Key Dates

Related Announcements

March 23, 2021 - Updated Reporting Requirements for RADx-rad Grant Recipients. See Notice NOT-OD-21-084.

PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)

RFA-OD-20-021 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (Fast-Track STTR Clinical Trial Not Allowed)

RFA-OD-20-017- Emergency Awards RADx-RAD: Screening for COVID-19 by Electronic-Nose Technology (SCENT) (U18 Clinical Trial Not Allowed)

RFA-OD-20-020 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (Direct to Phase II SBIR Clinical Trial Not Allowed)

Issued by

Office of The Director, National Institutes of Health (OD)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

NIH is issuing this NOSI in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency NOSI from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. The goal of the RADx-rad initiative is to encourage the development of novel, non-traditional approaches to identify the current SARS-CoV-2 virus or other markers of the COVID-19 disease that can be used in future outbreaks of COVID-19 and that could be applicable to other, as yet unknown, viruses. Specifically, the goal of this NOSI is to advance early stage biosensing technologies intended for the detection of volatile organic compounds (VOCs) emanating from skin and/or multiple (i.e., biologic, chemical and physical) biosignatures captured from the oral cavity in COVID-19. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020. Applications to this NOSI are limited to NIH Centers for Accelerated Innovations (NCAI).

Background

SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, chemosensory dysfunction, and serious cardiac, cerebrovascular and vascular complications. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Research is an important component of the public health emergency response before, during and after the emergency. The United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need for the National Institutes of Health (NIH) to support the development of a variety of approaches to testing.

Expanding the capacity, throughput, and regional placement of existing technologies and accelerating the development of new technologies will contribute significantly to the current national efforts to curb the COVID-19 pandemic. To help meet this need, NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The RADx initiative is a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies.

As a part of this initiative, the NIH developed the RADx Radical (RADx-rad) project. RADx-rad will support new, non-traditional approaches, including unconventional screening, biological or physiological markers, new platforms, and point-of-care devices, that address current gaps in COVID-19 testing. The program will also support new or non-traditional applications of existing approaches to enhance their usability, accessibility, and/or accuracy. Despite the variety of activities included, the overall RADx-rad effort will be centrally aligned and coordinated to harmonize the data collection, storage, and management, providing an opportunity to further explore and identify additional approaches to understand this novel virus. Beyond the current crisis, it is anticipated that the technologies advanced through RADx-rad may also be applicable to other, yet unknown, infectious agents.

Research Objectives

Biosensing and detection technologies submitted to this initiative should provide reliable associations between biomarkers emanating from skin or the oral cavity to patients with symptomatic and asymptomatic COVID-19. Leveraging the accessibility of human skin and the oral cavity, this FOA seeks (1) to advance novel biosensing technologies that are innovative, safe, and effective, and (2) to implement such technologies into devices with integrated artificial intelligent (AI) systems for the detection, diagnosis, prediction, prognosis and monitoring of COVID-19 in clinical, community and everyday settings.

To this end, dedicated engineering and artificial intelligence systems are required. For skin monitoring, the device can include Electronic-nose (E-nose) technology or Gas Chromatography (GC). Thus, biosensing technologies targeting VOCs emanating from skin or the oral cavity will be referred to as SCENT (Screening for COVID-19 by E-Nose Technology). Oral biosensing devices may consist of technologies that are thoroughly characterized as safe and effective in preclinical studies to conform to and perform in the oral cavity. Non-invasive, real-time, continuous or periodic measurements of VOCs and other biomarkers in breath, droplets, tissues and other samples emanating from the oral cavity as signatures of onset, progression, and resolution of COVID-19 are desirable

Multidisciplinary collaborations are expected to ensure project success. Disciplines may include: Biomedical engineers, material scientists, biosensing experts, software engineers, chemists, dentists, clinicians, virologists, clinical trialists, biostatisticians, data analysts and other relevant experts in academia and industry.

Additional Requirements

• NIH is requiring data sharing for all COVID-19 projects, where it is not prohibited (i.e., Tribal data sovereignty). The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health.
• Recipients are expected to work with the RADx-rad Data Coordinating Center (DCC) to submit common evaluation metrics on COVID-19 testing-related outcomes and implementation to the DCC. Recipients should identify a dedicated unit responsible for these data reporting activities.
• NIH expects that all projects funded under this NOSI will actively coordinate, collaborate, and share data with the RADx-rad Data Coordinating Center, as allowed, and with considerations under tribal IRB processes, as appropriate. Researchers applying to this funding opportunity are strongly encouraged to review the Data Coordinating Center (DCC) funding opportunity.
  • NIH Expects, data acquisition, collection, and curation strategies to be coordinated with the DCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort ( Annotation and benchmarking on understanding and transparency for machine learning lifecycles ; available athttps://www.partnershiponai.org/about-ml/).
  • In order to maximize progress and successful outcomes, recipients are expected to participate in DCC-organized activities, including regular (e.g., monthly) progress meetings with individual or subsets of awardees, and twice annual meetings with all RADx-rad awardees.
• Applications must include a timeline for completion. The timeline must include plans for regular reports of progress to be submitted to the DCC.
• Projects must include an evaluation plan demonstrating how the proposed COVID-19 diagnostic strategies/activities will be assessed for effectiveness and impact.
• Recipients are expected to obtain and retain personal identifiers on all research participants where it is not prohibited (i.e., Tribal data sovereignty) for future longitudinal follow-up and to be leveraged for intervention research. Data collected from this program will be protected by a Certificate of Confidentiality.
• Recipients must include measures and reporting of relevant testing implementation outcomes, to inform future community, local, state, and federal policies.
• As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB). Studies that have a DSMB are expected to coordinate with DCC for DSMB activities.
• Recipients are expected to disaggregate study results by sex and gender; race and ethnicity; age and other relevant demographic factors, and to consider intersectionality as appropriate

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIH staff, in accordance with the review criteria specified in PA-20-135 as well as these additional review criteria:

• Urgency and significance of research: How will successful completion of the aims contribute to or complement public health efforts for the control and detection of SARS-CoV-2 (COVID-19) infection and related pathogenic processes?
• Research strategy: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? How feasible and appropriate are the overall research design elements (including power calculations) for demonstrating the effectiveness and impact of the proposed COVID-19 diagnostic testing? Is the emergency time frame appropriate and feasible to support the aims and goals of the study?
• Investigators: Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
• Testing: How feasible and appropriate are the plans for access to FDA-authorized/approved test kits and related activities (i.e., ability to process tests in a timely manner and return of test results as quickly as possible)?
• Data Sharing Plan: If the proposed research will generate unique resources or data that may impact the public health response or medical countermeasure development, does the resource sharing plan adequately address the rapid dissemination of data, results, and analyses to the broader scientific community, using existing public repositories whenever possible when not limited by Tribal data sharing policy, as a foundation for further study?
• Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments, and outcomes/products to the DCC?

Funds awarded using appropriations provided by the Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139 will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.

Application and Submission Information

Application due date: December 4, 2020 by 5:00 PM local time of applicant organization.

Submit applications for this initiative in response to the following funding opportunity announcement (FOA) or the subsequent reissued equivalent through the expiration date of this notice:

• PA-20-135- Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)

Eligibility

Eligible existing grants that can be revised in response to this NOSI are limited. Only the listed NIH programs of participating Institutes and Centers are eligible for this NOSI, as follows:

• NCAI: NIH Centers for Accelerated Innovations

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-OD-21-035 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applications non-responsive to terms of this NOSI will be not be considered.
• Requests are expected not to exceed $500,000 in total direct costs. Total direct costs requested may not exceed the direct cost amount of the current year’s award. Maximum direct costs are exclusive of consortium/contractual Facilities and Administrative (F&A) costs.
• Requests are limited to two year of support.
• Regardless of the grant mechanism of the parent award, the Research Strategy section of the application is limited to 6 pages.
• Where applicable, provide details of appropriate biohazard management plans commensurate with the level of risk (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html). Applications conducting research on the SARS-CoV-2 virus or specimens with possible SARS-CoV-2 infection must address protections against potential biohazards, including details on access to special facilities, e.g., Biosafety Level 3/4 (BSL3/4) laboratories.
• Potential applicants are strongly encouraged to contact the Program Official listed in the Notice of Grant Award of the parent project to discuss responsiveness and appropriate mechanism before submission and to facilitate efficient processing of the request.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Amanda Melillo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
(301) 529-7217
[email protected]