Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30)

Activity Code

P30 Center Core Grants

Announcement Type

Reissue of PAR-11-005

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-12-298

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.397

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), invites new, renewal, resubmission or revision applications for P30 Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers. CCSGs support two types of cancer centers: 1) Comprehensive Cancer Centers, which demonstrate reasonable depth and breadth of research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based research, and which have substantial transdisciplinary research that bridges these scientific areas; and 2) Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these components. The purpose of both types of NCI-designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious programs in laboratory, clinical, and population research into a single transdisciplinary research enterprise across all institutional boundaries. Cancer Centers supported through this FOA are expected: to serve as major sources of discovery of the nature of cancer and of development of more effective approaches to prevention, diagnosis, and therapy; to contribute significantly to the development of shared resources that support research; to collaborate and coordinate their research efforts with other NCI-funded programs and investigators; and to disseminate research findings for the benefit of the community.

For detailed information on policies, application instructions, review criteria and its process, please refer to the CCSG Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf.

Key Dates
Posted Date

September 26, 2012

Letter of Intent Due Date

Six months prior to the application due date

Application Due Date(s)

Standard dates apply

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

(Now Expired November 8, 2013 per issuance of PAR-13-386), Originally January 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

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

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

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

Background

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

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

Although the CCSG does not directly fund the wider range of activities at Cancer Centers, an NCI-designated Cancer Center links state-of-the- art research and care, thus perpetuating the translational continuum. To decrease cancer incidence and mortality among populations within its catchment area1, including minority and underserved populations, it also establishes partnerships with other health delivery systems and state and community agencies for dissemination of evidence-based findings.

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

1NOTE: the catchment area must be defined and justified by the center, based on the geographic area it serves. It must be population based, e.g. using census tracts, zip codes, county or state lines, or other geographically defined boundaries. It must include the local area surrounding the cancer center

The NCI recognizes two types of Cancer Centers:

The Six Essential Characteristics of an NCI-designated Cancer Center:

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

Major Research Areas of Cancer Centers and Types of Interactions:

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

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

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

For detailed information on policies, application instructions, review criteria and its process, please refer to the CCSG Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

New (Type 1) applications should not exceed $1,000,000 in direct costs during the initial, year-one grant period. The budget for years

2-5 of new applications may receive cost-of-living adjustments consistent with the NCI policy in effect for the fiscal year.

Renewal (Type 2) with an existing direct cost award equal to or greater than $6,000,000 are capped at their current direct cost budget level. Renewal applications below this level may request a direct cost budget of $1,000,000, regardless of the prior award level, or 10% above the direct costs in the last year of their non-competing project period, whichever is greater. Funding may be requested for up to five years.

Larger budget increases for Type 2 applications should be requested only under exceptional circumstances (i.e., first recompeting application after a no-cost extension or reduced award). OCC program staff should be consulted prior to submission of such a request. Centers should clearly describe the unique circumstances leading to a larger budget request and provide compelling justification.

Award Project Period

The maximum period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

Foreign Institutions

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 allowed

Specifically to this FOA:

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

Specifically to this FOA:

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution is allowed.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Specifically to this FOA: Resubmission applications must include an introduction addressing the previous peer review critique (Summary Statement). The time limit on resubmission applications is 37 months from the date of the original submission; after that time, the application must be submitted as new.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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

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

The Letter of Intent should be sent to:

Director, Office of Cancer Centers
National Cancer Institute
National Institutes of Health
9609 Medical Center Drive, Room 2W212, MSC 9708
Bethesda, MD 20892-9708 (for U.S. Postal Service delivery)
Rockville, MD 20850 (for non-USPS courier delivery and campus visits)
Tel: (240) 276-5600
Fax: (240) 276-5625

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and three CD-ROM copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed with the additional requirements listed below and described in details in the the Cancer Center Support Grant Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf.

NOTE: Page limitations apply only to the narrative parts of each section including descriptions, objectives, goals, rationale, accomplishments, tables, figures, charts, etc. They do not include budget pages; budget justifications; biographical sketches; references or publication lists; tables on clinical trial accrual, or lists of grants. Page limits are not meant to suggest the optimal length of sections.

Resources Section

Supportive Data (Standard Cancer Center Summary Information): No page limit

These data tables (see CCSG Summary Data Guide for instructions and formats) 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.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions listed below and described in details are the Cancer Center Support Grant Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf

Specifically to this FOA, the application should include following elements:

Face Page
Description, Performance Sites, and Key Personnel
Table of Contents for all major sections and subsections of the application
Consolidated and Summary Budget Request 

History and Description of the Cancer Center Specifically Describing the Six Essential Characteristics of the Cancer Center

Director’s Overview: (limit to 12 pages)

Provide a short history and overview of the Cancer Center, especially its research activities. Briefly describe the most important research accomplishments during the last period of support and the vision and general plans for the future scientific development of the Center. If you are presenting a consortium Center, clearly outline the contributions of each institution, and the history, objectives, and benefits of the consortium arrangement.

Six Essential Characteristics of Cancer Centers

Facilities (limit to 6 pages): Centers are more successful in establishing an identity if they have a distinct physical location. Not all members of the Cancer Center need be physically located in facilities controlled exclusively by the Center; however, location of members across program areas (basic laboratory; clinical; and prevention, control, and population-based science) in close physical proximity enhances shared use of resources and facilitates scientific interactions. Even if proximity is impossible, Center shared resources and other services should still be reasonably accessible to all members.

In your application, discuss the size and other characteristics of the physical facilities dedicated to cancer research, Center shared resources, and administration. Provide a map that illustrates the main location of the Center’s research and administrative activities, and the physical relationship of any consortium institutions to the main campus. Indicate how the Center facilitates access to shared resources and other services (i.e., Clinical Protocol and Data Management).

Organizational Capabilities (limit to 12 pages): A Center should have an overall programmatic structure that effectively promotes collaborative scientific interactions both within the institution and with 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. It should sponsor or participate in education and training of biomedical researchers and health care professionals, including those from underserved populations, and have a process for integrating these activities into programmatic research efforts (the nature and range of these activities may vary by type of center). In addition to scientific questions of broad applicability, it should use its available expertise and resources to address cancer research within the catchment area1.

While a formal written strategic plan is not required, methods used by the Center to obtain effective internal and external advisory committee input, set priorities, make decisions, and evaluate Center plans and activities should be established and clearly documented, including those for determining and sustaining individual membership in the Center.

Using the above description, discuss the organizational structure, capabilities, and processes 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. A copy of formal written agreements documenting specifics of consortium arrangements and commitments relative to CCSG requirements should be made available at the site visit.

Transdisciplinary Collaboration and Coordination (limit to 12 pages): 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 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 Phase III trials or other types of definitive studies appropriate to the nature of the research) is also critical. NCI and other peer-reviewed translational science and clinical trial funding mechanisms (e.g., grants for SPOREs, multi-investigator R01s and program projects, phase I/II consortia, and the NCI NCTN) are important avenues for advancing discoveries originating in the Center and coordination of research across these mechanisms is strongly encouraged. Collaborative strategies may involve investigators within the Cancer Center, investigators in other Centers, industry, or other partners. The form and extent of these activities may vary, based on the type of Center, but all Centers are encouraged to establish collaborative links that result in appropriate application of findings, i.e., not all transdisciplinary research is translational.

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

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

Cancer Focus (limit to 6 pages): A clearly defined scientific focus on cancer research is demonstrated via the Center members’ grants and contracts, by the structure and objectives of its formal Programs, and the collaborations between laboratory researchers and other investigators more directly concerned with application of research knowledge. NCI recognizes that cancer-relatedness should be a matter of flexible interpretation (e.g., as with studies of basic mechanisms or of conditions or behaviors that influence a range of diseases), but the Center should be prepared to demonstrate how the scientific research it supports through the CCSG is linked to cancer.

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

Institutional Commitment (limit to 12 pages): 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:

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

Include a letter signed by the Dean and Hospital President or other appropriate institutional officials documenting specifics of institutional commitment both for the long-term future of the Center and for this award period.

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, and the provisions of formal agreements.

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

In your application, describe the scientific and administrative qualifications and leadership experience of the Center Director, as well as his/her time commitment to the Center. 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.

Descriptions, Budgets, and Narrative Justifications for Individual CCSG Components

Using the forms and instructions in the PHS Form 398 (rev. 06/09) for each allowable budget category for which funds are requested, prepare:

The CCSG provides reasonable costs for a great variety of activities clearly related to the research needs of the Cancer Center. The narrative describing the role and function of re­quested personnel should clearly justify the stated person months whether or not you request salary.

The major categories of allowable costs are:

Senior Leadership: No more than one page of narrative per senior leader, plus five additional pages for narrative discussion of their collaborative activities.

Individuals in pivotal leadership positions in the Center are eligible for salary support for the time and effort they devote to its research 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).

Prepare a description and a consolidated budget of person months for all senior leaders and narrative justifications that carefully describe their roles. Follow each narrative with a biographical sketch (see PHS Form 398 rev. 06/09).

In a short five-page description, discuss how the senior leaders have worked together to:

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

Leaders of Scientific Research Programs: Budget pages only.

Provide only a single consolidated budget that lists all Program leaders in the Center and their person months. This is merely a consolidation of the separate budgets provided and justified in Section "Description, Budget and Narrative Justification for Individual CCSG Components". Do NOT provide any narratives.

Planning and Evaluation: Limit of 5 pages.

Provide an overall description, a consolidated budget, and a narrative justification for each planning and evaluation activity. 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.

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.

The narrative should summarize how past CCSG funds were used, what was accomplished to improve and develop the Cancer Center and how future needs will be met with the requested budget. Discuss recommendations made by the EAC, any actions taken in response to those recommendations, or reasons for not responding. Provide a consolidated list of EAC members with titles and affiliations and attach their biosketches. and clinical resources, including institutional resources, and developmental funds) over the last project period. Although budgetary support for development of future scientific Programs is not allowable in the CCSG, plans for developing such Programs should be discussed in this section.

Developmental Funds: Limit of 12 pages.

Developmental Funds are the major source of budgetary flexibility in the CCSG and should be linked substantially to the planning and evaluation activities of the Center. These funds allow Centers to take risks and strengthen weaker scientific areas. They also provide opportunities for exploring innovative ideas and new collaborations and technologies to Center members.

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 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. Developmental funds are restricted, and may not be rebudgeted to other CCSG categories during the course of the project period.

Prepare an overall description and a composite budget that includes all requested developmental fund categories. Explain how funds are linked to the strategic and programmatic priorities and scientific opportunities of the Center, based on planning and evaluation activities. Provide individual budgets by category with separate narrative justifications. Narratives should summarize how past CCSG developmental funds were used, what was accomplished with them (e.g., establishment of a new shared resource, number of recruitments and areas of expertise, and number of pilot projects resulting in peer-reviewed funding) and how the new request will be used to meet the Center’s strategic goals. If pilot projects are proposed, describe how the projects are reviewed for scientific merit and selected for funding.

Use of Developmental Funds is restricted to the following:

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

In your application, explain how these developmental funds were used in the previous three to five year grant period, specifying which investigators and projects were supported, the rationale for recruiting these investigators relative to the needs of the Center, and to what extent these investigators were subsequently productive as evidenced by research grants, publications and leadership/participation in clinical trials.

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

Interim salary and research support: The Center Director may provide partial support for up to 18 months to an investigator who has a reasonable probability of regaining independent research support in the near future. Interim salary and support is independent of any salary funded by the CCSG in the Staff Investigator category. Individuals who are having chronic difficulty with peer-reviewed grant support, and for whom permanent institutional funds are not available, are ineligible.

Your application should include a description of the process and the criteria used to select investigators for interim support. Peer review at the next competitive evaluation will examine the uses of the interim support category and the success that individuals supported from this category have had in regaining peer-reviewed grant support.

NCI also encourages the development of new technologies that will advance cancer research (procedures, instrumentation, analytical tools, or reagents), e.g., the detection and analysis of molecular signatures of cancer in vitro or in vivo, biomedical imaging, model development, drug discovery, tumor targeting, drug delivery, survey development, and informatics.

Your application should describe the processes for eliciting and reviewing proposals, and list the awardees and their projects for the preceding project period. Describe the outcome of all projects supported by the CCSG through the pilot and technology/methodology development mechanisms (e.g., grant awards, publications, and patents).

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.

Development of new Shared Resources: CCSG funds may be used to help develop new shared resources when the Center recognizes a need. If the resources are sufficiently developed to be proposed and reviewed as established resources (e.g., a track record demonstrating its viability as a fully functioning shared resource), they should be proposed under the shared resources category. They may not be used for upgrades or routine purchases of equipment.

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).

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

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

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

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

Prepare an overall description for the component, and a consolidated budget. Identify each Staff Investigator by name and type. 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. Provide a separate narrative justification, with a description of duties, and a biographical sketch for each Staff Investigator proposed and clarify how your selection will enable the Center to meet overarching scientific and/or clinical objectives. 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.

Cancer Center Administration: Limit of 12 pages.

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

The CCSG central administrative budget may support an appropriate percentage of the salary of the chief administrator, secretarial and other staff, travel needs of senior leaders and Program leaders in the performance of their Center-specific roles, and supplies for the administrative functions of the Center. Funding for a percentage of salary for a staff person to support links with state health departments, other state agencies, or the Centers for Disease Control and Prevention (CDC) also is allowable. Partial salary support for a Center informatics lead to further NCI’s goals of increased interoperability both within the Center’s existing informatics systems and workflows, and between those systems and NCI informatics systems, may be included as well.

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

While organizational structures and functions vary, your application should describe, as appropriate:

Research Programs: Limit of 12 pages per Program, with exclusions as indicated below

Goals:

Cancer Centers foster cancer-focused research, in part through the creation of formal scientific Research Programs. In the context of the CCSG, a Program comprises the activities of a group of investigators who share common scientific interests and goals and participate in competitively 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. Ultimately, the success of Programs is measured by scientific excellence and the emergence of productive collaborations. How this is achieved will vary with the Center and the needs of particular Programs; there is no proscribed set or balance of activities for accomplishing these objectives. Formal or informal planning meetings, seminars and retreats, developmental funding of selected pilot projects, new shared resources or key recruitments may be effective ways of promoting increasing levels of interaction.

Selection of members:

Selection of members for a Center’s Programs is one of the most critical decisions made by leadership. Functional and productive Programs select individuals for their scientific excellence and, just as importantly, for their commitment to work together to further the scientific goals of the Cancer Center. Some Program members may not hold peer-reviewed grants, but contribute to the research objectives of the Center in other important ways (e.g., development and implementation of Center’s clinical activity, including authorship of clinical protocols, accrual of patients on interventional trials, and leadership roles in NCI National Clinical Trials Network studies), and these contributions should be recognized.

Many Programs in Cancer Centers involve sustained collaborations with scientists who clearly strengthen and enhance value-added interactions and the scientific productivity of the research but who have no formal appointment within the institutions that comprise the Cancer Center. 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, these members may have full access to shared resources and developmental funds.

Characteristics of Programs:

Programs should be of adequate size and scientific quality, should exhibit a high degree of interaction, and should be capably led. A Program must have at least five peer-reviewed and funded research projects (e.g., % R01 + % R21 + % U01 = 300%) from a minimum of three separate, independent PD(s)/PI(s) to be eligible, however successful programs substantially exceed this minimum. Peer-reviewed, funded research sub-projects of larger grants (e.g., P01s, P50s), but not shared resources, may be counted as separate projects.

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. Again, 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.

Definition of Peer-Reviewed, Funded Research Projects for Inclusion in Programs and for Designation of Users in Shared Resources:

Peer review as employed by the NIH is the acceptable standard for inclusion of a cancer-related research project within a formal Program. Eligible peer-reviewed grants and contracts, including those formally awarded to individual or multiple investigators, are as follows:

For descriptions of specific NIH funding mechanisms, see http://grants.nih.gov/grants/funding/ac_search_results.htm. Peer-reviewed, cancer-related support from a number of other NCI program-approved funding organizations can be included. An updated list of approved organizations is available at http://cancercenters.cancer.gov/documents/fundorg.pdf.

Formatting For Each Program Section: Limit of 12 narrative pages per Program, excluding title page; description; biosketches; budget; budget justification; and lists of members, funded projects, clinical trials, shared resources and services, and publications.

For each Program, please provide the following:

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.

Shared Resources: Limit of 12 pages per resource

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).

Budgets:

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

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

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

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

Formatting for the Shared Resource Section:

Prepare a description using page 2 of the PHS Form 398 (rev. 06/09), budget and narrative justifications for each resource.

In the narrative for each shared resource, describe the:

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

After completing a section for each individual shared resource, organize the resources into three groupings.  Groupings may be based on type of shared resource, e.g., basic, clinical, etc., or any other system you choose.  Indicate the chosen group name at the beginning of each grouping. A fourth grouping ‘Other’ may be added for shared resources that do not fit easily into the three already identified.

Sources of Support for Shared Resources

Income Source

Current Support ($)

Percent of Current Total Budget

Proposed Support - Year 1 ($)

Percent of Proposed Total Budget

CCSG

       

Fee for Service/ Chargebacks

       

Other

       

Total Operating Budget

     

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 (see discussion below), and other consultative services not typically charged to grant mechanisms.

Informatics: In Cancer Centers, informatics expertise and resources are critical shared resource functions. The CCSG may support applications of informatics directed toward cancer research (e.g., the acquisition, maintenance, and integration of database systems for clinical trials or studies in populations; data extraction, storage, and analysis tools for genomics, proteomics, or molecular structure; a database annotating a research repository involving human specimens; and tools that enable sharing of data sets with collaborating investigators in related areas of research). Performance of specific research functions, such as data entry, for individual research projects or clinical trials is excluded. As the interoperability of independently developed informatics systems is an important goal of the research community, informatics development efforts supported by CCSG funds must comply with evolving standards articulated by the NCI, the scientific community, and other standard-setting organizations in the medical and bioinformatics areas.

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 the this effort would normally be supported by an appropriate time-and-effort allocation as a collaborator on that grant.

Clinical Protocol and Data Management (CPDM)/Clinical Trials Office* (Limit of 12 pages) & Data and Safety Monitoring (limit of 5 pages)

*NOTE: Clinical Trials Office is not a Shared Resource.

Provide a description, budget and narrative justification. This component provides central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical trials of the institution(s) that define the Center, whatever the study origin (local, industrial, NCI National Clinical Trials Network, or other). As a tool for management of a Center’s clinical research program, 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 and training services for data managers and nurse; 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.

In addition, this component also may support:

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.

Provide an overview of accrual to interventional clinical trials over the five-year project period preceding the competing renewal application. (NOTE: This is a summary of Standard Cancer Center Data Table (Summary) 4 interventional trial data and the definitions, reporting years, and accrual sites used in Data Table (Summary) 4 apply to the data in this table.) A sample template is below:

Accrual to Interventional* Therapeutic and Other Interventional Clinical Protocols By Reporting Year (mm/yyyy)* and Source of Support

Reporting Year (specify mm/yyyy)

         

National Group

         

External Peer Review

         

Institutional (investigator initiated)

         

Industry

         

Total Accrual to Interventional Clinical Protocols

         

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

In addition to the above, Data and Safety Monitoring (DSM) should be addressed in this section. 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.

By NIH review criteria, the peer reviewers will be responsible for determining only whether the DSM plan is acceptable or unacceptable. Peers are expected to define the weaknesses of an unacceptable DSM plan and to reflect any weaknesses in the impact/priority score. The final approval of a DSM plan in its original form or later modified form is the responsibility of the staff of the OCC.

Provide a very brief summary of the Center’s DSM plan. Do not include the entire plan within the text but provide a copy at the site visit.

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.

Funding may be requested for appropriate support staff and supplies. If funding is requested for staffing related to DSM activities, provide a separate budget and justification pages and include in the narrative a summary description of:

Protocol Review & Monitoring System (PRMS, Limit of 10 pages exclusive of protocol listing)

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

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

The PRMS provides full scientific evaluation and prioritization of all Cancer Center trials derived and supported from institutional sources, including those originating from other cancer centers or from industry. However, the PRMS:

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

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

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

Describe the criteria for selection of the membership of the committee. List the members of the committee and their expertise. The biographical sketches of these individuals should be included at the end of this section. 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.

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

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

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

Describe the process, criteria, and authority for terminating a clinical protocol. 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 complementarily 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.

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

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

NCI will request a sample from the list for detailed review prior to the site visit. Do not include or append protocols to the CCSG application.

In addition, 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)

Year (Specify mm/yyyy-mm/yyyy)

     

Total

National Group

       

Externally Peer-Reviewed

       

Institutional

       

Industry

       

In cases of conditional approval or disapproval of the PRMS, the peer reviewers will clarify in the Summary Statement what steps or changes are needed for full approval, along with any recommendations on timing of re-evaluation by peers.

Early Phase Clinical Research Support (EPCRS, formerly Protocol Specific Research Support): Limit of 4 pages, excluding tables and lists of studies

Provide a description, budget and narrative justification. This CCSG component provides support for short term, pilot and phase I clinical research studies originat­ing from scientific investigators within the Cancer Center. Preliminary data generated from these studies, which historically have been rarely funded through other mechanisms, can be used as the basis for application for support of later phase studies through competitive grants or industry. Support is not meant for all early phase trials, for later phase trials, or for studies that do that do not involve testing of an agent or device. Center leadership must prioritize studies for support and oversee these funds.

These funds may be used for global health projects, but must meet all eligibility criteria listed below. NIH must track all projects in this category that include foreign components and , if necessary, State Department clearance must be obtained prior to implementation.  OCC staff will act as the liaison between the Centers and the NIH Fogarty International Center, which is responsible for coordinating all clearances.

Eligibility criteria are as follows:

Funding in these pilot and phase I clinical studies is limited to support of:

Funds in this component may not be used for any supervisory functions.

Provide a listing of all studies supported with EPCRS funds over the last project period, with investigator name, project name, phase, anatomic site (if applicable), duration, and outcome or impact (e.g., led to peer-reviewed funding for a later phase trial, a publication, a revised scientific approach, identification of investigational agents for further development or novel probes, etc.). Discuss the process used for prioritizing studies for support. Describe proposed uses of EPCRS funds for the coming project period (e.g. areas to be supported and examples). Base the budget request on the Center’s actual and projected clinical study activities, as well as on complexity of these studies.

Inclusion of Minorities and Women in Clinical Research (NIH Policy): No more than 6 pages in total, with section below on "Inclusion of Children in Clinical Research"

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

In your application, provide separate tables for accrual in interventional therapeutic, interventional nontherapeutic, and non-interventional studies (e.g., epidemiologic, outcome, observational).

Reviewers evaluating the section of the application on the inclusion of women and minorities in clinical research will consider separately whether the accrual of women and minorities to interventional therapeutic and non-therapeutic trials, and to non-interventional studies is proportionate to the cancer patient population in the cancer center's primary catchment area1. Reviewers will assess the total picture, taking interventional therapeutic and non-therapeutic  clinical trial accrual and accrual to non-interventional studies into account in relation to approval/disapproval of gender and minority accrual.

When women or minorities are substantially under-represented in relation to catchment area1 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 area1 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.

Include the following information in this section:

Demographics. Provide summary information showing the demographics of the primary geo­graphic catchment area1 of the Center by ethnic categories and subcategories and by gender, as well as for the cancer patient population treated at the Cancer Center. Centers have the option of also providing data on demographics of cancer patients in the catchment area, if available.

Accrual. Complete Parts A and B of the “Inclusion Enrollment Report Table”, found in the PHS Form (rev 06/09). Provide summary accrual information from the most recent 12-month period by ethnic categories and subcategories and by gender in the following o areas: (a) the interventional therapeutic clinical trials conducted at the cancer center, (b) the interventional non-therapeutic trials conducted at the cancer center, and (c) accrual to non- interventional epidemiologic, observational, outcome studies. Relate this information to the demographic information provided above.

In addition, the revised PHS Form 398 instructions (rev. 06/09) require applicants to provide data on the composition of proposed study populations in terms of gender and racial/ethnic groups. For CCSG applications, this requirement is limited to projected accrual to phase III studies that utilize CCSG resources and are not funded by any other PHS grant mechanism. See the PHS Form 398 (rev. 06/09) for table formats for both targeted/planned enrollment and actual enrollment. Please indicate if you have no phase III trials that meet this criterion.

In addition to the above, you may also include information in this section on other underserved populations (e.g., rural, elderly, low socioeconomic status) within the center’s catchment area1 if desired.

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

Any general policies of the parent institution designed to help with recruitment and retention of women and minorities.

Unavoidable circumstances that impede accrual 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 population, which demonstrate a clear effort to recruit women and minorities and correct deficiencies that are potentially avoidable.

Inclusion of Children in Clinical Research included in 6 pages limit for "Minorities and Women in Clinical Trials" above
Application for Comprehensiveness

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Specifically to this FOA:

Some Restrictions on Allowable Budgets: Requested and/or awarded funds may not duplicate or replace costs normally included in the institution’s indirect cost base or services and benefits normally provided by the institution (e.g., purchasing, personnel, and other ancillary services) to other departments, schools, or institutes. CCSG funds should not be used to compensate for NIH/NCI administrative reductions of active awards or to pay for shortfalls in funded research projects. They cannot supplement or offset any patient costs, even those directly related to clinical research protocols.

6. Other Submission Requirements and Information

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

The NCI Initial Review Group (IRG), NCI IRG Subcommittee A (NCI – A), reviews CCSG P30 applications.

For information about the site visit/ review process, please see Section 3 (Peer Review of the Application) of the Guidelines: http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf

For this particular announcement, note the following:

The term ‘project’ refers to the Center application and ‘project aims’ refers to the Center’s strategic goals.)

Overall Impact - Overall

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

Scored Review Criteria - Overall

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? What is the overall quality of the science in the Center? What has the Center contributed to the development of more effective prevention, diagnosis, and treatment for cancer (where appropriate)?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the Cancer Center add value over and above the separately funded research efforts themselves? Have thoughtful, coherent scientific Programs been assembled and Program members selected to maximize the cancer-related interactive science in the parent institution as a whole? How do the different cancer-related scientific themes in the parent institution fit together in the Center?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? What impact has the Center itself had (or is likely to have) on the quality of the science, the productivity of the scientists, and the transdisciplinary activities of the institution relating to cancer? Have the choices for Center membership made by its leaders resulted in a group of excellent cancer-focused scientists who are also committed to productive interactions with one another?

Additional Review Criteria

Ultimately, the application should reflect how the CCSG has influenced Center accomplishments, i.e., if the Center would have reported similar achievements without the benefit of the CCSG, the ‘value-added’ would be minimal and should be reflected in the overall impact/priority 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.

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/priority score, but will not give separate scores for these items.

Essential Characteristics of the Center

Facilities: (merit descriptor)

Organizational Capability: (merit descriptor)

Transdisciplinary Collaboration: (merit descriptor)

Cancer Focus: (merit descriptor)

Institutional Commitment: (merit descriptor)

Center Director: (merit descriptor)

Senior Leadership: (merit descriptor)

Planning and Evaluation: (merit descriptor)

Developmental Funds: (merit descriptor)

Cancer Center Administration: (merit descriptor)

Scientific Quality of Each Program: (merit descriptor for each Program)

Shared Resources and Services: (merit descriptor for all Resources)

Clinical Protocol and Data Management/Clinical Trials Office:  (merit descriptor)

Data and Safety Monitoring: (acceptable/unacceptable)

Protocol Review and Monitoring System (PRMS): (approve, conditionally approve, or disapprove)

Early Phase Clinical Research Support (EPCRS): (merit descriptor)

Inclusion of Minorities and Women in Clinical Research: (approval/ disapproval)

Inclusion of Children in Clinical Research : (acceptable/ unacceptable)

Comprehensiveness

The following review criteria apply for determination of comprehensiveness: (approve/disapprove)

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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

Additional Review Considerations - Overall

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Not Applicable

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will be assigned  to the NCI  and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone (301) 435-0714
TTY (301) 451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: (301) 402-7469 or (866) 504-9552 (Toll Free)
TTY: (301) 451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Office of Cancer Centers
National Cancer Institute
9609 Medical Center Drive, Room 2W212, MSC 9708
Bethesda, MD 20892-9708 (for U.S. Postal Service delivery)
Rockville, MD 20850 (for non-USPS courier delivery and campus visits)
Tel: (240) 276-5600
Fax: (240) 276-5625
Email: ncicenters-r@mail.nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Office of Grants Administration
National Cancer Institute
9609 Medical Center Drive, Room 2W344, MSC 9710
Bethesda, MD 20892-9750 (for express mail, use Rockville, MD 20850)
Telephone: 240-276-6277
Fax: 240-276-6300

Section VIII. Other Information

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

Authority and Regulations

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 Parts 74 and 92.


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