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

Tailoring Dental Treatment for Individuals with Systemic Diseases that Compromise Oral Health (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • Funding Opportunity Announcement (FOA) Number

    PAR-16-154

    Companion Funding Opportunity

    PAR-16-153, R21 Exploratory/Developmental Grant

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

    93.121 

    Funding Opportunity Purpose

    This Funding Opportunity Announcement encourages research to address gaps in our knowledge of how best to treat oral diseases of patients with systemic diseases or conditions known to compromise oral health, to identify factors predictive of treatment outcomes within patient groups, and to generate evidence for more precise dental treatment guidelines tailored to patient needs. It is expected that research applications will propose studies utilizing established cohorts of individuals with the disease of interest.

    Key Dates
    Posted Date

    March 25, 2016

    Open Date (Earliest Submission Date)

    May 5, 2016

    Letter of Intent Due Date(s)

    30 days prior to the application due date

    Application Due Date(s)

    Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

    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)

    Standard AIDS dates apply, 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 these dates.

    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
    Advisory Council Review
    Earliest Start Date
    Expiration Date

    May 8, 2019

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

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

    There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

    Problems accessing or using ASSIST should be directed to the eRA Service Desk.
    Problems downloading forms should be directed to Grants.gov Customer Support.
    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

    The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research to address gaps in our knowledge of how best to treat oral diseases of patients with systemic diseases or conditions known to compromise oral health, to identify factors predictive of treatment outcomes within patient groups, and to generate evidence for more precise dental treatment guidelines tailored to patient needs.  To capture longer term oral health outcomes and ensure that analyses can be completed within the project period, it is expected that applicants propose studies using established cohorts of individuals with the disease of interest.

    Background

    Systemic diseases and syndromes such as Sjögren’s syndrome, cleft lip/palate, ectodermal dysplasias, osteogenesis imperfecta, head and neck cancer, and diabetes can compromise oral health. Oral diseases are more prevalent and severe in affected individuals, and knowledge gaps exist in dental treatment guidelines for several systemic diseases long known to impact oral health. Most treatment guidelines for managing caries, periodontal diseases or malocclusions are derived from clinical trials or studies in relatively healthy subjects, and the long term successes of different treatment and restorative approaches for oral diseases in medically complex patients are not known.  Practitioners treating certain medically complex patient populations have called for more research to guide their treatment decisions, as many current recommendations are primarily based on expert opinion.

    Patients with certain systemic diseases and syndromes may spend significant time and resources maintaining their oral health. For example, studies of Sjögren’s syndrome patients find out-of-pocket spending for dental care is two to three-fold higher in Sjögren’s patients as compared with controls, but there are very few clinical studies examining the success of various dental treatments in patients with Sjögren’s syndrome.  

    Some systemic diseases can increase the risk for bleeding, infection, and slower wound healing, which may complicate dental treatment. While there has been significant research characterizing periodontitis in diabetes, especially type 2 diabetes, there is limited evidence supporting current clinical guidelines for treatment of diabetes-associated periodontitis.  

    Several rarer systemic diseases that impact oral health have been characterized through careful phenotyping and genotyping in the last 15 years, but there have been limited studies focused on determining outcomes of oral health preventive approaches and restorative treatment in patients with unique diseases.

    Scope

    Some systemic diseases and syndromes significantly impact oral health, and patients with these conditions are often managed with more frequent and aggressive dental treatment protocols. However, most of the evidence supporting these management strategies comes from clinical trials that enrolled healthy subjects, longitudinal studies with limited follow-up periods, or case reports and case series studies. Outcomes research supported by this FOA will help establish evidence-based dental treatment guidelines for patients with disease- or syndrome- related compromised oral health, to suggest appropriate adaptations (in timing, frequency, procedure or material) of recommended preventive, restorative, and treatment practices.

    To capture longer term outcomes and ensure that analyses can be completed within the project period, it is expected that research applications will utilize established cohorts of individuals with the disease of interest. The population for study should be representative of the disease and of sufficient size to obtain clinically meaningful oral health outcomes. The systemic disease or condition of interest should be well-characterized in the existing cohorts. Investigators planning to utilize databases or existing records at specialized treatment centers are encouraged to apply. In some circumstances, oral health treatment data may be available retrospectively (such as when an implant was placed or when orthodontic treatment was initiated), and collection of oral health outcomes will occur prospectively. If no oral health data are available for an existing disease cohort, oral health treatment and outcomes data may need to be collected prospectively. In this case, the applicant should demonstrate that clinically meaningful oral health outcomes can be evaluated within the proposed duration of the project.  Examples of established cohorts include, but are not limited to:

    • Established longitudinal cohorts sponsored by various NIH Institutes and Centers
    • Cohorts and registries established within patient advocacy groups for specific disorders
    • Existing cohorts within academic centers

    Applicants are expected to provide existing evidence that the disease or condition selected for study is associated with an increased risk of developing oral disease or developing more severe forms of oral disease. All study participants should have the disease or condition of interest, but analyses may consider the contribution of co-morbid conditions on treatment outcomes. Patient groups of interest would include, but are not limited to:  Patients post head-and-neck cancer treatment, those with autoimmune or rheumatologic conditions such as Sjögren's syndrome, patients post solid organ or hematopoietic stem cell transplant, individuals born with cleft lip/palate or other craniofacial disorders such as hemifacial microsomia or mid-face hypoplasia, individuals with rare syndromes such as the ectodermal dysplasias and osteogenesis imperfecta, individuals with inherited immunodeficiencies, and patients with chronic temporomandibular disorders.

    Study designs considered appropriate to this FOA would be cohort studies that provide longitudinal follow-up of an existing population, case-control studies, and retrospective database analyses beyond the scope of NIDCR Small Research Grants for Oral Health Data Analysis and Statistical Methodology Development (R03) or the companion R21 Funding Opportunity Announcement (such as those proposing extraction of data from individual health records with adjudication of findings). This Funding Opportunity will not support epidemiologic studies of disease prevalence or studies ascertaining risk factors for disease without assessment of oral health outcomes. It also will not support studies that meet the NIH Definition of a Clinical Trial. Investigators proposing clinical trials must use the R34 and/or U01 mechanisms (see http://www.nidcr.nih.gov/research/DER/ClinicalResearch/ClinTrials.htm).

    Encouraged research topics include: Studies identifying factors that predict treatment outcomes within patient groups; comparative effectiveness studies of preventive/maintenance therapies, dental procedures or reconstructive interventions; or cost-effectiveness assessments of existing interventions with demonstrated effectiveness, provided that the research meets NIH's priority areas for health economics research (see Clarifying NIH Priorities for Health Economics Research). The research should identify best frequency/timing, procedures, materials, devices, drugs or other interventions that restore oral health. Also considered appropriate would be studies identifying procedures that reduce treatment costs without compromising treatment outcomes. Examples of research topics include, but are not limited to:

    • Research to assess the effectiveness and survival of dental implants, crowns or prosthetics to restore oral function in medically complex patients, such as those with ectodermal dysplasias or Sjögren's syndrome.
    • Research to study the effectiveness of standard of care periodontal therapy for those with type 1 or type 2 diabetes and factors that predict response to therapy.
    • Research to assess long-term oral health outcomes in patients who develop chronic graft versus host disease following hematopoietic stem cell transplant.
    • Research to study the impact of early interventions (such as those for individuals born with oral clefts or other craniofacial dysmorphologies) on later clinical outcomes.
    • Research to assess outcomes of grafting or particular techniques for facial reconstruction in relevant patient populations.
    • Research to study the effectiveness of orthodontic / orthognathic therapy in individuals with osteogenesis imperfecta and factors that predict response to therapy.
    • Research to assess temporomandibular joint and pain outcomes following orthodontic treatment in patients with chronic temporomandibular disorders.

    Applicants should also consider the relevance of their proposed research to NIDCR programs and priorities as described in the "NIDCR Strategic Plan", which is available at http://www.nidcr.nih.gov/Research/ResearchPriorities/StrategicPlan/.  

    See Section VIII. Other Information for award authorities and regulations.
    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Resubmission
    Revision

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

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.

    Award Project Period

    A project duration of up to five years may be requested. 

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

    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.
    • 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
    Number of Applications

    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

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

    2. Content and Form of Application Submission

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

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

    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 Institute/Center 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
    National Institute of Dental and Craniofacial Research (NIDCR)
    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.  

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    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:

    Significance:

    -  Provide evidence that the disease group selected for study has an increased risk for prevalence or severity of a particular oral disease.   

    -  Describe the significance of the clinically relevant oral health outcome(s) of the proposed research.

    -  Clearly document either the lack of published information describing the oral health treatment outcomes for the condition of interest, or the need to update information due to developments in treatment of the medical condition that could influence outcomes of dental treatment.-  Describe if and how current treatment guidelines and quality of care measures may need to be modified as a result of the proposed research.

    Approach:  

    - Describe the established cohort of individuals with the disease of interest, characterize how the systemic disease or condition of interest was diagnosed in the established cohort, and describe the selection criteria for study inclusion.

    -  Provide evidence that all study subjects have in common the condition or disease of interest.

    -  Describe the oral health treatment(s) being studied, the oral health outcomes being used, and how each will be measured, and provide the analysis plan.

    -  For prospective studies, address the feasibility of recruiting participants from existing cohorts who are eligible for the proposed research. Specifically, applicants are expected to provide evidence that each recruiting clinical center has access to a sufficient number of study participants who meet the eligibility criteria. For multi-site applications, information should be provided for each participating clinical site.

    -  For longitudinal studies, provide evidence that clinically meaningful oral health outcomes can be evaluated within the proposed duration of the project and provide the plan for subject retention. 

    -  For retrospective data analyses, provide compelling justification as to the adequacy of the database or records to address the question(s). The proposed dataset must have sufficient numbers of the target patient group and sufficient clinical data to characterize the disease or condition of interest, ascertain the oral health treatment, and appropriately measure the oral health outcomes.  Discussion of the database or existing records should address data quality including the presence of relevant variables, completeness, bias, and any methods that will be used to control or account for deficiencies. Provide evidence that the study team has access to the data needed to complete the research, including the feasibility of re-consenting research subjects, if needed. If data will be extracted from individual medical records, describe how the data will be collected uniformly and how data will be validated.

    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.

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

    PHS Inclusion Enrollment Report

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

    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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Requests of $500,000 or more for direct costs in any year

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

    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? Is there evidence that the condition or disease group selected for study is associated with an increased risk for prevalence or severity of a particular oral disease? Does the proposed investigation address a clinically meaningful oral health outcome? Does the application address either the lack of published information describing the oral health treatment outcomes of the condition of interest, or the need to update information due to developments in treatment of the medical condition? Do the investigators articulate how the results of the proposed research will affect existing treatment guidelines and/or quality of care measures? 

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?   

    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? 

    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?

    Does the research propose to use an established cohort of individuals with the disease of interest? Does the application describe diagnosis of the disease or condition in the population, and are the selection criteria for study inclusion clearly articulated?

    Do all proposed participants in the patient group have the disease or condition of interest? Is confirmation of the underlying medical condition or disease appropriate? Does the application appropriately describe the oral health treatment(s) being studied, the oral health outcomes being used, and how each will be measured? Do the investigators have access to a sufficient number of potential participants or patient records of the target patient group to complete the research within the grant period?

    If proposing a prospective study, does the application provide evidence that each recruiting clinical center has access to a sufficient number of study participants who meet the eligibility criteria? For longitudinal studies, does the study timeline allow sufficient time for enrollment and evaluation of clinically meaningful outcomes within the proposed period of the grant?

    If proposing a retrospective data analysis, is there sufficient clinical data in the database to characterize the disease or condition of interest, ascertain the oral health treatment, and appropriately measure the oral health outcomes? If using existing data, does the application appropriately address existing data quality, completeness, bias and any methods that will be used to control or account for deficiencies? Does the study team have access to the data needed to complete the research, including the ability to re-consent research subjects, if needed? If data will be extracted from medical records, does the application sufficiently address data quality, such as uniform collection and validation of extracted data?

    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.

    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

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    Not Applicable

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    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.

    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.

    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.

    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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

    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 CenterTelephone: 800-518-4726
    Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-435-0714

    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)

    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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