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Related Announcements

PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

NOT-GM-20-033 - Notice of Special Interest (NOSI): Availability of Urgent Award for Competitive Revisions to IDeA-CTR Awards to Address the Need for Documenting 2019 Novel Coronavirus Disease (COVID-19)-Related Patient Outcomes

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

This Notice of Special Interest (NOSI) highlights the continued need for documenting COVID-19-related patient outcomes among medically underserved populations.

Background

Fatality rates of COVID-19 patients among racial and ethical minorities, and residents of rural areas and medically underserved urban communities are significantly higher than that of other populations. Documentation of COVID-19-related outcomes of patients including those suffering from the disparity is crucial to understanding the impact of the pandemic and developing effective interventions. In 2020, NIGMS-supported IDeA-Clinical Translational Research (IDeA-CTR) networks launched an IDeA State COVID-19 Patient Registry that collects, harmonizes and deposits COVID-19 patients’ anonymized electronic health records from IDeA states into the NIH-supported National COVID Cohort Collaborative (N3C). The Registry also facilitates the use of the N3C database by researchers to answer critical questions about the pandemic. The purpose of this Notice of Special Interest (NOSI) is to continue support and potentially expand the IDeA State COVID-19 Patient Registry.

Research Objectives

NIGMS will accept applications for Competitive Revisions to active IDeA-CTR U54 awards to rapidly provide supplementary funds to support and expand the IDeA State COVID-19 Patient Registry, which includes a defined set of common data elements and, through N3C, offers access to the deidentified data for researchers studying SARS-CoV-2 and/or the pathology of COVID-19. NIGMS requires applicants to make use of N3C’s approved Common Data Elements (CDEs) when developing their proposals. Applicants are encouraged to include support for an epidemiologist and a bioinformatician to oversee N3C Enclave Domain Teams and facilitate database use by IDeA-state researchers. A goal of the project should be to increase the diversity of patient populations represented in the N3C data resource.

One award is anticipated and the awardee is expected to collaborate with other IDeA-CTR awardees to ensure broad coverage of the registry.

Eligibility

Eligibility is limited to grantees with an active NIGMS IDeA-CTR U54 award.

Application and Submission Information

Applications in response to this NOSI must be submitted to PA-18-935 "Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)", which is intended to provide funds for NIH awardees applying to expand the scope of their active award. The activity code will be the same as that of the parent award.

All instructions in the SF424 (R&R) Application Guide and PA-18-935 must be followed, with the following additions:

• Application Due Date(s) – June 18, 2021 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-GM-21-050” (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.
• Requests may be for one year of support only.

• The parent award must be active when the supplemental application is submitted (i.e., within the originally reviewed and approved project period), regardless of the time remaining on the current project. Awards that are currently in a no-cost extension period are not eligible to apply for this administrative supplement funding opportunity.

• Application budgets are limited to no more than $2,000,000 in direct costs, plus applicable F&A, and must reflect the actual needs of the proposed project. Supplements may provide support above the established dollar limit for the parent grant award.
• The Research Strategy section of the application is limited to 3 pages. This section must include a plan for partnering with other IDeA CTRs and collaborating with N3C. This section must also include a plan to conduct educational outreach and training to investigators on using N3C.

Review Process

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

• Are there specific, detailed, and attainable goals for the registry?
• Is the overall strategy well-designed to contribute a sizable dataset of electronic health records from IDeA states to N3C?
• Are there appropriate resources, including epidemiology and bioinformatics expertise, to assist clinicians in using N3C to answer research questions?
• Are there plans to conduct educational outreach and training to investigators on using N3C?
• Are there appropriate plans to manage N3C Domain Teams?

Applicants are strongly encouraged to notify the program contact listed below when a request has been submitted in response to this FOA to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Hongwei Gao, MD, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email:hongwei.gao@nih.gov