Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title
Secondary Analysis and Integration of Existing Data to Elucidate the Genetic Architecture of Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed)
Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

Reissue of PA-17-243 - Secondary Analysis and Integration of Existing Data to Elucidate the Genetic Architecture of Cancer Risk and Related Outcomes (R21)

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-20-277
Companion Funding Opportunity

PAR-20-276, R01 Research Project Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393; 93.396; 93.172; 93.121

Funding Opportunity Purpose

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) along with the National Human Genome Research Institute (NHGRI) and National Institute of Dental and Craniofacial Research (NIDCR) encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate the genetic architecture of cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer genomic and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics and environmental, clinical, behavioral, lifestyle, and molecular profiles data. Applicants are encouraged to leverage existing genetic data and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in genomic and epidemiology cancer research.

Key Dates

Posted Date
July 22, 2020
Open Date (Earliest Submission Date)
September 16, 2020
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply.

The first standard due date for this FOA is October 16, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date
September 08, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) along with the National Human Genome Research Institute (NHGRI) and National Institute of Dental and Craniofacial Research (NIDCR) encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate the genetic architecture of cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer genomics and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics and environmental, clinical, behavioral, lifestyle, and molecular profiles data. Applicants are encouraged to leverage existing genetic data and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in genomics and epidemiology cancer research.

This FOA runs in parallel with another FOA of identical scientific scope,  PAR-20-276 , which utilizes the Research Grant (R01) mechanism.

Background and Rationale

National Institutes of Health (NIH) and other research funding organizations support numerous genomic and functional genomics studies that generate a large amount of genotype, phenotype, gene expression, and epigenetic data, which continue to be made available to the scientific community. Many of these datasets have not been analyzed to their full potential and further investigation will provide opportunities to answer important research questions at relatively low cost.

Several NCI programs support genomic and epidemiologic research to understand and clarify cancer risk, progression, and outcomes. These studies generate a wealth of individual- and population-level data, including molecular, lifestyle, clinical, and environmental data. Leveraging these various types of data through innovative data modeling and analysis allows new questions to be addressed and helps to advance the field of cancer research. NIH has made it a priority to make data more Findable, Accessible, Interoperable, and Reusable (FAIR) to researchers to further biomedical research, through several sharing policies, including the 2003 Data Sharing Policy, the 2015 Genomic Data Sharing (GDS) Policy, and the NCI Cancer Moonshot Public Access and Data Sharing Policy. NIH requirements for data sharing in grant applications, combined with public and private sector initiatives by donors, journals, and foundations, have led to unprecedented amounts of available data for secondary research. Publicly available molecular measurements have been successfully utilized to discover novel biomarkers of disease and to find novel uses for existing therapeutics.

The goal of this initiative is to address key scientific questions relevant to cancer genomics and epidemiology by supporting the analysis of existing genetic or genomic datasets, in combination with other omics, environmental, clinical, behavioral, lifestyle, and molecular profiles data, from various data sources whose number is expected to continue increasing as more data become available through data sharing.

Specific Research Objectives and Scope of the FOA

The integrative analysis of molecular data, especially the vast amount of genomic data obtained in recent years, has great potential to illuminate the complex interactions among genes, gene products, and the environment and thereby redefine cancer at the molecular level and lead to novel hypotheses regarding prevention and treatment of cancer.

Applicants are encouraged to leverage existing genetic or genomic data and perform innovative analyses of the existing data. Applications may include new aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer genomics and epidemiology. In addition, priority will be given to applications that incorporate at least one of the following features: the investigation of phenotypes not studied before using the proposed existing dataset, incorporation of additional studies or alternative data sets, exploration of multiple genetic and environmental factors, integration with multiple omics and other epidemiologic variables, and/or development or application of novel analytical approaches.

Specifically, through this FOA, the NCI along with NHGRI and NIDCR, encourages submission of applications that propose to leverage existing genetic or genomic data and could include one or more of (but not limited to) the following aspects:

  • link together genomic and epidemiologic data, including lifestyle and clinical factors from case-control studies, cohorts, consortia, and/or clinical trials;
  • integrate two or more omics data types derived from humans and obtained through various molecular techniques (genomics, transcriptomics, proteomics, metabolomics);
  • integrate germline and somatic variations;
  • develop or apply methods to overcome challenges associated with small sample sizes, be this cancer types, cell types, or unique human populations;
  • include and analyze longitudinal information, including on cancer survival;
  • combine studies and harmonize data across and within studies;
  • address cancer-related hypotheses using non-traditional/non-cancer databases;
  • employ innovative analytic techniques that demonstrate or promote methodological advances in genomic and epidemiologic cancer research;
  • seek to better understand complex interactions among genes and gene products in the context of cancer; and
  • promote research communities working together outside of their separate groups.

This FOA capitalizes on NIH's and NCI's past investments in several programs that have supported genomic and epidemiologic research of cancer risk, progression, and other health-related outcomes by leveraging the generated molecular, lifestyle, clinical, and environmental data. All data analyses must concern genomic and epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or cancer-related outcomes.

Addressing health disparities and improving inclusion is an area of interest across NIH, and research is needed to better understand the underlying factors contributing to disparities in several cancer types. While it is expected and understood that the research application will be constrained by the limited availability of existing genomic and epidemiologic data in minorities, the research plan should nevertheless adequately describe the investigators’ efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations, as well as address the translational impact of findings on these populations.

NCI focus. Applicants should consider the relevance of their proposed analyses to those NCI programs and priorities that can be tackled through the study of existing genomic and epidemiologic data, possibly together with other omics or clinical data. Potential applicants are encouraged to speak with the listed NCI program officials to discuss the relevance of the proposed research topic(s).

NHGRI focus. NHGRI welcomes applications that develop new approaches for elucidating the genetic architecture of human health and disease and that are broadly applicable to multiple diseases and outcomes, in addition to cancer. NHGRI is particularly interested in applications to develop novel methods for integrating multiple types of genomic data and possibly other data types. Projects that focus only on tumor genomics will not be appropriate for NHGRI funding.

NIDCR focus. NIDCR supports secondary data analysis and data integration research in the assessment of cancer risk, progression, and outcome that are relevant to oral, oropharyngeal, and salivary gland cancers. NIDCR will also consider applications that incorporate new statistical or computational methods to help improve the accessibility and/or speed of dissemination of data resources. Potential applicants are encouraged to speak with the listed NIDCR program officials to discuss the relevance of the proposed research topic(s).

This initiative optimizes the use of resources for epidemiologic studies by leveraging existing resources rather than creating new ones. The initiative will highlight examples of how data sharing and integration can strengthen cancer genomic and epidemiology research findings, thereby helping to overcome the real and perceived barriers to data sharing. In addition, it aims to encourage the collaboration of investigators outside of usual research groups.

Data Sources

Applicants are encouraged to collaborate with investigators holding publicly as well as non-publicly available data sets, using innovative statistical strategies to link methodologically comparable datasets.

A large volume of genotype and phenotype data are available to the scientific community. Some examples currently include (but are not limited to) the following:

  • Over 4,800 genotype and phenotype datasets from over 1000 studies deposited in dbGaP;
  • Genotype data from approximately 450 donors, including 9,600 RNA-seq samples across 51 tissue sites and two cell lines deposited in GTeX;
  • Gene expression profiles of over 2 million samples deposited in GEO;
  • Proteomic data measured by mass spectrometry in cancer biospecimens from CPTAC;
  • Nearly 73,000 high-throughput functional genomics experiments and over 2.4 million assays deposited in the ArrayExpress archive;
  • More than 15,000 DNA/RNA binding and DNA accessibility/methylation experiments deposited in ENCODE;
  • Multidimensional maps of genomic changes in 33 cancer types based on paired tumor and normal tissue sets collected from 11,000 patients deposited in TCGA;
  • Sequencing data from 685,000 human samples deposited in SRA;
  • Harmonized cancer genomic datasets from over 80,000 cases deposited in GDC;
  • Imaging information linked to clinical and genomic data from over 34,000 individuals and 27 cancer sites available in The Cancer Imaging Archive (TCIA);
  • Data on therapy outcomes from clinical trials and patient registries such as the Pediatric Proton Consortium Registry (PPCR);
  • Epidemiological, clinical, and molecular data from established cohorts such as the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial and other population-based studies in the Cancer Epidemiology Descriptive Cohort Data (CEDCD);
  • Exome and whole-genome sequence and phenotype data generated by NHGRI-funded consortia and deposited in the AnVIL project and through the NHGRI Genome Sequencing Program
  • Other NIH datasets.

This mechanism can also be used to merge secondary data sets with other data sets to better address important research hypotheses. For example, if allowed by informed consent, genetic datasets could be matched with hospital datasets or vital statistics.

Applicants who plan to utilize data not currently in their possession (originated from another party) should confirm availability of the data and the willingness and permissibility of the original investigators to share the data for the purposes of the secondary analyses, in accordance with all applicable rules for the protection of human subjects.

Collaborations and Authorship

Projects developed in response to this FOA must include expertise such as cancer epidemiology, omics, biostatistics, bioinformatics, and/or computational biology.

Any publications resulting from awards funded under this FOA must include acknowledgment of the source of shared data and any funding sources which supported the initial data collection.

Applicants should discuss co-authorship plans with original and/or contributing investigator(s) prior to submitting an application.

Data Sharing

Awardees are expected to broadly share the cleaned and harmonized datasets, analysis tools, and any other software developed for the secondary analysis and integration of the data, when appropriate and consistent with the participant informed consent. Sharing of adequate documentation and explanation is also encouraged so that data and tools can be used by researchers not associated with the original study.

Other Requirements

Applications can be related to but must be distinct from the specific aims and methods of the original data collection.

The primary analyzed data can be derived/redefined from existing data but should not be newly collected from study participants nor newly generated from existing biological specimens.

The FOA will allow up to 10% of the budget towards experimental approaches for validation of key findings.

Non-Responsive Applications

The following types of studies are outside the scope of this FOA and applications describing them will be considered non-responsive:

  • studies that propose to collect or generate new data for purposes other than limited validation of key findings;
  • studies that propose to analyze only non-genomic datasets;
  • studies that propose to analyze only data obtained from non-human samples;
  • studies that propose to carry out currently ongoing data analysis or to maintain and distribute data sets.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
Resubmission
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $275,000 over a two-year project period, with no more than $200,000 in direct costs allowed in any single year.

Award Project Period

The maximum project period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

 

All instructions in the SF424 (R&R) Application Guide must be followed.

The FOA will allow up to 10% of the budget towards experimental approaches for validation of key findings.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: All applications should include an overall strategy that leverages existing genetic or genomic data, possibly in combination with other omics, molecular, lifestyle, clinical, and environmental data. All data analyses must concern genomic and epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or cancer related outcomes. The study design should incorporate at least one of the following features: development or application of novel analytical approaches; exploration and integration of genetic data with multiple omics, environmental factors, and other epidemiologic variables; incorporation of additional studies or alternative data sets; and/or investigation of phenotypes not studied before using the proposed existing dataset.

Applications should clearly describe the proposed analytical methods, their feasibility and innovation in comparison to other existing methods and include possible evaluation and validation plans. Applicants should demonstrate knowledge of the proposed data set(s) and include details on data source, number of individuals, number and type of samples, type of genomic and other omics and/or molecular data, epidemiological and clinical information available and included in the analysis. Applicants should address how the proposed data set(s) are suitable and sufficient to fulfill the research aims and describe approaches to overcome challenges associated with small sample sizes, be this cancer types, cell types, or unique human populations. The proposed analyses should be feasible within the timeline proposed.

Addressing health disparities and improving inclusion is an area of interest across NCI and NIH, and research is needed to better understand the underlying factors contributing to disparities in several cancer types. While some progress has been made towards improving the inclusion of diverse populations in genomic studies, racial and ethnic minorities remain underrepresented in these studies. Such underrepresentation may have additional implications for genomic and cancer epidemiologic research, where understanding variation across populations is critical for accurate interpretation of findings. While it is expected and understood that the research application will be constrained by the limited availability of existing genomic and epidemiologic data in minorities, the research plan should nevertheless adequately describe the investigators’ efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations, as well as address the translational impact of findings on these populations.

This FOA is tailored to cost effective studies that reutilize existing resources for secondary data analysis, which may lead to findings that warrant experimental validation. Any proposed new experimental data generation within these applications should be limited (<10% of the budget) to the validation of key findings. If appropriate to the proposed science, applicants should describe how their findings could be experimentally tested in a follow up independent study.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Awardees are expected to broadly share the cleaned and harmonized datasets, analysis tools, and any other software developed for the secondary analysis and integration of the data, when appropriate and consistent with the participant informed consent. Sharing of adequate documentation and explanation is also encouraged so that data and tools can be used by researchers not associated with the original study.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

 

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, and responsiveness by NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
 

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA

What is the likelihood that the focus of the proposed secondary analyses to investigate novel scientific ideas or new models, systems, tools, methods, or technologies has the potential for contributing significantly to biomedical research in cancer? Have the investigators adequately addressed the translational relevance of the potential findings across populations?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this FOA

How novel are the developed or applied analytical approaches? How well are multiple genetic and omics data, environmental factors, and other epidemiologic variables explored and integrated into the analyses? Which additional studies or alternative data sets are incorporated into the analyses? Are the investigators proposing to analyze phenotypes that have not been studied before using the same existing datasets?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific for the FOA

How strong is the likelihood that the proposed data set(s) are suitable and sufficient to fulfill the research aims? How adequately have the investigators described their efforts, successes and challenges in finding and including in the analysis any relevant available datasets representing minority populations? How effective are the proposed methods to overcome challenges associated with small sample sizes, be this cancer types, cell types, or unique human populations? If the investigators are proposing new experimental data generation, is it limited to the validation of key findings? How likely is the proposed project to be completed within the timeline proposed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Applicable

 

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Melissa Rotunno, Ph.D.
National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS)
Telephone: 240-276-7245
Email: rotunnom@mail.nih.gov

Jiayin (Jerry) Li, M.D., Ph.D.
National Cancer Institute (NCI), Division of Cancer Biology (DCB)
Telephone: 240-276-6210
Email:jiayinli@mail.nih.gov

Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD)
Telephone: 240-276-5714
E-mail:ossandom@mail.nih.gov

Wendy Wang, Ph.D.
National Cancer Institute (NCI), Division of Cancer Prevention (DCP)
Telephone: 240-276-7117
E-mail:wangw@mail.nih.gov

Erin Ramos, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3288
Email:ramoser@mail.nih.gov

Chiayeng Wang, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4647
chiayeng.wang@nih.gov

Lu Wang, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4846
Email:wanglu@nidcr.nih.gov
 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email:Deanna.Ingersoll@nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email:rutbergd@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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