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: Coordinating Center (U01 Clinical Trial Required)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

April 13, 2018 - Notice of Correction to RFA-DE-19-002. See Notice NOT-DE-19-018.

NOT-DE-18-009

NOT-DE-18-010

Funding Opportunity Announcement (FOA) Number

RFA-DE-19-002

Companion Funding Opportunity

RFA-DE-19-001, U19 Research Program – 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 Coordinating Center; a separate FOA is soliciting applications for the national DPBRN Administrative and Resource Center (RFA-DE-19-001).

This clinical research network will develop and conduct multiple clinical studies and clinical trials in participating dental offices with consenting patients, on topics of interest to practitioners and their patients. The role of the national Coordinating Center will be to centralize and harmonize study operations, data management, and biostatistical support, to facilitate rapid development and implementation of oral health studies conducted in the national DPBRN. 

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

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. 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(s) 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 Coordinating Center; a separate companion FOA is soliciting applications for the national DPBRN Administrative and Resource Center (RFA-DE-19-001). The national DPBRN Administrative and Resource Center award 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 purpose of the national DPBRN Coordinating Center is to centralize and harmonize study operations, data management, and biostatistical support to facilitate rapid development and implementation of clinical studies conducted in the national DPBRN. The main goals of the national DPBRN 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.

    Applicants for the national DPBRN Coordinating Center and DPBRN Administrative and Resource 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 Administrative and Resource Center FOA (RFA-DE-19-001).

    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 settings/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 AND SCOPE

    This FOA solicits applications for a single national Coordinating Center to support the national DPBRN infrastructure and the development/implementation of multiple national oral health clinical studies during an up to 7-year project period. The national DPBRN will conduct multiple prospective and/or retrospective, observational clinical studies and clinical trials with a focus on general dental practice, and will also incorporate projects of interest to dental specialists and other dental professional groups, specific dental practice 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.

    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.

    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 consider how to enhance patient recruitment and retention and will solicit research ideas and work with potential investigators to develop research studies appropriate for the national DPBRN. Other important activities led by the Coordinating Center 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, and
    • Focusing efforts on electronic data collection when appropriate, to allow for data collection independent of office visits.

    OVERVIEW OF NATIONAL DPBRN INFRASTRUCTURE

    The national DPBRN infrastructure 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 Coordinating 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 PD(s)/PI(s) of this U01 award is/are the Coordinating Center Director(s) and will collaborate and interact with the National Network Director(s).

    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 is important to the success of the DPBRN. The U01 application must address collaboration and communication and division of responsibilities between the multiple PDs/PIs and with the national DPBRN Administrative and Resource Center PD(s)/PI(s). If the U01 application does not propose multiple PIs, the application must include a succession plan for the Coordinating Center Director in the event that the Director is unable to perform his/her responsibilities.

    National DPBRN Organizational Structure (Companion FOA, RFA-DE-19-001)

    A national DPBRN Administrative and Resource Center (described in RFA-DE-19-001) will coordinate efforts of dental practitioners across the US, representing general dentistry/specialty affiliation and a variety of practice settings/types. The national DPBRN organizational structure will comprise at least four regional Nodes or administrative hubs with wide geographic distribution that, combined, are capable of reaching all interested participants within all states in the US. In addition, there will be at least one specialty Node, which serves to recruit and engage practitioners within a specialty area of dentistry. 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. Each Node will be managed by a Node Director who 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. It is expected that the National Network Director will work collaboratively with the Coordinating Center Director(s) and Node Directors to oversee and coordinate research activities and utilization of Network resources throughout the Network.

    The DPBRN Administrative and Resource Center FOA addresses plans for and responsibilities of the overall DPBRN structure and functions, a practitioner Executive Committee, Node Organizational Structure, and infrastructure to support four required components of the DPBRN: a) Practitioner Recruitment and Engagement, b) Practitioner Training, c) Practitioner and Patient Compensation, and d) Communication and Dissemination. The National Network Director(s) 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.

    NATIONAL COORDINATING CENTER

    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 National Network Director(s) will work in a collaborative and interactive manner with the Coordinating Center Director(s) to oversee DPBRN administrative and research activities. The Coordinating Center Director(s) will be a member of the practitioner Executive Committee and will serve on other relevant national DPBRN leadership committees. Coordinating Center team members will work with PDs/PIs of potential new DPBRN research projects during the conceptual phase, and will serve on study teams of projects selected for funding during the study development and implementation phases.

    The national DPBRN Coordinating Center will serve as the central locus for the national DPBRN practitioner membership and participation database and the data coordination/management for network studies. Central data coordination can increase the efficiency of research by providing infrastructure, centralized resources, and support for investigators conducting studies within the national DPBRN. The data coordination/management functions will include developing and managing a system for electronic data capture in practices and implementing flexible and innovative technologies to capture research data, including the capability to accomplish research participant follow-up independent of in-office visits. Release of funds from this cooperative agreement funding mechanism will be contingent upon completion of network infrastructure and study support responsibilities on schedule.

    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 activities and division of tasks and responsibilities pertaining to management of the DPBRN infrastructure and research studies conducted through the DPBRN must be described. Applications submitted to this FOA must address communication and collaboration between the DPBRN Administrative and Resource Center and Coordinating Center, distribution of activities, and a plan for division of tasks and responsibilities in a Collaboration Plan, submitted as an Other Attachment.

    The Coordinating Center’s organizational functions to support the national DPBRN infrastructure will include, but are not limited to:

    • Designing and maintaining a secure, centralized national DPBRN membership database. This includes serving as the central locus for maintaining information about members’ participation in general and study-specific training as well as engagement and participation in network studies and activities, and for providing a secure means for approved users to access this information; and
    • Providing administrative support for network components and activities.

    The Coordinating Center’s data coordination/management functions for studies conducted within the national DPBRN will include, but are not limited to:

    • Providing expertise in oral health (e.g. caries, periodontal disease, etc.), behavioral sciences, survey design, epidemiology, interventional studies, and biostatistics;
    • Providing biostatistical support to study teams for study design and protocol development, including sample size calculations or simulations, study implementation (including but not limited to randomization) and data analyses, if needed;
    • Assisting study teams in the preparation of study protocols, case report forms, and other study-related documents;
    • Establishing and maintaining a data management system needed for study data collection and storage, including image capture and multiple types of data relevant to the individual studies;
    • Designing and implementing a strategy for data collection that is appropriate for each individual research study;
    • Training investigator staff on use of data collection systems;
    • Devising and maintaining a secure infrastructure for storing and providing access to study-related documents and materials, including IRB communication and data that might include identifiable information about human subjects. This includes serving as the central locus for accepting requests for the use of such materials and for providing a secure means for approved users to access those materials;
    • Developing and implementing a system for adverse event reporting;
    • Supporting and developing processes for study-specific data quality management procedures and remote and in-person ad-hoc study monitoring;
    • Preparing and distributing periodic technical and statistical reports of study activities and progress;
    • Preparing and distributing reports for Data and Safety Monitoring Boards (DSMBs) or other study oversight committees; 
    • Providing final datasets ready for analysis by individual study teams; and
    • Developing a Resource and Data Sharing Plan consistent with NIH policy and guidance. See https://grants.nih.gov/grants/policy/data_sharing/ for additional information.

    Coordinating Center personnel must have a strong record of developing, deploying and maintaining databases for multi-center studies. The Coordinating Center must have expertise in oral health, behavioral science, survey development, biostatistics, epidemiology and interventional research; experience in the design and supervision of complex, multisite clinical studies; and experience in the statistical analysis of oral health data. The Coordinating Center will be expected to work closely with and provide support to the study teams as needed.

    NATIONAL DPBRN RESEARCH STUDIES

    The national Coordinating Center will provide support for research studies conducted within the national DPBRN. The national DPBRN Administrative and Resource Center U19 award (RFA-DE-19-001) will include funds to support developmental/exploratory studies, pilot (feasibility) studies, and/or survey studies of practitioners and/or patients. For research study funds available through the U19 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. 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 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 should not propose specific clinical studies to be conducted by the DPBRN. However, the application must include a Study Record with information that demonstrates the capacity of the Coordinating Center to support clinical studies to be conducted within the DPBRN.

    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 $2,200,000 in \ in FY2019 to fund one award.

    Award Budget

    Application budgets must reflect the actual needs of the proposed 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 Administrative and Resource Center FOA (RFA-DE-19-001).

    Number of Applications

    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

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide,  except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    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

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

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed., 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 Administrative and Resource Center institution/entity or personnel in the Collaboration Plan. The page limit for the Collaboration Plan is 4 pages.

    SF424(R&R) Senior/Key Person Profile

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

    The Coordinating Center is expected to assemble a team with expertise in database development and programming, oral health, behavioral science, survey development, biostatistics, epidemiology and interventional research; experience in the design and supervision of complex, multisite clinical studies; and experience in the statistical analysis of oral health data. The investigators may be from either the same institution or different institutions. Applicants should describe experience in multisite study coordination, study design, and data management and analysis of oral health data.

    Coordinating Center personnel must be able to communicate effectively and work closely with and provide support to individual study teams to ensure that the network will achieve its goals. This requires that the Coordinating Center have personnel with sufficient knowledge to serve the multiple types of individual projects that will be supported.

    R&R or Modular Budget

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

    A detailed budget for the Coordinating Center should be provided. The budget should include all activities delineated in the list of functions stated in this FOA. The combined effort for PD/PIs (i.e. Coordinating Center Director(s), Coordinating Center Co-Director(s), Consortium PD/PI(s)) can be at least 6 and no more than 9 person months per year.

    The application should state the number of clinical research studies to be supported by the Coordinating Center with the proposed budget. It is expected that developmental/exploratory, pilot (feasibility), and/or survey studies using U19 funds will be developed soon after the network has been established. Then, several observational studies and clinical trials will be funded through a DPBRN-specific funding opportunity announcement and conducted over the 7-year project period.

    Activities to be budgeted include:

    • Developing and maintaining a practitioner membership database;
    • Developing and maintaining a secure website for the distribution of study documents and reports and IRB correspondence;
    • Providing support to potential PD/PIs for study concept development;
    • Developing data management system(s), study-related documents during the network research study development phase;
    • Provide training for network personnel and practitioners;
    • Overseeing network research study start-up and site/practitioner activation;
    • Providing randomization support;
    • Overseeing study implementation progress and adherence to protocol and enrollment/retention targets;
    • Preparing and distributing periodic technical and statistical reports of study activities and progress;
    • Preparing and distributing reports for DSMBs or other study oversight committees;
    • Developing and monitoring processes to ensure quality of data collected (data management systems, data quality processes, study monitoring);
    • Participating in network and study team meetings;
    • Implementing a method for timely monitoring and reporting of adverse events, unanticipated study events and protocol deviations to ensure participant safety;
    • Performing study close-out activities, providing final datasets ready for analysis by individual study teams.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy: Describe the plans for carrying out duties and functions needed to support the national DPBRN infrastructure and research studies conducted within the DPBRN.

    Innovation: Discuss innovation of planned approaches to project coordination, logistical support, data collection, and quality management.

    Approach:

    Leadership/Personnel

    • Provide an overview of how the National Network Director(s), Coordinating Center PD(s)/PI(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;
    • Discuss the combined qualifications of the national Coordinating Center Key Personnel/leadership team. Applicants should describe prior or ongoing experience functioning as part of a research network or other collaborative activities and should not duplicate information provided in individual biosketches;
    • Describe the combined expertise available in the leadership team at the Coordinating Center in developing and implementing complex and multisite clinical studies, including clinical trials. Applicants should not duplicate information provided in individual biosketches;
    • Discuss the plan for communication and interaction between the Coordinating Center and network administrative personnel.
    • 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 Administrative and Resource Center PD(s)/PI(s).
    • If the application does not propose multiple PDs/PIs, describe a succession plan for the Coordinating Center Director in the event that the Director is unable to perform his/her responsibilities.

    Network Resources

    • Describe the plan to develop and maintain the national DPBRN practitioner membership and participation database;
    • Provide a timeline for development of the practitioner database;
    • If any components will be coordinated and/or managed within the Coordinating Center, describe the plans for development and coordination and/or management of these components.

    Central Coordination

    • Provide an overview of the plan to centralize and harmonize study operations, data management, and biostatistical support. Provide an overview of the Coordinating Center's role in supporting other network activities;
    • Describe the role of the Coordinating Center in streamlining and coordinating implementation of studies across network nodes.

    Research Studies

    • It is anticipated that the DCC will provide full statistical and operational support for all network projects. However, the applicant should briefly describe how, in the alternative scenario of non-CC statistician or operations personnel, these personnel would be integrated in network CC operations of their project;
    • Describe the interaction of Coordinating Center personnel with study teams and the communication between the Coordinating Center and the study team PD/PI and other study team members;
    • Describe the plan to develop a secure infrastructure for storing and providing access to study-related documents and materials, including IRB communication;
    • Describe the plan to develop a data management system(s) for electronic data capture in network studies and how the data management system(s) will crosstalk with the practitioner database;
    • Discuss the plan to develop and implement flexible and innovative technologies to capture research data independent of in-office visits;
    • Provide an overview of the Coordinating Center's role in assisting with preparation of all the necessary documents and processes that the individual investigator teams will need to successfully implement and conduct a study;
    • Provide an overview of the types of training that will be offered to network personnel and practitioner participants, and how the training may be administered and tracked;
    • Describe the plan for development of data management, quality management, and monitoring processes to ensure quality of data collected for network studies;
    • Provide an overview of technical and statistical reports that will be provided to study teams to ensure successful study implementation and conduct. Discuss the types of and periodicity of those reports, and how the reports will enhance the conduct of the 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:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Because the national DPBRN Coordinating Center must demonstrate in the application that it has the capacity to support clinical trials, a Study Record must be entered as an example of how a clinical trial would be supported. The Study Record for this application requires completion of the following fields only, to allow reviewers to assess the Coordinating Center's capacity to support 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

    3.1  Protection of Human Subjects. Describe the plan to develop a secure infrastructure for

           storing data that might include identifiable information about human subjects.

    3.2  Multi-site question and associated single-IRB plan

    3.3  Data and Safety Monitoring Plan. Describe the plan to develop a method for timely

           monitoring and reporting of adverse events, unanticipated study events and protocol

           deviations to ensure participant safety, including notification and reports to the IRB and

           NIDCR.

    3.5  Overall Structure of the Study Team. Describe the role and functions of the Coordinating

           Center personnel during the conceptual phase of study development. Describe the functions

           of the Coordinating Center during the study development and implementation phases.

           Explain how Coordinating Center personnel (e.g. study manager, biostatistician) may be

           selected to serve a role on study teams.

    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 enter a delayed onset study. 

    PHS Assignment Request Form

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

    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). 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.

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and 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.

    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

    Does the application provide evidence of experience and participation as part of a research network or other collaborative research activities? Do the PD(s)/PI(s) and Key Personnel have a track record in successfully designing and implementing complex clinical studies and trials and

    performing the statistical and data management activities for multicenter clinical studies and trials? Does the applicant team include individuals with sufficient knowledge and expertise in oral health, survey design, and clinical research and trials to serve the multiple types of projects that will be supported by the Coordinating Center?

    Innovation

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

    Approach

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

    Does the application provide evidence of the ability of the Coordinating Center to support and coordinate activities within the network's organizational structure? Are the roles and responsibilities of Coordinating Center personnel clear and appropriate? Does the application demonstrate the commitment, availability, and flexibility of staff time for the satisfactory development and conduct of Network studies? Are the proposed interactions/communication between the Coordinating Center and network personnel, and Coordinating Center and study teams, clearly described and creatively optimized? Are the plan and timeline for development of the practitioner membership database appropriate? Are the plans for data management system, electronic data capture, and study-related document development appropriate and optimized? Are there adequate plans for training network personnel and practitioners and tracking training activities? Are the processes to ensure quality of data collected feasible and appropriate? Are the proposed plans for technical and statistical reporting appropriate to enhance the quality of network studies? Does the application provide an adequate plan to develop infrastructure for storing and providing access to study materials?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

    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?   

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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

    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

    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 (GDS).

    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). 

    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 or participating in teleconferences to facilitate collaboration and communication with the national DPBRN Coordinating Center and Key Node Organizational personnel, to accomplish the objectives of the national DPBRN;
    • Managing all aspects of studies supported 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 supported by 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 supported by this award. 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 to the Coordinating Center throughout development and maintenance of Network resources, centralization of study operations and biostatistical support, and accomplishment of the research by participating in the design of 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 and management of Coordinating Center resources, study development and implementation progress, and conduct of studies supported through this award;
    • Review the progress of each study supported through this award, 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 supported through this award, 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 supported by this Coordinating Center 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)

    Center for Clinical Research
    Division of Extramural Research
    National Institute of Dental and Craniofacial Research (NIDCR)
    All inquiries should be sent to: 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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