Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

National Dental Practice-Based Research Network: Administrative and Resource Center (U19 Clinical Trial Required)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices

April 12, 2018 - Notice of Correction to RFA-DE-19-001. See Notice NOT-DE-18-017.

NOT-DE-18-009

NOT-DE-18-010

Funding Opportunity Announcement (FOA) Number

RFA-DE-19-001

Companion Funding Opportunity

RFA-DE-19-002, U01 Research Project – Cooperative Agreements

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

 93.121 

Funding Opportunity Purpose

 The National Institute of Dental and Craniofacial Research (NIDCR) intends to continue support for research conducted within a national Dental Practice-Based Research Network (DPBRN). The NIDCR will fund one national DPBRN Administrative and Resource Center led by a National Network Director or Directors and one national DPBRN Coordinating Center, as companion awards, to support the infrastructure for and implementation of multiple observational studies and clinical trials. This funding opportunity announcement (FOA) is soliciting applications for the national DPBRN Administrative and Resource Center; a separate companion FOA is soliciting applications for the national DPBRN Coordinating Center (RFA-DE-19-002).

The main goals of the cooperative agreement funded under this FOA are to maximize efficiencies to conduct national oral health research studies in dental practices on topics of importance to practitioners and their patients, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice. It is expected that the DPBRN will continue work of the previous DPBRNs funded by NIDCR and will demonstrate continued growth and productivity.

Key Dates
Posted Date

March 7, 2018

Open Date (Earliest Submission Date)

June 17, 2018

Letter of Intent Due Date(s)

June 17,2018

Application Due Date(s)

July 17, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. Late applications in response to this FOA will not be accepted.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

October/November 2018

Advisory Council Review

January 2019

Earliest Start Date

April 1, 2019

Expiration Date

July 18, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    PURPOSE

    The National Institute of Dental and Craniofacial Research (NIDCR) intends to continue support for research conducted within a national Dental Practice-Based Research Network (DPBRN). The NIDCR will fund one national DPBRN Administrative and Resource Center led by a National Network Director (or Directors) and one national DPBRN Coordinating Center, as companion awards, to support the infrastructure for and implementation of multiple observational studies and clinical trials. This funding opportunity announcement (FOA) is soliciting applications for the national DPBRN Administrative and Resource Center; a separate companion FOA is soliciting applications for the national DPBRN Coordinating Center (RFA-DE-19-002). This FOA will include funds to support developmental/exploratory, pilot, and/or survey studies to be conducted in the DPBRN; a future FOA will solicit applications for investigator-initiated clinical observational studies and clinical trials to be conducted in the DPBRN.

    The main goals of the cooperative agreement funded under this FOA are to maximize efficiencies to conduct national oral health research studies in dental practices on topics of importance to practitioners and their patients, to provide evidence useful in daily patient care, and to facilitate the translation of research findings into clinical practice. It is expected that the DPBRN will continue work of the previous DPBRNs funded by NIDCR and will demonstrate continued growth and productivity by streamlining the implementation of clinical research across the network, facilitating practitioner and patient recruitment and retention, and developing public-private partnerships.

    Applicants for the national DPBRN Administrative and Resource Center and DPBRN Coordinating Center must prepare separate applications for peer review. A Program Director/Principal Investigator (PD/PI) for an application in response to this FOA may not be a PD/PI for a companion application in response to the national DPBRN Coordinating Center FOA (RFA-DE-19-002).

    BACKGROUND

    Practice-based research networks can generate important and timely information to guide the delivery of health care and improve patient outcomes. A DPBRN is a unique venue in which to conduct clinical research. It provides practitioners with an opportunity to propose or participate in research studies, conducted in participating dental offices with consenting patients. DPBRN studies draw on the experience and insight of practicing clinicians to help identify and frame research questions, which typically address issues faced by dental practitioners in the daily care of their patients. Because research is conducted in the real-world environment of dental practice, results have the potential to be readily accepted and adopted by practitioners and translated into daily practice. DPBRNs can support a variety of clinical studies to help expand and strengthen the profession’s evidence base and further refine care.

    One benefit of practice-based research is the ability to collect data from practitioners about factors contributing to decision-making and procedures performed, and separately, to collect data from a patient's perspective, either during a patient's visit with the practitioner or outside of the office visit. Another benefit is the ability to efficiently enroll large numbers of patients with a wide geographic distribution and from a variety of practice types; many practitioners have been engaged in DPBRN studies, with each contributing a relatively small number of patients. An important characteristic of the DPBRN is the ability to address emerging topics of public health interest, taking advantage of the existing infrastructure and capacity for launching studies in a timely manner.

    In 2005, the NIDCR launched the first phase of the DPBRNs by supporting three regional DPBRNs, which conducted multiple clinical studies over seven years. To build upon the strengths of the regional DPBRNs and coordinate their efforts, NIDCR launched the second phase of the DPBRNs in 2012 by funding one national, geographically diverse network. The DPBRNs have been successful in providing a clinical research infrastructure to address questions of everyday relevance to dental practitioners and their patients.

    RESEARCH OBJECTIVES

    The overall objective of this FOA is to support a third phase of the DPBRN by building on the knowledge gained from the previous two phases. It is envisioned that the future DPBRN will continue the work of the previous DPBRNs funded by NIDCR and will incorporate refinements based on published findings from the first and second phases. In this phase, the DPBRN will streamline the implementation of clinical research across network Nodes or administrative hubs, facilitate practitioner and patient recruitment and retention, and develop public-private partnerships. A national DPBRN Administrative and Resource Center, coordinating efforts of dental practitioners and their practices and clinics through a Node Structure, will maintain a geographically diverse network capable of reaching all interested participants. The DPBRN will conduct multiple national oral health clinical studies, including clinical trials, during an up to 7-year project period.

    It is envisioned that the network will be engaged in developing and refining its operations and activities during the entire funding period. During the start-up period, as well as during periods of time when new network projects will not take up the entire network capacity, the Nodes, under direction of the National Network Director(s) and in collaboration with the Coordinating Center, will recruit and engage practitioners in DPBRN activities and consider how to enhance patient recruitment and retention. Other important activities include:

    • Developing or refining processes to ensure the quality of data collected,
    • Standardizing study operations while incorporating the flexibility to efficiently collect data from dentists and their patients while they perform daily dental care,
    • Focusing efforts on electronic data collection when appropriate, to allow for data collection independent of office visits, and
    • Soliciting research ideas and working with potential investigators to develop research studies appropriate for the national DPBRN.

    RESEARCH SCOPE

    The national DPBRN will conduct multiple prospective and/or retrospective, observational clinical studies and clinical trials. The network will focus on general dental practice, but will also incorporate projects of interest to dental specialists and other dental professional groups, specific dental practice settings/types, and patient advocacy groups. The projects of interest to specific dental groups and practice types and patient advocacy groups may be addressed through public-private partnerships. The National Network Director(s) and Node personnel will be responsible for further engaging a national network of general dentists from a variety of practice settings/types to participate in studies related to general dentistry. They should also be prepared to address specific research questions by recruiting and coordinating networks of dental specialists, practitioners of specific practice settings/types (e.g. federal services, public dental health clinics), and practitioners with special interest in the diseases and conditions represented by members of patient advocacy groups.

    Research studies will address oral health issues of importance to dental practitioners. Studies may evaluate particular clinical approaches or evaluate the effectiveness of strategies for the prevention, management and treatment of oral diseases and conditions. While good evidence exists for many treatments used by dental practitioners to prevent and manage oral and craniofacial diseases, dissemination and implementation of this knowledge remains a challenge. Therefore, the goal of each study carried out by the national DPBRN is to strengthen the knowledge base for clinical decision-making, and the DPBRN is an ideal venue to translate research findings into practice.

    NATIONAL DPBRN ORGANIZATIONAL STRUCTURE & REQUIRED COMPONENTS/CORES

    1) Network Overview and Integration (Overall Component)

    a) Overview of DPBRN Organizational Structure

    The national DPBRN will comprise one national DPBRN Administrative and Resource Center and one national DPBRN Coordinating Center, funded as companion awards. This FOA is soliciting applications for the national DPBRN Administrative and Resource Center. The National Network Director(s) is/are the PD(s)/PI(s) of the national DPBRN Administrative and Resource Center and is/are responsible for the overall conduct of the network. The National Network Director(s) will work in close collaboration with the national Coordinating Center Director to oversee centralized DPBRN functions and the practitioner Executive Committee.

    The national DPBRN organizational structure will comprise Nodes or administrative hubs, defined by geographic area, plus at least one dental specialty Node that operates across all network geographic areas. Each of the Nodes will be managed by a Node Director who is responsible to the National Network Director(s). The National Network Director(s), Coordinating Center Director(s), and DPBRN Node Directors will work collaboratively to provide direction, oversight, and coordination of DPBRN studies and component operations and utilization of DPBRN resources.

    Further, the national DPBRN organizational structure must provide the infrastructure to support the following required components of the DPBRN: a) Practitioner Recruitment and Engagement, b) Practitioner Training, c) Practitioner and Patient Reimbursement, and d) Communications and Dissemination. The components may be coordinated and/or managed within the centralized DPBRN functions or Node Organizational Structure, as appropriate.

    The success of the DPBRN requires strong communication and collaboration between the DPBRN Administrative and Resource Center and Coordinating Center. The plan for distribution of administrative and research activities and division of responsibilities must be described. The NIDCR will be responsible for providing support to the DPBRN and will be substantially involved with the national DPBRN Administrative and Resource Center and Coordinating Center awardees as a partner in providing overall scientific and operational guidance, consistent with the Cooperative Agreement mechanism.

    If the application in response to this FOA proposes multiple PDs/PIs (e.g. multiple Coordinating Center Directors), it is expected that there will be strong collaboration and communication between the multiple PDs/PIs. The U19 application must address collaboration and communication and division of responsibilities between the multiple PDs/PIs and with the national DPBRN Coordinating Center PD(s)/PI(s). If the U19 application does not propose multiple PDs/PIs, the application must include a succession plan for the National Network Director in the event that the Director is unable to perform his/her responsibilities.

    b) Centralized DPBRN Functions & Responsibilities

    The National Network Director(s) is/are responsible for the overall scientific, technical, and administrative leadership for the Network. She/he will have primary responsibility for planning and directing all phases of the network’s infrastructure and for managing the network's operations and fiscal resources. In carrying out these responsibilities, the National Network Director(s) is/are expected to work collaboratively with the Coordinating Center Director and Node Directors to oversee and coordinate research activities and utilization of network resources throughout the network. Other responsibilities of the National Network Director(s) include: building community awareness and participation in the DPBRN; assuming a leadership role in administrative issues related to the network; and preparing budgets and annual reports. Further, in collaboration with the Coordinating Center Director, the National Network Director(s) will also establish and chair relevant centralized leadership oversight committees, including the Node Directors meetings, Practitioner Executive Committee, and Steering Committee meetings of all key Node and Coordinating Center administrative personnel. A designated NIDCR staff person will participate in the Node Directors meetings and will serve on the Executive Committee as a non-voting member. A leadership oversight committee will meet annually with NIDCR staff to review network accomplishments and challenges and planned network activities for the upcoming year.

    The National Network Director(s), with assistance from the Coordinating Center and in concert with the NIDCR and Node Directors, will be responsible for the following centralized DPBRN functions: 1) recruiting practitioners from a variety of practice settings and types for network membership; 2) enhancing practitioner engagement in network activities; 3) stimulating and soliciting ideas for new studies from practitioners and investigators; 4) educating study teams about study designs and data collection processes appropriate for network studies; 5) developing processes for network study development and implementation to be used by study teams; 6) developing processes to ensure complete and accurate data collection across participating practices/sites; 7) utilizing a single Institutional Review Board; 8) coordinating study deployment and practitioner/patient recruitment across nodes; 9) making decisions about operational issues, considering and adopting changes in study procedures as necessary; 10) reviewing progress of studies in achieving their main goals and taking steps required to enhance likelihood of success; 11) reviewing data collection and quality management procedures and progress as summarized in performance monitoring reports to identify and correct remediable deficiencies; 12) and disseminating research results from DPBRN studies and other oral health research.

    The funding of the DPBRN Nodes and components of the DPBRN infrastructure is to be accomplished through subcontracts from the parent grant to commercial or not-for-profit expert entities.

    c) Practitioner Executive Committee

    The Executive Committee will comprise the National Network Director(s), who serves as the Chair of the Executive Committee; the Coordinating Center Director; the NIDCR staff person in a non-voting capacity; and five to six representative practitioners from the national DPBRN who will serve for 3-year terms. The role of this committee is to evaluate the feasibility and clinical interest of research topics for protocol development or grant application submission, to review protocols prior to study implementation, and to provide input about study flow and operations in practices.

    The practitioners on the Executive Committee should be representative of the practice setting/type, sex/gender, and racial/ethnic distribution of the network. The plans for meetings of the Practitioner Executive Committee must be executed to efficiently accomplish the committee's responsibilities.

    National Coordinating Center (Companion FOA, RFA-DE-19-002)

    The national Coordinating Center has both scientific and administrative functions and will work in close collaboration with the national DPBRN Administrative and Resource Center, funded as a companion award. The DPBRN Coordinating Center will serve as the central locus for the national DPBRN practitioner membership and participation database and data coordination/management for network studies. The data coordination/management functions will include: supporting study-specific data management activities; overseeing data quality management and study monitoring procedures; and maintaining primary responsibility for reporting to the DPBRN, NIDCR and Data and Safety Monitoring Boards (DSMBs). Details of Coordinating Center activities will be included in the companion DPBRN Coordinating Center application (RFA-DE-19-002).

    To ensure success of the DPBRN, there must be strong communication and collaboration between the DPBRN Administrative and Resource Center and Coordinating Center. Applications submitted to this FOA must describe communication and collaboration between the DPBRN Administrative and Resource Center and national DPBRN Coordinating Center, distribution of administrative and research activities, and a plan for division of activities in a Collaboration Plan, submitted as an Other Attachment.

    2) Node Organizational Structure (Administrative Core)

    The national DPBRN is expected to include at least four regional Nodes with wide geographic distribution across the country that, combined, comprise all states in the US, a variety of practice settings/types, and general dentistry/specialty affiliation. In addition, there will be at least one specialty Node, which serves to recruit and engage practitioners within a specialty area of dentistry. It is envisioned that the specialty Node(s) will ramp-up participation in network activities when research studies of interest to the specialty organization are implemented through the DPBRN. Further, the national DPBRN will strive to establish a unique patient population Node, which may comprise practitioners linked by certain practice types (e.g. federal services, public dental health clinics) or those who treat patients with certain disease-specific conditions that may affect oral health. For the latter, practitioners may be associated through patient advocacy groups (e.g. Sjögren’s Syndrome Foundation, Osteogenesis Imperfecta Foundation).

    Each Node will have a Node Director who will manage a Node Organizational Structure and will provide direction and oversight of the Node to support its research and administrative functions. Each Node Director is responsible to the National Network Director. Working with the Coordinating Center, the National Network Director and Node Directors will work collaboratively to provide scientific leadership, infrastructure support, and coordination of the DPBRN activities and resources.

    The Node Organizational Structure must be composed of the Node Director and Node Coordinators who serve as liaisons to practitioners and their patients, and to study teams, to provide support for study operations and network activities. The Node Director and Node Coordinators will be responsible for the following Node functions: 1) stimulating and soliciting research ideas from practitioners and investigators; 2) recruiting practitioners for national DPBRN membership and engaging practitioners in study participation and other network activities; 3) participating on study teams to provide oversight of network resources and advising study teams about network operations; 4) providing significant input to study teams to ensure efficient development and implementation of network studies; 5) working collaboratively with study teams to develop clinical research training procedures and materials for practitioners; 6) assuring that practitioners are appropriately trained per NIH, IRB and study-specific requirements; 7) developing systems to assist practitioners in maintaining high rates of patient recruitment and retention; 8) monitoring study execution and the performance of practitioners; 9) hosting annual research meetings for participating practitioners; 10) facilitating regional dissemination of research findings; and 11) providing regional fiscal and operational management under the provisions of subcontracts from the National Network Director's institution(s).

    The U19 application must address the rationale for assignment of the Nodes into the proposed geographic regions, the plan for participation of the specialty Node, and the plan to develop the patient population Node. It is expected that practitioners will be recruited from a variety of practice settings/types and general dentistry/specialty affiliation. The plan for practitioner recruitment must be described. In addition, the application must provide evidence that the Node Directors have demonstrated leadership potential and the ability to productively engage and participate in a large research network.

    3) Required DPBRN Components (DPBRN Elements Core)

    The DPBRN Administrative and Resource Center must provide the infrastructure to support four required components of the DPBRN, described below. The components will be coordinated and/or managed within the centralized DPBRN functions or Node Organizational Structure, as appropriate. The National Network Director will be responsible for ensuring that these shared scientific and technical resources are efficiently configured and well-developed and that procedures are developed to ensure that such resources are available and evenly distributed to the research teams.

    a) Practitioner Recruitment and Engagement Component

    The Practitioner Recruitment and Engagement component will develop strategies to maintain interest and membership in the national DPBRN, recruit practitioners to participate in network studies, and engage practitioners in network activities. Node organizational personnel will work collaboratively across Nodes to refine strategies for recruitment and retention of practitioners who take an active role in various network activities. Through this component, practitioners may serve a role in engaging other practitioners to participate in network studies and activities. This component will work closely with the Communication and Dissemination component.

    Practitioners are defined in the national DPBRN as dentists, dental hygienists, and other dental professionals who are engaged in the daily practice of dentistry and dental hygiene. The participating practitioners are to be drawn from all states in the US, representing a variety of practice settings/types and general dentistry/specialty affiliation. Practitioners will enroll as network members, and the practices (offices) in which they practice dentistry are participating sites of the national DPBRN. Within these practices or sites, practice staff who have received study-specific training may participate in research activities and may recruit and enroll patients in national DPBRN research studies. Practitioners or networks from United States Federal Services including Uniformed Services, Public Health Service, Indian Health Service, Veterans Health Administration, and National Health Service Corps are also encouraged to participate in the national DPBRN. It is anticipated that the participating practices will be within the United States unless there is a compelling reason to include practices outside the United States.

    Practitioners should have the opportunity to take an active role in all aspects of network research studies, including generation of study ideas, protocol and study document development, data collection, interpretation of study findings, and publication of results.

    Since practitioner participation in the DPBRN is essential to its success, the eligibility criteria for practitioner network membership and study participation must be described.

    b) Practitioner Training Component

    This component will provide the oversight for practitioner training on general research principles, Good Clinical Practice, the protection of human subjects, data management and security, and other areas deemed essential for compliance with federal and other guidelines pertaining to the conduct of clinical research. The PTC will be responsible for development of processes to ensure that practitioners and other office staff receive study-specific training. The Practitioner Training Component will also be responsible for tracking all continuing dental education provided to members of the DPBRN and if appropriate, will provide for the award of continuing education credits.

    c) Practitioner and Patient Compensation System

    The Practitioner and Patient Compensation System should provide timely and accurate compensation to practitioners and patients engaged in national DPBRN projects. The U19 application should propose an efficient and contemporary system that is linked to predetermined deliverables obtained from data collected. This resource should be available for all network studies, and the system is expected to include an adjudication functionality to address disputes associated with compensation claims.

    d) Communication and Dissemination Component

    The Communication and Dissemination Component will provide oversight of communication operations. In coordination with the Practitioner Recruitment and Engagement component, the Communication and Dissemination Component will provide internal communication to inform network participants of study development and implementation progress and to recruit practitioners for studies, and should employ innovative strategies to engage network members in network activities. The Communication and Dissemination Component should also provide internal and external communications to ensure that knowledge gained through the network is shared quickly with the public and practitioners who can use the knowledge to inform decisions about oral health care. Communications with internal and external audiences, including Network members, health care professionals, patients, the general public, and the research community should include messages, materials and dissemination channels appropriate for the target audiences. These communications may include for example, print media, digital media, mobile technologies, RSS feeds, and social networking.

    NATIONAL DPBRN RESEARCH STUDIES

    The national DPBRN Administrative and Resource Center award funded through this FOA will include funds to support developmental/exploratory, pilot (feasibility), and/or survey studies of practitioners and/or patients. For research study funds available through this award, clinical research study concepts recommended by the Executive Committee will be submitted to the NIDCR for evaluation and future implementation in the network. The national DPBRN will coordinate the development of study concepts and clinical research budgets for studies funded through the U19 award. To ensure that the network is efficiently using resources from its inception, development of clinical research studies with U19 funds will begin soon after the network has been established.

    Further, a future national DPBRN-specific funding opportunity announcement will solicit applications for investigator-initiated clinical research studies to be conducted in the network through separate awards; these additional project-specific funds will support the development and implementation of observational clinical studies and clinical trials. Potential applicants will submit pre-applications to NIDCR for initial determination of study suitability for the DPBRN prior to grant application submission. Over the next 7-year project period and through the DPBRN-specific funding announcement, the NIDCR expects the network to conduct several NIDCR-funded clinical research studies, including clinical trials, involving prospective and/or retrospective data collection from practitioners and their patients. The exact number of studies supported will depend on the number and nature of the investigations proposed, the availability of funds, and the capacity of the network.

    Projects proposed to and conducted through the network may come from numerous sources, including investigators and practitioners within the network and clinical research investigators, small businesses or community partners outside of the network. Collaborative projects developed by practitioners and investigators with support from network personnel will be strongly encouraged.

    During the Conceptual Phase of each potential new network study, the national DPBRN Administrative and Resource Center in collaboration with the National Coordinating Center will be responsible for:

    • Working with potential new network project applicants in determining appropriateness of their study for implementation within the network;
    • Providing information necessary to the potential applicants as they apply for NIDCR funding (e.g., review study concept and schedule of activities, create project work scope and timeline, ensure the feasibility of the proposed research to be implemented in the network, assess availability and extent of network resources required to implement the research study);
    • Collaborating with and providing necessary information to potential investigators to develop a robust practitioner and patient recruitment and retention plan; and
    • Identifying network personnel (e.g. Node Director, Principal Node Coordinator, Biostatistician, Study Manager from Coordinating Center) and practitioners who will participate on the study team as key contributors to study development and implementation.

    Prior to initiating the Development and Implementation Phases of approved network studies, a project work scope and timeline will be finalized. The project work scope and timeline will include identifying who (e.g. which entity) is responsible for study development, start-up and implementation tasks, and time for completion of these tasks. It is expected that the national DPBRN Administrative and Resource Center will provide basic support for study team operations of approved network studies (e.g. teleconference line for study team meetings).

    It is expected that the DPBRN Administrative and Resource Center, working closely with the national Coordinating Center, will perform quality management and study monitoring activities to ensure completeness and accuracy of data collected. Further, independent safety and data monitoring entities will be convened by NIDCR to provide additional oversight as needed.

    Applications submitted in response to this FOA must include one or more delayed onset Study Records. The delayed onset Study Records represent future developmental/exploratory, pilot (feasibility), and/or survey studies to be conducted by the DPBRN and should not provide specific details about the proposed clinical studies.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.  

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Required: Only accepting applications that propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The NIDCR intends to commit up to approximately $3,200,000 in FY2019 to fund one U19 award.

    Award Budget

    Application budgets are limited to $3,200,000 per year and must reflect the actual needs of the project.

    Award Project Period

     The maximum project period is seven years.  

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

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

    Required Registrations

    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.

    Eligible Individuals (Program Director/Principal Investigator)

    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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility

    A PD/PI for an application in response to this FOA may not be a PD/PI for a companion application in response to the national DPBRN Coordinating Center FOA (RFA-DE-19-002).

    Number of Applications

    Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide,  except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

    Letter of Intent

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

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

    • 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:

    Yasaman Shirazi, PhD
    Telephone: 301-594-5593
    Fax: 301-480-8303
    Email: yasaman.shirazi@nih.gov

    Page Limitations

    Component Types Available in ASSIST

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (use for Administrative Core)

    12

    DPBRN Elements Core

    6

    Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: 1 required; maximum of 1
    • Administrative Core: 1 required; maximum of 1
    • DPBRN Elements Core: 1 required; maximum of 1
    Overall Component

    When preparing your application in ASSIST, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions, with the following additional instructions:

    Human Subjects: Indicate "Yes" to the question "Are Human Subjects Involved?"

    Other Attachments: The application must contain the following information, according to the instructions below. The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan.

    1.  Collaboration Plan. Include a Collaboration Plan describing communication and collaboration interactions between the national DPBRN Administrative and Resource Center and the national DPBRN Coordinating Center. The collaboration plan must describe the distribution of activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN and must include a conflict resolution plan. Do not name any proposed national DPBRN Coordinating Center institution/entity or personnel in the Collaboration Plan. The page limit for the Collaboration Plan is 4 pages.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Specific Aims:  Provide a concise description of the overall national DPBRN administrative and research goals, specific aims, and expected impact of the proposed network on oral health care.  

    Research Strategy:  The Research Strategy section for the Overall component should describe the overall approach of the network and integration of network Nodes and elements. Discuss the capability and capacity of the proposed network to accomplish the network's goals.

    Significance: Describe the public health and scientific significance of the overall network. It should be supported by the following:

    • Describe the scientific rationale and clinical need for the network
    • Describe the potential for the network to impact knowledge and clinical practice
    • Describe how the significance of individual Nodes and components are enhanced by their integration into a single overall network.

    Innovation: Summarize the special features and/or resources that make this application strong or unique.

    Investigators

    • If the application does not propose multiple PDs/PIs, describe a succession plan for the National Network Director(s).

    Approach: Include the following information to demonstrate feasibility and appropriateness of the proposed national DPBRN:

    DPBRN Organizational Structure

    • Provide an overview of and rationale for the overall network and Node organizational structure and leadership committees and plan for meetings/teleconferences and other forms of communication within the Network.
    • Describe the plans to monitor the progress of the overall network.
    • If the application proposes multiple PDs/PIs, describe the collaboration and communication and division of responsibilities between the multiple PDs/PIs and with the national DPBRN Coordinating Center PD(s)/PI(s).

    Centralized DPBRN Functions & Responsibilities

    • Describe how the National Network Director(s) will strive to fulfill the responsibilities detailed in the FOA.
    • Describe how the National Network Director(s), Coordinating Center Director(s) and DPBRN Node Directors will work collaboratively to provide direction, oversight, and coordination of network studies and component operations and utilization of network resources.
    • Describe how the National Network Director(s), Coordinating Center Director(s) and DPBRN Node Directors will strive to fulfill the centralized DPBRN functions described in the FOA.

    Practitioner Executive Committee

    • Describe how practitioners will be selected to serve on the Executive Committee, and describe the node, practice setting/type, sex/gender, and racial/ethnic distribution of practitioners selected for the Executive Committee. Do not contact or recruit members for the Practitioner Executive Committee prior to peer review of the grant application.
    • Describe the roles and responsibilities of the Practitioner Executive Committee.
    • Describe the plans for meetings of the Executive Committee.  

    Letters of Support: Letters of support from network or research collaborators, clinical partners, or other groups the network proposes to work with should be included.

    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 and a plan to share research resources (data collection instruments, study protocols) developed by the national DPBRN, as appropriate and consistent with achieving the goals of the program.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Overall)

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

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study records must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Other Requested Information: This attachment should indicate that all components (Overall component, Administrative Core, and DPBRN Elements Core) will contribute towards development and implementation of clinical trials in the network.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Because the Overall Network must demonstrate in the application that it has the capacity to develop and implement clinical trials, a Study Record must be entered as an example of how a clinical trial would be implemented in the network. This Study Record must be included in the Overall component because it spans all components and should include sufficient information for all involved components. The Study Record for this application requires completion of the following fields only, to allow reviewers to assess the network's capacity to develop and implement clinical trials. The fields listed here are required, and only these fields may be submitted in the Study Record:  

         1.1  Study Title. The Study Title may be a placeholder title.

         1.2  Is this Study Exempt from Federal Regulations?

         1.3  Exemption Number (if applicable)

         1.4  Clinical Trials Questionnaire. Indicate "Yes" to questions 1.4.a, 1.4.b, 1.4.c, and 1.4.d.

         2.1  Conditions or Focus of Study

         2.4  Inclusion of Women, Minorities, and Children

         2.5  Recruitment and Retention Plan

         3.1  Protection of Human Subjects

         3.2  Multi-site question and associated single-IRB plan

         3.3  Data and Safety Monitoring Plan

         4.7  Dissemination Plan

    Delayed Onset Study

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

    Do not add a Delayed Onset Study to the Overall component.

    PHS Assignment Request Form (Overall)

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

    Administrative Core

    When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. Indicate 'Yes' to the question, 'Are Human Subjects Involved?'

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Administrative Core)

    List all Nodes within the Node Organizational Structure.

    Research & Related Senior/Key Person Profile (Administrative Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Node Director’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
    Budget (Administrative Core)

    The network detailed budget should include central DPBRN administration at the institution(s) of the PD/PI(s) and funds to support one or more delayed onset developmental/exploratory, pilot (feasibility), and/or survey studies to be conducted in the national DPBRN. No more than 12.5% of the overall budget should be used for network studies. Budget justifications must be included.

    Budget forms for each Organizational Node subcontract will be included in the application package. Node (Consortium) PD(s)/PI(s) must be identified as Key Personnel. The combined effort for each Node's PD(s)/PI(s) (i.e. Node Director and co-Director) can be no more than 6 person months per year. Node Coordinators should not be listed as Key Personnel in the Administrative Core. Budget justifications must be included.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Administrative Core)

    Specific Aims: Describe the importance and role of the Node Organizational Structure in meeting the overall national DPBRN administrative and research goals and specific aims. 

    Research Strategy:  This section should describe the Node Organizational Structure, the rationale for the proposed structure, and the chain of responsibility within the overall network, including potential problems and alternative strategies to ensure network success.

    Approach:

    Node Organizational Structure

    • Discuss the management structure, personnel and their roles within the Node Organizational Structure.
    • Describe how the Node personnel will fulfill the responsibilities described in the FOA.
    • Describe how the Node Organizational Structure will facilitate coordination of network studies, activities and operations.
    • Describe the rationale for selection of the regional Nodes and the geographic distribution within each regional Node.
    • Describe the plan for practitioner recruitment to ensure a variety of practice settings/types and general dentistry/specialty affiliation.
    • Describe the process for forming and maintaining the specialty Node and how it will interact and coordinate with the regional Nodes.
    • Describe the plan to ramp-up specialty Node participation in network activities.
    • Describe the plan to develop a unique patient population Node.

    Node Directors

    • Describe the qualifications of the Node Directors and the ability of Node Directors to commit adequate time, engage and participate in the multiple functions of this large research Network.

    Research Studies

    • Discuss how the national DPBRN will coordinate the implementation of research studies to be conducted in the network and how research studies will be implemented across DPBRN Nodes.
    • For research study funds available through this award, discuss how the national DPBRN will coordinate the development of research study concepts and describe the process for selecting, developing, implementing, monitoring and terminating research studies.

    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 and a plan to share research resources (data collection instruments, study protocols) developed by the national DPBRN, as appropriate and consistent with achieving the goals of the program.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

    Other Requested Information: This attachment must indicate that the Study Record details are included in the Overall component.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Do not enter a Study Record into the Administrative Core since the required study record details should be entered into the Overall component.

    Delayed Onset Study

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

    DPBRN Elements Core

    When preparing your application in ASSIST, use Component Type ‘DPBRN Elements Core.’

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

    SF424 (R&R) Cover (DPBRN Elements Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (DPBRN Elements Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (DPBRN Elements Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. Indicate 'Yes' to the question, 'Are Human Subjects Involved?'

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (DPBRN Elements Core)

    Include sites relevant to each DPBRN Element, as appropriate. A site is not required for each of the 4 DPBRN Elements.

    Research & Related Senior/Key Person Profile (DPBRN Elements Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘DPBRN Element Lead' and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • A Senior/Key person is not required for each of the 4 DPBRN Elements.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (DPBRN Elements Core)

    Budget forms for each DPBRN Element with an individual budget must be included in the application package. A budget is not required for each of the 4 DPBRN Elements. Budget justifications must be included. If the budget for any DPBRN Element(s) is included in the  Administrative Core, describe in budget justification.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (DPBRN Elements Core)

    Specific Aims:  Describe the importance and role of the DPBRN Components in meeting the overall national DPBRN administrative and research goals and specific aims. 

    Research Strategy:  This section should describe the configuration of DPBRN Components and rationale for coordination and/or management within the centralized DPBRN functions or Node Organizational Structure.

    Approach:

    Network Resources

    • Describe the integration of each Component within the network and which entity (centralized DPBRN functions or Node Organizational Structure) will oversee management of each Component.
    • Describe the plans to ensure that network resources and Components are available and evenly distributed to research teams.

    Practitioner Recruitment and Engagement Component

    • Describe the plan for recruiting, engaging and retaining a national network of dental practitioners, representing a variety of practice settings/types and general dentistry/specialty affiliation.
    • Describe the plan for practitioner recruitment and retention of the specialty Node and practitioner recruitment into a unique patient population Node.
    • Describe the criteria for network membership and study participation eligibility.
    • Discuss strategies to engage practitioners in all aspects of network research studies.

    Practitioner Training Component

    • Describe the plans for practitioner training in areas pertaining to the conduct of human subjects research and processes to ensure that practitioners receive study-specific training.

    Practitioner and Patient Compensation System

    • Describe the plans for the compensation system, how it will be managed, and how to ensure that the resource will be available to study teams.

    Communication and Dissemination Component

    • Describe the plans for communication and dissemination within the network and with external audiences and the coordination between this component and the Practitioner Recruitment and Engagement component.

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

    All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and a plan to share research resources (data collection instruments, study protocols) developed by the national DPBRN, as appropriate and consistent with achieving the goals of the program.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information (DPBRN Elements Core)

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

    Other Requested Information: This attachment must indicate that the Study Record details are included in the Overall component, and the Delayed Onset Study Record(s) details are included in the Administrative Core.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Do not enter a Study Record into the DPBRN Elements Core.

    Delayed Onset Study

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

    Do not enter a delayed onset study into the DPBRN Elements Core.   

    3. Unique Entity Identifier and System for Award Management (SAM)

    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.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit 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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and for responsiveness by NIDCR, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

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

    For the NIDCR U19 multicomponent cooperative agreement applications, peer review of scientific and technical merit focuses on three areas: (1) Review of the overall merit of the DPBRN network as an integrated effort ('Overall' component), (2) Review of the 'Administrative Core,' or Node Organizational Structure, and (3) Review of the DPBRN Elements Core,' or DPBRN Components.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the network 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 network proposed).

    Scored Review Criteria - Overall

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

    Significance

    Does the network address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the network 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?  How will the individual nodes and components be enhanced by their integration into a single overall network?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the network? 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?

    Reviewers will consider the following during evaluation of the National Network Director(s):

    Does the National Network Director(s) have the experience and expertise and ability to commit adequate time to plan, direct and administer a network of this scope? If the application does not propose multiple PD/PIs, is there an appropriate succession plan for the National Network Director?  

    Innovation

    Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the network? 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 network 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 children, justified in terms of the scientific goals and research strategy proposed?  

    Reviewers will consider the extent to which the application adequately addresses the following criteria.

    Organizational Structure:  To what extent does the application describe collaboration and synergy of network personnel towards accomplishing the network's goals? Is there appropriate rationale for the overall network and Node organizational structure and leadership committees? Are the plans for communication among the individual parts of the Network appropriate and adequate? How feasible are the plans to monitor the progress of the overall network?

    Centralized DPBRN Functions & Responsibilities:  Does the application address how the National Network Director will strive to fulfill the responsibilities detailed in the FOA? To what extent does the application describe oversight and coordination of network studies and component operations and utilization of network resources? Does the application address how the network personnel will strive to fulfill the centralized DPBRN functions described in the FOA?

    Practitioner Executive Committee:  Are the roles and responsibilities of the Practitioner Executive Committee defined and appropriate? Does the application adequately describe how practitioners will be selected to serve on the Executive Committee?

    Environment

    Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

    Scored Review Criteria for Cores

    Each core will receive a single criterion score based on the following review criteria. 

    Review Criteria for Evaluating the Administrative Core

    Evaluate the extent to which the network structure will provide effective management and communication among all Nodes and components of the network to be effective on a national scale.

    Does the application adequately address the management structure, personnel and their roles within the Node Administrative Structure?

    Does the proposed Node Organizational Structure address potential problems and alternative strategies?

    Does the application address how the Node personnel will strive to fulfill the responsibilities described in the FOA?

    Will the Node Organizational Structure facilitate coordination of network studies, activities and operations?

    Are the plans for selection of the regional Nodes and geographic distribution appropriate? Are the plans for practitioner recruitment sufficient to ensure a variety of practice settings/types and general dentistry/specialty affiliation?

    To what extent is the process for forming and maintaining the specialty Node, ramping-up participation, and integrating with regional Nodes appropriate?

    Is the plan to develop a unique patient population Node appropriate?

    Node Directors:  Do the Node Directors and other Key Personnel have the experience and time commitment to engage and participate in the multiple functions of the Network?   

    Research Studies:  Does the application adequately describe how it will coordinate implementation of research studies to be conducted in the Network?

    Review Criteria for Evaluating the DPBRN Elements Core

    Does the application sufficiently describe the configuration of the DPBRN Components within the network?

    Does the application sufficiently address the integration of each Component within the network and management of each Component?

    Does the application sufficiently address plans to make network resources and components available and equitably distributed to all study teams?

    Practitioner Recruitment and Engagement Component:

    Are the practitioner recruitment, engagement and retention strategies sufficient to ensure diversity in demographic characteristics, geographic location, practice settings/types, and general dentistry/specialty affiliation?

    Is the plan appropriate to recruit and retain practitioners for the specialty Node and unique patient population Node?

    Are the criteria for network membership and study participation eligibility appropriate?

    Are the strategies to engage practitioners in all aspects of network research studies appropriate?

    Practitioner Training Component:

    Are the plans to train practitioners in all aspects of human subjects' research appropriate and adequate?

    Does the application adequately describe the processes to ensure that practitioners will receive study-specific training?

    Can the training plans be achieved and measured?

    Practitioner and Patient Compensation System:

    Does the application describe the plans for implementation and management of the compensation system?

    Are there processes to ensure that the compensation system will be available to all study teams?

    Does the compensation system provide for timely and accurate compensation?

    Communication and Dissemination Component:

    Do the communication and dissemination plans demonstrate sufficient expertise in both internal and external communications?

    Are there adequate plans for communication and dissemination within the network and with external audiences?

    Are there adequate plans for coordination between the Communication and Dissemination and Practitioner Recruitment and Engagement components?

    Additional Review Criteria - Overall

    As applicable for the network 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.

    Collaboration Plan

    Does the Collaboration Plan between the national DPBRN Administrative and Resource Center and national DPBRN Coordinating Center describe effective communication and collaboration between the two entities? Does it adequately address the distribution of activities between the two Centers? Is there an appropriate division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

    When the proposed network 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.

    Vertebrate Animals

    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.

    Biohazards

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

    Resubmissions

    Not applicable.

    Renewals

    Not applicable.

    Revisions

    Not applicable.

    Additional Review Considerations - Overall

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

    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).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

    Authentication of Key Biological and/or Chemical Resources

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDCR 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 Advisory Dental and Craniofacial Research Council. 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.  
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

    Prior Approval of Exploratory/Developmental, Pilot/Feasibility and Survey Studies

    Awardee-selected studies that involve human subjects require prior approval by NIDCR prior to initiation. 

    The awardee institution will provide NIDCR with written study protocols that address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.

    The awardee institution will provide NIDCR with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    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.

    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, 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 primary responsibility for:

    • Convening teleconferences to facilitate collaboration and communication with the national DPBRN Coordinating Center and Key Node Organizational personnel (e.g. Node Directors), to accomplish the objectives of the national DPBRN;
    • Managing all aspects of studies funded through this award, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIDCR staff in those aspects of scientific and technical management of studies funded through this award as stated in these terms and conditions;
    • Adhering to NIDCR policy requiring that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the studies. An NIDCR policy notice was published in the NIH Guide on March 27, 2008, and is available at: http://grants1.nih.gov/grants/guide/notice-files/NOT-DE-08-001.html. The full policy, including terms and conditions of award, is available at the following NIDCR Website: http://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/NIDCRClinicalTermsofAward.htm.
    • Upon implementation of each study conducted through the network, following the procedures required by the protocol regarding study conduct and monitoring, participant management, data collection, and quality control;
    • Retaining custody of and having primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies;
    • Managing involvement of industry or any other third party in studies conducted through the network. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIDCR;
    • Making all study materials and procedure manuals available in the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDCR/NIH;
    • Obtaining prior written approval of the NIDCR Grants Management Specialist, in consultation with the NIDCR Program Officer, for changes in any of the key personnel identified in the Notice of Grant Award.

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

    An NIDCR Project Scientist will be assigned. The NIDCR Project Scientist will:

    • Serve as a resource to provide scientific/programmatic support during the administration of the network and accomplishment of the research by participating in the design of the activities and advising in the management and technical performance;
    • Participate on regular teleconferences with PDs/PIs and network Key Personnel to monitor and review administration of the network, progress and conduct of studies implemented through the network, and accrual and retention of participants;
    • Review the progress of each study conducted through the network, through consideration of the annual reports, site visits, logs, etc. This review may include, but not be limited to, compliance with the study protocols, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting;
    • Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIDCR staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government right of access consistent with HHS, PHS and NIH policies.

    An NIDCR Program Official will be assigned. The NIDCR Program Official will:

    • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;
    • Have the option to withhold support to a participating institution if technical performance requirements are not met;
    • Perform other duties required for normal program stewardship of grants.

    An NIDCR Project Scientist (Medical Officer) will monitor the studies and serve as the Medical Monitor.

    • The NIDCR reserves the right to terminate or curtail a study or any portion of a study in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which the NIDCR does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or human subject ethical issues that may dictate a premature termination.

    Areas of Joint Responsibility include:

    • The National Network Director, Coordinating Center PD(s)/PI(s) and designated NIDCR staff person will participate on regular teleconferences to review progress and challenges with network administration and studies;
    • The National Network Director, Coordinating Center PD(s)/PI(s) and designated NIDCR staff person will participate on regular teleconferences with PDs/PIs and network Key Personnel to monitor and review administration of the network, progress and conduct of studies conducted through the network, and accrual and retention of participants;
    • Leadership Committees: In collaboration with the Coordinating Center, the National Network Director will establish and chair relevant leadership oversight committees. A designated NIDCR staff person will participate in the Node Directors meetings and will serve on the Executive Committee;
    • Study Team Meetings: Study teams will develop and implement research studies to be conducted through the national DPBRN. Designated network personnel will participate on study teams as key contributors, and a designated NIDCR staff person will participate on study team teleconferences periodically to monitor progress with study development and implementation.

    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.

    3. Reporting

    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. Progress reports should briefly describe status of projects funded through this award, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

    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.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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 Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Dena Fischer, DDS, MSD, MS
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4876
    Email:DentalPBRN@nidcr.nih.gov

    Peer Review Contact(s)

    Yasaman Shirazi, PhD
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-5593
    Email: yasaman.shirazi@nih.gov

    Financial/Grants Management Contact(s)

    Diana Rutberg, MBA
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4798
    Email: rutbergd@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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