NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

This Funding Opportunity Announcement (FOA) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-designated Cancer Centers. NCI-designated Cancer Centers serve as major sources of discovery into the nature of cancer and of the development of more effective approaches to prevention, diagnosis, and therapy. They contribute significantly to the development of shared resources that support cancer relevant research and they collaborate and coordinate their research efforts with other NCI-funded programs and investigators.

The objectives of the NCI Centers Program are to foster highly interactive cancer research through support of the following:

• Formal, interactive scientific research programs comprised of investigators with common scientific interests and goals, yielding competitively funded research grants and contracts and productive collaborations
• Centralized Shared Resources that provide access to technologies, services, and scientific consultation that enhance scientific interaction and productivity
• Strategic planning and evaluation that further the research agenda of the Center
• Developmental funding that allows the Center to pursue newly identified priorities, strengthen weaker scientific areas, and explore new collaborations and technologies
• Activities that engage the populations within the catchment area in the conducted research and other Center activities
• Efforts to coordinate and enhance existing cancer research education, training, and career development activities h
• Centralized Cancer Center administration for resources and services, fiscal management and other supportive activities, and
• Centralized scientific oversight of cancer clinical trials

NCI support to Cancer Centers is intended to foster excellence in research across a broad spectrum of scientific and medical concerns relevant to cancer. To facilitate discovery and its translation into direct benefit to patients and the general public, the NCI awards CCSGs to institutions that have a critical mass of excellent cancer-relevant scientific research. The CCSG focus on research derives from the belief that a culture of discovery, scientific excellence, transdisciplinary research, and collaboration yields tangible benefits extending far beyond the generation of new knowledge.

The National Cancer Act officially established the Cancer Centers Program in 1971.The legislation was based on the report of a congressional committee, which concluded that a formalized Cancer Centers Program would provide a unity of purpose, a centralized platform for sharing concepts and resources, and a management structure necessary to achieve progress toward the goal of preventing and curing cancer. The Act grandfathered in twelve existing Centers that were already receiving support through diverse NCI grants and contracts and authorized the establishment of additional centers. It also implemented a standard funding mechanism (the P30 Cancer Center Support Grant or CCSG) and guidelines, and created an administrative and organizational home for the program at the NCI.

Based on this early legislation, qualified applicant institutions receive the CCSG award and accompanying NCI designation for successfully meeting a spectrum of rigorous competitive standards associated with scientific and organizational merit. While CCSG requirements have evolved over the years, the grant continues to support research infrastructure that enhances collaborative, transdisciplinary research productivity. CCSG grants provide funding for formalized cancer research programs, shared research resources, scientific and administrative management, planning and evaluation activities, development of new scientific opportunities, and centralized clinical trial oversight and functions.

Although the CCSG does not directly fund the wider range of activities at Cancer Centers, an NCI-designated Cancer Center links state-of-the- art research and care, thus perpetuating the translational continuum. To decrease cancer incidence and mortality among populations within its catchment area, including minority and underserved populations, it also establishes partnerships with other health delivery systems and state and community agencies for dissemination of evidence-based findings.

Over the past several decades, the number of NCI-designated Cancer Centers has grown extensively - today they are in a variety of organizational settings across the United States. An NCI-designated Cancer Center is a local, regional, and national resource, directly serving its community and, through the knowledge it creates, the nation as a whole.

NOTE: The catchment area must be defined and justified by the center, based on the geographic area it serves. It must be population based, e.g. using census tracts, zip codes, county or state lines, or other geographically defined boundaries. It must include the local area surrounding the cancer center.

The NCI recognizes two types of Cancer Centers:

• Cancer Centers have a scientific agenda primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based science; or some combination of these areas. All areas of research are linked collaboratively. While not all basic findings require a translational endpoint, basic laboratory Centers develop linkages with other institutions that will foster application of laboratory findings for public benefit where appropriate.
• Comprehensive Cancer Centers demonstrate reasonable depth and breadth of cancer research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based science. Comprehensive Cancer Centers also have substantial transdisciplinary research that bridges these scientific areas. They are effective in serving their catchment area, as well as the broader population, through the cancer research they support. They integrate cancer training and education of biomedical researchers and community health care professionals into programmatic efforts to enhance the scientific mission and potential of the Center.

A successful NCI-designated Cancer Center demonstrates strength in six essential characteristics. Together, these characteristics maximize its scientific potential and produce a whole that is greater than the sum of its parts:

• Physical Space: Physical facilities dedicated to the conduct of cancer focused research, and to the Center’s shared resources, and administration, are appropriate and adequate for the task.
• Organizational Capabilities: The Center takes maximum advantage of institutional capabilities in cancer research, engaging in appropriate planning and evaluation of Center strategies and activities. If a consortium is proposed, the consortium institution(s) add significant cancer research expertise to the Center.
• Transdisciplinary Collaboration and Coordination: Substantial coordination, interaction, and collaboration, both among Center members from a variety of disciplines and between Center members and investigators in other institutions, enhance and add value to the productivity and quality of research. As appropriate to the nature of the research, Centers facilitate transition of scientific findings through the translational continuum, via coordination of research across NCI and other funding mechanisms and through collaborations with other partners.
• Cancer Focus: The Center members grants and contracts, as well as the structure and objectives of its formal research Programs, demonstrate a clearly defined cancer research focus.
• Institutional Commitment: The Center is a formal organizational component of the institution, with sufficient space, positions, and discretionary resources to ensure its stability and fulfill the Center’s objectives. The Center Director has authorities appropriate for managing the Center and furthering its scientific mission. The institution recognizes team science in its promotion and tenure policies.
• Center Director: The Director is a highly qualified scientist and administrator with leadership experience and expertise appropriate for establishing a vision for the Center, advancing scientific goals, and managing a complex organization. He or she is effective in using institutionally designated authorities to manage the Center and advance its scientific objectives.

An NCI-designated Cancer Center should feature vigorous interactions across its research areas, facilitating collaboration between basic laboratory; clinical; and prevention, control and population-based science investigators and the formal research programs of which they are a part. The organizational approach should serve the science of the institution, with reasonable breadth and depth of cancer-focused scientific faculty and dedicated research facilities.

In addition, Centers should ensure that they are both fostering basic discovery and, as applicable, facilitating transition of scientific findings through the translational pipeline (i.e., basic to pre-clinical and early clinical development, then to Phase III trials or other types of definitive studies appropriate to the nature of the research). Discoveries may be advanced through NCI and other peer-reviewed translational science and clinical trial funding mechanisms (e.g. grants for SPOREs, program projects, phase I/II consortia, and the NCI National Clinical Trials Network or NCTN) and other collaborative strategies, including external partnerships. All Centers are encouraged to establish collaborative links that maximize productivity and result in appropriate application of findings. The form and extent of these activities may vary, based on the type of Center.

Depending on Center type, the major research areas may include:

• Basic Laboratory Research: Centers use their base of support to promote breadth and depth in basic laboratory research and transdisciplinary collaborations among investigators in basic discovery and other research areas, both within the Center and with other external partners.
• Clinical Research: Cancer Centers engage in a broad spectrum of clinical studies with diverse forms of sponsorship. A Cancer Center is a major source of innovative investigator-initiated clinical studies that can be exported to NCI’s NCTN or other appropriate externally peer-reviewed funded mechanisms. Clinical studies involve relevant laboratory research whenever possible. Cancer centers foster translation between the laboratory and clinic and conduct early proof-of-principle clinical trials and lead, and/or participate in, NCI’s NCTN trials (including studies of rare cancers). Cancer Centers also participate in trials initiated by industry and other NCI-designated Cancer Centers and other external partners.
• Prevention, Control, and Population Science Research: While Cancer Centers may not be able to conduct research in all aspects of prevention, cancer control, and population science, and no one area is required, they demonstrate depth in grant support across several thematic areas (e.g., epidemiology, primary prevention, early detection, health services, dissemination, palliation, and survivorship). They also demonstrate appropriate collaborative links to other research areas within the Center and with other NCI-designated Cancer Centers and other external partners.

Consortium Centers

NCI supports consortium Centers in which investigators from distinct scientific institutions partner together to contribute actively to the development and actualization of the cancer research agenda; these formalized relationships have the potential to both strengthen the science of the Center and further extend the benefits of its cancer research. Partnerships between research institutions serving special populations or located in geographic areas not currently served by an NCI-designated Cancer Center are particularly encouraged.

Several basic principles apply to consortium arrangements in the context of the NCI designation:

• Each member institution adds strategic value to the research mission of the cancer center, i.e., holds a portfolio of peer-reviewed cancer related research grants that contribute to the center’s scientific goals. This clearly distinguishes consortium centers in the CCSG context from other types of partnerships, such as clinical networks or affiliations with community hospitals designed primarily for the purpose of enhancing clinical trial accrual or expanding the center’s patient base. To be eligible for consortium status, each consortium partner must, at a minimum, hold a peer-review funded portfolio of cancer-relevant research equivalent to a CCSG research program i.e., 7 R01-equivalent active grants or more, held by 5 independent principal investigators (the projects may be distributed across multiple Center programs). These grants, as well as other data such as clinical trial accrual, cannot be counted as part of the Center until the consortium arrangement is approved by NCI following acceptance of the consortium arrangement by the NCI’s Initial Review Group subcommittee A-Cancer Centers, as part of their overall review of the P30 CCSG application. is
• The consortium partner must contribute continuing tangible commitments to the Center. These may include: direct financial support of cancer research; protected cancer research time to support programmatic goals; leadership positions in the Center’s research programs or other components; common strategic planning and priorities (recruitment, clinical trials, grants, etc); physical space for cancer research, etc.
• At the time of application for a CCSG, the partnering institutions must already function as one cohesive cancer center. Their research must be integrated (as evidenced by a history of collaboration, including joint grants and publications) and mechanisms must exist for including geographically dispersed members in programmatic activities. Common fundraising and a joint Internal Review Board for evaluation of all cancer research across the partner institutions are encouraged, but not required.
• A formal, written agreement is in place to ensure the stability and integration of the consortium partnership. The agreement should include:
• A process for resolution of differences at the highest levels of institutional leadership.
• A single Protocol Review and Monitoring System and Data and Safety Monitoring Institutional Plan governing cancer clinical trial protocols across all partner institutions.
• An integrated planning and evaluation process that enables achievement of the center’s research goals, (e.g. identification of future recruitment needs, shared resources; and other activities).
• Ongoing, tangible institutional commitments to the cancer center from all consortium partners. Such commitments should be appropriate to the nature of the consortium and may be demonstrated in a number of ways, including financial and in-kind contributions based on agreed upon formulas, housing and funding of cancer center cores, accrual to center-wide trials, active representation and engagement of members in Cancer Center Programs and committees, etc.
• Full eligibility for membership in formal scientific Programs and leadership positions in the center
• Reasonable access to shared resources for all members.
• Center director oversight of CCSG-supported shared resources, including those located in partner institutions

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

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

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)

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)
• 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 Institutions) 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.

Specific to this FOA: An applicant institution must have a funding base of at least $10,000,000 in annual direct costs of peer-reviewed, cancer-related funding. If the cancer center is a consortium of institutions, the funding base of the center will be the sum of the funding bases of all participating institutions. However, funding (and other data) awarded to consortium partners may be included only if the partner has been previously evaluated in CCSG peer-review and approved by NCI.

Sources of Support That May Be Included for Determining Eligibility to Apply for a CCSG are:

NCI peer-reviewed grants, cooperative agreements, and contracts: R00, R01, R03, R15, R18, R21, R24, R25, R33, R35, R41, R42, R43, R44, R50, R55, R56, P01, P20, P30s other than the CCSG, P50, SC1, SC2, U01, U10, U19, U54, U56, T32, K and F series awards and N01s (excluding SEER and other N01s funding materials, services, or research resources). Cancer-relevant research funded by these mechanisms from other NIH Institutes may also be counted towards the minimum, as does cancer-relevant grants and contracts from the funding sources listed in: http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per institution, identified by a unique DUNS number, is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	30 pages
Admin Core (use for Cancer Center Administration)	12 pages
Core (use for: Cancer Research Career Enhancement and Related Activities Shared Resources)	6 pages each
Project (use for Research Programs)	12 pages each
CCSG component (use for: Community Outreach and Engagement Developmental Funds Leadership, Planning and Evaluation Clinical Protocol and Data Management Protocol Review and Monitoring System)	12 pages each

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) 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: required
• Cancer Center Administration: required
• Cancer Research Career Enhancement and Related Activities: required
• Shared Resource: at least one is required
• Research Programs: at least one is required
• Community Outreach and Engagement: required for clinical and comprehensive cancer centers; optional for basic centers
• Developmental Funds: optional
• Leadership, Planning and Evaluation: required
• Clinical Protocol and Data Management: required for clinical and comprehensive cancer centers Protocol Review and Monitoring System: required for clinical and comprehensive cancer centers

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Project Summary/ Abstract: Briefly describe the problems being addressed by the Cancer Center and how the Cancer Center solves target problems related to health effects.

Project Narrative: Indicate the relevance of the Center’s research to public health.

Facilities and Other Resources: Include a description of the following in a single attachment:

Physical Space

• A map that illustrates the main location of the Center’s research and administrative activities, and the physical relationship of any consortium institutions to the main campus may be provided.

Institutional Commitment

• A chart indicating the organizational status of the Cancer Center within the institution may be provided.

Other Attachments: The following "Other Attachments" should be included with the overall component in order 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.

I. Supportive data in a table format

These tables (if desired, applicants may use suggested Data Table format described in CCSG Summary Data Guide (https://cancercenters.cancer.gov/GrantsFunding/DataGuide) itemize the center’s formal research Programs, shared resources, base of funded research projects, patient information, clinical research protocols, and a comparison of current and requested budgets.

For each table, please use a separate attachment and title as suggested:

• Data Tables 1a, b, c, and d list the Center’s senior leadership (e.g., cancer center director, deputy director, and associate directors), leadership of the proposed Programs and shared resources, and cancer center membership. Please title this attachment "DT1".
• Data Table 2a lists all active cancer-related projects competitively funded by sources external to the fiscally responsible institution of which the cancer center is a part, as of the date of preparation of the data table. Grants are listed alphabetically by PD/PI in two parts active, funded peer reviewed research and active non-peer reviewed research projects. Do not include training projects (they are listed separately in Cancer Research Career Enhancement and Related Activities). Provide a DT2A for each member of a consortium Center. Please title this attachment "DT2A"
• Data Table 2b provides a consolidated list of the funding by category. Together with Data Table 2a, it indicates the size and scope of the funded research base of the center. Please title this attachment "DT2B"
• Data Table 3 provides cancer registry data regarding the numbers of patients newly diagnosed and treated at the cancer center during a recent 12-month period. Please title this attachment "DT3"
• Data Table 4 lists clinical research protocols open at the center during a recent 12-month period, sorted by Program, category of research, sponsor, and PD/PI. Please title this attachment "DT4"
• Data Table 5, which should be titled DT5
• for renewal applications list the current (last full non-competing year) budget in each CCSG budget category

II. Information on Consortium

• If the application is submitted as a consortium, a table listing locations of all partnering institutions may be provided. Supply a separate listing (for each consortium partner) in DT2A format of all active cancer-related research projects competitively funded by sources external to the fiscally responsible institution of which the consortium partner is a part, as of the date of preparation of the data table.
• Memorandum of Understanding between partnering institutions

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.

Include only the Project Director/Principal Investigator (PD/PI) (i.e. Director of Cancer Center) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

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.

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

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.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component

Specific Aims: Describe the mission and specific aims of the Cancer Center.

Research Strategy: This section must contain two parts:

Part I: Director’s Overview

Please provide a description of the following:

• The history and overview of the Cancer Center
• The most important scientific accomplishments during the last period of support, or, for new applications, the most significant scientific accomplishments in the period (as defined by the applicant) preceding the application
• Specific scientific examples of how the Center has taken advantage of its resources to significantly influence new approaches in cancer diagnosis, prognosis, treatment, and prevention during the last period of support

If you are presenting a consortium Center, describe the consortium relationships comprising the Center and the value added by the consortium in broadened expertise, patient population, catchment area, at-risk populations, collaborative scientific activities, etc. Briefly describe the contributions and tangible commitments of each consortium institution, and the history, objectives, and benefits of the consortium arrangement. Do not duplicate text in the Six Essential Characteristics below.

Part II: Six Essential Characteristics

1. Physical Space: Centers are more successful in establishing an identity if they have a distinct physical location. Not all members of the Cancer Center need be physically located in facilities controlled exclusively by the Center; however, location of members across program areas (basic laboratory; clinical; and prevention, control, and population-based science) in close physical proximity enhances shared use of resources and facilitates scientific interactions. Even if proximity is impossible, Center shared resources and other services should still be reasonably accessible to all members, including consortium members.

In your application, briefly describe the physical facilities dedicated to cancer research, Center shared resources, and administration. Indicate how the Center facilitates access to shared resources and other services (i.e., Clinical Protocol and Data Management). Discuss any plans for expansion.

2. Organizational Capabilities: A Center and its consortium partners should have an overall programmatic structure that effectively promotes collaborative scientific interactions both within the institution, with other NCI-designated Cancer Centers, and with other external partners. It should take maximum advantage of the institution’s cancer research capability (this is particularly important to explain when the Center includes multiple participating institutions in a consortium arrangement), as well as an efficient and cost-effective administrative organization with clear lines of authority.

While a formal written strategic plan document is not required to be included in the application or at the site visit, include a concise summary that includes the mission, vision, and research goals for the Center for the next five years and describe how these have been integrated into the research program’s specific goals.

Using the above description, discuss how the organizational structure enhances the capabilities of the Center.

Consortium centers should include a discussion of how differences are resolved among partners and how planning and evaluation processes are integrated to meet the strategic goals of the Center, including those for clinical trials, faculty recruitment, and other research activities.

3. Transdisciplinary Collaboration and Coordination: An actively functioning Center promotes innovative and interactive research opportunities through the formation of formal scientific research Programs, comprised of groups of investigators who share common scientific interests and goals and participate in competitively funded research and in publications and other interactive activities. Inter- and intra-programmatic collaborations are important, as well as collaborations with other NCI-designated Cancer Centers and other external partners. These activities maximize the potential of the institution, whether small or large, to conduct transdisciplinary and translational research.

Movement of scientific findings through the translational pipeline, (i.e., basic to pre-clinical and early clinical development, then to late phase trials or other types of definitive studies appropriate to the nature of the research) is also critical. NCI and other peer-reviewed translational science and clinical trial funding mechanisms (e.g., grants for SPOREs, multi-investigator R01s and program projects, phase I/II consortia, and the NCI NCTN) are important avenues for advancing discoveries originating in the Center and coordination of research across these mechanisms is strongly encouraged. Collaborative strategies may involve investigators within the Cancer Center, investigators in other Centers, industry, or other partners. The form and extent of these activities may vary, based on the type of Center, but all Centers are encouraged to establish collaborative links that result in appropriate application of findings, i.e., not all transdisciplinary research is translational.

In this section, describe accomplishments during the previous funding period in three distinct areas - transdisciplinary research, translational research, and collaborative research. For new applications, describe the most significant scientific accomplishments in the period (as defined by the applicant) preceding the application. In addition, describe how the Center has facilitated activities in each of these three areas. summarize the center’s major scientific strengths, its principal research opportunities, and the transdisciplinary coordination and collaboration between cancer center members, including inter-and intra-programmatic collaborations and those involving consortium institutions. Provide a brief description of how the center fosters transdisciplinary collaboration through collaborative research projects, joint publications, retreats, working groups, colloquia, joint seminar series, and other types of meaningful interchange that cement interactions around related or common goals. The type and balance of activities will vary from center to center. Discuss how productivity and quality of translational research in the center are enhanced by these collaborations and the mechanisms used by the center to promote interactive research opportunities. Describe strategies that have promoted appropriate movement of findings through the translational and clinical continuum both within and outside the Center, including coordination across NCI and other translational science and clinical funding mechanisms.

Consortium applications also should document the integration of research Programs and activities across the partner institutions, as well as cross-institutional access to Center resources and participation and leadership in Programs.

4. Cancer Focus: A clearly defined scientific focus on cancer research is demonstrated via the Center members grants and contracts, by the structure and objectives of its formal Programs, and the collaborations between laboratory researchers and other investigators more directly concerned with application of research knowledge. NCI recognizes that cancer-relatedness should be a matter of flexible interpretation (e.g., as with studies of basic mechanisms or of conditions or behaviors that influence a range of diseases), but the Center should be prepared to demonstrate how the scientific research it supports through the CCSG is linked to cancer.

Based on the description above, discuss how the projects in the Center’s peer reviewed, funded research support and the collaborations between Center investigators support the objectives of its cancer research Programs and reflect a scientific cancer focus.

5. Institutional Commitment: The NCI designation lends stature to an institution by attracting patients, industry research support, and philanthropy. The NCI substantially invests in cancer centers and expects similar commitment of the institution(s) to the Center.

Commitments of parent institutions to the Cancer Center generally include the following:

• An organizational status for the Cancer Center that is comparable or superior to that of departments.
• Funding from the institution and consortium partners.
• Research, clinical, and administrative space and positions.
• Measures that ensure other institutional leaders (deans, hospital presidents, and department chairs) will provide the long-term stable support necessary to accomplish strategic Cancer Center objectives.
• Joint control, at a minimum, with department chairs over faculty recruitments to the Cancer Center.
• A well-defined plan for a change in directorship and for continuing institutional commitment to support of the Cancer Center.
• Recognition of participation in team science in institutional policies, including those related to promotion and tenure.
• A commitment to facilitate clinicians to participate in clinical trials
• A commitment to facilitate research by clinician scientists
• Authority of the Center Director:
• As comparable or superior to that of department chairs, with appointments to decision making committees relevant to the Cancer Center and formally codified authorities.
• Over specific research and resource space and equipment dedicated to the Cancer Center for the enhancement of center research capabilities.
• Over inpatient and outpatient clinical research facilities and the appointment and evaluation of individuals critical to linking oncology care to clinical research.
• Over faculty appointments to the Cancer Center, and of their periodic review for continued membership.
• Over central discretionary funds (e.g., philanthropic funds, facilities and administrative costs, and clinical revenues).
• In consortium centers, Director oversight for integration of scientists in collaborating institutions into the research Programs of the center and CCSG-supported shared resources.

This section of your application should discuss the institutional commitment relative to the above description.

The stability of a consortium is demonstrated via provisions of formal written agreements, the record of tangible contributions of each consortium institution to the Cancer Center.

6. Center Director: The Director should be a highly qualified scientist and administrator with the leadership experience and expertise appropriate for establishing a vision for the Center, advancing scientific goals and managing a complex organization. In a consortium, the Director should play a major role in advancing the integration of the partner institutions into the research and other activities of the Center. He or she should have an appropriate time commitment to the directorship role.

In your application, briefly describe the scientific and administrative qualifications and leadership experience specifically pertinent to the Center Director role. Discuss activities of the Director relative to overall management of the Center and use of authorities and resources to advance the Center’s research mission.

Letters of Support: As the attachments, include letters of support signed by the Dean and Hospital President and/ or other appropriate institutional officials documenting specifics of institutional commitment both for the long-term future of the Center and for this award 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, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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, 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 SF424 (R&R) Application Guide must be followed.

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

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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: 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.

Other Attachments: In a table, provide sources of funding for activities of the administrative office, including the CCSG.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

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

Include the costs necessary for central administration of resources and services required for Center research activities, fiscal management of the Center, and reporting activities. Because administrative structures differ from Center to Center, carefully explain and justify requested support.

The CCSG central administrative budget may support an appropriate percentage of the salary of the chief administrator, secretarial and other staff, travel needs of senior leaders and Program leaders in the performance of their Center-specific roles, and supplies for the administrative functions of the Center.

Funding for a percentage of salary for a staff person to support links with state health departments, other state agencies, or the Centers for Disease Control and Prevention (CDC) also is allowable. Partial salary support for a Center informatics lead to further NCI’s goals of increased interoperability both within the Center’s existing informatics systems and workflows, and between those systems and NCI informatics systems, may be included as well.

Examples of non-allowable costs include non-research educational activities, public relations, fund-raising, and general grant application and manuscript preparation. Matrix Centers should not duplicate parent institution responsibilities (i.e., services normally supported through indirect costs or provided by the institution to other comparable research units such as academic departments).

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.

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed Core.

Research Strategy: The applicant should describe all processes overseen by the Administrative Core. While organizational structures and functions vary, your application should describe, as appropriate (Note: the Administration is not required to carry out all functions listed below):

• Roles of administrative staff in governance and decision-making processes at the Center
• Relationship of the Center (e.g., level of support, overlap of functions, and authorities) to other offices within the parent institution, such as the central grants office and clinical and other pertinent entities
• Roles of Center administration in CCSG-related activities, for example:
• Oversight of the CCSG application process,
• Oversight and management of shared resources, whether Center or institutionally managed, e.g., prioritization processes, prices, chargebacks, auditing, user satisfaction measures, and quality control
• Role in strategic planning, communications, and facilitating collaborations within the Center and with other institutions
• Faculty recruitment, retention, and tenure/promotion activities
• Management of membership processes
• Oversee research and grants administrative processes
• Processes for solicitation, receipt, review, award, and monitoring of pilot projects
• Space management, including policies on assignment and retention, and optimization of space utilization based on intensity of use, maximization of collaborative opportunities, and shared capabilities
• Arranging and documenting Center meetings
• Management of philanthropic and other funds
• Budgeting, accounting, and expenditure monitoring
• For consortium Centers, how CCSG functions are coordinated across the partner institutions.

The form and extent of these activities may vary, based on the type of Center. A Center’s Administrative Core is not necessarily responsible for all the activities list above; some Centers may place some activities in other components, such as Senior Leaders, or institutional resources may be used

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

When preparing your application in ASSIST, 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 (Cancer Research Career Enhancement and Related Activities)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Cancer Research Career Enhancement and Related Activities)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cancer Research Career Enhancement and Related Activities)

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: 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.

Other Attachments: List, in a table format, all active cancer-related research education and training grants competititvely funded by sources external to the applicant institution (applicants may use suggested data table format 2A for this purpose, if desired). Grants are listed alphabetically by PD/PI in two parts active, peer-reviewed funded cancer research education and training grants and active non-peer reviewed education and training grants.

Project /Performance Site Location(s) (Cancer Research Career Enhancement and Related Activities)

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 (Cancer Research Career Enhancement and Related Activities)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Cancer Research Career Enhancement and Related Activities)

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

Cancer Research Career Enhancement and Related Activites may support:

• Faculty Associate Director of Cancer Research Career Enhancement
• Education Coordinator(s) and other staff that assist in Cancer Research Career Enhancement activities
• Travel to professional meetings for mentees
• Funding for support of activities directly relevant to the core, such as scientific seminar speakers, workshops, short courses, etc.

PHS 398 Research Plan (Cancer Research Career Enhancement and Related Activities)

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

Specific Aims: Summarize the goals of the proposed Core.

Research Strategy: The Cancer Research Career Enhancement and Related Activites core will coordinate existing research education and training activities at the cancer center and provide additional educational opportunities by supporting travel to scientific meetings, scientific seminars, workshops, and related activities. In this section describe:

• The cancer research career enhancement activities in which the core will be engaged, such as coordinating travel opportunities, seminars, workshops, and related activities
• The process for coordinating existing cancer education and training activities at the center, including with other institutional efforts, and integrating them into programmatic efforts
• The inclusion of special or unusual areas of cancer research education (health disparities, global health, etc.)
• New initiatives and plans for the next funding cycle

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Cancer Research Career Enhancement and Related Activities)

Not Applicable

When preparing your application in ASSIST, 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)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Shared Resources)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resources)

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: 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.

Other Attachments: The requested budget for the Shared Resource should reflect realistic needs in terms of support from other sources (e.g., institutional or Cancer Center support or recovery from chargebacks) and any other specific additional requirements. Provide the following information for the most current grant year and for the proposed period of support.

Sources of Support for Shared Resources

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

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)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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, such as the shared resource director(s) and manager(s)
• 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)

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

Cancer Centers may use CCSG funding to support member’s access to either institutionally- or Cancer Center-managed shared resources, including those integrated through multiple NIH funding sources, such as Clinical and Translational Science Awards. CCSG funding should not be used to establish independent, Center-managed shared resources that duplicate institutionally managed resources if the latter provide cost effective, accessible, and quality services. It should also not be used to support shared resources that are offered free of charge to other investigators. If proposed or existing institutional shared resources are not structured to meet Cancer Center needs, separate shared resources may be supported through the CCSG, but must be rigorously justified. CCSG funding for any shared resource should be proportional to use by investigators within the Cancer Center that have cancer-related peer-reviewed funding.

The CCSG provides stability for some of the operating costs associated with salary of key personnel operating centralized shared resources and services; small equipment maintenance contracts; service contracts; and minimal supplies. Replacement of small equipment (less than $25,000) also is allowable. Other variable costs associated with specific research projects should be supported by other funding sources, e.g., user fees, chargebacks, and institutional funds.

No standard approach applies to all shared resources and services. NCI recognizes that virtually all shared resources derive a portion of their operating costs from multiple sources. Centers should justify the proportion of funding allocable to the CCSG in the context of this overall support. The scope of the budget request should be reflective of use of the shared resource by Cancer Center members with peer reviewed funding.

The primary costs of research are supported by the peer-reviewed, funded grants and research contracts of the Center. Consider the elements listed below in developing budgets for shared re sources and services as they will be factors in peer evaluation of the budget:

• Need for the resource relative to current and projected use by peer-reviewed funded Center members.
• Cost-efficiency, particularly in comparison to other options (e.g., purchase orders or contracts to an outside vendor).
• Stability of the operation and quality of the service.
• Accessibility of the resource or service to qualified member-investigators, including the critical consultative services performed by experts who direct selected shared resources such as biostatistics and informatics.
• Proportion of the total resource operation paid for by the CCSG relative to other sources.

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)

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

Specific Aims: Summarize the goals of the proposed Core.

Research Strategy: In addressing Research Strategy for the Shared Resource, the applicant must adhere to the general guidelines below.

Goals: Shared Resources provide access to specialized technologies, services, and expertise that enhance scientific interaction and productivity. The support of centralized shared services for Center investigators is intended to ensure greater stability, reliability, cost-effectiveness, and quality control.

The primary beneficiaries of CCSG-supported shared resources and services should be Cancer Center members with peer-reviewed, funded projects, a standard assuring funds support high-quality research. Support to others is at the discretion of the Center Director and should be justified by contributions to the overall cancer research objectives of the Center (e.g., access by a junior investigator funded by a pilot project).

Issues Regarding Unique or Specialized Shared Resources:

A center has the flexibility to propose the functions that it wishes to have funded as shared resources. Primary consideration should be given to resources that are critical to a center s research mission. Additional factors may include the needs of past and potential new users, accessibility to cancer center members, and the effectiveness and fairness of the process for setting scientific priorities for their use. While shared resources should never be established for primary use by one or two members, the absolute number of users is of lesser importance than the value of the resource to the science of the center. Some technically sophisticated or unique resources (e.g., x-ray crystallography, preparation of clinical grade gene therapy vectors, proteomics, family ascertainment, health communication, tracking, nutrition support) are not always adaptable to high-volume operation, or may have only a few very specialized users, or be used by only one Program (e.g., population science). Chargebacks may not be relevant for resources such as informatics and biostatistics, and other consultative services not typically charged to grant mechanisms.

Biostatistics: Biostatistics is a shared resource central to the mission of most Centers, particularly those that perform clinical or population research. Participation by statisticians in many collaborative activities of the Cancer Center is eligible for CCSG support. Salary support is allowable for participation in Cancer Center pilot projects, assistance to Center investigators in conceptualizing and developing research projects, analyses for publication, and the development of methodology clearly and closely related to the support of specific projects within the Cancer Center. The CCSG is not intended to support: 1) independent, investigator-initiated research in statistical methodology, for which statisticians, like other scientists, should be supported by project-specific grants or 2) a significant collaborative role for a statistician on a funded research project, since this effort would normally be supported by an appropriate time-and-effort allocation as a collaborator on that grant.

In the narrative for each shared resource, describe the:

• Major services, technologies, equipment, and expertise provided by the Shared Resource
• Importance to the scientific needs and objectives of the Center (i.e., how the shared resources support the research of the Programs)
• Management structure, i.e., by the Center, institution, or other entity
• Cost-effectiveness of the resource relative to other options for obtaining the service, such as outside vendors, when applicable
• Unique processes (such as an internal advisory board, survey of members, etc.) relevant to Shared Resource planning and oversight, if applicable, and new Shared Resource services under development
• Current and/or anticipated use of services providing total number of users, total number and percent of users who are center members with peer reviewed support, and total number and percent of users who are center members without peer-reviewed support. Do not provide a list of users. Do not include users from other Centers in your calculations.
• Policies on operation and use of the shared resource, e.g., access, priorities, hours of operation, staffing, etc., and charge back systems. For institutionally managed (as opposed to Cancer Center managed) resources, describe the Center’s role in planning and oversight of the shared resource(s).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Shared Resources)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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.

Other Requested Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

If CCSG funds are requested to support clinical research in this component, create an Inclusion Data Record (IDR ) for each study.

When preparing your application in ASSIST, use Component Type Project.

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

Goals: Cancer Centers foster cancer-focused research, in part through the creation of formal scientific research programs. A research program comprises the activities of a group of investigators who share common scientific interests and goals and participate in peer-reviewed funded research. Programs are highly interactive and lead to exchange of information, experimental techniques, and ideas that enhance the individual productivity of scientists and often result in collaborations and joint publications.

Selection of members: Selection of members for a Center s programs is one of the most critical decisions made by leadership. Functional and productive programs select individuals for their scientific excellence and, just as importantly, for their commitment to work together to further the scientific goals of the Cancer Center. The expectation is that most members will hold peer-reviewed research funding; however, some unfunded members may contribute to the research objectives of the Center in other important ways (e.g., development and implementation of Center’s clinical activity, including authorship of clinical protocols, accrual of patients on interventional trials, and leadership roles in NCI NCTN studies), and their roles should be carefully described.

Collaborators from other NCI-designated Cancer Centers or research institutions may become Center and program members. While the funded research projects of these members cannot count toward the funding base of the Program or the Center, these members may have full access to shared resources and developmental funds.

Characteristics of programs: Programs should be of adequate size and scientific quality, cancer-focused, and should exhibit a high degree of interaction within the program, with other research programs at the Center, and with researchers at other institutions. Each program must have at least seven fully cancer-focused, peer-reviewed funded research projects equivalent to an NIH R01 from a minimum of five different, independent PD/PI to be eligible; however, successful programs substantially exceed this minimum. For the purposes of this FOA, R01-equivalence equals a project funding for 3 years minimum with at least $125,000 direct costs per year. Grants under no-cost extension do not count. Peer-reviewed, funded research sub-projects of larger grants (e.g., P01s, P50s), but not shared resources, may be counted as separate projects. The program leader or leaders are expected to have active peer-review funding.

The interactive attributes of a program are documented by collaborative research projects, joint publications, colloquia, joint seminar series, and other evidence of meaningful interchange that cement interactions around related or common goals. The type and balance of activities will vary from Center to Center. In addition, effective scientific leadership, with a history of cancer-related funding appropriate to the nature of the Program, provides intellectual stimulation, cohesion, focus, and direction. Each Program leader should have a specific role in facilitating the discovery process and promoting transdisciplinary research important to cancer, and any projected use of funds to support other scientific activities.

Definition of Peer-Reviewed, Funded Research Projects for Inclusion in programs and for designation of users in shared resources: Peer review as employed by the NIH is the acceptable standard for inclusion of a cancer-related research project within a formal Program. Only research projects that are awarded based on this standard are eligible for inclusion in research programs. This includes:

• NIH grants, cooperative agreements, and research contracts from NIH with the following prefixes (see http://grants.nih.gov/grants/funding/ac_search_results.html)
• Components of NCI National Clinical Trials Networks (e.g., U10s, U19s)
• Individual research studies involving protocols approved by the NCI Cancer Therapy Evaluation Program (CTEP) and funded by NCI.
• Individual research studies involving prevention and control protocols approved by the NCI Cancer Control Protocol Review Committee and funded by NCI.
• Awarded cancer-related research grants, cooperative agreements, and research contracts from other institutes of the NIH (same prefixes as above).
• Research projects funded by the non-NIH organizations with peer review funding systems listed at http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf

SF424 (R&R) Cover (Research Programs)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Programs)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Programs)

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: Please provide the following:

• The central themes and scientific goals of the Program.
• The number of Program members and the number of departments and schools represented.
• The NCI and other peer reviewed cancer-related support for the last budget year.
• The total number of Program publications and the percent that is intra- and inter-programmatic and/or collaborative with investigators in other institutions. (Note: Inter-programmatic publications may be listed in multiple Programs, as relevant, but should be included only once in an overall count of interprogrammatic publications).

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: A list of shared resources and other services used by program members.

Other Attachments: Please provide:

• A list of the externally funded, peer-reviewed cancer-related research projects (no page limit) of the program by member, project and funding source, using suggested format described for Data Table 2A, if desired. Program leaders should exclude grants focusing on other diseases (e.g., diabetes, cardiology, neurological disease) or address their cancer relevance in the programmatic narrative. Do not include training grants or non-peer reviewed funding.
• A list of the members of the program (no page limit) in alphabetical order, with their departmental and institutional affiliation, their academic rank (or equivalent) and their role in the program (e.g. research; development and implementation of the Center’s clinical activity, including authorship of clinical trials, accrual of patients to interventional trials, and leadership roles in NCI NCTN studies). Do not duplicate information about Key Personnel listed on the Senior/Key Person form. Information on the latter is especially important for assessment of the transdisciplinary nature of the program, integration of member activities, and contribution of members to programmatic goals.
• A list of intra- and inter- programmatic activities and external collaborations (no page limit) e.g., meetings, seminars, multi-investigator grants and publications, retreats, and working groups; and other significant collaborative activities with investigators outside of the center
• A selected list of program-related publications (no page limit). Include only those that have made an important scientific contribution, had a significant effect for patients and the public, or particularly illustrate intra- and inter-programmatic or other multi-institutional collaborations. Publications should represent the broad diversity of program members. Note: PubMed Central (PMC) ID numbers are required for all publications receiving direct cost support through the CCSG Shared Resources and Developmental Funds. Divide the publications list into two parts, those with a PMC ID (i.e., meeting the criteria above) and those without. Renewal applications should limit this list to significant publications funded through non CCSG sources from the last project period. For Renewals, publications resulting from CCSG support must be listed on the Progress Report Publication List attachment on the Research Plan form.
• A list of the clinical research of the program, if applicable (no page limit) using the definitions and format specified in the instructions for Data Table 4. NOTE: Centers may present Data Table 4 in individual programs, in one centralized program, or in some combination of these approaches, depending on the organization of their center.

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

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 (Research Programs)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Program Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Program Leader(s) 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 (Research Programs)

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

Please provide budget for the person months of the first and future years for the Program Leader(s). A level of effort must be included for each Program leader even if salary is not requested. Indicate if salaries meet or exceed the NIH salary cap. Programs may also request modest funding for support of scientific activities directly relevant to Program goals, such as small pilot projects, seminar speakers, etc.

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 Programs)

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

Specific Aims: Summarize the themes and objectives of the proposed research program.

Research Strategy: Briefly discuss the following:

• The most significant scientific accomplishments of the program in the last cycle and their impact
• How the interests, expertise, and research approaches of the program members and other collaborators facilitate achievement of the central themes and scientific goals listed in the description above
• Discuss how the Cores (Shared Resources) have supported those accomplishments
• Examples of how scientific findings by Center investigators are advanced:

- via translational and clinical funding mechanisms from NCI (e.g., grants for SPOREs, Phase I/II consortia, program projects, and NCTN) and other sources.

- via collaborations with additional partners, such as other institutions or industry

• For programs with clinical trials:

- interventional clinical trials that are making a difference, e.g., advancing the field or changing medical practice

- accrual of patients to interventional clinical trials over the project period preceding the current application, including a brief overview of accrual by types of trials (national, institutional, externally peer-reviewed, and industry)

• In addition to questions of broader applicability, and as appropriate to the type of Program, briefly describe how the cancer research relevant to the catchment area is addressed. This may include, for example, a discussion of research focused on cancer health disparities (e.g., problems affecting racial and ethnic minorities, rural residents, women, children, elderly, persons of low socioeconomic status), cancer sites of high incidence/mortality, environmental exposures, behavioral factors, or other issues.
• Future plans for the program

NOTE: The NCI defines cancer health disparities as differences in the incidence, prevalence, mortality, and burden of cancer and related adverse health conditions that exist among specific population groups in the United States.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Research Programs)

Not applicable

When preparing your application in ASSIST, use Component Type CCSG component.

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

SF424 (R&R) Cover (Community Outreach and Engagement)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Community Outreach and Engagement)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Outreach and Engagement)

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: 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.

Project /Performance Site Location(s) (Community Outreach and Engagement)

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 (Community Outreach and Engagement)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Outreach and Engagement)

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

Community Outreach and Engagement may support:

• Faculty Associate Director devoted to center efforts in community outreach and engagement, such as cancer health disparities, recruitment of underserved populations to clinical trials, etc.
• Coordinators of outreach and engagement of local populations
• Coordinators of educational outreach and engagement of local populations
• Personnel, such as patient navigators, who facilitate the inclusion of underserved populations into the Center’s clinical research

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 (Community Outreach and Engagement)

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed CCSG component.

Research Strategy: Cancer Centers occupy a unique role in their communities. They are expected to perform research relevant to their catchment area and engage the populations within their catchment area in the research they conduct and other Center activities. To decrease cancer incidence and mortality among populations within its catchment area, including minority and underserved populations, Centers also establish partnerships with other healthcare delivery systems and state and community agencies for dissemination of evidence-based findings.

In the Community Outreach and Engagement, the applicant should describe the aspects in which the Center and its research engages its catchment area, and how the center extends its reach beyond the catchment area.

NOTE: The catchment area must be defined and justified by the center, based on the geographic area it serves. It must be population based, e.g. using census tracts, zip codes, county or state lines, or other geographically defined boundaries. It must include the local area surrounding the cancer center

In this component describe:

• The center’s catchment area, including the demographics of its population
• How the catchment area was determined
• The cancer research issues relevant to the catchment area, with particular emphasis on unique or unusual cancer incidence, underserved populations, or cancer health disparities
• How the center engages populations in their catchment area with respect to clinical studies
• The implementation of health policy recommendations, such as tobacco cessation, HPV vaccine uptake, colorectal cancer screening, etc., designed to decrease cancer incidence and mortality rates in the cancer patients they treat and the communities they serve
• How the center addresses cancer health disparities
• As applicable, how the center extends its reach within and beyond its catchment area, through affiliates and other networks that bring the center’s expertise to bear on wider populations, rural populations, global cancer research, etc.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Community Outreach and Engagement)

Not applicable

When preparing your application in ASSIST, use Component Type CCSG component.

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

SF424 (R&R) Cover (Developmental Funds)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Developmental Funds)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Funds)

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: 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.

Other Attachments: If a budget is requested to support pilot projects, please provide a list of awardees and their projects with the outcome for the preceding project period.

For new applications, discuss how developmental funds from other sources, such as institutional funds, have been used.

If a budget is requested to support Staff Investigators, please provide a biosketch for each proposed Staff Investigator with a list of her/ his grants or clinical trials that s/he oversees.

Project /Performance Site Location(s) (Developmental Funds)

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 (Developmental Funds)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Developmental Funds)

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

Prepare an overall description and a composite budget that includes all requested developmental fund categories. Provide individual budgets by Developmental Funds category with separate narrative justifications, and define the proportion of total funds devoted to each Developmental Funds category described in the Research Strategy of this component.

The Cancer Center must centrally monitor and evaluate the effectiveness of all developmental funds. These funds can be administered flexibly - dispensed centrally by the Director and senior leaders to achieve broad strategic objectives or delegated to individual Program leaders to target specific scientific objectives.

Developmental funds are restricted to the uses described in the Research Strategy of this component, and may not be rebudgeted to other CCSG categories during the course of the project period. Support for any particular use is limited to 2 years, except in the development of new shared resources or the purchase of shared resource services from another Center. Developmental funds may not pay for training, routine equipment purchases, upgrades for established shared resources, or salary support for Senior or Program leaders or shared resource personnel

Specific comments on budgetary allowances and restrictions for Developmental Funds categories:

Recruitment of faculty level scientists: Developmental funds may not be used to support costs associated with the recruitment process itself, training or tuition, or large equipment purchases, but may fund recruitment packages that include the staff needed (e.g., technicians, graduate students, and postdoctoral fellows) to initiate the research program of a new investigator. The duration of support from these funds should not exceed two years. This category should provide temporary support permitting a new cancer investigator to establish his/her scientific activities at the new Center and achieve independent funding. Developmental funds cannot support established cancer researchers already within the institution (excepting the awarding of Developmental Funds through a pilot project process).

Developmental funds cannot be used for retention of established cancer researchers already at the institution.

Development of new Shared Resources: CCSG funds may not be used for upgrades or routine purchases of equipment when developing a new shared resource.

Purchase of peer-reviewed shared services from other NCI-designated Cancer Centers: Centers may use developmental funds to purchase meritorious, peer-reviewed shared services from within the established shared resources of other NCI-designated Cancer Centers.

Support of Staff Investigators: There is no limit on the number of Staff Investigators, but choices should be made judiciously and justified by the description of duties. The CCSG Guidelines do not prohibit members with other official roles in the Center from receiving additional support as a Staff Investigator, but responsibilities for each role should be clearly distinguished.

Support of early stage clinical investigators: Centers may use Developmental Funds for salary support (up to 20% effort per investigator) of early stage clinical investigators.

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 (Developmental Funds)

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed CCSG component.

Research Strategy: Developmental funds are the major source of budgetary flexibility in the CCSG. They should be used to pursue research innovation and move the Center in new directions that match its strategic goals. The Center should establish a rigorous process for allocating developmental funds, and centrally monitor and evaluate the effectiveness of all developmental funds.

Provide a brief listing of key priorities served by Development Funds at the beginning of the Research Strategy.

The Research Strategy should explain how past and proposed use are linked to the strategic and programmatic priorities and scientific opportunities of the Center. The narrative should summarize how past Development Funds, whether from the previous project period, or for new applications, from other funding sources, were used and what was accomplished with them (strategic recruitments, grants, publications, collaborative/translational research, inter-cancer center collaborations, new shared resources, innovative early phase clinical trials, etc.).

Use of Developmental Funds is restricted to the following:

• Recruitment of faculty level scientists in areas of strategic need: Judicious recruitments strengthen underrepresented areas of science significant to the enhancement of the Center’s overall research strength. Eligible investigators are: (1) those newly recruited from outside the parent institution, with developmental support beginning at the time of, or very soon after, arrival at the grantee institution. (2) those inside the institution who, whether junior scientists or well established in other scientific areas, are entering the field of cancer research as independent investigators for the first time.

If applicable, in your application explain how developmental funds were used for recruitment in the previous grant period (for renewal applications), or, for new applications, how other funds were used in the period (as defined by the applicant) preceding the application. Specify which investigators were supported, the rationale for recruiting these investigators relative to the needs of the Center, and to what extent these investigators were subsequently productive as evidenced by research grants, publications and leadership/participation in clinical trials.

Identify the kinds of individuals the Center plans to recruit as part of its plans for developing the Center. Identification of particular individuals or research plans is not necessary.

• Support of pilot projects: Developmental funds may be used to pursue innovative, high-risk ideas or stimulate high priority research areas (e.g., translational research, research on underserved populations, development of new technologies or methodologies, early phase clinical trials). Centers are encouraged to make these funds accessible to basic laboratory; clinical; and prevention, control, behavioral and population-based research for projects of relatively short duration (1-2 years). Pilot projects may be awarded to new or established investigators, preparatory to the development of an application for independent peer-reviewed support, or to take maximum advantage of a unique research opportunity, nurture an innovative idea, stimulate a high priority research area, or encourage cross-disciplinary translational research.

Pilot projects may include interventional early phase clinical studies that have no or partial other source(s) of funding. Studies supported should be highly innovative, early phase clinical studies that are developed based on science from the Center’s Research Programs.

The application should describe the processes for soliciting and reviewing proposals, and list the awardees and their projects for the preceding project period.

If CCSG resources are used in partnership with industrial resources, the Cancer Center must assure that applicable federal law governs the public availability of any final products of the research.

NIH must track all pilot projects in this category that include foreign components and, if necessary, State Department clearance must be obtained prior to implementation. The NCI OCC staff will act as the liaison between the Centers and the NIH Fogarty International Center, which is responsible for coordinating all clearances.

Pilot projects supported via this application component may be subject to NIH requirements for approval of human subjects, planned enrollment and inclusion reporting for delayed onset awards. Further information is available at: http://grants.nih.gov/grants/guide/notice-files/not-od-12-130.html.

• Development of new Shared Resources: Centers may develop new shared resources when there is a recognized need. Describe the planned shared resources, including need, anticipated scope of the services and timeline for development, and potential usage (predicated on member surveys or other data). Report on the outcomes for funds used for this component in the prior project period (e.g., of a newly established shared resource).

If a resource is sufficiently developed to be proposed and reviewed as established resources (e.g., a track record demonstrating its viability as a fully functioning shared resource), it should be proposed under the shared resources category.

• Purchase of peer-reviewed shared services from other NCI-designated Cancer Centers:

Your application should briefly describe the anticipated shared resource needs in this category and the research areas to be supported, and identify the NCI-designated Cancer Center shared resource services and the personnel that will provide those services. Where appropriate, report on the outcome of funds used previously for this purpose in the past (e.g., successful grant applications, completion of projects, and publications). Funding should be consistent with CCSG guidelines on shared resources (e.g., need, cost-efficiency, and accessibility), but no specific types of financial arrangements are mandated due to variation in institutional policies, facilities and administrative costs, other pricing structures, and the type and volume of the services that may be required.

• Support of Staff Investigators: Members of the Center who are important contributors to the scientific, translational, and clinical activities of the Center may receive salary support as a Staff Investigator for their specific roles in the Center. To qualify, individuals should play a definable and special role in either helping the Center achieve scientific objectives above and beyond their own research (Research Staff Investigator), facilitating Center-wide clinical activities (Clinical Staff Investigator), or, as part of a larger cancer center effort, furthering Center research that focuses on cancer issues for minority and other special or underserved populations (Special Populations Staff Investigator). Examples include a person in charge of developing a SPORE application, initiating a new research program, increasing minority accrual, etc. The level of support (percent effort) should reflect the time commitment.

Research Staff Investigators must be a PD/PI or serve a significant leadership role on at least one NCI approved peer-reviewed and funded research-project award and should play a special role in helping the Center achieve scientific objectives beyond those of their own individual research.

Clinical Staff Investigators should be instrumental in the development and implementation of the Center’s clinical activity, including authorship of clinical trials, accrual of patients on interventional trials, and leadership role in NCI National Clinical Trials Network studies.

Special Populations Staff Investigators must have a track record of NCI approved peer-reviewed research focused on minority and other special and underserved populations and should have a special role in advancing Center research that focuses on cancer issues for minority and other special or underserved populations.

Identify each Staff Investigator by name and type. Additional information, (e.g., for Research Staff Investigators and Special Populations Staff Investigators, their research track record and a list of peer reviewed grants on which they serve as PD/PI or serve a significant leadership role; for Clinical Staff Investigators, a list of authored trials, etc.) should also be provided.

Subsequent applications should provide information on accomplishments of Staff Investigators funded in prior cycles (for renewal applications only).

• Support of early stage clinical investigators: Support in this category is limited to faculty (non-tenured, assistant professor level or lower, of all disciplines, including nursing) who are actively involved in the Center s clinical science effort, e.g. participating in institutional and national clinical trials. There is no limit to the number of faculty that may be supported in this category. Centers may but do not have to name potential investigators, but should describe the type of investigator they would support and the expected outcome(s). Use of Developmental Funds for this purpose will be evaluated based on potential return-on-investment, such as success in retention as research scientists, in obtaining cancer-relevant funding, recruitment of patients to clinical trials of all types, participation and leadership in NCTN trials, expansion of the Center’s trials portfolio, publication of clinical science, promotion and tenure, etc. Centers may discuss previous support of early stage clinical investigators through non-CCSG funding sources, particularly from institutional support of early stage clinical investigators. Investigators with current K or T32 support are not eligible for support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Developmental Funds)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

If CCSG funds are requested to support clinical research in this component, e.g. pilot projects, create an Inclusion Data Record (IDR )for each study

When preparing your application in ASSIST, use Component Type CCSG component.

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

SF424 (R&R) Cover (Leadership, Planning and Evaluation)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Leadership, Planning and Evaluation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Leadership, Planning and Evaluation)

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: 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.

Other Attachments: In one document, provide a consolidated list of EAC members with titles and affiliations and attach their biosketches.

Project /Performance Site Location(s) (Leadership, Planning and Evaluation)

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 (Leadership, Planning and Evaluation)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Leadership, Planning and Evaluation)

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

Provide an overall description, a consolidated budget, and a narrative justification for each planning and evaluation activity. Budgetary support is allowable for all activities listed in the Research Strategy section, with the exception of development of future scientific programs. Costs of planning and evaluation might include support for the external advisory committee and ad hoc scientific and technical consultants; a seminar series, when the speakers or invited participants also serve as consultants for the Center’s scientific or administrative activities; retreats designed to stimulate transdisciplinary research opportunities; and the regular assessment of Center goals and activities by the senior leadership.

Individuals in pivotal leadership positions in the center are eligible for salary support for the time and effort they devote to its CCSG activities. Consider the breadth and complexity of the role of each senior leader to determine the appropriate level of effort needed to meet this responsibility (i.e., there is no standard level of effort for all senior leaders).

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 (Leadership, Planning and Evaluation)

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed CCSG component.

Research Strategy: This section should describe the general processes used by the Center to obtain effective internal and external advice, set priorities, make decisions, and define and evaluate Center strategic plans and activities. The Center should have a formal standing External Advisory Committee (EAC), appropriately balanced for basic laboratory; clinical; prevention, cancer control and population science; and administrative expertise. The EAC should meet at least once yearly, and provide objective evaluation and advice in a consensus report to the Center Director. For new applications, centers are expected to have Leadership, Planning and Evaluation activities established prior to application submission.

Planning and evaluation activities may also include ad hoc scientific and technical consultation with experts outside the Center, seminar series (when speakers or invited participants also serve as consultants for the Center s scientific or administrative activities); retreats designed to stimulate transdisciplinary research opportunities; and the regular assessment of Center goals and activities by the senior leadership.

The narrative should describe the vision and general plans for the future scientific development of the Center, including plans for developing new programs. It also should summarize the activities that supported Center development and improvement over the last project period. Discuss recommendations made by the EAC, any actions taken in response to those recommendations, and reasons for not responding. Describe how internal evaluation processes have affected center planning and implementation activities (e.g., of shared and clinical resources, including institutional resources, and developmental funds) over the last project period.

Senior leadership of the Center sets and actualizes the Center’s goals, with guidance from Planning and Evaluation activities. Provide a short description of the role of each senior leader. Discuss (and provide specific examples) how the senior leaders have worked together to:

• Establish and implement a vision for the Center and address overall Center goals, policies, and operations
• Foster basic discovery and, as appropriate, implement strategies that advance early scientific findings via coordination across NCI and other funding mechanisms and collaborations with other NCI-designated Cancer Centers and other external partners

The form and extent of these activities may vary, based on the type of Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Leadership, Planning and Evaluation)

Not applicable

When preparing your application in ASSIST, use Component Type CCSG component.

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

SF424 (R&R) Cover (Clinical Protocol and Data Management)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Clinical Protocol and Data Management)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Protocol and Data Management)

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: 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.

Other Attachments:

I. Provide an overview of accrual to interventional clinical trials over the project period preceding the renewal application. [Note: This is a summary of data on interventional trials; the definitions, reporting years, and accrual sites used in Data Table 4 apply to the data in this table]. A sample template is below:

ACCRUAL TO INTERVENTIONAL* CLINICAL PROTOCOLS BY REPORTING YEAR (MM/YYYY)* AND SOURCE OF SUPPORT (FOR PRIOR FOUR YEARS OF ACTIVITY)

*Centers also may provide data on accrual to non-interventional clinical studies in a similar format if desired, using Data Table 4 data for observational, ancillary, and correlative studies.

II. For the Inclusion of Women and Minorities in Clinical Research, include in tables information on:

Demographics. In three sections, provide summary information showing the demographics of the primary geo graphic catchment area of the Center by ethnic categories and subcategories and by gender, as well as for the cancer patient population treated at the Cancer Center. Centers have the option of also providing data on demographics of cancer patients in the catchment area, if available.

Accrual. Using the official NIH gender and racial/ethnic categories and subcategories, provide summary accrual information from the most recent 12-month period for all clinical research studies conducted at the center in each of the following areas: (a) interventional therapeutic clinical trials, (b) interventional non-therapeutic clinical trials, and (c) non-interventional epidemiologic, observational, and outcome studies. Relate this information to the demographic information provided above.

Project /Performance Site Location(s) (Clinical Protocol and Data Management)

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 (Clinical Protocol and Data Management)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Clinical Protocol and Data Management)

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

Clinical Protocol and Data Management may support:

• Staff to assist in analysis and reengineering of protocol preparation and revision, and trial activation processes.
• Trial development managers whose primary responsibility is tracking and managing of protocols in development to assure timely completion of all required activities.
• Physician protocol officers, with primary responsibility for assembling scientific and clinical protocol content and coordination and resolution of unresolved scientific and clinical issues in protocol revision.
• Other staff positions that speed protocol preparation, revision, and activation, including those that focus on acceleration/facilitation of collaborative clinical trial activities crossing multiple Cancer Centers or NCI-funded mechanisms (e.g., SPOREs, NCTN, etc.).
• A partial staff position in the university legal and/or contracting office, with the funded time to be devoted exclusively to negotiating Cancer Center clinical trial agreements.
• Staff with responsibilities relevant to data submissions for the NCI Clinical Trials Reporting Program (CTRP).

The CCSG allows funding for oversight and quality control for the Center’s entire clinical trials effort but does not include tasks involved in the actual direct conduct of individual trials (such as data entry). Therefore, the CCSG request for this resource should not duplicate, replace, or make up for reductions in funding provided through the individual grants and contracts supporting the studies.

Data and Safety Monitoring: Funding may be requested for appropriate support staff and supplies. Do not include DSM activities directly supported on other grants and contracts.

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 (Clinical Protocol and Data Management)

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed CCSG component.

Research Strategy: This section must contain four parts:

Part I: Clinical Protocol and Data Management

The CPDM provides central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical trials of the institution(s) that define the center, whatever the study origin (local, industrial, NCI National Clinical Trials Network, or other). As a tool for management of a center’s clinical research enterprise, it complements the Protocol Review and Monitoring System. It also provides a central location for cancer protocols, a centralized database of protocol-specific data, an updated list of currently active protocols for use by center investigators, and status reports of protocols. Quality control functions might include centralized education services for data managers and nurses; data auditing for tracking of patient accrual, assessment of patient eligibility and evaluability, timely submission of study data, and other study compliance measures; and data and safety monitoring activities that ensure the safety of study participants.

Briefly discuss the role of the CPDM in relation to management and coordination of the cancer clinical trials of the center, ensuring timely completion and initiation of trials, and conducting effective quality control and education functions.

Part II: Data and Safety Monitoring

DSM is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

DSM functions are distinct and should not be the direct responsibility of the Protocol Review and Monitoring System (PRMS), which oversees scientific aspects of cancer clinical trials. Do not merge these activities and committees.

Provide a very brief summary of the Center’s DSM plan. Do not include the entire plan within the text of this FOA.

If funding is requested, include a description of: the DSM workload relevant to investigator-initiated studies and studies supported on competitive grants, including evaluation, auditing, and monitoring of patient safety based on phase, level of risk, or other pertinent factors. Do not include DSM activities directly supported on other grants and contracts.

Note: Review of the DSM plan by peers is an NIH requirement, separate from, and unrelated to, the separate review and approval of the plan by NCI program staff.

Part III: Inclusion of Women and Minorities in Clinical Research (only required for comprehensive and clinical cancer centers)

It is the policy of the NIH (NIH Revitalization Act of 1993-Section 492B of Public Law 103-43) that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.

When women or minorities are substantially under-represented in relation to catchment area demographics, the adequacy of the institution's policies, specific activities and a corrective plan become especially critical in convincing peer reviewers that the institution is serious about addressing the problem and is investing the appropriate effort to correct under-accrual. In addition, if the population of the catchment area of the cancer center has limited ethnic diversity, provide a discussion of the institution’s efforts to broaden the ethnic diversity of its clinical trial accrual.

In addition to the above, you may also include information in this section on other underserved populations (e.g., rural, elderly, low socioeconomic status) within the center’s catchment area if desired.

Plans for Accrual of Women and Minorities: In this section, include a description of:

• Any general policies of the parent institution designed to help with recruitment and retention of women and minorities.
• Evidence or data that support unavoidable circumstances impeding accrual and retention of women and minorities (e.g., a high proportion of non-eligible patients).
• Actions planned or being taken by the center, based on careful analyses of the catchment area, which demonstrate a clear effort to recruit and retain women and minorities and correct deficiencies that are potentially avoidable.

Part IV: Inclusion of Children in Clinical Research (only required for comprehensive and clinical cancer centers)

The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Clinical Protocol and Data Management)

Not applicable

Protocol Review and Monitoring System

When preparing your application in ASSIST, use Component Type CCSG component.

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

SF424 (R&R) Cover (Protocol Review and Monitoring System)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Protocol Review and Monitoring System)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Protocol Review and Monitoring System)

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: 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.

Other Attachments:

1. In Data Table 4 format, provide a list of all institutional protocols (i.e., studies that have not received external review) reviewed by the Protocol Review and Monitoring System (PRMS) for scientific merit or actively monitored for scientific progress in a recent 12-month period (Grant year, January to December [preferred format], or July through June). Add a column to the table to indicate which protocols have been approved and activated, approved but not yet activated, deferred for revision, disapproved, or closed. (For the last column, you may use a coding system, e.g., 1 for approved and activated, 2 for approved but not yet activated, 3 for deferred, 4 for disapproved, and 5 for closed) Provide only the code in effect at the time of table preparation.

Note: In a consortium Center, the table should include protocols from all partner institutions.

NCI will request a sample from the list for detailed review prior to the review as per Section V.2 (Review and Selection Process/ Review Materials to be Available) of this FOA.

2. Provide information for the most recent 3-year period (Grant year, January to December [preferred format], or July through June) on the number of trials reviewed or prioritized by sponsor. A sample template is below:

Number of Protocols Reviewed or Prioritized by Source of Support and Year (for most recent three years of activity)

Project /Performance Site Location(s) (Protocol Review and Monitoring System)

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 (Protocol Review and Monitoring System)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project 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.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Protocol Review and Monitoring System)

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

The budget may include appropriate personnel, administrative support, equipment appropriate to the task, and supplies.

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 (Protocol Review and Monitoring System)

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

Specific Aims: Summarize the broad, long-range objectives and goals of the proposed CCSG component.

Research Strategy: In addressing Research Strategy for Protocol Review and Monitoring System (PRMS), the applicant must adhere to the general guidelines below.

A critical activity for Centers involved in clinical research is a mechanism for assuring adequate internal oversight of the scientific aspects of all the cancer clinical trials in the institution or institutions that formally comprise the Center (i.e., consortium Centers should document that all protocols are reviewed through a central PRMS). This function is complementary to that of an Institutional Review Board (IRB), which focuses on the protection of human subjects.

The PRMS is not intended to duplicate, or overlap with, the responsibilities of the IRB. Auditing for quality control or safety reasons is not a function of the PRMS. DSM committee functions and PRMS committee functions are separate and distinct from one another and should not overlap. The focus of the PRMS is on scientific merit, priorities, and progress of the clinical protocol research of the center. The PRMS should have the authority to open protocols that meet the scientific merit and scientific priorities of the center and to terminate protocols that do not demonstrate scientific progress. Unique considerations may apply to trials of rare diseases (http://cancercenters.cancer.gov/NewsEvents/NewsEvents#), or targeted therapies, which often do not accrue rapidly. PRMS evaluations do not include quality control concerns, unless the problem is so serious as to make the results of the protocols meaningless.

The PRMS scientifically evaluates and prioritizes all cancer center trials derived and supported from institutional sources, including those originating from other cancer centers, or from industry. However, the PRMS:

• Should not duplicate traditional peer review, which includes peer-reviewed protocols supported by the various NIH mechanisms (e.g., R0ls, U0ls, U10s, P0ls, and P50s, etc.), other approved funding agencies (http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf) and clinical research protocols approved by the NCI’s Cancer Therapy Evaluation Program or the Cancer Control Protocol Review Committee. These protocols may receive an expedited administrative review for the purpose of prioritization.
• Is not required to evaluate or prioritize studies dealing with healthy human subjects and the population sciences, e.g., observational and epidemiologic studies.
• For multi-site institutional trials, the PRMS of the lead site is responsible for the full scientific review of the protocol (if the PRMS has been approved). The other participating sites are responsible only for an expedited review focused on prioritization, competing studies, and feasibility at that site. Should the PRMS at the lead site be conditionally acceptable or unacceptable, participating sites may select a single, acceptable PRMS at a participating NCI-designated cancer center to conduct the full scientific review.

All trials approved by the PRMS for merit, whether via full or administrative review, have access to CCSG-supported centralized resources such as informatics, biostatistics, and clinical protocol and data management.

The PRMS may elect to perform a 2-stage review in which institutional concepts, without a full protocol, are first reviewed for scientific merit. Concepts approved in this stage are then sent forward for full protocol development. Review of the protocol itself would occur as the second stage. The aims of this 2-stage review are to reduce staff effort in developing protocols of lesser scientific merit, and the timeframe from concept approval to protocol activation. If a two-stage review is performed, the Center should document interactions between the first stage review and that of the PRMS.

In the Research Strategy section:

1. Describe the criteria for selection of the membership of the committee. List the members of the committee and their expertise. Members should be drawn primarily from senior faculty, although junior faculty may be included to further their experience. Scientific expertise from basic laboratory; clinical; and prevention, cancer control, and population-based science should be represented on the PRMS committee. While there may be minimal overlap, committee representation should not duplicate that of the DSM Committee and the same individual should not chair, or have supervisory responsibility over, both committees. The CPDM leader should not chair or be a member of either the PRMS or DSMC, although they may have oversight over both committees.

2. Describe the procedures for scientific review and scientific monitoring of cancer clinical trial protocols, including the:

• Criteria and process for submission of institutional clinical trial protocols to the committee for review and approval
• Process for review of all cancer clinical research protocols of the institution
• Review criteria that are used to assess scientific rationale, study design, expected accrual rates, biostatistical input and feasibility for completion within a reasonable time period;
• Criteria used for monitoring ongoing institutional protocol research to evaluate scientific progress, including accrual rates, to ensure that the scientific aims of the study can be completed.

3. Describe the process and criteria used for prioritizing the activation of cancer clinical trial protocols at the institution with respect to scientific merit and patient availability. Describe the input, if any, of disease focused groups, to the prioritization process. Clarify whether a one or two stage review (e.g., full protocol only, or concept then full protocol) is conducted at the PRMS level and provide a prioritization schema.

4. Discuss the metrics used by the committee to assess the efficiency and timeliness of their activities.

5. Describe the process, criteria, and authority for terminating a clinical protocol. Discuss whether the committee has terminated any protocols, and for what reason. Note: the Protocol Review and Monitoring Committee should have final authority to close trials; no appeal should be allowed to any other person or entity.

6. Describe PRMS operations relative to the IRB approval process with emphasis on the complementarily of the two entities and absence of overlap or duplication.

7. If a consortium Center, discuss how the PRMS process is governed across the partner institutions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or 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
All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Inclusion Enrollment Report (Protocol Review and Monitoring System)

Not Applicable

See Part 1. 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.

Part I. Overview Information 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 Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact the NCI Office of Cancer Centers at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide

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

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Cancer centers may have a number of appropriate missions research, education, and care. Nevertheless, the CCSG predominantly supports the research mission of the center.

Successful cancer centers:

• Have a strong peer-reviewed research base in cancer-related science.
• Add tangible value to the research base already in place within the institution.
• Meet all six essential characteristics of an NCI-designated Cancer Center.

Ultimately, the application should reflect how the CCSG has influenced Center accomplishments, i.e., if the Center would have reported similar achievements without the benefit of the CCSG, the value-added would be minimal, which will be emphasized by reviewers and should be reflected in the overall impact score along with an assessment of the likelihood for the CCSG to exert a sustained and powerful influence on the cancer research fields highlighted in the Center’s application.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

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?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

Physical Space (merit descriptor)

• How adequate and appropriate are the Center’s physical facilities for its identity, objectives, and activities?
• How adequate are plans to align physical facilities with future program plans?
• How reasonable is access to shared resources and other services and resources facilitated for all members, including consortium members?

Organizational Capability (merit descriptor)

• How effective is the Center in taking full advantage of institutional capabilities in research?
• How effective is the Center in fostering scientific interactions and joint initiatives among programmatic elements, with other NCI-designated cancer centers, and other external partners?
• How successful is the Center in establishing an efficient and cost effective administrative organization with clear lines of authority?
• For consortium Centers:
• Do the proposed consortium partners have adequate cancer-focused peer-review funding to justify inclusion into the Center?
• Are institutions proposed for consortium status fully integrated into the Center, as demonstrated by a history of research collaboration?
• Is the partnership stable, as evidenced by a history of research integration and the provisions of formalized agreements?
• Are mechanisms in place to resolve differences?
• Is there an integrated planning and evaluation process that enables achievement of the center’s research goals?
• Do all members have reasonable access to shared resources and other services, participate in scientific Programs, and may assume leadership positions in the Center, even if partner institutions are geographically dispersed?

Transdisciplinary Collaboration (merit descriptor)

• How effective is the Center in promoting transdisciplinary and/or translational collaborations among basic laboratory; clinical; and prevention, cancer control, and population science Cancer Center members?
• To what extent have collaborations within and among (intra- and inter-programmatic) Programs added value to cancer related scientific activities?
• How effective is the Center in moving scientific findings forward to cancer-related endpoints appropriate to the nature of the research, through internal collaborations and/or external partners including other NCI-designated cancer centers?
• For consortium Centers, how adequate are mechanisms to ensure that research is integrated across partner institutions, as evidenced by programmatic structure and objectives, joint publications and grants and other transdisciplinary, cross-institutional activities?

Cancer Focus (merit descriptor)

• What are the breadth, depth, and significance of the cancer-related research base, as judged by the structure and objectives of the Programs, peer-reviewed research support, collaborative publications, and other activities of Center members?

Institutional Commitment (merit descriptor)

• To what extent has the institution (and consortium partners, where appropriate) met prior commitments and provided resources to ensure that the Center reaches its full potential?
• How appropriate are resources committed to the Center by the institution and any consortium partners for the next project period (e.g., return of indirect costs, endowment income, and clinical income), and the processes for determining how funds will be used?
• For matrix Centers, is there evidence that Cancer Center status is at least equivalent to that of an academic department and that other institutional leadership (department chairs, deans, etc.) provides support for strategic Center objectives?
• How appropriate is the Director’s position within the institution and his/her representation on the decision-making committees relevant to Center objectives?
• How adequate is the authority of the Center Director over:
• Appointment of new members and discontinuation of existing members?
• Appointments of faculty necessary to enhance the research objectives of the Center?
• Inpatient and outpatient research facilities necessary to achieve the Center’s clinical research objectives (in Centers with clinical research activities)?
• Philanthropy, clinical revenues, or other funding streams?
• What is the adequacy of the institution’s plan for dealing with a change in the directorship of the Center?
• How do institutional policies, including those related to promotion and tenure, recognize team science?
• How do institutional policies fulfill the expectation that clinicians participate in clinical trials and for clinician scientists to carry out research?
• For consortium Centers, how adequate are the mechanisms for ensuring the Center Director has authority over integration of investigators from all partner institutions into the scientific Programs of the Center and oversight over CCSG-supported shared resources in collaborating institutions?

Center Director (merit descriptor)

• How appropriate are the scientific and administrative qualifications and experience of the Director for the Center’s research activities and objectives?
• How effective is the Director in establishing a vision for the Center and using authorities to further its scientific objectives?
• How appropriate is the Director’s time commitment to the Center s scientific and management activities?
• For consortium Centers, how effective is the Director in advancing integration of the partner institutions?

Cancer Center Administration (merit descriptor)

• How qualified are administrative staff members for their roles?
• As applicable, how effective is the administration in:
• Oversight of the CCSG application process?
• Accuracy and completeness of CCSG reporting?
• Space management, including assessment of use, program-promoting proximities, and shared utilization of facility capabilities?
• Oversight and management of shared resources (whether Center or institutionally managed)?
• Budget, accounting, and expenditure monitoring processes, including management of philanthropic and other funding streams?
• Faculty recruitment and retention processes, including those related to promotion and tenure?
• Arranging and documenting meetings organized by the Center?
• Management of processes related to pilot project solicitation, review and award?
• Management of membership processes?
• Representing the Center with institutional offices, including the central grants office, and clinical and other pertinent entities?
• Supporting the strategic planning and evaluation activities?
• Fostering communications throughout the Center membership and staff, particularly in support of increasing the peer-review research project base of the Center?
• Facilitating multi-center collaborations
• For consortium Centers, how effective are mechanisms to ensure efficient administration of CCSG functions across institutions?

Cancer Research Career Enhancement and Related Activities (merit descriptor)

• What are the extent and quality of existing cancer research education, training and career development activities at the Center, as appropriate for the type (basic, clinical, or comprehensive) and size of center?
• How well does the center coordinate exciting training and career development activities?
• How appropriate is the Center’s process for integrating existing cancer education and training of biomedical researchers and health care professionals, including members of underserved populations, into programmatic and shared resource research efforts?
• Is the institutional commitment to the existing cancer education and training activities appropriate?
• How appropriate are proposed activities for the next funding cycle?

Shared Resources (merit descriptor for each Shared Resource)

• How well does the shared resource provide access to state-of-the-art capabilities?
• How critical is the shared resource to the research of the Center?
• Are the future plans for the shared resource aligned with member needs?
• What are the quality and cost efficiency of the services provided by the shared resource?
• How accessible to Center members, including consortium members, is the shared resource?
• How appropriate are the qualifications of staff and their time commitment?
• For institutionally managed resources, how accessible are the services for cancer center members?

Research Program (merit descriptor for each Program)

• What is the impact of the research of the program, as demonstrated by:
• Publications in top-tier journals for that field
• Widely-cited publications
• Generation of paradigm-changing hypotheses or scientific methods that move the field forward
• Movement of scientific findings through the translational pipeline
• Changes in public health policy
• Changes in standard of care of patients

Note: list not intended to be exclusive.

• How well are peer-reviewed non-NCI funded projects cancer-focused?
• How collaborative is the program, across the themes/specific aims within the program, with the Center’s other programs, with other NCI-designated Cancer Centers, and with other external partners?
• As appropriate to the type of program, and in addition to research questions of broader applicability, what is the evidence that research relevant to the catchment area is being addressed (e.g., problems affecting racial and ethnic minorities, rural residents, women, children, elderly, persons of low socioeconomic status, cancer sites of high incidence/mortality, environmental exposures, behavioral factors, or other issues)?
• How appropriate and effective is the program leader (or leaders) in relation to expertise, program management, and time commitment? If more than one Program Leader, how do the leaders work together to enhance the Program?
• What is the value added by the Center to programmatic efforts in terms of shared resources and other services such as Clinical Protocol and Data Management, Developmental Funds, etc.?
• For programs with clinical trials:
• What is the impact of the clinical trials in the program (see list above)?
• How well do the clinical trials in the program address cancer research issues and special populations in the Center’s catchment area?
• How successful is the program in translating research, particularly the basic science in the program and/or the Center’s other programs, and in using clinical observations to inform basic and population science research?
• Is the program a leader of the NCI-supported clinical trial networks, such as the National Clinical Trials Network (NCTN), the Early Therapeutic Clinical Trials Network (ETCTN), etc.?
• Does the program participate in accrual to NCI-supported clinical trials, particularly NCTN, ETCTN, NCORP?
• How appropriate is overall accrual to trials (taking into consideration those with unique accrual targets, e.g., rare cancers, targeted therapies)?
• For consortium Centers:
• What is the evidence for integration of members from all institutions into scientific programs and leadership positions?
• What is the evidence that research is integrated across all partner institutions represented?

Community Outreach and Engagement (merit descriptor)

• How appropriately does the Center define its catchment area?
• How well does the Center identify the cancer research issues relevant to its catchment area?
• How well has the Center taken advantage of its catchment area to address challenging questions in cancer research?
• How well has the Center developed processes for including underserved populations in its programmatic research?
• As applicable, are the Center plans for extending its reach within and beyond the catchment area, reasonable?
• How well is the Center taking advantage of appropriate relationships with networks and affiliates?

Developmental Funds (merit descriptor)

• How effectively has the center used developmental funds in the current funding period to pursue research priorities?
• What has been the return on developmental funds investment in the current funding period (e.g., strategic recruitments, grants, publications, collaborative/translational research, inter-cancer center collaborations, new shared resources, innovative pilot projects (including early phase clinical trials), etc.)?
• How well has the center used developmental funds to pursue innovation and to move in new scientific directions that matches the strategic goals of the center?
• How rigorous are the processes for the use of developmental funds?
• How appropriate are plans for use of future Developmental Funds with respect to the strategic priorities of the center?

Leadership, Planning, and Evaluation (merit descriptor)

• How effective are internal and external advisory and evaluation activities in the development of the Center’s scientific activities?
• How appropriate are the qualifications, time commitment, and effectiveness of each senior leader in relation to his/her role in planning and evaluation of the Center?
• How effective is the senior leadership in:
• Establishing and implementing a vision for the Center and advancing goals and policies relevant to the Center’s progress?
• Fostering basic discovery and advancing scientific findings?
• Oversight of the CCSG application?

Clinical Protocol and Data Management (merit descriptor)

• How effective is CPDM in centralizing, managing, and reporting on the cancer clinical trials of the Center?
• To what extent does CPDM help to assure timely initiation and completion of clinical trial activities?
• How effective are the quality control functions and training services offered by the CPDM?
• Does the CPDM successfully identify impediments to successful accrual of patients to the Center’s clinical trials and provide remedies?
• How reasonable is overall accrual, based on the nature/type of the individual trials supported?

Data and Safety Monitoring (acceptable/unacceptable)

• How adequate is the DSM plan in defining the overall structure of the monitoring entity and the mechanisms for reporting adverse events?
• For Consortium centers, is there a single DSM plan governing all cancer clinical trials across partner institutions?

Protocol Review and Monitoring System acceptable/conditionally acceptable/ unacceptable)

• How appropriate are the composition of the committee and the qualifications of its members for ensuring the breadth of expertise necessary to conduct a critical and fair scientific review of all institutional clinical cancer protocols?
• How appropriate are PRMS authorities and processes for initiating, monitoring and terminating all cancer clinical research protocols in the institution(s) comprising the Center?
• How appropriate are the criteria and processes for scientific review, taking into account the rationale and study design, potential duplication of studies elsewhere, adequacy of biostatistical input, and feasibility for completion within a reasonable time?
• How appropriate are processes for ensuring prioritization of competing protocols from all sources and optimal use of the Center’s scientific resources?
• How adequate are the criteria for monitoring trials to ensure they are making sufficient scientific progress?
• Are the criteria and process for terminating trials that do not meet scientific goals (trials involving rare diseases are excluded) adequate and used appropriately?
• If a consortium Center, is there a single PRMS governing all cancer clinical trial protocols across the partner institutions?

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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.

How proportional, based on demographic and accrual data provided, is the accrual of women and minorities to:

• interventional therapeutic trials
• non-therapeutic trials, and
• non-interventional studies

How appropriate are plans and processes for monitoring, retaining, and improving recruitment of women and minorities?

How appropriate is the plan for including children in clinical trials, or how acceptable is the justification for excluding children in clinical trials?

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.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Does the consortium partner have adequate peer-review funding to justify inclusion in the Center? Does the consortium partner contribute tangible commitments to the Center? Is the consortium partner fully integrated into the Center, as demonstrated by extensive scientific collaboration and participation in the Center’s research programs? Is the MOU adequate to ensure the stability and integration of the Center? How is the scientific mission of the Cancer Center enabled by cancer education of biomedical scientists and health care professionals?

Comprehensiveness (acceptable/unacceptable)

How adequate are the depth and breadth of science in each of the three major areas of basic laboratory; clinical; and prevention, control and population sciences? What is the degree of evidence for strong transdisciplinary research bridging these sciences? How effectively has the Center: 1) defined the cancer problems relevant to its catchment area and 2) served its catchment area (as well as the broader population) via the research it supports? How is the scientific mission of the Cancer Center enabled by cancer education and training of biomedical scientists and health care professionals?

Not Applicable

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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 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 submitted in response to this FOA. 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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.

Awardee-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 awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that 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 FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, 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 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 (currently 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 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Office of Cancer Centers
National Cancer Institute (NCI)
Telephone: 240-276-5600
Email: ncicenters-r@mail.nih.gov

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

Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6277

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 45 CFR Part 75.