Key Dates

Related Announcements

NOT-CA-22-064 - Pre-Application Webinar for NOT-CA-22-056, Administrative Supplements to Support Germline Genome-wide Genotyping and Sequencing of Existing Samples from Minority Racial/Ethnic Populations and Sharing of Associated Epidemiologic Data

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

National Institute of Environmental Health Sciences (NIEHS)

Purpose

Through this Notice of Special Interest (NOSI), the National Cancer Institute (NCI) and other participating Institutes seek to leverage existing biospecimens to increase representation of racial/ethnic minority individuals in germline genome-wide data repositories with accompanying exposure, phenotype, and outcome data. Funds obtained through these administrative supplements should be used for processing existing samples and analyzing and managing the derived data from understudied racial/ethnic populations. These studies will also need to successfully compete for germline genome-wide genotyping or sequencing services offered by the NIH Center for Inherited Disease Research (CIDR) program through a companion application to PAR-20-230. Data from this initiative is expected to be broadly shared with the extramural research community.

Background

Recent efforts have attempted to enhance racial and ethnic minority representation in research, including African American or Black, Asian, American Indian or Alaskan Native, Native Hawaiian or other Pacific Islander (e.g., Guam, Tonga), or Latino or Hispanic, as defined in the NIH Minority Health and Health Disparities Strategic Plan. However, disparities remain in the representation of racial and ethnic minorities in germline genetics studies with companion phenotypic and epidemiologic exposure information.

The inadequate representation of racial/ethnic minority populations in germline genetics data repositories limits the translational impact for disease control in these populations, thus potentially compounding preexisting health disparities seen in the United States. Understanding variability in germline genomic factors along with other exposures is critical for understanding the etiology of cancer and other diseases and for developing appropriate prevention and screening strategies for specific populations. Continued health disparities underscore the urgency to ensure appropriate representation of minority populations in genomic and epidemiologic research to improve the prevention and control of cancer and other diseases in all populations.

Research Objectives

For the purpose of this NOSI, the NCI and other participating Institutes seek to leverage existing biospecimens for supplemental research projects that will increase representation of racial/ethnic minority samples in germline genome-wide genotyping and sequencing data repositories with accompanying exposure, phenotype, and outcome data. Data from this initiative will be broadly shared with the extramural research community.

This NOSI is to support sample handling, statistical and informatic analysis, and data management to share phenotypic and risk factor data (e.g., environmental exposures and other covariate data and outcomes). A companion application to CIDR will support genotyping and sequencing services.

Applications relevant to this NOSI should propose germline genome-wide genotyping or whole exome/genome sequencing of underrepresented racial/ethnic minority populations to address research topics that include, but are not limited to, the following:

• identifying and validating novel associations of genetic variants with disease risk or outcomes;
• building and validating Polygenic Risk Scores (PRS) for the studied disease;
• investigating the combined influence of genetic and environmental factors on disease risk or outcomes; and
• serving as a resource or catalog of genetic variation for evaluation, interpretation, or future discovery, including a clearly articulated use case for the gap that will be filled by the resource or catalog.

NCI Priorities

NCI is interested in research topics that focus on cancer risk and related outcomes.

NIEHS Priorities

NIEHS has an interest in research topics combining genomics and epigenomics data with environmental data to understand complex disease outcomes.

Applicants are encouraged to discuss their application with the scientific/research contacts listed in this NOSI prior to submission.

Application and Submission Information

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

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

Eligibility and Eligible Individuals (Program Director/Principal Investigator):

• Administrative supplement applications are limited to currently funded projects supported by the participating Institutes and applicants must submit a companion application to CIDR as described below.
• PDs/PIs must hold an active eligible R01, R37, P01, U19, U01, UG3/UH3, or UM1 grant award supported through the participating Institutes. Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• The proposed project for supplemental funding is required to be within the scope of the parent award.
• The focus of the parent award does not need to have been on underrepresented racial/ethnic populations, although biospecimens for this supplement request must have already been collected.
• Applicants must submit a companion application by May 12, 2022, to CIDR through PAR-20-230 requesting to perform the genotyping or sequencing planned in the supplement application.
• For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
• Applicants must be willing and be able to deposit genetic and environmental data in dbGaP or another NIH data repository in a manner consistent with participant consent.
• Application Due Date: All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on May 26, 2022, for possible funding in FY 2022. This NOSI will expire on May 27, 2022.

Budget and Period of Support:

• The FY 2022 supplement budget requests should not exceed $200,000 in total costs and must reflect the actual needs of the proposed project.
• Funding is limited to sample handling, statistical and informatic analysis, and data management to share phenotypic and risk factor data (e.g., environmental exposures and other covariate data and outcomes data). Note: This opportunity will not support new biospecimen collection.
• At least one full year on the parent grant must remain at the time of funding. The application budget is limited to 1 year only.
• If an applicant anticipates a balance of 50% or more of the current total costs for the parent grant, please contact the scientific research contact prior to submitting an application.
• Only one supplement application per grant will be accepted for consideration through this NOSI.
• Requests: permitted for 1 year of support only. The earliest anticipated start date is September 1, 2022.

Submitting Applications:

• For administrative supplements to grants and cooperative agreements, supplement requests must be submitted in accordance with the parent program announcement, PA-20-272. NOTE: Administrative supplement requests (applications) for support of clinical trials will not be accepted and/or considered in response to this NOSI.
• Supplement requests should be submitted electronically through eRA Commons, see PA-20-272 for more information.
• Applicants should begin the supplement application abstract by stating This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-22-056.
• For funding consideration, applicants must include NOT-CA-22-056 (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.
• In order to facilitate efficient processing of the request applicants are strongly encouraged to notify the Institute Scientific Contact, as well as the assigned Program Official for the parent award that a request has been submitted in response to this NOSI.
• In order to be considered for this initiative, applicants must also submit an application to PAR-20-230 by May 12, 2022, for access to the CIDR Resource for genotyping and sequencing services. Submission of both applications is required for consideration for this supplement opportunity. Note: A letter from the sponsoring Institute documenting permission to apply to PAR-20-230 should be included in the CIDR application. NCI specific instructions for a CIDR submission are found on this page. Researchers with grant applications funded by other NIH Institutes should obtain instructions specific to that Institute by contacting the appropriate CIDR Program Liaison.
• Page Limits The Research Strategy of the Administrative Supplement application must not exceed five (5) pages and must summarize the activities of the parent grant that encompass those proposed in the supplemental request and describe how those activities are proposed for augmentation and/or enhancement in the supplemental request by:
  • Describing the supplement’s purpose, relationship of the supplement request to the parent grant (proposed research much be within scope of the parent grant), and the additional value provided to the underlying funded research (parent grant) of the PI and the collaborating investigators.
  • Detailing the proposed population, available biospecimens, and environmental or phenotypic data to be shared.
  • Justifying the population being investigated and how inclusion of this population will address gaps in representation of racial/ethnic minority samples in germline genome-wide genotyping or sequencing studies with accompanying exposure, phenotype, and outcome data.
  • Justifying the proposed genotyping or sequencing technology of choice among genotyping array, whole exome sequencing, and whole genome sequencing for the data generation to be performed at CIDR through a companion PAR-20-230 application.

Review and Selection Process:

Each participating Institute will conduct administrative reviews of applications submitted to their IC and will support the most meritorious applications submitted for consideration, based upon the programmatic priorities and availability of funds. Additionally, Program staff will evaluate applications using the following selection factors.

Review Criteria:

• Will the investigator at the time of funding decision be approved for access to the CIDR resource for the genotyping or sequencing for this project, through the X01 application process (PAR-20-230)?
• Does the administrative supplement reasonably allow for the proposed project to be completed, given the time and budget requested?
• Does the proposed project for supplemental funding include, and appropriately justify the inclusion of the underrepresented racial/ethnic minority population, biospecimens and/or data?
• Does the proposed project for supplemental funding fill an identified gap in the scientific literature that advances biomedical research?
• Does the applicant provide evidence of having access to the appropriate biospecimens and data to complete the project?
• Has the applicant agreed to share molecular and associated phenotypic data broadly via an NIH supported repository?

Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.

Inquiries

Please direct all inquiries to:

Melissa Rotunno, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7245
Email: [email protected]

Kimberly McAllister, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3287
Email: [email protected]