PAR-27-073-Full-Announcement.html

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 Cancer Epidemiology Cohort Studies (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

PAR-25-275

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-27-073

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.393

Funding Opportunity Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages grant applications to support research in cancer epidemiology cohort studies that address specific knowledge gaps in cancer etiology and survivorship. Applications should include hypothesis-based research, support for cohort infrastructure and/or maintenance, continued follow-up, and sharing of data and biospecimen resources as appropriate.

Funding Opportunity Goal(s)

To reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion strategies.

Key Dates

Posted Date

May 04, 2026

Open Date (Earliest Submission Date)

September 05, 2026

The following table includes NIH standard due dates marked with an asterisk.

October 05, 2026 *

November 05, 2026 *

Not Applicable

July 2027

February 05, 2027 *

March 05, 2027 *

Not Applicable

December 2027

June 05, 2027 *

July 05, 2027 *

Not Applicable

April 2028

October 05, 2027 *

November 05, 2027 *

Not Applicable

July 2028

February 05, 2028 *

March 05, 2028 *

Not Applicable

December 2028

June 05, 2028 *

July 05, 2028 *

Not Applicable

April 2029

October 05, 2028 *

November 05, 2028 *

Not Applicable

July 2029

February 05, 2029 *

March 05, 2029 *

Not Applicable

December 2029

June 05, 2029 *

July 05, 2029 *

Not Applicable

April 2030

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

July 06, 2029

Required Application Instructions

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages grant applications to support research in cancer epidemiology cohort studies that address specific knowledge gaps in cancer etiology and survivorship. Applications should include hypothesis-based research, support for cohort infrastructure and/or maintenance, continued follow-up, and sharing of data and biospecimen resources as appropriate.

Key Definitions for this NOFO

Established Cancer Epidemiology Cohort: A cohort that has achieved its initial planned recruitment goal.

Background Longitudinal prospective cohort studies have made major contributions to knowledge of environmental, behavioral, and genomic factors associated with cancer risk and outcomes and provided clues to intervention strategies to prevent or mitigate the effects of cancer and its treatment. NCI has invested significantly in establishing and maintaining prospective Cancer Epidemiology Cohorts (CECs) that have collected a wealth of exposure data, biospecimens and cancer information. As exposures and demographics evolve, prospective cohort studies remain essential for understanding cancer risk and outcomes in human populations and warrant a need to expand and modernize cohort resources. Further, there are opportunities to leverage existing cohort resources, which is critical to maximizing NCI’s investment toward better understanding the determinants of cancer occurrence and outcomes.

Well-designed CECs studies can provide a foundational framework for cancer prevention and control. New cohorts can yield information on the cancer burdens associated with emerging exposures, health habits, and treatments, while incorporating advanced technologies, such as wearable sensors, digital health tools, and artificial intelligence (AI) to capture and analyze these variables with greater precision and efficiency. Existing CECs are also valuable resources, providing data and biospecimen collections from various populations, with great potential for innovative research related to cancer risk and outcomes. Cohort studies have enabled research linking sleep duration to breast cancer risk, polygenic risk scores and cancer occurrence, cancer treatments and adverse toxicities or side effects, and lifestyle and cancer survival. Biospecimens collected in cohorts may reveal additional insights into the etiology and progression 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 newly collected as well as existing resources. These studies can offer essential insights for developing targeted interventions, ultimately reducing cancer incidence and mortality, as well as treatment-related morbidity, across all population groups.

Scope and Research Objectives of this NOFO Successful applications responding to this NOFO must address important scientific gaps in cancer epidemiology research and enhance our understanding of cancer risk among healthy populations or outcomes among cancer survivors. Applicants may propose research studies within an established cancer epidemiology cohort. Any request for infrastructure support for an established cohort (see definition) must be directly related to the proposed scientific research aims and will be evaluated based on the proposed scientific research questions and methods. The NOFO also supports applications for the establishment of a new cancer epidemiology cohort or an expansion of a recently formed cancer epidemiology cohort.

The followings are within the scope of this NOFO:

Expectations and Requirements for this NOFO:

1. Core Scientific Expectations:

Define the research gaps and broad scientific vision to be addressed by the proposed research or cohort Demonstrate appropriateness and, when possible and as appropriate, highlight innovation and novelty in population, exposures, biological factors, and/or outcomes For Risk/Etiology Cohorts: Given the varied latency of exposures associated with cancer incidence, applicants may propose to assess biomarkers (for example, key characteristics of carcinogenesis) of intermediate risk and provide scientific justification of appropriateness during the study period in lieu of cancer diagnosis endpoints

For New Cohorts: The primary aim should be to establish the proposed cohort. Additional hypothesis-driven scientific aims are encouraged as detailed below. Acknowledging the varied latency of exposures associated with cancer incidence (as well as certain outcomes), optional scientific aims could include, but are not limited to, methodological studies focused on testing (i) approaches to engage, recruit, and retain study participants; (ii) optimal and novel methods to collect accurate exposure and individual-level data; and/or (iii) methods for biospecimen collection and plan for assessment of stability of long-term storage when appropriate

For New Survivor Cohorts, describe the collection of data from the following five domains in order to cover the full extent of the cancer survivor experience: 1) disease characteristics (e.g., type, stage, tumor biomarkers), 2) individual survivor characteristics (e.g., comorbidities, social connections, information seeking, access to care measures), 3) treatment, treatment-related effects, and follow-up care (e.g. dose, adverse events, palliative care), 4) behavioral and lifestyle factors (e.g., diet, physical activity) and 5) quality of life outcomes (e.g., health-related quality of life, patient symptom reports). These domains may represent exposures and/or outcomes, depending on the research questions, and should be measured at multiple time points, when appropriate

Outline plans for long-term sustainability of the cohort and data preservation beyond the award period Describe strategies to maintain the cohort infrastructure, support on-going participant follow-up, and ensure sustainability

2. Community Engagement: The bi-directional partnership between the research scientists and community partners is integral to this NOFO. Applicants must describe robust community engagement activities, including but not limited to:

3. Data Accessibility and Sharing: The proposed study’s data management and sharing should promote rapid data sharing with the broad research community, ensuring that participants provide consent for general research use and be consistent with NIH data sharing policies, including the NIH Genomic Data Sharing Policy and adhere to the Findable, Accessible, Interoperable, Reusable (FAIR) guiding principles. The NCI-approved data management and sharing plan will become a term and condition of the award.

4. Other Requirements:

Other Considerations and Recommendations: Applicants are encouraged, where appropriate, to incorporate data through linkages to existing databases with relevant exposure, administrative, and health-related data. Linkages to state cancer registries through the NCI-funded Virtual Pooled Registry Cancer Linkage System (VPR-CLS) is an example of existing data that could be leveraged. Population-based cancer registries (Surveillance, Epidemiology, and End Results Program and State Cancer Registries, SEER) also provide frameworks for identifying and recruiting cancer cases.

Non-Responsive Applications Applications submitted in response to this NOFO that propose any of the following will not be reviewed, including:

IMPORTANT NOTE: Applicants should review relevant due dates and information on the website.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance 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 NOFO.

Application Types Allowed

New

Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed 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

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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

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 Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. The same UEI must be used for all registrations, as well as on the grant application.

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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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 their organization to develop an application for 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 How to Apply-Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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 How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

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

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: All applicants must include specific aims that address scientific gaps in cancer epidemiology cohort studies and the main requirements outlined in Part 2.Section I of this NOFO.

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 in this study population. Provide an overview of relevant scientific literature. Identify the novel scientific gap fulfilled by the proposed research and how the proposed project will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States.

Sub-section D. Cohort Overview (as applicable for the proposed study) Overview: Overall description and summary purpose of the 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 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, when and if applicable;

Describe the analytic plan, including calculations for sample size and power analyses for all aims as appropriate.

Sub-section F. Timelines Provide detailed timelines that are aligned with completing the Specific Aims (without duplicating information already provided in the PHS Human Subjects and Clinical Trials Information form Section 2).

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 How to Apply - Application Guide.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Expectations and requirements specific to this NOFO are described in the ‘Scope and Research Objectives of this NOFO’ section above.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.

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 How to Apply- 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

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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply – 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 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply – 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described 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 NOFO supports cancer research in cancer epidemiology cohort studies. Successful applications will address important research gaps with strong scientific approaches. 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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Factor 2. Rigor and Feasibility (Approach)

Rigor:

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

Factor 3.