Part 1. Overview Information

Key Dates

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

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.

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:

• RFA-CA-27-006: NCORP Research Bases (UG1 Clinical Trials Required);
• RFA-CA-27-007: NCORP Community Sites (UG1 Clinical Trials Not Allowed); and
• RFA-CA-27-008 (This NOFO): NCORP Academic Community Sites (UG1 Clinical Trials Not Allowed)

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:

• Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded in treatment and imaging studies.
• Assume responsibility for study operations and data management, including efficient protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; auditing; training; quality assurance; and support to Community Sites and Academic Community Sites.
• Be based at institutions with comprehensive cancer clinical research expertise (e.g., cancer foundation, NCI-designated Cancer Center, or healthcare research organization – including NCI's National Clinical Trials Network Group Operations Centers).

NCORP Community Sites are consortia of community hospitals and/or oncology practices, which may or may not be formally affiliated with a healthcare system, that accrues participants to cancer control, prevention, treatment, and care delivery clinical trials and other human subjects research.

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, an "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 on 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 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 Academic Community Sites will be expected to contribute to and focus on the following activities: 

• Participate as part of an integrated national network of community organizations to increase the involvement of community oncologists and other medical specialists, and their patients, in multi-institutional cancer control, prevention, and care delivery research, as well as quality-of-life studies embedded within treatment and imaging studies conducted under the NCORP and NCTN.
• Interact with the NCORP Research Bases by: 1) providing insight into clinical significance during concept development; 2) identifying care challenges in their local populations that could be studied; 3) providing input on feasibility during protocol development; and 4) serving as community champions for trials.
• Meeting or exceeding the required annual 70 new unique patient/participant accruals evenly distributed between cancer control, prevention, and screening/post-treatment surveillance trials, and treatment and imaging trials, respectively. Pediatric NCORP Sites must meet or exceed 50 new unique patient/participant accruals evenly distributed between cancer control and treatment trials. If accrual exceeds 200 unique patient accruals per year, the site will be considered high performance and must continue to meet this performance metric to continue reimbursement at the higher rate. Assessment of high performance status will occur every 2 years.
• For those who propose cancer care delivery participation, sites must meet or exceed a required annual minimum of enrolling individual participants or organizations to cancer care delivery protocols. These minima are defined as follows:
  • Adult and combined adult/pediatric NCORP Sites will be required to have three care delivery protocols actively enrolling per year.
  • Pediatric NCORP Sites will be required to have one care delivery protocol actively enrolling per year.
• Meeting or exceeding a required minimum of one Primary Affiliate participating in each capacity assessment as offered. Sites with adult and pediatric affiliates are required to have a minimum of one adult and one pediatric affiliate participating. 
• Participating in bio-specimen collection for biobanks that serve as a scientific resource for NCORP Research Bases.
• Participating in NCORP initiatives to document screening efforts including participation in DCP-001 for clinical trial enrollment. Pediatric sites are expected to participate in screening efforts through the Children's Oncology Group.
• Engaging with their community on the importance and impact of clinical trials.

Scope of Activities for NCORP Academic 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).

• Cancer control research is aimed at reducing the morbidities associated with cancer and its treatment, as well as improving the quality of life of individuals undergoing cancer treatment or with a history of cancer.
• Cancer prevention research is aimed at reducing cancer risk, incidence and mortality.
• Cancer care delivery research seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery.

Academic 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:

• Development and maintenance of a governance and organizational structure to coordinate NCORP activities at the Academic Community Site. The organizational structure of the Academic Community Site should be established with clear and appropriate staff roles and reporting responsibilities.
• Development of a plan and process for prioritizing the NCORP and NCTN trials to be activated at their institutions and assessing if the study can be successful at the Affiliate community sites.
• Development of procedures for high-quality, timely protocol data submission that are clearly communicated to all investigators at the Academic Community Site.
• Support other research activities as a research base member site contributing to industry support or foundation supported studies.

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

Section II. Award Information

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

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• 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

Additional eligibility provisions:

• Eligible institution/organization for the purposes of this application is defined as an academic hospital and/or academic clinic program providing direct medical care to patients that is considered one integral organizational entity under a single financial management system and governance structure. Academic centers for this application are distinguished from large medical centers whose primary mission is patient care. In addition to patient care, academic centers have comprehensive medical training programs and have preclinical laboratories that perform basic research.

Institutions not eligible to apply include:

• An institution that is an awardee or an affiliate of a NCTN Lead Academic Participating Site funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI.
• Department of Veterans Affairs hospitals or military treatment facilities are not eligible to apply. Such institutions may be included in an application as a member(s) of a consortium led by an eligible applicant institution, provided that they are not meant to be the major contributor to patient accrual.

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. 

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.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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.

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.

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:

• 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 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.

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

All instructions in the How to Apply - Application Guide must be followed.

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:

• For the most prevalent populations served in the catchment area, list the populations or cancers that are considered to be high risk or to have significant risk factors within them. 
• Ability to accrue under insured or uninsured patient to clinical trials.
• The salient features of the facilities and other resources available (committed) for use by the proposed Academic Community Site. Appropriate space must be available for administrative activities and personnel to serve as primary locus for data management, quality control, patient recruitment and evaluation, and communication. Include what services will be provided to the affiliate sites to support their accrual efforts.
• Organizational chart and a list of the primary affiliate(s) and sub-affiliate(s) (as applicable) that will be accruing participants to NCORP and NCTN clinical trials and other human subjects' studies. Definitions of primary affiliate and sub-affiliate can be found under the key definitions section of this NOFO. A table can be used to list this information for the entity category (primary affiliate or sub-affiliate), name of entity, site identifier (e.g. Cancer Therapy Evaluation Program (CTEP) ID), City and state where the entity is located.
• A diagram (and/or map) showing the distances between the above entities (including administrative office and shared resources) and location of proposed personnel.    
• A table documenting the radiation oncology treatment facilities within the applicant’s practice detailing by individual Community primary- and sub-affiliate Sites those with radiation therapy treatment machines on site.
• Characteristics of the catchment area from which the primary affiliate(s) and sub-affiliate(s) patients are drawn, including geographic boundaries, referral patterns, and cancer care delivery resources that are not included in the application (i.e., cancer centers, hospitals, clinics, and physicians). Also include estimates of the population demographics in the area, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).
• A table documenting an estimate of the incident cancer cases receiving care at the primary affiliate(s) and sub-affiliate(s) in the past 12-month period for which data are available, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).
• A list of the applicant’s current collaboration(s) and engagement(s) with professional organizations and research organizations to further define relevant cancer care delivery protocols for community settings.

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: 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: 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: 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: Committee Memberships).

• Renewal Applications: Provide a table summarizing the participation of members of the applicant team (over the past 5 years) on research base or NCI clinical trials committees as well as other oversight boards or steering committees related to clinical trials.  A table can be used to show the Category (e.g. type of committee, Steering Committee), member status (e.g. chair, vice chair, member),and length of service in the role.
• New Applications: Without repeating information in biosketches, list local, state or national roles held by senior/key personnel staff that demonstrate leadership or activities that highlight involvement in the cooperative groups and support of cancer clinical trials. 

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

Provide information on the timeline for the initial activation/opening of NCTN and NCORP trials at the affiliate sites. 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 academic site or integral component), 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: 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

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

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 trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

• IND-Exempt Intervention Trial: $5,000
• Non-CTEP IND Intervention Trial: $5,200
• CTEP IND Intervention Treatment Trial: $6,000
• Primary Imaging Base Intervention Trial: $1,300
• Screening Only on Treatment/Primary Imaging Trials: $650 (patient does not go onto intervention of trial)
• One Biospecimen Collection “Package” per Patient: $500 (for Intervention Treatment/Primary Imaging Trial enrollments only)
• Cohort study or Centralized NCORP Intervention Trial(range depending on workload): $1,200-$2,500
• Special entry credit: $50-$250

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

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

• IND-Exempt Intervention Trial: $3,000
• Non-CTEP IND Intervention Trial: $3,300
• CTEP IND Intervention Treatment Trial: $4,200
• Primary Imaging Base Intervention Trial: $1,300
• Screening Only on Treatment/Primary Imaging Trials: $650 (patient does not go onto intervention of trial)
• One Biospecimen Collection “Package” per Patient: $500 (for Intervention Treatment/Primary Imaging Trial enrollments only)
• Cohort study or Centralized NCORP Intervention Trial(range depending on workload): $1,200-$2,500
• Special entry credit: $50-$250

The applicant should sum the estimated total cost of 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 component 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 treatment 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

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

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 Academic Community Site in terms of accruing patients, clinicians, organizations to cancer control, prevention, screening/ surveillance, cancer treatment and care delivery 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. Academic Community Site Overview

Overview. The application should provide an overview that addresses the following:

• Outline the overall organization of the proposed Academic Community Site and the major collective strengths of the team.
• Describe the governance and organizational capabilities and commitment relevant to the award as well as the general expertise of the senior leadership team.
• Designate either the PD/PI (or one of the multiple PD(s)/PI(s)) or another senior researcher to have leadership responsibility for each of the following areas:
  • Cancer treatment and Symptom management research program,
  • Cancer prevention and screening/ surveillance research program,
  • Cancer Care Delivery Research program (if applicable),
  • Pediatric Research Program (if applicable).
• Define the organizational structure in terms of "Primary Affiliate(s)" or "Sub-Affiliate(s)," depending on their relationship to the proposed Academic Community Site institution. If the NCORP Academic Community Site applicants propose more than one Primary Affiliate or Sub-Affiliate, each must be listed in the application.
• Address how the leadership plans to encourage and facilitate enrollment of a representative patient population in clinical trials and other human subjects research through engagement of community sites.
• Explain any other leadership-related and/or administrative/coordination aspects, as applicable. Including, for example, the orientation and mentoring of new individuals to serve in leadership positions within the NCORP Academic Community Site.
• Provide the highlights of the group's accomplishments relative to implementing cancer control, prevention, care delivery and treatment clinical trials and other human subjects research in the group’s practice setting(s) during the past 5 years.
• Describe how participation as a NCORP Academic Community Site supports accrual to other non-NCI sponsored trials.

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

• The processes the applicant and Primary Affiliate(s) and Sub-Affiliate(s) have in place for ensuring compliance with regulations for research involving human subjects, including processes for IRB approval, informed consent, and other aspects relevant to protection of human subjects.
• Current (or planned) use of and participation in the NCI's Central IRB which is required of all applicants.
• Outlines of the standard operating procedures for activating clinical trials and other human subjects research; recruiting, enrolling, and monitoring participants; data collection and management; adverse event reporting; and investigational drug monitoring.
• Describe the operational efficiency of trial activation and conduct (including the timeliness of data submission and auditing results as well as how quickly the Site activates NCORP and NCTN trials).
• Processes for communicating with Primary Affiliates and Sub-Affiliates.
• Steps to ensure that investigators and other staff maintain sufficient proficiency level with regard to the conduct of clinical cancer research. These actions may include mandatory periodic training (such as Good Clinical Practice training).

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:

• Data collection and management processes including: collection from specific sources (e.g., hospital, office, clinic, registry), completion of study forms, collection of patient materials (e.g., pathology slides, port films, etc.) and providing to Research Base.
• The procedures for collecting patient demographic and lifestyle data during screening for research participation.
• The process for monitoring data quality, such as completeness of surveys including Quality of Life questionnaires and accuracy of records.
• Transmission of data to the Research Bases (e.g., batch mode or in real time) and whether mechanisms are in place for electronic data transfer.
• Distribution of data management responsibilities within and between primary and sub-affiliates and the central applicant office, if applicable.
• How NCI and FDA requirements for investigational drug management are handled. The internal quality assurance plan of the applicant must be described in detail for both clinical trials and cancer care delivery research. Assurance of quality is the joint responsibility of the NCORP Academic Community Site and its affiliated Research Bases. The applicant should describe its policies and procedures for complying with federal regulations related to confidentiality of patient data, including the Health Insurance Portability and Accountability Act (HIPAA) regulations.

Audit Performance.

• Describe the ability of the NCORP Academic 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. Academic 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:

• Describe the types of NCORP and NCTN protocols currently active across the Academic Community Site and include a description of the criteria to be used and the process by which applicants will select studies that will be appropriate for the main Academic Site and the community Affiliates and meet accrual minimums.
• The role of the Academic Site in supporting enrollment in the collaborating community sites and engaging community physicians in clinical research.
• The plans for implementing and conducting the selected studies, including approaches for engaging patients from populations typically not represented in research, as well as practices and organizations from hospitals, clinics, and other healthcare settings.
• The applicant’s anticipated strategies for recruitment and retention of patient/participants, including, as applicable, the role of patient advocates.
• If applicable, note any innovations related to screening, accrual, and recruitment strategies.
• Challenges surrounding recruitment and retention of patients as well as clinicians and other staff and any approaches to address these challenges
• If the site proposes to participate in CCDR activities, include the plans to  meet the requirements defined in Section I:
  • Adult and combined adult/pediatric NCORP Sites will be required to have three care delivery protocols accruing per year.
  • Pediatric NCORP Sites will be required to have one care delivery protocols accruing per year.
• As applicable, explain how the proposed Academic 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:

• All applicants should attempt to meet or exceed the required annual 70 new unique patient/participant accruals evenly distributed between cancer control, prevention, and screening/post-treatment surveillance trials, and treatment and imaging trials, respectively; and
• Meet or exceed a required annual minimum of enrolling individual participants or organizations to cancer care delivery protocols, if applicable.
• Ability to meet these requirements from the onset of awards may be viewed favorably in selection of applications for awards.
• However, the NCI realizes that some of the proposed Academic Community Sites may need a more relaxed timing. Applicants in such situations should explain why they need more time and provide specific plan for reaching the required recruitment levels later during the project period. At the time of awards, applications with such plans will be assessed on case by case basis, also in the context of other programmatic priorities (listed in Section V.2. Review and Selection Process).
• The current capacity for cancer care delivery research, particularly the recruitment of clinicians and collection of organization-level data, and plans to expand this research to additional Primary Affiliates and Sub-affiliates.
• The planned Research Base affiliations during the next project period:
• Provide a rationale for choosing these Research Base affiliations and explain how the proposed Academic Community Site may contribute to the scientific agenda of its affiliated Research Bases. Examples of contributions might include: participation/membership in Research Base scientific committees or community liaison committees or serving as study Chair(s)/Co-investigator.

Letters of Support

Include letters of institutional commitment and letters of Intent to Establish a Consortium, if applicable from all institutions that will be participating in the proposed Academic Community Site. The letters should indicate specific commitments, engaged clinical staff, and capabilities (e.g., in terms of potential for recruiting study participants).

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan

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.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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. 

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

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.

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).

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.

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.

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.

2. Review and Selection Process

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

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

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

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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 program priorities.
• Geographic distribution of sites.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

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 (HHS) grant administration regulations at 2 CFR Part 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 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 resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Oversight and accrual at the Academic NCORP Site on NCTN and NCORP clinical trials including use of the NCI Central Institutional Review Board (NCI CIRB) as the IRB of Record on all trials.
• Compliance with NCORP Program Guidelines/Handbook active at time of award and any subsequent updated versions of the Guidelines/Handbook.
• Recipients will comply with the Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI at (https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm), the NCI Guidelines for Auditing Clinical Trials for the National Clinical Trials Network (NCTN) Program including NCI Community Oncology Research Program (NCORP) and Research Bases at (https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm), and the NCI/DCTD CRADA agreements, and the Intellectual Property Option to Collaborators at (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies and within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and as governed by NCI-approved Data Management and Sharing Plans and NCI-approved review for use of biospecimens collected in association with NCTN trials. 
• Attendance at Annual NCORP meeting and active participation in Research Base committees and meetings.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Working with Academic NCORP Site to collaboratively manage major issues associated with their participating in the conduct of trials across the Network, including major initiatives for the Network such as streaming clinical trial conduct and broadening eligibility for patient enrollment to trials.
• Informing the PD(s)/PI(s) of the Academic NCORP Site of scientific opportunities resulting from NCI-supported clinical research programs and facilitating collaborations between the Network Groups and other NCI-sponsored programs.
• Facilitating the Academic NCORP Site scientific involvement in oncology treatment research, including advanced imaging research and radiation oncology research, as well as cancer prevention and control research and cancer care delivery research (if applicable), associated with NCTN and NCORP trials.
• Involvement in auditing of Academic NCORP Sites institutions via their membership in the Network Groups with oversight of compliance with applicable DHHS, FDA, OHRP, NIH, and NCI regulations for clinical research involving human research subjects.
• Review of accrual and overall performance of NCORP and NCTN trials.
• Advising recipients concerning mechanisms established for quality control of therapeutic and diagnostic modalities used in NCORP and NCTN clinical trials.
• The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. The NCI may also review all records related to recipients' performance under the award.
• Additionally, an agency program official (other than the NCI Project Scientist) 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:

• None; all responsibilities are divided between recipients and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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. 

4. 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

NCORP Director
National Cancer Institute (NCI)
Telephone: 240-276-7048
Email: NCORP@mail.nih.gov

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.