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)

Funding Opportunity Title
Research Opportunities in Established Cancer Epidemiology Cohort Studies (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices

  • April 19, 2022 - Notice of Pre-application Webinar for NCI Funding Opportunity Announcements for Cancer Epidemiology Cohorts (PAR-22-161, PAR-22-162). See Notice NOT-CA-22-081.
  • April 15, 2022 - Notice Title. See Notice NOT-CA-22-080.

Funding Opportunity Announcement (FOA) Number
PAR-22-162
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.393
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) encourages grant applications to support research in established cancer epidemiology cohort studies, defined as studies that have achieved their initial planned recruitment goal. Applications must include hypothesis-based research using data from an established cohort study and are expected to include support for cohort maintenance, continued follow-up, and sharing of the existing resources in addition to addressing research questions across the cancer control continuum.

Key Dates

Posted Date
April 14, 2022
Open Date (Earliest Submission Date)
June 29, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 29, 2022 Not Applicable Not Applicable November 2022 January 2023 April 2023
February 28, 2023 February 28, 2023 Not Applicable July 2023 October 2023 December 2023
July 28, 2023 July 28, 2023 Not Applicable November 2023 January 2024 April 2024
February 28, 2024 February 28, 2024 Not Applicable July 2024 October 2024 December 2024
July 29, 2024 July 29, 2024 Not Applicable November 2024 January 2025 April 2025
February 28, 2025 February 28, 2025 Not Applicable July 2025 October 2025 December 2025

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
March 01, 2025
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) encourages grant applications to support research in established cancer epidemiology cohort studies, defined as studies that have achieved their initial planned recruitment goal. Applications must include hypothesis-based research using data from an established cohort study and are expected to include support for cohort maintenance, continued follow-up, and sharing of the existing resources in addition to addressing research questions across the cancer control continuum.

Key Definitions for this FOA

  • Cancer Epidemiology Cohorts (CECs) are observational studies in which groups of people with a set of characteristics or exposures are prospectively followed for the incidence of new cancers, cancer mortality, and/or cancer-related outcomes.
  • Established Cohort Studies, for the purposes of this FOA, are those studies that have achieved their initial planned recruitment goal.

Background

Longitudinal prospective cohort studies have made major contributions to knowledge of environmental, behavioral, and genomic factors associated with cancer incidence, morbidity, and mortality and provided clues to intervention strategies to prevent or mitigate the effects of cancer and its treatment. NCI has made significant investments into establishing and maintaining large-scale prospective Cancer Epidemiology Cohorts (CECs) with a variety of exposure data, considerable follow-up time, and cancer information. Opportunities to leverage existing cohort data are critical to maximizing the investment toward better understanding the determinants of cancer occurrence and outcomes. CEC studies have helped advance our understanding of cancer etiology and outcomes, provided crucial insight into key environmental, lifestyle, and genomic factors, and informed intervention strategies to prevent or mitigate the effects of cancer and its treatment.

Well-designed, population-based cohort studies can provide a foundational framework for cancer prevention and control. NCI recognizes that CECs are valuable resources, providing data and biospecimen collections from diverse populations, with great potential for innovative research into cancer risks and outcomes following cancer diagnosis. For example, cohort studies have enabled research linking sleep duration and breast cancer incidence, polygenic risk scores to predict disease, diet quality and blood nutrient values to cancer risk, ambient air pollution and cancer risk, and a host of other relationships across race, ethnicity, and sex. Biospecimens collected in cohorts may reveal additional insight into the etiology of disease and provide a useful complement to participant-reported data. Because CECs collect a broad array of information across many domains, research can proceed in many directions that leverage existing data. Research should be driven by specific research questions that are important, innovative, and enable appropriate use of the existing data with the greatest potential to advance our understanding of cancer etiology and outcomes with the goal to improve cancer control.

Scope and Research Objectives of this FOA

This FOA is intended to support research using data from established cancer epidemiology cohort studies, defined as studies that have achieved their initial planned recruitment goal. Successful applications will address important hypothesis-based research questions using existing cohort resources, robust data collection as needed, and appropriate analytical plans. Support for the cohort study must be related to the scientific research aims and will be evaluated based on the proposed scientific research questions and methods. Applications designed solely to support cohort infrastructure are not appropriate for this FOA. Research questions that include understudied populations (e.g., race, ethnicity, SES, age, geography), less commonly studied cancer sites and exposures, and studies that directly inform interventions and guidelines are encouraged.

Non-responsive Applications

Applications that propose any of the following will not be reviewed, including:

  • Initiate new cohorts or propose new participant recruitment;
  • Applications designed solely to support cohort infrastructure;
  • Do not include hypothesis-based research in the specific aims that is based on data from an established longitudinal cohort study;
  • Do not focus on cancer-related endpoints and outcomes;
  • Have data and/or resource sharing plans that do not comply with NIH policy and follow the FAIR (Findability, Accessibility, Interoperability, Reusability) principles; or
  • Are based on cohorts that are currently funded by PAR 20-294 (These applications are not eligible until after the expiration of their current grant).

NOTE: Applicants to this FOA are strongly encouraged to listen to the pre-application webinar sponsored by the NCI (date to be published under separate cover) and contact NCI staff as soon as possible in the development of the application to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this FOA. A recording of the pre-application webinar will be available the Epidemiology and Genomics Research Program’s website.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Resubmission

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.

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

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 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 Government

  • Eligible Agencies of the Federal Government
  • 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.

  • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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

Number of Applications

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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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.

.

R&R or Modular Budget

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

Any individual designated as a PD/PI must commit a minimum of 1.8 person-months effort per year to the project (MPIs must commit a minimum of 1.2 person-months per NCI policy). The PD/PI person-months effort cannot be reduced in later years of the award.

The budgeted effort of other personnel must be appropriate to the needs and objectives of the project.

Applications should budget for at least one key personnel to attend a meeting (e.g., NCI Cohort Consortium’s annual meeting) for each year of a grant period. Meetings will take place at an NIH location in Maryland, if possible, or via video conference.

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:

Specific Aims: All applicants must include specific aims that address hypothesis-based research questions using data from established cancer epidemiology cohort studies, defined as studies that have achieved their initial planned recruitment goal.

Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.

Sub-section A. Background and Significance

Define, justify, and explain the rationale for the proposed research int this study population. Provide an overview of relevant scientific literature. Identify the novel scientific gap fulfilled by the proposed research using data from the established cohort.

Sub-section B. Preliminary Data

Summarize preliminary data that provide the underlying logic or rationale for pursuing the project in the manner proposed as well as data that demonstrates the ability to complete the scientific aims proposed. Summarize what is believed to be the major challenges and described alternative approaches that may need to be pursued.

Sub-section C. Cohort Overview

Overview: Overall description and summary purpose of the proposed cohort. Schematic representations of the overall structure and timeline of the cohort are encouraged, where appropriate.

  • Description of Study Population: The application must include table(s) with a detailed description of the study population, including age structure (at enrollment and current), vital status, and response rates of participants, with the percentage of gender and racial/ethnic subpopulations (as described in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-089.html.), number and type of cancer outcomes, and available biospecimens.
  • Retention: Approaches and methods proposed for follow-up of participants, assessment of outcomes, plans for retention, and methods for quality control must be described.
  • Collection and Management of Biospecimens: Describe the protocols for collection, processing, storage, and quality control of biospecimens. Investigators will be expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/bestpractices) for collection, processing, and storage of biospecimens.
  • Case Ascertainment Assessment: Describe the planned activities related to case ascertainment. If cancer registries are used for ascertainment, the quality of the registry is expected to be of comparable status to the North American Association of Central Cancer Registries' (NAACCR’s) silver or gold certification (https://www.naaccr.org/Certification/CertificationLevels.aspx). If other methods of case ascertainment are used, describe quality control or adjudication procedures.

Sub-section D. Approach

Describe methods/approaches that will be used to accomplish proposed Specific Aims;

  • Describe the relevant epidemiological information/data available.
  • Describe measures and methods of collection for any proposed new data collection.
  • Describe the analytic plan, including calculations for sample size and power analyses for all aims as appropriate.

Sub-section E. Timelines

  • Provide detailed timelines that are aligned with completing the specific aims.

Letters of Support: Applicants must include letters of support from collaborating entities (e.g., collaborating scientists, community partners, community-based organizations, etc.).

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:

  • Regardless of the amount of direct costs requested for any one year, all applications are expected to include a data sharing plan with: 1) the extent and type of data that have been and will be shared, 2) the data repository to which the data will be submitted (repository must be publicly accessible or controlled access, use of NIH repositories is encouraged, but not required, seewww.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html for a full listing of NIH repositories), and 3) the timeline for the data to be shared after each wave of data collection.
  • Applications must include hypothesis-based research using data from an established cohort study and are expected to include support for cohort maintenance, continued follow-up, and sharing of the existing resources in addition to addressing research questions across the cancer control continuum.
  • CECs are required to maintain a website that details the procedure for external investigators requesting and obtaining data; procedures and criteria for access must be compliant with NIH data sharing policies. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI. Resource sharing plans should follow the FAIR principles and be fully compliant with NIH policies, including the NIH Genomic Data Sharing Policy (https://datascience.cancer.gov/data-sharing/genomic-data-sharing).
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 Institutions

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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. For more information, please seehttps://epi.grants.cancer.gov/funding/large-grant-applications/.

Furthermore, applicants requesting $700,000 or more in direct costs in any year will be required to participate in a pre-submission consultation meeting with Program Staff at least 12 weeks prior to receipt date to ensure the scope of the application is appropriate to basic maintenance for existing cohorts to serve as a resource for research according to NIH data sharing policies. Additional information, including contact information and materials required, is outlined onhttps://epi.grants.cancer.gov/funding/large-grant-applications/. Applicants should contact NCI early enough to ensure the meeting will occur at least 12 weeks prior to submission. Failure to comply will result in the application being deemed non-responsive to the intent of the PAR.

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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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. 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:

This FOA supports cancer research in established cancer epidemiology cohort studies, defined as studies that have achieved their initial planned recruitment goal. .

Successful applications will address important hypothesis-based research questions with strong scientific approaches that use the existing cohort resources. Support for developing and maintaining the cohort study related to the scientific research aims, will be evaluated on the appropriateness of methods proposed and future application of the data collected.

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.

Significance

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

How likely is it that important scientific questions and/or gaps in knowledge related to cancer etiology and cancer-related outcomes will be addressed by data collected in this cohort?

Investigator(s)

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?

Innovation

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

Innovation could come different forms. For example, does the proposed project provide information about a novel exposure, understudied group of participants, or less common cancer site? Does the cohort study use state-of-the-art tools and technologies to maintain and manage the CEC? Have they developed a process that supports broad sharing of cohort data and biological specimens?

Approach

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?

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?

Specific for this FOA

Are there appropriate plans for the rigorous management and quality control of data and biospecimens collected by the CEC? How well does the study population approximate the relevant US population?

Are the CEC research objectives described feasible and likely to be completed during the requested period? Is there a strong plan for retention? Are follow-up rates and/or response rates adequate? Are the types and number of outcome variables tracked appropriate for the intended research scope?

How appropriate are the existing resources and/or current age distribution and vital status of participants in follow-up to support the proposed scientific aims?

Environment

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.

Resource/Data Sharing

To what extent does the application describe the facilitation of timely and broad access to cohort-related data and resources to the external scientific community?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

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.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Applications from Foreign Organizations

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.

Select Agent Research

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).

Resource Sharing Plans

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; (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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 NCI, 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. 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 NCI's 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 recipient's business official.

Recipients 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: Recipient 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 recipient 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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 75.205and 2 CFR Part 200.206 “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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the following primary responsibilities:

  • Define the overall research objectives;
  • Determine approaches, design protocols, set project-specific objectives (e.g., milestones), and oversee the conduct of the research;
  • Ensure compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
  • Adhere to the NIH policies regarding intellectual property, data release, and other policies;
  • Cooperate with NCI programmatic, technical, and administrative staff;
  • Participate in the Cohorts Program Steering Committee;
  • Attend annual meetings, be held either virtually and/or in-person at the Bethesda, Maryland, area;
  • In addition to standard annual Research Performance Progress Report (RPPR) submissions, PD(s)/PI(s) may be expected to supply additional progress-related information to the NCI.

The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award.

Awardees are required to provide annual progress reports and descriptive data to NCI, including counts of participants (including current age, vital status, response rates and losses to follow-up or withdrawals) and a summary of data shared (including number of requests, approvals, denials, and list of collaborators) when appropriate.

NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Coordinator(s), will coordinate in a centralized fashion various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s)/Coordinator(s) will include the following aspects:

  • Facilitate collaborations between the awardees and other NCI-sponsored programs, investigators, or organizations;
  • Assist with the coordination of efforts that may contribute to the projects’ goals and NCI’s priorities;
  • Advise awardees on compliance with NIH policies, such as NIH data sharing policies;
  • Attend the cohort’s steering committee/external advisory board meetings and/or other standing/ad hoc meetings as appropriate;
  • Organize and conduct annual meetings to discuss progress and longer-term projects or activities.
  • Provide input on methodological work or approaches, assist in designing protocols, and consult on updates to project progress;
  • Provide advice to the awardees on specific scientific and analytical issues;
  • Organize and participate in webinars with PDs/PIs to monitor progress and facilitate cooperation;
  • Monitor progress of the projects and adherence to the strategic goals of the program;
  • Track accrual of study participants to ensure proper completion of this essential step;
  • Provide administrative management to convening the Cohort Program Steering Committee, organize meetings, and monitor implementation of its guidelines and procedures;
  • Stimulate interactions among awardees; and
  • Contribute to publications and presentations resulting from the project if appropriate.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The NCI Project Scientist and the PD/PI of the Cooperative Agreement awards funded under this initiative will be jointly responsible for participating in initiative-wide and cohort-related activities and for establishing inter-project collaborations with other awardees of cancer epidemiology cohorts. In addition to the interactions defined above, the NCI Project Scientist and awardees shall share responsibility for the following activities via a Cohort Program Steering Committee, which will serve as a non-voting organizational body for the NCI and awardees.

The Program Steering Committee will consist of:

  • Principal investigator(s) of each award;
  • Two NCI Project Scientists (Cohort Co-Coordinators); and
  • One NCI Director assigned to the awarded grant.

The Cohort Program Steering Committee will be organized and administratively managed by the NCI program staff and will meet for at least one annual meeting (either virtually or in-person)during the grant period where all awardees will discuss award-related and program-related issues, including but not limited to progress on proposed specific aims, data collection meaures, methodologic work, recruitment/retention goals, data sharing, data deposition, and community-engagement activities. Additional webinar meetings will also be organized by the NCI program staff throughout the award period as needed. At the meeting(s), awardees will work together under the guidance of NCI program staff as a consortium of investigators to advance the objectives and goals of this initiative.

The NCI Project staff and awarded PIs will serve on the Steering Committee. In addition, other NCI Program Officials, may serve on the committee to help with issues regarding recruitment, follow-up, quality control, protocol adherence, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. The Steering Committee may establish working groups/sub-committees as needed, e.g., to address specific scientific or administrative issues.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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)

Joanne Elena, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6818
Email: joanne.elena@nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email:dmitchum@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 2 CFR 200, 42 CFR Part 52 and 45 CFR Part 75.

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