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

Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach (UH2/UH3)

Activity Code

UH2/UH3 Phase Innovation Awards Cooperative Agreement

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DE-15-006

Companion Funding Opportunity

RFA-DE-15-007, U01 Research Project - Cooperative Agreements

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

93.121

Funding Opportunity Purpose

The overall goal of this initiative is to establish effective interventions or programs to reduce or eliminate oral health disparities and inequalities in vulnerable U.S. children who are between 0 and 21 years of age. Multidisciplinary teams of investigators will refine and test an intervention or evaluate outcomes of an existing program or policy intended to reduce health disparities and inequalities. Community engagement and other partnerships are essential for the holistic, multilevel approaches required by this FOA. This research is intended to lead to identification, validation, dissemination and implementation of effective approaches to prevent disease or facilitate treatments, helping to reduce and ultimately eliminate oral health disparities and inequalities in children.

This FOA will use the UH2/UH3 cooperative agreement award mechanism and runs in parallel with a companion FOA that solicits applications for the Data Coordinating Center (RFA-DE-15-007). Funding for an exploratory UH2 stage  will be used for planning, feasibility testing, and developing study documents, including the study protocol and Manual of Procedures. UH2 projects that have met milestones will be administratively considered for transition to the UH3 implementation phase. Applicants responding to this FOA must address objectives for both the UH2 and UH3 phases. 

Key Dates
Posted Date

June 27, 2014

Open Date (Earliest Submission Date)

November 9, 2014

Letter of Intent Due Date(s)

November 9, 2014

Application Due Date(s)

December 9, 2014, by 5:00 PM local time of applicant organization.

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 27, 2015 by 5:00 PM local time of applicant organization.

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

June 2015

Advisory Council Review

August 2015

Earliest Start Date

September 2015

Expiration Date

February 28, 2015

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.


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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

This Funding Opportunity Announcement (FOA) is one of two FOAs with the purpose of implementing the program “Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach” (hereafter referred to as "MCRC for OHDC"). The program will support multiple investigator groups, each with an individual UH2/UH3 project designed to test, validate, disseminate or implement a population health promotion, disease prevention or treatment intervention, or to evaluate outcomes of an existing program or policy, with the overall goal of reducing oral health disparities and inequalities in vulnerable U.S. children 0-21 years of age. The UH2/UH3 funding mechanism supports individual projects in two phases, for a total funding period of up to five years. The UH2 planning phase (Phase I) will provide up to two years of support for exploratory and formative work, such as the collection of preliminary feasibility data, pilot testing, and development of the final protocol, Manual of Procedures and other study documents necessary for the UH3 implementation phase (Phase II). Funding of the UH3 phase is contingent on administrative review of work completed in the UH2 phase. A companion FOA (RFA-DE-15-007) solicits applications for a single Data Coordinating Center (DCC) that supports and coordinates activities during both the UH2 and UH3 phases. NIDCR will form Collaborative Working Groups (CWGs) around MCRC for OHDC themes and processes, composed of funded investigators, key study and DCC personnel, and NIDCR Project Scientists. The CWGs will be administratively supported by the DCC. 

This initiative calls for studies that take a holistic, population health approach to promoting health and preventing and managing disease in populations of children demonstrating health disparities and inequalities. Studies responsive to this FOA will address a range of determinants of health and risk factors at varied levels of influence, such as those found in a social ecological model (individual biological and behavioral, interpersonal/social, community, organizational/institutional, health services, or public policy), or in other models such as an expanded chronic care model that integrates health promotion and population health models with health care system improvement.

Numerous study designs may be appropriate for this type of complex research. This FOA will support intervention studies as well as studies designed to rigorously evaluate the outcomes of existing programs or policies to assess their capacity to influence oral health disparities and inequalities in U.S. children. These projects must evaluate multiple factors that the program is designed to influence, such as caregiver oral and general health literacy, social determinants that impact health behaviors, organizational processes that effect receipt of preventive care or receipt of comprehensive care.

This FOA cannot be used for the efficacy testing of drugs or devices (Phase I, II or III clinical trials). Applications proposing such trials will be deemed non-responsive and will not proceed to review. Applicants interested in conducting such efficacy trials are directed to the NIDCR Clinical Trials Program website http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm.

Background

Numerous studies have documented the disproportionate burden of oral disease that some U.S. children suffer. Children at risk for health disparities and inequalities include those from families that are low income rural or urban dwellers; Blacks; American Indians; Alaska Natives; Asians; Native Hawaiians and other Pacific Islanders; Hispanics/Latinos and their subpopulations, children living in medically/dentally underserved areas; and children with developmental or acquired disabilities. It is widely acknowledged that the determinants of health disparities and inequalities are complex and do not exist in isolation. Evolving theoretical frameworks and conceptual models such as the social ecological model and the expanded chronic care model highlight the importance of multilevel, holistic approaches to solve the problems of health disparities and inequalities. Such models acknowledge the importance of intersecting components, such as the individual’s biology (genomic, epigenetic, microbiological factors) and behavior, interpersonal dynamics and communication (provider-patient or peer-to-peer), community and cultural factors, features of health delivery and other systems, financing and public policy. While the importance of these factors is recognized, most interventions and programs tested to date have focused solely on a single level, such as individual biology or behavior. Models such as the expanded chronic care model can guide the development of interventions that include factors at levels including health systems organization, self-management support, decision support, delivery system design, clinical information systems, community resources and policy. This is particularly warranted as oral health care becomes increasingly integrated into primary health care and other paradigms of care delivery are explored. This FOA seeks to catalyze translation of theoretical frameworks and conceptual models into action, with studies that intervene across multiple levels of influence. Outcomes of these studies are expected to inform refinement of these frameworks and models.   

Healthy People 2020 draws attention to the high levels of untreated decay that affect some U.S. children across the age spectrum. Reports indicate that some children, with or without dental insurance benefits, receive screening examinations and limited preventive care but do not receive the comprehensive preventive care, therapeutic care or disease management needed. Children need easily accessible and affordable preventive and therapeutic care, disease management, systems that take an upstream approach to eliminating barriers of transportation, hours and days of operation, and appointment scheduling, and health promoting policies that enhance prevention at community, organization/institution and health care delivery levels. Strategies need to be tested, and the best methods to rapidly disseminate and implement efficacious approaches to all stakeholders need to be defined. 

Many factors that promote oral health also promote overall health. These include a diet low in refined carbohydrates with healthy snacks; ready access to healthful beverages (such as fluoridated tap or bottled water); accurate health information disseminated in a culturally appropriate, age appropriate and effective manner; attention to social networks and technology driven opportunities to enhance communications; and readily available health promoting products (such as fluoridated toothpaste, adapted toothbrushes for children with certain disabilities). Best methods need to be established to promote health literacy for young children’s caregivers and for adolescents and young adults as they transition to greater independence. There is a need for research that employs a community strength-based approach to social and behavioral change, focusing on “what works.”  This FOA will support a “common risk (and protective) factors approach” and allows investigators to include non-oral health secondary outcomes that may result from interventions.

Examples of multidisciplinary studies needed are those that promote:

  • Innovation in health care delivery systems, including prevention, disease management and receipt of comprehensive care;
  • Opportunities for the integration of oral health into primary health care, patient-centered care and other public and private systems;
  • Use of technology for telehealth, telemedicine/teledentistry and m-Health;
  • Optimization of financial and public policies;
  • Organizational and community changes based on context and processes;
  • Consideration of individual behavioral and biological factors for the tailoring of programs to population subgroups.

Clearly, research that informs individual and community action, public policy, clinical and public health practice cannot be undertaken by oral health researchers alone. This research must be multidisciplinary and community engaged. Research teams may include individuals with expertise in diverse areas, including dentistry and dental hygiene, medicine, nutrition, social and behavioral sciences, microbiology, genetics, epidemiology, health policy, health economics, and biostatistics. It is also essential to forge partnerships within and outside of the health sector, with programs such as NIH-funded Clinical and Translational Science Awards (CTSAs); other federally-funded programs such as the Centers for Disease Control and Prevention’s Prevention Research Centers, Health Resources and Services Administration’s Community Health Centers, U.S. Department of Agriculture’s Women, Infants and Children’s Supplemental Feeding Program (WIC), Centers for Medicare and Medicaid Services; State Children’s Health Insurance Programs and the Cooperative State Research, Education, and Extension Service; state and local health departments; dental school outreach programs; city or tribal councils; Head Start and school-based programs; YWCA/YMCA; 4-H; programs supported by foundations and programs to support children with special needs. Other potential partners are retail establishments, pharmacies, athletic programs, grocers/caterers, transportation departments and urban planners. Collaborations with global partners who can provide some support are permitted.

Research Objectives

The purpose of this initiative is to support research to improve oral health in vulnerable U.S. children, with the primary goal of preventing, reducing and ultimately eliminating health disparities and inequalities in this subgroup of the U.S. population. The individual UH2/UH3 projects should be designed to address persistent problems related to the receipt of care in underserved children or to identify sustainable strategies to improve oral health status in vulnerable children. The research must be designed to have a meaningful influence on clinical or public health practice, health policy, community and/or individual action, or organizational/systems change.

To be responsive to this FOA, factors from at least three levels of influence must be addressed by the proposed study. Studies supported by this FOA must be based on a clearly articulated multilevel theoretical/conceptual framework, such as a social ecological model or expanded chronic care model, and investigators must identify and justify which factors within the framework will be addressed. Investigators may draw from existing theoretical/conceptual framework/causal models or develop their own models, providing justification for the choice. It is expected that multidisciplinary teams along with community and other partnerships within and outside of the health sector will be needed to successfully design and conduct these studies. Investigators must consider issues of external validity, sustainability and community acceptance. 

Areas of research interest include, but are not limited to, those listed below. Examples of studies that might be proposed include multilevel interventions or assessment of programs intended to:

  • Improve strategies for the prevention of dental caries;
  • Increase provision of efficacious preventive care, such as dental sealants, and disease management;
  • Decrease caries promoting diet and beverage consumption in children including as they transition to adolescence and young adulthood;
  • Reduce incidence of untreated decay, especially in children who are eligible for comprehensive care under such programs as Medicaid;
  • Address the lack of comprehensive dental examinations and subsequent care before age 3 years;
  • Improve oral care and oral health status for children with developmental and acquired disabilities;
  • Improve identification and management of early onset periodontitis; and
  • Prevent oral mucosal pathologies through oral healthcare provider efforts to increase uptake of HPV immunization and decrease inappropriate use of smokeless tobacco and other tobacco products.

Oral health of very young children has been the focus of much research since the NIDCR Health Disparities Program was initiated in the late 1990s. While research directed at preventing Early Childhood Caries (ECC) would be supported by this FOA, projects in this area should enhance rather than simply recapitulate recent NIDCR studies or those currently in the field.

This FOA will not support efficacy testing of new drugs or devices (Phase I, II or III clinical trials).

Overall Program Structure and Scope

Prior experience indicates that oral health disparities and inequalities research is enhanced by creating a collaborative structure. Standard terminology and methodology, training and calibration, recruitment and retention strategies are some of the areas where collaboration may be synergistic. There will be a single Data Coordinating Center (DCC) for this initiative, for which applications are solicited in the companion FOA (RFA-DE-15-007).

The DCC will be expected to support and coordinate activities during both the UH2 and UH3 phases. Each UH2/UH3 award will support an individual project conducted by a team with an independent cooperative agreement award. A Steering Committee will be formed, to include all the Program Directors/Principal Investigators (PDs/PIs) of the UH2/UH3 awards, the DCC and the NIDCR. During the UH2 phase, the individual project awardees and key personnel, the DCC and the NIDCR will form CWGs to finalize study designs, decide on use of common approaches and outcome measures as appropriate, and finalize plans for implementation of the UH3 projects. In addition to the Steering Committee and CWGs, an external advisory board may be convened by NIDCR.

Applicants for the MCRC for OHDC program are strongly encouraged to read the FOA for the DCC (RFA-DE-15-007).

UH2 Phase

Activities supported during the UH2 phase could include 1) determining the level of the disease of interest, 2) quantifying potentially modifiable factors associated with oral health disparities and inequalities, 3) determining the prevalence of these modifiable factors in populations under study, and 4) developing and piloting components of the interventions or program evaluations with the necessary individuals, families, populations, communities, organizations/institutions and systems. 

Pilot-testing should be guided by the research question(s) proposed, but typically will include testing for feasibility of conducting the subsequent study, assessing acceptability of the intervention or data collection procedures to the proposed study population(s) and other stakeholders, or pilot-testing of the proposed mechanism of action of a behavioral intervention. Testing for feasibility and acceptability should be undertaken through community engagement and with partners from within and outside of the health sector.

A wide range of approaches may be used to gather information sufficient to plan multilevel intervention research or evaluation of the outcomes of existing programs or policies. Data may be collected through mixed methods that gather qualitative as well as quantitative data; social network analysis; systems modeling; health impact assessments; organizational contextual and process assessments; key informant interviews and focus groups; surveys and questionnaires; chart audits; case studies and secondary data analysis.

All projects will be milestone-driven, and all UH2 grants will need to meet milestones to have an opportunity to move to the implementation phase (UH3). The UH3 funding period will provide support for the research implementation phase (year 2 or 3 through year 5). The UH3 awards will be made after administrative review of UH2s. The UH3 awards will depend on the availability of sufficient funds and feasibility of the project. This FOA requires that the UH2/UH3 be submitted as a single application, and applicants should note specific instructions for each phase.

Criteria to determine which UH2 projects will be continued into the UH3 phase will include the following:

  • Successful achievement of milestones defined for the UH2 phase;
  • Demonstration that the level of disease exists in the proposed population;
  • Demonstration that a test of a proposed intervention or data collection for program evaluation is feasible;
  • Demonstration that a proposed intervention and/or planned data collection procedures are acceptable to the population(s) to be studied;
  • Demonstration that an intervention engages the mechanism of action target(s) it intends to, and that target engagement can be measured;
  • Potential for meeting the goals of the initiative after collection of formative, pilot and/or feasibility data;
  • Potential for successful conduct of a clinical study in the proposed setting, including statistical power to achieve study outcomes;
  • Successful preparation of the final study protocol, Manual of Procedures and plans for human subject recruitment;
  • Receipt of IRB approval;
  • Availability of funds;
  • NIDCR program priorities;
  • NIDCR Director's approval.

UH3 Phase

The final studies will be deployed during the UH3 phase, which may last up to a maximum of three or four years, depending on the length of the UH2 phase.

Applicants should propose the strongest research design that is appropriate, acceptable and feasible to answer the research questions and to evaluate the varied element  of a multi-level intervention or an existing program or policy. Randomized trial designs may be used where appropriate to establish efficacy or effectiveness of an approach. Applicants may also propose other types of clinical studies such as cohort or longitudinal studies. Some studies may propose multiple intervention arms that focus on individual factors selected from varied levels defined in the theoretical framework or conceptual model guiding the research. Other studies may evaluate factors from several levels addressed by a single intervention. In addition to assessing whether interventions produce an effect, applicants are highly encouraged to address how and for whom they produce their effects. Cost analyses of interventions are also a requirement of this FOA.

This FOA also will support applications that propose rigorous evaluation of “natural experiments” such as recently implemented programs or policies, or changes in oral health care provision or financing that may impact upon inequalities or health disparities. Applications proposing to study natural experiments are expected to clearly describe plans to determine how and for whom a program or policy produces its effect(s).

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDCR intends to commit $5,000,000 in FY 2015 to fund approximately 8 UH2/UH3 awards.

Award Budget

Application budgets are limited to $625,000 total costs per year for up to two years of the UH2 phase and $1,200,000 total costs per year for each year of the UH3 phase. Budgets need to reflect the actual needs of the proposed project.

Award Project Period

Up to 5 years total, including minimum of 1 and maximum of 2 years for the UH2 phase and maximum of 4 years for the UH3 phase

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 allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download 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, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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

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

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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 Budget

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

The total cost for each application cannot exceed $625,000 annually for the UH2 phase (years 1-2) and $1,200,000 dollars annually for the UH3 phase (up to 3 or 4 years). It is not a requirement to request both years of UH2 support, but at least one year of UH2 phase planning is required. Total costs must include the costs for all research conducted, including work performed at an organization other than the PD/PI institution. Budgets should include costs for statistical analysis of the final UH3 project and travel costs as detailed below.

Years 1 to 5 

  • Two persons attending one SC meeting to be held in locations convenient/central to the participants.
  • Two persons attending an annual External Scientific Advisory Committee. This committee will be appointed by NIDCR.
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:

Specific Aims: Provide the overall goals for the entire application and indicate separately Specific Aims to be accomplished in the UH2 phase and in the UH3 phase. Clearly label them as UH2 specific aims and UH3 specific aims.

Research Strategy:

1) Background and Significance:

  • Applicants should clearly describe the significance and relevance of the proposed intervention or program or policy evaluation research as it relates to the objectives of the MCRC for OHDC program.  The research should be designed to identify sustainable strategies to improve oral health status of vulnerable children.    
  • Applicants should define the specific oral health disparity or inequality that will be addressed, and discuss how their proposed study methods or approach, population to be studied or intervention, program or policy to be evaluated may lead to a reduction in health disparities or inequalities.
  • The multilevel conceptual framework that guides the study’s development should be described.
  • Outline the intervention that will be tested or the program or policy that will be evaluated and describe its potential to improve the oral health of vulnerable U.S. children who are between 0 and 21 years of age. If applicable, describe a specific hypothesis about how and for whom the intervention is expected to produce its effect(s), including identification of mechanism of action targets, and how these targets mediate the intervention’s effect(s).
  • A compelling argument of how the proposed study will inform individual, community, organizational/institutional action, shift clinical or public health practice paradigms or inform health policy should be presented.

2) Preliminary data

Describe the intervention to be developed or the program or policy to be evaluated and summarize any existing preliminary information documenting its potential to achieve the UH3 objectives. If the approach is being adapted from another field (such as a behavioral approach), describe how it will be adapted and tested.

3) Investigator team

Describe how the multidisciplinary investigator team will be organized and managed, including instituting a study team and/or community communication plan. Address the capabilities that will permit design and implementation of a complex study, and the coordination of efforts among team members. Discuss the extent of the team's collaboration and partnerships with the communities proposed for study. 

4) Approach 

  • The Approach section should have a clear demarcation of the UH2 and UH3 portions of the application. It is not necessary to repeat background information or details of methods in the UH3 portion that were provided in the UH2 portion.
  • The UH2 phase allows for final intervention development, planning, and feasibility testing for up to two years. Planning period work may include the development of strategies and partnerships in addition to those of the community, and will culminate in the development of a protocol, Manual of Procedures and other relevant study documents. Activities may include conducting small pilot studies testing such features as recruitment strategies, selection of research sites, selection of study champions in relevant locations, and leveraging resources available through partnerships.
  • Mechanisms of action pilot-testing should include a clear description  of the mechanism of action targets of the intervention and how those targets explain the intervention’s effect(s), demonstration that the intervention engages the proposed mechanism of action targets, and validation of measures of “target engagement” [i.e., that the intervention can change the intended target(s)].The UH2 section must include a description of the milestones that will be reached at the end of the UH2 phase. 
  • The UH3 phase will be devoted to the conduct of the intervention, analysis/evaluation and dissemination of findings or to the rigorous evaluation of an existing program or policy with appropriate dissemination of findings. The intervention or evaluation of an existing program must address no fewer than three levels of influence. The planned intervention or program evaluation must be described in sufficient detail to permit reviewers to assess significance and innovation of the proposed work and the strength of the experimental design. Include plans for cost analysis of interventions. Include an initial statistical plan for analyzing the proposed UH3 study project, a discussion of potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.
  • For UH3 phase studies involving human subjects, applicants should provide a description of the requisite study population with preliminary estimates of its availability, and describe plans to develop recruitment, outreach, follow-up and retention strategies. In addition, plans for addressing any ethical and safety issues and challenges anticipated regarding adherence to the proposed protocol should be included.
  • Include plans for all aspects of ethical and regulatory oversight, for both UH2 and UH3 phases.

Applicants must agree to work with and provide information to a central Data Coordinating Center (DCC) during the UH2 and UH3 phases. (See companion RFA-DE-15-007)

Protection of Human Subjects: Applicants must comply with the NIDCR Policy for Data and Safety Monitoring of Clinical Research. For guidance regarding the preparation of the protocol for the human subjects section of the application, we suggest following the NIDCR protocol template found in the Toolkit for Clinical Researchers. If investigators plan to perform feasibility studies during the UH2 phase that involve human subjects followed by a UH3 phase study that also involves human subjects, the protection of human subjects must be fully addressed for both the UH2 and UH3 phases. 

Letters of Support: Letters of support from community partners, agencies or other groups the investigators propose to work with must be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide,

Applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner with the DCC, the SC, other UH2/UH3 investigators, and with the NIDCR in all aspects of the MCRC for OHDC program. The DCC will be responsible for coordinating the dissemination of research findings and relevant protocol materials.

It is expected that MCRC for OHDC research resources, such as the Manual of Procedures, study manuals, case report forms, and ascertainment instruments will be made available to the public immediately after approval by the MCRC for OHDC SC and implementation into the study. The DCC applications are expected to include a plan for sharing these resources.

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

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review and responsiveness by the National Institute of Dental and Craniofacial Research, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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? 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 the proposed study addressing a major dental public health issue? Does the proposed study have the potential to improve the oral health of vulnerable U.S. children? Does the study have the potential to inform individual, community, organizational/institutional action, shift clinical or public health practice paradigms or inform health policy?

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? Do the PD(s)/PI(s) and key personnel have the necessary expertise in design and implementation of a complex study? Do the PD(s)/PI(s) have a track record of successful investigative collaborations or partnerships with (within) communities proposed in the application? Do the PD(s)/PI(s) describe the organization and management of the multidisciplinary teams and plans for study team and community communication?

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? Is the research innovative in its methods or approach, in the population being studied or in the intervention, program or policy being evaluated in ways that may lead to a reduction in health disparities or inequalities?

Approach

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

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 application describe the multilevel conceptual framework for the study? Does the intervention or program evaluation research address factors at no fewer than three levels of influence? 

If the approach is being adapted from another field, do the PD(s)/PI(s) describe how the approach will be adapted and tested?

Is the study intervention potentially sustainable? Will proposed planning activities (including plans for identifying an adequate study population) and proposed milestones be sufficient to inform an intervention or program evaluation?

If appropriate, does the application state clearly the intended mechanism of action targets of the intervention, and how those targets are hypothesized to mediate the intervention’s effect(s)? Does the application propose adequate testing of whether the intervention engaged the proposed mechanism of action targets?

Are cost analyses for an intervention included?

Does the application include an initial statistical plan for analyzing the proposed UH3 study project?

Does the application include a description of the requisite study population for a UH3 study, with preliminary estimates of its availability?  Does it describe plans to develop recruitment, outreach, follow-up and retention strategies, and plans for addressing any ethical and safety issues and challenges anticipated regarding adherence to the proposed protocol?

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? Are adequate facilities in place to conduct intervention studies or program evaluations? Is the study population required for the proposed study available?

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.

Milestones

Are the steps and milestones clearly defined? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments? Are adequate criteria provided for the UH2 phase that will be utilized in determining milestone completion before proceeding to the next phase of the project?  

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.

Reviewers will assess protections for human subjects for both UH2 and UH3 phases, if applicable.

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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 the National Institute of Dental and Craniofacial Research, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National 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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for:

  • All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators are the PD(s)/PI(s) responsibilities. The awardee agrees to accept close coordination, cooperation, and participation of NIDCR staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.
  • The PD(s)/PI(s) will meet NIDCR policy requiring that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An NIDCR policy notice was published in the NIH Guide on March 27, 2008, and is available at: http://grants1.nih.gov/grants/guide/notice-files/NOT-DE-08-001.html. The full policy, including terms and conditions of award, is available at the following NIDCR Website: http://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/NIDCRClinicalTermsofAward.htm.
  • Upon implementation of the protocol, each study, whether a single entity or a consortium of entities, will follow the procedures required by the protocol regarding study conduct and monitoring, participant management, data collection, and quality control.
  • The PD(s)/PI(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
  • The PD(s)/PI(s) will manage involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIDCR.
  • The PD(s)/PI(s) will make all study materials and procedure manuals available in the public domain. Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDCR/NIH.
  • The PD(s)/PI(s) will obtain prior written approval of the NIDCR Grants Management Specialist, in consultation with the NIDCR Program Officer, for changes in any of the key personnel identified in the Notice of Grant Award.
  • NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
  • An NIDCR Project Scientist will be assigned. The NIDCR Project Scientist will:
  • Have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIDCR staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government right of access consistent with HHS, PHS and NIH policies;
  • Work with the study PIs and the DCC to form the Collaborative Working Groups.
  • Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, advising in the management and technical performance, or participating in the preparation of publications;
  • Review the progress of the study, and of each participating component, through consideration of the annual reports, site visits, logs, etc. This review may include, but not be limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting;
  • Work with the DCC and UH2/UH3 investigators to facilitate the conduct of studies.

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

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

An NIDCR Medical Officer will monitor the studies and serve as the Medical Monitor.

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

Areas of Joint Responsibility include:

As appropriate to the funded study, the following collaborative responsibilities will be incorporated in the grant award:

  • A Steering Committee (SC), composed of the PDs/PIs of the studies funded under this initiative that form the Consortium and the Data Coordinating Center. The NIDCR Project Scientist or Program Official may be non-voting participants on the SC and, as appropriate, its subcommittees or working groups. Awardees are required to work with a common DCC and may be required to accept common procedures, methodologies, taxonomy, content, examiner training and calibration, and clinical research management systems and other methods necessary to develop and deploy studies. It is anticipated that working groups will be formed and the PIs or the designees and DCC will be expected to serve on the working groups. The SC will meet monthly by conference call, supplemented as deemed necessary by additional meetings. Each UH2/UH3 project contact PI or designee will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

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)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Center for Clinical Research
Division of Extramural Research
National Institute of Dental and Craniofacial Research (NIDCR)
All inquiries should be sent to: NIDCRHealthDisparitiesMCRC@mail.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: shiraziy@nidcr.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 Parts 74 and 92.

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