disease pathogenesis and/or enhance plasticity to address diseases of the nervous, neuromuscular, skeletal, lymphatic, cardiovascular, and other organ systems.

  • Novel approaches to definitively diagnose and cure chronic diseases including, but not limited to, diabetes, autoimmune diseases, neurodegenerative disorders (Alzheimer’s disease, Parkinson’s disease, ALS, etc.), and cancer.

  • Technologies that expand the precision, scale, and accessibility of brain circuit mapping technologies that enable causative neuropsychiatric links to mental health disorders leading to definitive diagnosis and reliable therapeutic monitoring.

• Transformative Tools

  Novel, agile solutions that will move from bench to bedside quickly, facilitating revolutionary advances in medical care.

  • Development of tools that counter idiosyncratic, off-target, or chronic effects of medicines that are commonly used or that are being used experimentally to treat or prevent disease.

  • Development of bionic or biohybrid devices that enable direct integration and communication with the body to activate restorative pathways that restore lost senses, physical abilities, immune functions, and other organ functions.

  • Site-selective neuromodulation to regulate specific physiological functions and treat chronic health conditions such as inflammation, pain, and metabolic or endocrine disorders.

  • Synthetic biology approaches incorporating novel logic mechanisms, disease targeting and response methods, and robust control strategies to diagnose, and/or cure a multitude of diseases.

  • Imaging or other technologies engineered from discoveries at the forefront of physics and/or chemistry that reduce cost, improve size and/or portability, increase availability, expand capability, improve resolution, reduce exposure to radiation, and accommodate pediatric patient populations.

  • Integrated sensing and therapy delivery devices for addressing chronic health conditions, including mental health conditions or substance use disorders.

• Platform Systems

  Adaptable, multi-application systems and technologies that are reconfigurable for a wide variety of clinical needs.

  • Novel molecular platforms to target and cure diseases, including the modulation of physiological systems, delivery to targets with spatial and temporal precision, and mitigation of off-target effects to accelerate interventions that dramatically improve health outcomes.

  • New approaches to accelerate and routinize mammalian and microbial cellular engineering to enable next generation therapeutic applications, develop multiscale interventions, and automate hypothesis generation and discovery to expand those applications to disease states in which cellular therapies have not traditionally been employed.

  • Innovative approaches at the intersection of artificial intelligence, high performance computing (including quantum computing) and biological systems, including enabling de novo design of biomolecules with entirely new phenotypes.

  • Revolutionary omics platforms that enable unprecedented spatial and temporal scales and resolution of physiological and disease mechanisms.

• Other Technologies

  Other high-quality submissions that propose revolutionary technologies that meet the goals of HSF will be considered even if they do not address the other listed topics.

  Proposals in response to this Innovative Solutions Opening (ISO) are expected to identify innovative approaches to enable revolutionary advances in medicine and healthcare and the science and technologies underlying these areas. While approaches that are disease agnostic are encouraged, ARPA-H welcomes proposals that offer radically new insights to address specific health conditions, including (but not limited to) cancer, cardiovascular, diabetes, infectious and neurological diseases, and pediatric and maternal/fetal health.

Are there any additional benefits I would receive?

Beyond the formal funding award, there are significant indirect benefits to receiving an ARPA-H Health Science Futures (HSF) agreement:

• Government Validation and Credibility:
  Being selected by ARPA-H—the nation’s newest high-impact biomedical research agency—signals exceptional scientific credibility and alignment with the federal government’s most forward-leaning health innovation priorities. This “ARPA-H validation” often accelerates partnerships with major healthcare systems, research institutions, and investors who recognize the rigor and selectivity of government-vetted innovation.

• Enhanced Market Visibility and Notoriety:
  Award recipients are frequently featured in ARPA-H announcements, federal health innovation communications, and national press coverage. This visibility positions your company as a recognized leader in translational health technology and attracts new collaborators, talent, and private-sector investment.

• Ecosystem Access and Collaboration Opportunities:
  ARPA-H performers gain access to a broad innovation ecosystem spanning federal health agencies, academic research centers, and industry partners. These relationships foster collaboration, facilitate regulatory readiness, and open pathways to follow-on contracts, pilot deployments, and commercialization opportunities within the U.S. health system.

• Nondilutive Growth and Strategic Leverage:
  Because funding is nondilutive, companies can scale and validate core technologies without giving up equity. This validation and maturity achieved under government sponsorship often lead to higher valuations and greater leverage in future fundraising or acquisition discussions.

What is the timeline to apply and when would I receive funding?

Open period: now through March 5, 2029.

• Step 1 (required): Submit a Solution Summary via the ARPA-H Solution Submission Portal. ARPA-H strives to provide written feedback within 30 business days of submission.

• Step 2: If encouraged, you’ll generally have 45 calendar days from feedback to submit a full proposal (unless ARPA-H specifies otherwise).

• Review cadence: ARPA-H reviews proposals on a rolling basis and strives to issue a decision within 60 calendar days of receiving a full proposal.

• Award timing: After selection, final negotiations for an Other Transaction (OT) award are completed rapidly, and invoicing is handled through Payment Management Services.

Because of this streamlined process, most ARPA-H applicants move from initial Solution Summary to award decision in approximately 4–5 months—making ARPA-H one of the fastest federal funders for high-impact health innovation projects.

Where does this funding come from?

The Advanced Research Projects Agency for Health (ARPA-H), a federal R&D agency within HHS, issuing awards under the authority of 42 U.S.C. § 290c(g)(1)(D) via OT agreements.

Who is eligible to apply?

Academia, non-profit organizations, for-profit entities, hospitals, community health centers, and non-federal research centers. Non-U.S. entities may participate if compliant with all applicable laws.

What companies and projects are likely to win?

Reviewers assess (in descending importance):

1. Scientific/technical merit—innovative, complete plans with clear deliverables, risks, and mitigations;

2. Contribution & relevance to ARPA-H’s mission—transformative potential, unmet need, commercialization/transition thinking, and IP/software approaches that enable adoption (preference for open standards/OSS where appropriate);

3. Team capabilities/experience—track record delivering similar efforts on budget/schedule;

4. Cost/budget alignment with the technical approach. ARPA-H encourages proposing the best technical solution over low-risk/minimal-uncertainty concepts.

Are there any restrictions I should know about?

• Standards & IP: strong preference for open, consensus-based standards (e.g., FHIR/TEFCA, DICOM) and commercial-friendly open-source licenses when feasible; proposals must justify any deviations/standard extensions and may need a pre-submission meeting for exceptions. Provide good-faith IP rights representations; pre-publication review may be required when sensitive info could be disclosed.

• Compliance: Human Subjects (IRB), Animal Subjects (IACUC), NIH Genomic Data Sharing (if applicable), CUI handling, research security disclosures (including CHIPS/NPSM-33 requirements), and OCI disclosures/mitigation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive full proposal under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $4,000 to submit a solution summary.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Continuing Enabling, Enhancing, Restoring and Sustaining (CHEERS) Multiple Authority Announcement (MAA)

Executive Summary:

The Air Force Research Laboratory’s Human Effectiveness Directorate (AFRL/RH) and the U.S. Air Force School of Aerospace Medicine (USAFSAM) are awarding up to $1 billion in total funding under the CHEERS Multiple Authority Announcement (MAA) to support U.S. companies, universities, and research partners advancing technologies that enhance human performance, resilience, and health in aerospace and defense environments.

White papers are accepted through September 30, 2027, and proposal invitations are issued on a rolling basis. Companies should submit white papers as soon as possible in order to have the highest likelihood of funding.

How much funding would I receive?

Funding is project-dependent and determined by the technical approach propose. Typical awards will range from $300,000 to $5,000,000.

What could I use the funding for?

Funding can used for the full range of R&D activities from basic and applied R&D to prototype and experimental testing. See a list of focus areas below:

• Airman Systems Directorate (RH)

  Activities within the 711HPW are organized into research areas which are categorized based on the technology readiness level (TRL). Product lines focus on advanced technology development and identifying paths for technology transition while the CTC’s and CRA’s focus on basic research through early applied research. Each division further breaks down the research into Lines of Effort (LoE) or Product Area (PA) for each CTC or PL, respectively. Descriptors of PL, CTC and CRA are provided below:

  • Product Line (PL): An organizational construct within the Airman Systems Directorate for engineering and transition of technology to the Department of the Air Force and Department of Defense. A Product Line organizes and manages inter-related technology demonstrations and transition paths for Airman Systems Directorate technologies at late applied and advanced technology development stages. The product line may integrate research and engineering tasks across several CTCs within AFRL.

  • Core Technical Competency (CTC): CTCs represent the technical foundation that is difficult to duplicate and allows AFRL to provide unique technical leadership. They span basic research, applied research, and advanced technology development encompassing the people, information, facilities, equipment, and programs allowing AFRL to solve critical AF and national security problems.

  • Core Research Area (CRA): A subset of the Core Technical Competencies within the Airman Systems Directorate. CRAs represent a focused group of basic and early applied research, focused on investigating revolutionary, higher risk concepts. The CRAs mature new foundational technologies and transition promising research to product lines of the organization.

  Airman Biosciences (RHB)

  • Aerospace & Operational Medicine PL1: Matures and transitions aeromedical knowledge, technology, and materiel solutions in force health protection, human health and performance, and aeromedical evacuation & enroute care in order to enable, sustain, enhance, and restore operational and aeromedical health and human performance for Airmen executing Air Force missions across all operational domains. Objectives focus on generating high performance Airmen and Guardians through medical availability, enhancing joint combatant commander capabilities, and maximizing human capital and strategic resources by aligning resources to strategic and workforce development. The goal is to transition products that address validated AF/AFMS requirements by focusing on stakeholder engagement to ensure clear demand signals and to create and maintain extensive partnership network to ensure rapid execution and flexibility.

    • Air & Space Austere Environment Patient Transport (En Route Care) PA1: Advances combat casualty care in the air through biomedical research into interventional strategies and technologies that mitigate the risks for additional insult due to aeromedical evacuation. Transitions promising Science and Technology (S&T) into knowledge and material products that promote the recovery and return to duty of injured or ill service members, from point of injury back to definitive care. Research within this program includes but is not limited to ground medical operations in agile combat employment, autonomous care of patient movement, and optimization of patient movement.

    • Air & Space Force Health Protection (FHP) PA2: Medical development and biomedical technology investments seek to deliver an improved FHP capability across the full spectrum of operations with research that prevents injury/ illness through improved identification and control of health risks. Under FHP, subproject areas include Occupational Hazard Exposure (Includes Flight Hazards and Integrated Risk), Targeted Risk Identification, Mitigation and Treatment (Formerly Pathogen ID and Novel Therapeutics and includes Big Data), FHP Technologies Development and Assessment (Assay and disease detection), and Health Surveillance, Infection, Injury & Immunity. FHP also includes Innovations and Personalized Medicine. Operational medicine is focused on in garrison care – our next most critical issue post OIF/OEF – and how to care for the whole patient and consideration of comorbidities in treatment of wounded warriors and dependents.

  • Biotechnology for Performance, Research, and Demonstration PL2: Develops and delivers capabilities to enhance human performance in near-peer conflict. Objectives focus on modular systems that integrate with warfighting platforms and maintaining and enhancing end-user engagement to ensure relevance and realism all while working in close sync with DoD and external partners to deliver high value solutions. The goal is to build momentum for Wearable technology, continue to develop and advocate for human assessment & tracking, strategically plan for product usage in austere environments, and expand on current platform products to develop and connect capabilities with operational challenges.

    • Airman Sensing & Assessment PA1: Develop and demonstrate advanced prototype products that integrate physiological, cognitive, behavioral, and environmental sensing capabilities with validated analytics, assessments, and intervention capabilities to sustain and enhance air and space operator performance.

    • Human Performance Augmentation & Development PA2: Develop and deliver capabilities to enhance human performance in near-peer conflict by focusing on modular systems that integrate with warfighting platforms. Working in close sync with DoD and external partners to deliver high value solutions to maintain and enhance end-user engagement to ensure relevance and realism.

    • Air & Space Physiology, Medicine, and Human Performance (HP) PA3: Enables, sustains, and optimizes performance of Airmen through elevation and alleviation of health effects associated with AF operational missions. Addresses operational environments such as the mitigation of stress in AF personnel, to include aircrew, care providers, aircraft maintainers, intelligence, surveillance and cyber operators, as well as remote piloted aircraft operators. Research within this project includes but is not limited to airman performance and readiness, advancing air and space medicine, and medical operator performance digital engineering. Advanced technology development to enable, sustain, and optimize cognitive, behavior and physiologic performance in highpriority career fields for the United States Air Force (USAF) and in multidomain operations. The sub-project areas include cognitive and physiologic performance under operational and environmental stressors, detection and improvement of physiological performance, and safety via sensor systems and targeted conditioning, which includes training techniques for optimal performance. This project also develops and demonstrates technologies which ingest health status monitoring data to provide scalable situational awareness of individual, unit, and group medical readiness in support of command and control and develops strategies to mitigate performance limitations through physical, pharmacological/non-pharmacological, or behavioral medical interventions and/or technological augmentation.

  • Medical and Operational Biosciences CTC1: Develops, validates, and enhances medical and operational biosciences and emergent biotechnologies for transition into advanced development products in the Air and Space operational environment to lead to a highly resilient and medically ready force. These products can sense, assess, sustain, and segment warfighter physiological-cognitive performance in multi-domain operations. Deliverables will be enhancing and researching new technologies and concepts to sustain, augment, and restore the multi-domain Airman & Guardian Health and Performance. Customers, end-users, and stakeholders include the DHP and DAF 6.3 programs and product lines: Human Performance/Medical Readiness, Force Health Protection, and En Route Care as some of the primary users.

    • Biotechnology for Health and Performance CRA1: The Biotechnology for Health and Performance CRA utilizes multivariant, systems biology approaches to provide advanced science and technology solutions to understand the warfighter’s biologic state and the underlying mechanism of responses with the goal of enabling, enhancing, and sustaining the human's ability to dominate air, space and cyberspace.

    • Applied Cognitive Neurosciences CRA2: Develops and validates technologies in cognitive neuroscience and physical performance to sustain, augment, and recover operator performance and determine medical attributes/metrics for optimal career field alignment.

    • Health and Performance Sensing and Assessment CRA3: Develops sensing technologies in a variety of form factors to identify, validate and monitor human signatures related to Airmen's and Guardians’ health, exposures and physical/cognitive performance in their associated environments. The research from this CRA will develop sensing solutions optimized for real-time, noninvasive and autonomous sensing and assessing capabilities to enhance and protect Airmen and Guardians in a variety of operational environments.

    • Biomedical Impact of Air and Space CRA4: Conducts research investigating Airman and Guardian performance degradation resulting from exposure to air and space environments and seek understanding the fundamental mechanisms driving environmental and operational risks. Develop technologies to mitigate or eliminate the root physiologic causes of these degradations and to ultimately optimize Airman and Guardian performance resulting in the capability to fly faster, higher, and longer than our adversaries.

  Bioeffects (RHD)

  • Bioeffects PL: Creates and demonstrates developmental technology & tools to generate products/applications. These products provide optimized design requirements for weapon systems & personal protection device developers, risk and collateral hazard assessments for directed energy systems, and analysis libraries for the representation of humans as part of model-based systems engineering approaches and within engineering-level models of system performance, informing overall system performance impacts and adding fidelity to concepts in wargames. Approaches include the integration of components in engagement and mission-level simulation tools within USAF and DoD software architectures, and model-based systems engineering artifacts to enable future integration and technology transition. Key technologies include directed energy bioeffects systems characterization and risk assessment, directed energy bioeffects components of modeling and simulation tools, and human representation in digital engineering.

  • Bioeffects CTC1: The Bioeffects CTC will conduct research to enable the maximum safe exploitation of the electromagnetic spectrum for nation defense by protecting personnel & communities and assessing weapons applications. CTC research will focus on characterizing fundamental bioeffects, optimizing the safety/effectiveness of directed Energy systems, developing/assessing dosimetry tools, modeling & simulation of products/applications, protecting device development and providing science-based information to national & international safety standards.

    • Directed Energy Bioeffects Modeling, Simulation, & Analysis CRA1: The directed energy bioeffects modeling, simulation, & analysis core research area emphasizes research that focuses on new modeling, simulation, and analysis techniques which represent and optimize concepts of directed energy systems employment from the bioeffect standpoint, develops capabilities for studies and means of measuring of effectiveness and suitability for directed energy systems to include direct, scalable, and collateral effects. Research areas include highperformance/ high-fidelity multi-physics simulations, advanced electromagnetic dosimetry models, mechanistic theories & models of injury, thermal/thermoregulatory response models, physics-to-physiology color vision theory, component models of human response to directed energy, statistical approaches for risk assessment, near-real-time numerical approaches and surrogating complexity through machine learning.

      • Directed Energy Bioeffects Modeling Simulation & Analysis LOE1: Develop and mature physics & engineering-level models for directed energy dosimetry & the resulting biological effects; create algorithms encapsulating empirical datasets & physics-level models of directed energy dose response; supports directed energy modernization campaign and enables the Directed Energy Weapons Review and Approval (DEWRAP) process.

      • Directed Energy Bioeffects Dosimetry LOE3: Develop novel dosimetry to better understand directed energy interactions and injury to inform software approaches enabling simulation of dynamic scenarios; supports directed energy modernization.

    • Directed Energy Bioeffects & Mechanisms CRA2: The directed energy bioeffects & mechanisms CRA provides fundamental knowledge of mechanisms of interaction of directed energy with molecules, cells, tissues, and organs in support of military directed energy systems and enables future weapon systems with scalable, disruptive, and ultra-precise effects. Research areas include: discovery science for understanding mechanisms, neurobiological & behavioral response to directed energy, hardening of biological targets to directed energy, mechanistic response of human vision to directed energy, epigenetic response to directed energy exposure, membrane and ion channel response to rapid onset exposures, supra-threshold response – severity of effects, and human factors in technologies for protection.

      • Research in Directed Energy Multi-Interaction Systems LOE2: Develop and deliver an integrated modeling environment and studies to address critical national defense interests & prevent technological surprises. Study radio frequency, combined or synergistic responses, and their interaction with biology.

      • Directed Energy Hazard & Protection Assessment LOE4: Feedback & expertise for DoD to optimize safety/performance trades for directed energy systems; evaluation of dose-response of directed energy exposures to achieve specific endpoint; understand human vision response to optical radiation and related protective devices; elucidate margin of effectiveness and safety to meet DoD mission success. Assure no technology surprise.

      • Directed Energy Weapon Effects LOE5: Feedback & expertise for DoD to optimize safety/performance trades for directed energy systems & provide scientific basis for risk criteria definitions; Allows directed energy weapon modernization & enables review and approval processes for weapons systems.

  Warfighter Interactions & Readiness (RHW)

  • Airman-Machine Integration PL1: Delivers advanced, situationally-adaptive and scalable interface technologies and decision aiding tools. S&T is focused on ABMS compliant, intuitive user interfaces, and intelligent aided decision support to provide rapid, accurate battlefield awareness, maximized distributed human-machine team performance and decision superiority. Operator-centric interfaces increase human combat capabilities while managing human cognitive workload in complex, degraded environments. Key technologies include human-autonomy collaboration and trust in autonomy, development of successful distributed, heterogeneous teams with metrics of team performance, exploitation of human perception and enhancement of operational communication. These efforts address the critical needs for ABMS and JADC2 with optimal human-machine teams ready to operate.

  • Readiness PL2: Develops and extends technologies and tools for improving the cognitive effectiveness, performance and proficiency of airmen in current and potential future operational mission contexts. Aims to deliver operationally relevant, unobtrusive, integrated metrics, software, & hardware to assess proficiency & readiness in real-time. Develops methodologies to create models & algorithms for performance prediction, training support, & automated instruction. Key technologies include the ability to support multi-capable airmen resilience and mission performance in austere deployed contexts and develop standards for sharable scenario content, data, models, & metrics.

  • Analytics PL3: Identifies & matures software that streamlines workflow & enables cognition at the scale of war, enabling airmen effectiveness in the air, space, & cyberspace domains for effective C2ISR in Multi-Domain Operations. Develops analytic tools that optimize human cognition with the power of machine computation, thereby enabling consumers to better visualize, interpret, and act on information. Aims to deliver software that is open-architecture, modular, networked, and distributed; able to leverage statistics, machine learning, and artificial intelligence; and focuses on speed, accuracy, insight, and action.

  • Warfighter Interfaces and Teaming CTC1: The Warfighter Interfaces and Teaming CTC will conduct research to enable robust decision superiority across our Air and Space Forces by dynamically optimizing the integration of Warfighter cognition with increasingly complex and intelligent machines/systems, creating maximally effective and resilient warfighting teams. CTC research will focus on discovering, developing, evaluating, and transitioning advanced adaptive warfighter interface technology, mission-optimized distributed team performance enhancements, communication management processes, and context-tailored intelligent decision aids/analytics in order to achieve and maintain decision superiority in uncertain environments against peer threats.

    • Distributed Teaming and Communication CRA1: The Distributed Teaming & Communication CRA emphasizes research that explores the rapid formation, real-time assessment, and dynamically optimized performance of distributed heterogeneous teams of warfighters as well as human-machine teams in order to enable rapid, agile & robust mission operations. Research areas will include: methods to enable the rapid formation of mission-effective heterogeneous teams, dynamic monitoring / assessment of team performance via optimal assemblage of novel and existing metrics, adaptive tactics for recovery from real or predicted team performance degradations, and novel distributed communication & collaboration tools, technologies and management methods that are responsive to variable network environments.

      • Dynamic Team Performance Assessment LOE1: Enable the rapid formation, real-time assessment, and dynamically optimized performance of distributed heterogeneous teams of warfighters as well as human-machine teams in order to enable rapid, agile & robust mission operations. Research areas include methods to support the rapid formation of mission-effective heterogeneous teams, dynamic monitoring of team performance via optimal assemblage of novel and existing metrics, and real-time contextual aids from team communication.

      • Team Optimization and Recovery LOE2: Design, develop, and evaluate team optimization and recovery technologies to enhance communication, coordination, and improve decision making among distributed teams. Research areas include interfaces to support joint tasking and team shared awareness (SA) across multiple domains as well as conversational AI technologies to enable high bandwidth natural communications.

    • Human Machine Interactions CRA2: The Human-Machine Interactions CRA emphasizes research to identify principles of human interaction with highly complex systems, including advanced automation & increasingly intelligent AI enabled machines. The goal of this research is to achieve and sustain decision superiority across complex & uncertain mission environments. Research areas include identifying, characterizing and overcoming key challenges to warfighter interactions with complex and intelligent systems such as situationally-adaptive interface design and usability, knowledge representation across sensory modalities, system observability & transparency, directability, joint cognitive decision making, and maintaining calibrated trust across changing conditions.

      • Rapid Joint-Cognitive Awareness LOE1: To develop human-centric interfaces and interaction strategies for improved AI/automation transparency, closed-loop adaptive systems that are responsive to warfighter state, and advanced techniques for effectively visualizing large, complex data sets.

      • HMI-enabled Decision Superiority LOE2: To develop capabilities for continuous planning for C2, next generation interfaces for complex intelligent platforms, and interfaces tailored for emerging Cognitive Warfare (CogWar) concepts.

  • Human Learning and Cognition (HLC) CTC2: The Human Learning and Cognition CTC enables more lethal Air and Space Forces through research on human multisensory perception, learning, information processing, and action. The research seeks to maximize mission effectiveness by (1) Establishing a persistent, global training and test ecosystem that creates the foundation for personalized, proficiency-based readiness for multi-capable Airmen and Guardians in joint all-domain operations, (2) Creating capabilities that allow teams of humans and machines to adapt and learn together in real time in training and operational settings, & (3) Advancing considerations of human performance in system development and operational planning with digital models of perception, cognition, & action.

    • Digital Model of Cognition CRA1: The Digital Models of Cognition Core Research Area emphasizes research to identify computational and mathematical mechanisms to represent human perception, information processing, and behavior, including the integration of models that reflect the role of internal and external factors that modulate performance efficiency and effectiveness. The goal is to develop holistic models that support quantitative understanding and prediction of mission effectiveness across domains and at different levels of abstraction for improved systems engineering, wargaming, and operational planning.

      • Holistic Models for Decision-Making LOE1: Develop models of cognitive systems that support quantitative understanding and prediction of mission effectiveness for decision superiority.

      • Information Mastery in Cognitive Warfare LOE2: Analytic methods, models, and tradecraft that enables operators to improve Information-Related Capability (IRC).

    • Learning and Operational Training CRA2: The Learning and Operational Training Core Research Area emphasizes learning and understanding in the context of evolving technology. This includes research to establish an ecosystem that maximizes mission effectiveness while minimizing costs by matching technologies to learning and performance needs; supporting high resolution human and system measurement and quantitative, proficiency-centric readiness assessment and prediction at the individual and team levels; and exploring how to enable human and machine co-learning to support mutual adaptation and understanding in human-machine teams.

      • Warfighter Learning Technologies LOE1: Research, demonstrate, & transition learning technologies, methods, & infrastructure for personalized, proficiency-based readiness.

      • Co-Learning for Adaptive Human and Machine Teams LOE2: Establish the foundation for interactive learning and collaborative training of humans and AI-enabled machines to enable uniquely effective human-autonomy teams.

• United States Air Force School of Aerospace Medicine (USAFSAM)

  Aerospace Medicine and Physiology

  • Aerospace Physiology: Solutions relating to physiologic assessment of aircrew in high altitude Fighters/Trainers.

    • Assessments of the physiologic response to exposures and stressors from the fighter/trainer environment; can cover any of the following: including effects of fluctuating pressure, high O2, air quality, breathing resistance, thermal burden, dehydration, rest/sleep (physical fatigue), cognitive fatigue, Aircrew Flight Equipment (AFE) integration (how AFE impacts in-flight physiology, and how AFE components interact with each other to impact physiology and aircrew performance), and combined stressors on performance and decision making in ground-based testing and operational environments, including the analysis of potential countermeasures to optimize pilot performance and eliminate sources of risk.

    • Solutions to sustain Aircrew performance in extreme environments.

    • Conduct comprehensive technology assessments of the current military health system simulators that can monitor and track physiologic responses from training student pilots.

    • There is a strong demand for wearables that are cross compatible across multiple systems to collect physiologic data, that are reliable and validated in the operational environment. Offerors are to conduct a comprehensive technology assessment of commercial off the shelf products, including their suitability for use in the operational environment and their validated measurement capabilities, to help aid aircrew and decision makers on what can be flown in the aircraft and what can be accurately collected from those sensors.

    • Musculoskeletal Injury Prevention and Treatment for Aircrew and Maintainers: Neck and back pain is a known occupational hazard for the high-performance aircraft community. The government seeks solutions, including tools to prevent, reduce, screen and diagnose musculoskeletal condition as well as alternative/integrative medicine approaches, for prevention or treatment of musculoskeletal injuries. Proposed solutions shall focus on providing reliable measurements to determine platform-specific neck/back dysfunction and improvements due to embedded care.

    • Gender-specific operational aircrew considerations

    • Assessment, modeling, detection, and/or mitigation Aircrew and Operator fatigue

  • Precision Medicine and Medical Standards: Development of solutions relating to the following areas:

    • Surveillance of conditions, indications, clinical practice guideline adherence, and outcomes to support cost benefit analyses for Air Force population.

    • Genomics for mishap investigations (gene expression, subtracting human and molecular autopsy).

    • Studies providing data to support evidence-based aerospace medicine standards and waivers.

    • Psychological Performance and Mental Health (solutions should relate to at least one of the following areas)

      • Mental health and psychological disorders amongst airmen and potential influence on readiness and retention.

      • Neurocognitive diversity; cognitive testing and correlates with mental health and other outcomes.

      • Assessment of the feasibility of integrating the use of personality data and wearable technology to facilitate adjustment and success during career specific training. Personality assessments and wearables both as tools to facilitate readiness via positive change, wellbeing, and performance by increasing self-awareness.

  Public Health and Preventative Medicine

  • Development, optimization, and validation of pathogen detection methodologies

  • Cancer analysis in the Air Force population

    • Development and evaluation of prototypes that can identify carcinogenic toxins or hazardous materials associated with military flight operations from shipboard or land bases or facilities.

    • Development and evaluation of prototypes that can identify exposures to ionizing radiation and nonionizing radiation from which airmen could have received increased radiation amounts.

    • Establishment of guidelines for carcinogen exposure as it relates to demographics for each airman to include duty stations, duties and aircraft flow.

    • Establishment of guidelines that outline the duties and potential exposures of airmen that are associated with higher incidence of cancer.

    • Development and evaluation of screening tools and/or methods that relate to carcinogen exposure to airmen.

  • Assess methodologies to prevent wound infection.

  • Assess infectious disease conditions in Air Force populations.

  Occupational Medicine and Bioenvironmental Engineering

  • Enhancement of capabilities to detect, measure, and assess occupational and environmental health hazard contaminants and extreme environmental conditions.

    • Assess technologies to enhance capabilities to detect and identify chemical, biological, toxins, radiological, directed energy, poisons and physical hazards on surfaces (including soil and powder), in liquids and in the air in near real-time at the detector's point of operation and notify end user of risk.

    • Assessment of Aviation-Specific Exposures

    • Develop, test and evaluate real-time health threat surveillance and reporting system inclusive of all available health information/databases to identify risks/outbreaks and provide decision support to operational commanders.

  • Evaluation/development of mitigation technology capable of reducing or eliminating occupational and environmental health hazard risks.

  En Route Care/Expeditionary Medicine/Prolonged Field Care: Needs in this area include medical capabilities to support in route care to/from remote, austere settings, and in extreme environments.

  • Training methodologies to improve operational readiness for individuals and teams responsible for delivering basic and advanced en route care capabilities within the aeromedical evacuation system.

  • Technology assessment/development to support the Air Force Surgeon General’s medical modernization priorities with a focus on modernizing outdated technologies and techniques to promote en route care growth/preparation for future peer/near-peer conflicts involving mass casualty care.

  Education and training technologies and methodologies to support efforts to generate, develop, and maintain skillsets across the AOME.

  Applications of data science to analyze medical and operational data and outcomes across the AOME, which may include implementation of AI and machine learning to answer operationally relevant questions.

Are there any additional benefits I would receive?

Beyond direct funding, CHEERS participation offers significant indirect advantages for growth and strategic positioning:

Government Validation and Credibility:
Selection under AFRL’s CHEERS program signals strong technical merit and alignment with Department of the Air Force human performance priorities—an endorsement that enhances your credibility with defense primes, OEMs, and investors.

Enhanced Market Visibility and Notoriety:
Awardees benefit from exposure in federal announcements, AFRL communications, and defense industry press—raising visibility and positioning your company as a trusted innovation partner in the human-performance and aerospace ecosystem.

Ecosystem Access and Collaboration Opportunities:
CHEERS projects operate within a national network that includes top-tier military researchers, AFRL directorates, and medical readiness centers. This access often leads to future R&D partnerships and contracting opportunities.

Stronger Exit and Acquisition Potential:
By advancing your technology with nondilutive support and demonstrating government-backed validation, companies can increase valuation and strengthen their position for acquisition or strategic investment by defense and medical technology leaders.

What is the timeline to apply and when would I receive funding?

• White Paper Deadline: Rolling through September 30, 2027. This means applicants should apply as soon as possible before funds are fully expended.

• Review Period: Technically 180 days for AFRL to review white papers - but it could also be reviewed faster.

• Proposal Invitation: AFRL will invite full proposals only from offerors whose white papers align with Air Force needs.

• Proposal Deadline: Defined in each Request for Proposal (RFP).

• Award Timing: Awards are issued once funds become available; no awards are made until funding is confirmed.

Where does this funding come from?

Funding is issued by the Air Force Research Laboratory (AFRL) under the following authorities:

• Open Period 1: 10 U.S.C. 4001 / FAR 35.016 (Broad Agency Announcement).

• Open Period 2: 10 U.S.C. 4023 (Procurement for Experimental Purposes).

These authorities allow AFRL to fund both research contracts and prototype agreements, depending on project maturity and experimental needs.

Who is eligible to apply?

1. Open to U.S. companies, universities, and research organizations.

2. Foreign participation is allowed subject to export and security controls.

3. Cost sharing is not required.

4. Offerors may submit multiple white papers, provided each represents a distinct technical approach.

What companies and projects are likely to win?

Offer innovative, defense-relevant solutions that measurably enhance warfighter performance, medical readiness, or operational resilience.

1. Demonstrate clear technical feasibility, transition potential, and sound risk mitigation.

2. Show strong alignment with AFRL’s human effectiveness and medical research priorities.

3. Have experienced teams capable of performing under experimental or prototype authorities.

Evaluation criteria (in descending order of importance):

1. Uniqueness and innovation.

2. Understanding of scope and technical approach.

3. Technical soundness and team qualifications.

4. Transition potential.

5. Cost realism and value.

Are there any restrictions I should know about?

• Export Control: Some projects may require U.S. or Canada Joint Certification (DD 2345).

• Human/Animal Subjects & Hazardous Materials: Approval requirements vary by project and will be outlined in each solicitation.

• S&T Protection: AFRL’s Science and Technology protection and OPSEC rules apply.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive white paper + full proposal will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for the White Paper for $3000. Full proposal quoted upon invitation.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the Funding Announcements:

• Continuing Human Enabling Enhancing Restoring and Sustaining (Master Announcement)

• CHEERS Open Period 1 - All Technical Areas

• CHEERS Open Period 2 - All Technical Areas

DARPA Biological Technologies Office (BTO) Broad Agency Announcement

Executive Summary:

DARPA’s Biological Technologies Office (BTO) is accepting rolling proposals to fund transformative biology-enabled capabilities for national security. An abstract is required before a full proposal, and both abstracts and proposals are accepted until September 30, 2026. For selected proposals ≤$2,000,000 that opt into the accelerated path, awards can be made within 30 days of selection. Companies targeting this BAA should submit an abstract as soon as possible as they are reviewed on a rolling basis.

How much funding would I receive?

Funding levels are not pre-set; BTO anticipates multiple awards across topics. An optional accelerated award path is available for selected proposals not exceeding $2,000,000 total, using model agreements tailored for small and large businesses.

What could I use the funding for?

Research & Development proposals that leverage biological properties and processes to revolutionize our ability to protect the nation’s warfighters. Specifically excluded is research that primarily results in evolutionary improvements to the existing state of practice.

• General Topics

  • Biological and/or chemical technology topic areas that fit the national security scope of BTO’s mission.

  • Research into market opportunities, constraints, and communities affecting financing and commercialization of bioindustrial and biomedical technologies.

• Machine Learning (ML) and Artificial Intelligence (AI)

  • Developing and advancing our understanding of the impact and principles underlying biological data generation, assessment and incorporation into the biological foundation models, or mixed-mode foundation models. This includes taking theoretical approaches as well as understanding the scaling laws of these data for various types of models.

  • Advancing the capabilities of broad or narrow biological and/or chemical or mixed-mode foundation models far beyond the state of the art.

  • Developing and proving non-experimental models or hybrid experimental/non-experimental assessment strategies for biological foundation model assessment.

  • Exponentially accelerating the time scale of biological system simulation from the subcellular through multicellular, organismal and environmental systems, including for threat prediction, impact assessment, and attribution modeling.

  • Developing ML and AI-enabled technologies to improve the accuracy, precision, and efficiency of warfighter decision-making in complex and dynamic environments (e.g., on and off the battlefield), including for real-time threat assessment and response planning.

  • The development of virtual testbeds, digital twins, and/or synthetic data to accelerate or improve the predictive modeling of human performance.

• Combat Casualty Care

  • Developing novel diagnostic, prophylactic, and therapeutic approaches for warfighter injury that can be provided even in austere settings and extreme conditions.

  • Developing capabilities and technologies that enhance the ability of non-skilled service members to perform essential medical tasks closer to the point of injury, reducing dependence on highly trained personnel through assistive devices.

  • Developing decision support tools that algorithmically optimize the alignment of medical requirements and resources in complex, data-constrained mass casualty scenarios to enhance near-real-time situational awareness and command and control (C2) planning and execution.

  • Development of capabilities and technologies that enhance the ability of non-skilled service members to perform essential medical tasks closer to the point of injury, reducing dependence on highly trained personnel through assistive devices.

• Human Performance

  • Understanding and improving treatment of and resilience in neurological health, transformative neural processing, fatigue, cognition, and optimized human performance and teaming, including in extreme stress conditions.

  • Discovering interventions that utilize biotechnology, biochemistry, molecular biology, microbiology, neuroscience, psychology, cognitive science, social and behavioral science, and related disciplines to assess and optimize human performance and teaming.

  • Developing and leveraging technologies to advance continuous or near-continuous monitoring of physiology to elucidate mechanisms of human readiness, cognitive status, and resilience.

  • Understanding and improving interfaces between the biological and physical world to enable seamless biohybrid systems and devices.

  • Developing approaches to enhance physiological resilience, performance, and survivability in extreme conditions (e.g., cold weather, extreme heat, high altitude).

  • Identifying technologies and tactics to increase or accelerate the impact of training regimens while reducing the risk of injury.

• Materials, Sensors, Processing

  • Designing novel materials, sensors, or processes that mimic or are inspired by biological systems.

  • Creating tools such as foundation models or prediction engines to understand the underlying rules defining biomolecular and biomaterial or hybrid biotic/abiotic material structure/function properties (individual properties or groups of properties) in order to predict desired outcomes for novel material development. Importantly, these predictions should hold from the molecular scale to the macro scale.

  • Developing new computational and experimental tools and predictive capabilities for engineering of biological systems, such as cells, tissues, organs, organisms, and complex communities, to both develop new products and functional systems, as well as to gain new insights into underlying mechanisms.

  • Developing technologies to leverage biological systems and enhance the acquisition and maintenance of critical and strategic organic and inorganic materials.

  • Understanding and leveraging complex biological systems into underlying functional rules and processes to provide models that govern interactions of biological systems from biofilms to organs or ecosystems.

  • Developing new platform technologies that integrate, automate, and miniaturize the collection, processing, and analysis via direct or indirect interrogation of biological and chemical samples.

  • Developing hybrid biological/engineered systems that integrate biological organisms, components, biologically-encoded circuitry, biogenic materials, or exploit biological phenomena to surpass capabilities of abiotic equivalents.

  • Developing novel biological sensor platforms with reduced size, weight, and power requirements of equivalent electro-optical or electro-mechanical systems with orders of magnitude increase in equivalent performance.

• Security, Safety, and Surveillance

  • Developing new technologies and approaches to ensure the biosafety and biosecurity of biological hardware and data. Ensuring the safety and security of AI technologies that accelerate biological research and development processes.

  • Developing innovative technologies to detect, characterize, treat, prevent, and forecast the effects of novel, engineered, or natural emerging pathogens that have the potential to cause significant health, economic, and social burdens, to prevent their spread and enable understanding of their origin.

  • Developing ML, AI approaches, and advanced data analytics for the rapid analysis, interpretation, identification, attribution, and origin tracing of large-scale, disparate biological and environmental surveillance data streams, enabling anomaly detection, pattern recognition, scalable detection, and predictive analytics to identify emerging threats or anomalous events and provide early warning and anticipatory action against natural or manmade biological threats.

  • Advancing technologies for determination and attribution along with data provenance analysis at chemical, isotopic, genetic, and community structure levels.

  • Developing novel sensing, surveillance, and processing technologies (including in-situ and remote modalities) to detect, identify, monitor, and analyze weak biological signals of emerging pathogens (novel, engineered, or natural) at all scales, including their secondary effects on the environment.

  • Developing new technologies and data analytics to support next-generation surveillance, detection, identification, and attribution of human and agricultural pathogens at scale and in near real-time.

  • Developing novel in-situ or remote sensing and surveillance technologies at the global, regional, and local scale that detect and identify novel, engineered, and/or natural emerging pathogens to prevent their spread or understand their origin.

• Biomedical & Biodefense

  • Developing new technologies for rapid, automated, and resilient manufacturing, delivery, and distribution of critical molecules for applications in therapeutics, chemical, and biological defense.

  • Developing new technologies to support next-generation cellular therapeutic applications.

  • Developing new platform technologies for targeted, effective, spatiotemporally controlled delivery of large and small molecules and biologics.

  • Leveraging biotechnology to create new platform solutions that combat antimicrobial resistance, generate novel drug and cell-based therapeutics, and treat warfighter injury and illness.

Are there any additional benefits I would receive?

Beyond the formal award, there are significant indirect benefits to receiving a DARPA Biological Technologies Office (BTO) contract or agreement:

• Government Validation and Credibility:
  Being selected by DARPA—the Department of Defense’s premier innovation agency—signals extraordinary technical credibility and alignment with national security priorities. This “DARPA validation” often accelerates partnerships with primes, OEMs, and investors who trust government-vetted innovation.

• Enhanced Market Visibility and Notoriety:
  Award recipients frequently receive public recognition through DARPA announcements, defense innovation conferences, and press coverage. This visibility helps position your company as a cutting-edge player in defense biotech and deeptech, attracting further investment and talent.

• Ecosystem Access and Collaboration Opportunities:
  DARPA performers gain access to the BTO’s extensive network, including technical advisors, transition partners, and resources. These programs support contractor readiness, compliance, and downstream transition—opening doors to additional government and industry contracts.

• Nondilutive Growth and Strategic Leverage:
  Because funding is nondilutive, companies can scale and validate core technologies without giving up equity. This validation and maturity achieved under government sponsorship often lead to higher valuations and greater leverage in future fundraising or acquisition discussions.

• Faster Execution and Credible Track Record:
  With DARPA’s accelerated contracting path, companies can move from selection to award in as little as 30 days—establishing a record of execution under one of the most selective R&D programs in the world, which strengthens competitiveness for future federal or dual-use opportunities.

What is the timeline to apply and when would I receive funding?

Abstracts are accepted on a rolling basis until September 30, 2026, 4:00 PM ET (abstract and DARPA invitation are required before any full proposal).

Full proposals are accepted on a rolling basis until September 30, 2026, 4:00 PM ET.

Accelerated option (≤$2M) awards may be issued within 30 days of selection notification if you submit the required election/attestations and use the model agreement.

Where does this funding come from?

The Defense Advanced Research Projects Agency (DARPA), Biological Technologies Office

Who is eligible to apply?

All responsible sources—U.S. and non-U.S.—may submit, except FFRDCs, UARCs, and Government entities (incl. National Labs), which are not eligible as prime proposers. NAICS: 541714 (biotech R&D). Submissions must comply with U.S. security, export control, and related laws.

What companies and projects are likely to win?

The scoring criteria reward proposals that:

1. Present a bold, high-impact technical approach. Proposals that merely increment the state of practice are explicitly out-of-scope;

2. Directly advance DARPA’s national-security mission; and

3. Show credible cost/schedule realism with clear deliverables and risk-mitigation. Prior experience executing similar efforts and leveraging relevant prior research strengthen competitiveness.

Are there any restrictions I should know about?

• Abstract is mandatory; DARPA must invite a proposal before it will be reviewed.

• Compliance areas include CUI handling, cyber (e.g., NIST SP 800-171 assessments), export controls, and human/animal research approvals where applicable.

• Certain entities/equipment (e.g., Kaspersky, certain telecom/DRONE restrictions, ByteDance apps) are prohibited by clause.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission under this BAA will likely take 120–160 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth under Federal & State R&D Initiatives.

How much would BW&CO Charge?

Our full service support is available for a flat fee of $15,000 Project + a 5% Success Fee.

Fractional support is $300 per hour, with most DARPA proposal projects requiring 80–100 hours of expert support from strategy through submission of full proposal.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

• Webinar - New Biotech Funding: $2M from the DARPA BTO Office

• See solicitation on Grants.Gov

The National Institutes of Health Small Business Innovation Research Program

Executive Summary:

The NIH, CDC, and FDA are jointly awarding up to $2.1 million per company through the SBIR Program to support U.S. small businesses developing innovative health, biomedical, and life science technologies. Companies can apply for Phase I (proof-of-concept), Phase II (R&D and commercialization), or Fast-Track awards. Applications are due on January 5th, April 5th, and September 5th each year, with funding typically beginning 9 months after submission. Companies should begin preparing applications at least 12 weeks before a due date to complete registrations and submission.

How much funding would I receive?

Awards provide up to $314,363 for Phase I projects (up to 6 months) and $2,095,748 for Phase II projects (up to 2 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funds may support research and development toward a commercially viable product or service aligned with the missions of NIH, CDC, or FDA (see below). Eligible costs include personnel, materials, prototypes, testing, IP protection, and other R&D expenses. Phase II and IIB funds may also be used for scale-up, validation, regulatory preparation, and commercialization efforts. Click below to see the various areas of interest:

• National Institute of Aging (NIA)

  • Alzheimer’s Disease (AD), AD-Related Dementias (ADRD), and Age-Related Change in Brain Function. Research and development of novel interventions to ameliorate AD/ADRD; improve AD/ADRD care; or further the understanding of the etiology of AD/ADRD, neurodegeneration, brain connectivity, neuroplasticity, or brain-– behavior relationships. This includes drug and non-drug interventions for age-related cognitive decline, delirium, sleep disorders, or other central nervous system dysfunctions, including dysfunctions of the motor, emotional, sensory, and neuroimmune systems. This also includes novel biomarkers of neural stem cell functions and new technologies or imaging devices that improve or study brain connectivity; metabolism; sleep; or cognitive, motor, emotional, or sensory activity.

  • Aging in Place of Choice. Research and development of social, behavioral, and environmental interventions that promote independence and aging in place by addressing the unique needs of older adults, their healthcare providers, and caregivers. This includes prosthetics, assistive devices and robotics, digital technologies and software, and technology to mitigate age-related physical and behavioral health challenges or toimprove healthcare delivery, care coordination, and disease management.

  • Age-Related Diseases and Conditions. Research and development of new diagnostic tools and methods, biomarkers, therapeutics, imaging devices, and technologies to monitor, diagnose, predict, prevent, treat, and further the understanding of the molecular mechanisms of aging or age-related diseases and conditions.

  • Research Tools. Development and validation of innovative tools, resources, or methodologies that promote the efficient, cost-effective, and high-quality collection, analysis, or interpretation of aging-related quantitative or qualitative data. This includes bioinformatics tools; screening platforms; surveying, sampling, and behavioral/behavioral economics methods; and clinical instruments to enhance the study of aging, cellular resiliencies, and aging-related diseases.

  • Special Areas of Interest. Areas of particular interest related to aging biology, aging-related diseases and conditions, behavioral health, and AD/ADRD include, but are not limited to the following:

    A. Companion diagnostics and other forms of personalized medicine.

    B. Bioinformatics, public health informatics, or data science technologies/methods (e.g., machine learning, artificial intelligence) to better understand aging biology and/or predict health outcomes.

    C. Novel cell and gene therapies, as well as other novel therapeutic approaches to AD/ADRD.

    D. Biomarkers and diagnostic tools for the early detection of disease.

    E. Prevention and therapeutics that directly target mechanisms related to aging biology.

    F. Assistive technology, devices, and mobile applications for older adults and caregivers.

    G. Tools, technologies, and analytic methods to address health disparities among older adults and/or biological determinants of health disparities.

• National Institute on Acohol Abuse and Alcoholism (NIAAA)

  • New tools, techniques, paradigms, and technology are needed to enable researchers to further understand the underlying biological and behavioral mechanisms through which conditions associated with AUD develop:

    • Induced pluripotent stem cells (iPS), including disease specific cell lines and gene-edited models (e.g., alcohol-related organ damage and disease with human iPS cell-derived organoids) and from adult-derived human iPSCs cells representing genetic variations in alcohol metabolism (e.g., alcohol dehydrogenase (ADH), aldehyde dehydrogenase (ALDH), cytochrome P450 isozyme CYP2E1, and glutathione S-transferase (GST)) or models of normal development and alterations by prenatal alcohol exposure, and embryonic stem cell models of development and effects of alcohol exposure.

    • Novel technologies to measure and interpret non-coding RNA (ncRNA) gene expression, following alcohol exposure, in the brain at the cellular level or in non-animal research models.

    • Using single-cell transcriptomics and multiomics technologies and sequencing to reveal the molecular fingerprint of cell states and their predicted signaling circuits in tissues across development and AUD.

    • Tools to detect dynamic and concurrent changes of neurotransmitters and neuromodulators in the brain of behaving animals.

    • Tools to detect the effects of alcohol on the central nervous system (CNS) structure and activity.

    • Novel animal models, including transgenic animals.

    • Hepatocyte cell line capable of maintaining viability and metabolic functions in culture systems for an indefinite period.

    • Experimental systems that mimic organ function.

    • New methods of ethanol administration to animals that produce precise dose control or that closely mimic types of alcohol exposure occurring in humans.

    • New ligands that will enhance the potential usefulness of PET and SPECT neuroimaging technologies for the study of the etiology of AUD and related brain pathology.

    • Humanized animal models to study AUD in different organ systems.

    • Methods to detect epigenetic changes as disease drivers due to metabolic reprogramming by alcohol.

    • Tools to determine the prevalence of alcohol associated organ diseases: alcoholic cardiomyopathy, sarcopenia, pancreatitis, pulmonary, immune and bone diseases.

    • Optoelectronics probes and devices used to manipulate nerve cell activity in awake animals to better study nerve cell function in the body’s periphery.

    • Generate organoids from iPSCs that specifically model sleep-regulating brain regions affected by alcohol, providing a platform for studying alcohol's neurobiological impacts on sleep at the organ level.

  • Prevention, Treatment, & Recovery. Prevention strategies/programs and educational services, behavioral treatment programs, medications, and digital health technologies are crucial in ameliorating the negative health effects and consequences associated with AUD and alcohol misuse and recovery.

    • Medications Development

      • Preclinical and/or clinical development of therapeutics for AUD and alcohol-related complications (e.g., craving, sleep problems, withdrawal symptoms, and negative affect).

      • Early therapeutic discovery activities (e.g., target ID, lead compound target validation).

      • Investigational New Drug (IND)-enabling studies.

      • Extended formulations or reformulations of existing medications that improve efficacy or compliance.

      • Therapeutics for individuals with co-occurring health conditions, such as post-traumatic stress disorder (PTSD), HIV, alcoholic hepatitis, liver fibrosis, cirrhosis, pancreatitis, cardiomyopathy, or other alcohol-induced tissue damage.

      • Development of precision medicine tools (e.g., biomarker panel) to predict treatment outcomes among AUD patients.

    • Programs or Therapies to Prevent or Treat AUD and/or the Consequences of Alcohol Misuse, Hazardous Drinking, and AUD Across the Lifespan

      • Novel behavioral health or educational programs aimed at preventing or treating AUD or associated consequences of AUD, alcohol misuse, or hazardous drinking across the life span.

      • Prevention or treatment programs tailored specifically to the needs of the following groups: children of individuals with AUD, women, racial and ethnic underrepresented populations, sexual and gender minority populations, individuals with Fetal Alcohol Spectrum Disorders (FASD) across the lifespan, persons with disabilities, adolescents/young adults, the elderly, individuals in rural settings, individuals with psychiatric comorbidities (e.g., PTSD, major depressive disorder, etc.).

      • Computerized versions of empirically supported prevention or treatment programs, including but not limited to in languages other than English.

      • Prevention curricula, videos, multi-media programs, and training materials for use with adolescents and other population groups and in the NIAAA priority areas.

      • Therapeutic, skill-building, and educational program products that enhance behavioral, neurocognitive, social, adaptive, and motor function to improve the overall well-being of individuals with FASD and their families.

      • Therapies to mitigate alcohol-associated adverse impact on the development of liver and/or lung diseases.

      • Strategies and methods to increase awareness and salience among high-risk groups of the tragic consequences of driving after drinking.

      • Therapies or programs specifically focused on sustaining mid- and long-term recovery from AUD.

    • Digital Health Tools (mHealth, health IT, wearable devices, telehealth, telemedicine, and personalized medicine)

      • Wearable Alcohol Biosensor - minimally invasive, near real-time detection, remote monitoring, infrared or other non-sweat based technology preferred.

      • Validation of promising technologies, biosensors, and research tools.

      • Development of precision medicine tools to predict an individual’s risk for developing AUD and/or quantify progression to an AUD diagnosis.

      • Tools to improve the prevention or treatment of AUD and alcohol-related problems.

      • Applications that facilitate long-term recovery support and improve continued engagement in recovery support services.

      • Tools to improve the identification and diagnosis of FASD and prenatal alcohol exposure.

      • Applications or tools to improve medication safety (e.g., multiple medications, interactions with alcohol).

      • Mobile device applications or other health technologies to improve the effectiveness, accessibility, and use of behavioral interventions for AUD and co-occurring disorders, including HIV.

      • Solutions or applications to improve minority health and health disparities with capabilities of reaching persons in rural, remote, and under-resourced/under-served communities.

      • Virtual reality (VR) technology to create immersive environments that simulate real-world scenarios involving alcohol consumption and its effects on behavior and sleep, for understanding environmental and social factors in AUD.

      • Non-invasive, wearable devices capable of monitoring physiological and biochemical markers of alcohol intake and its impact on sleep patterns in real-time, utilizing technologies like bioimpedance.App-based digital platforms that offer personalized cognitive-behavioral therapy forinsomnia (CBT-I) and other sleep improvement techniques for individuals with AUD, integrating wearable sleep data.

  • Diagnostics. Improving the current battery or developing new approaches to measurement, diagnosis, and assessment of the severity of AUD, alcohol misuse and health consequences, FASD, and alcohol- related organ damage.

    • Imaging Examination Technologies for Early and Precise Diagnosis of Alcohol-Related Organ Damage

    • Biomarkers for AUD and alcohol-related health effects

      • Detection (e.g., biochemical, unbiased assay) of alcohol intake for extended period (e.g., 2 weeks, 2 months) after drinking episode.

      • Signatures of alcohol-induced organ damage and familial risk.

      • Reduction of time to results for current assays (e.g., phosphatidylethanol (Peth), ethyl glucuronide (EtG)).

      • Increase accuracy of alcohol intake detection by developing a novel combination of biomarkers (e.g., PEth, EtG)).

      • Improve assay methodologies for established biomarkers of alcohol consumption considering cost, timeliness, and accessibility in a range of clinical settings.

      • Point of care devices, for use in rural or remote primary care and hospital settings.

      • Validation of promising biomarkers that can be used to improve clinical research and practice (for example, diagnosis, prognosis, and treatment response) for alcohol related health conditions, including AUD, FASD, and alcohol associated organ injury.

      • Tools or kits to measure aristolochic acid (AA)-adducts and advanced glycation end products (AGEs) in serum, cerebral spinal fluid, and brain and other organs impacted by AUD in animal models and pre-clinical settings including their relationship to the biomarkers of neuro- inflammation.

      • Tools to detect alcohol-induced damage in those patients with HIV infection or co-infection.

      • Measurement and integration of ‘omics data for AUD and alcohol-related organ damage.

  • Data Science. Software and tools can be used for discovery of new biomarkers and targets, precision medicine, and other applications to increase the efficiency and efficacy of treating AUD and alcohol-related health effects.

    • Algorithms for integrative analysis incorporating multiple current NIAAA supported (current and legacy), government, and public datasets, including machine learning, deep learning, artificial intelligence, data mining and other model based and model-free approaches.

    • Software applications for data interfaces for aggregation, imputation, harmonization, or visualization of data from multiple sources, including current and future NIH data systems.

    • Algorithms and/or software tools for improving data collection, i.e., smart phone apps, extraction of specific alcohol research parameters from existing large databases and established public health studies, biological sensors or wearable devices.

    • Computational and/or systems biology models of alcohol exposure, tolerance, and resilience.

    • Computational, statistical or bioinformatics tools to organize and manage high throughput data obtained by genomic, functional genomic, or other ‘omic strategies.

    • Computational tools to combine multiple data modalities (e.g., omics, imaging).

    • Application of machine learning and artificial intelligence, including large language models, in alcohol research, including ethics and privacy concerns.

    • Translation of ‘omics’ data into clinically relevant predictions and outcomes for AUD and alcohol- related organ damage.

• National Institute of Allergy and Infectious Diseases (NIAID)

  • Division of AIDS (DAIDS) supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) Reduce HIV incidence through the development of effective biomedical prevention strategies, including vaccines that are safe and desirable, 2) Develop novel approaches for the treatment and cure of HIV infection, 3) Develop interventions to treat and/or prevent co-infections and co-morbidities of greatest significance, and 4) Engage scientific and community stakeholders to equitably implement effective interventions.

  • Basic Sciences Program supports basic and applied research on the causes, diagnosis, treatment, and prevention of HIV and AIDS.

    • Epidemiology Branch. Population-based research, modeling, and comparative effectiveness studies (not including clinical trials) that assess the natural history, biologic, and clinical course of HIV/AIDS, and related outcomes, and could advance treatment and prevention of HIV. Specific interests include phylodynamics and other factors related to HIV transmission and associated biological and behavioral factors, basic research on immunology, virology, and antiretroviral therapy, issues surrounding care for HIV and other co-morbidities, interactions and impact on clinical outcomes. Development of novel electronic tools, including devices and computer programs to enhance behaviors, such as treatment adherence or uptake of treatment guidelines, is also of interest.

    • Pathogenesis & Basic Research Branch. Innovative technologies for at-home self-testing to directly detect HIV during the earliest stages of acute infection (before antibody response) or to detect viral rebound following long-term suppression of viremia. Identification and validation of new targets for discovery or design of strategies to prevent HIV transmission, inhibit replication, control viremia in the absence of antiretroviral drugs, or eradicate reservoirs of HIV that persist despite long-term antiretroviral therapy. Innovative approaches for predicting post-treatment immunologic control of viral rebound or for monitoring changes in the size of the rebound- competent HIV reservoir. Determination of atomic structures relevant to HIV prevention, treatment, or cure.

    • Targeted Interventions Branch. Discovery and development of small molecule inhibitors with novel or underexplored mechanisms of action using standard and high-throughput technologies; cell-based and gene therapies; RNA-based therapeutics; next-generation biologics; novel targeting and delivery vehicles for agents active against HIV; therapeutic vaccines and monoclonal antibodies; protein chemistry-based anti-HIV approaches; assays to quantitate latent virus; animal models to facilitate evaluation of agents to treat or cure HIV infection.

  • Vaccine Research Program supports the discovery, development and clinical evaluation of an HIV/AIDS vaccine.

    • Vaccine Clinical Research Branch. Research areas: (1) phase I, II, and III domestic and international clinical trials of candidate AIDS and TB vaccines and anti-HIV antibodies; (2) evaluation and characterization of immune responses, virologic markers, and improved diagnostic approaches in HIV-infected and uninfected immunized volunteers, and (3) technologies and methods to improve clinical efficacy or reduce the burden of vaccine or monoclonal antibody administration.

    • Preclinical Research and Development Branch. Preclinical research to assess and overcome specific biomedical obstacles in HIV vaccine discovery, especially by application of innovative technologies, and/or by the development and supply of novel reagents/resources useful for advancing original vaccine platforms including monoclonal antibody discovery and development for prevention of HIV infection.

    • Vaccine Translational Research Branch. VTRB enables research by advancing innovative vaccine concepts and scalable unit operations into the development of cGMP manufactured products. VTRB’s efforts to accelerate the development of preventive HIV-1 vaccines involves identifying, supporting and advancing: (a) cell line development to increase Env expression, production, quality, and yield; (b) evaluation of phase-appropriate upstream and downstream manufacturing processes;(c) scalable and prototype process development and purification platforms; (d) cGMP manufacturing of broad portfolio of vaccine products ranging from complex HIV Env protein immunogens, nanoparticle-based vaccines, viral vectors, virus-like particles (VLP), nucleic acid-based vaccines (DNA and mRNA), monoclonal antibodies for testing in early phase human clinical trials; (e) manufacturing new and/or alternative adjuvant analogs with similar agonist functions as those currently available for optimal immune response; (f) novel and emerging nanoparticle antigen and adjuvant delivery modalities and dosage forms, coformulation technologies and platforms for immunization; (g) antigen-adjuvant formulation development, analytics development to support product characterization, in-process operations, release, and stability testing; and (h) preclinical safety, immunogenicity, and toxicology testing.

  • Therapeutics Research Program develops and oversees research and development of therapies for HIV disease, including complications, co-infections and co-morbidities, in adults.

    • Drug Development and Preclinical Research Branch. Basic, preclinical, and translational research for development of new therapies for HIV and HIV-associated co-infections, including Mycobacterium tuberculosis and viral hepatitis; development of safer, more efficacious antiviral, antimicrobial, and immune-based therapies, and combinations thereof, including long-acting/extended-release approaches; target identification and validation for HIV-related co-infections and assay development for screening potential therapeutics; preclinical research to elucidate the biology of HIV-related co-infections, including pathogenesis, immune protection and control, and persistence and latency; maintenance of a database of potential anti-infectives for HIV and HIV-related coinfections.

    • Laboratory and Clinical Sciences Branch. Research focused on biomarker discovery/validation and assay development for diagnostics, including development and evaluation of practical and affordable tests to measure viral load, drug toxicities, and drug resistance for clinical use; development and testing of new or improved methodologies for diagnosing, monitoring, and following patients under treatment, including tests to detect early infection in seropositive HIV-infected adult and pediatric individuals in poor resource settings; clinical development of laboratory assays; clinical immunology, virology, and pharmacology related to the design and conduct of clinical trials; management of quality assurance contracts for oversight of the quality of clinical laboratory testing in support of clinical trials.

    • HIV Research Branch. Clinical research in adults to evaluate chemotherapeutic and immune-based interventions to treat acute and chronic HIV infection and approaches to achieve sustained remission or cure; strategies to augment HIV-specific immune responses and general host immunity to control or clear HIV infection.

    • Complications & Co-Infections Research Branch. Clinical research in adults to evaluate new or improved therapies and related strategies for the treatment and/or prevention of HIV-related co-infections (exclusive of Mycobacterium tuberculosis) and non-infectious co-morbidities, including Immune Reconstitution Inflammatory Syndrome (IRIS), in people living with HIV.

    • Tuberculosis Clinical Research Branch. Clinical research in adults to evaluate therapeutics, therapeutic vaccines and strategies to prevent disease recurrence for tuberculosis in people living with HIV, including those with additional medical conditions that may affect disease outcomes; clinical trials with a primary objective to elucidate the pathophysiology and immunopathogenesis of HIV/TB co-infection including the study of co-infection interactions and changes in the course, pathology, treatment responses, and outcome of either infection.

  • Prevention Science Program develops and oversees research and development of 1) non-vaccine biomedical HIV prevention strategies in adolescents and adults, and 2) therapies for cure, management, treatment and prevention of HIV and HIV-associated complications in pregnant women, infants, children, and adolescents, including pediatric-friendly formulations. Supports domestic and international phase I, II, and III clinical trials to evaluate these prevention or therapeutic strategies in relevant populations.

    • Preclinical Microbicides and Prevention Research Branch. Development of non-vaccine biomedical HIV prevention products including topical microbicides, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and multipurpose prevention technologies (MPT). Emphasis on drug delivery systems (DDS) designed to achieve systemic protection for ≥ 3 months. Development of shorter-duration products (i.e., minimum of 7 days to <3 months), which address a compelling specific public health need. Key populations are adolescents, cisgender women, men who have sex with men (MSM), and transgender people.

    • Clinical Prevention Research Branch. Development of safe and effective non-vaccine biomedical and integrated HIV prevention interventions to reduce the number of new HIV infections in adults and adolescents. Support the development of HIV incidence assays, biomarkers of adherence, mathematical modeling, and other tools needed to accomplish these objectives. Clinical development of topical microbicides to prevent HIV infection with the goal to advance safe, effective, and acceptable microbicide products toward licensure.

    • Maternal, Adolescent and Pediatric Medicine Branch. Therapies for cure, management, treatment and prevention of HIV and HIV-associated complications including TB, in pregnant women, infants, children, and adolescents, including development of pediatric-friendly formulations. Strategies to reduce transmission of HIV and HIV co-infections from mother to child.

  • Division of Allergy, Immunology, and Transplantation (DAIT). The Division of Allergy, Immunology, and Transplantation (DAIT) supports studies of the immune system in health and the cause, pathogenesis, diagnosis, prevention, and treatment of disease caused by immune dysfunction.

    • Allergy, Asthma and Airway Biology Branch. Conditions of interest: asthma, food allergy, eosinophilic esophagitis and gastroenteritis in relation to food allergy, atopic dermatitis, urticaria, rhinitis, rhinosinusitis, drug allergy, sepsis. The Branch supports basic and clinical studies investigating mechanisms of disease and new approaches to diagnose, treat or prevent these conditions. Special interest for SBIR/STTR includes a) the development of biomarkers as diagnostic markers, markers of disease severity and predictive markers for treatment effectiveness, particularly of immunologic interventions such as allergen immunotherapy for food and respiratory allergy; b) the development of new forms of allergen immunotherapy aiming at increased tolerogenic immune responses and decreased allergenicity.

    • Basic Immunology Branch. The Branch supports basic and clinical research in the following areas: adjuvant discovery and development; origin, maturation, and interactions of immune cells; immune cell receptors, and ligands; cytokine biology; molecular basis of immune activation, antigen recognition, and immune tolerance; immune response regulation; hematopoiesis and stem cell biology; computational immunology; immunologic mechanisms associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; assessment and analysis of vaccine effectiveness in neonates, pregnant women, and adults, and basic immunology of vaccines and immunotherapeutics as medical countermeasures for biodefense. Special interests for SBIR/STTRs include: adjuvant discovery , development, production of biosimilars, and/or head-to-head comparisons; bioinformatics tools for immune epitope predictions/visualization, and/or for the analysis of multi-parameter or systems immunology data; development and validation of immunologic reagents for analysis of immunity in non-mammalian (e.g., Xenopus laevis, zebrafish, C. elegans) and under-represented mammalian (e.g., pig, ferret, cow, sheep, bat) models, and development of novel/improved sample sparing methods to analyze human immune responses from limited amounts of human sample (tissue, cells, serum, etc.).

    • Autoimmunity and Mucosal Immunology Branch. Preclinical and clinical research to develop and improve the diagnosis and treatment of autoimmune diseases and primary immune deficiencies/inborn errors of immunity (not HIV); basic research of autoimmune disease mechanisms and biomarkers; immunotherapy of disease processes; disorders mediated by lymphocyte products; and discovery and/or development of reagents and other tools for analysis of mucosal immunity.

    • Transplantation Branch. Preclinical and clinical research in organ, vascularized composite tissue and cellular transplantation: acute and chronic graft rejection, allogeneic and xenogeneic transplantation, development of immunomodulatory agents to prevent and treat graft rejection and to promote acute and long term graft acceptance and immunologic tolerance, genomics of the alloimmune response, graft versus host disease for hematopoietic stem cell transplantation, minor histocompatibility antigens, complications of immunosuppression in transplantation, and major histocompatibility complex (MHC) region genomics, technologies for MHC typing, and clinical applications of high-resolution HLA typing.

    • Radiation and Nuclear Countermeasures Program (RNCP). The RNCP will consider preclinical research to support product development activities leading to interactions with the Food and Drug Administration (FDA). Approaches could include those used to diagnose, mitigate, and/or treat acute or delayed effects of radiation exposure resulting from a radiological or nuclear incident. It is anticipated that in most cases, approval will occur in accordance with the FDA Animal Rule (21 CFR 314.600 Subpart I for drug products and 21 CFR 601.90 Subpart H for biologic products).

      • Proposed activities could include:

        • Animal model studies or ex vivo approaches (e.g., human tissue chips) to confirm/optimize product efficacy;

        • Mechanism of action studies needed for FDA consideration;

        • Good Laboratory Practice (GLP)/non-GLP pharmacology/toxicology/pharmacokinetics/pharmacodynamics;

        • GLP pilot animal efficacy studies;

        • Good Manufacturing Practice product scale-up and stability studies;

        • Biomarker and biodosimetry assay/device development to determine radiation dose and/or the biological impact of radiation exposure (in vivo and ex vivo models acceptable).

      • Priority areas of product development include:

        • Approaches targeting organ systems/microbiota, for which no treatments are available (e.g., gastrointestinal, lung, kidney, cardiac, vascular, and skin);

        • Approaches to mitigate and/or treat radiation injury given 24 hours or later post-irradiation;

        • Minimally invasive, predictive radiation markers, diagnostics and devices for biodosimetry;

        • Radionuclide decorporation agents.

  • The Division of Microbiology and Infectious Diseases (DMID) supports research to better understand, treat, and ultimately prevent infectious diseases caused by virtually all infectious agents, except HIV. DMID supports a broad spectrum of research from basic molecular structure, microbial physiology, and pathogenesis, to the development of new and improved vaccines, therapeutics, and vector control measures. DMID also supports medical diagnostics research, which is defined as research to improve the quality of patient assessment and care that would result in the implementation of appropriate therapeutic or preventive measures. In addition, DMID supports studies to better understand mechanisms of pathogen transmission that may include environmental factors. DMID does not support research directed at decontamination or the development of environmentally oriented detectors, whose primary purpose is the identification of specific agents in the environment. Note that some of the organisms and toxins listed below are considered NIAID priority pathogens or toxins for biodefense and emerging infectious disease research.

    • Bacteriology and Mycology Branch. The branch oversees research and product development related to:

      • Bacterial infections with emphasis on hospital-associated pathogens, including Acinetobacter, Klebsiella, Serratia, Legionella, Pseudomonas, Aeromonas, Enterobacter, Proteus, non-enteric E.coli, staphylococci, enterococci, actinomycetes among others;

      • Bacterial zoonoses, including plague, anthrax, tularemia, glanders, melioidosis, Lyme disease, borrelial relapsing fevers, rickettsial diseases, anaplasmosis, ehrlichiosis, bartonellosis, scrubtyphus, Q fever, and leptospirosis;

      • Fungal infections including those caused by Candida, Aspergillus, Cryptococcus, Coccidiodes, Histoplasma, Blastomyces, Pneumocystis, Microsporidia, and other pathogenic fungi.

      • Research is encouraged in the following general areas: (1) vaccines, adjuvants, therapeutics and diagnostics (including target identification and characterization, device or apparatus development, novel delivery, and preclinical evaluation); (2) strategies to combat antibacterial and antifungal drug resistance; (3) applied proteomics and genomics; (4) host-pathogen interactions, including pathogenesis and host response; (5) genetics, molecular, and cell biology; and (6) microbial structure and function.

      • Research on all of the above is welcome, but the following areas are of particular interest to the branch:

        • Vaccines, therapeutics, and medical diagnostics for hospital infections

        • Adjunctive therapies and non-traditional approaches to combat and treat antimicrobial resistance

        • Diagnostics for invasive fungal diseases

        • Novel approaches for the diagnosis of Lyme disease

        • Vaccines against Coccidioidomycosis

    • Enteric and Sexually Transmitted Infections Branch.

      • Enteric Infections Section research portfolios focus on enteric bacterial pathogens, their toxins, and their infectious diseases; related sequela; and the gastrointestinal microbiota and microbiome. Special emphasis areas include but are not limited to those below:

        • Development of vaccines to prevent bacterial enteric diseases, to protect against neurotoxins and enterotoxins, and to combat enteric diseases in vulnerable populations.

        • Development of therapeutics that focus on novel targets, that target toxin activities, and that treat recurrent diseases.

        • Development of live biotherapeutic products to restore colonization resistance to enteric pathogens, to combat recurrent or chronic enteric disease, and to restore host immunity against enteric pathogens.

        • Development of adjunctive therapies and non-traditional approaches to treat resistant bacteria and to combat further development of antibacterial resistance.

        • Development of rapid diagnostics to identify multiple pathogens and their antimicrobial resistance profiles that are appropriate for use in low-resource, outbreaks, and clinical settings, as well as diagnostic approaches that differentiate asymptomatic colonization from infection.

      • Sexually Transmitted Infections. Areas of emphasis include the development of medical diagnostics including better and more rapid multiplex point of care tests, ability to rapidly determine antibiotic sensitivity, and novel technologies enabling testing in low resource settings while maintaining high sensitivity/specificity; development of new classes of antimicrobials and non-antimicrobial treatment approaches, particularly those focused on reducing the development of antibiotic resistance; novel delivery systems for multipurpose prevention technologies, vaccines and therapeutics for Sexually Transmitted Infections (STIs) and other reproductive tract syndromes such as bacterial vaginosis and pelvic inflammatory disease; understanding vaginal ecology and immunology and approaches to developing synthetic microbiota for use as biotherapeutics or as adjunct therapy to antibiotic treatment; development of epidemiologic and behavioral strategies to reduce transmission of STIs; developing and evaluating interventions and products to better serve adolescents, medically underserved populations, and minority groups who are disproportionately affected by STIs; development of multipurpose prevention technologies to prevent STIs, HIV, and unintended pregnancies; better understanding of the role of STIs in infertility, premature birth, and adverse outcomes of pregnancy and how to improve outcomes; and better understanding of the role of STIs in HIV transmission and the role of HIV in altering the natural history of STIs.

    • Respiratory Diseases Branch. Research areas include:

      • (1) viral respiratory diseases caused by influenza viruses, human coronaviruses including SARS, MERS, and novel emerging coronaviruses, rhinoviruses, respiratory syncytial virus and other related pneumoviruses and paramyxoviruses;

      • (2) mycobacterial diseases, including tuberculosis (TB) caused by bacteria of the Mycobacterium tuberculosis complex, leprosy, Buruli ulcer and non- tuberculous mycobacterial (NTM) diseases, particularly pulmonary infections in persons not afflicted with HIV/AIDS;

      • (3) other bacterial respiratory diseases including bacterial pneumonia primarily caused by Streptococcus pneumoniae, Pseudomonas aeruginosa, and Haemophilus influenzae, pertussis, Group A and B streptococcal diseases, meningitis, upper respiratory infections, acute exacerbations of chronic obstructive pulmonary disease, and cystic fibrosis; and (4) mixed viral/bacterial respiratory infections.

      • Special emphasis areas include:

        • Development of new or improved antimicrobials (especially for antimicrobial-resistant pathogens) and antivirals, including immunotherapeutics, immunomodulators, and host-directed therapies to augment anti-infectives;

        • New or improved vaccines (with and without adjuvants);

        • Improved delivery systems and formulations for drugs/vaccines;

        • Microbial and host biomarkers and biosignatures suitable for diagnostic tests;

        • Development of novel or improved diagnostic tools for detection of infection and drug resistance, including rapid point of care diagnostics and quantitation of pathogen in response to therapy;

        • Diagnostics to distinguish viral from bacterial infections.

      • There is particular need for preventive and treatment countermeasures for influenza, including universal vaccine platforms and broad-spectrum antivirals; for novel treatment of respiratory syncytial virus (RSV) and related pneumovirus and paramyxovirus infections; for next generation vaccines, therapeutics, and diagnostics for the prevention and treatment of COVID-19, including pan-coronavirus approaches; for diagnostics including diagnostics for pediatric populations, novel therapeutics, and vaccines (including adjuvants) against Mycobacterium tuberculosis (TB); for relevant diagnostics, preventive and curative interventions against non-HIV associated pulmonary Non-tuberculous mycobacteria (NTM); and for the prevention, diagnosis, and treatment of Bordetella pertussis, Group A streptococcus, and Streptococcus pneumoniae infections and other antibacterial resistant infections

    • Parasitology and International Programs Branch. Research areas:

      • (1) protozoan infections, including amebiasis, cryptosporidiosis, cyclosporiasis, giardiasis, leishmaniasis, malaria, trypanosomiasis, toxoplasmosis; helminth infections, including cysticercosis, echinococcosis, lymphatic filariasis, schistosomiasis, onchocerciasis, others (e.g., roundworms, tapeworms, and flukes); invertebrate vectors/ectoparasites responsible for human disease (.e.g., mosquitoes, black flies, sandflies, tsetse flies, ticks, triatomine bugs, fleas, lice, mites), and selected intermediate hosts of parasites (e.g., snails);

      • (2) parasite biology (genetics, genomics, physiology, molecular biology, and biochemistry);

      • (3) protective immunity, immunopathogenesis, and evasion of host defense;

      • (4) clinical, epidemiological, and natural history studies of parasitic diseases;

      • (5) research and development of vaccines, drugs, immunotherapeutics and immunoprophylaxis, and medical diagnostics; and

      • (6) vector biology and management/control and mechanisms of pathogen transmissions.

      • Research on the above is welcome, but research on the following is of particular interest to the branch:

        • New drug discovery or re-purposing of existing drugs to prevent infection and/or transmission, or to treat parasitic diseases

        • Highly sensitive and specific diagnostics tools for parasitic diseases

        • Vaccines and vaccine technologies, monoclonal antibodies, and other immune-mediated interventions applicable to prevention or elimination of parasitic diseases

        • Technologies or approaches that address arthropod vector monitoring, management, and control, to prevent transmission of vector-borne pathogens to humans

    • Virology Branch. The Virology Branch focuses on:

      • Acute viral infections caused by arthropod-borne (e.g., mosquito, tick-borne) and rodent-borne viruses, including: dengue, zika, west nile, Japanese encephalitis, chikungunya, yellow fever, hanta, crimean-congo hemorrhagic fever (CCHF), hazara, severe fever with thrombocytopenia syndrome (SFTS), heartland, bourbon, tick-borne encephalitis (TBE), powassan , lacrosse, cache valley, rift valley fever, punta toro, andes, sin nombre, hantaan; viruses causing hemorrhagic fevers:

        ebola, lassa, junin, venezuelan equine encephalitis (VEE), etc.; and other viruses, including nipah, hendra, measles, polio, coxsackie, entero, pox, rabies, rubella, astro, calici, and rota; pathogen X

      • Persistent viral infections caused by viruses including adeno, borna, corona, herpes, human T-lymphotrophic, human papilloma, parvo, and human polyoma (JC, BK, and emerging);

      • Acute infections with hepatitis viruses A, B, C, D and E (HAV, HBV, HCV, HDV, and HEV); chronic infections with hepatitis viruses, B, C, D and E;

      • Transmissible Spongiform Encephalopathies (TSE)

      • Areas of emphasis for SBIR/STTR applications include:

        • Development of vaccines and vaccine platforms;

        • Development of techniques to improve vaccine stability;

        • Approaches to identify antiviral targets and agents;

        • Chemical design and synthesis of novel antiviral agents;

        • Development of therapeutic, prophylactic, and postexposure prophylactic interventions;

        • Development and validation of point of care assays for disease diagnosis and to measure response to therapy;

        • Development of new preclinical animal model systems that predict clinical efficacy of vaccines, therapeutics and diagnostics.

  • The Office of Genomics and Advanced Technologies focuses on broad-based research that emphasizes the development and improvement of high-throughput and large-large scale genomics and other advanced technologies for the understanding of infectious diseases and the development of multiplex platforms for medical diagnostics. The technological scope encompasses genomics, genomic epidemiology, phylogenomics, functional genomics, proteomics, metabolomics, glycomics, structural biology, systems biology, computational biology, bioinformatics, and diagnostics, usually across multiple pathogens or pathogen groups. The goal of our program is:

    • (1) to support large-scale experiments using omics, structural and computational biology approaches,

    • (2) to deepen the comprehension of pathogen-host interactions and

    • (3) to accelerate the discovery of innovative diagnostics, vaccines, and therapeutics for infectious diseases. Our program supports the advancement of technologies and platforms that are pathogen-independent or address multiple pathogens and may include sample preparation, instrumentation, and instrument validation.

    • Special emphasis areas include:

      • Development and advancement of genomic, phylogenomic, proteomic, metabolomic, glycomic, structural biology and related technologies for infectious diseases, including single-cell omics technologies and platforms;

      • Development of bioinformatic and computational biology, including artificial intelligence/machine learning methods and tools to advance infectious disease research; and

      • Development of modeling and bioinformatic tools to integrate omics data that supports the development of vaccines, therapeutics and diagnostics.

  • The Office of Biodefense Research and Surety (OBRS) supports and oversees a trans-NIH research portfolio to advance discovery and early development of medical countermeasures (MCMs) against chemical threats. To learn more about OBRS and its leadership role in chemical countermeasures research at the NIH, see NIH CCRP: A Collaborative Opportunity to Develop Effective and Accessible Chemical Medical Countermeasures for the American People, published in the Wiley journal Drug Development Research.

  • Biodefense Research Countermeasures Branch (BRCB). The Chemical Countermeasures Research Program (CCRP) supports preclinical basic and applied research towards understanding acute and long-term chronic toxicity resulting from exposure to Department of Homeland Security-designated Chemicals of Concern (CoC) and early development of MCMs to prevent mortality and serious morbidities. The ideal MCM should have rapid post-exposure efficacy, is easily administered in a mass casualty situation (likely by first responders in personal protective equipment) and is widely accessible in the community.

    The specific injuries caused by toxic chemical exposure often manifest similarly to conditions observed in conventional clinical practice, such as acute lung injury, acute respiratory distress syndrome, coagulopathy, tissue fibrosis, keratopathy, neovascularization, seizure, and neurodegeneration. As such, "treat the symptom” projects aiming to repurpose already FDA-approved products or those in late-stage development for a conventional clinical indication are highly encouraged.

    Areas of Emphasis include but not limited to:

    • Pulmonary Agents: Development of MCMs to prevent and treat acute and/or chronic lung injury (including edema, capillary leak, and fibrosis) resulting from exposure to agents such as sulfur mustard, chlorine, acrolein, and phosgene.

    • Ultra-Potent Synthetic (UPS) Opioids: Development of MCMs to treat life-threatening respiratory depression caused by acute intoxication. Treatments should be fast-acting and effective against a variety of synthetic UPS opioids such as fentanyl, carfentanil, and related analogs, and have a mechanism of action different from existing opioid receptor antagonists.

    • Vesicants: Development of MCMs that mitigates dermal, ocular, and/or systemic (including myelosuppression) toxicities after exposure to chemicals such as sulfur mustard, nitrogen mustard, Lewisite, phosgene oxime. Candidate MCM(s) with the potential to prevent or ameliorate chronic effects such as keratopathy is encouraged.

    • Blood/Cellular Respiration Agents: Development of MCMs to treat metabolic dysfunction and/or coagulopathy resulting from exposure to agents such cyanide, hydrogen sulfide, and brodifacoum. Candidate cyanide and hydrogen sulfide MCM(s) should also be effective against smoke inhalation-related exposure.

    • Nerve Agents and Organophosphorus (OP) Pesticides: Development of MCMs to treat acute muscarinicand nicotinic toxicities, including benzodiazepine refractory seizures, after exposure to agents such as sarin, soman, and VX.

    • OBRS does not support research directed at diagnostic device development, decontamination, or the development of environmentally oriented detectors, whose primary purpose is the identification of specific chemicals in the environment.

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  Particular areas of programmatic interest relative to small business initiatives include, but are not limited to:

  • Innovative research on women’s health in the areas of musculoskeletal, rheumatic and skin diseases

  • Innovative research on health disparity in the areas of musculoskeletal, rheumatic and skin diseases

  • Innovative diagnostic technology for improving outcomes for maternal health in NIAMS mission areas

  • Innovative research on rare musculoskeletal, rheumatic and skin diseases

  • Multiplex assay development for arthritis and musculoskeletal and skin diseases

  • Lab to marketplace: translation of scientific discoveries in NIAMS mission areas f rom labs into products on the market

  • Test and/or validation of novel, state-of-the-art candidate biomarker platforms for predicting the onset and progression of inflammatory diseases of interest to the NIAMS and for determining the pharmacodynamics, safety and/or efficacy of therapeutic agents targeting those diseases.

  The general purpose of the SBIR/STTR program is to stimulate technological innovation and increase private sector commercialization of Innovations. Due to budget constraints, NIAMS will consider the following research topics a lower program priority:

  • Research on a product or a technology to show equivalence to existing products

  • A product or a technology has been well funded for more than 10 years, but has not shown any progress towards clinical testing

  • A research topic on which multiple similar technologies have been funded and have shown scientific success

• National Institute of Biomedical Imaging and Bioengineering (NIBIB)

  • Bio-Electromagnetic Technologies. Development of technologies that use static or dynamic electromagnetic fields for sensing, imaging, or therapeutic effects. The emphasis is on increasing the sensitivity, spatial/temporal resolution, efficacy, or safety of bioelectromagnetic devices through the development of novel hardware, method of operation, or pre-/post-processing techniques for single modalities or the combination of multiple modalities. This program may support the development of magnetic particle imaging, electrical impedance tomography, electroencephalography, magnetoencephalography, electromagnetic-field-induced hyperthermia/ablation, and microwave/terahertz imaging, for example.

  • Bioanalytical Sensors. Development of sensor technologies for the detection and quantitation of clinically relevant analytes in complex matrices for use in biomedical applications. Emphasis is on engineering the components and functionality of bioanalytical sensors. Detection could be based on optical, chemical, electrochemical, and/or physical (such as mechanical, gravimetric, thermal) perturbation of a sample, for example. Examples of technologies of interest include, but are not limited to, nano-textured substrates for analyte detection, DNA sensors for liquid biopsy, and small molecule detectors for diagnosing infectious diseases.

  • Image-Guided Interventions. Development of novel image-directed technologies for guidance, navigation, tissue differentiation, and disease identification for reaching specified targets during therapeutic procedures, which may range along the continuum from non-invasive to minimally invasive to open surgical interventions. These technologies may range from molecular to macroscopic scale levels. Overall emphasis is on the engineering of novel image-guided interventions to improve outcomes of interventional procedures. In addition, emphasis includes technologies that expand needed procedural access for individuals otherwise excluded by disease characteristics, co-morbidities, and other parameters. Areas of priority include development of real-time or near real-time novel image-guided technologies, with robust procedural direction or a robust receiver operating characteristic curve. In addition, cost-efficient technologies, appropriate for low resource settings, and/ or applicable to multiple types of interventions are strongly encouraged.

  • Magnetic Resonance Imaging. Development of in vivo MR imaging and MR spectroscopy, for both animal and human research and potential clinical applications. The emphasis is on the development of MRI hardware and methodologies, including image acquisition and reconstruction techniques, that would improve the speed, spatial resolution, information content, efficiency, robustness, quality, patient experience, and safety. The emphasis should be on technological development rather than detailed applications to specific diseases or organs.

  • Molecular Probes and Imaging Agents. Development and biomedical application of molecular probes and imaging agents across all imaging modalities for the visualization, characterization and quantification of normal biological and pathophysiological processes and anatomy in living organisms at the molecular, cellular and organ levels. The emphasis is on engineering of targeting and responsive molecular probes of high sensitivity and specificity for PET and SPECT (radiotracers), MR (T1, T2, CEST, hyperpolarized agents), EPR, CT, optical (fluorescent and bioluminescent probes), ultrasound (microbubbles) and photoacoustic imaging. The imaging agents may be based on nano- and micro-particles, liposomes, dendrimers, proteins, small organic and inorganic molecules etc., and detectable by one or more imaging modalities. Imaging agent development through methodologies such as chemical synthesis, biological mutagenesis, microfabrication, etc., may be pursued with an intent of leading to in vivo biomedical application.

  • Nuclear Medicine. Research and development of technologies and techniques that create images out of the gamma- ray (SPECT) or positron (PET) emissions from radioactive agents that are injected, inhaled, or ingested into the body. The emphasis is on simulation and development of new detectors, collimators, and readout methods that enhance the signal quality of detecting isotope emissions; designs of novel camera geometries; and correction methods that compensate for the radiation physics properties to improve the clinical reliability of the image. Of interest are improvements and corrections for interaction events in PET detectors and enhancement to time of flight (TOF) image generation methods (reconstructions algorithms); as well as new collimator and camera designs for SPECT.

  • Optical Imaging and Spectroscopy. Development and application of optical imaging, microscopy, and spectroscopy techniques for improving disease prevention, diagnosis, and treatment in the medical office, at the bedside, or in the operating room. Examples of research areas include fluorescence imaging, bioluminescence imaging, OCT, SHG, IR imaging, diffuse optical tomography, optical microscopy and spectroscopy, confocal microscopy, and multiphoton microscopy. The emphasis is on development of cost effective, portable, safe, and non-invasive or minimally invasive devices, systems, and technologies for early detection, diagnosis, and treatment for a range of diseases and health conditions.

  • Ultrasound: Diagnostic and Interventional. Development and improvement of technologies for diagnostic or therapeutic uses of ultrasound. The diagnostic ultrasound program includes, but is not limited to the design, development and construction of transducers, transducer arrays, and transducer materials, innovative image acquisition and display methods, innovative signal processing methods and devices, and optoacoustic and thermoacoustic technology. It also includes the development of image-enhancement devices and methods, such as contrast agents, image and data presentation and mapping methods, such as functional imaging and image fusion. The therapeutic ultrasound program includes, but is not limited to the design, development, and construction of transducers, transducer arrays, interventional technologies, adjunct enhancement of non-ultrasound therapy applications, high-intensity focused ultrasound (HIFU), or hyperthermia applications. It also includes non-invasive or minimally invasive interventional surgical or therapy tools, ultrasound contrast agents for therapy, targeted drug delivery, neuromodulation, and biopsy.

  • X-ray, Electron, and Ion Beam. Research and development of technologies and techniques that create images of internal structures, contrast agents, or molecular probes using x-rays transmitted through the body (CT, mammography) or x-ray stimulation of secondary emissions (x-ray fluorescence tomography). Emphasis is on simulation, design and development of new detector systems; new readout methods that enhance the signal quality for x-ray image generation; designs of novel imaging geometries; algorithms that compensate for the physical properties of the detection system to improve the clinical reliability of the image (reconstruction algorithms); and approaches to radiation dose reduction, especially in CT. Of interest are diagnostic image enhancements via photon counting, dual energy, and new applications of cone-beam tomography.

  • Biomolecular Technologies. Development and demonstration of broadly applicable biomolecular technologies to enable new paradigms of human health. The emphasis is on the development of biomolecular technologies and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: molecular switches for synthetic genetic circuits; nucleases and genome editors for DNA manipulation and regulation; engineered viruses and extracellular vesicles for therapeutic agent delivery; transmembrane CARs for extracellular sensing; photoactive molecular complexes for optogenetics.

  • Bionics. Development and demonstration of broadly applicable bionic systems to enable new paradigms of human health. The emphasis is on the development of bionic systems hardware, software, and methodologies to improve patient health. NIBIB interests include but are not limited to: artificial organs to replace function; electrodes and 3D printed tactile sensors for prosthetics; implantable bioelectronic sensors and actuators for real-time, closed-loop control of tissues and organs.

  • Cellular and Multicellular Technologies. Development and demonstration of broadly applicable cellular and multicellular technologies to enable new paradigms of human health. The emphasis is on the development of cellular and multicellular technologies and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: synthetic genetic circuits for cellular control and decision-making; engineered bacteria for microbiome regulation; engineered T-cells for immune regulation and cancer therapy; organoids and scaffold-free tissue assemblies for replacing organ function.

  • Living Materials. Development and demonstration of broadly applicable living materials to enable new paradigms of human health. The emphasis is on the development of living materials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: bacteria-laden hydrogels to deliver therapeutics; co-designed stem cells and scaffolds to grow implantable tissues.

  • Manufacturing and Biomanufacturing Tools. Development and demonstration of broadly applicable manufacturing and biomanufacturing tools to enable the translation of new paradigms of human health. The emphasis is on the development of manufacturing and biomanufacturing tools and associated computational models to enable biomedical interventions. NIBIB interests include but are not limited to: bioinks and bioprinters for 3D tissue construction; continuous production methods for scalable manufacturing of drug delivery vehicles; inline sensors for non-destructive evaluation of manufactured therapeutic cells; bioreactors for organoid manufacturing.

  • Medical Devices. Development and demonstration of broadly applicable biomedical devices to enable new paradigms of human health. The emphasis is on the development of medical device hardware, software, and models to improve patient health. NIBIB interests include but are not limited to: implantable bioelectronic stimulators and sensors for monitoring and modulating human physiology; wearable sensors for monitoring health vitals; micro devices and injection systems for therapeutic delivery; anti-bacterial and anti-coagulating coatings for implantable devices; biohybrid devices for replacing organ function.

  • Medical Simulators. Development and demonstration of broadly applicable medical simulators to enable new paradigms of human health. The emphasis is on the development of medical simulator hardware, software, and methodologies, primarily to improve patient outcomes, especially through the reduction of medical errors. NIBIB interests include but are not limited to: virtual coaches incorporating artificial intelligence for performance training in medical procedures and workflows; simulation interfaces to facilitate dissemination and use of virtual environments; realistic representations of anatomy, tissue, instrument, tactile feedback, and collision dynamics; simulator designs that focus on complicated or rare procedures, including rare adverse events; simulators that replicate realistic workflows, including planning, warm-up exercises, and rehearsal leading up to the actual procedure; portable, easy-to-use simulators for skilled practitioners in rural and low-resource settings.

  • Molecular Materials. Development and demonstration of broadly applicable molecular materials to enable new paradigms of human health. The emphasis is on the development of molecular materials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: lipid nanoparticle coatings for evading the immune system; supramolecular polymers for targeted protein degradation; drug conjugates for targeted drug delivery.

  • Nanomaterials. Development and demonstration of broadly applicable nanomaterials to enable new paradigms of human health. The emphasis is on the development of nanomaterials and associated computational models for biomedical intervention. NIBIB interests include but are not limited to: magnetic and acoustic nanoparticles for ablating cells and tissues; plasmonic nanorods for tissue suturing; functionalized nanocarriers for drug delivery and immunotherapy.

  • Physiomimetic Materials. Development and demonstration of broadly applicable physiomimetic materials to enable new paradigms of human health. The emphasis is on the development of physiomimetic materials and associated computational models for biomedical intervention. Projects might focus on: elucidating important engineering design rules or key foundational principles underlying future engineering, including the use of computational methods; prototyping or redesigning platform technologies; characterizing (in vitro, ex vivo, or in vivo) broadly applicable technologies and prototypes. NIBIB interests include but are not limited to: electrically conductive and mechano-sensitive scaffolds for repairing tissue; photoactive adhesives for surgical sealants; biomimetic matrices for T cell activation; artificial cells for therapeutic agent delivery.

  • Robotics. Development and demonstration of broadly applicable robotic systems to enable new paradigms of human health. The emphasis is on the development of robotic systems hardware, software, and methodologies to improve patient health. NIBIB interests include but are not limited to: robots for minimally invasive surgeries; microgrippers and drills for surgical robots; robotic nurses for isolated patient care; soft robotic exoskeletons to replace lost capabilities; soft elastomeric actuators for assistive robotics.

  • Screening and High-Throughput Tools. The emphasis is on the development of screening and high-throughput tools and associated computational models to enable biomedical interventions. Projects might focus on: elucidating important engineering design rules or key foundational principles underlying future engineering, including the use of computational methods; prototyping or redesigning platform technologies and approaches; characterizing (in vitro, ex vivo, or in vivo) broadly applicable technologies, prototypes, and lead candidate products. NIBIB interests include but are not limited to: evolution methods for identifying therapeutic protein targets; organs-on-chips for drug screening; microfluidic systems for high-throughput screening of extracellular vesicles.

  • Artificial Intelligence, Machine Learning, and Deep Learning. Design and development of artificial intelligence, machine learning, and deep learning to enhance analysis of complex medical images and data. The emphasis is on development of transformative machine intelligence-based systems, emerging tools, and modern technologies for diagnosing and recommending treatments for a range of diseases and health conditions. Unsupervised and semi-supervised techniques and methodologies are of particular interest.

  • Biomedical Informatics. Development of structures and algorithms to improve the collection, annotation, aggregation, anonymization, classification, retrieval, integration, analysis, and dissemination of quantitative and qualitative biomedical data. The emphasis is on using biomedical information to achieve better health outcomes and smarter health care. Examples of technical development areas in this program include but are not limited to informatics tools and resources such as: databases, standards for enhanced interoperability, collaborative analysis environments, data modeling and representation, and techniques for the integration of heterogeneous data, rational data-driven design of experiments, visualization of data, and digital representation of rich qualitative data. This program is intended to support NIBIB’s other program areas in biomedical imaging and bioengineering research.

  • Digital Health-Mobile Health and Telehealth. Development of enabling technologies that emphasize the integration of wireless technologies with human and biological interfaces. This program includes the development of software and hardware for telehealth and mobile health studies. This program includes the development of software and hardware for telehealth and mobile health studies and the input and delivery of healthcare information digitally for the analysis or monitoring of health or disease status. The emphasis is on developing mobile health technologies driven by clinical needs and integrating these technologies in healthcare delivery, wellness, and daily living.

  • Point of Care Technologies-Diagnostics. Development of rapid in-vitro diagnostic technologies and monitoring platforms that provide real time medical evaluation and analysis of the disease status or condition at the time and place of patient care. The program includes the delivery of healthcare that is safe, effective, timely, patient-centered, efficient, and available in centralized and decentralized locations. The emphasis is on developing technologies driven by clinical needs. Examples of technology development areas in this program include but are not limited to disposable lateral flow assays, nucleic acid testing platforms, glucose monitoring devices, etc.

  • Image Processing, Visual Perception, and Display. Design and development of algorithms for post-acquisition image processing and analysis, the development of theoretical models and analysis tools to evaluate and improve the perception of medical images, and the development of visualization tools for improved detection. The emphasis is on using image data to achieve better health outcomes and smarter health care. Examples of technology development areas in this program include but are not limited to models, algorithms, software, methodologies, and other tools that will: facilitate medical imaging research; support clinical detection, diagnosis and therapy; and improve patient healthcare.

• The National Cancer Institute (NCI)

  Major Portfolio Areas:
  

  • Therapeutics (e.g., Small Molecules, Biologics, Radiomodulators, and Cell-based Therapies)

  • In Vitro and In Vivo Diagnostics (e.g., Companion Diagnostics and Prognostic Technologies)

  • Imaging Technologies (e.g., Agents, Devices, and Image-Guided Interventions)

  • Devices for Cancer Therapy (e.g., Interventional Devices, Surgical, and Radiation and Ablative Therapies, Hospital Devices)

  • Agents and Technologies for Cancer Prevention

  • Technologies for Cancer Control (e.g., Behavioral Health Interventions, Tools for Genetic, Epidemiologic, Behavioral, Social, and/or Surveillance Cancer Research)

  • Tools for Cancer Biology Research

  • Digital Health Tools and Software Platforms for Cancer-Related Technologies

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  The major NICHD research priority areas for each Branch are listed below. Investigator initiated applications that have commercial potential that fall outside these topic areas but fall within the research mission of the NICHD are also considered through this Omnibus solicitation.

  A. Child Development and Behavior Branch. The CDBB encourages innovative developmentally-sensitive, theoretically-grounded, and evidence based small business initiatives that develop technology and products addressing the psychological, social and emotional, psychobiological, language, numerical, literacy, cognitive and intellectual development and health of persons from infancy through the transition to adulthood, recognizing the important role others have in contributing to the healthy development of an individual. Products that target at-risk populations and/or exploit new technologies that can expand the effective reach or inclusion of underserved populations in order to encourage healthy development and/or our understanding of the inf luences of context and/or behavior on development are especially encouraged. CDBB is also interested in research on innovative approaches to both imaging and other non-invasive measurement approaches to capture real time brain activation activity in typical and atypical infants and young children (birth to age three). Foci of specific interest include, but are not limited to:

  • Enhancing Bilingual and Biliteracy Development: Adaptive learning technology to enhance bilingual and/or biliteracy development in English-language learning children and youth.

  • Bi- or Multi-Lingual Measures of Neurodevelopment: Develop easy to administer objective neurodevelopmental measures f rom evidence-based neurocognitive research specific to typically developing infants through pre-K children f rom diverse language homes that are shown to correlate with development of brain connectivity and activation. Remote administration measures are a high priority.

  • Pediatric Primary Care Behavioral and Health Promotion Interventions: Facilitate research on the impact of behavioral and health promotion interventions in pediatric primary care and related clinical settings with a focus on child and adolescent health outcomes.

  • Psychosocial Adjustment for Individuals in High-Risk Environments: Develop measures to identify and tools to stimulate developmental factors and mechanisms which promote short- and long-term psychosocial adjustment for children and adolescents exposed to high-risk family and neighborhood environments.

  • School Readiness Skills in Economically and Socially Disadvantaged Children: Develop mobile device apps and/or hand-held devices that assess and/or promote the development of executive functioning (EF) and school readiness skills and abilities in infancy and early childhood and in diverse populations of children as well as measures of home, childcare and preschool environments and practices that are related to child learning and development.

  • Reading, Writing, and Mathematics Struggling Learners: Develop assistive technology to enhance learner outcomes for individuals that struggle to acquire literacy and/or numeracy skills, grounded in current scientific understanding of these challenges.

  • Assessment and Enhancement of Reasoning Development: Develop validated and specific assessment tools that are sensitive to contributing factors (e.g., biobehavioral, environmental, cultural, academic, and cognitive factors) to facilitate research on and the promotion of neurocognitive development of reasoning (e.g., quantitative, deductive, inductive, causal) in typically developing populations.

  • Fostering inclusion of typically-developing or at-risk infants, toddlers and children in neuroimaging activities: Develop products or new strategies to facilitate neuroimaging of typically-developing or at-risk infants, toddlers and children.

  B. Contraception Research Branch. The CRB supports research on developing new and improved methods of fertility regulation as well as research on the benefits and risks of contraceptive drugs, devices and surgical procedures. Areas of interest include, but are not limited to:

  • Development of new and improved methods of fertility regulation, for men and women, that are safe, effective, inexpensive, reversible and acceptable with priority given to nonhormonal and on-demand methods.

  • Synthesis and testing of novel chemical compounds that are potential contraceptives

  • Multipurpose prevention technologies designed to prevent sexually transmitted infections, such as HIV, as well as pregnancy

  C. Developmental Biology and Congenital Anomalies Branch. The DBCAB supports biomedical research on the cellular, molecular, and genetic aspects of typical and atypical embryonic development including early embryogenesis, organogenesis, as well as topics in stem cell and regenerative biology. The overall goal is to promote research on developmental biology to understand the causes of structural birth defects. Areas of interest include but are not limited to:

  • Development of new model systems (animal or other) to study developmental mechanisms and causes of structural birth defects

  • Innovative technologies for in vivo imaging of developmental processes (cell and tissue dynamics) and gene expression

  • Development of antibodies, novel ligands, and other probes to facilitate our understanding of typical and atypical embryonic development in model organisms

  • Technologies for quantitative measurement of physical properties of cells/tissues in vivo during development

  • Innovative technologies for studying metabolomics in developing vertebrate embryos

  • Technologies to facilitate and advance systems biology approaches to the study of embryonic development and structural birth defects

  • Technologies to facilitate and advance high throughput chemical screening (including small molecules) for advancing structural birth defects research

  • Software development to facilitate the collection and analyses of data generated using medium-high throughput screening platforms in model systems (model organisms, cellbased models)

  • Software development to facilitate the collection, mining and analyses of genomic and phenotypic data f rom children affected with structural birth defects, and cross-analysis with model organism data

  • Development of user-friendly software for biomedical researchers with limited knowledge of computational biology to analyze large-scale human and other datasets associated with structural birth defects

  • Technologies/methodologies to generate, and software to mine, data related to wound healing and regenerative responses across animal species

  • Novel reagents for activation and mobilization of endogenous/adult stem cells to promote in vivo tissue regeneration

  • Methodologies to drive limb regeneration in higher vertebrates (including in mammals) that might otherwise lack the capacity for regeneration.

  • Technologies for iPSC-based regenerative medicine in the context of structural birth defect

  • Screening technologies for small molecules in human Embryonic Stem (ES) Cells or Induced Pluripotent Stem Cells (iPSCs) and disease specific iPSCs for targeted modification of regulatory networks affected in structural birth defects

  D. Fertility and Infertility Branch. The FIB supports research on the reproductive processes of men and women and of animals with similar reproductive systems related to developing safer and more effective means of regulating, preserving or achieving fertility. Areas of interest include but are not limited to:

  • Development of reagents and tools, such as high-resolution technologies to facilitate study of reproductive and developmental processes, including gamete and early embryo development, and reproductive track development

  • Development of techniques and identification of novel biomarkers to produce, identify, and use healthy gametes as well as advancement on preservation of human gametes

  • Development of organoid cultures and physiomimetic systems ideal for study of gametogenesis and normal or diseased reproductive tissues/organs

  • Development of improved methods of growing and differentiating stem cell lines in vitro, including feeder cell-free approaches to facilitate reproductive research

  • Development of improved technologies for the reprogramming of cells, including embryonic stem cells or adult cells, into eggs and sperm

  • Development of improved technologies for preimplantation genetic diagnosis

  • Development of omics technologies to diagnose impairments in sperm function, fertilization, ovulation, implantation, decidualization and other aspects of reproductive processes

  • Use of genomics and proteomics to develop novel diagnostics and treatments for reproductive diseases and disorders

  • Use of semen, vaginal or cervical fluid, or menstrual effluent to diagnose fertility status or other health conditions

  • Development of novel assays, kits, and devices to monitor and treat infertility

  • Development of Artificial Intelligence techniques/methods for selection of best sperm cells, oocytes, and embryos to generate better predictive models for in vitro fertilization

  • Development of innovative technologies for point-of-care testing for fertility/infertility and reproductive diseases and disorders

  • Development of patient-specific treatment regimen for infertility diseases using Artificial Intelligence methods/technologie

  • Development of tools, technologies or apps for diagnosis and treatment of infertility in resource limited settings to increase community and individual resources to address infertility

  • Development of tissue engineering technologies for uterine tissue regeneration and reproductive track reconstruction for treatment of infertility

  • Identification and/or validation of putative male or female infertility targets

  • Development of novel drugs or devices to treat male or female infertility.

  • Development of high-throughput screening methodologies for small molecule drugs addressing infertility

  E. Gynecologic Health and Disease Branch. The GHDB supports biomedical research related to gynecologic health throughout the reproductive lifespan, beginning at puberty and extending through perimenopause. Areas of interest include, but are not limited to:

  • Development of new diagnostic approaches and treatments for female pelvic floor disorders, including drugs, and devices used for treatment of pelvic organ prolapse, urinary incontinence, fecal incontinence, and other female pelvic floor disorders

  • Development of new diagnostic methods and novel surgical and non-surgical treatments for uterine fibroids, endometriosis, adenomyosis, and benign ovarian cysts. Non-invasive diagnostics and/or diagnostics that make use of menstrual effluent are of particular interest.

  • Production of marketable novel or improved methods, devices, and technologies for the diagnosis, monitoring and therapy of gynecologic pain disorders including chronic pelvic pain, vulvodynia/vestibulodynia, and dysmenorrhea

  • Generation of new approaches for the diagnosis, monitoring and treatment of abnormal menstrual cyclicity

  • Surgical and non-surgical treatments for girls and women with reproductive tract abnormalities, including congenital structural abnormalities and complications f rom female genital cutting

  • Devices and/or technologies designed to address surgical challenges in gynecologic surgeries, including hysterectomy

  • Technologies designed to apply -omics platforms (genomics, proteomics, metabolomics etc.) to questions of gynecologic health and disease

  F. Intellectual and Developmental Disabilities Branch. The IDDB sponsors research aimed at preventing, diagnosing, and ameliorating intellectual and developmental disabilities (IDD). Emphasis is on studies related to IDD, including common and rare neurodevelopmental and neuromuscular disorders, such as autism spectrum disorders, Down, Fragile X, and Rett syndromes, mitochondrial conditions, inborn errors of metabolism, and others. Areas of interest include, but are not limited to:

  • Innovative tools, including molecular, imaging, statistical or behavioral tools, to characterize the etiology and pathophysiology of abnormal nervous system development.

  • Methods and devices to delineate genetic, genomic, and epigenetic causes of IDD and develop gene-based treatments.

  • Methods or devices designed to screen for, diagnose, treat, and manage IDD and other conditions, particularly those identified or identifiable by newborn screening.

  • Assessment tools for use in the clinic or community settings to enable the accurate measurement of change in response to interventions.

  • Development of early interventions leading toward the prevention, diagnosis, treatment, and management of IDD.

  • Methods or devices to develop or adapt smart technologies (such as wearable devices, mobile health applications (apps), and electronic medical records (EMR)-based tools) to assist in remote health monitoring, to service as point -of-care diagnostic tools, and/or to enhance screening, diagnosis, prevention, treatment, or management for individuals with IDD to improve their quality of life.

  • Development of assessment measures or treatments for co-morbid symptoms in those with IDD including disordered sleep, self-injurious behaviors, obesity, gastrointestinal dysfunction, seizures/epilepsy, attention def icit/hyperactivity disorder, anxiety, depression, psychosis, immune dysregulation, self-injurious behaviors, and ADHD and other mental health disorders.

  • Innovative and new digital technologies and mHealth solutions for improving transition of adolescents to adult healthcare providers by improving health literacy, enabling self -management, and encouraging adherence to existing treatments among adolescents.

  • Methods and devices to facilitate inclusion of people with all levels of IDD in research and clinical care – both research/care targeted toward IDD populations and research/care for more general populations where people with IDD are typically categorically excluded.

  G. Maternal and Pediatric Infection Disease Branch. MPIDB supports domestic and international research on human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) and other infectious diseases (such as CMV, Syphilis, tuberculosis, hepatitis and malaria) in people of child bearing age, pregnant people, mothers, fetuses, infants, children and adolescents. Specific areas of interest include but are not limited to epidemiology, clinical manifestations, immune-pathology, pathogenesis, transmission, treatment and prevention (including immune-therapeutics like monoclonal antibodies, vaccines and other biomedical modalities) of HIV infection, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and other pertinent infectious diseases in children, adolescents and pregnant people, with a focus on prevention of vertical transmission of HIV and other congenital infections, and HIV-related and other infectious-disease related complications in these populations. Additional areas of interest include:

  • New technologies relevant to resource-limited countries for:

    • Screening, diagnosis, and management of infectious diseases in pregnant women, infants, and children, including but not limited to HIV such as SARS -CoV-2, congenital CMV, congenital Syphilis, tuberculosis, and Zika virus)

    • Rapid assays to monitor disease activity and response to therapy as well as immune response to vaccinations against relevant infections in infants and children (e.g., malaria, tuberculosis), which can be used at the individual level and/or as part of public health campaigns (e.g., eradication of outbreaks and prevention of spread)

    • Diagnosis and treatment of HIV-related co-morbidities (e.g., diagnosis of tuberculosis, STIs)

    • Diagnosis and treatment of SARS-CoV-2 infection-related outcomes in mothers and infants

    • Simple and less technologically demanding point of care assays to monitor CD4 cell percentage/count, HIV viral load, or other surrogate markers of HIV disease progression in children

    • Simple and easy to use/at home use diagnostics and point of care assays to monitor clinical symptomatology and prognosis of SARS-CoV-2 infection and recovery in children

  • Interventions designed to promote or optimize medication adherence

  • Child-friendly formulations (preferably not liquid preparations) of drugs used to treat or prevent HIV infection, complications of HIV infection, and/or other high-priority infections such as tuberculosis, hepatitis, Syphilis, CMV, and malaria relevant to children, particularly in resource- limited countries; Fixed-dose drug formulations and innovative methodologies for development of solid heat stable formulations capable of being administered to young children (e.g., sustained release beads, etc.) and/or improve pill or volume burden

  • Innovative long-lasting drug formulations for antiretroviral and other anti-infective drugs that would allow less frequent drug administration (e.g., once daily, weekly, or monthly)

  • Simple, standardized, validated tools to evaluate neurodevelopmental outcomes in children

  • Innovative data collection and database development approaches to leverage and link electronic medical records and/or other health information systems to better understand treatment and prevention of infectious diseases among infants, children, adolescents, and people of child-bearing age.

  • Biomedical modalities including vaccines and methods to assess efficacy of vaccines, to prevent acquisition of HIV and other infectious diseases in children, adolescents, and women.

  • Topical microbicide agents, wearable, implantable, or insertable devices releasing medications alone or as part of multipurpose prevention technologies (MPTs), to prevent sexual acquisition of HIV and other sexually transmitted infections in adolescents, adult women, and pregnant or postpartum people.

  • New, non-invasive technologies to evaluate complications of antiretroviral drugs (e.g., mitochondrial toxicity, bone toxicity) in HIV-infected infants, children, adolescents, pregnant people, and their fetuses.

  • New or improvements to existing technologies for measuring the HIV latent reservoir, or other long-term effects of infectious diseases, including high-throughput, visualization algorithms, and improvement in assay reliability and sensitivity in children.

  H. Obstetric and Pediatric Pharmacology and Therapeutics Branch. The OPPTB supports research and research training on the development and use of safe and effective therapeutic drugs and therapeutic -related medical devices for children and pregnant and lactating people, including during the postpartum period. The branch promotes basic, translational, and clinical research to improve the safety and efficacy of therapeutics, primarily pharmaceutical drugs and medical devices. It is responsible for developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, lactation, infancy, childhood, and adolescence using evidence-based therapeutic approaches. This includes support for the development and validation devices to inform treatment decisions and enhance precision drug delivery. The goal of these efforts is to assure that medications are appropriately tested for dosing, safety, and effectiveness for individuals within their target populations. Of note: NICHD considers applications for pediatric conditions that have significant efforts at other NIH institutes (e.g., sickle cell disease, pediatric oncology, juvenile diabetes) to be of lower programmatic priority. Applications to advance the study of obstetric and pediatric therapeutics include but are not limited to:

  • Understanding Differences and Heterogeneity in Pediatric Disease Treatment. Research to quantitatively understand differences in drug action and related pathophysiology between childhood and adult disease and conditions unique to pediatrics. This includes developing tools (e.g., biomarkers, outcome measures, and physiologically based pharmacokinetic/pharmacodynamic models) to support pediatric drug discovery and development and to facilitate the application of precision medicine approaches in children.

  • Pharmacology and Pathophysiology of Pregnancy. Developmental pharmacology research and approaches that explore the intersections of physiological changes in pregnant people and during fetal development with drug action (e.g., pharmacokinetic, pharmacodynamics, and pharmacogenomics) and with molecular pathways that may serve as novel therapeutic targets for disease-modifying therapies specific to these populations. Critical areas include pain management in pregnant and lactating people and treatment of gestational diabetes, preeclampsia, and prevention of preterm delivery.

  • Novel Alternatives to Traditional Pediatric and Obstetric Clinical Trials. Development of innovative approaches and algorithms to determine drug dosing, safety, and effectiveness in children and in women during pregnancy and lactation. This includes artificial intelligence-driven modeling and simulation methods, novel approaches to utilizing existing data and archived biosamples/biospecimens, and pragmatic trials.

  • Population- and Individual-Specific Diagnostic and Therapeutic Devices that can advance precision medicine through individualized diagnosis, drug delivery, and non-drug therapy appropriate for use in neonates, children, and obstetric and lactating people. This may include 3D bioprinting, AI-enhanced pharmacometrics modeling, AI-driven diagnostic and decision-making tools, novel drug delivery devices, and formulations.

  • New Uses for Drugs, Biologics, and Other Therapeutics. This includes the development and use of preclinical experimental models (e.g., animal models and human biomimetics), use of organotypic microphysiologic cell culture systems and strategies for assessing pharmacologic and toxicologic effects of therapeutics, use of genetically diverse model organisms to assess precision prescribing approaches for interindividual manifestation of disease or response to therapeutic agents, and computation models or the accumulation of real-world evidence in support of new therapeutic uses.

  I. Pediatric Growth and Nutrition Branch. The PGNB supports research designed to support short and long-term health so that children can achieve their full potential through an expanded understanding of those factors that influence metabolism, growth (body composition and linear growth) and neurodevelopment. An additional focus is on those biological (e.g., genetic, nutritional, endocrinological) factors that contribute the early life origins of non-communicable disease (e.g., obesity, diabetes, cardiovascul ar disease, osteoporosis). The PGNB encourages research that focuses on detecting the biological antecedents of these conditions during pregnancy, infancy, and childhood. Areas of interest include, but are not limited to: New research tools, improved measurement methods, and technologies that enhance our understanding of:

  • Growth:

    • Physical growth, body composition, bone health, nutrition, and obesity

    • Determinants of normal bone mineral accretion and peak bone mass. Interactions of muscle and bone during infancy and childhood

    • Neuroendocrinology of puberty, linear growth, body composition

    • Mechanisms of hormone action during linear growth, pubertal maturation, and other aspects of physical development

  • Biological antecedents of childhood obesity and its short and long-term consequences:

    • Genetic and molecular mechanisms of obesity, psychosocial risks of obesity, and therapeutic interventions for obesity in children and adolescents

    • Impact of early life exposures including infant feeding practices on short and long- term health and development

  • Biology of nutrition as it pertains to health and development (physical and neurological function) during pregnancy, infancy and childhood including discovery, development and deployment of biomarkers for early detection of :

    • Mal-(over-/under) nutrition; including biomarkers of exposure, status, function and effect (i.e., impact on early life development including neurodevelopment)

    • Enhanced understanding of the role of human milk in child health and development.

    • Maternal nutrition (pre-pregnancy, pregnancy, and lactation)

    • Novel approaches to enhanced infant feeding practices in term and pre-term infants

  • Developmental origins of health and disease including:

    • Ascertain biomarkers early in life that predict the onset of chronic diseases such as diabetes, osteoporosis, and the metabolic syndrome later in life. The PGNB emphasizes the life course model to develop primary preventive approaches to chronic diseases.

    • Develop platforms for implementation of biomarkers of disease status, nutritional status, and biological function f rom infancy through adolescence

  J. Pediatric Trauma and Critical Illness Branch. The PTCIB supports research and research training in pediatric trauma, injury prevention, and critical illness across the continuum of care. These efforts include research focused on the prevention, treatment, and management of physical and psychological trauma and the surgical, medical, psychosocial, and systems interventions needed to improve outcomes for critically ill and injured children and adolescents. Additionally, the PTCIB supports basic, clinical, and translational research that explores short - and long- term consequences of traumatic experiences such as exposure to disasters, all forms of violence against children, exposure to critical illness environment, and experiences of bereavement, grief, and loss. Applications of interest include, but are not limited to the research and development of:

  • Technologies, devices, and equipment used by pediatric critical care, emergency care, and trauma care personnel.

  • Novel technologies in caring for injured children prior to and during transport to treatment settings.

  • Tools and technologies for screening and diagnosis of injuries related to forms of child maltreatment.

  • Devices and innovative therapeutic technologies for management of medical conditions and related problems stemming f rom critical illness and serious or life-threatening injuries.

  • Preventive intervention tools, materials, and technologies designed to improve clinical practice, parenting, and social system support for injured or traumatized children.

  • Tools, materials, and technologies designed to reduce pediatric trauma exposure and the number and severity of pediatric injuries and deaths.

  • Tools and technologies to improve the environment of pediatric intensive care including resources to promote patient safety and to enhance clinical education and training of critical care personnel

  • Tools and technologies that support the diagnoses and treatment of critical illness in children, including nosocomial infections and iatrogenic injury.

  K. Population Dynamics Branch. PDB supports research and research training in demography, reproductive health, and population health. In demography, the Branch supports research on the scientific study of human populations, including fertility, mortality and morbidity, migration, population distribution, nuptiality, family demography, population growth and decline, and the causes and consequences of demographic change. In reproductive health, the Branch supports behavioral and social science research on sexually transmitted diseases, HIV/AIDS, family planning, and infertility. In population health, the Branch supports data collection and research on human health, productivity, behavior, and development at the population level, using such methods as inferential statistics, natural experiments, policy experiments, statistical modeling, and gene/environment interaction studies. Applications are encouraged, but are not limited to these areas:

  • Technological innovations or inventions to improve collection of biomarker and anthropometric data in large population-representative surveys

  • Hardware or software to improve the collection of accurate cause of death information or health diagnosis such as information related to infant and maternal morbidity and mortality, in large population-representative surveys or in administrative data sets

  • Methods for integrating data science, including artificial intelligence and machine learning, into demographic research

  • Methods for improving the collection, documentation, archiving, linking, and dissemination of population representative data sets, especially data sets that are complex, multilevel or multimodal

  • Methods for protecting and assuring confidentiality for human subjects when collecting, archiving, linking, or disseminating population-representative data sets, especially data sets that are longitudinal or that include both spatial and individual -level data

  • Methods for reducing the costs of collecting, linking, and disseminating large-population representative data sets

  • Development and dissemination of effective tools for prevention research and intervention programs related to STIs/HIV; pregnancy; contraceptive use; adolescent, young adult, and maternal mortality; child health; at -risk youth; and other health-related topics relevant to PDB science

  • Innovative approaches and techniques for research design, measurement, and data collection and analysis in the social and behavioral sciences, with particular attention to methodology and measurement issues related to protecting research subjects, archiving and disseminating complex datasets, and studying diverse populations and/or sensitive or confidential behaviors

  L. Pregnancy and Perinatology Branch. The PPB supports research in the following areas: the physiology of pregnancy and labor; high- risk pregnancies, including those with hypertensive disorders, diabetes or seizure disorders; fetal pathophysiology; premature labor and birth; diagnostic, monitoring, and therapeutic devices and instruments for newborn infants in the nursery and in Neonatal ICU setting; improving the existing products or developing new products that would improve the routine and extended care of the newborn infants; products and agents related to breastfeeding; hospital supplies specifically related to use in the care of newborn infants; nanotechnology and its application for the care of newborn infants; instruments and devices for assessing and monitoring the nursery environment (noise, lighting, and odor); disorders of the newborn; sudden infant death syndrome; and biological and behavioral antecedents of low birth weight. The following topic areas are of high priority:

  • Non-invasive (or minimally invasive) methods to assess preeclampsia; gestational diabetes; fetal well-being; spontaneous preterm birth; and stillbirth

  • Methods to characterize the bioactive components of human milk

  • Non-invasive methods to longitudinally identify predictors and indicators of placental dysfunction including malperfusion, abnormal placental development, and impaired placental function (nutrient transfer, metabolic function, exchange of respiratory gases, and hormone production).

  • Devices, instruments, and tools to minimize bacterial colonization, reduce proclivity forthrombus formation, and reduce healthcare associated infection risks

  • Lab-on-a-chip; specifically, non- or minimally-invasive approaches for assessing metabolic profiles (e.g., glucose and lactate/pyruvate), ketone bodies, bilirubin (unconjugated, free, indirect, and total), and other major analytes (Na+ Ca+ Cl+ K+ etc.)

  • Rapid methods for diagnosis of bacterial infections and the assessment of antibiotic sensitivity

  • Improved syringes, needles, and injection set ups to help administer small doses of medications over prolonged periods (e.g., insulin for treating hyperglycemia)

  • Methods to assess pain in the newborn, analgesia, and the evaluation of neonatal opioid withdrawal syndrome

  • Non-invasive measures to assess brain energy utilization in the newborn, especially glucose, oxygen, lactate, ketones, and other energy substrates

  • Improved devices and instruments for assisted ventilators for use in the neonatal ICU

  M. National Center for Medical Rehabilitation Research. This Center supports innovative research on the restoration, replacement, enhancement or adaptation of function for people with chronic physical disabilities. This includes rehabilitative approaches across etiologies and the lifespan, as well as the environmental and policy factors that promote full participation. We encourage studies that integrate biomedical, engineering and/or psychosocial approaches to develop practical and creative solutions to the daily functioning of people with disabilities and their families. The mission of the NCMRR is to increase the effectiveness of medical rehabilitation practices through research. Information about specific program areas within NCMRR can be found here. Examples may include but are not limited to:

  • Adaptation and Plasticity: Develop non-invasive and surrogate measures of plasticity that would be appropriate for use in a clinical setting to target rehabilitation therapies and monitor treatment effectiveness (e.g., biomarkers, imaging)

  • Novel Technology: Orthotics, prosthetics, and robotics devices and interfaces; Assistive technologies; Invasive and non-invasive biological sensors, prosthetic systems or implants to improve function; New control methods and improved sensory feedback; Strategies for controlling and adapting to the environment; Advanced wheelchair designs and enhancements and other mobility devices; Biomaterials and tissue interfaces, nanotechnology, bionics

  • Rehabilitation Interventions: Development and use of robotics; Gaming applications; Virtual and Augmented Reality; Simulations; M-health and other approaches to promote participation, understand and support healthy behaviors, reduce health disparities, and enhance clinical compliance, especially in children with physical disabilities.

  • Chronic Symptom Management: Methods to increase screening for chronic conditions or preventable secondary conditions in individuals with physical disability; Prevention and treatment strategies for mitigating symptoms associated with multiple chronic conditions in individuals with physical impairments, including persistent pain, symptoms of obesity, diabetes, cardiovascular deconditioning, fatigue, symptoms of overuse injuries, pressure ulcers, sleep disturbances, and depressive symptoms; Improving muscle capacity in chronic physical disability to include therapeutic or adaptive exercise and muscle stimulation; muscle-disuse syndromes and contractures; Rehabilitation interventions for improvement of physical disability and comorbid cognitive, sensory, or somatic consequences of impairment, disease or injury; Autonomic function in the context of injury or specific conditions.

  • Rehabilitation in the Community: Strategies to build or modify community and/or environmental resources that provide effective rehabilitation and health promotion services within the individual’s own community. Development of engineering, crowdsourcing, and social science approaches to promote, monitor, and sustain outcomes in real world settings.

• National Institute on Drug Abuse (NIDA)

  The major NIDA SBIR/STTR portfolio areas of interest are listed below as a general guide. Applications proposing innovative technologies in substance use and addiction with strong commercial potential that fall outside these portfolio areas are also encouraged through this Omnibus solicitation.

  Biomarker Development for SUDs. Currently, there are no biomarkers to assess or predict treatment efficacy or categorize SUDs into clinical subtypes. Thus, it is impossible to design treatments for effective and long-term recovery by classifying SUD patients into categories that have reproducible and predictive validity. Long-term use of opioids and other substances alters the integrity of homeostasis, changing the endogenous opioid, endogenous cannabinoid, and almost all receptor systems studied so far in the brain and peripheral immune cells. Biomarkers and signatures in patients diagnosed with an SUD can be very different from those observed in patients without SUDs. These biomarkers or potential predictive markers could serve as objective prognostic indicators to develop SUD. In addition, they could act as response predictors to SUD therapeutics in adults, or as diagnostic biomarkers for infants with neonatal abstinence syndrome (NAS). Furthermore, artificial intelligence (AI)-related technologies are being investigated in healthcare to analyze patients’ big data, such as electronic health records of historical and current patient treatments, to create more effective and better patient outcomes and to identify new diagnostic tools and novel analyses. Accordingly, AI-related tools are of interest to accelerate traditional and innovative areas of SUD biomarker development. The proposed biomarker research should emphasize the importance of biomarker signatures that can intersect SUD and related conditions that are considered important to the mission of NIDA. Proposed projects may include biomarkers that assess the probability of SUD or allow an assessment of the treatment trajectory in patients under treatment for SUD. Specific projects may encompass, but not restricted to:

  • Biomarkers with high specificity and sensitivity for opioids, stimulants, cannabis and other emerging substances;

  • Biomarkers that can detect substance use in early stage;

  • Development of biomarkers that provide objective measures of substance use.

  • Biomarkers that can predict an individual’s response to different treatment modalities.

  • Biomarkers suitable for longitudinal monitoring of substance use.

  • Biomarkers capable of detecting concurrent use of multiple substances

  Projects solely focused on biomarkers for pain and alcoholism are of limited interest.

  Personalized Medicine for SUDs. Advancements in technology and our deepening understanding of underlying neurobiology have provided us with the chance to target specific neurobiological processes and tailor interventions approaches to individual patients based on their unique genetic, neurobiological, and environmental characteristics. This personalized approach recognizes the significant variability among individuals in how they respond to medications, therapies, and other interventions. Genetic variations can influence a person’s susceptibility to developing SUD, and treatment response. Genetic testing would identify specific gene variants associated with SUD risk, metabolism of drugs and treatment response. Further, neurobiological differences in brain structure and function can impact how an individual’s experiences and respond to different substances. Identifying aberrant brain connectivity patterns and assessing neurotransmitter levels can guide the treatments to modulate the pathways. Finally, social, cultural, and environmental factors play a significant role in the development and course of SUDs. Areas of interest include but are not limited to: a) Identifying and leveraging existing social support networks and recognizing environmental triggers that contribute to substance use and modifications to mitigate the impact and b) utilizing big-data analytics and predictive modeling to identify patterns and predictors of treatment response and refine personalized treatment approaches. Overall, personalized medicine holds promise for improving the effectiveness and outcomes of SUD treatment by addressing the biological and social factors that contribute to substance use disorders.

  SUD Drug Discovery and Development. Pharmacotherapy offers an important means of treating SUDs. Currently, there are five pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of Opioid Use Disorder (OUD) and mitigation of opioid withdrawal symptoms: methadone, buprenorphine, extended-release naltrexone, naloxone, and lofexidine. In addition, varenicline is an approved drug for the treatment of nicotine cessation. However, given the diverse nature of SUDs, many patients have limited responses to available medications and, consequently, there is an urgent need for novel treatments. It remains of program interest to identify and develop improved pharmacotherapeutics with clear advantages over our current approved pharmacotherapeutics for OUD treatment and for nicotine cessation treatment. Additionally, there are no FDA-approved medications for cocaine, methamphetamine, or cannabis use disorders. Broadly, novel pharmacotherapeutics are encouraged for the range of unmet medical needs in SUD, for polysubstance use, and for emerging novel treatment modalities and mechanisms of action for SUD treatments. Developing and evaluating new, more efficacious medications remains a high priority. Candidate medications may include either novel or re-purposed compounds. Specific areas of interest include medications that target one or more domains of the addiction cycle, including reward, stress and negative affect, incentive salience, executive function, habituation, and impulsivity/compulsivity. Proposed projects may include emerging technologies and platforms for SUD medication development with a focus on products with the potential to minimize drug seeking, compulsive behavior, overdose prevention, and reversal. Specific projects may include, but are not limited to:

  • Early therapeutic discovery activities ranging from target identification and validation through lead development;

  • SUD phenotypic assay development (e.g., organoids, organ-on-a-chip technologies, and higher content invertebrate models, ex vivo bioassays) with validation studies in animal models (e.g., rodent models).

  • Preclinical and/or clinical drug development;

  • Medications that would address specific symptoms of withdrawal, such as cravings, depression, cognitive impairments, pain, and sleep problems;

  • Medications (neurochemicals) involved in social bonding that also modulates key processes associated with addiction, including reward and stress responses, and may enhance the efficacy of psychosocial addiction treatments;

  • Big-data analytics and machine-learning algorithms analysis yielding insight into behavioral and biological markers of relapse risk;

  • Artificial Intelligence (AI)-related tools in SUD drug discovery and development to increase innovation and support a cost- and time-effective SUD drug development of pharmacotherapies.

  • Combination of pharmacotherapeutics to improve SUD treatment adherence and decrease risk of relapse. Molecules may include new and investigational compounds and repurposed approved medications

  Projects proposing to study compounds already extensively investigated or currently being studied in patients with SUD, and projects solely focused on pain or on alcoholism not associated with SUD are of limited interest.

  FDA-regulated Medical Therapeutic and Diagnostic Devices for Substance Use and Addiction. Medical Devices, including Software as Medical Device (SaMD), offer promising means to monitor, diagnose, and treat patients who use substances for medical purposes, in addition to patients with SUDs. Currently, there are only a few devices that are cleared by the FDA for the treatment of SUD. As such, the investigation and development of new safe and effective medical devices intended to prevent, monitor, diagnose, and treat substance use and addiction is a high priority. Applications in this area are expected to address the needs of those who actively use substances, chronically use substances, or have a diagnosed SUD, and their caregivers, to ensure access to high-quality, safe, and effective medical devices. It is expected that proposed approaches will include activities that will lead to regulatory submissions for pre-market clearance / approval, including interactions with the FDA via the following pathways: pre-submission (Q-submission), Investigational Device Exemption, 510(k), DeNovo, or Premarket Approval (PMA) application. Additional pre-clinical activities may include, but are not limited to, a) bench testing or computational modeling studies; b) good laboratory practice animal studies; c) good manufacturing practice studies; d) toxicology and biocompatibility studies; e) software verification and validation; f) usability/user experience testing. Specific areas of interest include, but are not limited to:

  • Imaging devices intended to investigate brain function and enhance monitoring, diagnosis, and/or treatment of SUD;

  • Devices that directly diagnose and/or reduce craving and withdrawal symptoms;

  • Devices that identify and/or treat NAS;

  • SaMD focused on behavioral health interventions to alleviate the burden of SUD;

  • Therapeutic devices (e.g., neuromodulation) intended to improve SUD treatment outcomes and relapse prevention;

  • Physiological monitoring devices, including remote detection (e.g., wearables, sensors, health monitoring/emergency notification systems), specifically intended for use in patients affected by substance use and addiction.

  Harm Reduction Technologies. Harm reduction is an evidence-based public health approach that that directly engages people who use drugs (PWUD) to prevent overdose, disease transmission, and other harms associated with drug use. NIDA included harm reduction in its FY 2022-2026 Strategic Plan in Priority Scientific Area #2: Develop and Test Novel Prevention, Treatment, Harm Reduction, and Recovery Support Strategies. Harm reduction was also identified as a federal drug policy priority in the 2022 National Drug Control Strategy from the White House Office of National Drug Control Policy (ONDCP) and is also one of the strategic priorities of the U.S. Department of Health and Human Services (HHS) Overdose Prevention Strategy. Decades of evidence has shown that strategies for harm reduction substantially reduce HIV and hepatitis C infection among people who inject drugs, reduce overdose risk, enhance health and safety, and increase the likelihood of PWUD to initiate substance use disorder (SUD) treatment (SAMHSA Harm Reduction Framework 2023). The ideology behind harm reduction is based on helping PWUD increase their quality of life even if they are not yet ready to enter treatment. The ONDCP’s Guiding Principles on Harm Reduction are: 1) supporting individuals and overcoming obstacles in accessing all types of care, from overdose prevention strategies to medications and mental health services, 2) providing ongoing support to individuals once harm reduction or treatment services are initiated, 3) creating connections for PWUD with caring staff or volunteers as part of receiving health and social services, and 4) treating PWUD with respect and dignity to help them achieve better outcomes. Harm reduction strategies can address safer practices, safer settings, access to healthcare, transitions to care, sustainable infrastructure, and a sustainable workforce. Applications addressing harm reduction principles include, but are not limited to, technologies for:

  • Education about the value of harm reduction and reduction of stigma surrounding drug use;

  • Prevention, treatment, recovery, and general health promotion for PWUD;

  • Addressing overdose education, detection, and naloxone use;

  • Promoting safer use (e.g., drug-checking, reducing infection risk);

  • Prevention, testing, and treatment for sexually transmitted infections;

  • Ensuring access to and assistance with nutrition, clothing, shelter, housing;

  • Enabling peer support and the inclusion of people with lived experience in all aspects of care;

  • Increasing access to low-barrier treatment services, including access to healthcare and oral health services;

  • Ensuring access to medication and treatment on-demand, including mobile buprenorphine and methadone;

  • Expanding telehealth and addressing low technology literacy;

  • Ensuring coordination of care for individuals leaving carceral settings.

  Technological Approaches to Decrease Stigma Associated with Substance Use and Addiction. Stigma is understood as a socially constructed phenomenon that occurs when members of a group experience status loss or discrimination based on some shared characteristic that is deemed undesirable by others. Its effects can occur through attitudes and beliefs internalized by impacted individuals (self- stigma), through overt discrimination by others (experienced or enacted stigma), and through the fear of such discrimination (felt stigma). The stigma around substance use and addiction represents a significant public health problem, despite the growing understanding that substance use and addiction are complex brain disorders with behavioral and physiological components. As for other disorders, medical care is often necessary to facilitate recovery and prevent adverse outcomes, including overdose. Patients can recover from substance use and addiction and lead healthy lives; however, stigma limits successful access to care. Stigma often may be related to multiple conditions, such as SUD, mental illness, or infectious disease; behaviors such as specific drug use practices (e.g., opioid injection); or identity statuses related to gender, sexual orientation, sexual identity, race/ethnicity, or socioeconomic factors, such as personal income. It is expected that leveraging state-of-the-art technologies and the latest science will allow to develop and commercialize the products and services aimed at reducing the stigma around substance use and addiction. Applications in this topic may propose projects demonstrating how latest technology and evidence-based science could meaningfully reduce the stigma associated with substance use and addiction. Applications may address individual (internalized, anticipated, or enacted), interpersonal, organizational, and/or structural levels of stigma. Applications and focus can be on any entry point along the continuum of care. Areas of specific research interest and substance use and addiction service contexts include, but are not limited to:

  • Providing anti-stigma training for medical professionals;

  • Targeting stigma reduction of non-medical providers (social workers, criminal justice, family members, and educators);

  • Enhancing both employee well-being and effectiveness of a drug-free and stigma-free workplace program;

  • Anti-stigma training specific to adolescent substance use and prevention;

  • Digital certification program for nonprofessional care givers who provide support services for patients with SUD;

  • Virtual employee assistance programs with focus on SUD and mental health.

  Additionally, examples of technological approaches include, but are not limited to:

  • Natural language processing, computer vision, and other machine learning tools to detect and analyze provider behaviors and medical records reflecting stigma around substance use and addiction alone and intersectional stigma;

  • Digital compassion (anti-stigma) coaching for medical professionals delivering treatment to SUD patients exploring immersive technologies such as extended reality;

  • Ecological momentary sampling and other digital phenotyping patient-centered tools to detect points of vulnerability and counteract internal stigma supporting the whole-person model of recovery;

  • Neural activity-based tools and services to help develop and disseminate the most effective anti-stigma campaign.

  Prevention Technology to Address Substance Use and Addiction in Various Underserved Populations. Differences in race, socioeconomic status, sex, and geography have created inequities in care for substance use and addiction. Alternatives in healthcare that emerged during the pandemic, such as virtual doctor visits, along with new tools to facilitate telehealth, may help address some of the barriers to SUD care for currently underserved populations. There are three categories for which prevention technology can address substance use and addiction in various underserved populations despite the aforementioned differences. Primary prevention provides tools to intervene before health effects occur. Secondary prevention provides screening tools to identify diseases in the earliest stages before the onset of signs and symptoms. Tertiary prevention provides tools to manage disease post-diagnosis to slow or stop disease progression. Applications may address micro- (individual, internalized, anticipated, or enacted), or macro- (interpersonal, organizational, and/or structural) levels of health inequities related to various underserved populations. The focus of applications can be on any entry point along the continuum of substance use and addiction care. Examples include:

  • Primary prevention through measures such as altering risky behaviors (cannabis and/or tobacco use), and banning substances known to be associated with a disease or health condition.

  • Secondary prevention through measures such as SBIRT (Screening, Brief Intervention, Referral to Treatment).

  • Tertiary prevention through measures such as rehabilitation, and medication assisted therapy.

  Areas of specific research interest with respect to substance use and addiction service contexts include, but are not limited to:

  • Providing prevention education and behavior change training for medical professionals; targeting knowledge awareness and behavior change for non-medical providers (social workers, criminal justice, family members, and educators);

  • Digital or non-digital behavior change interventions enhancing both employee well-being and effectiveness of a drug-free workplace program;

  • Digital or non-digital prevention education training specific to adolescent substance use and prevention;

  Additionally, examples of technological approaches include, but are not limited to:

  • Machine learning tools (e.g., natural language processing) for provider/medical record substance use and addiction bias;

  • Digital mindfulness coaching for medical professionals delivering substance use and addiction services with virtual reality;

  • Ecological momentary sampling and other digital phenotyping patient-centered tools to detect points of vulnerability and address them with a whole-person model of recovery.

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  The NIDCD accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. Some examples of research topics within the NIDCD mission areas include topics shown below; further example can be found on the NIDCD Strategic Plan website (https://www.nidcd.nih.gov/about/strategic-plans).

  Priority is given to meritorious applications that are likely to develop innovative technologies, provide clear evidence of effectiveness, and bring novel products to the commercial marketplace.

  Hearing and Balance Program

  Development of treatment modalities to prevent or lessen the effects of hearing disorders; development of new hearing aids, over the counter hearing aids, cochlear implants, and other assistive devices; development of improved screening technologies to assess hearing loss, in adults as well as in neonates and infants. Development of technologies that provide self-fitting, self-adjusting, or other features that increase performance, accessibility, or affordability of hearing aids; development of new outcome measures for assessing the efficacy of treatments for hearing disorders. Development of technologies for the diagnosis and treatment of tinnitus. Development of technologies for the diagnosis and treatment of otitis media including non-invasive diagnostics to identify middle ear pathogens, novel antibacterial strategies, and prophylactic anti-microbial strategies. Development of technologies for the study, diagnosis and treatment of noise-induced and age-related hearing loss.

  Development of technologies for the study, diagnosis and treatment of balance disorders, particularly for the elderly; development of clinical tests and instruments to assess balance/vestibular function; development of instruments and tests measuring head stability and vestibular function during natural stimulation of the vestibular system; development of perceptual reporting techniques and psychological indices for clinical assessment of the balance-disordered patient; development of tests and new outcome measures for assessing the efficacy of physical rehabilitative regimens for balance disorders; and development of assistive devices for balance disorders, including neural prostheses for the vestibular system.

  Development of new research tools to aid in the study of the auditory and/or balance systems that can provide an improved understanding of fluctuating patterns of neural circuit structure and function over time and across large assemblies of neurons; new animal models of impaired function; improved diagnostic tools for inner ear function, including DNA-based assays and biochemical markers of disease; innovative tests and instruments to screen for and diagnose inner ear function. Development of technologies to enable gene transfer to the inner ear, including viral vectors and cell type specific markers and probes to examine cell lineage in inner ear regeneration. Development of innovative in vivo imaging capabilities to significantly advance visualization, diagnosis, and treatment of disorders in the clinic.

  Voice, Speech, and Language Programs

  NIDCD is interested in the development of technologies for the study of communication disorders: nature, causes, diagnosis, treatment, and prevention. These communication disorders include but are not limited to: aphasia, apraxia, developmental language disorders, dysarthria, dysphonia, and stuttering. In addition, research is needed for communication challenges that may accompany individuals with autism, deafness, hearing loss, or the inability to rely on spoken language as a primary means of communication. NIDCD is particularly interested in projects that employ a user-centered design or similar approach that engages the target end user throughout the development and research process. In addition, these technologies should be accessible to culturally and linguistically diverse populations.

  The emphasis of responsive projects may include the development of technologies such as: augmentative and alternative communication (AAC) devices; assistive device enhancements that better simulate natural speech (e.g. age, gender, emotion); brain computer interface (BCI) communication prosthesis; mobile health applications; gender affirming voice care; flexible and adaptable treatment delivery systems or intervention protocols that can be easily tailored to the needs of an individual; improved artificial larynges and tracheoesophageal shunts; artificial intelligence computer models that simulate normal and disordered communication; virtual/augmented reality approaches to treatment; and technologies that assist in the access to or delivery of healthcare during a public health crisis.

  Taste and Smell Program

  Development of easily administered diagnostic tools for testing human chemosensory function throughout the lifespan; development of intervention strategies and targeted drugs for the treatment of taste and smell disorders; preventive measures to limit the harmful effects of infections, airborne toxins, radiation, chemotherapy and other drugs on chemosensory function; novel therapies to stimulate regeneration of mature sensory neurons in damaged and/or aged tissue; development of biomarkers for neurodegenerative disease; development of tools to facilitate chemosensory research including improved neuroimaging techniques and visualization at structural and cellular levels.

• National Institute of Dental and Craniofacial Research (NIDCR)

  Translational Developmental Biology and Mammalian Genetics and Genomics

  Priorities are to 1) understand the development of craniofacial complex and 2) elucidate the mechanisms underlying dental, oral, and craniofacial (DOC) conditions and disorders. The ultimate goal is to enable early prevention, diagnoses, and treatments of DOC conditions and disorders on individual basis. Interests in this area include but are not limited to:

  • Develop advanced assays and reagents that allow robust and scalable throughput to genetically engineer and functionally characterize organisms in craniofacial development and genetics studies.

  • Develop novel or improved methods and devices that are minimally or non-invasive, cost effective, and sensitive, for early detection of DOC conditions and disorders using imaging, multi-omic, and other state-of-the art technologies and approaches. Methods and devices suitable for Point of Care, at home, and telemedicine uses are encouraged.

  • Develop methods that are applicable to early treatments (as early as in utero or perinatal, or at a later developmental stage) for human DOC conditions and disorders.

  Translational Dental, Oral, and Craniofacial Data Science

  Priorities are to 1) maximize the utility of Big Data to accelerate DOC research and 2) better enable evidence-based and data science-driven clinical practices. Interests in this area include but are not limited to:

  • Develop advanced analytics to retrieve diverse, multi-dimensional data from data repositories, knowledgebases, literature, electronic health/dental/medical/records, and other sources, and infer relations between data elements to inform basic and clinical DOC research. Machine Learning/Deep Learning/Artificial Intelligence (ML/DL/AI) and natural language processing tools are considered highly relevant.

  • Develop phenotyping, data curation, and data analysis web interfaces for clinicians to support clinical decision making.

  • Develop devices, including those for Point of Care, at home, and telemedicine uses, for the diagnoses of DOC conditions and disorders. Examples include, but are not limited to, imaging and AI based facile devices.

  Infectious Diseases and Immunity

  Research relating to the etiology, pathogenesis, prevention, diagnosis and treatment of infectious diseases of the oral cavity is supported by the NIDCR. This includes research on practical ways to effectively use the host immune system to prevent or treat oral infectious diseases and microbial-induced inflammation. Infectious diseases of the oral cavity include caries, periodontitis, candidiasis, peri- implantitis, pulpitis, and various viral, bacterial, and fungal infections of the oral mucosa and research on the diagnosis and prevention of oral manifestations and malignancies of HIV infection and AIDS. Specific examples of technology development needs include but are not limited to:

  • Develop ways to overcome or eliminate the risk of oral infections in persons who smoke or chew tobacco, drink alcohol, or are immunosuppressed, have diabetes, are malnourished, or are psychologically stressed.

  • Explore novel methods or agents to eradicate oral biofilms (dental plaque) on teeth, oral soft tissues, and dental implants without adversely affecting the normal oral flora.

  • Isolate, synthesize or prepare new antibiotics and antimicrobial agents that can overcome bacterial and fungal resistance to current compounds. Formulate combinatorial drug regimens to attack microbes growing in oral biofilms (dental plaque).

  • Develop controlled release systems for local delivery of synthetic peptides, recombinant proteins, or other chemical or immunotherapeutic agents to prevent, control, and/or treat oral infectious diseases, or the oral manifestations of HIV infection.

  • Develop biological response modifiers or other immunological approaches to reduce or eliminate microbial-induced chronic inflammation or the tissue destruction associated with chronic inflammation in the oral cavity.

  • Develop ways to interfere with microbial colonization and growth through the use of antimicrobial agents and chemotherapy.

  • Identify and exploit the structural features of oral biofilms for increased therapeutics delivery.

  • Develop computer programs and apply systems biology approaches to model biologically active peptide regions of oral components that have anti-fungal, anti-bacterial and anti-viral activities.

  • Develop substitutes of naturally occurring chemicals (phytochemicals) known to have a role in controlling opportunistic infections induced by HIV.

  • Develop synthetic peptides and recombinant proteins of oral components with anti-fungal, anti- bacterial and anti-viral activities including those against HIV and oral opportunistic pathogens.

  • Develop oral topical formulations with combined microbicide, analgesic, and anti-inflammatory activities to enhance oral mucosal defenses and prevent and/or control oral infections and lesions in HIV-infected and/or immunosuppressed subjects.

  • Discover, test, standardize, and validate novel biomarkers present in oral biospecimens for screening and clinical diagnosis of HIV, and oral opportunistic pathogens infections and AIDS malignancies. Apply similar strategies as listed below for oral, oropharyngeal and salivary gland cancers to AIDS malignancies.

  • Develop the next generation of rapid tests and point of care devices to detect, quantify, screen, and diagnose HIV and oral opportunistic pathogens. Develop novel assays to quantify oral mucosal reservoirs for oral viruses, oral immune responses to viral prophylactic and therapeutic vaccines, and viral changes due to anti-viral treatments.

  • Develop safe and effective targeted diagnostic and therapeutic technologies in response to endemic and pandemic infections.

  Oral, Oropharyngeal and Salivary Gland Cancers

  Emphasis is on molecular mechanisms of oral epithelial cell deregulation that lead to oral cancers. Research related to early detection, diagnosis, and prevention, and treatment of oral cancers is of particular interest. Examples include but are not limited to the following areas:

  • Develop imaging techniques for the early detection, diagnosis and prognosis of pre-malignant lesions.

  • Develop effective pharmacological, immunological and radiological modalities for treatment of pre- malignant and malignant lesions in preclinical models.

  • Develop novel technologies for the genetic and molecular-targeted therapy (e.g. siRNAs, peptide- based therapies) in preclinical models.

  • Develop genetic animal models of oral cancer premalignancy and oral cancer progression that mimic human oral cancers, including HPV-associated oropharyngeal cancers.

  • Develop animal models to facilitate the testing of therapeutic and chemopreventive agents for oral cancers.

  Temporomandibular Disorders and Orofacial Pain

  Emphasis is on research for chronic disabling painful diseases of the oral-craniofacial-dental areas including chronic pain, neuropathies, and diseases of the temporomandibular joint. NIDCR encourages applications that include but are not limited to:

  • Develop improved methods and technologies for measuring nociceptive, chemosensory, tactile, kinesthetic, or proprioceptive function involving craniofacial structures. Such measures may be useful in screening for deficits, improving diagnosis, or for evaluating responses to orofacial treatments or interventions.

  • Develop improved biomarkers for neuropathic pain conditions affecting oral-craniofacial tissues or structures.

  • Develop assays facilitating reliable evaluations of relationships between biological and other risk factors as they relate to onset, and exacerbation of pain and for examining transition from acute pain to chronic pain conditions.

  • Identify and develop novel pharmacologic or biological agents, and non-pharmacologic methods/approaches, including but not limited to small molecules, peptides, recombinant proteins, nucleic acids, electrical stimulation, and others which could be grouped broadly to electromagnetic induction to modulate mood/nerves, to prevent, control, and/or treat orofacial pain.

  • Develop animal models to facilitate testing of therapeutic agents for orofacial pain.

  Saliva, Salivary Diagnostics, and Salivary Gland Diseases

  Emphasis is on salivary gland physiology and pathophysiology and in the repair and restoration of the damaged gland. Examples include but are not limited to:

  • Develop viral, non-viral and gene therapy-based approaches to address compromised salivary gland function. Develop cell and tissue-based strategies and technologies for restoration of damaged or destroyed salivary gland function.

  • Develop novel compounds or materials that protect and preserve salivary glands from head and neck cancer irradiation therapy.

  • Develop non-invasive methods for the determination of efficacy and safety of artificial saliva, sialogogues, and their delivery vehicles used in addressing the diminution or lack of saliva (xerostomia) due to Sjögren’s Syndrome or head and neck cancer irradiation therapy.

  • Develop biomarker-based technologies for the identification of Sjögren’s Syndrome using blood or saliva as body fluids.

  • Identify biomarkers derived from oral fluids that are predictive of the onset, progression and recurrence of oral diseases and conditions, such as periodontal diseases, caries, and oral, oropharyngeal and salivary gland cancers.

  • Develop immunological strategies and immunotherapy-based approaches for addressing xerostomia from Sjögren’s Syndrome.

  • Improve existing or develop new tools for early detection of salivary gland cancers.

  Biotechnology, Biomaterials, and Applications for Regeneration and Restoration of Oral, Dental and Craniofacial Tissues

  Emphasis is placed on the development of a broad range of technologies targeted at regeneration and restoration of diseased and injured hard and soft tissues of the oral and craniofacial complex and on translating these applications to the clinic. Tissues of interest include craniofacial and alveolar bone, the periodontal ligament, TMJ bone and cartilage, oral mucosa, facial skeletal muscle, vasculature and nerves. Also of interest are multi-tissue composites and organs, such as vascularized and innervated bone and muscle, salivary gland, tooth, periodontium, bone-periodontal ligament-cementum interface and osteochondral complexes. Specific topics could include but are not limited to:

  • Develop technologies for design, fabrication, and manufacturing of biomimetic and biocompatible biomaterials and a range of structurally complex scaffolds, including nanomaterials and self-assembling nano-scaffolds, for tissue engineering and regenerative medicine applications. Projects need to include assessments demonstrating the ability of biomaterials and scaffolds to support generation and regeneration of mineralized tissues that replicate the mechanical, physical and biological properties of dentin, enamel, cementum, or bone.

  • Develop cell-based technologies, including stem cell-based technologies. These include, designing strategies for isolation, purification, differentiation, scaled up production, manufacturing, standardization and quality control of stem and progenitor cells and their differentiated progenies, derivation of efficient and predictable methodologies for cellular reprogramming, and advancing technologies for reconstruction of stem cell niches for augmenting tissue regeneration.

  • Develop bioreactor systems to facilitate design, fabrication, and manufacturing of soft and hard tissues of dental, oral and craniofacial complex. These bioreactors may be able to mimic biophysical forces, such as mechanical and electrical forces that normally guide tissue morphogenesis in vivo. Among other desirable features of the bioreactors are maintenance of tissue construct oxygenation and real-time tissue assessment to encompass metabolites, gene expression, or proteomics evaluation, in addition to morphology and spatial imaging by labeling capabilities.

  • Develop improved dental composite materials and bonding agents, including biomimetic and self-healing materials and adhesive sealants. These include but are not limited to materials to replace Bis-GMA resin-based systems that are suitable for restoring crowns of posterior teeth and exposed roots of the teeth. Any novel dental composite restorative components or systems must include assessments in a physiologically relevant test system that mimics microbial and physicochemical conditions found in the oral cavity.

  • Develop methods, materials, and devices for orthodontic, prosthetic, periodontic, endodontic and craniofacial applications including those that can be used for craniofacial bone distraction, reconstruction, hard and soft craniofacial tissue healing and regeneration, and scarless craniofacial tissue repair.

  • Develop miniaturized artificial tissue and organ mimics/tissue chips and organoids that can be adapted to high-throughput formats for a broad range of applications, such as analysis of biomaterial and tissue function, drug efficacy and toxicology assays, biocompatibility assays, genetic screening and elucidating mechanisms of dental, oral and craniofacial development and disease.

  • Develop mathematical, computational, and bioinformatics approaches for modeling oral and craniofacial tissues and organ function and physiology to address needs of systems biology, synthetic biology, and single cell analysis. Develop new approaches for utilizing novel biomolecules, including growth factors, cytokines, small molecules, siRNAs, and others for counteracting diseases and injuries of oral and craniofacial tissues and promoting their healing and regeneration.

  • Develop new approaches to study molecular or cellular interactions between hard and soft tissues such as between the nervous system and mineralized tissues. Approaches can include development of new technologies or application of existing technologies that are newly applied to the dental and craniofacial field.

  • Develop advanced viral and non-viral based biomolecule delivery approaches, including nanotechnology-based technologies that can precisely deliver and release therapeutic proteins, nucleic acids, small molecules, or combinations thereof with predictable temporal kinetics to target specific tissue sites.

  • Develop imagining diagnostics to accelerate clinical implementation of reliable, reproducible, highly specific and sensitive diagnostic instruments for various applications, including but not limited to dental caries, cracked teeth, pulp vitality, bone quality, and periodontal disease.

  • Develop imaging diagnostics to accelerate clinical implementation of reliable, reproducible, highly specific and sensitive diagnostic instruments for various applications, including but not limited to dental caries, cracked teeth, pulp vitality, bone quality, and periodontal disease.

  • Develop safe and effective biosensors for noninvasive, dynamic real-time monitoring of physiological processes in the human body using the oral cavity as the sensing site. These biosensors will be able to assess health and disease states and receive feedback from body fluids and clinical compounds that are found in or pass through the oral cavity and in certain cases, will be able to communicate these outputs wirelessly and remotely.

  • Develop safe and effective biosensors, monitoring devices and systems, data driven and computer science tools for automated detection, diagnosis and treatment of dental, oral and craniofacial disease.

  • Develop effective multimodal breakthrough technologies for real-time detection of proven disease biomarkers, viruses and/or pathogens with high sensitivity and specificity that integrate detection technologies, such as optical spectroscopy, electrical impedance, radio frequency, acoustic, and immunosensing, with multiplexing capability.

  Preclinical Research

  Preclinical research and development activities for dental and craniofacial technologies including the translation of innovations devices, drugs, biologic and combination products (reconstructive materials, regenerative products, pharmaceuticals, therapeutics, vaccines, digital health technologies) that require review and approval by the FDA as a regulated product before commercial distribution.

  Biomedical Clinical Research

  Emphasis is on development of methods, drugs and materials to diagnose or treat oral and craniofacial diseases and conditions. Areas of interest include but are not limited to projects that:

  • Develop improved methods to detect and predict progression of dental caries, periodontal disease, reversible and irreversible pulpitis.

  • Develop improved methods or materials to prevent dental, oral, and craniofacial diseases or conditions.

  • Develop new or improved methods or materials to enhance oral and craniofacial surgery. This would include both intraoral and extra-oral surgery.

  • Develop improved methods or materials to mechanically and/or biologically repair or treat tooth structure damaged by dental caries or periodontal disease.

  • Develop, customize, and validate data-driven technologies coupled with automated high throughput tools that accelerate development and regulatory evaluation of novel biomaterials.

  • Develop improved appliances to aid suckling and improve speech production by newborn infants with cleft palate and cleft lip.

  • Develop safe and efficacious methods to diagnose caries, pulp vitality and / or periodontal diseases utilizing non-ionizing radiation.

  • Develop technologies for local delivery of drugs to treat oral and craniofacial diseases or disorders.

  • Develop novel non-opioid pharmacological medications for management of acute dental pain.

  • Develop safe and efficacious methods or medications to manage complications of head and neck cancer treatment.

  • Develop tools for implementation of precision medicine in the oral cavity.

  • Develop methods and tools to detect soft tissue pathologies in the oral cavity.

  • Develop oral devices and materials for monitoring local and systemic conditions.

  Behavioral Clinical Research

  Provides support for the development of evidence-based products related to behavioral and social aspects of oral health, oral health prevention or treatment interventions, and other patient-oriented aspects of oral health. This includes support for clinical trials and patient-oriented research to establish safety and initial efficacy of products. NIDCR is especially interested in applications that significantly improve oral health by 1) being broadly applicable to many populations, 2) contributing to meaningful oral health improvements for a specific population, 3) expediting translation of research findings into oral health improvements, and/or 4) equipping oral health care providers, educators or researchers with tools to improve public oral health. Examples of studies of interest include, but are not limited to, the following:

  • Develop and test the effectiveness of innovative teaching or educational tools or curricula to inform oral health professionals and dental students regarding the role of genetics and genomics, including the oral microbiome, in oral diseases, conditions and oral health care; and/or oral cancer prevention and early detection.

  • Develop and test digital health, connected technologies, and approaches to improve time- sampled monitoring of behavioral adherence with preventive, condition management, or therapeutic regimens specifically relevant to oral diseases/conditions. Such devices or methods could be utilized in a variety of settings, including naturalistic settings, within clinical trials, within oral health care delivery systems, etc.

  • Develop and test novel compliance and survey measures or tools to identify the underlying causes of insufficient preventive dentistry for specific underserved populations.

  • Develop and test for safety, efficacy, and/or effectiveness of measures or materials for diagnosing, preventing, or treating oral, dental, and craniofacial conditions and disorders.

  • Develop or adapt for use in new populations or settings: Novel measures or methods for identifying individual, family, group, or other processes that explain oral health behavior; oral health interventions utilizing technology to improve efficiency of delivery (e.g., management of chronic pain related to temporomandibular joint disorders, etc.); interventions addressing health behaviors highly associated with oral health (e.g., tobacco, alcohol, and other drug use; management of diabetes, HIV infection, or other chronic illnesses; etc.).

  • Develop and test innovative methods for facilitating collaborations, referrals, and/or ongoing follow- ups between oral health professionals and other health care professionals across primary and specialty practices.

  • Develop technologies or modules beyond existing web-based platforms to improve preventive oral health hygiene for children and adolescents (e.g., social marketing via app- and web- based interaction, virtual reality “worlds”, “massively multiplayer online games”, etc.).

  • Develop and test web-based training or other innovative approaches for oral health care professionals to accelerate accurate translation of new knowledge regarding oral diseases and their effective prevention or treatment into clinical or public health practice.

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  Diabetes, Endocrinology and Metabolic Diseases

  The Division of Diabetes, Endocrinology and Metabolic Diseases supports SBIR/STTR projects in the areas of type 1 and type 2 diabetes, endocrine disorders, and neuroendocrinology. High priority topic areas are listed below:

  • Sensors, Hormone Replacement, Delivery Devices, and Other Technologies for Diabetes Treatment:

    • Novel accurate, reliable, and user-friendly continuous monitoring sensor technologies relevant to diabetes treatment and monitoring. Preferably, these sensors should have long functional life, and for glucose sensing be accurate at all glycemic ranges, particularly at concentrations below 54 mg/dl.

    • Use of Artificial Intelligence, Machine Learning (AI/ML) tools to enable fully automated closed loop pancreatic hormone delivery systems in response to multi-analyte physiological input.

    • Novel insulin and glucagon formulations showing improved kinetics and stability.

    • Telemedicine/remote monitoring approaches that can be incorporated as components/and or adjuvants of closed loop systems for better diabetes self-management.

    • Technologies that may promote and facilitate adherence/compliance by users of diabetes monitoring and control devices.

    • More reliable and efficient biocompatible infusion sets for automated hormone delivery and improved kinetics.

    • New implantable and easy to replace technologies that may mimic the beneficial effect of gastric bypass/bariatric surgery for the treatment of diabetes without the need of a major invasive surgical procedure.

  • Diabetic Wound Healing and Diabetic Neuropathy:

    • Drugs, biologic therapies, and novel delivery systems that accelerate healing of diabetic foot ulcers and prevent recurrences.

    • Off-loading devices that improve patient acceptability and adherence.

    • Diagnostic and predictive biomarkers, including improved outcome measures, for diabetic foot ulcers that can be used to diagnose biofilms, predict healing, select treatment strategies, or determine risk of primary or secondary occurrence of foot ulcers. The biomarkers may use biosamples, images or sensors.

    • Educational approaches and new technologies that increase adherence to preventative measures for diabetic foot ulcers in high-risk patients or increase adherence to off-loading and other recommended treatment regimens for diabetic foot ulcers.

    • Disease-modifying therapies for the prevention and treatment of diabetic neuropathy.

    • Sensors, algorithms, and patient interfaces that can provide feedback to diabetic individuals with insensate feet to prevent diabetic foot ulcers.

    • Biomarkers to monitor disease progression and response to therapy for diabetic neuropathy, including peripheral sensory, autonomic, and painful diabetic neuropathy.

  • Immune Modulation and Cell Replacement Therapies:

    • Development of immunomodulation/tolerance strategies, including cell-based, to prevent, revert or slow progression of type 1 diabetes.

    • Development and optimization of engineered islet cell replacement sources with improved transplant graft attributes, including but not exclusive to: graft function durability under transplantation and metabolic stress; graft survival with lowered or no systemic immunosuppression and non-invasive quantitative monitoring of graft mass.

    • Novel biomimetic and immuno-engineering strategies for the development of immune evasive cells/islets and biomaterials/devices for successful long-term engraftment with no need of systemic immunosuppression.

    • Development of reproducible methods that improve yield/viability/function of islets/insulin producing cells and allow their ex-vivo expansion for transplantation.

  • Prediction, Screening, Diagnostics, and Monitoring:

    • Development of methodologies, products, or biomarkers useful for predicting, preventing or delaying progression of pre-diabetes or diabetes, including tests for identifying patients at risk, and methods of monitoring disease progression.

    • Validated tests for autoantibody detection, auto-reactive T-cells and other immune/metabolic parameters for type 1 diabetes early diagnosis and monitoring. Improvements could include higher throughput - point of care technologies (reliable, accurate, cost-effective, highly sensitive, and standardized with rapid turnaround time).

    • Multiplexed assays for peptides and proteins that are used as biomarkers in diabetes and metabolic diseases (e.g., insulin, pro-insulin, glucagon, c-peptide, HbA1c..etc).

    • Development of non-invasive technologies such as imaging for the in vivo measurement/evaluation of pancreatic islet’s cell mass, function and inflammation.

    • Artificial Intelligence, Machine Learning, and Deep Learning driven methods and technologies that may optimize prediction, diagnosis, monitoring and treatment of diabetes, endocrine and metabolic disorders.

  • Pre-Clinical Research and Disease Modeling:

    • Development and optimization of microphysiological/organ on chip platforms in the application of pre-clinical testing and/or modeling of physiological and pathophysiological aspects of diabetes, endocrine and metabolic disorders.

    • Development of methods utilizing replenishable cell sources, that generate functional islet like cells/tissues that can be successfully tested in microphysiological systems and/or in vivo models of the disease.

    • Development and testing of in silico/simulation models with predictive capability to complement and/or replace in vitro and in vivo pre-clinical testing.

  • Tools for Measuring Peripheral Neurotransmitters and Neuromodulation:

    • Devices that modulate or control the hepatic or pancreatic branches of the vagus nerve with the aim of relieving diabetes or other metabolic disorders. Projects concerned with the liver should be focused on the regulation of glucose or lipid metabolism. Technologies would include closed

      - or open-loop neural stimulators of sensory or motor nerves originating from or terminating in the endocrine pancreas or liver.

    • Tools that provide high spatio-temporal resolution of neurotransmitter release in the endocrine pancreas or liver.

    • Tools that measure autonomic activity in the liver, endocrine pancreas, or adipose tissue in animal models or humans.

  Digestive Diseases and Nutrition

  The Division of Digestive Diseases and Nutrition supports research in diseases and disorders of the digestive tract; esophagus, stomach, intestine, colon, anorectum, pancreas, liver, gallbladder, and biliary tract; as well as research in nutrition and obesity. Innovative investigator-initiated projects that are not mentioned below are also encouraged. Examples of areas that may be of interest to small businesses include, but are not limited to:

  • Gastrointestinal

    • Development of new diagnostic techniques and tests, including non-invasive tests and imaging for detecting Barrett’s esophagus, GERD, and other intestinal disorders.

    • Development of agents and techniques to measure, diagnose, stimulate regeneration of enteric neurons, and treat motility disorders.

    • Development of novel therapies to modulate/enhance GI lymphatic function for the treatment of GI pathologies.

    • Development of gut-derived biomarkers of neurodegenerative brain disease.

    • Development of approaches to simultaneously interrogate or modulate the central nervous system (CNS) and the gastrointestinal system.

    • Development and validation of neurotechnologies that improve the association of symptoms, pathophysiology, and function for gastrointestinal disorders.

    • Development of novel proteomic or metabolomic technologies designed to study digestive diseases and their complications.

    • Development of assays and screening methods for detection of biomarkers for diagnosis, grading and staging digestive diseases.

    • Development of Live Biotherapeutic Products (LBPs), such as probiotic organisms for the prevention or treatment of gastrointestinal conditions, or to enhance the nutritional properties of dietary components. These LBPs would not include vaccines, oncolytic bacteria, or gene therapy agents.

  • Liver

    • Development of novel antifibrotic therapies for chronic progressive liver diseases.

    • Development of quantitative tests of hepatic “reserve” for assessment of therapeutic intervention, transplantation, or surgical risk in patients with liver disease.

    • Development of point-of-care, serologic, and rapid tests for rapid diagnosis, treatment requirements and genotyping of hepatitis.

    • Development of rapid, reliable, and inexpensive tests for genetic screening and risk markers important in liver disease.

    • Development of sensitive and reliable non-invasive techniques to detect and monitor liver fibrosis and other chronic liver diseases and the associated complications.

    • Creation of bio-artificial organs for temporary hepatic support in patients with acute liver failure.

  • Pancreas

    • Development of and validation of therapeutic interventions for treatment of pancreatitis and its complications.

    • Development of more accurate, non-invasive approaches to the diagnosis of chronic pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.

  • Nutrition/Obesity

    • Development of novel methods and tools to accurately evaluate nutritional status, physical activity, and energy expenditure.

    • Development of non- or minimally invasive technologies that allow access and/or delivery to discrete regions of the digestive tract.

    • Development of novel breath, urine, or blood tests to accurately measure dietary intake.

    • Development of non-invasive neurotechnologies to stimulate and/or modulate hormone/peptide release from the gastrointestinal system for the treatment of metabolic disorders such as obesity.

  Kidney, Urologic and Hematologic Diseases

  The Division of Kidney, Urologic, and Hematologic Diseases provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs. Projects may include development of tools to improve understanding of the physiology, pathophysiology, and diseases of the kidney, urinary tract, and blood and blood forming systems, or to develop rational diagnostics, treatments, and prevention strategies for these diseases. Projects may be to develop tools/technologies to support clinical care, population health and/or pragmatic research to improve health outcomes in populations with kidney diseases and/or urologic conditions. Projects to develop tools or technologies to address health disparities or promote health equity are encouraged. NIDDK encourages research that takes a holistic perspective of human health by considering biological, behavioral, and social contributors to the scientific exploration, prevention, and management of these diseases/conditions. Development of -omics, bioinformatics, and multi-scale technologies for the study of these systems, especially where these systems interact, is also encouraged. Research opportunities that may be of interest to small businesses include, but are not limited to:

  • Kidney Diseases. Areas of research include chronic kidney disease, end-stage renal disease, diabetic kidney disease, polycystic kidney disease, hypertensive kidney injury, acute kidney injury, kidney donation (delayed graft function and chronic rejection), congenital kidney disorders, glomerular and tubulointerstitial diseases, IgA nephropathy, hemolytic uremic syndrome, fluid and electrolyte disorders, kidney repair and regeneration, and normal and abnormal kidney development and physiology.

    • Dialysis, Devices and Medical Technologies

      • Development of innovative forms of renal dialysis which improve efficiency, have lower associated morbidity (e.g., tissue engineered artificial kidneys, implantable or wearable dialyzers), reduce side effects and constraints of dialysis treatment, and/or improve access, experience, and quality of life.

      • Development of functional nephrons for transplantation.

      • Development of pharmacological agents, devices, techniques, or diagnostics that enhance maturation and longevity of a vascular access.

      • Development of dialysis membrane technologies with enhanced biocompatibility and anti- fouling properties.

      • Development of a means to provide continuous anticoagulation to permit renal replacement therapy.

      • Development of reliable, non-invasive, wearable or online monitoring systems for real- time assessment and adjustment of treatment parameters such as blood volume, access flow, and urea clearance.

      • Development of hemodialysis or peritoneal dialysis catheters using improved biomaterials, which reduce catheter-related infections, the foreign body response, biofouling, and biofilm formation.

      • Development of novel methods to generate dialysate for hemodialysis or peritoneal dialysis.

      • Development of devices or techniques to enhance the long-term success of kidney transplantation (e.g., techniques for repairing kidneys or for kidney storage and preservation).

      • Development of technologies to improve kidney biopsies (i.e., to improve safety or tissue acquisition).

    • Health Information Technologies

      • Development of health information technologies or mobile technologies that enhance delivery of care, population health management, health equity, and/or research for patients with kidney diseases.

      • Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, and societal/contextual data for research and care of individuals with kidney diseases.

      • Development of technologies to engage patients with kidney diseases in their care or to support interaction with caregivers.

      • Development of innovative technologies or platforms to facilitate kidney research training and education, which could include software or simulation tools.

      • Development of clinical assays that enable biopsychosocial precision medicine approaches to treating kidney diseases.

      • Development of technologies that use artificial intelligence/machine learning (AI/ML) or other advanced statistical approaches to integrate disparate data types to inform diagnosis of kidney diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.

      • Development of platforms for pre-analytical preparation, imaging, and automated analysis of kidney tissue.

      • Development of non- or minimally invasive methods for evaluating kidney functions, including in individuals with congenital genitourinary conditions.

        • Reliable, non-invasive, non-radioactive methods of measuring glomerular filtration rate (GFR) or tubular functions.

        • Translation of biomarkers of acute kidney injury or chronic kidney disease with clinical utility into commercial assays.

        • Translation of biomarkers for early detection of kidney diseases or prediction of kidney disease progression, recovery, or drug response.

      • Development of improved renal imaging techniques, differential renal function assessment, diagnostic assessment of non-malignant kidney diseases, or measurement of perinatal nephron endowment.

      • Development of technology to improve collection of real-time data (e.g., biomarkers, diet, physical activity, patient reported outcomes, vital signs, patient experience of kidney or urologic disease or its treatment, social or environmental factors which affect the development or progression of kidney disease), patient outcomes, and adherence for clinical studies.

      • Development of imaging or molecular analysis technologies to enhance information extraction from renal biopsies and development of antibodies or other probes for unique cell types of the kidney.

    • Therapeutics Discovery and Development

      • Lead optimization and preclinical development of pharmacological agents that might be used to intervene in acute or chronic renal disorders and in disorders of renal hemodynamics, blood pressure, electrolyte metabolism, and extracellular volume regulation.

      • Development of drugs or biologics designed to specifically target kidney cell types.

      • Development of drugs or biologics to stimulate productive kidney repair or regeneration.

      • Development of technologies to enhance the validation of kidney disease targets or to screen compounds for efficacy or toxicity (e.g., kidney organoids or tissue chips, more relevant animal models of acute kidney injury).

      • Development of data and cell banks (e.g., of diabetic kidney disease families and polycystic kidney disease families) for use by the research community.

      • Development of preventative measures for acute kidney injury (e.g., during coronary artery bypass grafting, sepsis, or treatment with nephrotoxic agents).

  • Urologic Diseases. Areas of research include benign prostatic hyperplasia, lower urinary tract symptoms (LUTS) including urinary incontinence, urinary tract infections, urinary stone disease, erectile dysfunction, urologic chronic pelvic pain syndromes (including interstitial cystitis and chronic prostatitis), congenital urologic disorders, repair and regeneration of lower urinary tract organs, normal and abnormal lower urinary tract development, and physiology of the urinary system and male genital organs (excluding applications targeting male fertility).

    • Diagnostics and Imaging

      • Translation of blood or urine biomarkers in the lower urinary tract or other urologic disorders into commercial assays with clinical utility.

      • Development of non-invasive or minimally invasive methods to diagnose bladder inflammation or changes in the urothelium that are not of a cancerous origin.

      • Development of new technologies for rapid clinical diagnosis and characterization of urinary tract infection (UTI).

      • Development of new technologies or methods with reduced radiation dose for evaluating vesico-ureteral reflux in children and infants.

      • Development of diagnostic modes to clinically and non-invasively or minimal- invasively measure bladder outlet obstruction before and after surgical or pharmaceutical intervention.

      • Development of objective diagnostic devices or methods for the assessment of urinary storage and voiding disorders, including stress, urge, and mixed incontinence, in both adults and children.

      • Development of wireless and non-invasive or minimally invasive measurement technologies for real-time assessment of lower urinary tract function, which can include neuro- pharmacological/neuro-physiological urodynamics.

      • Development of radiation-free and accurate imaging technologies for urinary stone disease.

      • Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types to inform diagnosis of urologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.

      • Development of platforms for pre-analytical preparation, imaging, and automated analysis of genitourinary tissues.

    • Drug and Device (Therapeutic) Interventions

      • Lead optimization and preclinical development of pharmacological agents for treatment or prevention of urinary stone disease, urological chronic pelvic pain syndromes, urinary tract infections, or other urologic diseases or conditions within NIDDK’s mission.

      • Development of novel neuromodulation devices, which restore function or mitigate pain conditions of the lower urinary tract.

      • Development of urinary catheters which reduce the incidence of infection in the urinary tract and decrease urethral and bladder inflammation.

      • Development of technologies for treatment of bladder outlet obstruction.

      • Development of bioengineered materials or structures, including cell-laden structures, for the repair or regeneration of genitourinary organs.

    • Health Information Technologies

      • Development of health information technologies or mobile technologies that enhance delivery of care, population health management, health equity, and/or research for patients with urologic diseases or conditions.

      • Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, or social data for research and care of individuals with urologic diseases or conditions.

      • Development of technologies to engage patients with urologic diseases or conditions in their care or to support interaction with caregivers.

      • Development of innovative technologies or platforms to facilitate urology research training and education, which could include software or simulation tools.

    • Research Tools

      • Development of tools for elucidating the role of urinary or gut microbiome in urinary stone disease or other urologic diseases or conditions within NIDDK’s mission.

      • Development of novel models of benign prostatic hyperplasia.

      • Development of technology to improve collection of real-time data (e.g., biomarkers, diet, physical activity, vital signs, psychological parameters, and social or environmental factors), patient- reported outcomes, and adherence for clinical studies (e.g., studies of gene-environment interactions in the manifestation of urologic diseases).

  • Hematologic Diseases. The NIDDK hematology research program focuses on understanding basic cellular and molecular mechanisms that underlie the production and function of blood cells in health and disease. The program emphasizes translational applications of new insights and knowledge gained from basic research in these areas toward the development of novel or improved approaches for the diagnosis, stratification, and treatment of hematologic diseases. This includes the development of disease biomarkers, gene targeted therapies, or hematopoietic stem cell transplantation for acquired and heritable blood diseases (e.g., hemoglobinopathies, such as sickle cell disease or thalassemia; hemochromatosis, iron overload, porphyrias, amyloidosis, iron deficiency anemia, and cytopenias resulting from bone marrow failure disorders, congenital dyserythropoietic anemias, Schwachman-Diamond syndrome, myelodysplastic syndrome, neutropenias, myelofibrosis, essential thrombocythemia, or polycythemia vera), and the measurement and chelation of tissue iron in iron overload disorders. The NIDDK hematology research program provides resources for basic and preclinical development efforts leading up to IND or IDE submissions but does not fund clinical trials. The program has a particular focus on myeloid lineage and hematopoietic stem cells, including the effects of aging on hematopoiesis.

    • Drug Discovery and Development

      • Establishment of robust in vitro or animal models of benign hematologic diseases for drug discovery or development.

      • Development of therapeutics that target elements of hematopoietic stem cell niches (e.g., stromal cells, osteoblasts, endothelium, macrophages, pericytes, nerve cells).

      • Development of novel bone marrow conditioning regimens that promote hematopoietic stem cell homing, engraftment, and hematopoiesis.

      • Development of therapeutics that modulate blood cell production from hematopoietic stem cells and progenitors based upon understanding of physical and chemical regulatory pathways.

      • Development of therapeutics that modulate metabolism, storage, and transport of iron or heme.

    • Cell Therapies

      • Development of equipment, chemically defined reagents, and methods for high volume ex vivo expansion, isolation, and/or differentiation of highly purified human hematopoietic stem and progenitor cells.

      • Development of equipment, chemically defined reagents, and methods for selective removal or destruction of diseased human hematopoietic stem and progenitor cells (e.g., in myelodysplastic syndrome, MDS). Treatment of malignant clones and blood cancers are not within the scope of the NIDDK Hematology mission.

      • Development of therapeutics that induce fetal hemoglobin synthesis by chemical means, genome editing, or other means.

      • Development of therapeutics that target blood cell membrane structure.

    • Diagnostics and Imaging, Medical Technologies, and Research Tools

      • Development and validation of sensitive, specific, reproducible, quantitative, and clinically applicable assays for measuring levels or expression of iron regulatory molecules or for measuring misfolded or aggregate amyloid proteins such as amyloid A transthyretin or immunoglobulin light chain in blood.

      • Development of technologies to track, purify, monitor or assay single-cells in vivo or in vitro.

      • Development of non-invasive systems for monitoring circulating blood cells, blood chemistry or blood cell production.

      • Development of imaging technology for the non-invasive measurement of bone marrow cellularity, fibrosis, and function.

      • Development of imaging technology for the non-invasive measurement of tissue iron loading and distribution.

      • Development of technologies to understand the roles of mitochondria in non- malignant hematologic diseases.

      • Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types (e.g., histomorphology, karyotyping, next generation sequencing, immunophenotyping, and flow cytometry) to inform diagnosis of non- malignant hematologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.

      • Development of platforms for pre-analytical preparation, imaging, and automated analysis of the bone marrow.

      • Development of innovative technologies or platforms to facilitate hematology research training and education, which could include software or simulation tools.

• National Institute of Environmental Health Sciences (NIEHS)

  Exposure Assessment Tools

  The NIEHS Exposure Biology and the Exposome Program supports technologies to better understand how a person’s environment contributes to their health. Sensor technologies, computational approaches, improved biomarkers, and biomonitoring capabilities, are needed to measure, analyze, and predict a wide range of internal and external exposures and health outcomes across diverse geographic populations. These tools should be designed fit-for-purpose in collaboration with the stakeholders (e.g., community engagement programs, citizen scientists, disaster response personnel, epidemiologists, or clinical researchers).

  Examples include:

  • Sensors and Other Exposure Assessment Tools

    • Technologies and methodologies to assess personal exposure to specific or combined air pollutants in population studies, including wearable monitors and sensor networks.

    • Devices for collecting exposure measurements across multiple stressors and scales, with an emphasis on high sensitivity and specificity and low-cost devices, when feasible. High-priority analytes include contaminants of emerging concern (e.g., perfluorinated compounds, and toxins produced in harmful algal blooms) as well as ultrafine particulates, microplastics, pesticide exposures, and industrial chemicals.

    • Novel sampling technologies to enable subsequent targeted and untargeted laboratory analysis

    • Sensor technologies that can be integrated into existing smart devices for sensing personal environment as well as provide chemical speciation data.

    • Tools and approaches for identifying and characterizing contaminants in drinking water that may pose a risk to human health, with a particular emphasis on new contaminants or compounds that are of emerging concern.

      Note that identification of environmental pathogens in drinking water is not within the NIEHS mission.

  • Computational and Informatics-based Tools and Methods for Exposure Assessment

    • Informatics tools and platforms to organize, store, retrieve, extract, and integrate data on exposures and health effects.

    • Application of machine learning methods and natural language processing for extracting and integrating diverse data types and for generating causal networks from experimental data and public knowledgebases

    • Computational and statistical approaches to integrate exposure data from different sources, including publicly available databases and information from monitoring approaches (e.g., sensors, remote sensing, and biomonitoring), to provide quantitative exposure estimates, identification, and characterization of adverse effects on human health.

    • Adapting or developing new methods and tools for automating environmental health-related literature and systematic reviews, including article selection and prioritization, data extraction, study quality evaluation, and summarization of for environmental health impacts

  • Nano Environmental Health and Safety. The NIEHS Nano Environmental Health and Safety (Nano EHS) program is interested in the detection of engineered nanomaterials (ENMs) in the environment, in consumer products, and in biological samples, and is interested in technologies or methods that can predict toxicity potential of ENMs.

    High priority engineered nanomaterials of interest are those with a potential for human exposure. Examples include:

    • Sensors, tools or technologies that can detect metal and carbon-based engineered nanomaterials or micro/nanoplastics in air, water, and consumer products, and provide a contextual assessment of the toxicological potential.

    • Mid- to high-throughput and high-content assays using in vitro or tissue chip technologies to screen and rank toxicity of emerging engineered nanomaterials for cytotoxicity, genotoxicity, and metabolic or other human relevant toxicity.

    • Methods and tools to assess leaching of engineered nanomaterials from nanotechnology-based water filtration systems.

    • Technologies to assess the life cycle of nanomaterials from nano-enabled products in the market

    • Development of tools and technology platforms for the isolation, quantification, physical and chemical characterization of various forms of micro/nanoplastics from diverse media including biological samples, aqueous sources, air and food samples and assessment of their toxicity potential and human health effects

  • Toxicity Screening, Testing, and Modeling. NIEHS supports research to identify the hazards, as well as the mechanistic understanding, of the effects of environmental stressors on biological systems that can lead to adverse human health outcomes. To increase the ability to characterize or predict the toxicity and hazard of environmental stressors, the National Toxicology Program (NTP) Home - National Toxicology Program (nih.gov) at NIEHS is interested in technologies to support the goals and initiatives of the Tox21 Program Tox21 (nih.gov).

    Technologies that support Tox21 and other NTP goals may include the development and/or application of in vitro physiologically relevant cell-based systems that effectively model responses in humans or animals and may be used to reduce or replace in vivo animal use. High priority areas are the development of metabolically competent in vitro screening models and assay systems for various tissue types (e.g., cardiac, neurological, liver, GI tract, kidney, mammary gland, lung, and immune function) for assessing the effects of the environmental stressors.

    • Toxicity Screening Approaches

      • Improved or new approach methodologies (NAMs) including human organotypic culture models (OCM), and microphysiological systems (MPS) that more accurately predict in vivo function for characterizing toxicity and/or related disease processes. Priority areas are improved capability for generating more mature cells from embryonic stem (ES) or induced pluripotent (iPS) cells for organotypic models, integrating multiple MPS together under physiologically relevant conditions, and the ability to conduct in vitro pathology studies using OCM, MPS or 3D culture models.

      • Organotypic models using cells from rat or mouse models or other experimental animal models, with a focus on comparisons between in vivo and in vitro toxicity endpoints.

      • Approaches to characterize and integrate key molecular and cellular changes related to effects of toxicant exposures in carcinogenicity, developmental neurotoxicity, cardiotoxicity or immune functions.

      • In vitro model systems that incorporate barrier functionality and transport functions into tissue models (e.g., kidney, placenta, or blood-brain barrier)

      • Enhanced lower organism models (e.g., zebrafish or C. elegans) for toxicity screening.

      • Stem cell models and assays for evaluating the effects of toxicants on cell differentiation with multiple functional endpoints.

      • Screening systems that incorporate genetic diversity into toxicology testing (e.g., panels of tissue- specific human iPS cells or rodent stem cells)

      • In vitro systems that focus on responses to mixtures of xenobiotics, chronic exposure studies, or provide insights into the molecular characteristics of multiple chemical-biological interactions and toxicodynamics.

      • Short-term tests, assays, or systems designed specifically to reduce or replace existing regulatory animal studies for acute toxicity (oral or inhalation), reproductive or developmental toxicity, carcinogenicity, or ocular toxicity.

      • Cage-based technologies to monitor physiological and behavioral changes in experimental animals in chemical toxicology studies.

    • Computational Approaches for Predictive Toxicology

      • New computational systems and tools for integrating toxicity data, including in vivo and in vitro data, to analyze and visualize data across different screening systems and predict chemical hazard/risk.

      • Computational tools to integrate and visualize transcriptomic and metabolomic data in affected signaling and biochemical pathways.

      • Improved computational tools for in vitro to in vivo extrapolation of xenobiotic exposures and modeling metabolic transformation of xenobiotics.

      • Advanced computational approaches (e.g., artificial intelligence/machine learning) to integrate and develop multi-omics classifiers for exposures and pathology image analysis tools for environmentally induced diseases.

    • Other Technologies Focused on Enhancing Toxicology Testing

      • Alternative or improved methods for fixing and preserving tissues that maintain cellular structure for histopathology while minimizing degradation of nucleic acids (RNA, miRNA, DNA, methylated DNA), proteins or metabolites, so that archival tissue blocks can be better used for molecular analysis.

      • Liquid biopsy methods for isolation and novel assays of circulating nucleic acids that reflect environmental chemical exposures or toxicity. These could include exosome-packaged or cell-free nucleic acids altered by environmental exposures.

      • Alternative or improved methods for extracting high quality RNA, miRNA, DNA, methylated DNA, proteins, or metabolites from existing archived tissues.

      • Tools and technologies for isolation and characterization of exosome and/or extracellular microvesicles from biological fluids

  Biomarkers of Exposure and Response

  To better understand the risks to human health from environmental agents, NIEHS supports the development and validation of biomarkers of exposure, including improved measures of internal dose, DNA adduct identification, and untargeted analysis for metabolite identification, and biomarkers of response, including assays that can distinguish reversible from irreversible changes in target organs or surrogate tissues. Examples include:

  • Biomonitoring Technology

    • Personal or point-of-care monitoring technologies for rapid detection of multiple exposures in biospecimens using non- or minimally invasive approaches.

    • Improved methods to detect DNA or protein adducts resulting from exogenous exposures

    • Exposure assessment methods in novel matrices or small volumes

  • Biological Response Markers

    • Markers of oxidative stress, inflammation, DNA damage response, immune function, mitochondrial dysfunction, or altered epigenetic regulation.

    • High priority human biomarkers include, but are not limited to inflammation biomarkers, plasma- or serum-based markers that reflect altered RNA, protein expression, or metabolite profiles, markers developed in exhaled breath, buccal cells, or other easily accessible, non-invasive biological samples, miRNA or other exosome biomarkers, and epigenetic markers in surrogate tissue reflecting modifications in target tissues

  • Intervention Technologies. NIEHS supports efforts to prevent or reduce exposures to environmental chemical stressors that affect human health. Technologies to reduce exposure may include:

    • Technologies for detecting and/or removing contaminants from drinking water, primarily for home use.

    • Approaches for use in the home, workplace, and school settings for reducing volatile compounds and other inhaled toxicants. Examples may include improved air filtration systems as well as technologies to monitor the efficacy of filtration systems.

    • Technologies and applications that can provide real-time alerts about relevant environmental exposure levels for sensitive populations (such as asthmatic populations)

  Education and Participatory Science

  As part of its Partnerships for Environmental Public Health (PEPH) Program, NIEHS is interested in developing tools that build capacity, improve environmental health literacy, and support participatory science endeavors. These approaches or resources should be fit for purpose to meet the needs of the following audiences: community members, health care and public health professionals, educators, and students of all ages. Approaches may include:

  • Mobile applications that provide environmental health information about exposures of concern in food, air, drinking water, or consumer products. These may include

    • Interactive apps that provide the context and risks of exposures such as single or multiple, interacting exposures, level of exposure, frequency and proximity to source and health risks

    • Apps that can be adapted for various age groups, races, ethnicities and/or languages

  • Devices for collecting and reporting information on exposures in environmental samples for educational purposes in schools or communities.

  • Systems that can utilize public and voluntary population data from sensors, activity trackers, GIS enabled devices, social communications, and surveillance cameras; for example, to assist disaster response and communication.

  • Educational resources and tools related to environmental health in school settings or community education programs.

  • Training materials for wider dissemination of risk information (e.g., resources for high school students or community leaders to build capacity of other community residents)

  Exposure and Response to Vaping and Electronic Nicotine Delivery Systems (ENDS)

  NIEHS is interested in technologies to assess exposure to aerosols from e-cigarettes and other vaping devices, including analyses of the chemical constituents in these aerosols. In addition, approaches to test the toxicity and biological responses to ENDS aerosol constituents are of interest.

  Disaster Response

  NIEHS is interested in sensors and informatics tools that can be rapidly deployed after disasters, including extreme weather events or climate change-related events. These tools can be used by researchers to follow emergency response workers and individuals in the community to help understand dermal, water and/or airborne exposure levels, locations, and times.

  • Environmental sensors that can be rapidly deployed during or after a disaster to track exposures.

  • Informatic tools to rapidly build environmental health disaster research protocols similar to the NIEHS RAPIDD Protocol Disaster Research Response (DR2) Program (nih.gov) from existing information, tools, and platforms (e.g., PhenX, PROMIS, and Disaster Research Response DR2 Repository) to support rapid research response efforts

  • Data management tools for disaster response that enable rapid collation and integration of data from stationary sources and personal exposure monitors and survey information collected from individuals.

  • Mobile devices and applications for collecting information on environmental exposures from study participants involved in disaster research responses.

  Hazardous Substances Remediation and Site Characterization SBIR Program

  The NIEHS Superfund Research Program (SRP) "Hazardous Substances Remediation and Detection Program" supports Small Business Innovation Research Grants (SBIR R43, R44) to foster the commercialization of novel, cost-competitive technologies, products, and devices for remediation and detection of hazardous substances in the environment. The SRP is specifically interested in proposals applying new engineering, materials science, and biotechnology approaches. In addition, applicants are encouraged to develop sustainable strategies such as offering low carbon footprint, reduced energy consumption, utilization of renewable energy sources, resilient to weather extremes, and with reuse / regeneration capabilities.

  • Remediation

    • Novel technologies for in situ remediation of contaminated sediments, soils, and groundwater with testing/modeling to optimize product for long-term stability

    • Innovative bioremediation technologies including development and culturing/propagation of novel plants, bacterial strains, or fungal species for implementing bioremediation

    • Technologies to remediate chemical mixtures in environmental media

    • New strategies for delivery of reagents/amendments for groundwater remediation and/or recovery/extraction of contaminants in groundwater

    • New amendments to stabilize contaminants and/or to use in caps for soil and sediment remediation

    • New technologies and strategies to cleanup large complex sites with multiple sources

    • Resilient novel remediation approaches capable of withstanding climate change-related impacts such as: fire, flooding groundwater level fluctuation, land use changes, and other catastrophic events

    • Sustainable, energy efficient approaches with a net lifecycle benefit such as net zero emission technologies; technologies that reduce waste generation; processes that recycle/reuse/regenerate active components; long-term remediation approaches equipped with solar or wind energy

  • Detection Technologies

    • Machine learning, computational, geographical information system-based, or modeling products for predicting fate and transport of contaminants, rates of remediation, bioavailability, or for identifying contamination sources

    • Real-time, field deployable, on-site analysis: soil, surface water, groundwater, subsurface, sediments, air (such as volatile releases from sites), including

      • rapid, portable monitoring and screening of contaminants

      • multi-analyte sampling

      • remote monitoring/data capture/data processing capabilities such as time-integrated and/or repeated measures

    • Accurate and reliable new passive sampler devices

    • Products that allow for rapid sample clean-up/preparation for analysis of environmental samples and/or technologies for rapid extraction or processing of soil for incremental sampling methodologies (ISM)

    • Non-targeted or multi-analyte field sampling devices or kits, including sample collection products that can sequester a suite of analytes for later analysis

    • Novel techniques, sensors, and field analytical methods and real-time mapping/data visualization for development of subsurface conceptual site models

    • Innovative tracer technologies for tracking contaminant migration/pathways

  • Examples of remediation and detection technology needs:

    • Vapor Intrusion: Improved technologies for predicting/anticipating time-periods for occurrence of reasonable maximum indoor exposure(s) in impacted buildings, during which sampling is recommended.

    • PFAS: Soil, sediment, and groundwater remediation technologies for mixtures and degradation byproducts of per- and polyfluoroalkyl substances (PFAS); including technologies for complete PFAS destruction; sustainable solutions with low energy input and/or minimal secondary waste generation;

      and/or PFAS removal technologies for heterogenous water chemistries; rapid sensors to aid in site monitoring and/or prioritizing site sampling protocols.

      • Novel, sustainable, nontoxic chemistries or processes to aid regeneration, reuse, and/or reactivation of spent treatment residues (e.g., from granular activated carbon).

      • Development of adsorption and concentration materials to reduce the volume of material to be treated and/or to further concentrate the waste stream generated from standard treatment technologies (e.g., granular activated carbon, reverse osmosis) as part of a “treatment train”.

      • Development of polishing treatments tailored for specific PFAS (e.g., shorter chain, emerging PFAS replacements).

      • Development of novel catalysts or other additives to lower needed temperature for complete thermal destruction.

      • Development of novel air pollution control technologies as a polishing step to reduce emissions from PFAS management or treatment facilities (e.g., thermal destruction, air sparging, Supercritical water oxidation (SCWO), hazardous waste landfill facilities, etc.).

      • Development of novel materials or processes for solid waste and/or biosolids treatment and/or stabilization.

    • Mining: Active or passive remediation technologies for mining influenced water; technologies to mitigate effects from acid drainage; portable neutralization treatment systems; strategies to target remediation of sources such as mining waste piles; and separation technologies that remove elements or compounds of concern from water and/or reclaim potentially valuable critical elements dissolved in contaminated fluids

    • Complex Site/Geology:

      • Site characterization techniques and strategies for complex geology (fractured bedrock, karst, and heterogeneous layered deposits) including understanding the fate of contaminants within rock matrices and properties that affect back diffusion

      • Improved technologies for treating low permeability and heterogeneous lithology, including amendment delivery methods

      • Devices to detect and measure non-aqueous phase liquids (NAPLs) in the subsurface

      • In-well real-time and/or continuous monitoring tools to assess the efficacy of remediation; presence/absence of key factors required for remediation (e.g., biological, geological, chemical); and/or to identify rebound events

      • Robotic sampling for highly contaminated / remote sites

    • Disaster Response: Technologies for measuring/treating environmental contamination as part of a disaster response effort

  Worker Training Program

  The major objective of the NIEHS Worker Training Program (WTP) is to prevent work related harm by training workers in how best to protect themselves and their communities from exposure to hazardous materials. The NIEHS WTP is interested in the development of e-Learning Technology- Enhanced Training Products from a variety of delivery methods to assist both students and instructors in the training and education process. These Technology-Enhanced Training Products are for the health and safety training of hazardous materials (HAZMAT) workers; waste treatment personnel; skilled support personnel associated with an emergency/disaster; emergency responders in biological hazard response, infectious disease response and medical waste cleanup; emergency responders in disasters; and worker resiliency training. Technology-Enhanced Training Products as defined by the WTP includes, but are not limited to, online training, mobile device training, augmented reality (AR), virtual reality (VR), and serious gaming. These advanced technologies complement all aspects of training that can enhance, supplement, improve, and provide health and safety training for hazardous materials workers. WTP accepts solicitations via requests for applications (RFA). Please contact Kathy Ahlmark (ahlmark@niehs.nih.gov) for information on the next solicitation date, which differs from the standard receipt dates of this NIH omnibus.

  Information on the WTP program can be found at About the Worker Training Program (WTP) - Training for Workers in Hazardous Environments (nih.gov)

• National Eye Institute (NEI)

  • General Research and Development Topics: NEI is interested in providing support for the development of new technologies, strategies, research tools, reagents and methods that can be applied to basic and translational research which will benefit vision health. This encompasses research and development of innovative enabling technologies in areas of genomics, proteomics and nanotechnology. More specific topics include drug and high throughput assays; drug delivery systems; gene therapy, cell-based therapy and regenerative medicine; development of in vitro and in vivo disease models; surgical devices and materials; telemedicine, mobile health, and health education; and design/fabrication of new or improved ophthalmic instruments for diagnosis and treatment of eye disorders.

  • Retinal Diseases: New therapeutic approaches for inflammatory and degenerative diseases and for inhibition of abnormal angiogenesis in the retina and choroid; Better methods of diagnosing and treating diabetic retinopathy and other vascular diseases; Non-invasive techniques for early diagnosis of macular degeneration and other retinal degenerative diseases; Instruments and procedures for improved surgical management of retinal detachments; Retinal prostheses to help restore visual function; Gene therapy/optogenetic methods for light sensitivity restoration in the retina; Better methods for cell or tissue transplantation; New animal models/systems that better mimic human retinal disease.

  • Corneal Diseases: New diagnostic tools, therapeutic agents and drug delivery methods for the treatment of corneal injury, infection, dry eye, ocular pain, and other ocular surface disorders; New biomaterials for corneal prostheses and corneal transplants; Instruments and procedures for correcting the refractive power of the cornea and/or measuring the cornea's optical properties or other physiological properties.

  • Lens and Cataract: New approaches in the post-operative management of cataract surgery; New surgical instruments for cataract extraction and new biomaterials for replacement of the natural lens; Design/fabrication of aspheric, toric, multifocal and accommodating intraocular lenses.

  • Glaucoma and Optic Neuropathies: New therapeutic agents, instruments, and procedures for the diagnosis and treatment of glaucoma; Non-invasive methods to measure changes in the optic nerve head and retinal fiber layer.

  • Strabismus, Amblyopia, and Refractive Error: New approaches to detect and treat strabismus, amblyopia, and myopia; New tools and techniques for vision screening; New or improved methods and materials for correcting the refractive power of the eye and/or measuring the eye's optical properties or other physiological properties; New materials and manufacturing processes for eyeglasses and contact lenses; prosthetic devices (both cortical and subcortical) for vision restoration.

  • Visual Impairment and Blindness: Instruments and methods to better specify, measure, and categorize residual visual function; New or improved devices, systems, or programs that meet the rehabilitative, adaptive, and everyday living needs of visually impaired/blind people.

• National Institute of General Medical Sciences (NIGMS)

  Biophysics, Biomedical Technology, and Computational Biosciences.

  • Bioinformatics and Computational Biology Branch

    • Health Informatics. Development of computational and informatics tools and methods for data privacy, harmonization, integration and analysis using electronic health records and other biomedical data aimed at elucidating biological function, ontology development, or developing models of biological and biochemical processes. Areas of interest include population pharmacokinetics, pharmacovigilance, drug discovery and drug repurposing.

    • Bioinformatics. Development of algorithms and computational tools for collecting, managing, analyzing, visualizing, and interpreting complex biomedical data; or using data science methods and tools to extract and discover new knowledge about biological systems. The scope of studies includes the development of computational algorithms to analyze data from nucleic acid sequencing, proteomics, metabolomics, and multi-omics, and development of methods for large scale data management including data curation, standardization, and ontology.

    • Biostatistics. Development of advanced statistical techniques and methodologies for study design, data analysis and interpretation. The scope of studies ranges from those focused-on sequencing, -omics, bioimaging, high-through-put technologies in molecular and cellular biology data, pharmacology, and populational studies.

    • Software and Tools. Algorithm design and software development for bioinformatics research. The scope of studies includes software and tools development to facilitate biological data analysis, interpretation, and visualization to address research questions in basic biology. Areas of interest include software to analyze cellular processes and interactions and software engineering for ontology and data structure.

    • Multi-scale Modeling. Development of new computational algorithms and mathematical methods for integrative understanding of biological systems that may span temporal and spatial domains. The system scale ranges from subcellular to cellular to tissue, organ, organoids/3D cultures, and organismic systems. Topics include cellular regulatory processes such as gene expression and metabolism, cellular architecture and intracellular dynamics, cell communication and motility, cell division and differentiation, tissue formation, organogenesis, and tissue and organ functions.

    • Infectious Disease Modeling. Development of computational modeling for understanding population dynamics related to the interaction of organisms with their physical environment and between species. In this context, infectious disease models are used to understand the spread of parasites, viruses, and infectious diseases.

  • Biomedical Technology

    • Technologies for Structural Biology. Development of new or improved instruments, methods, and related software to elucidate 3D structures of macromolecules and macromolecular complexes. Relevant technologies cover areas of sample handling; X-ray diffraction and other X-ray techniques; magnetic resonance techniques such as NMR, EPR, and ESR; microscopic techniques that resolve at the molecular level such as single particle cryo-electron microscopy, micro electron diffraction (micro-ED) and tomography (cryo-ET); computational tools for data collection, processing, interpretation, curation, and mining.

    • Bioanalytical Technologies. Development of new or improved techniques, instruments, tools, or methods for quantitative analyses of biomolecules such as proteins, carbohydrates, lipids, nucleic acids, metabolites, and complexes. Technologies and methods development areas include mass spectrometry; magnetic resonance technologies; surface plasmon resonance; optical and vibrational spectroscopy; sample handling and separations; labeling methods; microfluidics, flow-based systems; high-throughput techniques; biosensors and electrochemical tools; and associated computational tools for data mining, analysis, interpretations, -omics, and simulation of molecular dynamics.

    • Technologies for Microscopy and Imaging. Development of new or improved laboratory/experimental techniques, instruments, or supporting software that measure the location and dynamics of molecules in situ, and organelles, cells, or tissues on the nanometer and micrometer length scales. These include instrument design; development of integrative multiscale or multimodal approaches for measuring cell structure and function; new illumination/excitation sources and detectors of heat, sound, light, electrons, and X-rays; imaging modes of spectroscopy; development of particles, physiochemical or mechanical probes; computational approaches to image formation including super-resolution microscopy and tomography; image analysis and processing algorithms of image sets for data interpretation, curation, mining, and visualization; development of sample preparations and modifications for imaging; probes, molecular reporters and fluorescent indicators for structural or functional imaging or microscopy/nanoscopy.

    • Technologies for Investigating and Manipulating Cells. Development of new or improved tools and methods that directly manipulate or investigate the properties of cells and their environment. These include the development of methods for the design and delivery of molecules and nanoparticles into cells or transport between cellular compartments, such as electroporation, co-transporters, or partitioning; tools for cell engineering or direct measurement of cell function; development of biological, chemical, or physical assays for measuring the function of macromolecular complexes within the cellular milieu, the behavior of organelles, or for characterizing cell phenotype.

  • Biophysics

    • Molecular Modeling, Theory, and Design. Includes theoretical, computational, and physics-based studies of the fundamental behaviors of atoms to molecules and their interactions, including predominantly theoretical and computational studies in the following areas: quantum mechanical and molecular dynamics simulations; thermodynamics and statistical mechanics; basic principles of molecular recognition; development and validation of force fields and scoring functions; and algorithms for prediction of molecular properties; macromolecule-ligand binding predictions by docking and other in silico screening methods applicable to drug design; predictions of protein and other macromolecular structures; and studies in macromolecular design, protein folding, RNA folding, macromolecular dynamics, molecular interactions, membrane and membrane protein simulations, phase separation, aggregation, and complex formation.

    • Biophysics of Proteins – Folding, Interactions, Structure/Dynamics, Mechanisms. Biophysical studies of all aspects of protein structure and function in which the goal is to elucidate general principles, including establishing the physical and thermodynamic basis for native structure; protein-protein interactions; protein-ligand recognition; folding mechanisms and kinetics; and protein de novo design and engineering. Experimental studies of intrinsically disordered proteins; folding upon binding, protein aggregation, and phase separations. Included are studies of structural dynamics in protein function and allosteric control. Experimental methods may include confirmatory in vivo studies and/or established computational methods.

    • Biophysics of Nucleic Acids and Nucleoprotein Complexes. Research involving the application of physical principles to the study of nucleic acids and protein-nucleic acid complexes. Areas of research include physical and chemical studies on the structure of nucleic acids and protein-nucleic acid complexes; analysis of protein–nucleic-acid interactions and assembly mechanisms; ligand-nucleic acid interactions; development of physical, chemical, and theoretical/computational techniques for the analysis of nucleic acids and their complexes.

    • Biophysics of Membranes and Membrane Proteins. General principles of membrane structure and function, including the behavior of lipids, bilayers, and other lipid phases; membrane protein structure and function, including folding, assembly, dynamics, and general mechanisms of action, conformational changes, and energy coupling; membrane protein-lipid interactions, effects of lipid compositions and phase separated domains; physical studies of fusion, fission, and deformation processes; as studied through the application of primarily biophysical methods and approaches.

    • Biophysical Studies of Supramolecular Complexes. Research on the mechanisms of assembly, structure, and function of cellular ultra-structures larger than a few million Daltons and dependent on high levels of molecular organization. These include large cellular machines such as the ribosome, spliceosome, cytoskeletal structures, interactions between intracellular and extracellular matrix components, signaling networks that depend on large-scale interactions when studied primarily by multiple methods and/or by methods that are not routine, such as single particle cryo-electron microscopy, cryo-electron tomography, scanning probe microscopy, and other force transduction methods.

    • Biophysical Studies of the Viral Life Cycle. Research involving the application of physical principles to the study of viral attachment, fusion/penetration, uncoating, assembly, and budding/release. Areas of research include analysis of virus-host interactions; phage and viral packaging; the structure and mechanism of assemblies from viral and host components; and determining factors and energetics that regulate protein-nucleic acid interactions necessary for virion entry, packaging, maturation, and release.

  Pharmacology, Physiology, and Biological Chemistry

  • Physiology and Clinical Sciences

    • Anesthesia and Perioperative Pain. Basic, translational, and clinical research in anesthesiology, as well as studies of pain in the perioperative period. This may include studies focusing on: molecular pharmacology and mechanisms of action of local and general anesthetics; pharmacokinetics and pharmacodynamics of anesthetics; pharmacological effects of anesthetics on tissue, organ, and organ systems; mechanisms of adverse action and toxicity of anesthetics; underpinnings of anesthesia-induced unconsciousness and emergence from anesthesia; malignant hyperthermia as it relates to anesthesia; or mechanisms involved in acute pain or the transition to chronic pain following surgery, and resolution of postoperative pain.

    • Drug Metabolism, Transport, and Kinetics. Research on generalizable principles of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenomics (PG), as well as drug-drug, drug-nutrient, drug-microbiome interactions and consequent adverse effects. Areas of interest include drug metabolizing enzymes, drug transporters (excluding nutrient and neurotransmitter transporters), the role of the gut microbiota in drug metabolism, studies to examine the impact of genetic variability on drug response, large-scale evaluation of information on drug pathways from studies using biobanks and electronic health records, and studies on developing and employing optimal technologies and tools (e.g., biomarkers, research organisms, and 3D tissue models) for PK/PD/PG studies. Studies may include approaches to understand population pharmacogenetics, pharmacogenomics, physiologically based pharmacokinetic (PBPK) studies, and drug toxicity. NOTE: When the research is focused on a specific organ or organ system, disease or condition, it will likely fall within the mission of the appropriate categorical institute. 

    • Injury and Critical Illness. Research on total body responses to injury (traumatic, thermal, or surgical) and shock from post-injury period to acute phase through long-term effects, until recovery or mortality. Studies on host response to injury and shock may include research on mechanisms of pathophysiological systemic responses (e.g., altered immune response, hypermetabolism, endotheliopathy/coagulopathy) or research on complications seen in critical care medicine (e.g., systemic inflammatory response syndrome, multiple organ dysfunction syndrome mechanisms and others). NOTE: Studies focused on specific organs or conditions, such as traumatic brain injury, pathogenic infections, skin grafts, etc., are outside NIGMS mission and should be directed to the institutes covering those mission areas.​​

    • Multi-organ Physiology. Research on systemic biological responses to challenges spanning multiple organ systems, including the physiological consequences of circadian rhythms and stress, as related to human health. This may include research on the physiology of integration of total body responses or interdisciplinary studies aimed at elucidating the complex interactions between circadian rhythms, metabolism, immune function, and physiological processes across multiple organ systems. NOTE: Studies of pathophysiology of sleep and circadian rhythm disorders are outside the NIGMS mission, as are studies focusing on physiology of specific organs or organ systems within the missions of other institutes.

    • Drug Delivery Systems. Research on delivery systems and novel strategies designed to improve permeability, absorption, stability, bioavailability, biodistribution and pharmacokinetics of small molecules and biologics. These can include antibodies, aptamers, extracellular vesicles, nanoparticle systems (e.g., lipid nanoparticles, solid lipid nanoparticles, liposomes, dendrimers, micelles, nanospheres, silica particles), nucleic acids, proteins and peptides, viruses, chemical cages, novel materials, polymeric particles and implants, and platforms/devices with an emphasis on drug targeting, release and pharmacokinetics. May also include studies on understanding and manipulating the transport of therapeutic agents across biological barriers, routes of administration to improve drug delivery, engineering approaches to enhance drug and gene delivery, and development of next-generation drug delivery systems to improve the efficacy and specificity of treatments by leveraging advanced materials and nanotechnology. NOTE: Studies aimed at efficacy for specific diseases (including but not limited to pre-clinical models), or those focused on obtaining regulatory approval, will not be accepted and should be discussed with the institutes focused on those missions.

    • Sepsis and Septic Shock. Basic and clinical studies focused on sepsis and septic shock, with an emphasis on the host response. This includes studies on unraveling the complex pathophysiology and heterogeneity of sepsis, identifying novel biomarkers for early diagnosis and patient stratification, and developing strategies for translating this knowledge into improved diagnostics and therapies for sepsis patients. Preclinical studies relying on murine models of sepsis are unlikely to be supported by NIGMS; for more details on NIGMS priorities for sepsis research, please see NOT-GM-19-054.

    • Systemic Immune/Inflammatory Responses. Research aimed at improving understanding the mechanisms governing innate immune responses and host-pathogen dynamics. This includes studies elucidating the complex networks and pathways that underpin innate immunity and acute inflammation, with implications for developing novel therapeutic strategies against infectious diseases, inflammation, and immune dysregulation. Examples of studies in this portfolio include cellular and molecular mediators of inflammation and immunity underlying complex body-wide pathophysiological responses, examination of the host defense mechanisms in model organisms (such as plants, C. elegans, and fruit flies), in vitro studies of host defense using cutting-edge technologies, host defense mechanisms in the context of multi-organ interactions or evolution, and novel non-organ-specific host defense pathways. NOTE: Studies focusing on the pathogenicity of microorganisms, antibiotic resistance, adaptive immunity or its mechanisms in allergic or autoimmune diseases, or of immune cells related to immune-related conditions will, in most cases, be more appropriate for NIAID.

    • Wound Healing. Basic mechanistic, translational, and clinical studies addressing physiology, biochemistry, and immunology of wound healing after injury (traumatic, burn, and surgical). This includes: research directed toward an improved understanding of the fundamental processes underlying normal, excessive or impaired wound healing, tissue repair and regeneration; studies aimed at understanding phases and signaling pathways that regulate the wound healing process; and how dysregulation of these processes impacts injury-related wound healing. Research focusing on healing of wounds associated with specific conditions (e.g., diabetic chronic wounds, keloids, fibrosis, mouth ulcers) should be directed to the appropriate categorical institute.

  • Biochemistry and Molecular Pharmacology

    • Bioenergetics and Mitochondria. Energy transducing enzymes of the mitochondrial inner and outer membranes, chloroplasts, and microorganisms; electron transport, photosynthesis, including biogenesis of cofactors and substrate transport.

    • Calcium Signaling and Compartmentalization. Temporal and spatial signaling within cells, including calcium fluxes, diffusion, and pumps; regulation of signaling molecules by compartmentalization within organelles, and cellular sinks and releasing proteins.

    • Cell Surface Receptors, Ligands, and Interactions. G protein-coupled receptors and cell surface receptors for drugs, endogenous ligands, and other stimuli; purpose is to understand basic biology and/or for validation as potential therapeutic targets.

    • Enzyme Mechanisms, Regulation, and Inhibition. Individual enzyme mechanisms, regulation, modification, and inhibition to understand the catalytic specificity of synthesis, modification, or degradation of metabolites and macromolecules.

    • Intracellular Mediators of Signal Transduction. Molecular pathways for signal transduction and regulation within cells, including second messengers such as kinases, phosphatases, adapter proteins, lipid messengers, phospholipases and others (excluding calcium). Includes intracellular nuclear and cytosolic receptors.

    • Membrane Channels. Pore-forming proteins specialized for ions (Na, K, Cl), ligand and voltage-gated, found at cell surface and organelle membranes. Includes ion channel blockers such as venoms and toxins.

    • Membrane Components and Cell-to-Cell Communications. Scaffolding and functional components of cellular membranes and vesicles: structural lipids (e.g., cholesterol), integral proteins, and their modifications. Gap junctions and communications between cells.

    • Metalloprotein Mechanisms. Functions and mechanisms of metalloenzymes, including natural and synthetic macromolecules that form transition metal-utilizing proteins and transporters.

    • Pathways of Intermediary Metabolism and Catalysis. Metabolic pathways and information flow; includes studies of transient intermediates and stable multi-enzyme complexes, and how catalytic processes and fluxes are affected by the intracellular milieu.

    • Redox Reactions and Oxidative Stress. Pathways responsible for generation or decomposition of reactive species (O, N, S), and the modification of cellular constituents by oxidative stressors; chemistry and maintenance of cellular redox balance.

    • Trace Metal Transport and Homeostasis. Regulation of trace metal ions (e.g., Fe, Co, Ni, Cu, Zn, As, Se, Mo, W), their transport, intracellular concentrations and speciation, and metal ion chaperones and ionopheres. Includes restriction of metal ion availability as a therapeutic intervention.

  • Chemistry and Chemical Biology

    • Bioinorganic Chemistry. Research focused on understanding and manipulating the roles of metal ions in biological processes by investigating their complex interactions with biological systems. Approaches that leverage a multidisciplinary approach, combining cutting-edge techniques in synthetic chemistry, spectroscopy, and molecular biology to create and study novel metal complexes and their interactions with enzymes and other biological molecules essential to life.

    • Chemical Biology. Technology development for basic biomedical research, including engineering tools and materials for applications at the molecular level. Using chemical methods to produce tools to study or manipulate biology. Development of chemical tools, such as probes, polymers, and nanostructured assemblies for potential use in biological systems and medical applications.

    • Chemical Catalysis. Development of catalytic reactions, including transition metal catalysis, organocatalysis, photochemical and electrochemical reactions.

    • Chemical Synthetic Methods. Development of reagents and new synthetic methods. Includes theoretical studies of reaction mechanisms and computational approaches.

    • Design and Synthesis of Chemical Probes. Design, synthesis, and testing of novel small molecule probes that target specific biological entities and pathways intended for the study of biological function. Includes development and approaches with docking libraries and screens. Research aimed at an organ or organ system, or the pathophysiology or treatment of an identified disease, will in most cases be more appropriate for another institute.

    • Glycochemistry. Design and synthesis of carbohydrate structures and their production through chemical synthesis or chemoenzymatic synthesis. This includes the development of sophisticated glycochemical techniques (design and assembly of sugars and their analogs) that expand current methodologies for the synthesis, analysis, and utilization of complex carbohydrates, driving forward both fundamental science and translational research opportunities.

    • Glycosciences. Carbohydrate-containing macromolecules with an emphasis on carbohydrates and their binding partner(s). Includes sugar transporters and carrier lipids, glycan processing enzymes, protein: glycan mediated interactions, and peptidoglycans.

    • Natural Products Discovery and Analysis. Identification and study of substances produced by living organisms that may form the foundation for therapeutic development. Analysis of organisms and their environments through the study of genetic information and biosynthetic pathways. Includes molecules produced and altered in microbial communities. Studies focused on human microbiome metabolites and their associated disease pathogenesis may be more appropriate for other NIH Institutes or Centers.

    • Peptide Chemistry and Engineering. Advancements in peptide research from the synthesis of novel scaffolds for enhanced stability and function to the use of peptides as chemical biology tools for studying enzyme functions and cellular processes. This also includes innovative methods in peptide synthesis, improved strategies for overcoming cellular barriers, and new therapeutic strategies.

    • Synthetic Biology. Engineering technologies to produce useful biological materials. Uses biological methods to produce tools to study or manipulate biology. Mixture of physical and genetic engineering to create new biological entities and systems, or redesign of naturally occurring systems.

• National Heart, Lung, and Blood Institute (NHLBI)

  • Cardiovascular Sciences. The Division of Cardiovascular Sciences (DCVS) supports basic, clinical, population, and health services research on the causes, prevention, and treatment of cardiovascular diseases. The research programs of the Division encompass investigator-initiated research, Institute-initiated research in targeted areas of research need and scientific opportunity, specialized centers of research focused on selected research topics, and clinical trials. Research supported by the Division is concerned with the etiology, pathogenesis, prevention, diagnosis, and treatment of coronary artery disease and atherothrombosis; pediatric and structural heart disease; heart failure and arrhythmias; and hypertension and vascular diseases. DCVS also supports investigations into the development and use of medical devices, imaging devices, software programs, AI/ML technologies, molecular technologies and other tools to improve cardiovascular health. A broad array of epidemiological studies is supported by the DCVS to describe disease and risk factor patterns in populations and to identify risk factors for disease. Also supported are clinical trials of interventions to prevent and treat disease; studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and studies of the application of prevention and treatment strategies to determine how to improve clinical care and public health. If you would like to learn more about the scientific areas covered by the DCVS and connect with a program officer, please visit the division website: Division of Cardiovascular Sciences | NHLBI, NIH.

  • Lung Diseases. The Division of Lung Diseases (DLD) supports research on the causes, diagnosis, management, prevention, and treatment of lung diseases and sleep disorders. Research is funded through investigator- initiated and Institute-initiated grant and contract programs in areas including asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, critical care and acute lung injury, developmental biology, pediatric and neonatal pulmonary diseases and care, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis. Also supported are mechanistic and non-mechanistic clinical trials to predict, prevent and treat pulmonary disease; digital health including mobile / tele-health, wearable devices, respiratory surgical devices, aerosol drug or gas delivery, supplemental oxygen, bioinformatics, mechanical ventilation, imaging devices, personalized medicine and AI/ML to help inform clinical decision making in pulmonary medicine. If you would like to learn more about the scientific areas covered by the DLD and connect with a program officer, please visit the division website: Division of Lung Diseases | NHLBI, NIH.

  • Sleep and Circadian Biology. The National Center for Sleep Disorders Research (NCSDR) supports research on the causes, prevention, and treatment of sleep disorders and the promotion of sleep health. Research is funded through investigator- initiated and Institute-initiated, grant, and contract programs in sleep and circadian biology research projects. The NCSDR is interested in funding projects related to the regulation of sleep and sleep disorders including circadian disorders, insomnia and obstructive sleep apnea. The NCSDR is also interested in research focused on the development of tools, devices and data science approaches for the early prediction, detection, and treatment of sleep deficiency and sleep and circadian disorders. If you would like to learn more about the scientific areas covered by the NCSDR and connect with a program officer, please visit the website: National Center on Sleep Disorders Research | NHLBI, NIH.

  • Blood Diseases and Resources. The Division of Blood Diseases and Resources (DBDR) supports research on the causes, prevention, and treatment of nonmalignant blood diseases, including anemias, sickle cell disease, hemophilia and thalassemia; premalignant processes such as myelodysplasia and myeloproliferative disorders; and other abnormalities of hemostasis and thrombosis; and immune dysfunction. Research supported by the Division encompasses a broad spectrum of topics ranging from basic biology and mechanism of action, to medical management of blood diseases. The Division has a major responsibility for research to improve the adequacy and safety of the nation's blood supply. It also plays a leading role in transfusion medicine and blood banking, including research to evaluate blood donation screening, manufacturing, processing technologies and storage. The Division also has a major responsibility supporting research in hematopoiesis and stem cell biology and disease. It also supports hematopoietic stem cell transplantation research and the application of stem cell biology findings to the development of new cell-based therapies to repair and regenerate human tissues and organs. If you would like to learn more about the scientific areas covered by the DBDR and connect with a program officer, please visit the division website: Division of Blood Diseases and Resources | NHLBI, NIH.

  • Center for Translation Research and Implementation Science. The Center for Translation Research and Implementation Science (CTRIS) plans, fosters, and supports an integrated and coordinated program of research to understand the multi-level processes and factors that are associated with successful integration of evidence-based interventions within specific clinical and public health settings such as worksites, communities, and schools; identifies and makes readily available to implementation and dissemination practitioners emergent knowledge about the late phases of translation research, especially the "T4" phase, for rapid and sustained adoption of effective interventions in real world settings; leads the NHLBI effort in the rigorous, systematic evidentiary reviews and subsequent NHLBI participation in the collaborative model for clinical practice guidelines development; supports training and career development of personnel in "T4" translation research and health inequities relating to heart, lung, and blood diseases; provides a focal point for advice and guidance on matters pertaining to minority health, health inequities and minority participation in research; represents the NHLBI to other governments, other Federal Departments and agencies, international organizations, and the private sector on global health issues; and provides data analytics and portfolio analysis to evaluate and inform future directions of implementation research programs. If you would like to learn more about the scientific areas covered by the CTRIS and connect with a program officer, please visit the division website: Center for Translation Research and Implementation Science | NHLBI, NIH.

• National Human Genome Research Institute (NHGRI)

  • Technology and Methods Development. Technology development in DNA sequencing, genotyping, and single-cell analysis are examples of activities that have changed the nature of what scientific research questions are practical to address, have enabled new approaches, and have facilitated the development of new community resource data sets. Many areas of critical importance to the realization of the genomics-based vision for biomedical research require continued technological and methodological developments before pilots and then large-scale approaches can be attempted. Accordingly, the NHGRI will continue to support the development of new, fundamental technologies in all areas of genomics. Important areas in which technology development applications would be responsive include (but are not limited to) experimental technologies and computational methods to analyze gene expression and other molecular phenotypes; discovery and characterization of genetic variation; identification of the genetic contributions to health, disease, and drug response; statistical analytic methods for understanding human genomic variation and its relationship to health and disease; and chemical genomics. There is also continued need to support technology development for the comprehensive discovery of functional elements in the human and model organism genomes and new nucleic acid sequencing technology. Many of these assays would benefit from the ability to work with very small amounts of starting material down to the level of single cells and subcellular compartments, along with minimally invasive human specimens that are easy to collect, handle, and store. As these technologies mature, emphasis should be on high throughput, cost-effective methods that consistently produce very high- quality data.

    The Institute also places high priority on contributing selectively to the development of new and needed technology in related areas, such as proteomics and systems biology research, when NHGRI funding can be used to further a truly unique development that will have a significant impact on the field.

    Further information on opportunities related to technology and methods development is available on the NHGRI Genome Technology Program website.

  • Bioinformatics, Computational Genomics, and Data Science. The ongoing development of new sequencing technologies has dramatically increased the amount of data produced for genomics in basic science and translation to medicine. NHGRI encourages new computational approaches for the analysis, visualization, and integration of genomic information in basic and clinical research and in applications to improve its utility in healthcare. These approaches may include the development of methods for processing, annotating, interpreting, analyzing, and sharing of sequencing data with associated phenotypes and other large-scale genomic data sets such as haplotype maps, genetic variants, transcriptome measurements, functional elements, and, in some cases, protein interactions. New tools for population-based analysis using the pangenome reference are of interest. NHGRI also encourages the development of better computational solutions for storage, access, compression, secure sharing, privacy, and transfer of large genomic datasets by biomedical researchers.

    NHGRI will support projects to improve informatics tools to make them more easily adopted by any biomedical research laboratory that wishes to use genomic technologies to address biomedical questions. This may include making them more efficient, reliable, robust, well- documented, and well- supported, or deploying them in containers or at scale in a cloud-based platform.

    Where possible, existing or emerging community data standards, models, and methods for data representation and exchange should be used in the development of these new methods and tools as well as other approaches to enhance reproducibility. Standards-based approaches such as GA4GH are also encouraged to integrate and share genomics and phenotype data for data mining with other sources including for clinical application. Projects that will make genomic digital objects Findable, Accessible, Interoperable, Reusable (FAIR) in the broader community are highly recommended.

    Further information on programs related to NHGRI supported research in these areas is available on the Computational Genomics and Data Science Program website.

  • Population Genomics and Genomic Medicine. Advances in the understanding of genomic variation across human populations and the functional consequences of variants independently, in combination, and in different environmental contexts have significantly impacted how genomic information can be used in both public health and clinical practice settings, alternatively known as genomic medicine. An existing challenge is how to capture, interpret, and return genomic information at high volumes and in a cost-effective manner. Innovative technologies and methods are needed to allow information on genomic variation to be used broadly in clinical settings while meeting regulatory requirements, to inform public health efforts, and to accurately convey genomic risk profiles to a lay audience.

    Biotechnology and informatics have enhanced our ability to survey the entire genome within and among populations. This progress has allowed for improved inferences about evolution of the genome and better characterization of populations, key elements of populations genomics. An existing challenge is how to assemble and analyze multiple genomes using computational methods to identify patterns of genomic divergence. Technology is needed to enable nuanced incorporation of population-based discovery with detailed investigation of disease-based cohorts and prospective variant evaluation. Population genomic information can be used to understand disease process, improve risk prediction, and apply the results in patient care.

    The research scope of Population Genomics and Genomic Medicine at NHGRI includes: characterizing the spectrum and distribution of genetic variation in humans and other biomedically relevant organisms; developing statistical and computational methods for comparing genomes and genome function within and across species as well as for relating genetic variation to health- and disease-related traits; developing resources and statistical methods for observational studies and clinical trials incorporating advanced genomic technologies; conducting proof-of-principle studies that apply genomic technologies to epidemiologic and clinical research; developing research methods and infrastructure needed for future epidemiologic and clinical studies of genetic and environmental contribution to disease; investigations of whether and how clinical genome variation impacts disease prevention diagnosis, and treatment; studies of approaches to improve the identification and interpretation of genomic variation for dissemination in clinical settings; assessing phenotypic manifestations of genetic variation through electronic medical records (EMRs); integrating genomic results and clinical decision support into EMRs; studies that address current barriers to the implementation of clinical genome sequencing; and assessing the impact of genetic information on clinical utility, health outcomes, and delivery of care.

    For additional information about Genomic Medicine at NHGRI, please visit the Division of Genomic Medicine website.

  • Ethical, Legal and Social Implications. NHGRI, through the ELSI Research Program, supports research studies that examine and address the ethical, legal, and social implications of genomics. These studies may focus on issues associated with genomic research, genomic healthcare, the interplay between the field of genomics and organizations, institutions, or other organized stakeholders, and broader values and societal effects that shape and are shaped by genomics.

    More detailed information on specific ELSI research priorities within each of these broad areas is available on the ELSI Research priorities website.

  • Genomic training and education. NHGRI supports educational activities and curriculum development that increase genomics knowledge of students, trainees, and genomics professionals. The goal of these activities is to provide an avenue for entry and pursuit of genomics careers. The widespread impact of genomics creates a need to train diverse groups of people to develop innovative and impactful genomic research approaches and resources. Training opportunities may be proposed at the undergraduate, postbaccalaureate, graduate, postdoctoral, or professional level.

    For more information on genomic training and education at NHGRI, please visit the Training Program website.

• National Institute of Mental Health (NIMH)

  Division of Neuroscience and Basic Behavioral Science (DNBBS)

  The Division of Neuroscience and Basic Behavioral Science provides support for research programs in the areas of basic neuroscience, genetics, basic behavioral science, research training, resource development, technology development, drug discovery, and research dissemination. The Division has the responsibility, in cooperation with other components of the Institute and the research community, for ensuring that relevant basic science knowledge is generated and then harvested to create improved diagnosis, treatment, and prevention of mental and behavioral disorders.

  In this Division, the SBIR and STTR programs support research and the development of tools related to basic brain and behavioral science, genetics, and drug discovery and development relevant to the mission of the NIMH. Such tools include software (such as informatics tools and resources and tools for analyzing data); hardware (such as the development of instrumentation or devices); wetware (such as the use of iRNAs or other bioactive agents as research tools or molecular imaging agents or genetic approaches to label neural circuits or modify circuit functions); and drug discovery related technologies such as high throughput screening (HTS) or computational pharmacology approaches. Assay development projects should follow the best practices laid out in the Assay Guidance Manual: https://www.ncbi.nlm.nih.gov/books/NBK53196/.

  Areas of Emphasis:

  • Novel imaging probes to study brain structure and function at all levels, from the molecular level to the whole organ, using any imaging modality (PET, fMRI, optical, etc.) in animal or human studies.

  • Drug discovery/drug development of novel compounds which act on molecular pathways (receptors, enzymes, second messengers, etc.) that are not typically targeted with currently available psychiatric drugs, and that have a strong biological justification as a novel mechanism for treatment of psychiatric disorders.

  • First in human drug trials.

  • Novel screening assays for high throughput acquisition and analysis of data about behavior and the brain, from the level of genes to behavior.

  • Novel technologies that would enable researchers to study how populations of neural cells work together within and between brain regions, in order to understand how changes in neural activity contributes to mental disorders, using animals or when applied to humans.

  • Develop informatics tools to facilitate the analysis and sharing of data between laboratories about behavior and the brain. This could include common data element efforts but is not limited to that area.

  • Technologies consistent with the goals of the BRAIN Initiative: http://www.braininitiative.nih.gov/, including human/ clinical-based technologies.

  Division of Translational Research (DTR)

  The DTR directs, plans, and supports programs of research and research training that translate knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental disorders and develops effective interventions for children and adults. DTR supports integrative, multidisciplinary research on the following areas: the phenotypic characterization and risk factors for psychiatric disorders; neurobehavioral mechanisms of psychopathology; trajectories of risk and resilience based on the interactive influences of genetics, brain development, environment, and experience; and design and testing of innovative psychosocial, psychopharmacologic, and somatic treatment interventions.

  In this Division, the SBIR and STTR Programs support research aimed at facilitating the validation and commercialization of new methods of assessing psychopathology and measuring treatment response to therapeutic agents. In addition, the SBIR and STTR Programs support the clinical development of interventions, including novel pharmacologic agents or brain stimulation devices as well as technology development used to deliver novel psychosocial approaches to the treatment of mental illness in adults, pediatrics and geriatrics. For more information on NIMH supported clinical trials and requirements, see: https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml

  Areas of Emphasis:

  • Develop valid measures of the various constructs in the Research Domain Criteria (RDoC) matrix (see https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/index.shtml), e.g., behavioral tasks, psychometrically sophisticated self-report measures, and measures of physiological and neural activity, into a commercial product.

  • Conduct early stage, proof of concept clinical trials to advance the development of novel therapeutics. The clinical trials are expected to include biological/behavioral data to assess target engagement and to help determine potential success or failure of the compound before moving on to larger clinical trials (see NOT-MH-11-015 http://grants.nih.gov/grants/guide/notice-files/NOT-MH-11-015.html).

  • Develop, test and perform initial validation of reliable and stable biomarkers that can identify at-risk individuals prior to disease onset, improve diagnosis and classification, predict treatment response, or to measure disease progression. Biomarkers are also needed in clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll in a treatment trial, or to measure efficacy or toxicity/side effects. Biomarkers in psychiatry will initially be appropriate as clinical research tools, and only after significant technical and clinical validation, could move toward diagnostic utility or other context of uses.

  • Development of novel diagnostic tools and innovative measures of treatment response and disease progression, preclinical or clinical efficacy testing, or toxicity measures for drug development.

  • Development of hardware and software tools to enable refined physiological and behavioral assessment of normal and atypical neurodevelopment focused on pediatrics, adult and geriatric age ranges.

  • Web-based tools and biosensors to enhance prevention, early identification and treatment of pediatric mental disorders by various educational and health professionals.

  • Development of hardware and software tools to support operations of multi-site clinical trials.

  • Development of novel methods to enhance efficiency of early phase clinical trials.

  • Novel technologies and data analytic tools to enable quantification of behavioral data that is relevant to research or clinical trials in mental disorders and/or autism.

  • Development of imaging technologies that can reveal specific pathologies in major mental disorders.

  Division of AIDS Research (DAR)

  The NIMH DAR supports scientific research to understand and alleviate the consequences of HIV disease on the central nervous system, and research to strengthen the provision and outcomes of HIV/AIDS prevention and treatment. Examples of high-priority research areas for SBIR/STTR applications are described below.

  • Develop and test novel, non-invasive diagnostic approaches (instrumentation, imaging, biomarkers, central nervous system [CNS] cell-based in vitro models) to comprehend HIV-1 associated CNS dysfunction and innovative technologies to study the mechanisms involved in HIV-1 associated neuropathogenesis and persistence of HIV-1 in the CNS.

  • Design and test novel therapeutic interventions aimed at amelioration of HIV-1 associated CNS dysfunction, and/or eradication of HIV-1 from CNS reservoirs, and/or strategies to prevent viral resurgence in the CNS upon cessation of anti-retroviral therapy.

  • Tools to assess neurotoxicity profiles of antiretroviral medications and pharmacological strategies to reduce adverse effects of anti-retroviral drugs (neuropsychiatric side effects and drug-drug interactions).

  • Develop new tools/ techniques to aid in deciphering the complex neuro-immune interactions at a molecular and cellular level in the context of HIV.

  • Develop or adapt neurological/neuropsychological/neurobehavioral assessments to evaluate HIV-1 associated abnormalities in adults or children in resource limited environments that are adaptable to different cultures and languages.

  • Build and optimize informatics tools to aid in analyzing and characterizing the phenotype of CNS disease modalities associated with HIV by using machine learning, big data and systems biology- based approaches.

  • Develop technologies and tools to increase regular HIV testing and support uptake, adherence, and persistence to biomedical HIV prevention regimens among persons behaviorally vulnerable to HIV or to biomedical HIV treatment regiments among people newly diagnosed with HIV.

  • Develop innovative tools and approaches that use existing patient-level data, such as electronic medical records and prescription refill or claim data, to improve engagement in HIV care or HIV treatment adherence to strengthen sustained viral suppression, including development and testing of predictive algorithms to identify those at risk for future non-adherence.

  • Develop approaches that seamlessly integrate tools for mental health screening and treatment into HIV healthcare or increase the capacity of HIV clinics to address mental health concerns.

  • Develop decision support tools that help individuals, couples, and clinicians make informed choices about the increasing number of proven and available HIV prevention and treatment regimens, including long-acting regimens and multipurpose prevention technologies (MPTs).

  • Develop innovative wireless technologies, remote sensing devices, biomarkers, assays, or other novel methods to improve scientific measurement of HIV exposure due to sexual behavior, or scientific measurement of social determinants that influence HIV treatment and prevention. Assessment approaches could occur retrospectively (not a clinical trial – using existing data, such as electronic medical records).

  • Develop and improve digital communication technologies to raise HIV awareness and promote accurate and timely health information to users, groups, and geographic regions most impacted by HIV.

  • Develop and test tools, curricula, and strategies that seek to reduce documented HIV-related disparities and health inequities (e.g., age, sex, gender identity, sexual orientation, race, ethnicity, socioeconomic circumstance, etc.) in HIV incidence and HIV prevention, treatment, and cure outcomes.

  • Develop innovative long-acting systemic and non-systemic multipurpose prevention technologies that prevent HIV infection and pregnancy (hormonal and non-hormonal methods) in adolescents and young women.

  Division of Services and Intervention Research (DSIR)

  The Division of Services and Intervention Research (DSIR) SBIR/STTR supports two critical areas of research for people with or at risk for mental illness:

  • Intervention research to evaluate the efficacy and effectiveness of pharmacologic, psychosocial, somatic, rehabilitative, sequential and combination interventions on mental and behavior disorders- including acute and longer-term therapeutic effects on functioning across domains for children, adolescents, and adults.

  • Mental health services research to improve the access, continuity, equity, value, quality and outcomes of mental health care, as well as to improve the dissemination of information about and the implementation of effective interventions, to strengthen the public health impact of NIMH research.

  The intervention research program aligns with NIMH Strategic Objectives 3.2 and 3.3 and addresses the efficacy/effectiveness of treatment and preventive interventions in usual practice and community settings with the purpose of informing clinicians, patients, families, and health policy makers on evidence-based practices. In funding decisions, special emphasis is placed on the potential clinical and/or public health impact of the research activities and on the implications of the research findings for improving community practice and health outcomes. Types of interventions include the full range of behavioral, psychotherapeutic, pharmacologic, and non-pharmacologic somatic or complementary/alternative interventions, as well as rehabilitation or other adjunctive services, e.g., integrated approaches to chronic mental illness. Examples of areas of interest are:

  • Analyses of naturalistic databases to evaluate the effectiveness of preventive and treatment interventions.

  • Randomized clinical trials evaluating the effectiveness of preventive and treatment interventions that have been augmented or refined with the intent to enhance their clinical potency or efficiency.

  • Identifying moderators and mediators of intervention effects as a step to design and test personalized interventions.

    • Moderator/mediator identification could occur retrospectively (not a clinical trial – using EHR).

    • Moderator/mediator identification could occur prospectively (within the context of a clinical trial).

  • Evaluating the effectiveness of predictive algorithms to improve identification and intervention of individuals at elevated risk of mental illness and suicide.

  • Evaluating the combined or sequential use of interventions.

    • Evaluation of combined/sequential interventions could occur retrospectively (not a clinical trial – using EHR).

    • Evaluation of combined/sequential interventions could occur prospectively (within the context of a clinical trial).

  • Determining the optimal duration, frequency and intensity of an intervention to optimize improvements in symptoms and functioning, establishing the utility of preventive intervention or continuation or maintenance treatment (that is, for prevention of relapse or recurrence).

    • Evaluation of the optimal length of an intervention could occur retrospectively (not a clinical trial – using EHR).

    • Evaluation of the optimal length of an intervention could occur prospectively (within the context of a clinical trial).

    • Evaluating the long-term impact of preventive and therapeutic interventions on symptoms, functioning, and quality of life.

    • Evaluation of the optimal length of an intervention could occur retrospectively (not a clinical trial) – using EHR or survey data).

    • Evaluation of the optimal length of an intervention could occur prospectively (within the context of a clinical trial).

  Services research covers all mental health services across the lifespan for all mental health disorders, includes clinical trial and non-clinical trial designs, and aligns with NIMH Strategic Objective 4 , which includes but is not limited to:

  • Service settings at the patient, provider, health system, and cross system levels to include primary care, specialty mental health, emergency departments, integrated care, general medical, and other delivery settings (such as employment, educational, veteran, military, criminal justice, child welfare, juvenile justice and other community settings).

  • Enhanced capacity for conducting services research by developing and utilizing innovative and established methodologies, including health economics, to inform decisions about the organization, delivery and financing of care.

  • The clinical epidemiology of mental disorders to include development and use of data sets from health surveillance activities, decision support tools, administrative claims, mobile apps and similar technologies, electronic health record (EHR), disease registries, and other databases where epidemiological data (to include big data) reside.

  • Interventions and other research to improve access, continuity, engagement, quality, uptake, equity, efficiency, and cost of care.

  • Research that reduces disparities and advances equity in mental health interventions, services, and outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons and other underserved groups.

  • The dissemination of information about and implementation of evidence-based interventions, programs, support tools, or other practices or technologies into service settings.

  For both interventions and services research, DSIR supports the development and testing of digital health tools. These tools include technology-assisted approaches to assessment (e.g., technology-assisted screening and diagnosis) and intervention (e.g., m-health and other technology platforms to support the delivery of preventive, therapeutic, and services interventions). DSIR encourages efforts to employ technology-assisted approaches to expand the reach, efficiency, continuity, quality, and/or boost the therapeutic benefit of research-informed strategies, rather than mere translation of research-supported strategies onto new or emerging technology platforms. Collaboration with NIMH-supported researchers for the development of software for new analytic techniques and/or decision-making algorithms is encouraged. Also supported is research and the development or adaptation of tools and technologies to be used to enhance the training and development of new generations of researchers and practitioners and to keep established researchers and practitioners up-to-date on the findings, implementation, and methods of interventions and services research.

• National Institute on Minority Health and Health Disparities (NIMHD)

  Applicants are encouraged to engage in research and development that results in a product, process or service that will improve minority health and eliminate health disparities and that by design targets or involves any of the topics listed in the NIMHD waiver list or otherwise will contribute to the NIMHD mission.

• National Institute of Neurological Disorders and Stroke (NINDS)

  The NINDS accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. Examples of research topics within the mission of NINDS are shown below. This list is not all inclusive and some research areas fall into multiple categories.

  • Therapeutics and Diagnostics Development for Neurological Disorders, including biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for treatment of neurological disorders, and technologies/methodologies to deliver therapeutics to the nervous system.

  • Clinical and Rehabilitation Tools, including intraoperative technologies for neurosurgeons, rehabilitation devices and programs for neurological disorders, and brain monitoring systems

  • Technology and Tools, including technologies to image the nervous system, neural interfaces technologies, and tools for neuroscience research and drug development.

• National Institute of Nursing Research (NINR)

  NINR has developed a research framework that takes advantage of what makes the Institute unique by focusing on a holistic, contextualized approach to optimizing health for all people, rather than on specific diseases, life stages, or research topics. The framework builds on the strengths of nursing research, spans the intersection of health care and public health, and encompasses the clinical and community settings where nurses engage in prevention, treatment, and care—including hospitals and clinics, schools and workplaces, homes and long-term care facilities, justice settings, and throughout the community. The framework encourages research that informs practice and policy and improves health and quality of life for all people, their families and communities, and the society in which they live. NINR’s research framework includes guiding principles and research lenses that promote innovative and rigorous multilevel study designs that look upstream, midstream, and downstream to discover solutions to the nation’s most pressing and persistent health challenges. NINR’s guiding principles describe the qualities that investigators should emphasize in all NINR-supported research. In considering awards for funding, the extent to which studies reflect these principles will factor into our decisions.

  NINR will prioritize research that:

  • Tackles today’s pressing health challenges and stimulates discoveries to prepare for, prevent, or address tomorrow’s challenges.

  • Discovers solutions across clinical, community, and policy settings to optimize health for individuals, families, communities, and populations.

  • Advances equity by removing structural barriers from research, cultivating diversity in perspectives and ideas, and fostering inclusion and accessibility in designing, conducting, and participating in research; and

  • Is innovative, develops or applies the most rigorous methods, and has the potential for the greatest impact on health.

  NINR identified five complementary and synergistic research lenses that best leverage the strengths of nursing research and promote multilevel approaches, cross-disciplinary and -sectoral collaboration, and community engagement in research. It is important to note that the lenses are not research topics, but rather perspectives through which to consider the full spectrum of nursing research topics that encompass health and illness within the context of people’s lived experiences. These lenses allow nursing research to examine new topics while also allowing scientists to take a different look at long- standing areas of interest. The research lenses are:

  • Health Equity: Reduce and ultimately eliminate the systemic and structural inequities that place some at an unfair, unjust, and avoidable disadvantage in attaining their full health potential.

  • Social Determinants of Heath: Identify effective approaches to improve health and quality of life by addressing the conditions in which people are born, live, learn, work, play, and age

  • Population and Community Health: Address critical health challenges at a macro level that persistently affect groups of people with shared characteristics

  • Prevention and Health Promotion: Prevent disease and promote health through the continuum of prevention – from primordial to tertiary

  • Systems and Models of Care: Address clinical, organizational, and policy challenges through new systems and models of care

  NINR does not generally support the development of technologies in the following topic areas:

  • Technologies designed for staffing purposes.

  • Technologies designed to provide nurse educational and professional training (e.g., VR simulations).

  • Technologies that assess or limit exposure to occupational health stressors.

  • Technologies for sanitization or decontamination in a clinical setting.

• National Center for Advancing Translational Sciences (NCATS)

  Preclinical Drug Discovery and Development

  • Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact; such as those that are: implicated for disease, have genetic variations that have been identified in functional regions of receptor targets, and/or have high potential for biased signaling that would promote the beneficial effects of receptor signaling and reduce the unwanted effects

  • Tools and technologies to enable high throughput screening of compound activity on currently “non- druggable” targets

  • Assays for high-throughput screening of rare-diseases-related targets

  • Co-crystallization high-throughput screening techniques

  • Fluorescence probes to replace antibodies for determination of cellular protein translocation

  • Phenotypic assay development, including stem cell technology platforms for human “disease-in-a- dish” applications and the evaluation of toxicity

  • Interventions that target molecular pathways or mechanisms common to multiple diseases

  • Platforms for non-antibody biologics, cell-based therapies and gene therapy discovery

  • Small molecule and biologics analytical characterization

  • Accelerated bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics and/or diagnostics

  • Development of novel technologies for enzyme replacement therapies (e.g., new cell culture/expression system) to solve major bottlenecks in rare diseases research

  • Innovative methods to determine alternative uses for existing therapeutic interventions for high priority areas, such as rare diseases and pain.

  • Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic or other intervention optimization

  • Technologies to deliver nucleic acid therapeutics to tissues other than the liver

  • Methodologies and technologies to increase efficiencies of manufacturing therapeutics

  • Development of novel high-throughput technologies that focus on making translational research more efficient

  • GMP production of exosome/extracellular vesicles

  • Generation of producer lines for large scale production of exosomes/extracellular vesicles

  • Extracellular RNA-based biomarkers and therapeutics of human diseases

  • Approaches to targeting the human microbiome for therapeutic or diagnostic purposes

  • Scale up, manufacturing and characterization of IPS cells

  • 3D printing technologies

  • Technologies to substantially improve the efficiency and reduce the cost of clinical grade gene therapy vector manufacturing

  • Development of in vitro human tissue models (organs, 3D printing)

  • Technologies to allow therapeutic proteins other than lysosomal enzymes to be secreted and taken up by other cells via cross-correction

  • Novel strategies to prevent deleterious immune responses to gene therapy, to improve efficiency genome editing and/or enzyme replacement therapy

  • Establishing more robust phenotypic screens that may help prioritize candidate compounds for further testing

  • Innovative technology for non-small molecule delivery

  • High-throughput epigenetics screening/characterization tools and technologies

  • Microphysiological systems (MPS)/Tissue Chips, including MPS/Tissue Chips that incorporate known functional variants, e.g., ACMG 59 or CPIC A alleles, for study comparison using the same derived genetic background across a set of tissue chips with the functional variant

  • Volatile organic compounds (odors, scents) as biomarkers for disease

  • Bacteriophage-based therapeutics for disease and as modulators of the microbiome and microbiome natural products

  • High throughput Surface Plasmon Resonance devices for detecting protein small molecule interactions

  • New class of quantum-enabled sensing technologies for advancing translational sciences (e.g., point of care ultrasensitive high-throughput technologies for diagnostics, and miniaturized benchtop technologies for chemical/bioanalyte characterization).

  • Development of diagnostics or useful drug targets for rare diseases by using Pangenome data.

  Biomedical, Clinical, & Health Research Informatics

  • Searchable access to information about research resources, facilities, methods, cells, genetic tests, molecules, biologic reagents, animals, assays, and/or technologies with evidence about their use in research studies

  • Cloud-based tools and methods for meaningful sharing, re-use and integration of research data

  • Novel platforms, technologies and tools for: (1) enabling clinical and translational research, particularly those with mechanisms for inclusion of patient-reported data and (2) integration of patient data collected from multiple devices and multiple/diverse clinical studies

  • Development of personalized phenotypic profiling (as well as personalized intervention) based on patient-centered integration of data from multiple data sources, including social media

  • Development of predictive models for translational science

  • Digital applications and tools (including telemedicine platforms) that facilitate/enhance translational research and medicine in rural populations

  • Generic Disease Registry template platforms that can be reused for multiple diseases.

  • Mobile device validation tools to ensure data from different brands or versions have compatible results.

  • Tools to assess with algorithms developed with artificial intelligence, machine learning.

  • Tools that allow for persistent identifier and attribution for data contributors that give credit to the data producers while ensuring that shared data has not been altered

  • Patient Mobile Tool Platforms that facilitate tool developers to build “apps” that integrate into their medical records.

  • Tools and environments that enable an easy interrogation of publicly available data

  • Innovative approaches like nanoneedles and nano particles to help improve early disease detection and targeted therapeutic delivery

  • Tools and technologies that leverage AI and real-world data for enhanced product evaluation and surveillance that could be used to provide a resource for rapid response to public health needs

  Clinical, Dissemination and Implementation Research

  • Tools and technologies that:

    • increase the efficiency of human subjects research, that facilitate the rapid diagnosis and/or clinical trial recruitment and subject tracking, institutional review board evaluation and/or regulatory processes

    • evaluate and improve the process of informed consent

    • address medication adherence in clinical settings

    • address and improve community engagement

    • address the rapid diagnosis and/or clinical management of rare diseases

    • help characterize human disease states and assist in assessing the impact of interventions

    • support unique approaches to advance diversity, equity and inclusion.

    • mine published data and generate usable knowledge and analytics to advance research

  • Increased efficiency of clinical research conduct, including but not limited to regulatory decision support, patient eligibility analysis and recruitment and retention tracking

  • Educational tools for clinical and translational science

  • Computational or web-based health research methods, including:

    • Platforms for generally applicable and scalable multi-disease registries and natural history studies

    • Clinical trial designs and analyses (e.g., for pragmatic clinical trials)

  • Approaches, tools, platforms and environments that:

    • Integrate data in novel ways for development of new biomarkers that can be tested in translational research paradigms for which there are barriers or bottleneck

    • Engage prospective research participants who are from under-represented communities and impacted by disparities and the digital divide

  • Strategies to enhance the quality of and accelerate the conduct of dissemination and implementation research

  • Sustainable solutions for effective tools and environments in translational research

  • Development and validation of patient reported outcomes, clinician-reported outcomes and biomarkers for rare diseases that are not already supported by a disease-specific NIH Institute or Center

  • Patient empowerment tools/apps that allow users to compare their treatment and outcomes to normative populations existing treatment guidelines

  • Telemedicine or digital health applications that focus on research in rural populations

  • Tools and technologies that enhance the quality, safety, efficiency, effectiveness of new innovations in community settings

• National Center for Complementary and Integrative Health (NCCIH)

  Natural Products (including botanicals, herbs, probiotics, prebiotics, dietary supplements, special medicinal diets, and microbiome- /microbial-based therapeutics):

  • Development and validation of technologies for standardization and characterization of biologically active ingredients in natural products.

  • Development and validation of technologies for taxonomic identification of botanical raw materials or detection of adulterants.

  • Development and validation of technologies for the identification and characterization of bioactive metabolites derived from oral consumption of natural products.

  • Development and validation of methods for the sustainable production of low-yield natural products of commercial interest.

  • Development of novel analytical tools and technologies to study the microbiome, including its composition, genetics, and bioactivity, that can help clarify associations between the human microbiome and brain function and health.

  • Development of gut microbiome monitoring assays for validating safety and functional analysis of genomic and microbiota interactions.

  • Development of complementary and integrative therapeutic approaches to modify and balance the gut microbiota in healthy populations and individuals with disrupted microbiota and related diseases.

  • Clinical testing of natural products for the management of hard-to-treat symptoms such as pain, sleep disorders, or mild-to-moderate anxiety and depression to allow development of an evidence base that would accelerate U.S. Food and Drug Administration (FDA) approval of a drug indication for the natural product.

  Mind and Body Approaches (including meditation, mindfulness, hypnosis, yoga, tai chi, acupuncture, manual therapies, and music/art therapies):

  • Development, testing, and validation of appropriate objective and/or quantitative measures and instruments to assess or monitor mind and body approaches in different contexts (e.g., classrooms, families, child welfare, juvenile justice systems).

  • Development, testing, and validation of measures and tools to assess training or fidelity of implementation of mind and body approaches in different settings (e.g., health care, community, families, schools, child welfare, juvenile justice systems).

  • Development and testing of technologies for the implementation of mind and body approaches in group or individual settings and/or self-care strategies. Examples may include but are not limited to the use of mobile health technologies such as smartphone apps, sensors, online delivery, or phone- based delivery.

  • Development and validation of methods for standardization and characterization of the active components of mind and body approaches.

  • Development and validation of methods for standardization of multimodal interventions to study whole person health.

  • Development and validation of imaging tools or instruments for studying manual therapies, including but not limited to massage, acupuncture, or spinal manipulation.

  • Development and testing of innovative technologies for multisensory delivery of mind and body approaches.

  • Development, testing, and validation of innovative technologies to enhance sensory-based (temperature, light, olfaction, etc.) therapies.

  • Development, testing, and validation of innovative technologies to facilitate delivery of music/art- based interventions and to identify novel outcome measures and biomarkers for these interventions.

  General Tool/Technology Development:

  • Development and validation of biomarkers that correlate with efficacy of complementary and integrative health approaches.

  • Development and validation of standardized, reliable, and cost-effective tools that correlate with brain imaging in response to mind and body interventions.

  • Development and validation of tools, technologies, and instruments, including gaming and virtual reality technologies, for the accurate assessment of adherence and/or fidelity to the use of mind and body practices and interventions.

  • Development and validation of tools to improve patient-reported outcome measures of importance in clinical studies of complementary and integrative health approaches.

  • Development, pilot testing, and validation of wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals for mind and body approaches.

  • Development or adaptation of biochemical or epigenetic monitoring devices for complementary and integrative health approaches.

  • Development and validation of tools to improve biological and physiological outcome measures for use in clinical studies of complementary or integrative health approaches.

  • Development or adaptation of technologies for objective assessment of pain with relevance to complementary and integrative health approaches.

  • Development of sleep monitoring technologies or biomarker panels to assess sleep deprivation, sleep deficiency, circadian rhythm dysregulation, and connection of sleep disturbances with health risks.

  • Development and testing of in vivo labeling technology of tissues or cells responsible for generating signals in response to different internal senses (e.g., mechanical force, temperature, osmolarity, oxygen levels).

  • Development and testing of technology or methods for quantifying biomechanical forces applied to internal tissues or cells.

  • Development and testing of mobile health technology or nonmobile technology and methods to monitor or quantify physical and/or emotional well-being, breathing, or sleep.

• National Library of Medicine (NLM)

  NLM’s SBIR/STTR grant programs are focused on areas of particular interest from small business. The following narrative indicates the scope of projects suitable for the SBIR/STTR program that fit within the mission of NLM. They are not listed in priority order.

  1. Development of new, innovative tools and methods for annotating, curating, and managing biomedical data resources

  2. Advanced information retrieval and knowledge discovery from very large and/or heterogeneous data sets to support biomedical research

  3. Development of novel approaches enabling analysis and discovery at scale across biomedical domains, research institutions, or health care sectors, including those leveraging high-performance cloud computing and federated learning

  4. Novel platforms, technologies, tools, and techniques enabling multimodal data analysis to support health research or health care applications

  5. Multi-level, reusable, data analytic models, simulations, information visualization, and presentation approaches to enhance decisions, learning or understanding of biological and clinical processes

  6. Computational approaches integrating structured and unstructured data, natural language processing, automated metadata assignment to support biomedical research

  7. Data science methods, approaches, or tools that enhance the quality, confidentiality, security, and/or utility of biomedical data, including personal health information

  8. Artificial Intelligence techniques for characterizing and minimizing the impact of errors, incompleteness, missingness, within health-related data sets

  9. Novel data-driven methods to facilitate real-time decision-making in clinical practice and public health

  10. Analytical tools, technologies, and other data-driven strategies to track disease outbreaks, epidemics, and pandemics

  11. Tools and technologies for understanding and predicting climate and environmental effects on human health

• Office of Research Infrastructure Programs (ORIP)

  Division of Comparative Medicine

  • Development of in vitro animal cell culture techniques, microphysiological systems (organs- on-a-chips, organoids) or computational (in silico) methods to reduce the number of animals used in studies and to replace certain tests conducted in animal models with novel alternative methods (NAMS).

  • Development of improved reagents and cost-effective methods and technologies to accurately screen and diagnose selected diseases of laboratory animal, and to perform overall assessments of animal quality and health status. An urgent need currently exists for the development of improved methods for detection of active tuberculosis in nonhuman primates (NHPs).

  • Development of improved reagents, techniques, and devices/tools for genomic and transcriptomic analysis and data mining from tissue or single cells of laboratory animals and animal models of human diseases.

  • Development of new technologies for rapid or high throughput animal characterization and deep phenotyping (at tissue, organ, cellular or molecular levels) .

  • Development of nonintrusive, wearable technologies to identify or assess biomarkers in well validated animal models.

  • Development of prophylactics or new therapeutic agents to prevent and/or control infectious diseases of laboratory animals. One high priority need is to develop methods to control and prevent monkey B virus (Macacine alphaherpesvirus-1) infections.

  • Identification, development, and characterization of spontaneous (naturally occurring) and engineered vertebrate animal models for studies of various human diseases (excluding most random mutagenesis projects performed on rodents).

  • Development and refinement of high-throughput technologies, cryoprotectants and devices for the cryopreservation, vitrification, long-term maintenance, and revival of cells, tissues and organs, as well as laboratory animal embryos and gametes, especially for Drosophila, aquatic models of biomedical value, swine, and NHPs.

  • Development of technologies, tools, and devices for the effective monitoring of frozen, cryopreserved cells and biological materials/tissues as well as laboratory animal embryos and gametes (including monitoring conditions during their distribution).

  • Development of technologies for improved embryo transfer within a single animal species or of intraspecific embryo transfer to allow preservation of rare or unique animal species that may have unique value in biomedical research as animal models for human disease.

  • Development of improved reagents, artificial intelligence/machine learning technologies, tools, devices, and high-throughput technologies to perform, analyze, capture, and process data gathered in “omics” studies (genomics, transcriptomics, epigenomics, proteomics, lipidomics, glycomics, metabolomics, and phenomics, among others) in normal, diseased, and intervention conditions in animal/biological models to support or validate pre-clinical analyses.

  • Development of biological tools and reagents for reconstruction, remodeling, repair, and regeneration of tissues damaged by injury or disease. Development of the technologies and procedures to test efficacy and safety of these experiments in animal models. Approaches to detect and track survival of implanted cells and tissues in vivo.

  • Development of reagents (including antibodies), assays, and technologies that will facilitate research using aquatic biomedical models, such as zebrafish or Xenopus, for understanding basic aspects of development, physiology, or genetics.

  • Development of reagents (including antibodies), assays, and technologies that will facilitate research using NHPs for understanding basic aspects of development, physiology, or genetics. High priority needs include reagents for NHP species other than the rhesus macaque.

  • Development of rapid and sensitive technology for the accurate detection and diagnosis of polymicrobial infections in biomedical laboratory animal models, including those agents involved in vertical transmission of diseases into embryos and larvae.

  • Technologies for improved sex determination of embryonic, neonatal, and juvenile stages of animals, with one high priority need being nonmammalian species.

  • Development of rapid and sensitive technology for the detection and study of emerging human pathogens in animal models.

  • Development of non-invasive, micro-sensor technologies (e.g., embedded sensors, devices, microchips) for NHPs and other live animal models to collect data related to neuroimaging, behavioral and cognitive assessments, metabolism, microbiomes, and other biomedical research areas. Of special interest are wearable, swallowable sensitive and selective probes/sensors for detecting physiological fluctuations in living animals, with the capability of monitoring at deep tissues level.

  • Development of technologies for cell-based therapies that could be used as implantable biocomputers in animal models of human disease, to perform complex logic computations that integrated signals from multiple metabolites/pathways. These include remote-controlled switches and natural, nontoxic, highly soluble, and potentially beneficial to health trigger molecules.

  • Development of technologies and tools (biosensors, imaging approaches, and reagents such as antibodies (especially nanobodies)), to facilitate validation and use of multiple model organisms in research studies to enhance the rigor, and reproducibility of animal research and their clinical and translational research potential.

  Division of Construction and Instruments

  The Division of Construction and Instruments supports the development and implementation of technologies that enhance and improve the welfare and research facilities of animal models in biomedical and behavioral research. In particular, the areas being supported include novel tools and equipment that improves and facilitates the care and monitoring of animals. One area of interest is the integration of technological features for detecting, measuring, monitoring, recording, analyzing, and reporting physiological, biobehavioral, and environmental conditions to allow for documenting these physiological parameters and extrinsic factors and enhancing scientific rigor and reproducibility in animal studies. Another area of interest encompasses the improvement of laboratory equipment to maintain the environmental conditions and upkeep of the infrastructure within animal facilities. Of special importance is the employment of green technologies. Examples of topics of special interest include (but are not limited to) the development of better, more reliable, and more efficient:

  • Equipment such as vacuum cleaners, air filters, hoods, snorkels, and autoclaves for animal research facilities, for barrier facilities, and other facilities with special needs and requirements.

  • Equipment/devices to distribute water and food and to monitor and record their intake by research animals.

  • Equipment to increase the quality of life and prevent injuries of research animals, staff, and investigators.

  • Technology to monitor and protect the well-being of animals, including IT-supported tools.

  • Equipment and its use for maintenance of disease-free colonies and healthy animals.

  • Equipment to disinfect devices, furnishings, and other apparatus in animal facilities such as aquaria, cages, tunnels, and racks.

  • Cost-effective husbandry and colony management techniques, equipment, and/or new approaches to improve laboratory animal welfare and assure efficient and appropriate research use.

  • Specialized equipment and caging for laboratory animals to permit optimal environmental control, and operational efficiency, including improvements in caging, identification/tagging of animals and remote monitoring in animal facilities.

  • Specialized equipment to permit integrated environmental factor measuring, monitoring, reporting, recording and documentation (such as for air quality, temperature, humidity, lighting, sound, and vibration level).

• Office of Research on Women's Health

  ORWH will consider co-funding for applications that have a central focus on the health of women, as demonstrated through specific aims that EITHER explicitly address a particular condition in women OR focus on one of the high priority topics below. In either approach, intersectional and/or multidimensional approaches that consider the health of women in context (e.g., projects accounting for social and structural variables—including race, ethnicity, socioeconomic status, and State and Federal policies— that affect women’s health) are strongly encouraged. While projects are not required to exclusively focus on women for ORWH co-funding, studies that include more than one sex or gender should be designed and powered to make generalizable conclusions about women and enable sex or gender difference comparison. ORWH intends to prioritize interdisciplinary research that:

  • Addresses the influence of sex-linked biology, gender-related factors, or their intersections on health.

  • Addresses how physical, mental, and psychological health outcomes interact with structural factors to either mitigate or exacerbate health disparities and aims to create behavioral interventions to address these issues.

  • Advances the translation of research advancements and evidence in women’s health into practical benefits for patients and providers.

  • Informs and develops multi-sector partnerships to advance innovation in women's health research.

  • Increases public awareness of the need for greater investment in and attention to women’s health research, as well as women’s health outcomes across the lifespan.

  • Advances research to reduce health disparities and inequities affecting women’s health, including those related to race, ethnicity, age, socioeconomic status, disability, and exposure to environmental factors and contaminants that can directly affect health.

  • Increases uptake of evidence-based interventions that advance women’s health.

  • Addresses topics identified in the Women’s Health Innovation Opportunity Map.

  • Reduces violence, stigma, and trauma related to HIV.

  • Develops woman-centered self-tests for HIV viral load monitoring, including in breast milk.

  • Develops topical microbicide agents, wearable, implantable, or insertable devices releasing medications alone or as part of multipurpose prevention technologies (MPTs), to prevent sexual acquisition of HIV, other sexually transmitted infections and/or unplanned pregnancy across the lifespan including in pregnant or postpartum people.

  • Promotes the use of advanced statistical modeling, data visualization, artificial intelligence (AI), and machine learning (ML) methods for research on the health of women.

  • Develops methods, tools, or technologies to increase data sharing and improve data management practices to align with the Findability, Accessibility, Interoperability, and Reusability (FAIR) data principles and enhances the utility of new and existing data on the health of women.

  • Methods for integrating data science, including artificial intelligence and machine learning, into research on the health of women.

  • Develops cutting-edge computational tools and technologies to facilitate screening for prevention, diagnosis, and treatment of diseases that affect women.

  • Improves estimates of the impact of chronic conditions in women, including projects to diagnose and reduce misclassification of female-specific and gynecologic conditions, conditions that predominantly impact women or affect women differently, and projects to characterize differences in chronic condition presentation by gender, race and ethnicity and the various structural and social determinants that these women experience or are affected by.

  • Explores the role of hormonal fluctuations on the development of chronic conditions in women, including the influence of age of menarche; the role of menstrual cycle ir/regularity, length, and phase; the length of the reproductive window; the link between adverse pregnancy outcomes and development of chronic conditions later in life; and the effect of exogenous hormones on the development of chronic conditions

  • Develops new and better approaches for addressing the symptoms that affect women during perimenopause, menopause, and postmenopause

  • Improves early and accurate detection and diagnosis of chronic conditions in women, including the diagnosis of multiple chronic conditions

  • Elucidates gender differences in access and use of health care services, including methods for assessing discrimination (e.g., sexism, racism, ageism, and homophobia) encountered by women when accessing health care services for chronic conditions.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for

• Phase I: $9,000 Flat Fee + a 5% Success Fee.

• Phase II: $13,000 Flat Fee + a 5% Success Fee.

• Fast-Track: $13,000 Flat Fee + a 5% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Webinar - NIH Grant Admin for Academic Spin-Outs & First-Time Applicants