It is critical that applicants follow the Research (R) 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

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the establishment of the Coordinating and Data Management Center (CDMC), one of the two scientific units of the Translational and Basic Science Research in Early Lesions (TBEL) program. The TBEL program aims to integrate basic and translational cancer research studies to further understand the biological and pathophysiological mechanisms driving or restraining precancers and early cancers and facilitate biology-based precision prevention approaches. The responsibilities of the CDMC will be to (1) coordinate program-wide meetings and conferences, and cross-network collaborative activities; (2) provide statistical and computational analysis support; and (3) serve as a program data hub for data capture, curation and management, and protocol development.

In addition to the CDMC (this FOA), TBEL will include up to five Research Centers, supported by a companion FOA:

The aim of each Research Center (RFA-CA-21-054; U54) is to integrate basic and translational cancer research studies to iteratively examine the direct causal relationships and interactions of an early lesion, its microenvironment, and host-systemic factors as co-organizers of tumor initiation (or suppression) and malignant progression in conjunction with the clinical characteristics of the lesions.

Increasingly sensitive imaging/cancer-screening modalities have led to the detection of a significant number of precancers and early cancers, whose clinical management presents a serious challenge, as it is often not possible without an understanding of the underlying biology to distinguish those that will progress to aggressive disease (and require intervention) from those that will remain indolent (for which active surveillance may suffice). Despite the strong links between early lesions and cancer risk for many tumor types including colon, breast, head and neck and numerous clinical conditions ranging from chronic inflammation to obesity/metabolic disorders, and tissue stiffness/desmoplasia, only limited insights exist on the nexus between early lesion drivers and regulators of malignant progression. Elucidation of the basic mechanisms driving or restraining precancers/early cancers would allow differentiation and stratification between aggressive, potentially lethal cancers ( clinically important cancers ) and indolent types and further personalize care.

There is a strong inter-related basic and clinical justification to pursue a more integrated approach to understand what defines early cancer lesions and drivers or blockers of these lesions. Cancer screening reduces mortality from breast, colon, cervical, and lung cancer. However, screening also increases the likelihood of finding lesions that would have never progressed to cancer which are often over-diagnosed, over-treated and result in unintended morbidity, stress, and health care resource and access issues. For example, the sustained increase in incidence of pre-invasive and early-stage breast and prostate cancer had no subsequent impact on late stage or metastatic disease in some populations. Furthermore, many additional lesions are identified incidentally ( incidentalomas ) through the increased use of diagnostic imaging procedures. The fraction of malignant incidentalomas identified by imaging is typically small but varies by organ, ranging from <5% for brain, parotid, and adrenal gland to more than 40% for breast. Regardless of how early lesions are found, the current standard of clinical care requires a determination of how the patient with a detected lesion will be managed. Many lines of evidence suggest that integrating basic biology and translational approaches is essential to understanding lesion dynamics and its progression. This integration will also necessitate expanding the focus beyond the early lesion to include the surrounding microenvironment as a co-organizer and enabler of progression and their dependence on clinical parameters such as age, systemic factors, tissue density/architecture, inflammation and/or immunocompetence. Focusing solely on molecular and genomic alterations in early lesions is insufficient especially if driver mutations commonly found in malignant lesions are also found in early lesions that do not necessarily progress to cancer or in normal tissues.

Validated cellular, molecular and biochemical features that define early non-progressing lesions from early aggressive lesions remain elusive and insufficient for appropriately managing the increased detection of early lesions including DCIS, early-stage prostate cancers, or melanoma precursor lesions and lung nodules. Efforts in systematically characterizing the early lesion more broadly and comprehensively by including microenvironmental components are also limited but will undoubtedly be instrumental in differentiating indolent from progressive lesions. Clinical and epidemiologic data also provide evidence that genetic factors, health conditions and systemic indicators of physiologic status (such as tissue density, inflammatory and other stress responses and immune competence) or the microbiome can act as modifiers and cofactors influencing early lesion trajectories. New -omics technologies (e.g., genomics, transcriptomics, epigenomics, proteomics, and radiogenomics) could yield a more comprehensive analysis of early lesions. Employment of these approaches will enable a multidimensional characterization of lesion heterogeneity and the identification of molecular, histological, and physical/architectural features that distinguish early, non-progressing lesions from those that will evolve to malignancy; and help establish direct causal relationships between cellular and molecular features and disease outcomes. Fortunately, retrospective cohorts of patients with early lesions are available that include longitudinally and serially collected biospecimens, imaging data, and cancer incidence information.

The progression of an early lesion to malignancy is a complex process that can occur over a period of many years. At the basic biology level, evidence points to early- and later-stage tumor dynamics being governed by distinct mechanisms and pathways. An example of such context-dependent contradictory roles is transforming growth factor (TGF ), which is known to exhibit both tumor suppressive (early) and tumor promoting (late) roles. Likewise, autophagy can play an early tumor suppressive role via maintenance of tissue homeostasis in contrast to its late-stage cancer promotion role via both cell autonomous and non-autonomous mechanisms. Another example of context driving biology/disease progression is senescence, which can prevent the growth of premalignant cells and support immune surveillance. Senescence can also promote tumor initiation via transition of normal fibroblasts to cancer associated fibroblasts (CAFs) and induction of a field effect that facilitates the conversion of actinic keratosis to squamous cell carcinoma. Establishing early lesion models to study their complex environments, heterogeneities, and cooperativity with the surrounding stroma can potentially outline important biological distinctions for these lesions and ultimately inform their clinical management.

Chronic microenvironmental conditions can contribute to cancer risk, perhaps in a coordinated manner with the incipient mutant tumor cells. For instance, chronic pulmonary inflammation can initially drive DNA damage response, along with nitric oxide synthase and p53 induction in preneoplastic lesions, followed by epigenetic silencing of p16 as the lesion evolves to cancer, without necessarily acquiring classic driver mutations at the early stages of transformation. Also, studies have established links between the acellular stroma/extracellular matrix (ECM)-based microenvironment and epithelial cell survival, fate determination, indicating that both stromal content and architecture can modulate suppression/promotion of malignant conversion or even normalization of tumor cells. It will be important to comprehensively study driver pathways in early lesions within the context of the heterogeneous microenvironment that not only hosts and supports the incipient tumors but could also drive and shape its evolution/fate.

Systematic investigations that integrate basic biology and translational efforts to develop mechanistically informed signatures of early lesions (ranging from incipient lesion to stromal composition and heterogeneity) and their trajectories over time will allow the establishment of direct relationships between different subtypes of lesions and stromal cells, extracellular matrix and biochemical events in a clinically meaningful manner. This will not only provide a deeper understanding of the microenvironmental influencers (including clinically relevant systemic factors) that either block or drive a lesion progression to cancer but, importantly, identify biomarkers that could inform efforts to stratify patients more precisely along a continuum of risk progression and tailored treatment needs. Statistical modeling approaches that use data generated at the basic biological level together with data from omics technologies in patients with early clinical lesions may be also helpful in uncovering pathways and sequences of events that lead early lesions to progress. The TBEL program is designed to foster multi-disciplinary collaborations within each Research Center and across the TBEL Network to promote a deeper understanding of early lesions, their microenvironment, and reciprocal interactions that drive early lesion fate and clinical outcomes.

TBEL will be structured around the two main units the Research Centers and the CDMC. Although individual teams of TBEL recipients (Research Centers and the CDMC) will operate independently, they will be required to interact closely with other TBEL recipients and engage in collaborative activities with them.

Steering Committee: The TBEL administrative structure and all activities will be governed by its Steering Committee, which will include representatives of the TBEL recipients and the NCI. The Steering Committee will be the governing body of TBEL that will integrate the efforts of all recipients and will provide oversight of collaborative activities. The Chair and co-Chair of the Steering Committee will be PDs/PIs of TBEL cooperative agreement awards and will be elected by the Steering Committee. Any member of the Steering Committee can offer nominations for the Chair and co-Chair.

Further details of the Steering Committee composition and responsibilities are provided in Section VI.2. Administrative and National Policy Requirements: Cooperative Agreement Terms and Conditions.

Scope. This FOA encourages the submission of applications to establish the TBEL CDMC. The CDMC must have expertise and capabilities in biostatistics and statistical modeling, computational analysis, information technology and bioinformatics, data management, protocol development, and in coordinating and providing logistical support for meetings and conferences. The CDMC is expected to evolve and adapt in response to the needs of the TBEL community. It is essential that the CDMC applicants familiarize themselves with the companion FOA for the Research Centers (RFA-CA-21-054), with which the CDMC must work.

CDMC responsibilities include but are not limited to:

• Provide statistical analysis for TBEL-collaborative studies.
• Support the development, coordination, implementation, and conduct of TBEL-collaborative research protocols.
• Support NIH Single-IRB policy to enhance and streamline the IRB process for multi-site research studies.
• Deploy state-of-the-art management of data and protocol development, Laboratory Information Management System (LIMS), which provides a comprehensive array of support services including study development, documentation of Common Data Elements (CDEs), data entry checks and specimen tracking for biospecimens used in collaborative studies, data harmonization and study-specific reports.
• Work closely with TBEL investigators to support data analysis and utilize visualization tools. Additional consultations and support on statistics and modeling will be made available through the NCI Division of Cancer Prevention's Biometry Research Group as directed by the Steering Committee and NCI staff.
• Enhance, improve, and maintain TBEL network integration and coordination.
• Provide logistical and administrative assistance in arranging TBEL-wide meetings and workshops and employ various electronic channels of communication to promote and disseminate information among TBEL investigators and the broader scientific community.
• Coordinate the collection, curation, and dissemination of all data and metadata, data analysis and visualization tools, and computational models and lead the development of CDEs as needed, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines. Guide and lead a Network-wide effort to prepare and make data and resources broadly available through the Cancer Research Data Commons (e.g., dbGaP), and/or other public repositories as appropriate and as directed by the TBEL Steering Committee.

Data Science

TBEL Program components share a mandate to develop an understanding of mechanisms that drive or restrain early lesions based on integrated basic and translational cancer research studies. Given the high-content data-intensive nature of this work, it is expected that members of the TBEL Program will adhere to data management and sharing policies developed in conjunction with NCI staff within the Cooperative Agreement environment that facilitate harmonization and interoperability of multiscale data and diverse data types. This will poise TBEL as a unique contributor of multi-modal precancer/early cancer data at the intersection of both basic cancer biology and translational research to the broader National Cancer Data Ecosystem. In leveraging existing data infrastructures, it is anticipated that TBEL will become increasingly engaged in alliances with other data-intensive programs (e.g., Cancer Systems Biology Consortium, Human Tumor Atlas Network, Acquired Resistance to Therapy Network, Radiation Oncology-Biology Integration Network, Pancreatic Ductal Adenocarcinoma Stromal Reprogramming Consortium, NCI-DOE Joint Design of Advanced Computing Solutions for Cancer) as the network matures, creating additional opportunities for collaboration and scientific discovery consistent with the goals of the cancer data ecosystem.

Note: NCI will hold a pre-application informational webinar for this FOA. When published, the related Notice will be linked with the FOA.

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

An investigator designated as a Contact PD/PI of an application under this FOA must not be the designated Contact PD/PI or a Multi-Principal Investigator (MPI) or co-I on another application under the companion FOA (RFA-CA-21-054).

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Christos Patriotis, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7134
Email: patriotisc@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

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

Budget-related Information Specific for this FOA:

a) Leadership Effort Commitment: The contact PD/PI must commit a minimum of 1.8 person months of his/her time per year and all other PDs/PIs (if multiple) must commit a minimum of 1.2 person months of their time per year to the U24 award. This commitment cannot be reduced in later years of the award.

b) Travel Funds: Applicants must budget for travel and per diem expenses for Steering Committee meetings. Applicants should plan for the PD(s)/PI(s) and an additional senior investigator to attend two semi-annual Steering Committee meetings per year.

c) Other: It is expected that funds will be allocated to open-access publishing.

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

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

The standard PHS398 Research Plan (Item 3 as per Revision 08/12 of the PHS 398 Table of Contents) is altered as follows: Standard Items 2-5 of the PHS 398 Research Plan are replaced by the following three sections: 1) Investigators' Leadership and Experience; 2) Plans for The Required Areas of Responsibility; and 3) Compliance with Consortium Cooperative Agreement Terms.

Specific Aims: The CDMC will serve as the scientific and organizational hub for the entire TBEL program. In light of this significance, the applicants should describe the scope and innovation of the proposed strategies for coordinating the TBEL program, as well as available expertise, resources, and capabilities for supporting the program's research on early lesions.

Research Strategy: Specific Sections to be included in Research Strategy are described below.

The responsibilities of the TBEL CDMC are diverse. Each of the responsibilities described in the section "Section I. Funding Opportunity Description: 1. Research Objectives is relevant to the overall performance of the Consortium.

Section 1. Investigators' Leadership and Experience

• Describe the applicant organization's facilities and resources, and how the strengths of the PD(s)/PI(s) and other key personnel in biostatistics, data management, data analysis, and project management have been used in previous, successful collaborative research projects;
• Describe the knowledge and experience of the PD(s)/PI(s) and other key personnel in research on cancer and technologies used in cancer detection, diagnosis, and prognosis;
• Describe the experience of the key personnel in protocol design, data entry procedures, and manual preparation, and in data collection and data quality control for previous large-scale, complex research projects;
• Present the applicant's record in generating reports on data collection and performance in previous collaborative projects, including preparation of manuscripts;
• Describe how logistical services and organizational support have been utilized in managing resources and monitoring performance in previous collaborative research; and
• Describe the applicants experience and accomplishments in the development of statistical and computational tools, statistical modeling, innovative sampling and study designs, and present a plan to develop a research project that is relevant to cancer biology, detection and prognosis.

Section 2. Plans for the Required Areas of Responsibility

Applicants must describe in detail the development, implementation, and maintenance plans for each required area of responsibility (defined in Section I. Research Objectives of this FOA). These main areas of responsibility include:

(a) Consortium Coordination:

• Provide logistical and administrative assistance in arranging meetings of the Steering Committee (e.g. preparing, distributing, and maintaining minutes of meetings), including the selection and contract development with appropriate venues as decided by the Steering committee. There will be one face-to-face Steering Committee Meetings per year and monthly teleconferences;
• Provide other operational support for TBEL (e.g., communications, subcommittee meetings, teleconferences);
• Employ various electronic channels of communication to promote and disseminate information among TBEL investigators, other NCI-supported programs, and the broader scientific community;
• Develop and maintain all documents, including a Manual of Operations and other procedure manuals as needed with oversight and guidance by the TBEL Steering Committee and input from NCI staff;
• Contribute to the development and maintenance of an interactive TBEL website to disseminate information on important accomplishments of the Network, and to publicize the availability of TBEL-supported resources;
• Develop and maintain a "listserv" interactive email system for communication within the Network;
• Work with the NCI Project Scientists/Coordinators on the review of collaborative study proposals submitted by Research Centers to the TBEL Steering Committee for the use of set-aside funds;
• Work with the NCI Project Scientists/Coordinators on the review of Associate Membership applications submitted to the TBEL Steering Committee.

(b) Statistical and Computational Analysis Support:

• Provide statistical support for TBEL-collaborative studies;
• Conduct data analysis and assist in the publication of results of TBEL collaborative studies;
• Demonstrate expertise in data integration and statistical modeling approaches for using data generated from early lesions at the basic biological level together with data from -omics technologies;
• Demonstrate expertise and flexibility to accommodate increasing data volume/types from TBEL studies (bioinformatics, imaging, data science, modeling, visualization tools, etc.);
• Demonstrate expertise in data mining using AI and bioinformatic tools;
• Utilize data analytics (statistics, AI, ML, Deep Learning, bioinformatics tools, etc.) to improve the understanding of early lesion progression towards malignancy.

(c) Data Management and Protocol Development:

• Support the development, coordination, and implementation of TBEL collaborative research protocols and their registration on the interactive TBEL website;
• Develop uniform investigative protocols for data and specimen collection as appropriate, including development of CDEs;
• Support the collection, assembly, and distribution of biospecimen sets for TBEL collaborative studies and analyze data that result from the use of these specimens;
• Provide a mechanism for rapid and routine (to be decided by the Steering Committee) transmittal of materials (e.g. computer output, reports, etc.) among the Network participants and the NCI Project Coordinators and other NCI staff;
• Provide advice and consultation to TBEL investigators in study design and protocol development of TBEL collaborative studies, after the study has been reviewed and approved by the TBEL Steering Committee;
• Capture and deposit consequential data sets, visualization tools, computational models and other resources developed by TBEL to NCI designated Cancer Research Data Commons (e.g., dbGaP) and/or other public repositories as appropriate and as decided by the Steering Committee.

These plans should include description of design, personnel requirements, and infrastructure (hardware, software, other). Applicants are encouraged to describe in their application the cost-efficient use of existing technologies.

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 and Resource Sharing Plan.

In addition to the standard NIH rules, the following TBEL-specific expectations apply:

• Collaboration among TBEL investigators, as well as between Network investigators and third-party is a core mission of the TBEL program, which entails the sharing of Intellectual Property (IP) arising out of research resources developed in Network-related activities.
• IP, data, and associated materials developed under this funding mechanism will be managed in accordance with NIH Grant Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.

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

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). 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.

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) 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. See Section III of this FOA for information on registration requirements.

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. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is 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?

Specific to this FOA:

• How well do the proposed theoretical and applied research management and program coordination plans, methods, and approaches address the overall TBEL program needs, including study design, and the analysis, harmonization, and stewardship of generated data?
• Over the project period, is there potential for the applicant to develop statistical and analytical approaches other than those specified in the application?
• Are the structure and activities planned for the CDMC adequate for the needs and coordination of the proposed studies and the anticipated trans-TBEL activities?
• How likely is the proposed CDMC to contribute unique expertise, capabilities, and/or resources to the entire Network?

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?

Specific to this FOA:

• Are the PD(s)/PI(s) and their collaborators appropriately trained and have demonstrated experiences in the areas of program management, statistical, mathematical, and computational biology?
• Will this team of investigators contribute unique skills to the overall objectives of the TBEL program?
• Is the commitment of the PD(s)/PI(s) and other senior investigators adequate?
• To what degree, does the applicant team take advantage of a collaborative and interactive model of research management and coordination? How likely are the applicants to engage in collaborations, sharing information, and work towards the priorities and goals agreed upon by the Steering Committee for trans-Network collaborative studies?
• Are the PD(s)/PI(s) and support personnel adequately trained and qualified for participating and managing multi-institutional collaboration?

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?

Specific to this FOA: Does the proposed approach/methodology challenge existing paradigms or develop new computational/statistical approaches?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the 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?

Specific to this FOA:

• Does the application adequately address how each of the goals set for the required areas of responsibility will be accomplished?
• Are relevant technical problems and their timely and effective solutions adequately addressed?
• Are the conceptual framework, design, methods, and analyses adequately developed and appropriate for providing data and resource management and program coordination?
• Does the applicant acknowledge potential problem areas and consider alternative approaches?
• Will the proposed approaches be generally applicable to the systematic analysis of early lesions and their classification depending on their identification by different modes of detection or between indolent and aggressive/progressive early lesions?

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?

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?

Specific to this FOA: Are facilities and equipment for data management, data security, and data analysis appropriate to support the objectives of the FOA? Has the applicant demonstrated adequacy of proposed infrastructure and commitment and documented evidence of institutional support for proposed endeavor and institutional support for computer services?

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.

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.

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.

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

Not Applicable

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.

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 (GDS).

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’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.

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

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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Participate in the annual TBEL Steering Committee meetings, monthly conference calls organized by the TBEL Coordinating Center, and collaborative TBEL activities;
• Participate in scientific working groups to facilitate TBEL research and program objectives, including collaborative pilot projects and validation of experimental concepts and observations;
• Promote trans-TBEL and external collaborations to advance early lesion basic-translational research;
• Abide by the governance of the TBEL and all program policies agreed upon by the TBEL Steering Committee and approved by NCI Program Officials to the extent consistent with the applicable rules and regulations;
• Report progress to the NCI Program Officials on all TBEL research and activities annually. The PD(s)/PI(s) may be expected to provide additional information, outside the scope of the standard reporting requirement, as needed and requested by NCI program staff members;
• Ensure that data are deposited in a timely manner in appropriate publicly available databases, and that models, software, and other tools and resources developed as part of this Research Center are made publicly available according to TBEL policies;
• Ensure that results of the Research Projects are published in a timely manner.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Awardees will be expected to participate in an external TBEL program evaluation process that will be coordinated by NCI Scientific staff.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI Program Directors serving as Project Scientists/Coordinators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Additionally, an NCI program director acting as Program Official will be responsible for the standard scientific and programmatic stewardship of the award and will be named in the award notice. The specific roles of the substantially involved NCI staff members include the following activities:

• Serve as the NCI lead Project Scientists and voting members of the TBEL Steering Committee;
• Serve as a liaison for TBEL in promoting interactions with other ongoing NCI activities and programs that may be relevant to the goals of TBEL;
• Assist in avoiding unwarranted duplications of effort across the TBEL Program;
• Facilitate collaborative research efforts that involve multiple TBEL Research Centers and the CDMC;
• Evaluate the effectiveness of the program and facilitate program-wide adoption of resources, policies, and practices;
• Monitor operations of the TBEL recipients and make recommendations on overall project directions and allocations of TBEL Research Center funds;
• Monitoring the progress of individual Research Centers and the CDMC on the program goals and specific activities shared among the Research Centers and the CDMC;
• Participate in organizing annual TBEL Steering Committee meetings, and other specialized workshops, and webinars;
• Review the compliance of TBEL recipients with the recommendations developed by the Steering Committee;
• Coordinating the external evaluation of the TBEL program;

Areas of Joint Responsibility include:

TBEL will have a Steering Committee as a governing body. The TBEL Steering Committee will consist of the following voting members:

• The PD(s)/PI(s) and Project leaders of each awarded Research Center who will collectively have one vote;
• The PD(s)/PI(s) of the CDMC and a designated senior investigator who will collectively have one vote; and
• The NCI Project Scientists/Coordinators who will collectively have one vote for the NCI.

Additional NIH/NCI program staff and other government staff may participate in TBEL Steering Committee meetings as non-voting members. The structure is designed to allow awarded investigators and NCI staff to work together to facilitate trans-TBEL activities based on synergistic expertise and projects.

Two PD(s)/PI(s), representing two different TBEL awards, will be selected to serve as chairs of the Steering Committee starting at the first meeting of the Steering Committee following award issuance. Chairpersons will be subject to a full rotation to two new chairs midway through the third year of the program. All TBEL Steering Committee decisions and recommendations that require voting will be based on a majority vote.

The Steering Committee will meet twice a year, at locations selected by the Steering Committee in consultation with the NCI.

Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.

The Steering Committee will have primary responsibility for:

• Establishing sub-committees for specific purposes as necessary to ensure progress of the individual Research Centers, Projects, and the entire Network. The NCI Project Scientists/Coordinators and other NCI program directors will serve on such sub-committees, as they deem appropriate.
• Setting the overall research priorities for the TBEL initiative; and identifying emerging research opportunities which can be best explored through a joint collaborative effort via the Network;
• Reviewing the potential of shared support infrastructure(s) at individual Research Centers to serve the needs of other Research Centers and the TBEL program;
• Developing procedures for soliciting and evaluating ideas for pilot projects across TBEL, as well as criteria for their prioritization and approval;
• Ensuring that the Research Centers and CDMC leverage existing NCI and NIH resources and programs;
• Participating in the development of the agenda for the Steering Committee meetings to present scientific progress and future plans from TBEL investigators;
• Coordinating the dissemination of TBEL findings, data, and resources to the broader cancer research community.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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

Christos Patriotis, Ph.D.,
National Cancer Institute (NCI)
Telephone: 240-276-7134
Email: patriotisc@mail.nih.gov

Sharmistha Ghosh-Janjigian, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7122
Email: ghoshjanjigias@mail.nih.gov

Elisa Woodhouse, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6220
Email: woodhousee@mail.nih.gov

Rihab Yassin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6230
Email: yassinr@mail.nih.gov

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

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6885
Email: amy.bartosch@nih.gov

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, 45 CFR Part 75, and 2 CFR 200.