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 Infrastructure Access (X01 Clinical Trial Not Allowed)
Activity Code
X01 Resource Access Award
Announcement Type

New

Related Notices
  • May 05, 2020 - Notice of Additional Receipt Dates for PAR-20-073 National Dental Practice-Based Research Network Infrastructure Access (X01 Clinical Trial Not Allowed). See Notice NOT-DE-20-024
  • May 01, 2020 - Notice of Special Interest (NOSI): Infrastructure Access for Research on Coronavirus Disease 2019 (COVID-19) Conducted in the National Dental Practice-Based Research Network. See Notice NOT-DE-20-023
  • March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
Funding Opportunity Announcement (FOA) Number
PAR-20-073
Companion Funding Opportunity

none

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

93.121

Funding Opportunity Purpose

The National Institute of Dental and Craniofacial Research (NIDCR) is continuing support for research conducted within a dental Practice-Based Research Network (PBRN). The National Dental PBRN Administrative and Resource Center and National Coordinating Center support the infrastructure for and implementation of multiple clinical studies. This Funding Opportunity Announcement (FOA) is seeking applications for small developmental/exploratory, feasibility (pilot), and/or survey studies of practitioners and/or patients to be conducted in the National Dental PBRN. Successful X01 applicants will be given access to the National Dental PBRN infrastructure to support an individual project. Successful applications will utilize the resources of and be funded through the National Dental PBRN Administrative and Resource Center and/or National Coordinating Center for study planning and implementation. This FOA seeks projects up to two years in length.

The main goals of the dental PBRN are to streamline the implementation of 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. This FOA encourages applications proposing research studies that align with the goals of the dental PBRN.

Key Dates

Posted Date

December 9, 2019

Open Date (Earliest Submission Date)
January 24, 2020
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

February 24, 2020, June 1, 2020, September 1, 2020, November 2, 2020, September 1, 2021, and September 1, 2022.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

February 24, 2020, June 1, 2020, September 1, 2020, November 2, 2020, September 1, 2021, and September 1, 2022.

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Scientific Merit Review

March 2020, June 2020, October 2020, November 2020, October 2021, October 2022

Advisory Council Review

Not Applicable

Earliest Start Date

April 2020, July 2020, November 2020, December 2020, November 2021, November 202

Expiration Date
September 02, 2022
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in 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 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 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    PURPOSE

    The National Institute of Dental and Craniofacial Research (NIDCR) is continuing support for research conducted within a dental Practice-Based Research Network (PBRN). The National Dental PBRN Administrative and Resource Center and National Coordinating Center support the infrastructure for and implementation of multiple clinical studies. The NIDCR provides two pathways to propose studies that utilize the PBRN infrastructure. This FOA describes one of the pathways and seeks applications for small developmental/exploratory, feasibility (pilot), and/or survey studies of practitioners and/or patients to be conducted in the National Dental PBRN. Successful X01 applications will be given access to the National Dental PBRN infrastructure to support an individual project. Successful applicants will utilize the resources of and be funded through the National Dental PBRN Administrative and Resource Center and/or National Coordinating Center for study planning and implementation. This FOA seeks projects up to two years in length.

    The main goals of the dental PBRN are to streamline the implementation of 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. This FOA encourages applications proposing research studies that align with the goals of the dental PBRN.

    BACKGROUND

    Practice-based research networks can generate important and timely information to guide the delivery of health care and improve patient outcomes. A dental PBRN 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. Dental PBRN studies draw on the experience and insight of practicing clinicians to address issues faced by dental practitioners in the daily care of their patients.

    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 practitioners and their patients with a wide geographic distribution and from a variety of practice settings/types. An important characteristic of the dental PBRN 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.

    OVERVIEW OF NATIONAL DENTAL PBRN INFRASTRUCTURE

    The dental PBRN infrastructure comprises one National Dental PBRN Administrative and Resource Center and one National Coordinating Center, funded as companion awards.

    The National Dental PBRN Administrative and Resource Center is responsible for recruiting practitioners for network membership, which comprises dental practitioners representing general dentistry/specialty affiliation and a variety of practice settings/types. The National Dental PBRN is organized into 6 regional Nodes or administrative hubs with wide geographic distribution that, combined, are capable of reaching interested participants within all states in the US. In addition, there is one specialty dentistry Node that operates across all network geographic areas, and the network will establish a unique patient population Node, which may comprise practitioners linked by certain practice types (e.g. federal services, dental public health clinics) or those who treat patients with certain disease-specific conditions that may affect oral health. The Administrative and Resource Center also manages a single Institutional Review Board (IRB), ensures that practitioners and office/clinic staff receive responsible research conduct training required by NIH and IRBs, and coordinates study deployment. Further, the Administrative and Resource Center infrastructure includes the following resources that are equitably available to research teams: a) Practitioner Recruitment and Engagement Component, b) Practitioner Training Component, c) Practitioner and Patient Compensation System, and d) Communication and Dissemination Component. A practitioner Executive Committee will provide input about the feasibility and clinical interest of research topics.

    The National Coordinating Center is the central locus for data coordination and management of studies conducted within the National Dental PBRN. The National Coordinating Center functions include developing and managing study-specific data management systems that allow for electronic data capture in practices and utilizing flexible and innovative technologies to capture research data, including the capability to accomplish research participant follow-up independent of in-office visits.

    Node Directors and Node Coordinators from the Administrative and Resource Center, who serve as liaisons to practitioners and their patients, will participate on study teams of X01 projects selected for National Dental PBRN access during the planning and implementation phases to: provide input about network resources and operations; recruit practitioners for participation in research studies; and support implementation of the study protocol.

    National Coordinating Center personnel will also serve on study teams of X01 projects selected for National Dental PBRN access to: provide additional scientific expertise to study teams, including biostatistical leadership for statistical design and data analyses, and psychometrics expertise if needed; provide a Study Manager who will manage study development/implementation progress and assist teams in the preparation of study-related documents; and develop and maintain a data management system for study data.

    OVERALL RESEARCH SCOPE AND OBJECTIVES?

    The NIDCR provides two pathways to propose studies that utilize the dental PBRN infrastructure. This FOA describes one of the pathways and is seeking applications for small developmental/exploratory, feasibility (pilot), and/or survey studies of practitioners and/or patients to be conducted in the National Dental PBRN. A second pathway, described in a separate FOA, seeks applications for clinical trials or large observational clinical studies conducted in the National Dental PBRN.

    Each successful X01 application will receive support for study planning and implementation of an individual project that will utilize the resources of and be funded through the National Dental PBRN Administrative and Resource Center and/or National Coordinating Center awards. The NIDCR will work with successful applicants and the National Dental PBRN infrastructure to ensure equitable access to National Dental PBRN resources and infrastructure support and to coordinate timelines according to network capacity.

    Applications should be limited to studies that can be completed within 2 years. This mechanism would be appropriate to propose national survey studies of practitioners with a wide geographic distribution, addressing topics such as practitioner decision-making related to patient management, diagnosis, and/or treatment practices. Also appropriate would be small developmental/exploratory or feasibility (pilot) studies that involve clinical data collection from practitioners and/or their patients. Examples of such studies include those ascertaining feasibility of and refining a future intervention, assessing willingness and acceptability of practitioners and patients to perform study procedures or introduce additional clinical care practices into their office flow, or developing technology for use by practitioners and patients. Developmental/exploratory or feasibility (pilot) studies should involve no more than 25-40 practitioners total within one Node or across multiple Nodes. Each practitioner is expected to enroll ~20-40 patients, depending upon the study design and data collection procedures.

    Public-private partnerships may be proposed as part of the recruitment or research plan (e.g. private partner contributing to recruitment strategy to promote practitioner participation in dental PBRN studies). If so, the rationale for this approach should be provided.

    Potential applicants are strongly encouraged to contact NIDCR Scientific/Research staff well in advance of the application due date and no later than ten weeks before that date to discuss the suitability of conducting the proposed study within the dental PBRN infrastructure. Pre-application consultation may include an introductory conference call with NIDCR Scientific/Research staff and National Dental PBRN Administrative and Resource Center and National Coordinating Center personnel. Potential applicants are strongly encouraged to review the process for potential grant applicants to interact with and utilize National Dental PBRN resources, available at https://www.nidcr.nih.gov/research/grant-applicants.

    Additional Information

    (1) Applicants to this FOA will be required to incorporate the dental PBRN infrastructure into their proposed study plans, including central study coordination and operations through the National Dental PBRN Administrative and Resource Center and project management, data management, and statistical leadership through the National Coordinating Center. Successful applicants will be required to use the single IRB that has been established for the National Dental PBRN and is consistent with NIH’s Single IRB Policy as described in NOT-OD-16-094.

    (2) National Dental PBRN Administrative and Resource Center and National Coordinating Center personnel will be active participants on study teams of X01 studies that receive PBRN infrastructure access.

    (3) For successful X01 applications, priority and timing for access to National Dental PBRN resources and infrastructure support will be based on factors including infrastructure capacity and availability of practitioners to participate in a study during a specific time period.

    (4) The X01 mechanism does not provide budgetary support for the proposed research. Successful X01 applications will receive access to the National Dental PBRN resources for study planning and implementation. Successful X01 applicants may request budgetary support for the proposed research through the National Dental Administrative and Resource Center and/or National Coordinating Center awards, as subrecipients of these National Dental PBRN infrastructure awards. The request for budgetary support will be made directly to the National Dental Administrative and Resource Center and/or National Coordinating Center awards and will be considered after the X01 has been awarded. Examples of budgetary support that may be considered include practitioner/patient remuneration, study materials, and minimal support for study team personnel and/or consultants.

    (5) At the time of an award, the PD(s)/PI(s), National Dental PBRN personnel, and NIDCR will negotiate a project work scope and study development/implementation activity timeline. The project work scope and timeline will include identifying the primary individual or entity and other contributors responsible for study development, start-up and implementation activities, and the timeline for completion of these activities.

    (6) The proposed clinical study must meet all applicable NIH and Office for Human Research Protections (OHRP) policy requirements. Awardees are required to comply with the NIDCR Clinical Terms of Award and the NIDCR Policy on Data and Safety Monitoring for all study planning and implementation activities. It is recommended that applicants use the NIDCR tools and templates for development of the clinical study documents, located in the NIDCR Toolkit for Clinical Researchers.

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

    Section II. Award Information

    Funding Instrument
    Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.
    Application Types Allowed
    New
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?
    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    Funds are not awarded via the X01 mechanism. The total number of approvals for access is dependent on the number of meritorious applications and the capacity of the National Dental PBRN infrastructure.

    Award Budget
    Not Applicable. There is no budget associated with X01 Resource Access Awards.
    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is two 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 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) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    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

     

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

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

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

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in 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.
    Page Limitations
    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed

    For this specific FOA, the Research Strategy section is limited to 6 pages.

    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.

    Total Federal Funds Requested: Enter $0.

    Total Federal & Non-Federal Funds: Enter $0.

    Estimated Program Income: Enter $0.?

    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.

    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. The following document must be uploaded as a separate pdf file with the name indicated below.

    1. Schedule of Events. The filename "Schedule of Events" should be used to name this attachment.

    Provide a schematic, table, or text description of the protocol-specified schedule of events for an individual study participant. It should capture each study visit/assessment time point and planned activity(ies) for each time point.

    SF424(R&R) Senior/Key Person Profile
    All instructions in the SF424 (R&R) Application Guide must be followed.
    R&R Subaward Budget
    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

    Significance:

    The significance, biological and clinical relevance of the proposed study must be stated clearly. It should be supported by the following:

    • A clear statement of the question(s) the study will address and its importance.
    • The scientific rationale and clinical need for the study, including an assessment of previous preclinical and/or clinical studies and their quality (if applicable).
    • The potential for the study results to impact knowledge or clinical practice.

    Approach:

    • Provide a concise snapshot of the planned clinical study. It is expected to:
    • Clearly state the study objectives.
    • Describe and provide rationale for the study design, including study groups.
    • Specify the primary and important secondary outcome measures that align with each objective and provide justification for selection of the study outcomes.
    • Describe how the primary and important secondary outcome variables will be collected and the criteria for measuring the outcomes.
    • Describe the study population, including the sample size, pertinent demographic information, required health status or disease condition, and geographic location. Explain why the study population is an appropriate group to address the study objectives. Do not duplicate information described in Section 2 (Study Population Characteristics) of the Study Record: PHS Human Subjects and Clinical Trials Information form.
    • Discuss potential biases or challenges in the proposed study and how they will be minimized and/or addressed.

    Environment:

    • Provide rationale for why the dental PBRN is an appropriate venue for the proposed study.

    Letters of Support: Since the National Dental PBRN Administrative and Resource Center and National Coordinating Center will not serve as collaborators or consultants, l etters of support from the National Dental PBRN Administrative and Resource Center or National Coordinating Center will not be accepted. Letters of support from research collaborators, patient organizations, or other groups the investigators propose to work with may 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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address: 1) A Data Sharing Plan describing the plan to make final datasets available in the public domain, managed by the National Dental PBRN infrastructure, and 2) a plan to make study materials and procedure manuals (data collection instruments, study protocols) available in the public domain, managed by the National Dental PBRN infrastructure, as appropriate and consistent with achieving the goals of the dental PBRN 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 human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Section 2 - Study Population Characteristics

    2.5 Recruitment and Retention Plan

    The dental PBRN infrastructure personnel will contribute towards recruiting practitioners for participation in studies conducted within the National Dental PBRN and developing systems to assist practitioners in maintaining high rates of patient recruitment, enrollment, and retention.

    2.7 Study Timeline

    Applicants should provide a project performance timeline for planning and implementation of the clinical study. The timeline should include the estimated time for completion of the study planning, including finalization of study-related documents, study implementation, and data analyses.

    Section 3 - Protection and Monitoring Plans

    3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

    In the associated single IRB plan attachment, indicate that the study will be submitted to the single IRB that has been established for the National Dental PBRN.

    3.3 Data and Safety Monitoring Plan

    Section 3.3 must be completed for all applications. Indicate that data and safety monitoring will be the joint responsibility of the study team, the National Dental PBRN Administrative and Resource Center, and the National Coordinating Center. The National Coordinating Center will develop a data management system for study data collection and adverse event recording. The study team will maintain primary responsibility for reporting adverse events, unanticipated study events and protocol deviations to ensure participant safety.

    3.5 Overall Structure of the Study Team

    Section 3.5 must be completed for all applications. Indicate that National Dental PBRN Administrative and Resource Center personnel will participate on study teams to provide input about network resources, activities, and operations; recruit practitioners for study participation; and support study implementation. Indicate that National Coordinating Center personnel will serve on study teams to provide input about National Coordinating Center resources and activities; provide project management, data management, and statistical leadership; and provide additional scientific expertise if needed.

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

    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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant 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.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    For this particular announcement, note the following:

    The X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 FOA.  This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research.  Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.

    Successful X01 applications will utilize the National Dental PBRN infrastructure and resources for study planning and implementation, available through the National Dental PBRN Administrative and Resource Center and National Coordinating Center. Resources include scientific expertise that will be added to study teams as appropriate.

    The dental PBRN is a unique venue in which to conduct clinical studies. The National Dental PBRN infrastructure will provide centralized study operations, data management, and coordination. The National Dental PBRN includes a strong, flexible network of practitioners and offices/clinics (sites) with capacity to implement numerous clinical studies. Study enrollment and retention will be overseen by the National Dental PBRN.

    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.

     

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

    Does the proposed study have a clear statement of the question(s) that the study will address and its importance? Does the application provide sufficient scientific rationale and clinical need for the study? How compelling is the potential for the proposed study to increase knowledge or inform clinical practice?

     

    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 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?

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    Are the study objectives stated clearly? Is there a description of the proposed study design, and is it appropriate to address the study objectives? Are the primary and secondary outcome variables described, justified, and is there a description of how they will be collected and measured? Is the study population appropriate and justified? Does the application address potential biases or challenges, and are plans to minimize these biases appropriate? Is the timeline for developing, implementing, and completing the study appropriate?

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

     

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

    Is the dental PBRN an appropriate venue in which to conduct the research? How well does the project leverage resources of and ensure collaboration with the National Dental PBRN?

    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.

    Study Timeline

    Is the project performance timeline feasible to accomplish the proposed study development and implementation activities within the proposed timeframe?

    Other Attachments

    Regarding the additional documents included as "Other Attachments":

    Schedule of Events

    Is the Schedule of Events for an individual study participant described and appropriate for the study design and data to be collected? Are the procedures and frequency of visits in the proposed schedule of events for the study reasonable and feasible?

     

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

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

     

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

     

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

     

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

     

    For Resubmissions, NIH staff will evaluate the application as presented, taking into consideration changes made to the project.

     

    Not Applicable

     

    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.

     

    Not Applicable

     

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

     

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

     

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

     

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

    2. Review and Selection Process

    X01 applications will undergo an administrative evaluation by NIH staff, not a full peer review. Applications submitted for this funding opportunity will be administratively evaluated using the criteria shown above.

    The following will be considered in making decisions:

    • Scientific and technical merit of the proposed project as determined by administrative review
    • Available capacity of the network at the time of review
    • Impact of the requested study on resources available to support other projects
    • Relevance of the proposed project to program priorities

    Applications will compete for available resources with all other recommended applications submitted in response to this FOA.

    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.

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

    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.

    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.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    Cooperative Agreement Terms and Conditions of Award
    Not Applicable

    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. 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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

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

    Peer Review Contact(s)

    Applications submitted to this FOA will not undergo peer review. Questions should be directed to the Scientific/Research Contact.

    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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