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). 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 Cancer 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;
• 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;
• 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 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 Resources, scientific and administrative management, planning and evaluation activities, development of new scientific opportunities, community outreach and engagement, coordination of cancer training and education, 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 underrepresented 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.

The NCI recognizes three types of Cancer Centers:

• Basic Cancer Centers have scientific agendas primarily focused on basic laboratory research. While not all basic findings require a translational endpoint, basic cancer centers conduct pre-clinical translation and develop linkages with other institutions that will foster application of laboratory findings for public benefit where appropriate.
• Clinical Cancer Centers have scientific agendas focused on basic laboratory; clinical; and prevention, cancer control, and population-based science. All areas of science are linked collaboratively.
• Comprehensive Cancer Centers demonstrate reasonable depth and breadth of cancer research activities in each of three major areas: basic laboratory; clinical; and prevention, control, population-based science, as demonstrated in the formal Research Programs. Comprehensive Cancer Centers also have substantial transdisciplinary research that bridges these scientific areas, which is evaluated in the Research Programs and as part of the Six Essential Characteristics (i.e. Transdisciplinary Collaboration and Coordination; see below). They are effective in serving their catchment area, as well as the broader population, through the cancer research they support and the cancer control activities they undertake, as demonstrated in Community Outreach and Engagement. 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, as demonstrated by the Cancer Research Training and Education Coordination component. Comprehensive Centers are expected to be strong in all four areas indicated above; strengths in some areas cannot mitigate weaknesses in one or more other areas.

NOTE: Clinical and Comprehensive Cancer Centers serve a specific catchment area, and in addition to cancer research of broad applicability, they conduct research of particular relevance to their catchment area. A Center’s catchment area is the self-defined geographic area that the Center serves or intends to serve in the research it conducts, the communities it engages, and the outreach it performs. It must include the area from which the Center draws the majority of its patients, but may extend beyond that, and it must include the local area surrounding the Cancer Center. It must be population-based, e.g., using census tracts, zip codes, county or state lines, or other geographically-defined boundaries.

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 structure and objectives of the Center's Research Programs and other components, as well as, the Center members' grants, contracts, publications, 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. She or he is effective in using institutionally designated authorities to manage the Center.

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, consortia for Phase 0/I/II Cancer Prevention Clinical Trials Program, 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 the following:

• 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. 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.

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-reviewed funded portfolio of cancer-relevant research equivalent to a CCSG Research Program i.e., seven R01-equivalent active grants or more, held by five independent PD/PIs (the projects may be distributed across multiple Research 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.
• 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 (IRB) 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 Research 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

NOTE: Centers may not propose consortium partners in a New (Type 1) application.

DURATION: The initial budget period will be five years. In order to enable more long-range planning and pursue high-risk research, Centers may be eligible for an additional two years, for a maximum award period of seven years. Eligibility for the additional years will be based on merit at peer review, sustained exceptional progress, stability, and longevity of the Cancer Center. Additional years will be contingent upon an administrative review by NCI staff and approval of the National Cancer Advisory Board.

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 from 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)

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)
• 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

Specific to this FOA:

For New (Type 1) applications, an applicant institution must have a funding base of $10,000,000 in annual direct costs of NIH funding that is cancer-focused, as defined by the Research Condition and Disease Categorization (RCDC) system. Please contact the NCI Office of Cancer Centers (https://cancercenters.cancer.gov/) for assistance in determining the RCDC funding base.

For Renewal (Type 2) applications, 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 an approved 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.

Example of NCI peer-reviewed mechanisms that may be included for determining eligibility to apply for a CCSG: DP1, DP2, R00, R01, R03, R15, R18, R21, R24, R25, R33, R35, R37, R41, R42, R50, R55, R56, P01, P20, P30s other than the CCSG, P50, SC1, SC2, U01, U10, U19, U24, U54, U56, UH2, UH3, UG3, 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 do cancer-relevant grants and contracts from the peer-reviewed funding sources listed in: http://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf

NOTE: New (Type 1) applications cannot request evaluation for comprehensiveness status.

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.

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

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).

Specific to this FOA: Only one application per institution is allowed normally identified by having a unique DUNS number or NIH IPF number.

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	30 pages
Admin Core (use for Cancer Center Administration)	12 pages
Core (use for Cancer Research Training and Education Coordination)	6 pages
Project (use for Research Programs)	12 pages each
CCSG Component [use for: Community Outreach and Engagement (COE Clin. Comp. Ctr.) Developmental Funds (Dev. Funds) Shared Resource Management (Shared Res. Mgmt.) Leadership, Planning and Evaluation (Lead. Plan. Eval.) Clinical Protocol and Data Management (CPDM Clin. Comp. Ctr.) Protocol Review and Monitoring System (PRMS Clin. Comp. Ctr.)]	12 pages each
SR Component (use for Shared Resources)	3 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.

The application should consist of the following components:

• Overall: one required
• Cancer Center Administration: one required
• Cancer Research Training and Education Coordination: one required
• Research Programs: at least one is required
• Community Outreach and Engagement:
• one required for Clinical and Comprehensive Cancer centers
• not allowed for Basic Cancer Centers
• Developmental Funds: one optional
• Shared Resource Management: one required
• Leadership, Planning and Evaluation: one required
• Clinical Protocol and Data Management:
• one required for Clinical and Comprehensive Cancer Centers
• not allowed for Basic Cancer Centers
• Protocol Review and Monitoring System:
• one required for Clinical and Comprehensive Cancer Centers
• not allowed for Basic Cancer Centers
• Shared Resources: at least one is required

When preparing your application, 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.

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

1. Physical Space: A map that illustrates the main location of the Center’s research and administrative activities, and the physical relationship of all consortium institutions to the main campus must provided.

2. Institutional Commitment: A chart indicating the organizational status of the Cancer Center within the institution must be provided.

Other Attachments: The following "Other Attachments" must 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.

A: Supportive data in a table format: These tables (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.

1. Data Tables 1A, B, C list the Center’s senior leadership (e.g., Cancer Center Director, Deputy Director, and Associate Directors), leadership of the proposed Programs and Shared Resources. Title as "DT1".

2. 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 and their direct costs 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 the Cancer Research Training and Education Coordination component). Provide a DT2A for each member of a consortium Center. Title as "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. Title as "DT2B".

3. 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. Title as "DT3".

4. Data Table 4 lists clinical research protocols open at the Center during a recent 12-month period. Beginning with applications submitted May 25, 2020, DT4 interventional treatment trials must be generated using the Clinical Trials Reporting Program (CTRP) database. Ancillary, correlative and observational studies may be submitted using CTRP or independently of CTRP. Title as "DT4 . New (Type 1) applications are not required to use CTRP in preparation of DT4.

5. Data Table 5 for Renewal (Type 2) applications list the current (last full non-competing year) budget in each CCSG budget category. Title as "DT5".

B. Information on Consortium:

1. If the Renewal (Type 2) application is submitted as a consortium, provide a table listing locations of all partnering institutions. 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. Title as "[Consortium partner's] DT2".

2. Provide a Memorandum of Understanding between partnering institutions. Title as "MOU".

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) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. i.e. Director of Cancer Center.

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.

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

• The history and overview of the Cancer Center
• The most important scientific accomplishments during the current period of support, or, for New (Type 1) 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 current 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 information 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 use of Shared 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 (if applicable) 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.

Provide the complete strategic plan at the site visit; eliminate sensitive information, if applicable. In the application, provide 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, consortia for Phase 0/I/II Cancer Prevention Clinical Trials Program, and the NCI NCTN) are important avenues for advancing discoveries originating in the Center and coordination of research across these mechanisms is strongly encouraged. If commercial development is an important mechanism for translation at the Center, the application should describe Center efforts to assist its members in moving their innovations along the development pipeline. 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 current funding period in three distinct research areas - transdisciplinary, translational, and collaborative. For New (Type 1) 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 Shared Resources and participation and leadership in Programs.

4. Cancer Focus: A clearly defined scientific focus on cancer research is demonstrated by the structure and objectives of the Center's formal Research Programs or other CCSG components, its members grants and contracts, publications and collaborations. 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. Centers should describe a rigorous method for determining the cancer relevance of non-NCI funded research projects.

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 superior to that of academic departments
• Funding from the institution and consortium partners
• Research, clinical, and administrative space and positions
• Measures that ensure institutional leaders (health systems executive, university presidents, deans, etc.) will provide the long-term stable support necessary to accomplish strategic Cancer Center objectives. This may include a formula-based return to the Center of financial resources from clinical revenue, indirect costs, proceeds from commercialization of center discoveries, and other mechanisms of direct support to the Cancer Center. In order to ensure that research mission and cancer care is aligned, the Center Director should have some influence, or control, of the cancer service line
• Joint control with deans, or 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:
• Superior to that of department chairs, with appointments to decision making committees and formally codified authorities that enable the Director to influence cancer policies at the institutional level
• 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

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.

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

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. She or he 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 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:

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

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

When preparing your application, use Component Type Admin Core.

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

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 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) is also 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.

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 Cancer Center's Administration. While organizational structures and functions vary, your application should describe, as appropriate:

• 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's Administration in CCSG-related activities (the Administration is not required to carry out all functions listed below):
• 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
• Oversight of 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

Note: The form and extent of these activities may vary, based on the type of Center. A Cancer Center’s Administration is not necessarily responsible for all the activities listed above; some Centers may place some activities in other components, such as Leadership, Planning and Evaluation, and Institutional Commitment 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:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type Core .

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

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 Training and Education Coordination)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cancer Research Training and Education Coordination)

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.

Other Attachments: List, in a table format, all active cancer-related research education and training grants competitively funded by sources external to the applicant institution (applicants may use Data Table 2A for this purpose). Grants are listed alphabetically by PD/PI in two parts: (1) active, peer-reviewed and (2) active, non-peer reviewed funded cancer research training and education grants. Also, summarize this information in Data Table 2B format.

Project /Performance Site Location(s) (Cancer Research Training and Education Coordination)

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 Training and Education Coordination)

• 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 Training and Education Coordination)

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

This component may support:

• Faculty Associate Director of Cancer Research Training
• Education Coordinator(s) and other staff that assist in Cancer Research Training and Education activities
• Travel to professional meetings for individuals in training who do not have access to other sources of travel funds
• Funding for support of activities directly relevant to the core, such as scientific seminar speakers, workshops, short courses, etc.

CCSG funding cannot be used to duplicate costs of NIH training awards, including travel.

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 (Cancer Research Training and Education Coordination)

Specific Aims: Summarize the goals of the proposed Core.

Research Strategy:

In this section describe:

• The cancer research training and education activities, in which the core will be engaged, such as coordinating the distribution of travel funds to those who do not have access to them, organizing educational seminars, workshops, and related activities
• Efforts by the Center to assist trainees, including junior faculty, in preparing grant applications, and for senior faculty in preparing institutional training grant applications
• General outcomes of education and training activities, as available
• The process for coordinating existing cancer education and training activities at the Center, including with other institutional efforts, and integrating them into programmatic efforts
• Financial commitments of the institution to further the Center’s training activities
• Special areas of cancer research training and education (health disparities, global health, etc.)
• The inclusion of underrepresented populations in education and training activities
• 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:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type Project.

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

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. In addition to questions of broader applicability, Research Programs at Clinical and Comprehensive Cancer Centers address, at a level appropriate to the type of Program, cancer research issues of particular relevance to the Center s catchment area.

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 for their commitment to work together to further the scientific goals of the Cancer Center. Although the expectation is that most members will hold peer-reviewed funding, members without peer-reviewed funding may contribute to Research Programs in a number of ways. If a Research Program has the critical mass of peer-reviewed funding to achieve significant scientific impact, the presence and overall percentage of unfunded members who contribute to the scientific effort should not be considered detrimental.

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, be appointed as Program and/or senior leaders, be awarded developmental or other CCSG funds, and other benefits of membership.

Characteristics of Programs: Programs should be focused on cancer research, should be of adequate size and quality to achieve a high degree of scientific impact 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 should 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/PIs to be eligible; however, successful Programs substantially exceed this minimum. For the purposes of this FOA, R01-equivalence equals a project with funding for three 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, U54s), but not Shared Resources, may be counted as separate projects. The Program leader or leaders are generally expected to have active peer-reviewed funding; however, a Center may appoint, with appropriate justification, a Program leader who is unfunded. For large Programs, the Center may form a Program leadership team, which may include more than two co-leaders, to facilitate the Program’s activities and maximize impact.

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: 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 are considered. Mechanisms include:

• Research grants, cooperative agreements and research contracts from the NCI including all awards with the following activity codes: DP1, DP2, R00, R01, R03, R15, R18, R21, R24, R25, R33, R35, R37, R41, R42, R55, R56, P01 and P50 sub-projects, P20, R41, R42, SC1, SC2, U01, U10, U19, U54, U56, UG1, UG3, UH2, UH3, UM1, UM2, N01 research contracts and peer-reviewed, funded subcontracts of Center members participating in collaborative research. (NOTE: shared resources of multi-component grants are not eligible for inclusion)
• Components of NCI National Clinical Trials Network
• 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 activity codes as above)
• Research projects funded by the non-NIH organizations with peer review funding systems listed at https://cancercenters.cancer.gov/documents/PeerReviewFundingOrganizations508C.pdf

NOTE: Fully cancer-relevant peer-reviewed funding from an eligible source other than NCI should be regarded as equivalent to an NCI grant.

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 inter-programmatic publications

Project Narrative: Do not complete.

Facilities and Other Resources: A list of Shared Resources and other services used by Program members.

Other Attachments: Must provide:

1. 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. 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, non-peer reviewed funding, or funding that does not directly support a research project (i.e., infrastructure, cores, etc.). In addition to a programmatic DT2A, provide a summary of peer-reviewed funding of each Research Program in DT2B format.

2. 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.

3. 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.

4. 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 (Type 2) applications should limit this list to significant publications funded through non CCSG sources from the current project period. For Renewals (Type 2) applications, publications resulting from CCSG support must be listed on the Progress Report Publication List attachment on the Research Plan form. For New (Type 1) applications, list significant publications in the past three to five years.

5. A list of the clinical research of the Program, if applicable (no page limit) using the CTRP database, in the Data Table 4 format. 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. New (Type 1) applications are not required to use CTRP in preparation of DT4.

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 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 (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)

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 current project period 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 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, consortia for Phase 0/I/II Cancer Prevention Clinical Trials Program, program projects, and NCTN) and other sources
• collaborations with additional partners, such as other institutions or industry
• For Programs with clinical trials provide information on:
• 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 current project period, including a brief overview of accrual by types of trials (national, institutional, externally peer-reviewed, and industry)
• In addition to questions of broader applicability, 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, sexual and gender minorities, and 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:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type 'CCSG Component.'

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

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.

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
• Coordinators of outreach and engagement with local populations, including education
• Personnel, such as patient navigators, who facilitate the inclusion of underrepresented populations into the Center's clinical research
• Funding to conduct continuing community health needs assessment
• Funding for the formation and operation of a community advisory board(s)
• Funding for pilot projects specifically directed at cancer issues in the catchment area

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)

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 of particular relevance to their catchment area and engage the populations within their catchment area in the research they conduct. In order to facilitate this, Centers thoroughly analyze the demographics and cancer burden of their catchment area. In addition, Centers are expected to engage communities within their catchment area to decrease their cancer burden, particularly among minority and underrepresented populations. To facilitate these activities, Centers establish community advisory board(s) and partnerships with other healthcare delivery systems and state and community agencies for dissemination of evidence-based findings.

NCI recognizes that a long-term commitment to community outreach and engagement is required in order to have a profound impact on the cancer burden of a center’s catchment area. Centers are therefore encouraged to emphasize in the application the needs of their catchment area, efforts undertaken, and the progress accomplished, along the pathway to achieving the goal of reducing the cancer burden.

Centers are encouraged to describe knowledge, best practices, and tools developed by COE activities, and to share these with other NCI-designated cancer centers. Additionally, centers are encouraged to adopt, adapt, implement, and/or evaluate others best practices in order to advance progress against the burden of cancer and cancer risk factors in their catchment areas.

In this component, the applicant should describe the aspects in which the Center engages its catchment area, and how the Center extends its reach beyond the catchment area.

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

In this component:

• Define and justify the Center’s catchment area
• Identify the major factors that characterize and influence the cancer burden in the catchment area. These may include:
• demographic factors (race, ethnicity, sex, gender, age)
• cancer risk factors or unique environmental exposures
• underrepresented populations
• disparities in cancer risk factors, incidence, mortality, access to care, and insurance coverage
• socioeconomic status
• rurality
• sexual and gender minority populations
• cancers of unusual incidence or mortality
• other factors relevant to the cancer burden
• Describe how the Center has reached out to and engaged with community members and organizations in its catchment area to inform cancer research and control efforts of particular relevance to the catchment area population. Include how the Center has developed infrastructure (offices or centers established by the Center, community advisory boards, partnerships with government offices, employers, schools, churches, donors, etc.) and sought input to prioritize, facilitate, and expand cancer research and control activities
• Describe how the Center has communicated community needs to Center members and catalyzed research in all areas of science (basic, clinical, translational, and population sciences). Centers should not repeat or summarize information presented in the Research Programs but may illustrate with examples of research projects how outreach to and engagement of communities resulted in high-impact science
• Describe the cancer control efforts undertaken by the Center to reduce the burden of cancer in its catchment area, including dissemination and implementation of evidence-based interventions, public education, health policy recommendations, influence on health policy, etc. Include current and planned efforts, metrics for success, and outcomes of past and current efforts as available
• Describe how the Center has expanded its reach within and beyond its catchment area, including globally, that bring the Center’s expertise to bear on wider populations

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component may support research involving human subjects. If applied, 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.

When preparing your application, use Component Type 'CCSG Component.'

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

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.

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 (Type 1) 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. 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. 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 or retain established cancer researchers already within the institution (excepting the awarding of Developmental Funds through a pilot project or the Senior Investigator process)
• 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

Developmental Funds may no longer be used to develop new Shared Resources; CCSG funds for the development of new Shared Resources may be proposed in the Shared Resource Management component.

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)

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 Developmental Funds at the beginning of the Research Strategy.

The Research Strategy should explain how current and proposed use are linked to the strategic and programmatic priorities and scientific opportunities of the Center. The narrative should summarize how current Developmental Funds, whether from the current project period, or for New (Type 1) applications, from other funding sources, have been used and what have been accomplished with them (strategic recruitments, grants, publications, collaborative/translational research, inter-cancer center collaborations, 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 have been used for recruitment in the current grant period for Renewal (Type 2) applications, or, for New (Type 1) applications, how other funds have been used in the period (as defined by the applicant) preceding the application. Specify which investigators have been supported, the rationale for recruiting these investigators relative to the needs of the Center, and to what extent these investigators have been 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 underrepresented populations, development of new technologies or methodologies, early phase clinical trials).
  
  Centers are encouraged to make these funds accessible to basic laboratory, clinical, and population science research for projects of relatively short duration (one-two 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, reviewing, and selecting proposals and list the awardees and their projects for the current 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: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-128.html.

• 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 who 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 underrepresented 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 underrepresented populations and should have a special role in advancing Center research that focuses on cancer issues for minority and other special or underrepresented 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 (Type 2) 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, NCORP, ETCTN, and other national NCI 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:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component may support research involving human subjects. If applied, 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.

When preparing your application, use Component Type 'CCSG Component.'

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

PHS 398 Cover Page Supplement (Shared Resource Management)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Shared Resource 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.

Other Attachments: The requested budget for the Shared Resources 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 an overall CCSG budget for all Shared Resources and provide the following information for each Shared Resource supported by the CCSG for the most current grant year and for the proposed period of support:

Sources of Support for Shared Resources

	CURRENT SUPPORT					PROPOSED SUPPORT (YR 1)
	Operating budget ($)	CCSG ($)	CCSG (%)	Chargeback (%)	Other (%)	Operating budget ($)	CCSG (%)
Shared Resource #
TOTAL

NOTE: The proposed allocation of funding among individual Shared Resources may be changed during the subsequent grant cycle as demand for services changes. A Center may terminate individual Shared Resources and allocate funds to other Shared Resources, including for development of new Shared Resources with NCI approval.

Project /Performance Site Location(s) (Shared Resource 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 (Shared Resource 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 (Shared Resource Management)

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 (CTSA). 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 members of the Cancer Center.

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 members of the Cancer Center.

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 Resources 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

Cancer Centers may use CCSG funding to develop new Shared Resources.

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 Resource Management)

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

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.

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.

Research Strategy: It should discuss:

• How the Center manages Shared Resources and establishes appropriate policies governing their use, including assuring accessibility to members across campuses or consortia partners
• How the Center monitors quality and user satisfaction
• How the Center determines the current and future scientific needs of its members, including relevant processes such as internal advisory boards, surveys, etc.
• Future plans for Shared Resources, including those in development
• For institutional Shared Resources, how the Center ensures access and quality of services offered, and the role of the Center in planning and oversight of institutional services

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type 'CCSG Component.'

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

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.

Other Attachments: In one document, provide a consolidated list of External Advisory Committee (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.

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).

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.

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)

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.

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 should also summarize the activities that supported Center development and improvement over the current 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 current 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:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type 'CCSG Component.'

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

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.

Other Attachments:

I. Provide an overview of accrual to interventional clinical trials over the current project period for Renewal (Type 2) application, or, for New (Type 1) applications, over the period defined by the applicant. (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). As for Data Table 4, beginning with applications submitted May 2020, data must be generated from the CTRP database. New (Type 1) applications are not required to use CTRP in preparation of DT4.

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)

Reporting Year (specify mm/yyyy)
National Group
External Peer Review
Institutional (investigator initiated)
Industry
Total Accrual to Interventional Clinical Protocols

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

II. Data and Safety Monitoring Plan

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

Demographics: In three sections, (1) provide summary information showing the demographics of the geographic catchment area of the Center by ethnic categories and subcategories and by gender; (2) provide the demographics of the cancer patient population in the catchment area; and (3) provide the demographics of the Center s cancer patient population.

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)

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 NTCN, 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. The Director of the CPDM should report to the Center Director or Deputy Director.

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. Discuss efforts to reduce activation time of all types of clinical trials.

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 summary of the DSMP in the text and include the DSMP as an attachment.

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 ; 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 underrepresented populations (e.g., rural, elderly, low socioeconomic status) within the Center’s catchment area, if desired.

Plans for Accrual of Women and Minorities: A plan must be presented in the application regardless of the Center's success in accruing women and minorities. In this section, include a description of:

• Any general policies of the parent institution designed to help with accrual 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 accrue and retain women and minorities and correct deficiencies that are potentially avoidable

Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research (only required for Comprehensive and Clinical Cancer Centers)

Section 2038 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions requiring NIH to address the consideration of age as an inclusion variable in research involving human subjects, to identify criteria for justification for any age-related exclusions in NIH research, and to provide data on the age of participants in clinical research studies.

It is the policy of NIH that individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. The inclusion of individuals across the lifespan as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations.

If your Center conducts human subjects research, include plans for including individuals across the lifespan or provide an acceptable justification for exclusion.

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type 'CCSG Component.'

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

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.

Other Attachments:

1. In Data Table 4 (CTRP format), provide a list of all institutional protocols (i.e., studies that have not received external review) reviewed by 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.

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)

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 rigorous internal oversight of the scientific aspects of all the cancer clinical studies 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 IRB, which focuses on the protection of human subjects.

The PRMS typically contains two stages of scientific review:

First stage: Disease- or discipline- (e.g., Phase 1, molecular pathways, cancer immunotherapy, etc.) focused groups (for brevity’s sake, hereafter referred to as disease groups), consisting of scientists, clinicians, nurses, pharmacists, etc., with expertise in a disease or discipline are responsible for the initial scientific review of concepts and protocols. Biostatistical input is not essential during the first stage of review, although Centers may want to incorporate biostatistical review of investigator-initiated trials.

Second stage: The Protocol and Monitoring Committee (PRMC) is ultimately responsible for the scientific review of protocols and has the sole authority to authorize activation of clinical studies. The PRMC is responsible for review not only of each protocol but of how each protocol complements the overall trial portfolio of the Center. The PRMC should ensure thorough statistical review and establish a defined process for prioritization. The PRMC (and/or the disease groups) should give reasonable consideration as to whether protocols under review have the potential to accrue participants of underrepresented populations, and other populations, in the Center’s catchment area, although protocols may not be specifically written for that purpose. The PRMC is responsible for continuing review of open protocols, including accrual, new safety information, and scientific relevance, and has sole authority to close trials for these reasons. The Center must be able to document interactions between the PRMC and the disease groups.

In the Research Strategy describe:

I. First stage review: because there may be too many disease groups to describe in detail, Centers may briefly discuss the general operations and composition of the groups in the written application, including:

• The methods by which concepts and protocols are assessed and prioritized for recommendation to the PRMC, including frequency of meetings
• Methods for interactions between the disease groups and the investigators developing clinical protocols, and between disease groups if necessary
• The support from the Center to facilitate meetings and operations of the groups
• How the disease groups communicate with the PRMC

II. Second stage review: for the second stage of review by the PRMC, briefly describe:

• The criteria for selection of the membership of the committee. List the members of the PRMC 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 procedures for scientific review and scientific monitoring of cancer clinical trial protocols, including:
• 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
• How the accrual of minorities and other underrepresented populations into clinical trials is considered and monitored in open protocols
• Criteria used for monitoring ongoing institutional protocol research to evaluate scientific progress, including accrual rates, new safety information (any new safety information that might significantly alters the scientific value and safety of a particular trial should be conveyed to PRMC), and scientific relevance, to ensure that the scientific aims of the study can be completed
• The process and criteria used for prioritizing the activation of cancer clinical trial protocols at the institution. Discuss the metrics used by the committee to assess the efficiency and timeliness of their activities
• The process, criteria, and authority for terminating a clinical protocol. The PRMC should have final authority to close trials; no appeal should be allowed to any other person or entity. Discuss whether the committee has terminated any protocols, and for what reason
• Describe PRMS operations relative to the IRB approval process with emphasis on the complementarity of the two entities and absence of overlap or duplication
• If a consortium Center, discuss how the PRMS process is governed across the partner institutions
• If a multi-Center PRMS has been initiated (with prior NCI approval), discuss its governance and scope of operations

NOTES:

• At the site visit, Centers should be prepared to present detailed information, such as documentation of concepts and protocols considered, prioritized, etc., of the disease groups; and for the PRMC, minutes, submission, approval, and rejection rates, etc.
• Centers must be able to document interactions between the disease groups and the PRMC
• Because protocols undergo a thorough first stage of scientific review, the rate of rejection of protocols as a result of PRMC review may be minimal and should not be seen as a lack of rigor; however, the Center should still document the approximate number of protocols considered, submitted protocols and the rate of revisions and rejections by the PRMC
• Centers may establish more than one PRMC if trial activity warrants it; however, each PRMC should follow the same processes
• The scientific review of protocols and clinical trial operations are separate activities; the Director of the CPDM should not be a voting member of the PRMC (or DSMP), and the Chair of the PRMC should report to the Center Director or Deputy Director (although the CPDM Director may facilitate operations of the PRMC and DSMC)
• Protocols that address rare tumors or molecular phenotypes should be exempt from the normal accrual expectations of other types of trials, and policies should be established to identify such trials
• Feasibility review may be carried out by the disease group, or by a separate committee or group under the CPDM, or as part of the PRMC’s duties
• 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
• 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 review of 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

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component does not support research involving human subjects.

When preparing your application, use Component Type SR Component.

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

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.

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.
• 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.

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)

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

Research Strategy: For each CCSG supported Shared Resource describe:

• 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 Resource support the research of the Programs)
• Cost-effectiveness of the Shared 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 and non-members. 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.

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

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

Appendix:

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Specific to this FOA: This component may support research involving human subjects. If applied, 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.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 a Scientific/ Research Contact 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. Any instructions provided here are in addition to the instructions in the policy.

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

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, or may influence, 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.

In addition, for appliciations involving clinical trials:

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

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

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?

In addition, for applications involving clinical trials

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

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?

In addition, for applications involving clinical trials

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

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

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

1) the protection of human subjects from research risks, and

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

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?

In addition, for applications involving clinical trials

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

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

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

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

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

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

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

Specific to this FOA: These review criteria are only applicable to components in which CCSG might be used to fund clinical trials, i.e. Developmental Funds, Community Outreach and Engagement, Research Programs, and individual Shared Resources.

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?
• How well are institutions proposed for consortium status fully integrated into the Center, as demonstrated by a history of research collaboration and leadership from the consortium partners?
• How stable is the partnership, as evidenced by a history of research integration and the provisions of formalized agreements?
• How robust are the mechanisms in place to resolve differences?
• How good is the 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 and Coordination (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 Research Programs (for example, intra- and inter-programmatic publications) added value to cancer related scientific activities within the cancer center?
• How effective is the Center in moving scientific findings forward to cancer-related endpoints appropriate to the nature of the research, through internal collaborations, external collaborations with partners including other NCI-designated Cancer Centers, commercial development, etc.?
• 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 evidenced by the structure and objectives of the Programs, peer-reviewed research support, collaborative publications, and other activities of Center members?
• How well has the Center established a rigorous method for determining the cancer relevance of publications and non-NCI peer-review funding?

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, clinical income and proceeds from commercial development of Center discoveries, etc.), and the processes for determining how funds will be used?
• For matrix Centers, what is the evidence that the status of the Cancer Center is superior to that of an academic department and that institutional leadership provides stable 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 Training and Education Coordination (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 existing training and career development activities, including in preparation of grant applications?
• How appropriate is the Center’s process for integrating existing cancer education and training of biomedical researchers and health care professionals, including members of underrepresented populations, into programmatic and Shared Resource research efforts?
• How appropriate and effective is the leader (or leaders) in relation to expertise and time commitment?
• How appropriate is the institutional commitment to the cancer education and training activities?
• How appropriate are the proposed initiatives and plans for the next funding cycle?

Research Program (merit descriptor for each Program)

• What is the quality 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 listed in DT2?
• 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?
• In addition to research questions of broader applicability, what is the evidence that research relevant to the catchment area is being addressed at a level appropriate to the type of Program (e.g., problems affecting racial and ethnic minorities, rural residents, women, children, elderly, sexual and gender minorities, 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 to enhance collaborations within and among Research Programs, Shared Resources, and other services such as Clinical Protocol and Data Management, Developmental Funds, etc.?
• For Programs with clinical trials:
• What is the impact (see list above) of the clinical trials in the Program?
• How well do the clinical trials (listed in DT4) 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?
• What is the evidence that the Program is 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.?
• What is the evidence that Program participates 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 tumors, molecular phenotypes)?
• How reasonable are the future plans of the Research Program?
• 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 has the Center defined and justified its catchment area?
• How well has the Center identified and prioritized the cancer research and control needs of its catchment area population?
• How effectively has the Center established the necessary institutional- and community-based infrastructure to involve stakeholder’s participation in the planning, prioritization, and conduct of cancer research across the spectrum of basic, clinical, translational, and population sciences?
• How effectively have community needs been communicated to Center leadership and Research Programs to catalyze research?
• How effectively has the Center enacted cancer control efforts designed to reduce the burden of cancer within its catchment area, by disseminating and implementing evidence-based interventions and guidelines, public education, public health policy recommendations, influence on health policy, etc.?
• How appropriate and effective is the leader (or leaders) in relation to expertise and time commitment?
• As applicable, how reasonable and appropriate are the Center’s plans for extending its reach within and beyond the catchment area, including globally?

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, 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?

Staff Investigators (acceptable/unacceptable)

• If the Center proposes Staff Investigator(s), how appropriate is the candidate and will the candidate strengthen cancer-related science in the proposed role?

Shared Resource Management (merit descriptor)

• How effectively has the Center established Shared Resources that meet the scientific needs of its members?
• How effective are the management and oversight of existing Shared Resources?
• How effective are the mechanisms used to determine member needs to monitor quality of services, and for training of researchers?
• How well has the Center planned for future Shared Resource needs?
• How effective are the mechanisms in place to ensure accessibility and quality of institutionally-managed Shared Resources, or of Center-managed Shared Resources across multiple campuses or consortia partners?

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?

Protocol Review and Monitoring System (satisfactory/conditionally satisfactory/ unsatisfactory)

• How appropriately has the Center established disease groups with proper qualifications to review concepts and protocols in their area of expertise?
• How appropriate is the first stage of scientific review, as demonstrated by the rigor of scientific review in evaluating concepts and protocols?
• How strong is the evidence indicating robust communications between the disease groups and the PRMC?
• How appropriate is the second stage of scientific review carried out by the PRMC, as demonstrated by the composition of the membership, criteria and processes for scientific review, considering 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 the PRMC’s processes and frequency for continuing monitoring of trials for accrual, new safety information, and scientific relevance?
• Has the PRMC established reasonable accrual expectations for rare tumor and molecular phenotypes driven studies?
• How appropriate is the PRMC’s prioritization of how individual protocols fit into the overall trial effort of the Center?
• How effectively is the potential for accruing minority and underrepresented patients from the catchment area considered during either stage of scientific review and during continued monitoring of open 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?
• For consortium centers, is there a single PRMS governing all cancer clinical trial protocols across the partner institutions?

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 the Shared Resource's leader(s) and their time commitment?

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

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

Specific to this FOA:

Data and Safety Monitoring Plan (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?

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

Specific to this FOA:

Inclusion of Women, Minorities, and Individuals Across the Lifespan (acceptable/ unacceptable)

• How proportional to catchment and cancer patient demographic data provided is the accrual of women and minorities to:
• interventional therapeutic trials?
• non-therapeutic trials?
• 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 individual across the lifespan in clinical trials, or how acceptable is the justification for exclusion?

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.

Not applicable

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

Not applicable

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.

Consortium (satisfactory/ unsatisfactory)

• Does the consortium partner have adequate peer-reviewed 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?

Comprehensiveness (satisfactory/ unsatisfactory)

• 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, as reflected in the peer evaluation of the Research Programs?
• What is the degree of evidence for strong transdisciplinary research bridging these sciences, as demonstrated in the peer evaluation of Transdisciplinary Collaboration and Coordination?
• 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 and the cancer control activities it has undertaken, as evaluated in Community Outreach and Engagement?
• How is the scientific mission of the Cancer Center enabled by cancer education and training of biomedical scientists and health care professionals, as evaluated in Cancer Research Training?

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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

Milestones: Future support of a study funded under this FOA is contingent upon adequate participant recruitment based on projected milestones.

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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 RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Office of Cancer Centers
National Cancer Institute (NCI)
Telephone: 240-276-5600
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

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.