(CLOSED) RFA-OD-20-013 Emergency Awards: RADx-UP Coordination and Data Collection Center (CDCC) (U24 Clinical Trial Optional)

Sponsor Name: 
NIH
Description of the Award: 

NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency cooperative agreement funding opportunity announcement (FOA) from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) initiative, a consortium of community-engaged research projects to understand factors that have led to disproportionate burden of the pandemic on the underserved and/or vulnerable populations so that interventions can be implemented to decrease these disparities. This FOA seeks to fund a single Coordination and Data Collection Center (CDCC) as an integral part of the consortium. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

The Office of the Director (OD) is therefore supporting a new cooperative agreement addressing the objectives described below. This FOA is therefore released in parallel with three companion emergency Notices of Special Interest (NOSIs)

  • NOT-OD-20-121 encourages community-engaged Testing Research Projects to supplement large scale networks, consortia, or centers, will examine SARS-CoV-2 infection patterns and efforts to increase access and effectiveness of diagnostic methods.

  • NOT-OD-20-120) encourages community-engaged Testing Research Projects, but shifts the pool of eligible grants for supplementation to individual research awards that include community collaboration or partnership, generally targeting specific populations.

  • NOT-OD-20-119 seeks research to understand the Social, Ethical and Behavioral Implications (SEBI) of COVID-19 testing in these populations.

The CDCC will serve as a national resource, working with NIH scientific staff and consortium members to coordinate and facilitate research activities. The CDCC will also serve as a spoke in the larger NIH initiatives by providing deidentified individual data to an NIH-based data center. The RADx-UP CDCC will provide overarching support and guidance in the following four domains: (1) Administrative Operations and Logistics, (2) COVID-19 Testing Technology, (3) Community and Health System Engagement and (4) Data Collection, Integration and Sharing. The CDCC will facilitate RADx-UP collaborative research by providing organizational and analytical infrastructure and expertise, supporting data integration and analysis, and coordinating across RADx-UP projects and the NIH-supported RADx initiatives that are developing and validating new COVID-19 testing technologies.

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, 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. 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 NIH to apply scientific methods to ensure that all populations have optimal access to and uptake of COVID-19 testing, and to build effective point-of-care infrastructures.

The overarching goal of the RADx-UP initiative is to reduce disparities in COVID-19 associated morbidity and mortality disparities and to lay the foundation to reduce disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. This goal will be accomplished by strengthening the available data on disparities in infection rates, disease progression and outcomes, and on differences in testing access and uptake patterns, and identifying strategies to address disparities in COVID-19 diagnostics (and related repeat testing, contact tracing, and referrals. These projects will both enable a targeted public health response to COVID-19 and build evidence-based approaches to identify and address disparities in COVID-19 diagnostic testing uptake and effectiveness in underserved and vulnerable populations.

Sponsor LOI Deadline: 
Jul 08, 2020
Sponsor Final Deadline: 
Aug 07, 2020
OVPR Application or NOI Instructions: 

Interested applicants should apply through the InfoReady link and upload the following documents in sequence in one PDF file (File name: [Last name]_NIH RFA-OD-20-013.pdf no later than 4:00 p.m. on the internal submission deadline:

1. Cover Letter (1 page, pdf):

  • Descriptive title of proposed activity
  • PI name, departmental affiliations(s) and contact information
  • Co-PI's names and departmental affiliation(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

2. Project Description (no more than two pages, pdf) and identify the project scope that addresses the key aspects and elements, principal investigators, collaborators, and partner organizations.

3. 2-page CV's of Investigators

Formatting Guidelines:
Font/size: Times New Roman (12 pt.)
Document margins: 1.0” (top, bottom, left and right)
Standard paper size (8 ½” x 11)

To be considered as a Penn State institutional nominee, please submit a notice of intent by the date provided directly below.
This limited submission is in downselect: 
Penn State may only submit a specific number of proposals to this funding opportunity. The number of NOIs received require that an internal competition take place, thus, a downselect process has commenced. No Penn State researchers may apply to this opportunity outside of this downselect process. To apply for this limited submission, please use this link:
OVPR Downselect Deadline: 
Thursday, June 25, 2020 - 4:00pm
Notes: 
Vernon Chinchilli (CoM)