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 Revisions to Existing NIH Awards (Emergency Supplement Clinical Trial Optional)

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

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

Issued by

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

National Library of Medicine (NLM)

Purpose

The National Institutes of Health (NIH) is issuing this funding opportunity announcement (FOA) in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). NIH is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for accelerating research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). This emergency NOSI provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020. NIH is seeking applications from current NLM R01 awardees that can, in one or two years, enhance public health infrastructure for predicting and monitoring viral disease outbreaks.

Background on RADx-rad

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) program to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The RADx program 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 program, the NIH developed the RADx Radical (RADx-rad) initiative. RADx-rad will support new, or non-traditional applications of existing approaches, to enhance their usability, accessibility, and/or accuracy. RADx-rad 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.

Goal of Wastewater Surveillance Research Projects

To predict the spread of COVID-19 and identify potential hot spots where intensive testing is needed, public health officials and health care organizations need data on the presence of the SARS-CoV-2 virus in and around their communities. These data, in combination with data on demographic and environmental factors affecting the health status of local populations can lead to improved prediction of and response to pandemic conditions. Computational and analytic methods can quickly bring together genomic, viromic, and health data with environmental data such as wastewater contamination, in a secure way to provide visualizations and predictions that help local officials track the presence, spread and impact of SARS-Cov-2 and the scope of testing needed.

Applications are expected to focus on informatics and data science methods to help address wastewater surveillance to identify hot spot geographic areas for public response, handling data in a secure way that protects personal privacy.

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.
• Grantees 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. Grantees 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.
  • To the extent possible, data acquisition, collection, and curation strategies should be coordinated with the DCC guidance for annotation and benchmarking of data, including obtaining appropriate consent for data sharing
  • Grantees 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 milestones towards progress and 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.
• Grantees must include measures and reporting of relevant testing implementation outcomes, to inform future community, local, state, and federal policies.
  

Nonresponsive

Applications nonresponsive to the terms of this NOSI will not be considered. The following applications would be non-responsive and withdrawn without review.

• Applications that do not focus on integrating wastewater surveillance data with other relevant health or geographic data.
• Applications that do not have an infrastructure to rapidly report study findings and impact to the Data Coordinating Center.

Review Process

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

• Do the investigators have immediate access to the data sources (e.g. wastewater samples, health data, environmental data, etc.) at sufficient quantities to achieve the aims of the proposed research?
• If the proposed research will generate unique resources or data that may impact the public health response or medical countermeasure development, is the resource sharing plan adequate?
• Is there evidence of strong established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the study?
• Urgency and significance of research: Will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 (COVID-19) infection and related pathogenic processes? Does the proposed research fit within the mission of an emergency response to provide critical expertise, resources or activities?
• Feasibility of research: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the emergency time frame feasible for the proposed research?
• Outcomes: Could outcomes or products result that could be used to improve access, acceptability, and uptake of COVID-19 testing?
• Is the timeline (with milestones) appropriate and feasible to support the aims and goals of the study?
• Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
• How feasible and appropriate are the plans for sustainability of project infrastructure and partnerships that may be leveraged for future engagement work surrounding public health pandemic mitigation efforts, including potential vaccine and/or therapeutic implementation efforts?
• Data sharing plan: Are there timely plans consistent with the goals of the program to make instruments, products, results and data findable and accessible to the research community, where not limited by Tribal data sovereignty?
• Coordination plans: How feasible and appropriate are the plans to submit data, data collection instruments and outcomes/products to a data coordination center?

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-135: Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional), which is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• The parent award must be active when the supplement application is submitted regardless of the time remaining on the current project.
• Eligible activity codes for applications to PA-20-135 are limited to the following mechanism: NLM-issued R01 Research Project Grant.
• The funding instrument, or activity code, will be the same as the parent award.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-20-135 must be followed, with the following additions:

• Applications will be accepted immediately through August 21, 2020.
• For funding consideration, all applicants must designate NOT-OD-20-159 (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.
• The Research Strategy section of the application is limited to 6 pages and must describe a feasible plan for testing the proposed enhanced public health infrastructure.
• The award project period of the Competitive Revision must not exceed two years.
• Application budgets may exceed the amount of the current parent award with strong justification and must reflect the actual needs of the proposed project.
• Applications will be accepted through August 21, 2020, 5:00 PM local time of the applicant organization. An application submitted in response to this NOSI that is received on or later than August 22, 2020 will be withdrawn.
• Competitive revision applications to PA-20-135 must use the application form package with the Competition ID of FORMS-F-COMP-REV .
• Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the program officer listed below to discuss the proposed project in the context of the parent award.
• Support for relevant pre-award costs incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award may be requested but approval is at the agency’s discretion
• 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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Hua-Chuan Sim, MD
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: [email protected]

Financial/Grants Management Contact(s)

Samantha Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: [email protected]