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: Data Coordinating Center (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DE-15-007

Companion Funding Opportunity

RFA-DE-15-006, UH2/UH3 Phase Innovation Awards Cooperative Agreement

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 solicits applications for the Data Coordinating Center (DCC) and runs in parallel with a companion FOA that solicits applications for the individual projects to be funded under a UH2/UH3 cooperative agreement mechanism (RFA-DE-15-006).

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. This FOA solicits applications for a single Data Coordinating Center (DCC) to support multiple UH2/UH3 projects and Collaborative Working Groups (CWGs) formed by NIDCR around MCRC for OHDC themes and processes; the companion FOA solicits individual UH2/UH3 projects (RFA-DE-15-006).

The MCRC for OHDC 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 the UH2/UH3 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. The UH2/UH3 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.

Background

Numerous studies have documented the disproportionate burden of oral disease that some U.S. children suffer. 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. The MCRC for OHDC initiative 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. 

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.

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; YMCA/YWCA;

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.

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. This FOA solicits applications for a single Data Coordinating Center (DCC) to support studies under the UH2/UH3 initiative, for which applications are solicited in the companion FOA (RFA-DE-15-006).

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 DCC award are strongly encouraged to read the FOA for the individual UH2/UH3 applications (RFA-DE-15-006).

Research Objectives for the DCC

Central data coordination can increase the efficiency of research by providing infrastructure, centralized resources, and support for investigators conducting studies of similar diseases. The objective of the central DCC is to increase the efficiency of UH2/UH3 oral health disparities projects through shared infrastructure, development of common outcome measures when possible through working groups, and encouragement of information exchange between investigators to improve the quality of all UH2/UH3 projects.

To accomplish the overall goal of the program, the multidisciplinary research projects will operate as a consortium that will be composed of the individual UH2/UH3 PDs/PIs, the DCC and NIDCR Project Scientists (PS). The UH2/UH3 projects supported by the DCC will conduct multilevel interventional or observational research studies that will use a variety of approaches appropriate to the questions being asked.  Study data may come from a variety of sources such as surveys, observations (direct, photographic, audio or video recorded), focus groups, microbial and genetic assessments. 

The DCC will have primary responsibility for developing common resources; facilitating the conduct of studies; designing and implementing a strategy for data collection that is appropriate for each individual project; training study staff to collect outcome measures; conducting calibration of examiners for determining caries or periodontal status; training investigator staff on use of data collection systems; managing study data; and disseminating analysis-ready data sets to individual investigators for final analysis by statisticians of the individual UH2/UH3 projects. The DCC will also enable the performance and productivity of the Consortium by helping to identify synergies and points of leverage.

The DCC's roles include but are not limited to:

Serving as the MCRC for OHDC data management center by:

  • Providing expertise in caries, periodontal and behavioral analysis as well as health disparities research;
  • Providing biostatistical support for study design and protocol development, including sample size calculations or simulations;
  • Establishing and maintaining a computer system and software needed for the storage and analysis of study data, including audiovisual and multiple types of data relevant to the individual UH2/UH3 projects;
  • Devising and maintaining a secure infrastructure for storing and disseminating data that might include identifiable information about human subjects. This includes serving as the central locus for accepting requests for the use of such materials and for providing a secure means for approved users to access those materials;
  • Preparing and distributing periodic technical and statistical reports of study activities and progress.
  • Providing final datasets ready for analysis by individual UH3 study teams.

Serving as the MCRC for OHDC organizational and logistical center by:

  • Providing administrative support for Consortium activities, including CWGs;
  • Coordinating, planning, making arrangements for, and participating in meetings of the study committees;
  • With the individual UH2/UH3 investigators and NIDCR, providing logistical and financial support for the annual face-to-face meeting of the Consortium and the annual External Scientific Advisory Committee;  
  • Coordinating, planning, and hosting, either on site or through contractual arrangements, annual calibration sessions such as those needed for assessment of caries and periodontal disease, including providing statistical support to certify acceptable calibration.

DCC staff must possess strong scientific qualifications related to bioinformatics and biostatistics. The DCC must have oral health, behavioral and community-based intervention expertise; experience in the supervision of complex, multisite clinical studies; and experience in the statistical analysis of oral health data. The DCC will be expected to work closely with the UH2/UH3 PDs/PIs, to participate intellectually in all aspects of the Consortium, including developing Consortium procedures and committees, assisting with writing protocols and sample informed consent documents, and helping with recruitment and retention strategies.

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 fund one award, corresponding to a total of $2,200,000, for fiscal year 2015. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $2,200,000 total costs per year and must reflect the actual needs of the proposed project.

Award Project Period

The project period should be 5 years.

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)
  • U.S. Territory or Possession

Other

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

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
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. 

The DCC is expected to assemble a team of experts in data management and interpretation, biostatistics, clinical epidemiology, biomedical informatics or other relevant area with experience in multisite clinical research. The investigators may be from either the same institution or different institutions. Applicants should describe experience in coordinating multisite studies, study design and statistical analysis of oral health data.

Although the activities of the DCC are largely in the areas of data management, analysis, and logistics, the DCC must be able to communicate effectively with the individual UH2/UH3 PDs/PIs if the Consortium is to achieve its goals. This requires that the DCC have personnel with sufficient knowledge to serve the multiple types of individual projects that will be supported. Applicants for the DCC are expected to demonstrate that their teams include expertise in oral health and social, behavioral and community-based research sufficient to support the UH2/UH3 project teams. The areas of expertise included should cover the priority areas described in the accompanying FOA for the individual UH2/UH3 projects (RFA-DE-15-006).

R&R or Modular Budget

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

Costs should include, but are not limited to, costs for the following:

  • Day-to-day operations;
  • Training and certification of staff in needed operations and procedures (e.g., data entry and transmission systems, etc.);
  • Planning and conducting regular meetings and conference calls for the SC and External Scientific Advisory Committee (ESAC), including costs for meeting space; preparing minutes of meetings and distributing to members. The budget should include funds supporting the travel costs of the ESAC and select DCC personnel to the ESAC meeting. Travel for the individual UH2/UH3 personnel should not be included, as these funds are included in their project’s budget.
  • Compensating consultants to act as members of the ESAC;
  • Hosting webinars and teleconferences, and producing binders, etc;
  • Developing and maintaining a secure website for the distribution of study documents and reports;
  • Designing questionnaires, data collection forms, and database structures and implementing systems for data collection, including participant accrual, follow-up rates, adherence to protocol, and data quality that are available to all UH2/UH3 investigators on a 24-hour, 7-days-a-week basis with appropriate feedback, monitoring, backup, and security;
  • Supporting the UH2/UH3 PDs/PIs during the development of an individual protocol and Manual of Procedures (MOP) for each final UH3 study;
  • Implementing a method for timely monitoring and reporting of adverse events, unanticipated study events and protocol deviations to ensure participant safety, including notification and reports to the NIDCR, their clinical operations contractor, and the Data and Safety Monitoring Board;
  • Preparing and distributing periodic technical and statistical reports of study activities and progress;
  • Providing final datasets ready for analysis by individual UH3 study teams.

Members of the External Scientific Advisory Committee will be appointed by the National Institute of Dental and Craniofacial Research and should not be named in the application.

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: In lieu of a Research Strategy with its usual sections, the applicant should describe the plans for carrying out duties described below and any additional functions needed to support the complex array of studies described in the FOA and its companion RFA-DE-15-006. Duties include, but are not limited to:

  • Training and certification of staff in needed operations and procedures;
  • Planning and conducting regular meetings and conference calls for the SC, CWGs and ESAC;
  • Hosting webinars and teleconferences, and producing binders, etc.;
  • Developing and maintaining a secure website for the distribution of study documents and reports;
  • Designing questionnaires, data collection forms, and database structures and implementing systems for data collection, including participant accrual, follow-up rates, adherence to protocol, and data quality that are available to all UH2/UH3 investigators on a 24-hour, 7-days-a-week basis with appropriate feedback, monitoring, backup, and security;
  • Supporting the UH2/UH3 PDs/PIs during the development of an individual protocol and Manual of Procedures (MOP) for each final UH3 study;
  • Implementing a method for timely monitoring and reporting of adverse events, unanticipated study events and protocol deviations to ensure participant safety, including notification and reports to the NIDCR, their clinical operations contractor, and the Data and Safety Monitoring Board.

The description of plans should include a timeline as well as the milestones to be achieved for each proposed year of funding. The milestones must be concrete and provide specific targets.

Technical and Statistical Report Preparation

The DCC must have experience preparing all the necessary documents that the individual investigator teams will need to successfully implement and conduct a study. Applicants should provide a description of the types of technical and statistical reports that will be provided, the periodicity of those reports, and how the reports will enhance the conduct of the studies.

Collaboration and Interaction Plan

The MCRC for OHDC structure mandates robust and productive collaborations between the individual UH2/UH3 projects to achieve the Consortium's goals. Applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner with the UH2/UH3 investigators and the NIDCR in all aspects of the program. Applicants should describe prior or ongoing experience functioning as part of a research Consortium or other collaborative activities to meet individual study and collaborative goals. They should also describe how the proposed organization of the DCC will enhance the Consortium structure and facilitate collaboration when possible.  

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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and a plan to distribute research resources (Manual of Procedures, study manuals, case report forms, ascertainment instruments) developed by the Consortium.

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.

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? 

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?  Does the applicant team include individuals with sufficient knowledge and expertise in oral health, community-based, social and behavioral research to serve the multiple types of individual projects that will be supported by the DCC?

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? 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?

Are plans described for enhancing the performance and productivity of the UH2/UH3 investigator teams, including providing support for development of protocols and Manuals of Procedures and maintaining a secure website for distribution of study documents and reports?

Are plans described for training and certification of staff in needed operations and procedures?

Are appropriate processes described for designing questionnaires, data collection forms, and database structures and for implementing systems for data collection that are available to UH2/UH3 investigators on a 24-hour, 7-days-a-week basis?

Are the processes described for data quality control, feedback to study teams, data backup and security both implementable and appropriate?

Are the proposed plans for preparing and distributing periodic technical and statistical reports for the management of the individual UH3 projects well-described and will they enhance the quality of the UH3 studies?

Are approaches described for planning and conducting regular meetings, webinars and conference calls to support collaborations between projects involved in the research Consortium?

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? Are methods for timely monitoring and reporting of adverse events, unanticipated study events and protocol deviations to ensure participant safety described? 

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.

Milestones

Are the milestones and timelines reasonable and appropriate?

Collaboration Plans

Is there an implementable plan for collaboration and interaction with the individual UH2/UH3 investigators?

Is there evidence provided that the applicant has the ability to function productively within a larger Consortium?

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 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 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 the 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: NIDCRHealthDisparitiesDCC@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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