Key Dates

Related Announcements

NOT-GM-21-021 - Notice of Special Interest (NOSI): Urgent Competitive Revisions to IDeA and NARCH Programs to Address SARS-CoV-2 Vaccine Hesitancy

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

The continuing emergence and subsequent circulation of SARS-CoV-2 variants in populations world-wide is of concern for the global effort of controlling the COVID-19 pandemic. To develop national surveillance of SARS-CoV-2 variants, the US Center for Disease Control and Prevention (CDC) launched the National SARS-CoV-2 Strain Surveillance (NS3) program in November 2020. However, only 0.3% of SARS-CoV-2 positive cases in the US had been sequenced (National Genomic Surveillance Dashboard) as of January 26, 2021. SARS-CoV-2 sequencing data from underserved communities including those in the IDeA states and Tribal Nations is still underrepresented in this dataset. To advance research on the spread, pathogenicity, and continuing evolution of SARS-CoV-2 variants in these regions, NIGMS is providing supplemental funding to support IDeA and NARCH grantees efforts to sequence and analyze the genomes of SARS-CoV-2 variants circulating in their communities.

Research Objectives

Applicants must propose SARS-CoV-2 viral genome sequencing and analysis studies. 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 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:

• Are there different variants 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 particular 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?
• For study populations undergoing vaccination, what percentage of the participants were SARS-CoV-2 positive prior to the first vaccine shot?
• Do pre-vaccination SARS-CoV-2 positive participants become SARS-CoV-2 negative post-vaccination without therapeutic treatment? If these participants remain SARS-CoV-2 positive, do they carry the same or a different variant?
• Do vaccinated study participants still acquire the SARS-CoV-2 virus, and if so, what variants do they carry?

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:

• IDeA Program Infrastructure for Clinical and Translational Research (IDeA-CTR, U54)
• 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 grant 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.

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 have prior experience relevant to the proposed COVID-19 research.

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 grantees applying to expand the scope of their active grants.

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

• Application Due Date: March 31, 2021 by 5:00 PM local time of the applicant organization.
• For funding consideration, applicants must include NOT-GM-21-031 (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.
• Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-18-935. Paper submissions and applications submitted as email attachments will be rejected without review.
• The Title of the supplement must reflect the proposed research project; thus it will likely be distinct from the title of the parent award.
• The Research Strategy is limited to 6 pages and must clearly describe the significance of the project.
  • The goals and testing population, 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 be 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 or complement public health efforts for the control of SARS-CoV-2 infection?
• Investigators: How well qualified is the project leader or team to direct the proposed research? Is the prior research experience of the designated project leader(s) relevant and appropriate to oversee the SARS-CoV-2 research project? Are collaborators and other researchers well-suited and appropriate to carry out the project? Do the collaborators and other investigators have complementary and integrated expertise? 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? How feasible and appropriate are the research design elements (including any power calculations) of the study? Is the study population appropriate for the research question? Are there potential sources of bias related to the methods used to sample the population of interest? Is the time frame feasible for the proposed research? Will the resources of the parent grant be leveraged?
• Testing: How feasible and appropriate are the plans to access FDA authorized/approved tests? Do the investigators propose to use CDC/NIH-recommended protocols, standards, and resources for SARS-CoV-2 sequencing and data processing? Are there plans to adjust for any changes in COVID-19 diagnostics?
• Outcomes: Will the proposed outcomes advance and improve surveillance of SARS-CoV-2 viral strains? Are there adequate plans to report outcomes back to testing or vaccine program partner(s)?
• 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 application with the NIGMS contact listed below and to notify the contact when a request has been submitted.

Inquiries

Please direct all inquiries to:

Hongwei Gao, M.D., Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]