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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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.
   
   



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

The National Cancer Institute (NCI) invites applications for U54 Specialized Programs of Research Excellence in Cancer Health Disparities and Minority Health (CHD-MH SPOREs). The program will fund a network of multidisciplinary, multi-institutional U54 CHD-MH SPOREs uniquely focused on health disparities and/or minority health translational research for improved prevention, early detection, diagnosis, and treatment of cancer in populations who are underserved (and/or underrepresented). U54 CHD-MH SPOREs can investigate more than one cancer type in underserved populations, including groups of highly related cancers (e.g., gastrointestinal, neuroendocrine, and head and neck). The research supported through this program must be translational and must stem from knowledge of human biology, addressing the interplay of various determinants of health with the biology of the disease. U54 CHD-MH SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant.

Key Definitions for the Context of this NOFO

1. Translational Research: Using knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determining the biological basis for observations made in individuals with cancer or in populations at risk for cancer. The term "interventions" is used in its broadest sense to include molecular assays, imaging techniques, drugs, biological agents, and/or other methodologies applicable to the prevention, early detection, diagnosis, prognosis, and/or treatment of cancer. SPORE translational research projects may involve the use of any cellular, molecular, structural, biochemical, and/or genetic experimental approaches. By this definition, SPORE projects are permitted to move not only in the forward direction, toward clinical trials and human studies in areas of prevention, early detection, treatment, development of biomarkers, and population science, but also in the reverse direction. Reverse translation involves using human biospecimens (often from clinical trials) or imaging data to discover new cancer biomarkers, study new phenomena, optimize previous findings, or develop new hypotheses based on results from human studies.

2. Cancer Health Disparities (CHD): Health differences that adversely affect specific populations, based on one or more of the following health outcomes: higher incidence, prevalence, or earlier onset of cancer; higher prevalence of risk factors, unhealthy behaviors, or clinical measures in the causal pathway of a cancer outcome; higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized measures; premature and/or excessive mortality from cancer where population rates differ; or greater global burden of cancer using standardized metrics.

3. Populations who are Underserved (and/or Underrepresented): NIH-designated populations with health disparities, including Black/African American, Hispanic/Latino, Indigenous and Native American persons; Asian Americans, Native Hawaiians, and Pacific Islanders; less privileged socioeconomic status populations; persons who live in rural areas; persons with disabilities; and sexual and gender minority populations including, but not limited to, persons who identify as lesbian, gay, bisexual, asexual, transgender, Two-Spirit, queer, and/or intersex.

4. Minority Health: The investigation of distinctive health characteristics and attributes of underserved populations in biomedical research to understand health outcomes in these populations.

5. Scientific Collaborations:

Horizontal Collaboration: Collaboration with others outside the SPORE grant to complete the research aims and/or goals of a SPORE project. These collaborations may be done in the laboratory, at the clinical trial stage, or as a part of a population science study. Examples of these collaborations include projects with other SPOREs, with investigators funded by other non-SPORE mechanisms, or the use of industry-provided agents. Interactions between Projects and Cores within a SPORE grant do not meet the definition of Horizontal Collaboration.

Vertical Collaboration: Collaboration with an entity outside the SPORE grant that extends SPORE translational research along the translational continuum beyond the specific aims of the projects (e.g., from discovery to pre-clinical development, to Phase I trials or studies, to later phase studies, and possibly to a final hand-off to a commercial company).

6. SPORE Key Personnel:

The following are considered named key personnel: SPORE PD/PI(s), Project co-leaders, Core directors, CEP director(s), DRP director(s), and SPORE administrator(s).

Background

Development of the U54 CHD-MH SPORE Program

SPOREs are multi-project, multidisciplinary translational research programs focused on prevention, early detection, diagnosis, and treatment of human cancers. P50 SPOREs have traditionally focused on organ-specific or highly related groups of cancers with the goal of understanding the mechanistic aspects of the biology of human cancer. However, CHD-MH translational research requires unique multifaceted approaches to address the interplay of various determinants of health with the biology of human cancer. Moreover, CHD-MH research relies on extensive community outreach, engagement, and collaboration that may be more efficiently supported within a collaborative network under a cooperative agreement mechanism. Therefore, the U54 CHD-MH SPORE Program was developed to better address the unique needs of CHD-MH translational research and incorporate critical elements needed for effective research in populations who are underserved, including community outreach and engagement; community advisory boards and advocates; resource sharing; development of novel methodologies; and human endpoints centered around pilot/feasibility studies, retrospective analysis of tissue samples/existing clinical datasets, and community-based oncology.

General Description of U54 CHD-MH SPOREs

1. Translational Research Focus

All SPORE projects must be focused on translational research that meets the definition provided above (see key definitions section). SPOREs are dedicated to capitalizing on research opportunities that have the potential to change the current paradigm in the prevention, detection, diagnosis, and/or treatment of human cancer. SPORE projects may include basic science objectives if those objectives are relevant to human cancer and will lead to a human endpoint within the 5-year project period of the grant.

2. Flexibility to Change Research Direction/Team Approach

The flexibility of the SPORE program was established for the PD(s)/PI(s) to terminate research projects that accomplished translational goals earlier than anticipated or that demonstrate little or no translational progress, and to replace them with new projects that have translational potential. As a result of this flexibility, the team of scientists that participate in SPORE projects may or may not remain the same, and the roles of co-leaders on projects may change throughout the course of the funding period. The flexibility option may not be used to add full scientific projects over and above the number of projects that were peer-reviewed, even if no new funds are requested.

The PD(s)/PI(s) of the SPORE are expected to make decisions about the continuation or discontinuation of projects in consultation with internal and external advisors, as well as with other lead investigators on the SPORE. The flexibility option is available only after the first year of the funding period for SPOREs with three or more scientific research projects; a new project cannot be proposed for one that has overlap with an awarded or soon-to-be awarded U.S. Public Health Service (PHS) grant.

3. Specialized Research Infrastructure

SPOREs are expected to establish the critical research infrastructure needed to sustain the translational research projects, collaborations, and community outreach and engagement proposed within the U54 SPORE network. SPOREs must be able to facilitate the complex research objectives inherent in studying human cancer. It is essential that robust mechanisms be in place for making shared resource data generated by the SPORE readily accessible to research and clinical investigators in the broader scientific community. Moreover, the U54 SPORE infrastructure must be able to support intra- and inter-U54 CHD-MH SPORE activities, including patient accrual, engagement with community advocates and partners, participation in NCI-sponsored SPORE investigator meetings, and sharing of resources, methodology, and best practices.

SPOREs should support the establishment of translational research cores that fill broad institutional infrastructure gaps. SPOREs also should utilize and augment existing cores within Cancer Centers and other institutional facilities wherever feasible. SPORE cores should not duplicate existing institutional cores or other resources.

4. Fostering Translational Research Careers

SPOREs provide a unique environment for translational research that can be used to prepare new scientists for careers in this evolving field or provide the opportunity for established scientists to re-orient their research careers toward translational research.

5. Research Collaborations, Networks, and Consortia

SPOREs are expected to identify the kinds of research questions that can only be accomplished through collaborations, networks, and consortia and take full advantage of SPORE's scientific expertise and infrastructure, particularly through the activities of the required Community Outreach and Engagement Core (COE).

6. Participation in NCI-Sponsored SPORE-related Meetings, Workshops, and other Activities

SPORE Directors and other SPORE investigators should participate in NCI-sponsored meetings, workshops, and working groups to share expertise and research results with other translational research grantees. The goals of these meetings may include identifying consensus data standards, sharing materials and data, assessing progress, and identifying new collaborative opportunities.

Research Objectives

Overarching Goals

This NOFO supports a collaborative network of SPOREs, under the U54 cooperative agreement mechanism, that is uniquely focused on CHD-MH translational research in populations who are underserved. Applicants are encouraged to focus on cancer types for which health disparities are particularly well documented, including cancers of the breast, prostate, lung, gastrointestinal systems, cervix, endometrium, head and neck, liver, lung, and kidney, as well as leukemia and myeloma. Although studies involving these cancers are strongly encouraged, other cancer types can be included if a disparity or disparities population is appropriately justified. Unlike minority health projects, proposed CHD projects will include a reference or comparator group to assess disparities in cancer outcomes. However, the identified reference group would be based on the scientific rationale or question proposed and is not by definition required to be non-Hispanic White.

While the goals of the proposed research may vary widely, examples are listed below:

• Discovery, validation, and assessment of how various determinants of health intersect with the biology of cancer to affect cancer incidence, diagnosis, treatment, early detection, and prevention in populations who are underserved.
• Characterization of the biological impact of social determinants of health and identifying specific biological pathways that might be targeted by clinical or public health interventions.
• Hypothesis generating studies characterizing risk factor prevalence or biological differences in populations who are underserved.
• Investigating the role of determinants of health and comorbidities on toxicity of therapeutic interventions in populations who are underserved.

Human Endpoints

Every SPORE project must be translational and include both a laboratory component and a human endpoint reached during the project period of the grant. Therefore, proposed projects must combine experimental/laboratory approaches with studies involving human specimens or other types of human-focused applied research (e.g., epidemiology, population studies, or clinical trials). Laboratory/experimental research may involve any relevant cellular, molecular, structural, biochemical, and/or genetic approaches in vitro and/or in vivo.

In each SPORE project, at least one of the following types of human endpoints should be proposed:

• Early phase clinical trials, including pilot/feasibility studies, of new investigational drugs, biologics, experimental procedures, medical devices, or combinations
• Early phase clinical trials, including pilot/feasibility studies, of new combinations or new uses of Food and Drug Administration (FDA)-approved agents and devices
• Discovery and development of biomarkers, only when measurements are made in human specimens, or directly in human subjects
• Laboratory studies that begin with an observation in the clinic, for example development of therapeutic resistance, and use human specimens to generate new clinical hypotheses
• Population, behavioral, or psychosocial studies, including pilot/feasibility studies, addressing mechanistic aspects of the biology of the disease
• Investigational New Drug (IND)-directed toxicology studies conducted following a pre-IND meeting with the FDA in which the plan proposed by the investigators is acceptable to the FDA

Note: Although IND-directed toxicology studies do not involve human beings, these studies are the last steps before interventional clinical trials begin and are therefore considered programmatically appropriate as a human endpoint for SPORE translational projects. Additionally, experiments using cell lines, xenografts, patient-derived xenografts (PDX), organoids, paired germline samples, or engineered tissues may be important to the translational studies proposed and are recommended, but they are not sufficient to meet the human endpoint requirement.

Major Components of SPORE Applications

1. Research Projects

Research projects may be conducted solely through the parent institution, or through collaborative associations that have been developed and/or are planned with other SPOREs and/or with other investigators in the biomedical research community. All SPOREs should meet the following criteria:

1. A minimum of three projects, each with a human endpoint, must be proposed.  A clinical trial may be proposed as a human endpoint but is not required. Each project must have at least one basic and one applied/clinical co-leader (e.g., clinical researcher, epidemiologist, social scientist).
2. Each proposed project must meet the definition of translational research as described in the key definitions section. Investigators who are not certain about whether their project fits this definition are advised to consult with the Scientific/Research staff listed in Section VII. Agency Contacts.
3. Each proposed research project should be designed to test the relevance and/or potential importance of the research to human cancer within the project period of the grant. Projects containing basic research (e.g., employing animal models or cell lines) qualify as translational only if a human endpoint is included in the specific aims.
4. SPOREs that include a clinical study should describe a program-wide consent process that will inform patients about the 1) risks and rewards of participating in the clinical study of the SPORE program and 2) the possibility that some data may be made available to private sector collaborators that would enable the use of individual patient information in research that is not envisioned at the time of consent.

SPORE applications are encouraged to include the following:

• Patient, research and/or community advocates with a collective patient perspective.
• Research involving biospecimens and patients in rural and community hospitals/facilities.
• Project and Core leadership with expertise in applied research areas, such as social science and epidemiology.
• Individuals from underserved racial and ethnic groups, women, and individuals with disabilities as research subjects.
• Research projects that bring together investigators from multiple institutions to facilitate the development of large-scale team-based projects.
• Balanced and diverse translational research objectives (e.g., early detection, prevention, diagnosis, and treatment).

2. Administrative Core

An Administrative Core is required. This Core describes the SPORE's organization and capabilities, including organizational, administrative, scientific, and clinical trial management within the SPORE. Moreover, the Core explains how coordination, communication, and diverse perspectives will be achieved among the different projects and programs, Shared Resources Cores, and participating institutions at the overall program level. Additionally, this Core includes activities of the required External Advisory Board (EAB) and Community Advisory Board (CAB). An Internal Advisory Board (IAB) is optional.

3. Shared Resources Cores

SPORE applications are required to include a Biospecimen/Pathology Shared Resources Core and a Community Outreach and Engagement (COE) Shared Resources Core. SPOREs also have the option to include other Shared Resources Cores that provide laboratory and/or clinical facilities, equipment, and/or services to be shared by one or more research projects and developmental programs. A Biostatistical Core is strongly advised. Shared Resources Cores may include non–hypothesis-driven research activities (e.g., technology development) provided that the research is designed to improve Core services.

The Shared Resources Cores within the SPORE should not duplicate any shared resource facilities that are already in place or supported by the Cancer Center's CCSG (P30), but the proposed Cores may build upon these facilities for unique capabilities required by the SPORE.

4. Developmental Research Program (DRP)

Each SPORE must allocate a significant effort to support pilot projects that take maximum advantage of new research opportunities in CHD-MH research that are the focus of the SPORE. The pilot projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE community. High-risk/high-payoff pilot projects are especially encouraged. These pilot projects are not required to reach a human endpoint during the project period as do full projects.

As a required component of a SPORE, a DRP must be maintained throughout the entire term of the grant. The DRP should be structured in a way that the awards run in parallel with the current budget period. With the approval of the SPORE’s External Advisory Board and the assigned NCI Program Official, DRP studies may become full SPORE projects as part of the flexibility option if the DRP study has translational research potential within the SPORE and incorporates a human endpoint within one of the project’s aims.

5. Career Enhancement Program (CEP)

The SPORE must demonstrate a consistent and substantial commitment to a Career Enhancement Program (CEP) in translational research. As a required element of the SPORE, the CEP must be maintained throughout the entire term of the funding period. The CEP should be structured in a way that the awards run in parallel with the current budget period. Funds from this program may be used to support early-career or established faculty/investigators who wish to enhance or refocus their careers on translational cancer research. CEP recipients are expected to interact with SPORE-associated translational research advisors to guide the project and monitor progress. This program is not a training program and does not support pre- or post-doctoral fellows, irrespective of whether they are working in the pre-clinical or clinical domain. However, advanced post-doctoral or clinical fellows who provide a letter from an institution stating that the candidate will be joining its faculty within one year are eligible for this program. Investigators supported by NCI career development awards (K series) may also be eligible for support through this program. Similar to DRP projects, CEP projects may become full projects as part of the flexibility option with the approval of the SPORE’s External Advisory Board and the assigned NCI Program Director.

6. Scientific Collaboration

Each SPORE must demonstrate a commitment to both horizontal and vertical collaboration (see key definitions section) in completing preclinical projects and moving promising results along the pathway of translational/clinical development. Through the promotion of inter-SPORE research, SPOREs also conceive and initiate research that is further linked to other key programs of the NCI, NIH, and other government and non-government programs. Acceleration of therapeutic agent development or biomarker development is encouraged.  However, not every project within a SPORE must involve collaboration.

Non-Responsive Applications

The following types of activities are examples that remain outside the scope of this NOFO and are non-responsive (non-responsive applications will not be reviewed):

• Applications lacking a cancer health disparity or minority health focus.
• Applications that do not have access to underserved populations/biospecimens that are the focus of the application.
• Applications that do not propose translational research and do not include appropriate human endpoints (as defined above).
• Projects lacking a laboratory component to investigate or understand the biology of human cancer.
• Applications that do not meet the Minimum Research Base requirement (as defined in Section III. Eligibility Information).

Pre-application Communications with NCI Staff

Prospective applicants are encouraged to consult with the NCI scientific staff member(s) listed in Scientific/Research Contact(s) (See Section VIII. Other Information for award authorities and regulations). Consultations are intended to help the PD(s)/PI(s) (along with one or more of their intended co-investigators) understand the SPORE program, understand the SPORE translational objectives, and discuss strategies for preparing a competitive application. SPORE requirements, current NCI budget allocations, and the peer-review process will also be clarified. Additionally, consultations can also address questions about the NCI-supported clinical trials and other collaborative resources that might be available beyond the funded activities of the SPORE as part of planned vertical collaborations.

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. 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 registration; 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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.

Investigators may serve as a PI/multi-PI on only one funded U54 or P50 SPORE at a time. However, investigators may have other roles (i.e., co-leader, Core director) on multiple U54 or P50 SPOREs concurrently, even from more than one institution.

Minimum Research Base:  For a SPORE application to be programmatically considered for award by NCI, the application must include four or more independent investigators who currently serve as PDs/PIs (or project leaders) on peer-reviewed research grants (e.g., R01, R21, P01, U01, U10, U19, American Cancer Society [ACS], U.S. Department of Defense [DOD], or equivalent) or are overall chairpersons or site chairpersons on an active NCI-sponsored clinical trial. These activities must be directly related to the cancer(s) being investigated in the SPORE or the specific expertise required for the SPORE, including CHD-MH. PDs/PIs supported by the NCI’s non-mentored “K” career development grants or the R00 portion of the K99/R00 award can also be included in the research base requirement if the career award is directly relevant to the cancer(s) being investigated or the specific expertise required for the SPORE project. Please note that an investigator who is a PD/PI on multiple qualified grants or clinical trials counts only once towards the research base, and to qualify, the investigator must be the PD/PI on the highlighted activity. The qualifying investigators also must serve on the SPORE as a PD/PI, a multi-PD/PI, project co-leader or Shared Resources Core director.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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).

Note: It is acceptable for investigators to concurrently submit the same or overlapping research project as a SPORE project and an independent R01, R21, etc., application to the NIH. However, PD(s)/PI(s) must be prepared to relinquish the R01 (or other single projects) award if both are determined to be eligible for funding. Investigators may not concurrently submit a P01, P50, and/or U54 application requesting support for the same projects/activities. The potential overlap will be evaluated by NCI staff prior to award; submitted applications will not be reviewed if they do not conform to NIH policies or if they fail to meet the minimum requirements of the SPORE Program.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Leah Hubbard, Ph.D.
Translational Research Program (TRP)
Division of Cancer Treatment and Diagnosis (DCTD)
National Cancer Institute (NCI)
Telephone: 240-276-5693
Email: leah.hubbard@nih.gov 

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide overall goals/abstract/summary for the entire SPORE application.

Project Narrative: In the "Project Narrative", the relevance of the SPORE's research to public health should be stated.

Facilities and Other Resources: Provide a description of all resources available for the entire SPORE.

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included with the Overall component to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Overall component may be attached and cross-referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative. New information is not allowed in Other Attachments.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

If an applicant's institution is associated with an NCI-designated Cancer Center, the SPORE PD/PI should hold a senior position in the Cancer Center. Alternatively, if this position is not currently held, an appointment for such a position should begin once NCI SPORE funding is secured. The PD/PI's prominent role in the Cancer Center is expected to facilitate interactions between the SPORE and Cancer Center leadership. The PD(s)/PI(s) of the SPORE may be the Cancer Center Director.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Each PD/PI must serve a combined effort of at least 2.4 person months (PM) unless there are three or more PD/PIs in multiple PD/PI applications. In such a case, the minimum level of effort can be reduced to 1.8 PM for each multiple PD/PI.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Succinctly list the specific objectives and goals of the SPORE as a whole. Summarize the expected outcome(s) of the SPORE as a whole, including the impact that the results of the proposed translational research will have on risk assessment, prevention, early detection, diagnosis and/or treatment of the organ-site specific cancer(s) and CHD-MH translational research.

Research Strategy:

Organize the overall Research Strategy section in the specified order using the instructions provided below. Start each subsection with the appropriate heading: Overall Significance; Overall Innovation; and Overall Approach. Additional subsections of Preliminary Studies must be included in this section as well. This section should be used to discuss the overall translational strategies that will be employed in the SPORE to reach human endpoints within the project period. In addition, discuss planned activities relating to Scientific Collaboration in a separate subsection. Applications may include discussions of all the projects together for overall significance, innovation, and approach for the SPORE, or discuss each project separately.

Overall Significance

• Explain the importance of the proposed translational goals, including the overarching problems or critical barriers to translational progress in the organ site(s) and CHD-MH research areas that the SPORE addresses.
• Explain how the SPORE as a whole will improve scientific knowledge, technical capability, and/or clinical practice in prevention, detection, diagnosis or treatment of cancer in the specific organ site(s) and CHD-MH research areas that the SPORE addresses.
• Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive translational research in CHD-MH will be changed if the overall aims are achieved.

Overall Innovation

• Explain how the overall SPORE challenges and seeks to shift current translational research or clinical practice paradigms.
• Summarize novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used in the projects and Shared Resources Cores.
• Summarize how the SPORE as a whole will refine, improve, or provide new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions in CHD-MH translational research.

Overall Approach

• Summarize the global strategies, methodologies, and analyses that will be used to accomplish the overall specific aims and objectives of the SPORE.
• Address potential problems, alternative strategies and benchmarks for success in achieving the aims of the overall SPORE.
• Explain how the SPORE as a whole will establish strategies to enhance feasibility and manage high risk aspects of the work, particularly if any of the proposed projects or aims in the Shared Resources Cores are in the early stages of development.
• Discuss the collaboration of applied researchers (e.g., clinical researchers, epidemiologists, social scientists) with basic investigators in the design and implementation of translational research that is most likely to have an impact on human cancer.
• Explain how the proposed research projects, developmental research and career enhancement programs, and Shared Resources Cores will, together, address the overall goals and aims of the SPORE more effectively than if the projects were done independently.
• Explain how each Shared Resources Core is justified and will provide centralized high-quality services to the SPORE as a whole, support collaborations and U54 network activities, and produce an economy of effort and/or save overall costs compared to each project in the SPORE performing its own tests, assays, animal derivations, clinical studies, etc.
• Describe the resources and processes to be used to apply the appropriate data standards to represent the data and information being generated through the proposed SPORE research activities and to submit these data to the appropriate NIH/NCI data repositories.

Preliminary Studies

Summarize the preliminary studies that led to developing the SPORE application. More detailed preliminary studies sections should be included in the individual research projects and Shared Resources Cores.

Scientific Collaboration

Information related to scientific collaborations must be provided within the Overall component. Succinctly address the following:

• Horizontal Collaboration: Describe the nature, logistics, timelines, milestones, agreements and/or any other pertinent aspects of planned, ongoing, and completed collaborations that the SPORE has performed for projects and developmental programs in which groups work together to accomplish a set of research aims. Discussion of barriers to collaboration and the process for overcoming obstacles in achieving goals are appropriate in this section. The specific role of SPORE leadership in initiating and implementing successful collaborations should be discussed here instead of in the Administrative Core. Specific discussion of scientific data and conclusions reached from experimental results should be included in the individual research projects and developmental program sections.
• Vertical Collaboration: Describe the planned, ongoing, or completed integration of scientific achievements from the SPORE across NCI-sponsored clinical trial mechanisms (grants, cooperative agreements, and contracts), and other government and non-government mechanisms to move promising translational concepts rapidly and seamlessly from the bench to the bedside and beyond into clinical practice.

Applicants should describe potential collaborative arrangements for developing therapeutics, biomarkers, and novel methodologies and for expanding population and cancer prevention studies beyond the limits of the SPORE, should pilot or early clinical studies prove to be successful. Describe plans for any future horizontal and vertical collaborations for forward translational projects that will eventually reach a clinical study and for reverse translational projects, such as projects in biomarker discovery, that will eventually require analytical and clinical validation. The plans for scientific collaborations may not be applicable to every research project.

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.

Other Plan(s): 

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing (DMS) Plan. Attach one DMS Plan in the Overall that describes plans for each SPORE component as described in the SF424 (R&R) Application Guide.   Note that for SPORE applications this attachment is allowed to exceed 2 pages.  Do not include a DMS plan attachment within the components; however, any budget information related to DMS should be included within the component budgets.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Core: Administrative Core
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide overall goals/abstract/summary for the Administrative Core.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: If this component will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" should be included with the application. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Administrative Core component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative. New information is not allowed in Other Attachments.
• Attach a figure showing the institutional organization chart for decision-making and administration within the program.
• Attach a table showing the person months effort for SPORE named key personnel dedicated to each project, Core, and the Developmental Research Program (DRP) and Career Enhancement Program (CEP).
• Attach a table that describes for each Shared Resources Core the percentage of effort that is dedicated to each project, CEP and DRP. This table should be referred to in the narrative(s) of each component served by the Shared Resources Core.
• Provide up to a 5-page attachment entitled SPORE Data Systems. Provide a plan describing the SPORE bioinformatics capabilities and SPORE data management capabilities, systems, platforms, and tools needed to support human and non-human research within the Projects and Cores, as they relate to the cancer center, institution, or activities of other NIH/NCI initiatives. In addition, for projects with clinical trials, include the following information in the attachment:
  • The procedures for data management, quality control and quality assurance of data at clinical site(s) or at center laboratories, as applicable.
  • The methods for standardization of procedures for data management to assess the effect of the intervention and quality control.
  • The plan to complete data analysis within the proposed period of the award.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• Biosketches or resumes of EAB, IAB, and CAB members should be included in the Administrative Core component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  
• A SPORE Administrator who has experience managing multi-project grants involving clinical trials should be included in the Senior/Key person list.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The SPORE PD/PI (or at least one of the SPORE PD/PIs in multiple PD/PI applications) is expected to serve as Core Lead of the Administrative Core with minimum effort of 0.6 PM. If multiple PDs/PIs serve as co-Core Leads, each must devote a minimum effort of 0.6 PM. The minimum total effort for PD/PIs on a SPORE application is 2.4 PM. However, if a SPORE is submitted as a multiple PD/PI application with three or more PD/PIs, the required total minimum is reduced to 1.8 PM each. The minimum PM time commitment should be an aggregate of efforts in different components.

Budgets are also required for each consortium (subaward) if they are part of the Administrative Core.

Budgets may include costs to cover the travel of investigators to the required NCI-sponsored annual U54 CHD-MH SPORE Investigator Meeting and other network activities, and allowable advocate-associated costs should be included. Any costs related to advisory board meetings should be included. Funds should not be requested for participation in grant review meetings, special emphasis panels, and other evaluation groups where reimbursement derives from other sources. 

The budget may include a request of up to $50,000 direct costs per year to be used as discretionary funds. These funds are included in the total cost. A justification for the discretionary fund is not required.

Budget Justification: In the Personnel Justification section, discuss the time commitment of the Core Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Succinctly describe the list of specific objectives and goals of the Administrative Core.

Research Strategy: Succinctly address the following items:

Leadership: Detail the plans for the organizational, administrative, and scientific management (both basic and clinical/applied research) of the SPORE program. Describe and/or diagram the chain of authority for decision-making and administration within the program. Leadership with respect to initiating, facilitating, and implementing successful translational/clinical research collaborations should be discussed in the SC section of the Overall component.

Administrative Management: Describe the plans for the fiscal management, clerical support, manuscript preparation, and organization of meetings. Quality control and communication aspects of the grant, particularly if more than one institution is involved in the SPORE should be discussed. A succession plan should be included which describes the process by which new leadership will be selected if the SPORE PD(s)/PI(s) is no longer willing or able to lead the SPORE. A statement of commitment to attend the required NCI-sponsored annual U54 CHD-MH SPORE Investigator Meeting and other network activities should also be included.

Integration between SPORE, Institution, and NIH/NCI initiatives: Provide a narrative of how the SPORE integrates with NCI-supported existing Cancer Center/institutional resources (e.g., use of clinical data and safety management systems, biostatistics, etc.) Explain how coordination and communication among the different projects and programs, Shared Resources Cores and participating institutions will be achieved at the overall program level. [Note: SPORE projects are not required to interact with each other.]

Cancer Patient Population: Each SPORE must document access to a substantial patient population for the organ site and underserved populations that are the focus of the application. Provide reasonable assurance that the patients and human specimens needed for translational research are readily available. If the appropriate patient population is not available at the applicant institution, a consortium agreement may be established with a different institution(s) to provide adequate access to clinical specimens and/or patients. Describe the access to cancer patients and populations for conducting current and projected therapeutic, prevention, detection, and control research within the SPORE and collaborating institutions.

Planning and Evaluation Activities:  Discuss the planning and evaluation of SPORE activities, e.g., the evaluation of the translational research productivity of existing projects and Shared Resources Core; the process for discontinuing projects and replacing them with more promising projects; and the initiation of activities in response to important translational research opportunities.

Describe the establishment of the required Community Advisory Board (CAB), required External Advisory Board (EAB), and if proposed, the recommended Internal Advisory Board (IAB). If the CAB, EAB, or IAB have already been established, list active members. If the CAB and EAB have not been established at the time of submission, describe needed areas of expertise but do not contact new members until after peer review. In addition to the list, describe the role of the CAB, EAB, and IAB in planning and evaluation processes, including CAB input and assessment of the SPORE in addressing the needs of the SPORE catchment area population.

Interaction between the SPORE and NCI-designated Cancer Center: If a SPORE application originates from an institution that is supported by an NCI Cancer Center Support Grant (CCSG; P30), the following are also expected:

• The SPORE must be an integral part of the Cancer Center and the lines of authority should be clearly indicated.
• Cancer Center Director(s), or their designee, are encouraged to directly interact with the proposed SPORE (e.g., serve as an Internal Advisory Board member).
• The applicant should discuss how the SPORE will interact synergistically with existing P30 programs and their resources to maximize both SPORE and Cancer Center research objectives. This includes CCSG Community Outreach and Engagement Component activities. While the SPORE is expected to become an integral element within the NCI-designated Cancer Center, a distinct institutional commitment to the SPORE must still be maintained throughout the term of the SPORE grant.
• The proposed Cores within the SPORE should not duplicate any available facility already in place or supported by the Cancer Center's CCSG P30 grant. Applicants may, however, augment pre-existing Cancer Center or institutional resources to direct these activities toward more effective fulfillment of the requirements of the SPORE. For example, the SPORE should use the Cancer Center-specific IRB(s) and DSMB(s) as well as other clinical trial resources, whenever possible.

Letters of Support: Attach letters of support addressed to either the SPORE PD(s)/PI(s) or the NCI and must be signed by the appropriate institution’s leaders (e.g., Dean of the School of Medicine, President, Vice President for Research).

A letter of support from the institution must be attached addressing: the commitment to support the proposed SPORE, a plan describing how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution. The letter should describe the integration and synergies between the institutional resources and those of the overall SPORE and its components. The institutional commitment may come in the form of support for the recruitment of scientific talent, providing protected time for physicians, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution.

A separate letter of support from the Cancer Center is required for host institutions associated with an NCI-designated Cancer Center. The NCI-designated Cancer Center letter of support should describe the integration and synergies between the Cancer Center resources and those of the overall SPORE and its components and delineate organizational relationships and responsibilities between the SPORE and the NCI-designated Cancer Center. If the SPORE PD/PI does not hold a prominent position within the Cancer Center, the letter should describe the future authority of the SPORE PD/PI within the Cancer Center once the NCI SPORE funding is obtained. Whenever there is dependence on Institute-wide Core Resources, a letter of agreement from the Core Director should be included.

In the case of a SPORE that involves two or more institutions, the applicant institution must submit a formal written agreement(s) from the other participant organization(s) that states how the participating institution will commit to the SPORE. The primary institution (as well as any participating institutions) is strongly encouraged to demonstrate commitment by providing financial support to the Developmental Research and Career Enhancement Programs on an awarded SPORE, as well as to other programmatic needs identified as high priority in the application.

The institution(s) is encouraged to provide the SPORE PD/PI with discretionary funds. These funds can be used to support anticipated as well as unanticipated activities during the funding period.

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.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.  

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Shared Resources Cores

When preparing your application, use Component Type "Core”.

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

SF424 (R&R) Cover (Shared Resources Cores)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Core(s) starting with "Core A: Title", "Core B: Title", etc.
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Shared Resources Cores)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources Cores)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide overall goals/abstract/summary for the Shared Resources Core

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources:

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Institutional Commitment: Discuss how the institutional commitment to the core will facilitate the research proposed. Examples include providing support for recruitment of scientific talent, providing discretionary resources to the Core Director, assigning specialized research space, cost sharing of resources, and other assurances proposed by the applicant institution.

Other Attachments: The following "Other Attachments" should be included with each Core component to aid in the review of the application. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the Shared Resources Core component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Distribution of Shared Core's Effort to Projects.
• Attach a table showing the percent effort dedicated to each project as well as to the Developmental Research Program (DRP) and Career Enhancement Program (CEP).

Project /Performance Site Location(s) (Shared Resources Cores)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Shared Resources Cores)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Shared Resources Cores)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of any Cores.

Core Director(s) must commit to a minimum of 0.6 PM of effort.

Budget Justification: In the Personnel Justification section, discuss the time commitment of the Core Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Shared Resources Cores)

Specific Aims: Succinctly list the specific objectives and goals of the Core.     

Research Strategy: It should be the objective of all involved Shared Resources Cores to ensure that biospecimen-related, community outreach and engagement, biostatistical, bioinformatics, and clinical activities are performed in a cost effective and coordinated manner. Shared Resources Cores must address how related activities (e.g., specimen banking, or community outreach and engagement) are coordinated with the Cancer Center, if applicable. Prior to an award, NCI will carefully review proposed SPORE Core activities and budgets for overlap with ongoing CCSG Cores. If a proposed Core duplicates the efforts of other facilities at the applicant institution(s), justification should be provided as to why these institutional resources cannot be used for the SPORE activities.

Biospecimen/Pathology Core (Required)

Describe the plans for collecting and distributing human cancer site-specific and/or related specimens, including fixed tissue, frozen tissue, paraffin blocks, slides, preserved cells, serum, plasma, urine, sputum samples, and other body fluids, as appropriate for the cancer site. Describe the plans for achieving detailed annotation of parameters of collection and preservation that are pertinent to the pre-analytic and analytic considerations of potential SPORE studies as well as essential pathological, clinical, and family history information needed for conducting a wide range of translational research activities. These plans should include detailed biospecimen quality assurance and control measures and standardization of procedures across performance sites to ensure sample quality. Describe the informatics that will be used for tracking specimens, as well as linkage to clinical and follow-up data sets. Networking with informatics systems at other SPORE sites is encouraged but is not required. Address development, acquisition, storage, and usage of standardized reference specimens and materials, and any other services related to the analysis of specimens (e.g., tissue microdissection, immunohistochemistry) that will be provided. Describe and justify any research activities to improve Core services and how they will benefit the SPORE.  Describe integration with the cancer center biospecimen core resources and the clinical laboratory.

Provide a plan for prioritizing distribution of biospecimens to SPORE scientists and others, both inside and outside the parent/consortium institution(s), based on the merit of the proposed translational cancer research projects. If significant collaborations have emerged from this Core, over and beyond the distribution of specimens, the data should be discussed in this section, but the details of the collaboration itself, including the strategy for moving the project through the translational research pathway to the clinic should be discussed in the SC section of the Overall component.

Community Outreach and Engagement (COE) Core (Required)

SPOREs are expected to engage with and perform research relevant to the populations within their catchment area to achieve SPORE research objectives and decrease cancer burden, particularly in populations who are underserved. This includes thoroughly analyzing the demographics and cancer burden of their catchment area. To facilitate these activities, SPOREs must establish partnerships with individuals and groups in the SPORE catchment area. These individuals and groups may include community members, patients, advocates, healthcare delivery systems, state and community agencies, and coalitions.

In the COE, applicants should describe plans for the following intra- and inter-SPORE activities:

• Outreach to and engagement with underserved populations within the SPORE catchment area to inform cancer research efforts. This may involve collaboration with other SPOREs and community partners, including patients and community members; patient advocates/navigators, research advocates, community health educators, and lay health advisors; community hospitals, healthcare delivery systems, and state and community agencies; Historically Black Colleges and Universities, Minority Serving Institutions, and Tribal Colleges and Universities; and coalitions. Descriptions should also include how the SPORE has developed infrastructure (e.g., offices or centers established by the SPORE, community advisory boards, partnerships with government offices, employers, schools, faith-based institutions, donors) and sought input to prioritize, facilitate, and expand cancer research activities.
• Communicating the needs of underserved populations and community partners within the SPORE catchment area to SPORE members in order to catalyze research in all areas of science (e.g., basic, clinical, translational, and population sciences). This includes needs assessments of the catchment area, efforts undertaken, and progress toward reducing cancer burden and addressing the goals and objectives of the SPORE.
• Facilitation of patient accrual to clinical trials and pilot/feasibility studies, if applicable, including description of efforts to achieve planned enrollment, stated objectives, and clinical endpoints.
• Dissemination and implementation of evidence-based interventions, public education, health policy recommendations, influence on health policy, etc. This may include precision medicine approaches in community-based oncology settings (e.g., genetic testing of molecular biomarkers). Descriptions should include current and planned efforts/SPORE collaborations, metrics for success, and outcomes as available.
• Development of novel methodologies, including machine learning, and standardization of metrics for assessment of disparities and health outcomes in underserved populations. Include description of knowledge, best practices, and tools to be developed in the COE and how this will be shared with other SPOREs in the U54 network. SPOREs are also encouraged to adopt, adapt, and implement best practices of other groups.
• Integration of SPORE COE activities with the Cancer Center COE Component, if applicable.

Note that the SPORE’s catchment area is the self-defined geographic area that the SPORE serves or intends to serve in the research it conducts, the communities it engages, and the outreach it performs. It must include the area from which the SPORE draws the majority of its patients, but may extend beyond that, and it must include the local area surrounding the SPORE performance/research sites. It must be population based, e.g., using census tracts, zip codes, county or state lines, or other geographically defined boundaries.

Other Cores (Optional)

Additional Shared Resources Cores (e.g., biostatistical, clinical, animal, etc.) may also be proposed as distinct components that are supportive of one or more of the research projects of the SPORE. These Cores may also include other analytical or non-hypothesis-driven research activities designed to enhance a service. A Biostatistical Core is strongly encouraged. If a Clinical Core is proposed, the application also should discuss how duplication in the reporting of clinical trial data to the NCI will be avoided.

Describe the facilities and/or services that will be provided and state the rationale for centralizing them in the Core, rather than including them in individual projects. Cores must indicate why they are an essential part of the SPORE, and how the proposed services will facilitate accomplishment of the proposed goals and objectives of the SPORE as a whole. Cores may include efforts aimed at improving/optimizing approaches and procedures (both experimental and/or bioinformatic) with the goal to enhance Core services offered. Address plans for prioritization of services (if necessary). Summarize the preliminary studies and experimental protocols that support the ability of the Core to provide the proposed services.

Letters of Support: Attach appropriate letters relevant to each Core detailing the nature and extent of participation. Include appropriate letters of support from community partners and organizations to demonstrate feasibility in meeting the proposed goals and objectives of the COE.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Shared Resources Cores)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Research Project

When preparing your application, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project starting with "Project 1: Title", "Project 2: Title", etc.
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Project Summary/Abstract: Provide overall goals/abstract/summary for the project.

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: State the relevance of the Research Project's activities to public health. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: If this component will benefit from a funded institutional, local, state, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The filename provided for each attachment will be the name used for the bookmark in the application image.

• To aid in review of the application, tables, graphs, figures, and images relevant to the Project may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific Project.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with category of ‘basic co-leader, clinical co-leader, or applied co-leader' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• Biosketches or resumes of EAB, IAB, and CAB members should be included in the Administrative Core component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Each project must include both basic and applied/clinical co-leaders who will use their combined expertise to design and implement the project. Each co-leader must commit individually to a minimum of 0.6 person months (PM) of effort. It is not necessary that the co-leaders commit an equal amount to the project.

For SPORE-designated clinical trials, the SPORE-funded budget for the clinical trial must be included and described.

Budget Justification: In the Personnel Justification section, discuss the time commitment of the Project Leaders and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: State concisely the translational goals of the proposed Research Project and summarize the expected translational outcomes(s), including the impact of Research Project results on CHD-MH, the proposed human disease site(s), and populations who are underserved. List succinctly the specific objectives of the Research Project, e.g., to test a stated hypothesis, to generate new hypotheses relevant to translational research, to solve a specific problem that has yet been unsolved in the field, to challenge an existing paradigm or clinical practice, to address any critical barrier(s) to progress in the field of CHD-MH translational research, or to develop new technologies, detection methods, or biomarkers appropriate for testing in human cancer patients or populations at risk for cancer. At least one specific aim must address a human endpoint. Proposal of a clinical trial or a human pilot study is optional.

Research Strategy: Organize the Research Strategy, using the instructions given below, including the Preliminary Studies. Start each subsection with the appropriate heading. Experimental details should be cited using the Bibliography and References Cited section and need not be detailed in the Research Strategy.

Only pilot/feasibility studies, Phase I, and early Phase II clinical trials may be supported by funds from the SPORE program. SPOREs are strongly encouraged to establish collaborative clinical trial activities with other SPOREs and NCI-funded mechanisms.

For multicenter, randomized Phase II therapeutic trials, SPOREs wishing to collaborate as an inter-SPORE endeavor or with investigators funded by other grant mechanisms, should use the appropriate NCI Disease Specific Steering Committees and their Task Forces (http://restructuringtrials.cancer.gov/steering/overview) working together to develop clinical concepts from early SPORE trials that could move forward, beyond SPORE grant support, to the NCI Clinical Trials Network (NCTN). Collaborative trials using this opportunity may also include correlative studies. However, correlative studies associated with an NCTN trial may be supported within a SPORE project.

It should be noted that a clinical trial may not be the goal of many SPORE projects. Some projects will reach a human endpoint by focusing on retrospective cohort analysis that includes a laboratory component or by using human specimens in the laboratory to expand upon observations made in the clinic (a process known as “reverse translation”). However, when biomarker studies are ready for clinical trials, SPOREs are encouraged to collaborate with trans-NCI clinical trial mechanisms to validate the biomarkers clinically.

Significance

• Explain the importance of the problem or the critical barrier to progress in CHD-MH translational research that the proposed project addresses.
• Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.
• Explain how the proposed translational science project will improve scientific knowledge, technical capability, and/or clinical practice in the organ site(s) and proposed CHD-MH research areas.
• Describe how the concepts, methods, technologies, treatments, services, or preventive interventions that drive CHD-MH research will impact the field if the proposed aims are achieved.

Innovation

• Explain how the project challenges and seeks to shift current translational research or clinical practice paradigms, in relation to CHD-MH.
• Describe any novel theoretical concepts, approaches or methodologies, instrumentation, or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation, or intervention(s).
• Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed, and interpreted.  Emphasize how the experimental design and methods proposed will achieve robust and unbiased results.
• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the specific stated aims and the overall aim of reaching a human endpoint within the 5-year funding period.
• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high-risk aspects of the proposed work.
• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised.

If a project contains a clinical trial, including human pilot/feasibility studies, describe the study keeping the relevant review criteria in mind, but do not duplicate information in the required clinical trial documents (e.g., PHS Human Subjects and Clinical Trials Information Form or IRB-approved clinical trial protocol):

• Describe the scientific rationale/premise of the study that is based on previously well-designed preclinical and/or clinical research.
• Describe the planned analyses and statistical approach for the proposed study design.
• Demonstrate that the eligible population is available.
• Address potential ethical issues.
• Describe how the recruitment timelines are feasible and adequate to monitor accrual.
• If appropriate, address the need for randomization (or not), masking, controls, and inclusion/exclusion criteria.
• Address the differences, if applicable, in the intervention effect due to sex/gender and race/ethnicity.
• Describe the plans to standardize, assure quality of, and monitor adherence to, the clinical protocol and data collection or distribution guidelines.
• Describe the plan to obtain required study agent(s).
• Describe how existing available resources, as applicable, will be used.
• Address compliance to Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP), if applicable.

Preliminary Studies: Include information on Preliminary Studies as part of the Approach section. Discuss the preliminary studies, data, and/or experience of the co-leaders of the project that are pertinent to the project. Discuss any preliminary plans for vertical and/or horizontal collaborations in the Scientific Collaboration section of the Overall component.

Letters of Support: Attach appropriate letters specific to the project detailing the nature and extent of participation. The letter of commitment from the host institution should describe the integration and synergies between the institutional resources and those of the SPORE project.  If applicable, letters of commitment from proposed subawardees and from collaborating institutions should also be provided.

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

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

A copy of a draft or Institutional Review Board (IRB)-approved clinical trial protocol, along with informed consent forms, are required and must be included in the Appendix if the trial is already underway or is anticipated to begin within the first year of the award. If the trial will be performed during the latter part of the grant term (i.e., delayed onset), submission of these items to NCI program staff is required prior to the initiation of the trial.

PHS Human Subjects and Clinical Trials Information (Research Project)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Developmental Research Program (DRP)

When preparing your application, use Component Type ‘Dev Res Prog.’

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

SF424 (R&R) Cover (DRP)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project: "Developmental Research Program"
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (DRP)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (DRP)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide overall goals/abstract/summary for the DRP.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the DRP, if provided, will specifically facilitate the research proposed.

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the DRP component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Inclusion of the RFA, timeline, review and award information are encouraged.

Project /Performance Site Location(s) (DRP)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (DRP)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘DRP Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  

Budget (DRP)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of the DRP.

DRP Director(s) must commit to a minimum of 0.3 PM of effort.

The DRP, as a required component of a SPORE, must be maintained throughout the entire term of the grant. A minimum commitment of $50,000 direct costs per year from SPORE funds per year must be proposed and maintained for a DRP. The NCI will monitor the activities of the DRP during non-competitive years to ensure that the NCI commitment is being maintained. DRP funds should be used for research activities and cannot be used for the purchase of any large equipment.

Budget Justification: In the Personnel Justification section, discuss the time commitment of the DRP Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (DRP)

Specific Aims: Describe the specific objectives and goals of the DRP.

Research Strategy: Clearly describe the process for solicitation of DRP projects in CHD-MH, including pilot and collaborative projects. Describe the institutional review process for evaluating and funding DRP projects that generate feasibility data. These funds are intended to remain flexible and to support studies of 2 years or less. The expectation is that successful feasibility studies that have translational potential will replace full projects that are not progressing satisfactorily toward their translational research objectives within the SPORE or projects that have been completed or will be the subject of a new grant application.

Describe the processes for setting up the DRP within the SPORE and for the continuous reviewing and funding of the pilot and collaborative projects based on quality and importance to the overall SPORE goal. Describe plans for monitoring funded projects. A short description of eligible projects may be provided as examples.

Letters of Support: Attach appropriate letters relevant to the DRP detailing the nature and extent of participation.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (DRP)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Career Enhancement Program (CEP)

When preparing your application, use Component Type ‘Career Enh Prog.’

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

SF424 (R&R) Cover (CEP)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project: "Career Enhancement Program"
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (CEP)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (CEP)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Summary/Abstract: Provide overall goals/abstract/summary for the CEP.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Institutional Commitment: Discuss how the institutional commitment to the CEP, if provided, will specifically facilitate the research proposed.

If this component will benefit from a funded institutional, local, State, or national resource/consortium, the funded resource should be described in the application.

Other Attachments: The following "Other Attachments" may be included to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image.

• Tables, graphs, figures, and images that are relevant to the CEP component may be attached and cross referenced with the narrative of the component. Images may be enlarged with the same caption key as the narrative.  New information is not allowed in Other Attachments.
• Inclusion of the RFA, timeline, review and award information are encouraged.

Project /Performance Site Location(s) (CEP)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (CEP)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘CEP Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.  

Budget (CEP)

Budget forms appropriate for the specific component will be included in the application package.

Budgets are also required for each consortium (subaward) if they are part of the CEP.

CEP Director(s) must commit to a minimum of 0.3 person month of effort.

The CEP, as a required component of a SPORE, must be maintained throughout the entire term of the grant. A minimum commitment of $50,000 direct costs per year from NCI SPORE funds must be proposed and maintained for CEP projects. These funds are restricted to the CEP. The NCI will monitor the activities of the CEP during non-competitive years to ensure that the NCI commitment is being maintained. CEP funds should be used to support research activities, including partial salary support for the candidate, research personnel, supplies, travel, and/or other expenses, and cannot be used for the purchase of any large equipment.

Budget Justification: In the Personnel Justification section, discuss the time commitment of the CEP Director(s) and other named personnel for the overall successful conduct of the SPORE. The justification should not duplicate the biosketch or Research Strategy section.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (CEP)

Specific Aims: Describe the specific objectives and goals of the CEP.

Research Strategy: Clearly describe the plans for this program, including the process for soliciting and awarding CHD-MH translational research applications and the policies, criteria, and processes for selecting candidates (e.g., advanced post-doctoral fellows who are ready to transition to a faculty position within one year, junior faculty, and established investigators). NIH encourages the recruitment of prospective candidates from diverse backgrounds, including women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities. The plan should include the number and types of positions that will be made available, the criteria for eligibility and selection of candidates, a description of the selection process, and the process for mentoring or advising junior level candidates or monitoring the progress of all candidates. Applicants should provide short descriptions of potential candidates, as well as the names and research activities of mentors/advisors. Support of a CEP awardee should not exceed 2 years.

Similar to the DRP, outstanding career enhancement projects may be promoted to full projects to replace those that are not meeting their translational research objectives within the SPORE or projects that have been completed. Successful CEP awardees may be provided continued support as project co-leaders of the promoted projects.

Letters of Support: Attach appropriate letters specific to the CEP detailing the nature and extent of support and/or participation.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (CEP)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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) using ASSIST or other electronic submission systems. 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 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.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 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 the NCI, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed. 

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists for inclusion in the SPORE application will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this NOFO, note the following: 

Scoring: Reviewers will provide an overall Impact Score for the entire SPORE based on their assessment of each of the review criteria below, considering the merit of research projects, cores, developmental research, and career enhancement programs, and scientific collaborations in the determination of scientific merit of the entire application. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. For example, a SPORE that by its nature is not innovative may be essential to advance a field.

If a study involving human participants is proposed, the application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of a study may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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, but not individually score, each of the review criteria below, taking into account the merit of research projects, clinical trials, population science studies, cores, developmental research and career enhancement programs, and scientific collaborations in the determination of scientific merit of the SPORE grant. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a SPORE that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific for this NOFO: How is the SPORE, as a whole, expected to contribute to scientific knowledge, technical capabilities, patient care, and/or community outreach and engagement relevant to the prevention, detection, diagnosis or treatment of cancer and to CHD-MH?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

Specific for this NOFO: 

How appropriate is the collaboration of applied researchers (e.g., clinical researchers, epidemiologists) with basic investigators in the design and implementation of CHD-MH translational research that is most likely to have an impact on human cancer?

How strong is the team in terms of balanced representation of investigators across basic and applied/clinical research?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, its potential for information, or its potential to advance scientific knowledge or patient care for populations who are underserved.

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this NOFO: If pilot/feasibility studies and studies involving retrospective cohort analysis are proposed, how well-reasoned and appropriate are the strategies, methodologies, and analyses to accomplish the specific aims of the project?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Is the trial appropriately designed to conduct the research efficiently, answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

Specific for this NOFO: How well do the proposed  community outreach and engagement activities  uniquely benefit the needs of the project(s)?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Scientific Collaboration (in the Overall component)

The Scientific Collaboration section is part of the Overall component. Reviewers will assign a numerical score to only this section of the Overall based on the following criteria.

• Horizontal Collaborations: How well do any/many of the proposed projects (and the Developmental Research Program, if appropriate) detail plans for scientific collaboration with investigators outside of the SPORE, including other SPOREs, other NIH/NCI programs, or other government or non-government organizations such that information, expertise, and resources are shared to complete translational goals within the SPORE more rapidly and efficiently? How well are the plans to promote collaborative projects by the SPORE leadership  addressed? How sufficient are plans described for collaborative projects, and are these plans sufficient? How well does the participation in and outcome of collaborative projects and programs contribute to the overall translational goals of the SPORE?
• Vertical Collaborations: Should the proposed studies prove to be successful, how sound is the plan for potential collaborative agreements in developing cancer therapeutics and biomarkers, or for expanding population and cancer prevention studies beyond the limits of the SPORE?

Additional Review Criteria - Overall

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Criteria--Overall

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria - Administrative Core, Projects, Shared Resources Core(s), and NOFO-Specific Components

Review Criteria for Administrative Core

Reviewers will assign a numerical score based on the following criteria (these criteria do not receive separate scores).

Leadership

How sufficient are the scientific qualifications, involvement, leadership, and time commitment of the co-leaders for the requirements of the proposed SPORE? (Leadership for collaborations will be reviewed in the Scientific Collaboration section, now part of the Overall component.)

Administrative Management

How well does the plan for the Administrative Core  address how the SPORE will be managed administratively, including the fiscal and data operations? How well are the communication aspects of the SPORE facilitated by this Core  addressed, particularly if there is more than one institution involved in the proposed research? Is there evidence that appropriate clerical and administrative personnel and quality controls are in place for the smooth running and total integration of the SPORE? How adequate and appropriate are  the qualifications, experience, and commitment of the Shared Resources Core Director(s) and other key personnel  for providing the proposed facility or services? Will this Core provide adequate meeting/travel support, and support for the advisory boards? How adequate are the qualifications, experience, and commitment of the Core Director(s) and other key personnel? Does the proposed plan include a succession plan for SPORE leadership that could be enacted in the event that the SPORE PD(s)/PI(s) is no longer willing or able to lead the SPORE? If patient advocates are included, how appropriate are their activities  to the goals of the SPORE?

Institutional Commitment

How sufficient is the institutional commitment for facilitating the research objectives of the SPORE (e.g., through special facilities, recruitments, discretionary funding, supplemental resources for CEP and DRP)  documented?

Integration of the SPORE within the Institution

How well are the activities of SPORE projects and proposed Cores integrated into the institution? Does the entire SPORE integrate with the existing cancer center/institute (e.g., use of clinical data and safety management systems, biostatistical and other Cores, etc.)? Is there evidence of, or plans for, coordination and communication across all components of the SPORE and among all participating institutions at the overall SPORE level?

Cancer Patient Population

How adequate is access to patients/populations who are underserved and the focus of the proposal  to ensure likely success of the SPORE?

Planning and Evaluation of Activities

How sufficient are the plans for and/or track record of advisors who will evaluate the translational research productivity of existing projects and Cores for the requirements of the proposed SPORE?

Data Systems

How well are the plans described for the SPORE data management capabilities as they relate to the cancer center, institution, or activities of other NIH/NCI initiatives?

Review Criteria for Research Projects

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

Significance

Does the project address an important translational research goal or barrier in CHD-MH? Is the prior research that serves as the basis for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved for underserved populations who are the focus of the proposal? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventive interventions that drive the field of CHD-MH?

For applications involving clinical trials

Are the scientific rationale and need for a trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigators

Are the Project co-leaders, collaborators, and other researchers well suited to the project? Is there adequate evidence of co-leadership of the project by basic and applied/clinical investigators in the conception, design, and proposed implementation of the project? If investigators are in the early stages of independent careers or are new to translational cancer research, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative with other groups, do the investigators have complementary and integrated expertise; are their leadership approaches, governance, and organizational structures appropriate for the project?

For applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

For applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, its potential for information, or its potential to advance scientific knowledge or patient care for populations who are underserved?

Approach

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

Specific for this NOFO: How well does the application adequately address the following, as applicable?

How well are the cancer health disparity or minority health research questions defined and are the approaches appropriate for addressing the proposed research questions? How adequate is access to biospecimens, patients, and populations, particularly populations who are underserved, for conducting the projected therapeutic, prevention, detection, and/or control research projects proposed in the SPORE?

If pilot/feasibility studies and studies involving retrospective cohort analysis are proposed, how well reasoned and appropriate are the strategies, methodologies, and analyses to accomplish the specific aims of the project?

How likely is it that the research will achieve the proposed human endpoint within the 5-year project period? How likely is it that all the aims will be completed within the project period? How justified are the plans for (1) protection of human subjects from research risks and (2) inclusion of underserved, women, and individuals of all ages (including children and older adults) as research subjects in terms of the scientific goals and research strategy proposed?

Note: Aspects of collaboration unrelated to scientific data will be reviewed in the Scientific Collaboration section (Overall component) and not in the SPORE Research Projects section. 

For applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Is the trial appropriately designed to conduct the research efficiently, answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

Specific for this NOFO: Does the application adequately address the following, if applicable?

In the case of multiple institutions involved in a single SPORE, how adequate is the plan for communication among investigators to achieve the goals of the grant? How evident is the institutional support? How evident is the effective use of SPORE Cores?

For applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and (4) operate within the proposed organizational structure?

Review Criteria for Shared Resources Core(s)

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each Shared Resources Core. 

Does the Shared Resources Core(s) provide essential functions or services for at least one project?

Biospecimen/Pathology Core

Investigator

How sufficient is the evidence of proficient personnel dedicated to the activities of specimen collection, annotation, quality control, storage, distribution, and analysis? How sufficient is the oversight of the collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks?

Approach

How adequately does the proposed plan for this Core address the development, annotation, and maintenance of a human cancer site-specific specimen resource, including linkage of specimens with pre-analytical parameters and pathological, clinical, and family history data that maximize their potential use in translational research? How adequate are plans to implement biospecimen quality assurance and control measures to ensure sample quality?

How adequately does the proposed plan address and prioritize the distribution of specimens within and outside the SPORE?

If applicable, how adequately does the proposed plan address the performance of specimen analysis (e.g., tissue microdissection, immunochemistry) and/or the development of new technologies and methodologies that enhance or benefit activities of the SPORE?

How adequately does the proposed plan give sufficient evidence that the activities of the Core are well integrated with those of the projects and that the investigators within the projects are working closely with those of the Core to meet project objectives?

How adequately does the proposed plan address if and how the investigators will obtain written informed consent for all prospectively collected tissues/specimens in a manner that will protect patient confidentiality and enable studies?

Environment

How well does the proposed plan augment and/or complement any existing specimen resource supported by a Cancer Center Support Grant (CCSG; P30 grant mechanism)? Do investigators applying from institutions with a CCSG and multiple SPORE grants address how well their Core will benefit from already established infrastructure, databases, etc., that will enable this proposed specimen Core to be more cost effective and efficient?

Community Outreach and Engagement (COE) Core

Investigator

How appropriate and effective isthe Core Directors' expertise and time commitment for the work of this SPORE?

Approach

How appropriately has the SPORE defined its catchment area?

How well has the SPORE identified and prioritized the cancer research needs of its catchment area population? Are plans adequate to communicate the needs of underserved populations within the SPORE catchment area to SPORE members to catalyze proposed research?

How effectively has the SPORE established the necessary infrastructure to involve underserved populations and community partners in the planning, prioritization, and conduct of cancer research across the spectrum of basic, clinical, translational, and population sciences?

How adequate are plans to facilitate accrual to clinical trials (if proposed) from the catchment area?

If proposed, how adequate are plans to disseminate and implement evidence-based interventions, guidelines, or public health education to reduce the burden of cancer within the catchment area?

Environment

How well does the proposed plan augment and/or complement any COE Component supported by a Cancer Center Support Grant (CCSG; P30 grant mechanism) or other funding mechanism(s)? How well do investigators applying from institutions with a CCSG and multiple SPORE grants address how their Core will benefit from already established infrastructure, databases, etc., that will enable this proposed specimen Core to be more cost-effective and efficient?

Other Cores

Investigator

How adequate and appropriate are the qualifications, experience, and commitment of the Shared Resources Core Director(s) and other key personnel for providing the proposed facilities or services?

Approach

How well matched is the proposed Shared Resources Core to the needs of the overall SPORE? Does it provide essential facilities or services for one or more scored research projects?

How well does the proposed plan demonstrate that the activities of the Core are well-integrated with those of the projects and that the investigators within the projects are working closely with those of the Core to meet project objectives?

What is the overall quality of the proposed Core services? How adequate are the proposed quality control processes for the facilities or services provided by the Shared Resources Core (including procedures, techniques, and quality control)? How appropriate are the criteria for prioritization and usage of Shared Resources Core products and/or services?

How adequate and cost-effective are the proposed Shared Resources Core(s) services provided for the SPORE? How adequate are there plans to augment and/or complement an existing shared resource supported by an NCI Cancer Center Support grant (P30), if applicable?

Environment

How adequate is the environment for the Shared Resources Core to support the program as proposed?

Review Criteria for the Developmental Research Program (DRP)

Reviewers will assign a numerical score based on adherence to the following:

How well described is the proposed plan for the DRP attract new ideas and pilot studies within and/or outside the SPORE institution(s)? How adequate is the plan for periodic solicitation, review and funding of a spectrum of pilot projects, as well as for promoting pilot projects with translational research potential to full projects within the SPORE?

Review Criteria for the Career Enhancement Program (CEP)

Reviewers will assign a numerical score based on the following:

How adequate is the proposed plan to select promising candidates for independent careers (academic, clinical, industrial, governmental) in CHD-MH translational cancer research? How adequately addressed is the plan for recruitment, retention and communication with awardees?

How well does the proposed plan address how the investigators will recruit prospective candidates from diverse backgrounds, including women, individuals from underrepresented racial/ethnic groups, and individuals with disabilities for the program?

How well does the proposed plan address periodic review of the CEP awardees and the role of mentors/advisors?

Additional Review Criteria - Administrative Core, Projects, Shared Resources Core(s), and NOFO-Specific Components

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.

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

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

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

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

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

Additional Review Considerations - Administrative Core, Projects, Shared Resources Core(s), and NOFO-Specific Components
 

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

Applications from Foreign Organizations
Not Applicable

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

Resource Sharing Plans
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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

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

 

2. Review and Selection Process

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

When an award is made, it is the policy of NCI that meritorious projects reviewed as part of the SPORE be funded as part of the SPORE even though other funding may be available. Duplicate funding will not be awarded.

NCI program staff may administratively delete funding or reduce the duration of support for components of SPOREs that are judged by peer review to be less meritorious and/or nonessential to the conduct of the SPORE. Also, note that if a required SPORE component, including Scientific Collaborations, is judged by peer review as less meritorious, NCI program may decide to not fund the entire application regardless of whether the application is in the fundable range for that fiscal year.

The NCI program staff may reduce SPORE funding to support only two scientific research projects in cases where the overall impact score is within the funding range for the fiscal year but one of more projects are judged significantly less meritorious compared with the overall impact score. The exercise of this option by the NCI staff is expected to be a rare event. Under no circumstances may a new applicant submit an application with less than three research projects. 

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.  

Prior Approval to Substitute Research Projects

Substitution of the research projects that have been proposed as part of a reviewed and funded SPORE application requires prior approval of the External Advisory Board and the NCI Program Official. Such substitution can be allowable if the original project is not performing as expected (i.e., unlikely to reach its proposed translational goals) or if the translational goals have been accomplished earlier than anticipated. The awardee is required to provide justification of the proposed changes. Project substitutions cannot be approved during the first year of the current SPORE project period.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.

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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the awardees' activities by involvement in and otherwise working jointly with the awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and NIH as defined below.

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

• PD(s)/PI(s) Commitments. The PD/PI (or multiple PDs/PIs, if applicable) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of projects conducted. The PD/PI assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the proposed research in accordance with terms and conditions of the award. Awardees must be committed to making the research tools and materials they develop available to the cancer research community. For effective leadership, individuals designated as PD(s)/PI(s) are expected to be meaningfully committed to participation in the activities of the Inter-U54 CHD-MH SPORE Program Coordinating Committee (PCC), including the annual U54 CHD-MH SPORE investigator meetings, monthly calls, COE Core network activities, and intra- and inter-SPORE network collaborations.
• Inter-U54 CHD-MH SPORE Monthly Meetings. As a member of the PCC, PD(s)/PI(s) should be represented during regular inter-U54 CHD-MH SPORE meetings (no less than monthly) to discuss research progress, strategies, sharing of resources, collaborations, and planning of the Annual U54 CDH-MH SPORE Investigator Meeting. Monthly meetings will be in the form of virtual conferencing.
• Annual U54 CHD-MH SPORE Investigator Meeting. As a member of the PCC, PD(s)/PI(s) must attend the Annual U54 CHD-MH SPORE Investigator Meeting to discuss research progress, strategies, sharing of resources, and established/future collaborations with other funded CHD-MH SPOREs. Other key personnel, advocates, and investigators will be encouraged to attend as determined by the PCC.
• Reports. Each SPORE will submit annual progress reports to the NCI that describe activities and accomplishments during the previous funding period as part of the RPPR.
• Sharing Experiences. SPOREs are expected to participate in sharing their research approaches, technologies, and experiences with other U54 CHD-MH SPOREs.

Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

• Serve as a member of the PCC.
• Assistance to awardees in performing project activities, including:
  • re-establishment of objectives during the course of a project,
  • adjusting projects/programs or approaches as warranted,
  • working with individual investigators and teams to facilitate collaborations,
  • coordinating approaches between SPOREs,
  • facilitating access to NIH- and NCI-supported research resources,
  • identifying other researchers/resources for projects,
  • Advise the contractor as needed on the selection of subcontractors or subawards, and selection of key project personnel other than co-leaders of projects or cores.
  • integrating the CHD-MH activities of the U54 SPOREs into the activities of the organ-specific P50 SPOREs through teleconferences and workshops, and
  • coordinating activities with other ongoing projects supported by NCI, such as P50 SPOREs and P01s, to avoid duplication of efforts.
• Facilitating the dissemination of experiences and approaches among SPORE awardees and other NCI-supported networks.
• Providing for an option to halt a project activity if technical performance requirements are not met or if program objectives have already been met, including:
  • assisting the EAB in the concurrence of new/replacement pilot and full projects/programs when requested for ongoing activities, and
  • helping reprogram efforts within the peer-reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the timeline for achieving the objectives of the NOFO.

The dominant role and prime responsibility of activities reside with the project's awardees. However, specific tasks and activities in carrying out the projects/programs will be shared among the awardees and the NCI Project Scientist.

The NCI Project Scientist will not attend peer review meetings of supplemental applications. If such participation is essential, the NCI Project Scientist will seek an NCI waiver per the NCI procedures for managing conflict of interest if such participation is deemed necessary.

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

Areas of Joint Responsibility include:

Awardee institutions and the NCI staff members will work together to establish the Inter-U54 CHD-MH SPORE Program Coordinating Committee (PCC) and participate in its activities. The PCC will be comprised of the following members:

• The contact PD(s)/PI(s) (including multiple PD(s)/PI(s)) from each U54 CHD-MH SPORE as voting members with one vote per U54 award.
• NCI Project Scientist that will have one vote on the PCC and NCI Program Officer/Coordinator as non-voting members.

The activities of the PCC will include:

• Voting on an annual basis to select a chairperson to organize, convene, and create the agenda for the Inter-U54 CHD-MH SPORE Monthly Meetings and the Annual U54 CDH-MH SPORE Investigator Meeting.
• Organizing and convening working groups/subcommittees with SPORE investigators to address emerging areas of high priority to the NCI and cancer health disparities in underserved populations.
• Making recommendations and establishing priorities for the PCC.
• Participating in the Inter-U54 CHD-MH SPORE Monthly Meetings in the form of virtual conferencing to discuss research progress, strategies, sharing of resources, collaborations, and planning of the Annual U54 CDH-MH SPORE Investigator Meeting.
• Participating in the Annual U54 CHD-MH SPORE Investigator Meeting to discuss research progress, strategies, sharing of resources, and established/future collaborations with other funded CHD-MH SPOREs.
• Inviting SPORE key personnel and advocates, as needed, to participate in Inter-U54 CHD-MH SPORE Monthly Meetings, the Annual U54 CDH-MH SPORE Investigator Meeting, and ad hoc working groups/subcommittees.

Dispute Resolution:

• Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between awardees 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 awardee'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

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

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. 

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Leah Hubbard, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5693
Email: leah.hubbard@nih.gov

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

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov

Section VIII. Other Information

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

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.