Related Announcements

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

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

The National Institute of General Medical Sciences (NIGMS) announces the availability of funds to supplement active Institutional Development Award (IDeA, P20, P30, and U54) and Native American Research Centers for Health (NARCH, S06) awards for surveillance studies of SARS-CoV-2 viral strains.

Background

To strengthen national research on SARS-CoV-2 variant evolution and spread, NIGMS provided supplemental funding in 2021 to support Institutional Development Award (IDeA) and Native American Research Centers for Health (NARCH) program efforts to sequence and analyze the genomes of SARS-CoV-2 variants circulating in their communities (NOT-GM-21-031). The continuing emergence and rapid spreading of new variants illustrates the need for a continued effort to study the spread, pathogenicity, and evolution of SARS-CoV-2 variants.

Research Objectives

Applicants must propose SARS-CoV-2 viral genome sequencing and analysis studies using samples from COVID-positive individuals. Projects are expected to expand on, or collaborate with, ongoing SARS-CoV-2 testing studies or programs in order to leverage resources and deliver results quickly to help address the urgent challenge. Projects that propose sequencing analysis of pooled samples, such as those from wastewater, must also include analysis of samples of COVID-positive individuals within the study population. Projects that propose surveillance studies among populations undergoing vaccination must partner with ongoing vaccination programs, as no vaccination-related expenses will be paid by this supplement. The proposed research must address one or more of the following questions:

• What variants are present in the study population, and how has the number of cases caused by different variants changed over time in the study population?
• Are cases of infection by different variants associated with outbreak events, geographic locations, or specific times?
• How are different variants distributed among different racial, ethnical, gender, and/or age groups?
• Are specific variants associated with different levels of manifestation of COVID-19 symptoms?
• For sequencing and analysis projects of participants enrolled in COVID-19 therapeutic trials, does the specific variant influence the therapeutic outcome?
• Are specific variants associated with more frequent vaccine break-through cases?

Applications that are not responsive to the Research Objectives will be withdrawn without review.

Eligibility

Eligibility for this supplement program is limited to current awardees of the following NIGMS programs:

• Institutional Development Award (IDeA) Networks for Clinical and Translational Research (IDeA-CTR)
• Centers of Biomedical Research Excellence (COBRE, P20, P30)
• IDeA Networks of Biomedical Research Excellence (INBRE, P20)
• Native American Research Centers for Health (NARCH, S06)

Only one supplement request per IDeA-CTR, COBRE, INBRE, or NARCH award in response to this NOSI will be accepted.

The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project.

Supplement requests must be consistent with the terms and conditions of the parent award, which include:

• The PD/PIs of IDeA awards cannot serve as project leader(s) for the proposed supplement project or use the supplement to support research in their own laboratories.
• For supplements to IDeA awards, funds cannot be used by, or for collaborators at, institutions in non-IDeA states or foreign sites, except for fee-for-service or consulting activities.
• NARCH awardees may support foreign components only when the ancestral catchment area(s) of tribe(s) cross(es) national boundaries.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following funding opportunity or its subsequent reissued equivalent.

• PA-18-935- Urgent Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional), which is intended to provide funds for NIH recipients applying to expand the scope of their active grants.

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

• Application Due Date: March 21, 2022, by 5:00 PM local time of the applicant organization.
• For funding consideration, applicants must include “NOT-GM-22-026” 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.
• Every PD/PI of the parent award must be listed as a PD/PI on the application, but another investigator or co-investigator team may lead the research project. The designated project leader(s) must be named as key personnel and must have prior experience relevant to the proposed COVID-19 research.
• The Research Strategy is limited to 6 pages and must clearly describe the significance of the project.
  • The goals and testing population of the project must be described clearly.
  • The scale and methodology of ongoing testing studies or programs that the proposed project will expand or collaborate with must be described clearly in the application. If the project proposes a collaboration with ongoing SARS-CoV-2 testing studies or vaccination programs, a Letter(s) of Support from collaborating program(s) detailing the support offered should be included in the application.
  • Testing for SARS-CoV-2 infection must use United States Food and Drug Administration (FDA)-authorized/approved COVID-19 diagnostic tests.
  • The target number of viral samples to be sequenced must be clearly stated in the application. Effective workflows, from sample collection to laboratory analysis and data dissemination, that enable cost-effective and accurate sequence surveillance using currently available instrumentation must be clearly described.
• Requests may be for one year of support only.
• No more than $500,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts can be requested.
  • A major portion of the budget request should be devoted to genome sequencing and analysis efforts and should be justified by the proposed target number of viral samples to be sequenced and analyzed.
  • As part of the budget justification, a statement regarding the expenditure of currently available unobligated grant funds should be included. Supplements may provide support above the established dollar limit for the parent grant award.
  • This funding opportunity does not support the development of sequencing or testing technologies, or acquisition of equipment over $5,000.
• NIH requires access to research data on all projects. Accordingly, applications must commit to depositing sequence data from appropriately consented samples frequently into NCBI’s Genbank, where not prohibited (i.e., Tribal data sovereignty), to assure open and timely public access.

Applications that are not responsive to the terms of this Notice will not be considered for this initiative.

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:

• Significance of research: How will successful completion of the aims contribute to understanding of viral variant evolution, spread, pathogenicity, or vaccine or therapeutic evasion/resistance?
• Investigators: How well qualified is the project leader or team to direct the proposed research? Are Letters of Support from any proposed collaborating testing or vaccination programs provided, and will they adequately meet the needs of the proposed sequencing project?
• Research design: Are the overall strategy, methodology, and approach well-designed and appropriate to accomplish the specific aims of the project in the time frame available?
• Data sharing plan: Is the plan well developed for making sequences with metadata and research results accessible to the research community rapidly, as allowable?

Before developing a research project in response to this NOSI, applicants are strongly encouraged to discuss the scientific focus of their applications with the NIGMS contact listed below and to notify the contact when a request has been submitted.

Inquiries

Please direct all inquiries to:

Crina Frincu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: cfrincu@mail.nih.gov