DHS SBIR FY22 Solicitation

Each Coast Guard Command Center has a human listening to radio distress frequencies - namely listening to static for 12 hours per day. This is a monotonous, but a critical duty. Because of the nature of these calls, and the numerous hoax calls, it is often difficult for a human to glean the criticality of these calls and get all the required information from them. The challenge is a watchstander may be less attentive after spending 12 hours throughout the day listening for distress activities.

An Artificial Intelligence (AI) system could consume the audio, analyze the audio in real time, learn to detect a real call from a hoax, and then send the information to a watchstander. This system could alleviate hundreds of watchstanding positions therefore, making Search and Rescue (SAR) distress monitoring much more successful. An Artificial Intelligence/Machine Learning (AI/ML) system could listen to thousands of historical calls to learn proper detection techniques and utilize voice inflection technology to greatly improve existing capabilities. The AI/ML system would need to cue watchstanders and potentially initiate processes such as initiating a case file within the Marine Information for Safety and Law Enforcement (MISLE) database. Connection to standard Coast Guard networks such as CG1View may be necessary for watchstander cuing through an existing platform. Potential use cases should be evaluated to determine future opportunities and connectivity requirements.

Voice and acoustic forensics applications already exist and have been used to evaluate known hoax maritime distress calls. This capability was employed after repeat hoax calls had already become a problem in a specific location. In this case, a specific individual had made several hoax calls costing the U.S. Coast Guard thousands of dollars in response operations. Recorded audio files were analyzed to identify acoustic characteristics that helped prosecute this hoax call case and others like it. Rather than waiting to use this technology on the back end as in this example, proactively employing voice forensics in radio frequency monitoring technology could cue watchstanders to anomalies that could possibly be associated with hoax calls. Additional potential use cases such as the acoustic detection of intoxicated mariners and subsequent cuing to watchstanders should be evaluated. Acoustic forensics and AI technologies should be evaluated for their ability to account for and differentiate between other variables that may be encountered such as different regional dialects and accents.

For the proposed solution, an AI/ML application would monitor radio frequencies, relieving watchstanders from the tedious task of listening for hours where cost and time savings could be realized by employing Coast Guard personnel with other mission critical tasks. For initial capability exploration, the AI/ML should monitor VHF distress frequencies between 4 and 10 MHz. VHF Channel 16 is the single channel within this range, but there are several simultaneous sources from different Rescue 21 towers. Building upon the initial capability, AI/ML monitoring could be expanded into the UHF or other Coast Guard VHF working channels.

Law Enforcement Officers (LEO) are often called upon to secure buildings and structures during events with a large number of attendees. During celebratory or protesting events, portions of crowds may become destructive or aggressive and enter or attempt to enter restricted, private or protected sites or structures. Law Enforcement Officers (LEO) deploy physical barriers and other countermeasures in an attempt to mitigate incursions. However, protection of sites against incursions would benefit from an additional layer of advanced technology solutions to delay crowd advancement, prior to the need for direct engagement, while LEOs can muster additional staffing and/or resources.

There is a need to develop a capability to immobilize aggressors through deploying a substance/material to a surface which would, remain passive until activated or be activated concurrent with deployment. The capability will need to be able to be rapidly deployed in an active state or deployed beforehand and rapidly activated to prevent malicious actors from breaching perimeters. If the identified solution exists in ready-to-deploy state, it must blend in aesthetically to existing infrastructure prior to activation. Successful deployment of this technology would deter or delay incursion to allow LEOs the time and space needed to dispatch additional reaction forces and countermeasures to defend sites or structures. The desired technical solutions would minimally occupy the initial staff once activated and should not contribute to LEO entanglement with the crowd. Lastly, once activated, the solution should be highly visible (brightly colored, impregnated with flash material, etc.) so as to mark the deployed location and prevent any person not attempting incursion from accidentally becoming immobilized.

Key requirements of a proposed solution must include:
• Preparation/set-up time to apply solution should not exceed 4 hours per acre
• Ability to be activated near instantaneously (threshold: < than 3 minutes to activate and objective: =/< than 3 seconds to realize initial effectiveness)
• Once activated, remain effective until no longer needed and/or be able to be quickly reactivated within original activation threshold
• Once activated the solution should be highly visible both at night and during the day (containing a bright color, flash material, etc.)
• Ability to be cleaned up safely with minimal logistics within 12 hours and not require advanced or specialized personal protective equipment (PPE), beyond Level D and N95 mask, to handle deployed material
• Solution must be effective in all four seasons
• Low-cost, targeted coverage cost of $15,000 or less per acre
• Solution be compliant with guidance found in DHS Policy Statement 044-5, Department Policy on the

Use of Force and must operate within legal authorities established under Title 18 U.S. Code § 3056
Technical solution should NOT include:
• Launching of projectiles
• Energy-based systems or weapons
• Physical barriers
• Requirement for active steering or guidance by LEOs to be effective

Factors that could be considered beneficial when key requirements are met:
• Mobility of solutions that could facilitate protection of locations based on evolving or emerging event concerns
• Technology solutions that are reusable subsequent to deployment and activation
• Resilient to weather and other environmental and situational conditions
• Minimal potential for serious injury when deployed and activated
• Compact storage
• Lightweight and man-portable (time required to be worn or lifted should be balanced with weight and size)

Counterfeit electronics are a growing issue in the global market, and some counterfeits are infiltrating high-risk applications. The growing volume of inbound electronics parts passing through U.S. Ports of Entry (POEs) requires new or improved inspection techniques that can be a force multiplier to help prevent entry of counterfeit chips and tampered systems in the homeland. Current techniques are extremely slow (take hours to days depending on the size of the device under test) and costly (thousands of dollars). Most techniques are based on electrical testing which is labor-intensive and timely process and require either a subject matter expert (SME) to analyze the results or expensive (hundreds of thousands of dollars) machines for imaging such as heavy X-ray imaging microscopes which can reveal physical defects/abnormalities.

Of particular interest are advanced image-based machine learning algorithms and image analysis and processing techniques that rely on handheld physical inspection modalities capable of providing real-time detection of counterfeits integrated circuits (ICs) and printed board circuits (PCBs). As a result, the solutions must require little to no operational requirement (e.g., the handheld device could be within 1-2 feet distance from device under test, easy to use, connected to cloud to transmit the images and receive notification), must be non-destructive, it should not require human in the loop for image processing and analysis, provide high confidence in detection, and be user-friendly for non-technical, minimally trained operators.

The end state of this effort is a solution to support highly accurate, real-time (within seconds) counterfeit microelectronics (ICs and PCBs) detection enabled by a low cost (few hundreds of dollars) handheld device feasible for use by CBP agents or DHS law enforcement. The only operational requirement would be to have the ability for a CBP agent to capture a number of images from ~1-2 feet distance using handheld device, while the entire transmission of the images, analyzing the images, and making final decision is performed in the cloud environment.

Broadband Push-to-Talk (PTT) services are offered by a diverse group of vendors. These PTT services provide important communication services for the first responder community during public safety incidents and events. U.S. and state local territorial and tribal (SLTT) agencies may utilize different PTT services which can result in obstacles to interoperable communications.

PTT communication platforms have been developed to support first responder communications over the past 15 years. Some of these services are based upon the Internet Engineering Task Force (IETF) Real Time Protocol (RTP) and Real Time Control Protocol (RTCP) for payload and control plane communications. In some instances, platforms utilize the secure versions (SRTP and SRTCP) of these protocols to provide encrypted communications. PTT services offered by non-network operators are an important subset of available product offerings as they are network agnostic and can facilitate interoperability between diverse responder communities and across multiple cellular networks. With major U.S. network operators providing priority and preemption for first responders, non-network-based PTT services can deliver mission critical grade services to end users.

Cellular network operators are also offering Mission Critical Services (MCS), including Mission Critical Push to Talk (MCPTT), to support the needs of first responders. These services are based upon standards developed by the Third Generation Partnership Project (3GPP) and are tightly integrated with the Enhanced Packet Core (EPC). One primary advantage of core based MCS is elevated priority access that delivers the highest level of priority service for first responders. These include the following 3GPP solutions: FirstNet MCPTT (Samsung), FirstNet MCPTT (Motorola), Verizon PTT Responder.

We are seeking a broadband PTT interface solution that will provide a method to combine these diverse communication platforms while maintaining critical meta data that is needed to insure that first responders maintain interoperable communications during critical incidents and planned events.

The solution needs to define the base architecture along with a catalog of service offerings that would be candidates for inclusion in the research conducted. The architecture and approach need to:
1. Document a set of interoperability requirements and define a feature requirements matrix for the interface.
2. Include a security policy for the interface that will address the use of encrypted services. This policy, to the extent possible, needs to prioritize end-to-end encryption.
3. Develop an interface specification that can serve to enable current and future PTT service  vendors to maintain compliance with the broadband PTT interface.

As of mid-2021, the DHS BioWatch system detects only small and specific DNA-signatures of six commonly known biological agents. Both the biological threat landscape and public health requirements have evolved significantly since the United States Government (USG) deployed BioWatch in 2003; accordingly, the USG must now similarly evolve its biological hazard perception capabilities and its population health monitoring posture.

The long-term vision (2035) is to instantaneously detect any biological agent or form of matter present in an atmospheric sample with high specificity and sensitivity as it passes through a portable detector module. This topic requests a proposed creative solution that addresses the problem of rapid spectral deconvolution of complex samples. There has been palpable innovation in spectrometer miniaturization over the past decade, some of which has been powered by advanced algorithmic techniques, and we expect scientists and engineers to apply machine learning (ML) to such algorithms in the immediate future.

In response to this topic we request a proposed ML-based algorithm solution that instantaneously identifies a molecule based on its spectral properties. Given a set of spectral data such as mass, Raman, infrared, optical and/or other spectral data on a compound, the algorithm should be able to identify the molecular structure of that compound. Proposed solutions can begin with the identification of individual compounds (as opposed to complex samples) and even use spectral data sets (including two dimensional) that are not yet generally gleaned from miniaturized spectrometers [e.g., nuclear magnetic resonance (NMR) or electron spin resonance (ESR)]. The goal is to get the ML-logic in place such that given a set of peaks, stretches, chemical shifts, coupling constants, etcetera, a machine can identify a compound with high sensitivity and specificity. In addition to chemical and biochemical compounds, we also encourage ideas relating to living biological agents.

The Air Carrier Access Act of 1986 (ACAA) addresses the access to air travel for handicapped and elderly air travelers, ensuring equal access to air travel accommodations and directing equal or similar treatment to that of other travelers. The Transportation Security Administration (TSA) is tasked with screening all air passengers at airport checkpoints before they board outgoing aircraft. However, while the ACAA dictates that an individual with a disability must undergo the same security screening as any other member of the traveling public, under current policies, these travelers cannot be screened without subjecting them to manual searches typical of only a small percentage of other travelers.

Current airport checkpoint screening consists of X-ray screening of carry-on belongings, followed by millimeter-wave based body scanning or metal detection screening for threat item alarm, followed by manual pat down for those individuals alarmed on. However, in the case of elderly or handicapped individuals with an ambulatory disability that prohibits a typical body scan (e.g. standing with arms over head for five seconds), current policy dictates that these passengers be diverted and manually screened for contraband and threat items, and all assistance devices (e.g. wheelchairs, canes, etc.) be searched for any hidden items. This step can add additional time and inconvenience for elderly and handicapped travelers and represent a general delay to the overall flow of passengers.

These constraints require the development of additional capabilities that will allow rapid airport checkpoint screening of handicapped and elderly travelers with ambulatory disabilities that is on par with that of other travelers in terms of speed and convenience to the passenger.

Key objectives include:
• Screening must be done via non-ionizing radiation, possibly leveraging currently deployed screening systems
• Passengers must be able to remain seated, either in wheelchair or a bench, etc.
• Solution should alarm on concealed threat objects of TSA interest (e.g. explosives, guns, knives, etc.) without interference from wheelchair, etc.

While these key requirements are broad to allow for a variety of solution types, the optimal solution would allow for the use of automated threat detection algorithms that can be specific to emerging threats of interest and rapidly differentiate between threat items and the passenger and ambulatory aid (e.g. wheelchair), while respecting passenger privacy.

As seen recently at the Surfside Condominium Collapse, the recovery of human remains following an MCI provides responders with a multitude of difficult challenges. Without a formal system in place to collect consistent and quality recovery information in a repeatable process causes both a delay in relevant information collection and the likelihood to miss important location details.

The initiation of a human remains recovery record should begin with the collection of comprehensive documentation describing the point of discovery and location to preserve all key forensic data. Following an MCI, these critical pieces of information may be invaluable in identifying the individual, determining cause of death, and documenting evidence. Further, the addition of photos and site details will assist in all aspects of the tasks mentioned above. At present, First Responders, Urban Search & Rescue (US&R), Disaster Mortuary (DMORT) teams, Coroners, and Medical Examiners do not have a system to adequately support the immediate collection and processing of hundreds or thousands of human remains. Falling behind on this effort will inflict compounding levels of disorder as related implications grow. The reality of this situation is that local communities are not prepared to support the information collection and maintenance requirements for the recovery, processing, and storage of large quantities of fatalities.

The DHS S&T Project Responder 5 Report (August 2017) identifies one of the Capability Domains as “Casualty Management.” This topic addresses 3 of the 4 capabilities within the domain:
• The ability to identify the location of injured, trapped and deceased casualties on the incident scene.
• The ability to track the status of known and potential casualties from site through reunification.
• The ability to manage and track large numbers of fatalities through all phases of response.
This requirement has also been confirmed by the National Disaster Medical System (NDMS), and the FEMA's DMORT Services Team.

This effort will propose the development or adaption of a low-cost and spatially aware electronic tag to catalogue all human remains location information within a centralized cloud-based data storage and display tool. The proposed effort will be required to remain viable in harsh outdoor environments and be self-powered for up to 30 days. It will establish a Recovery ID number to serve as the initial identifier to allow for a fully connected and relational information management solution. Data attributes would include victim/environmental details, photos, and general descriptive text. This solution will ensure that all investigators (radiologists, forensic pathologists, forensic dentists, etc.) have the point of recovery location details available to expedite the identification of remains and ensure that a comprehensive record of all remains recovered has been initiated and maintained.

The economic value of the United States (U.S.) poultry industry is approximately $50 billion. Avian Influenza, Virulent New Castle Disease, and Marek’s Disease are caused by viral pathogens that are highly contagious and pose the risk of significant economic impact to U.S. security. Likewise, the economic value of the pork and beef industries are approximately $39 billion and $77 billion, respectively. Nipah virus encephalitis, Classical and African swine fevers, Lumpy skin disease, and Bovine spongiform encephalopathy are just a few examples of infectious diseases that threaten pork and beef industry food security. As the world euphemistically shrinks, the risk of pathogens arriving in the U.S. is an ever-growing concern. Despite numerous efforts, significant gaps remain regarding detection/identification or medical countermeasures development to combat the etiological agents of these diseases. Development of diagnostics for these pathogens would serve to mitigate the risk of serious disease outbreaks by providing early warning, so that countermeasures may be put into place before the respective industry is severely damaged or irrecoverably affected.

Zoonotic pathogens are microorganisms that are the main drivers for emerging (or re-emerging) infectious diseases in humans. Numerous wild and domestic animals serve as amplifying hosts for various viruses. Transmission to humans occurs through various mechanisms such as direct contact with animal fluids and secretions. The 2017 U.S. One Health Zoonotic Disease Prioritization workshop identified eight zoonotic diseases of concern including: zoonotic influenza, Salmonellosis, West Nile virus, Plague, emerging coronaviruses, Rabies, Lyme disease, and Brucellosis. Our lack of ability to detect certain high zoonotic propensity pathogens in a field forward environment represents a significant gap in homeland security. Reliable diagnostics for these pathogens would greatly reduce risk to the U.S. population by providing early detection and therefore additional time to employ countermeasures, both medical and physical, resulting in a dramatically reduced impact on society and human health.

Worldwide, the high consequence transboundary animal pathogens of concern include those pathogens listed in the World Organisation for Animal Health - OIE lists A and/or B. At the U.S national level, reportable animal pathogens of concern include those listed in the United States Department of Agriculture (USDA) National Animal Health Reporting System (NAHRS) and/or CDC One Health Zoonotic Disease Prioritization (OHZDP) Process and its workshops. Of particular interest are those animal pathogens with high zoonotic potential, for one or more species considered critical domestic sources of protein (e.g., poultry, swine, cattle, etc.).

The proposed technology must meet the following performance objectives:
• The ability to detect at least two transboundary or nationally reportable animal pathogens, including those with zoonotic potential in a sample specimen (blood, secretions, excretions, tissue, food/feed products, etc.)
o Note: the use of non-pathogenic surrogates is sufficient for demonstration of proof-of-concept work
• Be field deployable for rapid diagnosis
• Produce results within 1 hour
• Detect directly from samples currently used in animal health, food safety, or environmental surveillance diagnostics
• Minimal to zero upfront sample preparation
• Per test costs for the multiplexed cartridges less than ~$50 and a reader/reporter cost less than $1,000
• Quantitative or qualitative results are acceptable (e.g., copy/colony number vs. yes/no pathogen detected)
• Detection limit less than one log 10 less sensitive than the ‘gold standard,’ resulting in prediction conditions of correlating with at least 95% sensitivity and 95% specificity
• Electronic reporting of results in a secure manner

A system capable of conducting point-of-care (e.g., pen-side or port-side) detection/diagnostics could greatly aid the USDA, Department of Health and Human Services (HHS), and Department of Homeland Security (DHS), as well as State, Local, Tribal, and Territorial (SLTT) personnel. The benefits of early detection and identification could include reducing manpower requirements and costs; improving human health and animal safety; and mitigating the overall risk to the homeland posed by pathogens and other materials of food, agriculture, and veterinary defense (FAVD) concern. This same strategy applies to pathogens that are suspected of having the capacity to initiate zoonotic events. Affordable diagnostics with a Clinical Laboratory Improvement Amendments (CLIA) waiver would place a powerful tool in the hands of Transportation Security Administration (TSA) agents, Customs and Border Protection (CBP) inspectors, USDA inspectors, and foreign animal disease diagnosticians surveying or intercepting food items that may be contaminated with these highly contagious animal pathogens. These diagnostics would be valuable to farmers/ranchers for animal feed sampling and surveillance and the potential identification of outbreaks in an early stage so that countermeasures could rapidly be put in place. First responders and medical institutions would also benefit from access to these tools.

High consequence toxins such as those included in the US Select Agent and Toxin list, have a propensity to be fatal to humans and most animals in low concentrations. These toxins are some of the deadliest chemicals known posing an ongoing public health threat. A remaining challenge for National Security programs is the availability of commercial, field-forward detection systems that are sensitive and reliable. Development of detection systems for these high consequence toxins would serve to reduce the public health risk to humans and animals, by providing an early warning, enabling countermeasures to be put into place before a more consequential event occurs.

The proposed technology must meet the following performance objectives:
• The ability to detect a minimum of six high consequence toxins in an environmental sample
• Be fieldable for rapid detection
• Produce results within 1 hour
• Detection of toxins directly from environmental samples
• Minimal to no upfront sample preparation
• Per test costs for the multiplexed cartridges (or another format diagnostic) less than ~$100 (threshold) and ~$20 (objective)
• A reader cost of less than ~$1000 (threshold) and ~$200 (objective)
• Quantitative or qualitative results are acceptable
• Detection limit 10 parts per million (ppm)

The government is seeking innovative technologies to detect aerosolized chemical threats, such as Chemical Warfare Agents (CWAs), Toxic Industrial Chemicals/Materials (TICs/TIMs), and Pharmaceutical-Based Agents (PBAs) in the field. This detection technology would be used to detect multiple chemicals threats within a sample in a complex environmental background. Preferable technology would be a small, wearable, multi-threat chemical detector that can be employed by DHS emergency response and law enforcement personnel. The envisioned usage of this product would warn the user about current exposure levels to potential threats before they reach concentrations immediately dangerous to life or health (IDLH). This allows the user to adopt a more protective posture through awareness of the contaminated area and allow for proper donning and doxing of personal protective equipment. Further uses may include incorporation on Unmanned Ground Vehicle or Aerial Systems (UGV, UAS) for remote detection and hazard plume mapping.
Current CBRN response equipment does not provide a single continuous monitoring detection system to alert personnel to the presence of aerosolized airborne chemical threats and hazards. Lightweight chemical sampling and detection innovations which can be automated for such monitoring applications are desired. The technology is intended to be used by personnel investigating incidents or potential threats in indoor and outdoor environments, to include large open areas and small confined spaces. The device should alert a user to the presence of aerosolized hazards in time to take protective measures for the duration of a regular duty shift without requiring frequent user interaction with the device.

The desired technology capabilities are listed below:
• The ability to detect multiple chemical threats in solid or liquid aerosol form. Approaches that can address more than one threat class (pharmaceutical, nerve, blister, TIC/TIM) will be prioritized.
• Detect anomalous chemical hazards distinct from common background aerosols as a threshold capability, with classification of threats as an objective capability
• Ability to add new chemicals of interest to the library
• The ability to operate in various operational environments such as at temperature and humidity extremes (50 °C to -10 °C temperatures; 5% to 95% relative humidity).
• Operate with multiple alarm settings (audible, visual, and vibratory)
• Detect threats at IDLH concentration levels as determined by NIOSH or OSHA
• Detection speed: objective <30 seconds threshold <1 minute
• Low-Size Weight and Power (SWaP), wearable form factor that does not pose a strain on operators 

     o Size: The system should have a small and unobtrusive form factor, and should not exceed a volume of 500 cm3
     o Weight: The system should not exceed 1 kg in weight
     o Power: The system must have a battery life of at least 4 hours, but an 8-hour minimum battery life is preferable. Approaches that use commercially available or rechargeable batteries are preferred.
• Low logistics burden: Minimal training, calibration, maintenance and charging requirements; no special tools needed for maintenance

The economic value of the United States (U.S.) poultry industry is approximately $50 billion. Avian Influenza, Virulent New Castle Disease, and Marek’s Disease are caused by viral pathogens that are highly contagious and pose the risk of significant economic impact to U.S. security. Likewise, the economic value of the pork and beef industries are approximately $39 billion and $77 billion, respectively. Nipah virus encephalitis, Classical and African swine fevers, Lumpy skin disease, and Bovine spongiform encephalopathy are just a few examples of infectious diseases that threaten pork and beef industry food security. As the world euphemistically shrinks, the risk of pathogens arriving in the U.S. is an ever-growing concern. Despite numerous efforts, significant gaps remain regarding detection/identification or medical countermeasures development to combat the etiological agents of these diseases. Development of diagnostics for these pathogens would serve to mitigate the risk of serious disease outbreaks by providing early warning, so that countermeasures may be put into place before the respective industry is severely damaged or irrecoverably affected.

Zoonotic pathogens are microorganisms that are the main drivers for emerging (or re-emerging) infectious diseases in humans. Numerous wild and domestic animals serve as amplifying hosts for various viruses. Transmission to humans occurs through various mechanisms such as direct contact with animal fluids and secretions. The 2017 U.S. One Health Zoonotic Disease Prioritization workshop identified eight zoonotic diseases of concern including: zoonotic influenza, Salmonellosis, West Nile virus, Plague, emerging coronaviruses, Rabies, Lyme disease, and Brucellosis. Our lack of ability to detect certain high zoonotic propensity pathogens in a field forward environment represents a significant gap in homeland security. Reliable diagnostics for these pathogens would greatly reduce risk to the U.S. population by providing early detection and therefore additional time to employ countermeasures, both medical and physical, resulting in a dramatically reduced impact on society and human health.

Worldwide, the high consequence transboundary animal pathogens of concern include those pathogens listed in the World Organisation for Animal Health - OIE lists A and/or B. At the U.S national level, reportable animal pathogens of concern include those listed in the United States Department of Agriculture (USDA) National Animal Health Reporting System (NAHRS) and/or CDC One Health Zoonotic Disease Prioritization (OHZDP) Process and its workshops. Of particular interest are those animal pathogens with high zoonotic potential, for one or more species considered critical domestic sources of protein (e.g., poultry, swine, cattle, etc.).
The proposed technology must meet the following performance objectives:
• The ability to detect at least two transboundary or nationally reportable animal pathogens, including those with zoonotic potential in a sample specimen (blood, secretions, excretions, tissue, food/feed products, etc.)
o Note: the use of non-pathogenic surrogates is sufficient for demonstration of proof-of-concept work
• Be field deployable for rapid diagnosis
• Produce results within 1 hour
• Detect directly from samples currently used in animal health, food safety, or environmental surveillance diagnostics
• Minimal to zero upfront sample preparation
• Per test costs for the multiplexed cartridges less than ~$50 and a reader/reporter cost less than $1,000
• Quantitative or qualitative results are acceptable (e.g., copy/colony number vs. yes/no pathogen detected)
• Detection limit less than one log 10 less sensitive than the ‘gold standard,’ resulting in prediction conditions of correlating with at least 95% sensitivity and 95% specificity
• Electronic reporting of results in a secure manner

A system capable of conducting point-of-care (e.g., pen-side or port-side) detection/diagnostics could greatly aid the USDA, Department of Health and Human Services (HHS), and Department of Homeland Security (DHS), as well as State, Local, Tribal, and Territorial (SLTT) personnel. The benefits of early detection and identification could include reducing manpower requirements and costs; improving human health and animal safety; and mitigating the overall risk to the homeland posed by pathogens and other materials of food, agriculture, and veterinary defense (FAVD) concern. This same strategy applies to pathogens that are suspected of having the capacity to initiate zoonotic events. Affordable diagnostics with a Clinical Laboratory Improvement Amendments (CLIA) waiver would place a powerful tool in the hands of Transportation Security Administration (TSA) agents, Customs and Border Protection (CBP) inspectors, USDA inspectors, and foreign animal disease diagnosticians surveying or intercepting food items that may be contaminated with these highly contagious animal pathogens. These diagnostics would be valuable to farmers/ranchers for animal feed sampling and surveillance and the potential identification of outbreaks in an early stage so that countermeasures could rapidly be put in place. First responders and medical institutions would also benefit from access to these tools.