Required Application Instructions

It is critical that applicants follow the 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) solicits applications for Research Centers for Barrett’s Esophagus Translational Research Network (BETRNet). The BETRNet is an NCI program established to address the rising incidence of esophageal adenocarcinoma (EA) in the United States and to energize the field of EA research. Specifically, the program seeks a better understanding of the biology of EA and its precursor lesion, Barrett’s esophagus (BE), as the foundation for developing preventive measures that would improve patient management. The BETRNet will be comprised of the following parts:

• Three to four multi-institutional, trans-disciplinary Research Centers (to be supported by the companion FOA, RFA-CA-16-006);
• One Coordinating Center (to be supported by this FOA).

The Research Centers will serve as the scientific platform of the BETRNet Program. Each Center will encompass a multi-institutional, trans-disciplinary group with basic, clinical, and computational research expertise. Each Center will be supported by critical cores and strong organizational oversight to enable the investigation of novel research questions, development of important resources and models, and outreach to the larger scientific community.

The BETRNet Coordinating Center will provide leadership and infrastructure to facilitate communication between the components of the BETRNet program and between BETRNet and the research community at large. The Coordinating Center will have an important role in integrating the efforts of the Research Centers and will be expected to offer administrative and logistic support for interactions and collaborations of the Research Centers and their participation in the patient registry-virtual biorepository and in cross-BETRNet pilot projects. The Coordinating Center will connect available resources to minimize effort duplication and serve as the network data management center. Through these collaborative efforts, BETRNet can accelerate the integration and translation of important research findings generated from individual laboratory- and clinically-based studies into applications for EA prevention.

Esophageal adenocarcinoma is a highly lethal malignancy that had risen in incidence more than 600% in the United States in the previous four decades. The incidence and incidence-based mortality of EA continue to increase, with five-year survival of 16% and median survival of less than one year. Notwithstanding an identified precursor lesion, BE, that increases individual risk by 11-30-fold, it became apparent that better characterization of EA pathogenesis as well as new biologically-based strategies for EA prevention and detection are greatly needed to decrease the impact of this deadly cancer.

Research on the biology of EA has revealed various molecular and cellular events associated with malignant transformation in the esophagus. However, the significance of these events for esophageal cell transition and their utility for EA early detection, risk prediction, or prevention has not been demonstrated. Systematic investigations in rare cancers require focused and coordinated efforts with access to resources including in vivo and in vitro models that replicate the human disease, as well as sufficient numbers of annotated human specimens and clinical cohorts for prospective screening, detection and preventive intervention studies. In the past, inadequate access to these resources has limited the capabilities of individual investigators, in both basic and clinical research. Accordingly, the BETRNet program is designed to foster trans-disciplinary collaborations within each Research Center and across the Centers to enable a deeper understanding of EA biology, provide strategies for EA prevention, and better define individuals at risk. The ultimate goal is to decrease the incidence, morbidity and mortality of EA.

The proposed BETRNet Coordinating Center must meet the following main attributes (for additional details on the requirements, please see Section IV. Application and Submission Information):

(A) Overall Role. The BETRNet Coordinating Center will have an important role in integrating the effort of individual BETRNet Research Centers (to be funded under a companion FOA, RFA-CA-16-006). The Coordinating Center should provide administrative and logistic support for the BETRNet program and be able to connect available resources as well as serve as the network data management center. The Coordinating Center will be expected to integrate the activities of the awarded Research Centers to minimize resources/effort duplication and utilize existing resources.

(B) Leadership and Administration. The Coordinating Center must be able to provide close coordination of trans-disciplinary research conducted by the BETRNet Research Centers. This role will require strong leadership, scientific oversight, and managerial capacity to bring diverse teams together.

(C) Patient Registry-Virtual Biorepository. An important aspect of the BETRNet program is the establishment of the centralized multi-institutional Patient Registry-Virtual Biorepository that will be coordinated and managed by the Coordinating Center. The repository will contain clinical, demographic, and molecular data sets associated with biospecimens collected and available at each participating Research Center. The cohort of patients will include individuals at all levels of risk for BE and EA (and controls), thus providing opportunities for understanding the biology of EA and determining molecular risk stratification criteria. This resource is envisioned to function as a centralized shared Core for the entire program. All BETRNet Research Centers are required to participate in this resource.

The BETRNet (i.e., Research Centers and Coordinating Center) will be governed by the BETRNet Steering Committee. Details on the composition and functions of BETRNet Steering Committee are provided in Section VI.2, Administrative and National Policy Requirements, Cooperative Agreement Terms and Conditions.

BETRNet awardees will be expected to participate in an external evaluation process that will be coordinated by the NCI Scientific staff. This evaluation will largely be based on the overall progress towards achieving the scientific goals of the entire BETRNet Program. The evaluation will assess the quality and innovation of the research conducted by BETRNet, progress of the research projects, effectiveness of the collaborative pilot projects, and critical antecedents and intermediate determinants of the overall success. Specific aspects may include: peer-reviewed publications, achievement of planned milestones, development of infrastructure and research capacity, efficiency of resource utilization, and data sharing arrangements within and among BETRNet Research Centers. Particular focus areas will be on improved understanding of EA carcinogenesis, and the development of EA preventive modalities that are based on the biological mechanisms of the disease.

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

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

Applicant organizations may submit only one Coordinating Center application in response to this FOA.

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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

Although a letter of intent 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); and
• Number and title of this funding opportunity.

The letter of intent should be sent to:

Rihab Yassin, Ph.D.
National Cancer Institute
Telephone: 240-276-6230
Email: [email protected]

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.

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:

Research Strategy: Instead of standard sub-sections, Research Strategy must consist of the following sub-sections A, B, and C.

Sub-section A. Overall Vision of the Proposed Coordinating Center

In this sub-section, address the following strategic goals:

• Facilitating multi-institutional, trans-disciplinary research through scientific, administrative, and organizational support with emphasis on efficient communications, coordination of efforts, and trans-consortium scientific collaborations (within the BETRNet network and between BETRNet investigators and outside investigators);
• Providing infrastructure to support the required administrative activities of such program, including, but not limited to, monitoring and coordinating the joint activities of all the participating sites, preparing required reports, addressing logistics, and preparing for group meetings, site visits, and outcome dissemination.

The description must include the following specific aspects:

• The scientific vision of the proposed BETRNet Coordinating Center;
• Major strengths and critical experience of the research team particularly in coordinating multi-disciplinary and multi-institutional programs (explain collective strengths without repeating information in individual biosketches);
• Innovative aspects of the Center and its potential for coordinating the trans-disciplinary research conducted through the entire BETRNet program;
• Available infrastructure to support the required administrative activities of the BETRNet including, but not limited to, monitoring and facilitating the activities of the BETRNet Research Centers, preparing required reports, addressing logistics, and preparing for various meetings, site visits, outcome dissemination, Steering Committee meetings, and periodic conference calls.

Sub-section B. Leadership and Administration Unit

In this sub-section, address the following strategic goals:

• Facilitating the discussion, solicitation, and review of the cross-BETRNet collaborative pilot projects;
• Facilitating and mediating communications between the Research Centers and NCI scientific staff to allow for efficient interactions, consultations, and oversight functions;
• Providing logistical and administrative support for the activities of the BETRNet Steering Committee and its subcommittee(s)/Working Groups;
• Organizing the annual Steering Committee meeting (in collaboration with NCI project scientists) and periodic conference calls for the Research Centers;
• Assisting the Steering Committee in assembling appropriate panels such as a subcommittee of experts to advise the Steering Committee;
• Creating opportunities for disseminating research results across multiple venues.

The description must include the following specific aspects:

• The organization of the leadership structure;
• Plans for participation in the activities of the Steering Committee including workshops, conferences and other functions;
• Plans for supporting data sharing among all BETRNet participating sites as appropriate and consistent with achieving the goals of the program;
• Plans for participation in administrative site visit conducted by NCI staff.

Sub-section C. Patient Registry-Virtual Biorepository Unit

In this sub-section, address the following strategic goals:

• Establishing and operating a centralized data collection, management, analysis, and dissemination unit for the entire network to support this repository. This includes the capacity for setting-up a registry database that collects clinical, demographic, and molecular information of patients participating in the studies conducted by the BETRNet program, including information on the availability of biological specimens at all participating sites (including archived specimens). The biospecimen data must also include information about the regulatory approvals of specimen collections and the level of informed consent;
• Establishing specimen and data access procedures that would allow for efficient sharing of specimens and data for collaborative research studies across BETRNet as well as with outside investigators as appropriate and consistent with achieving the goals of the program. The procedures should address the process for review and approval of applications submitted to access the specimens and/or data. The procedures should also describe the tracking and distribution of available specimens to investigators, consistent with achieving the goals of the program.

The description must include the following specific aspects:

• Plans for creating a patient registry with virtual biorepository that will collect and assemble clinical, demographic, and molecular information of all patients participating in the BETRNet program (including archived specimens);
• Plans for collecting information about the availability of biological specimens at all the BETRNet participating sites, including information about the regulatory approvals of specimen collections and the level of informed consent;
• An access mechanism that will facilitate the sharing and distribution of information and biospecimens across the BETRNet program for collaborative research studies (between BETRNet Research Centers and between BETRNet investigators and other investigators) as appropriate and consistent with achieving the goals of the program.

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

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

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

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) 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 NCI, 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 NOT-OD-13-030.

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

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.

Significance

Does the proposed Coordinating Center address the needs of the BETRNet research network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the BETRNet research network?

Are the available research infrastructure, programs, and scientific expertise adequate to support the BETRNet Research Centers?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing multi-institutional research? Do the investigators demonstrate significant experience with coordinating collaborative trans-disciplinary research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts in coordinating the BETRNet research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

Leadership and Administration Unit

Are the research infrastructure, programs, and collaborations adequate to support the BETRNet Research Centers? Is there adequate evidence for the managerial and collaborative capabilities of the proposed Coordinating Center leadership? How appropriate is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of BETRNet program; (b) the coordination of multiple institutions participating in the BETRNet Research Centers; and (c) understanding and familiarity with the state of the science in this field of research? Will the Center have the appropriate capabilities to support proposed projects and data sharing among all BETRNet participating sites? How adequate are the plans to achieve compatibility with the research Centers to facilitate data and resource sharing across BETRNet? Does the administration infrastructure demonstrate the capacity of the BETRNet Coordinating Center to collaborate with the BETRNet Research Centers and NCI program staff on scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships?

Patient Registry-Virtual Biorepository Unit

How appropriate and balanced are the proposed plans to create the Patient-Registry-Virtual Biorepository? Does the Coordinating Center have the capacity for setting-up a database that collects clinical, demographic, and molecular information of all patients participating in the studies conducted by the BETRNet program, including information on the availability of biological specimens at all participating sites? Are the plans well justified and include appropriate safeguards for privacy and confidentiality protections of identifiable data? Does the plan describe a program that will efficiently support the sharing of specimens and information across the BETRNet as well as access by extramural collaborating investigators as appropriate and consistent with achieving the goals of the program? Does the plan enable the tracking and distribution of available specimens to investigators, consistent with achieving the goals of the program?

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

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

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

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 last 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.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities. In particular, consideration will be based on the relevance of the proposed Coordinating Center to the scientific priorities defined in this FOA.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the following primary responsibilities:

• Determine the Coordinating Center's scientific directions and progress on its goals;
• Determine and coordinate research approaches and procedures for the collection and analyses of research and specimen data from the BETRNet Research Centers;
• Oversee the timely release and sharing of specimens and data from the program according to the approved plans;
• Participate in the development and evaluation of Pilot Projects, cross-BETRNet Projects, and cross-BETRNet activities that will cross-test novel projects;
• Participate in the annual BETRNet Steering Committee meeting, and periodic conferences organized by the BETRNet Coordinating Center;
• Cooperate with NCI Project Scientists in the program evaluation process;
• Accept and implement all scientific and practical decisions approved by the BETRNet Steering Committee to the extent consistent with applicable grant regulations;
• Provide information to the NCI Program Directors concerning progress by submitting annual progress reports in a standard format;
• Prepare for administrative site visits by NCI staff members.

The following additional responsibilities will also apply for the Coordinating Center awardee:

• The Coordinating Center and the entire BETRNet program will be subject to periodic performance evaluation (coordinated by the BETRNet Steering Committee Chair) and external evaluation (coordinated by the NCI). BETRNet Awardees will be expected to participate in such evaluations;
• 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 DHHS, PHS, and NIH policies;
• All institutions/organizations participating in the BETRNet program Center will be expected to share with the BETRNet program knowledge, specimens, data, research materials, and any other resources necessary and relevant to the Research Center award.

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

The designated NCI Program staff members will have substantial involvement as Project Scientists in the awards under this FOA. 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 BETRNet Steering Committee;
• Assist in avoiding unwarranted duplications of effort across the BETRNet program;
• Help coordinate collaborative research efforts that involve multiple Research Centers;
• Monitor the operations of the BETRNet Research Centers and make recommendations on overall project directions and allocations of funds;
• Review the progress of individual Research Centers and specific activities shared among the Research Centers and Coordinating Center;
• Participate in the development and evaluation of cross-BETRNet Projects;
• Co-organize and participate in the annual BETRNet Steering Committee meeting;
• Participate as Collaborators of the BETRNet investigators in some shared activities, if appropriate;
• Assist the BETRNet awardees as a liaison in stimulating their broader interactions with other NCI and NIH programs to disseminate results and outcomes and effectively leverage existing NIH/NCI resources and infrastructures;
• Evaluate the adherence of BETRNet awardees to the approved data and resource sharing plans.

Areas of Joint Responsibilities include:

The BETRNet Steering Committee will serve as the main governing board of the BETRNet program.

The committee will consist of the following voting members:

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

The BETRNet Steering Committee will meet at least one time per year in a face-to-face meeting. A chair of the BETRNet Steering Committee will be selected at the first meeting to coordinate the committee's operation. The BETRNet Steering Committee chair will meet by teleconference with NCI Project Scientists as needed to address program issues.

Additional non-voting members who can serve in an advisory capacity may be added to the BETRNet Steering Committee as needed by a decision of the existing voting committee members. These additional non-voting members may include other NCI and NIH Program Staff members and/or Program Staff members from other Federal agencies.

The BETRNet Steering Committee will have the following primary responsibilities:

• Oversee the overall BETRNet program and review its research progress;
• Review the potential of shared support infrastructure(s) at individual Research Centers to serve the needs of other Research Centers and the entire program;
• Develop procedures for soliciting and evaluating ideas for pilot projects across the BETRNet as well as criteria for their prioritization and approval;
• Ensure that the Research Centers and the Coordinating Center take advantage of existing NCI and NIH resources and programs;
• Make recommendation for termination of pilot projects that become unpromising or unproductive;
• Participate in the development of the agenda for the annual Steering Committee meeting to present scientific progress and future plans from BETRNet investigators.
• Establish advisory groups as necessary to ensure the progress of individual Research Centers as well as of the entire BETRNet program.
• Ensure that individual BETRNet members (i.e., Research Centers and Coordinating Center) accept and implement as appropriate actions (recommendations, directions, etc.) approved by the BETRNet Steering Committee.

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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Rihab Yassin, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6230
Email: [email protected]

Ellen Richmond, MS, GNP-BC
National Cancer Institute (NCI)
Telephone: 240-276-7043
Email: [email protected]

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

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

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.