Key Dates

Related Announcements

April 6, 2022 - Emergency Award: Rapid Acceleration of Diagnostics Tribal Data Repository (RADx TDR) (U24 Clinical Trial Not Allowed). See Notice RFA-OD-22-011

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)

NOT-OD-20-144 - Notice of Intent to Publish Funding Opportunity Announcements for the RADx-rad Initiative

RFA-OD-20-022 - Chemosensory Testing as a COVID-19 Screening Tool (U01 Clinical Trial Optional)

RFA-OD-20-019 - Emergency Awards: RADx-rad Data Coordination Center (DCC) (U24 Clinical Trial Not Allowed)

Issued by

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

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Purpose

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 solicit proposals to enhance the utility of chemosensory testing as a COVID-19 screening tool by using objective tests to examine the onset and prognostic value of chemosensory loss and to encourage the development and/or deployment of home-based and on-site chemosensory tests. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

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.

Sudden loss of smell or taste is formally recognized as one of the hallmarks of COVID-19 by the CDC and has emerged as the main neurological manifestation of the disease with as many as 80% of patients infected with SARS-CoV-2 reporting chemosensory dysfunction. In fact, recent observational studies indicate that the loss of smell and taste is one of the most common symptoms of COVID-19 and more predictive than all other symptoms, including fatigue, fever, or cough. Most studies to date have used self-report rather than objective chemosensory testing, leading to the possibility that the prevalence of chemosensory loss may be even higher among patients with COVID-19 than previously reported. These findings highlight the need for objective chemosensory tests for COVID-19 screening, which yield immediate results and are validated across the lifespan, easy to self-administer, and quantitative and graded to allow the determination of diminished as well as profound sensory loss. This initiative aims to support further development, commercialization, and implementation of technologies for chemosensory testing to screen patients for COVID-19 and to complement current temperature screening procedures.

Research Objectives

This NOSI will fund competitive revisions to existing NIH awards to support chemosensory testing as a COVID-19 screening tool by using objective tests to examine the onset and prognostic value of chemosensory loss and to encourage the development and/or deployment of home-based and on-site chemosensory tests. Areas of interest include:

• Development and deployment of standardized and validated over the counter testing kits or tests that utilize common household items for remote, home-based screening through telemedicine for mild to moderately affected individuals.
• Modification of existing test platforms (e.g. NIH Toolbox ) to improve efficiency of administration, data collection and evaluation using mobile phone apps and telemedicine.
• Development of innovative chemosensory platforms that can be implemented for testing of large, at risk populations, for example, health care workers, pregnant women, and older adults and caretakers residing/working at nursing homes and long-term care facilities.
• Establishment of appropriate odorants, optimal odorant concentrations, and standardized delivery systems and protocols for the development of onsite, group testing stations for those working or living in high-density, high risks environments.
• Analysis of test results to determine the specificity of chemosensory testing with respect to COVID-19 versus influenza, the onset of chemosensory dysfunction, and the prognostic value of chemosensory testing in predicting neurological and other manifestations.

To maximize research and rapidly implement approaches to address the COVID-19 pandemic, comparisons across datasets or studies and data integration are essential to collaboration. Projects funded through this FOA are strongly encouraged to use the following resources as applicable:

• Data Harmonization for Social Determinants of Health via the PhenX Toolkit: Investigators involved in human-subject studies are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. In particular, studies with human participants should incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).
• A trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) [https://dr2.nlm.nih.gov/] and the PhenX Toolkit [https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based or for clinical research, are strongly encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded.

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 at https://www.partnershiponai.org/about-ml/).
  • In order to maximize progress and successful outcomes, recipientsare 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.
• Recipientsare 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
• Accuracy, sensitivity, specificity, accessibility and affordability are key considerations for chemosensory tests.
• Odor and taste assessment and delivery tools should follow FDA guidelines including performance testing to demonstrate reliability in detection of loss of chemosensory function and be considered Generally Recognized As Safe (GRAS).

Non-responsive

• Projects that do not have an infrastructure to rapidly report study findings and impact to the DCC.
• Projects that have limited testing capacity, that do not include FDA-authorized/approved testing strategies or present a plan to incorporate approved testing strategies

Review Process

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?
• Outcomes: Will outcomes or products proposed impact and improve acceptability, accessibility, and effectiveness of COVID-19 testing?
• 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?

Pre-Award costs

• Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

Reporting

• 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: September 15, 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

• Active research and resource grants, cooperative agreements and small business grants (SBIR and STTRs). NRSA training and fellowship grants are not eligible to apply for funding. Product development, validation, scale-up and activities supporting commercialization are all within scope of this NOSI.
• To be eligible for a competing revision award under this NOSI, the parent award on which the revision application is based must be an active award (including those in a no-cost-extension period) managed by one of the participating institutes or centers.
• Grants currently in a no-cost extension are eligible to apply.

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

• For funding consideration, applicants must include NOT-OD-20-152 (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 $250,000 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 one 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.

Inquiries

Please direct all inquiries to one of the following contacts:

Susan Sullivan, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD):
301-451-3841
[email protected]

Amanda Melillo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR
301-312-9037
[email protected]

Coryse St. Hillaire-Clarke, Ph.D.
National Institute on Aging (NIA)
301-827-6944
[email protected]

Nahida Chakhtoura, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
301-435-6872
[email protected]

Jim Gnadt, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-9964
[email protected]

Michelle Hamlet
National Institute of Nursing Research (NINR)
301-496-9623
[email protected]

Rajasri Roy
Office of Research on Women's Health (ORWH)
301-451-0993
[email protected]