RFA-CA-27-007-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

NCI Community Oncology Research Program (NCORP) Community Sites (UG1 Clinical Trial Not Allowed)

Activity Code

UG1 Clinical Research Cooperative Agreements - Single Project

Announcement Type

Reissue of

RFA-CA-18-016

Related Notices

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

Funding Opportunity Number (FON)

RFA-CA-27-007

Companion Funding Opportunity

RFA-CA-27-006

, UG1

Clinical Research Cooperative Agreements - Single Project

RFA-CA-27-008

, UG1

Clinical Research Cooperative Agreements - Single Project

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.393, 93.395, 93.399

Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human subject research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.

NCORP is a community-based research network that:

NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:

The NCORP Community Sites is a healthcare system, a consortium of healthcare systems, or a consortia of community hospitals and/or oncology practices, public hospitals, and/or health care centers that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research conducted through NCORP and NCTN.

Funding Opportunity Goal(s)

To identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans.

Key Dates

Posted Date

May 21, 2026

Open Date (Earliest Submission Date)

August 18, 2026

September 18, 2026

September 18, 2026

Not Applicable

July 2027

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

September 19, 2026

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 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human research study results through accrual in a variety of community settings. The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.

NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below:

NCORP Community Sites is a healthcare system, a consortium of healthcare systems, or a consortia of community hospitals and/or oncology practices, public hospitals, and/or health care centers that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research conducted through NCORP and NCTN.

NCORP Academic Community Sites are a consortium led by an academic center with a network of community hospitals and/or oncology practices, public hospitals, and/ or other healthcare centers that serve a patient population that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research. The academic medical center should have a robust infrastructure to support the accrual of participants across their affiliate organizations.

NCORP Research Bases will serve as the program's research hubs and are expected to:

Key Definitions for the context of this NOFO:

The terms “Clinical Research” and “Clinical Trials” in this NOFO follow the NIH definitions (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#ClinicalResearch).

The terms “Human Subject” and “Human Subjects Research” in this NOFO follow the NIH definitions (https://grants.nih.gov/grants/glossary.htm#HumanSubject) NCI Central Institutional Review Board (Central IRB): is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards (https://www.ncicirb.org/about-cirb/).

Community Site Primary Affiliate: In the context of NCORP community-based structure, a "primary affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials and other human subjects research available to the NCORP Community Site or Academic Community Site.

Community Site Sub-Affiliate: In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, and is managed by the primary affiliate under the primary Affiliate Site’s Federal Wide Assurance (FWA).

Research Base Member Sites: Members sites affiliated with a given Research Base may include NCORP Community and Academic Community Sites, Main members, affiliates, and Lead Academic Participating sites.

Background Whereas various academic medical centers play a crucial role in cancer clinical research, the majority of cancer care takes place in the community setting. Academic centers can play a critical role in helping to support enrollment in their network of community sites. Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population treated in a variety of healthcare delivery settings, which can accelerate accrual to cancer clinical trials and other human subjects research and increase the generalizability and relevance of study findings. In addition, research in community settings reflects the complexity of cancer care delivery and engages community oncologists in research to develop care delivery approaches that can be implemented within usual clinical workflow.

NCI has supported cancer clinical research within community settings for over three decades. The participation of community oncologists, clinicians, non-oncology specialists, and primary care physicians in cancer clinical trials has facilitated the introduction of research advances into practices throughout the country. The era of genomics and molecularly-targeted therapy necessitates shifts in the delivery of cancer-related care.

The foundation of NCORP is the conduct of multi-site cancer clinical trials and other human subjects research in primary focus areas of cancer control, prevention and care delivery. In addition, NCORP plays an important role in the National Clinical Trials Network (NCTN), a major NCI-supported infrastructure for cancer clinical trials. Approximately 30 -35% of the patients enrolled in NCTN clinical trials, including precision medicine studies, are from NCORP sites.

The Academic Community Sites, in particular, allow academic centers with strong research in cancer control, prevention, and cancer care delivery to link physicians caring for large numbers of patients to the NCI clinical trials network and provide support to their affiliate community sites to accrue a representative patient population to clinical trials.

The NCORP Community Sites and Academic Community Sites have responded to many of the challenges associated with implementation of precision medicine by providing quality specimens for genomic sequencing and establishing a multidisciplinary team to support the newer generations of clinical research. Recent advances in technology are providing new opportunities to characterize premalignancies in ways that will enhance the development of cancer prevention interventions, and biomarkers of response to those interventions, and biomarkers of risk. NCORP’s diversity in patient age, race/ethnicity, and geographic location as well as partnerships with non-oncology practices provides a natural laboratory for the development of strategies for precision prevention to improve efficiency and to balance the risks and benefits of interventions. Community organizations have proven to be well positioned to promote the science of symptom management, cancer prevention, and surveillance and increase the representativeness of clinical research.

NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts. Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subject review, all of which increase efficiency and reduce redundancy. The infrastructure supports all areas of science and study designs including observational, interventional, and mixed methods.

Overall Goals of NCORP and Scope of this NOFO The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes.

The role of NCORP Research Bases is to serve as a main research infrastructure for NCORP Community Sites and Academic Community Sites. Through affiliations with one or more NCORP Research Bases the Sites gain access to this infrastructure as well as provide valuable community perspective and input on the relevance and feasibility of the trial menu.

The roles of NCORP Community Sites and Academic Community Sites are to provide access to clinical trials close to where patients live in the community.

To address the NCORP goals, NCORP Community Sites will be expected to contribute to and focus on the following activities:

Scope of Activities for NCORP Community Sites The scope of research activities for the proposed NCORP Academic Community Sites should encompass three major areas delineated below.

Area 1: Cancer Control Research; and Area 2: Cancer Prevention Research; and Area 3: Cancer Care Delivery Research (optional).

Community Sites must be capable of participation and accrual to NCTN treatment trials.

NCORP Trans-network Interactions All NCORP participants will be expected to work jointly towards the overall NCORP goals by using the following general strategies:

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

Renewal - Renewal (but only for the awards supported under RFA-CA-18-016)

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: Only accepting 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 National Cancer Institute intends to commit $73 million in FY 2027 for up to 50 awards across the Community and Academic Community Sites.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project and should be based on a projected annual accrual plus necessary infrastructure costs to support accrual at the proposed Affiliate sites.

Award Project Period

All applicants should request a 6-year project period.

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

Institutions not eligible to apply include:

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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 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 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:

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 How to Apply - 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

SF424(R&R) Other Project Information

Facilities & Other Resources:

Provide documentation on the characteristics of the scientific environment in which the cancer clinical trials and other human subjects research will be conducted. Include such aspects as:

Other Attachments:

Applicants must provide the following additional materials specified below. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks). Suggested table templates to capture information for Attachments 1-6 are available at: https://ncorp.cancer.gov/resources/applicants.html.

Attachment 1: Accrual Cancer Control, Prevention, and Screening Trials (use filename: 1-Accrual CPS).

Provide a summary table on accrual accomplished by the applicant team to NCI-sponsored cancer control, prevention and screening trials. This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025. The summary table should include information about enrollment onto NCI-tissue acquisition studies, if applicable. Please note the number of affiliate sites that activated the trial.

Attachment 2: Accrual Cancer Treatment, QoL, and Imaging Studies (use filename: 2-Accrual CTI) Provide a summary table on accrual accomplished by the applicant team to NCI-sponsored treatment and imaging trials noting the number of QoL accrual where applicable. This information should be provided only for NCTN trials that activated on or after August 1, 2020, through July 31, 2025. Please note the number of affiliate sites that activated the trial.

Attachment 3: Accrual to other Research Base and Industry Studies (use filename: 3-Accrual Other) Provide a summary table on accrual accomplished by the applicant team to Research Base and Industry sponsored studies not sponsored by the NCI for cancer control, prevention, screening/ surveillance, treatment, and imaging trials. This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025. The summary table should include information about enrollment onto biospecimen acquisition studies, if applicable.

Attachment 4: Collective Bodies/Committees (use filename: 4-Committee Memberships).

Attachment 5. Summary of Timelines for Local Activation of NCTN and NCORP Clinical Trials at Main Site and Affiliate Sites (use filename 5-SummaryActivationTimelines).

Provide information on the timeline for the initial activation/opening of NCTN and NCORP trials at the main site and affiliated sites if those sites open studies via a different process and different timeline from the main site. This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025. This information may be provided in a table with column headings for the site name, site category (main site or affiliate), major disease category, trial phase, trial number and brief title, date the study was activated/opened for patient accrual by the Lead Group, date the trial was submitted for evaluation by at the site, date the trial opened at the site for patient enrollment, # days from evaluation to opening at the site, and an optional comments field. The data in the table should be sorted by affiliate site, Lead Group trial activation date, and trial #. Please note that the date the site began the process for evaluation of opening the trial is the date the site starts with formal resource or other review of the trial by any review committee/process at the site.

Attachment 6: Accrual to Cancer Care Delivery Research Studies (use filename: 6-Accrual CCDR). (if applicable) Provide a table summarizing accrual accomplished by the applicant team to NCI-sponsored cancer care delivery research studies, if applicable, and to cancer care delivery studies sponsored by other organizations, if applicable. This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025. Please note the number of affiliate sites that activated the trial.

SF424(R&R) Senior/Key Person Profile

R&R Budget

a) General determination of level of overall funding. The NCORP provides general total cost support for different types of accrual depending on the accrual type category and site category where patient enrollment occurred.

A minimal effort level of 1.2 person-months is required for each PD/PI regardless of whether that individual is designated as contact PD/PI or not. (This commitment cannot be reduced below that level during the projects period).

For intervention accrual at the High Performance NCORP Sites (Based on a total anticipated site accrual of over 200 participants per year) Total cost funding for "per case management" for treatment intervention trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

For NCORP Sites (Based on a total anticipated site accrual of less than 200 participants per year), reduced accrual may be appropriate in the first 2 years for new applicants.

Total cost funding for "per case management" for treatment intervention trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

The applicant should sum the estimated total cost funding for all categories (as noted above) for the “anticipated” number of patient accruals and collections that the applicant envisions on an annual basis. The applicant should then add an additional 10-30% to the annual total sum for coordination of patient screening, followup, and regulatory support across all its affiliate/ subaffiliate sites to Group trials depending on the number of sites you support with staffing and the indirect rate. This annual Grand Total Amount represents the estimated “ballpark” total cost figure for the entire grant application each year of the project period. The applicant should then create a standard grant "level-of-effort" budget using the cost categories for the standard R&R budget application.

The applicant can allocate the total cost amount across all allowable cost categories in any amount or distribution pattern that the applicant believes is appropriate. The applicant can request more (or less) than the estimated amounts with appropriate budget justification; however, the estimates amounts should be presented using the categories above.

To justify the budget, the applicant needs to describe using an "Accrual Input Table or Narrative" in the budget narrative detailing the number of patients expected to be accrued in the various accrual categories listed above: (1) intervention category for trials by various IND status; (2) intervention category for primary imaging trials; (3) "screen only" category for treatment and/or imaging trials; (4) 1 biospecimen collection “package” for each enrollment on a treatment or primary imaging trial; (5) Cohort and Central intervention NCORP trials. Justification should also include the number of patients in active follow-up and in long-term follow-up.

b) Travel Expenses: Applicants must budget travel funds for two persons to attend up to 4 NCORP Research Base Meeting in-person meetings and at least 3 persons (two PDs/PIs or one PD/PI and an additional senior investigator as well as the Program Administrator) to attend the NCORP Annual Meeting over the grant's entire project period in addition to other travel expenses.

c) Routine Patient Care: NCI does not support costs associated with routine patient care as a budget expense under this NOFO.

d) Restricted Cancer Care Delivery Budget (if applicable) To justify the budget, the applicant needs to describe CCDR studies that are actively recruiting at your Site and the CCDR studies you plan to open each year with planned changes in the number of participating affiliates/ sub-affiliates, and any CCDR specific activities underway including number of patients in follow-up. The applicant should then create a standard grant "level-of-effort" budget using the cost categories for the standard R&R budget application restricted for CCDR activities.

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 Aim: Outline the overall goal and research strategy for the proposed Community Site in terms of accruing patients, clinicians, organizations to cancer control, prevention, screening/ surveillance, cancer treatment and care delivery (if applicable) clinical trials and to other human subjects' studies developed and conducted by NCORP Research Bases and the NCTN.

Research Strategy: Organize the Research Strategy section with sub-sections in the specified order and follow the instructions provided below. Start each sub-section with the appropriate sub-section heading.

Sub-section A. Community Site Overview Overview. The application should provide an overview that addresses the following:

Note that additional documentation for Sub-section A is requested under "Other Attachments" and under "Facilities & Other Resources".

Sub-Section B. Operations/Data Management Unit - Address all the areas identified below:

General Operations

Data Management & Quality Assurance. Procedures for data management and investigational drug monitoring must be described in the application. For cancer control, prevention and care delivery research, address the following items:

Audit Performance.

Describe the ability of the NCORP Community Site to conduct cancer clinical trials and other human subjects research with good clinical practice stewardship as demonstrated by audit results from NCI-sponsored studies as well as studies sponsored by other organizations.

Sub-Section C. Community Site Accrual Program In this subsection, explain how the proposed NCORP cancer clinical research program will include the required research activities (cancer control, prevention and care delivery clinical trials and other human subjects research as well as cancer treatment and imaging trials).

Provide a description of the following:

As applicable, explain how the proposed Community Site can contribute to other NCI programs focused on precision medicine, e.g., by tissue acquisition.

NOTE: Regarding Accrual Goals referenced under Section I, note the following: