70RSAT22R00000004 - SVIP HPR Topic Call QA - 20211220.pdf

PIID: 70RSAT22R00000004

Department of Homeland Security

Silicon Valley Innovation Program Human Performance and Resiliency Topic Call: Industry Day Q&A Responses

The Department of Homeland Security (DHS) Silicon Valley Innovation Program (SVIP) held an Industry Day event on November 10, 2021 as part of its open Human Performance and Resiliency Topic Call (Notice ID 70RSAT22R00000004). Information about the Industry Day, including links to a recording of the event and the presentation slides can be found at: HPR Industry Day (regfox.com). SVIP was unable to answer all the questions that were received during the Q&A portion of the Industry Day and is providing the following information to answer some of the remaining questions. There is also an FAQ document posted with the solicitation that may be helpful. Please direct any additional inquiries to DHS-Silicon-Valley@hq.dhs.gov.

QUESTION: From where was this Wellness Continuum adopted? Is it somewhat related to medical burnout identified through Maslach’s Burnout Inventory?

ANSWER: The continuum wasn't necessarily "adopted," rather it was used as an example to illustrate the concept of keeping personnel from experiencing a physical or emotional crisis.

QUESTION: What does "mind tactics" mean? This is one of your focus areas. Can you describe more?

ANSWER: Mind Tactics is a component of mental performance and individual wellness strategies such as contemplation, visualization, self-talk, attention control, self-regulation and breathing to name a few.

QUESTION: Many of the requirements appear to be classified by the FDA as dispensing medical advice and thus would require FDA pre-market approval or an exemption under section 515 of the FD&C Act.

Do you have exemption from FDA regulations, and how have you coordinated these requirements with the FDA?

ANSWER: DHS has not coordinated with the FDA at this point. The intent of this project is to provide information that will enable users to monitor and act on general health, wellness, and resiliency enhancements. Data and alerts are not meant to be used as medical diagnosis or prognosis and is not to be used as a replacement for formal medical advice from trained and certified healthcare professionals.

https://sam.gov/opp/30884f66312844dea5bed2d473e0ac80/view https://sri-csl.regfox.com/hpr-industry-day https://sam.gov/opp/30884f66312844dea5bed2d473e0ac80/view https://sam.gov/opp/30884f66312844dea5bed2d473e0ac80/view mailto:DHS-Silicon-Valley@hq.dhs.gov

QUESTION: What has overall compliance been with past projects implemented, i.e., what percentage of employees have used products regularly in the past?

ANSWER: Past pilot deployments have typically included volunteers. As a result, participation levels have been high within the selected user groups. Likewise, this project’s participants will be on a voluntary basis.

QUESTION: We would like to know if it will be important to monitor biometric and metabolic indicators while driving? Use biometric driver monitoring system as an additional sensor to collect biometric and metabolic indicators.

ANSWER: Yes. DHS employees often spend considerable amounts of time in motor vehicles.

QUESTION: Can a solution incorporate emergency alerting? (i.e., somehow notify an officer’s team that he/she may be in trouble?)

ANSWER: Yes, as an additional selectable option.

QUESTION: With the goal of a fully deployed "human sensor" array for the CBP officers, how are you planning to manage the ingest and analysis of the data coming from phase one sensors, and sensors yet to be deployed? Are you considering "data feed agnostic" platforms to do this?

ANSWER: The current requirement in the solicitation is for commonly used, non-proprietary data standards so meaningful data aggregation and analysis is possible now and in the future.

QUESTION: What if the technology involves multiple programs? For example, a technology that improves Slow Wave Sleep for cognitive performance and restorative processes, uses AI/ML and is a wearable biosensor.

ANSWER: Solutions may span multiple Technology Topic Areas (TTA). The application should explain how the solution aligns to one or more of the TTAs and how the solution addresses the capability that it will provide. If a company’s solution or suite of solutions align to more than one TTA, the company may only submit a single application that covers all solution capabilities. Companies may not submit separate applications for individual TTAs.

QUESTION: Would the DHS consider non-wearable monitoring devices that can offer more detailed and relevant measurements, such as specific metabolites relevant to stress and performance? Or do the desired technologies need to be wearable and continuous?

ANSWER: Companies are encouraged to present new approaches to the challenges presented in the Topic Call. Strong applications will effectively describe the solution, the approach, and its benefits.

QUESTION: Can you provide any data on health status of CBP employees - Chronic diseases, percentage of folks with diabetes, weight/body fat %/BMI of employees, etc.?

ANSWER: This information is not available for the general public. It is reasonable to assume that CBP employees are dealing with similar health issues and trends as the American public.

QUESTION: Are there physical readiness requirements that employees have to uphold?

ANSWER: Yes, some DHS jobs require physical fitness standards for initial on-boarding, academy graduation, and/or continued employment.

QUESTION: Which offices will have access to the data outside of immediate supervisors? For instance, will the insider threat program have access to pertinent data?

ANSWER: The initial focus of the pilot will be on providing information to employees only to improve their individual self-awareness and decision-making processes regarding their performance and wellness. At some point in the future, sharing information with teammates or others may be considered on a voluntary basis.

QUESTION: What is being done to convert the sensor measurements to knowledge and information that can provide a diagnostics and prognostics?

ANSWER: Diagnosis and prognosis is the responsibility of medical professionals and is not the intent of the current Topic Call. Our goal is to find innovative ways to highlight data or current conditions that can improve employee performance, wellness, and resiliency.

QUESTION: For the mobile app - usually data that is programmed on or pushed to an APP has a cloud on the backend that is receiving the information and compiling it. Should the solution address the centralized system?

ANSWER: Any backend should be deployable to standard cloud environments, such as Amazon Web Services (AWS) and Google Cloud Platform (GCP).

QUESTION: If you’re interested in PII/PHI protection, do you need to have an IL4/5 instance, for example an AWS Gov Cloud?

ANSWER: CBP does not currently support solutions deployed to AWS GovCloud. Non-FedRAMPed cloud-based solutions must be deployed internal to the CBP network in either CBP's AWS or GCP environments. Additional hardware and software specifications will be provided as needed upon contract.

QUESTION: Do CBP wear smart watches now?

ANSWER: While some CBP employees do wear their own personal smart watch, they are not standard issued equipment for CBP employees.

QUESTION: What are the experiences and challenges with respect to battery charging and related performance issues with Biometric wearables in the field? any data that can be shared?

ANSWER: Size, weight, and power are always important factors to consider when developing any system. As was stated during the briefings, solutions should be simple to use and unobtrusive to the wearer.

QUESTION: Could you provide any context with respect to types, volumes of data that is currently being collected?

ANSWER: Other than academy physical fitness data and infrequent safety and health studies, very little data is currently captured in the arena of human performance and resiliency.

QUESTION: If an offeror is providing devices that capture human performance data, will the successful offeror be provided a set of this data?

ANSWER: To be determined depending on the specific capability, Agency policy, and contract details.

QUESTION: Do you want a management-only-accessible system that flags specific individuals who may be at risk of burnout, resignation, suicide, etc?

ANSWER: No. The emphasis is on the individual employee.

QUESTION: Are you only looking for hardware solutions?

ANSWER: No. Hardware and software solutions are acceptable.

QUESTION: What TRL is SVIP looking for?

ANSWER: A Technology Readiness Level of at least 4 is desirable, meaning that the technology has been validated in lab setting.

QUESTION: Will IP Rights be negotiable under the OTA?

ANSWER: Under SVIP, the startup will retain all Intellectual Property (IP) that is brought to the project as well as any IP that is created as part of the project. The government will be afforded a license for the use of the technology during the project.

QUESTION: Is there any advantage to submitting a proposal earlier in the submission window (January) rather than later (April)? Will awards be made on a rolling basis and perhaps funding will diminish over those 4 months?

ANSWER: All applications will be evaluated equally, regardless of the application cycle in which it was received. However, if DHS receives a sufficient number of acceptable proposals in the first cycle, DHS has the right to cancel the second application cycle. If an application is not selected for funding in the first cycle, the company may re-do its application and submit again during the second application cycle.

QUESTION: When developing the application, will there be subject matter experts available to ask specific technology questions (based on duty assignments/specific needs) or should these be addressed as FAQs to all offerors?

ANSWER: To the greatest extent possible, DHS will attempt to make responses to questions available to the public to ensure equity and fairness to all potential offerors. However, we are prohibited from discussing potential content of your application. Our advice is to read the Topic Call and other documentation associated with the calls to make your decision.

QUESTION: If a company currently does more than $1M in business with DOD not eligible?

ANSWER: The opportunities are targeted toward small businesses and start-ups; however, we ask everyone to self-certify their eligibility. Please consult the Topic Call as well as the application template.

Should your entity fall within those guidelines, please feel free to submit.

In order to be considered a non-traditional government contractor the sum of all contracts, Federally awarded grants or cooperative agreements that total more than $1M, must need to have ended more than 12 months prior to the date of application submission. In this case, Federally awarded contracts, grants or cooperative agreements applies to activities with any U.S. federal government agency.

Companies should only count the value of payments received directly in any capacity (e.g., prime, subcontractor, consultant, etc.), not the total contract value.

QUESTION: Is DHS only looking to work with start-up limited by size? Many of the capabilities on the DHS wish list are much further along than a Phase 1 or prototype?

ANSWER: The opportunities are targeted toward small businesses and startups; however, we ask everyone to self-certify their eligibility. Please consult the Topic Call as well as the application template.

Should your entity fall within those guidelines, please feel free to submit.

Eligible companies with mature technologies are still able to apply for SVIP funding and direct their Phase 1 projects to adapt their existing technology to address DHS requirements that are not currently met. The Phase 1 does not need to be the full $200,000 maximum allotment if a minimum viable product can be achieved for less. After the Phase 1 effort DHS can evaluate the current performance and capabilities of the technology and cooperatively determine an appropriate R&D project plan, including the opportunity to skip or combine future SVIP phases as appropriate.

SVIP is authorized to work with startup companies that have less than 200 employees and have not received more than $1M in contracts, Federally awarded grants, or cooperative agreements with any Federal agency within the past 12 months. Companies that are not eligible for participation in the SVIP may still consider other DHS S&T business opportunities by visiting Current Opportunities | Homeland Security (dhs.gov) or Engage with S&T | Homeland Security (dhs.gov).

QUESTION: Unlike the military, how much of traditional disability and labor law will be an issue to the DHS workforce? This goes to the commercialization potential -- mandatory monitoring of employees’ well-being raises a host of legal issues in the private sector.

ANSWER: There are policy and privacy questions that will likely need to be addressed and worked through depending on each specific submission/capability. "Mandatory monitoring" is not the intent of this pilot. Participation will be 100 % voluntary and consideration for expansion will depend on performance during the execution of the developmental SVIP contract. DHS is working with appropriate privacy, legal, and human resources experts within DHS to ensure the project is conducted in compliance with existing law and regulations.

QUESTION: While we do not plan to jointly apply with another organization, we are interested in possibly teaming with a government research lab and/or academic institution for this effort (for work such as testing services). Would such organizations be permissible as subcontractors, contractors or consultants on this project?

Answer: Any entity receiving funds under an award through the SVIP Topic Call must be individually eligible to participate in the SVIP. If a company retains the services of a separate firm ineligible to participate in the SVIP, that work must remain outside the scope of the SVIP award and must use other funds from the company as part of the ongoing development of its product. That relationship will not disqualify an eligible company from participating in the SVIP.