Pre-Solicitation Notice of Intent to Sole Source Digital Health Solutions for COVID-19; COVID Community Action and Research Engagement (COVID-CARE)

Contracting Office Address Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA), Rockville, MD. Description The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has a requirement to complete work already underway that is aimed at demonstrating the utility and value of a digital health solutions platform to support individual, organizational, community and societal-level decision-making in the COVID-19 pandemic response. The NCI intends to modify Contract No: 75N91020C00038, with Vignet Inc., entitled - Digital Health Solutions for COVID-19 Community Action and Research Engagement (COVID-CARE) to extend the period of performance by three months. The contract was awarded using Other Than Full and Open Competition in accordance with FAR 6.302-2 - Unusual and Compelling Urgency as part of a NIH's congressionally supported response to COVID-19. The original period of performance was September 14, 2020 through September 13, 2021. The total contract value is $4,025,915, inclusive of options. The planned contract modification would change the period of performance end date to December 13, 2021, without change to the total contract value. The current contract is in the midst of performing large-scale validation among diverse user groups (e.g., race, ethnicity, age, socioeconomic and health status) to support individual, organizational, community and societal-level decision-making in the COVID-19 pandemic response. The current contract involves two studies which were designed to establish the effectiveness of symptom screening and at-home testing as well as generalizability and acceptability of this testing strategy in an underrepresented population. Patient enrollment was slower than anticipated during the spring and early summer 2021, in part due to the substantial increase in COVID-19 vaccinations and corresponding decrease in infections across the US, including the catchment area for these particular studies. Subsequently, the emergence of the COVID-19 delta variant in July 2021 led to a new wave of COVID-19 infections. This re-emergence of new infections has contributed to a recent increase in enrollment for the studies. Current trends in COVID-19 positivity rate in the regions where the studies are being performed indicate a high likelihood that 3 additional months will be sufficient to achieve the total recruitment goals for these studies. In order to complete the aims set forth in the contract and to successfully validate the contractor's COVID-CARE digital health solution for pandemic response, three additional months of performance are necessary. The planned contract action to extend the period of performance is being conducted in accordance with FAR 6.302-1. Vignet Inc. possesses the facilities, resources, and expertise that make it uniquely qualified as the only source who can reasonably complete the work begun under this contract. Vignet Inc. developed and enhanced a proprietary digital health solutions platform and is currently performing large-scale validation through ongoing clinical studies among diverse user groups (e.g., race, ethnicity, age, socioeconomic and health status) to support individual, organizational, community and societal-level decision-making in the COVID-19 pandemic response. No other source has been found that possess all the necessary elements to perform the services in a way that would satisfy NCI and NIBIB's requirements. Award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. This is not a request for proposals, proposal abstracts, or quotations and does not commit the Government to any contractual agreement. A related Request for Information for initial award opportunities was previously posted on May 26, 2020 as HHS-NIH-NCI-RFI-COVID19-01. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Interested parties may contact the points of contact reference in this attachment.