PAR-28-022-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

National Institute of Dental and Craniofacial Research (NIDCR)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title

Specialized Programs of Research Excellence (SPOREs) in Human Cancers for Years 2027, 2028, and 2029 (P50 Clinical Trial Required)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of

PAR-23-284

Related Notices

Funding Opportunity Number (FON)

PAR-28-022

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.395, 93.121

Notice of Funding Opportunity Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPOREs). Based on the proposed research, applications may be jointly funded with the National Institute of Dental and Craniofacial Research (NIDCR). This is a re-issuance of PAR-23-284. The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a highly related group of cancers. The research supported through this program must be translational and be based on human biology research using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must reach a translational human endpoint within the project period of the grant.

Funding Opportunity Goal(s)

To develop the means to cure as many cancer patients as possible and to control the disease in those patients who are not cured. Cancer Treatment Research includes the development and evaluation of improved methods of cancer treatment through the support and performance of both fundamental and applied laboratory and clinical research. Research is supported in the discovery, development, and clinical testing of all modes of therapy including: surgery, radiotherapy, chemotherapy, and biological therapy including molecularly targeted therapies, both individually and in combination. In addition, research is carried out in areas of nutritional support, stem cell and bone marrow transplantation, image guided therapies and studies to reduce toxicity of cytotoxic therapies, and other methods of supportive care that may supplement and enhance primary treatment.

Key Dates

Posted Date

October 14, 2026

Open Date (Earliest Submission Date)

December 25, 2026

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

January 25, 2027 *

January 25, 2027 *

Not Applicable

December 2027

May 25, 2027 *

May 25, 2027 *

Not Applicable

April 2028

September 25, 2027 *

September 25, 2027 *

Not Applicable

July 2028

January 25, 2028 *

January 25, 2028 *

Not Applicable

December 2028

May 25, 2028 *

May 25, 2028 *

Not Applicable

April 2029

September 25, 2028 *

September 25, 2028 *

Not Applicable

July 2029

January 25, 2029 *

January 25, 2029 *

Not Applicable

December 2029

May 25, 2029 *

May 25, 2029 *

Not Applicable

April 2030

September 25, 2029 *

September 25, 2029 *

Not Applicable

July 2030

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date

September 26, 2029

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

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

Key Definitions in the Context of SPORE

1. Translational Research: Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer.

2. Early detection, Prevention, or Population Science (EPPS) Research Projects:

Early Detection: An early detection Research Project is one that is focused on the discovery of early detection biomarkers and/or on the development of an assay that determines the presence of precancerous lesions or early cancer. For either type of Research Project, there would need to be an already established or experimental subsequent intervention for treating the detected lesions. Qualified Research Projects may include early detection of a new primary tumor that appears as a result of a cancer field effect . Testing for metastases or recurrence of the primary tumor is not early detection.

Prevention: A prevention Research Project investigates a medical, surgical, or lifestyle intervention that aims to reduce cancer incidence in individuals at risk. A Research Project that addresses the prevention of a second primary tumor is also appropriate. A Research Project that addresses the prevention of cancer recurrence or develops a therapeutic vaccine in a no-evidence-of-disease state in treated cancer is not acceptable as an EPPS Research Project. However, vaccines targeting "at-risk" lesions (e.g., pancreatic cysts, Barrett's esophagus, or ductal carcinoma in situ (DCIS)) are appropriate.

Population Science: Population science aims to understand the causes and distribution of cancer across all populations, supports the development of effective interventions to reduce cancer risk, mortality, and morbidity, as well as the social cost of cancer, and monitors and explains cancer trends . A population science Research Project specifically in the SPORE may focus on study participants selected from sampling frames drawn from the general population, individuals at risk for cancer, or cancer patients. Unlike clinical trials with their specific inclusion criteria, population science studies should be sufficiently representational to allow for substantial external validity, i.e., generalized inferences to the target populations in the studies. Likewise, population science studies that focus on biomarker discovery and/or validation may not draw on specimens from convenience samples, such as a case series of highly selected patients, but instead must be drawn from a sampling frame that represents the target population under study and must be based on samples that allow for inferences to the target populations.

3. Scientific Collaborations:

Horizontal Collaboration: Collaboration with others outside the SPORE grant to complete the research aims and/or goals of a SPORE Research 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 Research Projects with other SPOREs or the use of industry-provided agents. Interactions between Research 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 beyond the specific aims of Research Projects along the translational continuum (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).

SPORE Features and Objectives All SPOREs include the following common features:

1. Translational Research Focus: All SPOREs are 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 Research Projects may investigate basic science objectives if those objectives are relevant to human cancer and will lead to a human endpoint within the 5-year period of the grant.

2. Flexibility to Change Research Direction/Team Approach: The flexibility of the SPORE program allows PD(s)/PI(s) to replace projects that are completed ahead of schedule or projects that are making little or no translational progress with new translational projects. . The team of scientists that participate in SPORE Research Projects may or may not remain the same, and the roles of co-leaders may change throughout the funding period. Review and approval by the External Advisory Board (EAB) and NCI Program Staff are required. The flexibility option is available only after the first year of the funding period. This option may not be used to add full scientific Research Projects over and above the number of Research Projects that were peer-reviewed, even if no new funds are requested.

3. SPOREs support Specialized Research Infrastructure by:

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 aimed to identify research questions that can only be accomplished through collaborations, networks, and consortia and take full advantage of SPORE's scientific expertise and infrastructure.

6. Participation in NCI-Sponsored SPORE-related Meetings, Workshops, and other Activities: Key personnel share expertise and research results with other translational research grantees in NCI-sponsored meetings, workshops, and working groups. The goals of these meetings may include the identification of consensus data standards, sharing of materials and data, assessing progress, and identification of new collaborative opportunities.

7. Research Objectives The SPOREs are focused on organ-specific cancers, groups of highly related cancers, or cancers driven by common activation pathways or cross-cutting themes (including, but not limited to, targeting of commonly mutated oncogenes or reactivating tumor suppressor genes; cancers centered around a common biological mechanism; pediatric cancers; or cancer research with a unique focus on population groups experiencing differences in cancer outcomes.).

Pre-application Communications with NCI Staff Each prospective SPORE applicant is advised to schedule a pre-application consultation with the NCI staff using contact information in Section VII of this NOFO. The consultation should be scheduled at least 4 to 6 months in advance of the application due date and is intended to help the PD/PI (along with one or more of his/her intended co-investigators) understand the Program and its translational objectives and discuss strategies for preparing a competitive application. NCI staff will clarify SPORE requirements, and current NCI budget allocations, and describe the peer-review process. The NCI staff can also answer 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.

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

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Renewal

Resubmission

Revision

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

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Approximately six to ten SPORE awards per year are anticipated.

Award Budget

Applicants may request a maximum of $1,400,000 in direct costs per year, which excludes third-party indirect costs.

Applications that include one or more qualified Early Detection, Prevention, or Population Science (qualified EPPS) Research Project(s) may request up to an additional $120,000 in direct costs per year to support this project(s) and supporting cores, if appropriate. Only one request for $120,000 direct cost per year per grant for each of the 5 years of support is allowed, even when more than one EPPS Research Project is proposed.

Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations/International Collaborations

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 not allowed.

Required Registrations

Applicant organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The applicant institutions should have a demonstrated ability to conduct translational research (see key definitions) in the prevention, early detection, diagnosis, and/or treatment of human cancer. Investigators may only serve as a PI/multi-PI on one funded SPORE P50 at a time. However, investigators may have other roles (i.e., Co-Leader, Core Director) on multiple SPORE P50s concurrently, even from more than one institution.

Minimum Research Base: In order for a SPORE application to be 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, U54, 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. PDs/PIs supported by the NCI's non-mentored "K" career development grants or the R00 portion of the K99/R00 award may 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. Applications that do not meet the Minimum Research Base requirement will be considered not responsive and will not be reviewed or considered for funding.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Note: It is acceptable for investigators to concurrently submit the same or overlapping Research Project as a SPORE Research 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 Research Projects) award if both are determined to be eligible for funding. Investigators may not concurrently submit both a P01 and a P50 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.

An applicant organization cannot have multiple SPOREs with the same overall scientific focus/theme, even if there is no overlap in scientific content. Moreover, an applicant organization cannot have a SPORE with a Research Project that overlaps with the overall scientific focus/theme of another SPORE at the applicant organization. This is particularly relevant for SPOREs focused on groups of highly related cancers or a cross-cutting theme.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) 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.

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

Required

Required

Required

Required

Required

Required

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.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

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) Follow standard instructions.

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 across all components 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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

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 prevention, early detection, diagnosis and/or treatment of the organ-site specific cancer, group of highly related cancers, or cross-cutting cancer theme chosen for study.

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 (for new and renewal applications) and Progress Report (for renewal applications) 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. PDs/PIs of renewal applications should succinctly address the most significant translational research achievements in the current funding period of support, including results that were the basis of further movement across translational and clinical trial programs, and their potential impact on human cancer. Renewal applications should also discuss the use of the SPORE's flexibility to replace projects that are not meeting translational research milestones or that have been completed successfully with new, promising projects, during the current award period.

Overall Significance

Overall Innovation

Overall Approach

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 Core(s).

Scientific Collaboration (SC) Information related to scientific collaborations must be provided within the Overall component. The definition of Horizontal and Vertical Collaborations in the context of this NOFO may be found in Part 2 Section 1 Key Definitions. Succinctly address the following:

Progress Report (for Renewal Applications)

Progress Report Publication List: Include here publications and accepted manuscripts that cite the SPORE grant and have resulted from projects that are not being continued in this application. Emphasize in bold font each listed publication that is the result of formal collaborations with other SPOREs, or with other funded NCI networks, such as the NCI Clinical Trials Network, the Early Detection Research Network (EDRN), or the Experimental Therapeutics Clinical Trials Network (ETCTN). For publicly available citations, PMC submission identification numbers (PMCID), if required, should accompany the full reference. Publications resulting from projects that are continuing in the proposed application should be included within each Research Project component section. Copies of these publications should not be included as appendix material.

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:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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:

PHS 398 Cover Page Supplement (Administrative Core) Follow standard instructions.

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.

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)

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 person month (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 for costs to cover the travel of (up to) 10 investigators per SPORE to NCI-sponsored meetings/workshops and NCI-related 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.

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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

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

Research Strategy: Succinctly address the following items:

Leadership: Describe the plans for the organizational, administrative, and scientific management (both basic and clinical research) of the SPORE program. Describe and/or diagram the chain of authority for decision-making and administration within the program.

Administrative Management: Describe the plans for fiscal management, grant administration, and meeting coordination. Quality control and communication aspects of the grant for all institutions is involved should be discussed. Include a succession plan that describes the process for changing leadership if the SPORE PD(s)/PI(s) is no longer willing or able to lead the SPORE. A statement of commitment to attend NCI-sponsored meetings/workshops and other NCI-related activities should also be included.

Cancer Patient Population: Each SPORE must describe and document access to a substantial patient population for the cancer organ site, subtype, or group of related cancers that are the focus of the application.Provide reasonable assurance that the patients and human specimens needed for translational research are readily available. A consortium agreement may be established between institutions to provide adequate access to clinical specimens and/or patient populations. For renewal applications, document the accomplished translational goals, including evidence of human subject enrollment on clinical/population research studies during the past funding period.

Planning and Evaluation Activities: Discuss the planning and evaluation of SPORE activities, e.g., the evaluation of productivity of existing Research Projects and Shared Resources Core; the process for discontinuing Research Projects and replacement and the responses to important…