EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30 Clinical Trial Optional)
P30 Center Core Grants
Reissue of PAR-17-095
June 30, 2020 - Notice of Correction to Expiration Date for PAR-20-043. See Notice NOT-CA-20-081.
March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research.
PAR-20-043
None
93.397
This Funding Opportunity Announcement (FOA) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-designated Cancer Centers. CCSGs support three 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) Clinical Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these areas, and 3) Basic Cancer Centers, which focus on basic laboratory research. The purpose of all types of NCI-designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious 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.
November 4, 2019
December 25, 2019
Not applicable
Standard dates apply.
All applicants are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date
Not applicable
Standard dates apply
Standard dates apply
Standard dates apply
New Date October 12, 2021 per issuance of PAR-21-321. (Original Expiration Date: September 26, 2022)
Not Applicable
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:
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:
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:
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:
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:
NOTE: Centers may not propose consortium partners in a New (Type 1) application.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
New (Type 1) applications: Budget should not exceed $1.2 million (Basic Cancer Center), $1.4 million (Clinical Cancer Center) in direct costs per year for the project period.
Renewal (Type 2) applications: Application budgets are not limited but need to reflect the actual needs of the proposed project.
5 years
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
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
Governments
Other
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.
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:
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:
|
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:
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
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:
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:
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.
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:
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:
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)
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:
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:
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:
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:
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:
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)
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:
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:
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)
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:
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:
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:
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)
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:
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:
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:
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)
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:
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:
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:
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)
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:
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:
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)
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:
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:
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:
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)
Year (Specify mm/yyyy-mm/yyyy) |
Total |
|||
National Group |
||||
Externally Peer-Reviewed |
||||
Institutional |
||||
Industry |
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)
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:
II. Second stage review: for the second stage of review by the PRMC, briefly describe:
NOTES:
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:
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)
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:
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:
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)
Organizational Capability (merit descriptor)
Transdisciplinary Collaboration and Coordination (merit descriptor)
Cancer Focus (merit descriptor)
Institutional Commitment (merit descriptor)
Center Director (merit descriptor)
Cancer Center Administration (merit descriptor)
Cancer Research Training and Education Coordination (merit descriptor)
Research Program (merit descriptor for each Program)
NOTE: list not intended to be exclusive
Community Outreach and Engagement (merit descriptor)
Developmental Funds (merit descriptor)
Staff Investigators (acceptable/unacceptable)
Shared Resource Management (merit descriptor)
Leadership, Planning, and Evaluation (merit descriptor)
Clinical Protocol and Data Management (merit descriptor):
Protocol Review and Monitoring System (satisfactory/conditionally satisfactory/ unsatisfactory)
Shared Resources (merit descriptor for each Shared Resource)
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)
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)
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)
Comprehensiveness (satisfactory/ unsatisfactory)
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:
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:
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.
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: GrantsInfo@nih.gov (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: support@grants.gov
Office of Cancer Centers
National Cancer Institute (NCI)
Telephone: 240-276-5600
Email: ncicenters-r@mail.nih.gov
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6277
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.