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)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Addressing Social Determinants of Health to Eliminate Oral Health Disparities (UG3/UH3 Clinical Trials Optional)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-DE-22-002
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.121, 93.313
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support research on how to effectively identify and optimally address upstream social determinants of health that can often present as a barrier to optimal oral health, impede the effectiveness of interventions, and contribute to oral health disparities in vulnerable and underserved groups. To achieve this goal, this FOA will encourage multi-disciplinary collaborations, mechanistic research, multi-level research, and/or the use of systems science research approaches. Applications in response to this FOA must propose research that involves improving oral health outcomes through addressing or better understanding one or more upstream social determinants of health that operate beyond the individual-level of influence (as indicated in the National Institute on Minority Health and Health Disparities Research or Social-Ecological Model frameworks). Study designs appropriate for this FOA would be clinical trials, observational cohort studies, or studies conducting multi-level systems science analyses.

Awards made under this FOA will initially support a planning phase (UG3) for up to one year, with possible transition to an implementation phase of up to five years (UH3) for a total of up to six years of funding.

Key Dates

Posted Date
April 29, 2021
Open Date (Earliest Submission Date)
June 08, 2021
Letter of Intent Due Date(s)

06/08/2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 08, 2021 Not Applicable July 26, 2021 November 2021 January 2022 April 2022

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

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

Expiration Date
July 27, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background:

Despite remarkable improvements in the oral health status of the general population in the United States over time, health disparities continue to persist in certain groups, such as racial/ethnic minorities, individuals of lower socioeconomic status, rural and urban dwellers, sexual and gender minorities, and individuals at the intersection of these and other vulnerable and underserved populations who experience a higher prevalence of most oral diseases across the lifespan than their counterparts. Interventions that have attempted to improve oral health outcomes and reduce oral health disparities by focusing solely on modifying individual health behaviors, have proven to be largely unsuccessful.

The National Institute on Minority Health and Health Disparities (NIMHD) has developed a research framework to model factors or determinants that can occur at multiple levels beyond the individual, to influence health outcomes in populations. Similarly, the Social-Ecological Model displays levels of influences beyond the individual-level (e.g. relationship/interpersonal, community, societal) where determinants can operate. The factors or determinants occurring at levels beyond that of the individual, are often referred to as "upstream factors" or "social determinants of health." The term social determinants of health (SDOH) has been defined by the Centers for Disease Control and Prevention as, "the conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of-life risks and outcomes." HealthyPeople has organized SDOH into the following domains: 1) economic stability, 2) education access and quality, 3) healthcare access and quality, 4) neighborhood and built environment, and 5) social and community context. Examples of these determinants include: socioeconomic conditions (e.g. employment and poverty status), access to healthy foods, housing quality, transportation options, access to healthcare, neighborhood characteristics (e.g. public safety and neighborhood infrastructure), and societal norms and attitudes (e.g. discrimination, racism, and policies).

The important role that SDOH can play in influencing health outcomes, particularly in vulnerable and underserved populations, has received much attention in recent years. A report by the National Academies of Sciences, Engineering, and Medicine provided recommendations to not only better incorporate SDOH into clinical healthcare practice, but to also advance research on better understanding SDOH and how to optimally intervene on them at the population-level. As it relates to oral health research, the concept of multi-level research, which recognizes influences beyond the individual level is not new. However, there has been limited research on understanding the specific mechanisms and pathways through which SODH influence oral health outcomes, the complex interplay between different SDOH, and how comprehensive oral health interventions can incorporate addressing SDOH to improve oral health outcomes and reduce disparities.

Given the complexities around understanding the specific pathways through which SDOH influence health, emerging research methodologies, such as those utilizing data science or system science approaches, have the potential to help elucidate complex interrelationships between SDOH and oral health, and inform interventions. Although no simulation models can replace real world settings or scenarios, many are becoming beneficial for decision making, such as national or local planning, and can have a profound impact on health policies relevant to minority health and health disparities. Data science methodologies and the use of simulation modeling and systems science (SMSS) analyses may help to guide oral health disparities research in identifying causal processes and which SDOH will be most amenable to change, policy, and population-level interventions, and in suggesting where leverage may be best applied to improve oral health.

To advance knowledge on the understanding of SDOH impact on oral health and how to optimally intervene on SDOH as part of comprehensive oral health promotion, this FOA will encourage multi-disciplinary collaborations, mechanistic research, multi-level clinical research, and/or the use of data science or SMSS research approaches.

Scope:

Applications submitted to this FOA should have a central focus on addressing knowledge gaps related to SDOH and their role in influencing oral health outcomes. Because SDOH conditions and factors often operate in a negative manner in underserved communities, it is expected that research proposed in applications will have an overarching focus on reducing oral health disparities and inequities. Further, given that SDOH impact various sectors, collaborations between researchers from different scientific domains and research expertise are strongly encouraged. This may include, but would not be limited to, collaborations among those with research expertise in oral health, health disparities, public health, community-based participatory research, data or systems sciences, health economics, and non-health fields/sectors related to SDOH.

All proposed research must incorporate or evaluate one or more SDOH that typically operate beyond the individual-level as depicted in in the National Institute on Minority Health and Health Disparities Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html.Only research proposing to examine SDOH that operate beyond the individual level of influence, in the context of their impact on oral health outcomes or oral health status will be considered for this FOA.

Preference will be given to those projects proposing to examine SDOH which have not been previously explored in the context of oral health research. Examples of SDOH can be found in the HealthyPeople topic area on SDOH: https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. While SDOH are vast, it is expected that some of these determinants may be more amenable to oral health-related research questions than others. Therefore, applicants should carefully consider their research aims in determining which SDOH they propose to examine. Proposed research must also focus on SDOH in the context of their impact on oral health outcomes (e.g. dental caries, periodontal disease, or oral cavity and oropharyngeal cancer) or oral health behaviors.

Study designs appropriate for this FOA include clinical trials, observational cohort studies, or studies conducting SMSS analyses, depending on the specific research question. Any proposed clinical research should demonstrate community engagement and partnerships that are essential for successful implementation of the research. Any SMSS projects should have compelling justification as to the adequacy of the data source(s) being used to address the research question(s). Data sources used for analyses must have adequate data on SDOH and clinical data to appropriately ascertain oral health outcomes. Additionally, data quality of data sources must also be addressed, including: the presence of relevant variables, completeness, bias, validity, feasibility of obtaining data, data harmonization and interoperability, and methods that will be used to account for data quality weaknesses.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators seeking to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study design in which groups subjected to the intervention are compared to groups that are exposed to an appropriate comparison condition. The comparison condition should be justified based on the state-of-the-science for the intervention and the nature of the research question. Designs that might be proposed for studies that randomize groups or deliver interventions to groups include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster- randomized trials, multiple baseline designs, and other quasi-experimental designs. Whenever participants are assigned in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states), or participants receive some part of their intervention in a group or cluster, and observations on individual participants are analyzed for between-group effects, special methods are required for analysis and sample size. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Specific areas of research interest may include, but are not limited to:

  • Elucidating mechanisms and causal pathways between SDOH and oral health outcomes across multiple socioecological levels.
  • Conducting multi-level interventions that incorporate addressing SDOH as part of the overall intervention to improve oral health outcomes.
  • Conducting interventions that address SDOH related to structural racism in settings where oral health care is delivered across multiple domains (e.g. provider-patient interactions, service delivery, access to care, etc.) to improve oral health outcomes and reduce disparities.
  • Leveraging strategies or conducting interventions that integrate oral health into primary care, non-health sectors, or community-based settings to address SDOH and improve oral health outcomes.
  • Demonstrating the use of non-traditional healthcare practitioners (e.g. social workers or case managers) to promote oral health and address SDOH barriers.
  • Demonstrating the use of technology, including electronic health records, mobile health technologies, smart devices, or sensors to address SDOH barriers and improve oral health, without exacerbating health disparities.
  • Utilizing SMSS approaches to identify modifiable SDOH barriers across various sectors (e.g., food access, transportation, healthcare) and provide evidence-based simulation or prediction of the impact of effective interventions delivered in real-world settings to address these barriers to improve oral health outcomes.
  • Utilizing SMSS approaches involving big data or other appropriate data sources to elucidate etiology and complex interrelationships between different SDOH, and causal pathways by which they lead to oral health disparities and provide targets for population-based interventions.

Planning Phase (UG3)

The UG3 award will provide one year of support for planning activities, such as finalizing the protocol and preparing other documents or required data sources to implement the full study. Additional planning activities are allowable, such as evaluating the number of participants at a site who would fulfill eligibility criteria, data collection or intervention delivery for the purpose of user acceptance testing, establishing acceptability and feasibility of the study procedures, and/or study intervention delivery/fidelity monitoring. The UG3 phase cannot be used to test for intervention efficacy.

Examples of activities supported during the UG3 phase include, but are not limited to, developing the following:

  • A final clinical protocol, prepared using the standard NIDCR observational or interventional protocol template (see NIDCR Toolkit for Clinical Researchers), that is ready for submission to the central IRB;
  • Successful preparation of the manual of procedures, quality management plan, and data management plan, as applicable;
  • Finalization of all documents necessary to implement the full study (e.g., case report forms, etc.);
  • Consent form(s) and, if applicable, assent form(s);
  • A final statistical analysis plan;
  • A plan to administer study intervention, train interventionalists, and monitor intervention delivery, for clinical trials;
  • A recruitment/enrollment and retention plan for the clinical study; and
  • Obtainment, quality review, assurance of data harmonization and interoperability, and preparation of all data sources for proposed SMSS or data science-focused studies.

 

Implementation Phase (UH3)

The UH3 award will provide up to five years of support to conduct the full study in accordance with activities planned in the UG3 phase, and is contingent upon successful completion of the UG3 milestones. NIDCR expects studies supported during the UH3 phase to be hypothesis driven and have defined milestones. UH3 activities may include the following operational activities, expressed as UH3 milestones:

  • Completion of data management system(s)
  • Completion of regulatory approvals
  • Study activation
  • Registration of clinical trial in ClinicalTrials.gov (for clinical trials)
  • Enrollment of the first subject for studies with prospective enrollment
  • Enrollment and randomization, if applicable, of 25%, 50%, 75% and 100% of the projected study population for studies with prospective enrollment
  • Completion of data collection for studies with prospective enrollment
  • Completion of primary outcome data analyses
  • Reporting of results in ClinicalTrials.gov (for clinical trials)

UG3/UH3 Transition

All projects must be driven by well-defined milestones for the UG3 planning phase and annual milestones for the UH3 implementation phase. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition application, which will undergo an administrative review to determine whether the study will be awarded funding for the UH3 implementation phase. Continued funding during the UH3 phase will be dependent upon meeting annual UH3 milestones, and it is expected that the study will be completed within the UH3 grant period.

Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 implementation phase. Transition to the UH3 phase is dependent on having successfully met the UG3 planning milestones, NIDCR program priorities, and availability of funds. The quality of the study-related documents and plans are given key consideration when the NIDCR considers the transition to the UH3 phase.

Additional Information

Awardees are required to comply with the NIDCR Clinical Terms of Award for any planning phase activities that involve human subjects and all subsequent UH3 implementation phase studies. It is recommended that applicants use the NIDCR Toolkit for Clinical Researchers for development of the clinical study documents.  Implementation of the Clinical Terms of Award ensures that the conduct of the clinical study meets widely-accepted standards for ethical and rigorous research. The clinical study must meet all applicable NIH, and Office of Human Research Protections (OHRP) policy requirements.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDCR intends to commit $3 million in FY 2022 to fund 3-4 awards, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to less than $300,000 in direct costs for the UG3 phase; Application budgets are not limited for the UH3 phase, but need to reflect the actual needs of the proposed project.

Award Project Period

The total project period may not exceed one year for the UG3 phase and five 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local 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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Telephone: 301-594-5593
Email:yasaman.shirazi@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments. Applications responding to this FOA must include one additional attachment:

1. Milestone Plan

The filename "Milestone Plan" should be used to name this attachment. A milestone is defined as: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. The Milestone Plan must describe objective, measurable milestones with separate milestones for the UG3 and UH3 phases. The milestone plan must include clearly stated milestones that will be reached at the end of the UG3 phase and annual milestones that will be completed during the UH3 phase. The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies.

Milestones to be completed during the UG3 phase, should include, as applicable:

  • Finalization of the clinical protocol, prepared using the standard NIDCR observational or interventional protocol template (see NIDCR Toolkit for Clinical Researchers), that is ready for submission to the central IRB;
  • Successful preparation of the manual of procedures, quality management plan, and data management plan, as applicable;
  • Finalization of all documents necessary to implement the full study (e.g., case report forms, etc.);
  • Finalization of consent form(s) and, if applicable, assent form(s);
  • Finalization of the statistical analysis plan;
  • A plan to administer study intervention, train interventionalists, and monitor intervention delivery, for clinical trials;
  • Finalization of the recruitment/enrollment and retention plan for studies with prospective enrollment; and
  • Obtainment, quality review, assurance of data harmonization and interoperability, and preparation of all data sources for proposed SMSS or data science-focused studies.

Milestones to be completed during the UH3 phase should include, at a minimum:

  • Completion of data management system(s)
  • Completion of regulatory approvals
  • Study activation
  • Registration of clinical trial in ClinicalTrials.gov (for clinical trials)
  • Enrollment of the first subject for studies with prospective enrollment
  • Enrollment and randomization, if applicable, of 25%, 50%, 75% and 100% of the projected study population for studies with prospective enrollment
  • Completion of data collection for studies with prospective enrollment
  • Completion of primary outcome data analyses
  • Reporting of results in ClinicalTrials.gov (for clinical trials)

 

2. Data Management Plan

The filename "Data Management Plan" should be used to name this attachment.

The purpose of the Data Management Plan is to establish validated systems and controls to ensure the integrity of the clinical research data being collected for the proposed study.

  • Describe the methods and systems for data verification and data validation. Describe the frequency of data verification, data query process, and any planned mitigation strategies in the event of data system noncompliance.
  • Describe methods and systems to ensure data confidentiality and subject privacy.
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.

For the initial UG3/UH3 application, a complete detailed budget is required for both the UG3 phase and the UH3 phase. The applicant should estimate the costs for the UH3 phase based on the scope of work described in the application for the UH3 phase. Budget justifications must be included.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

For this announcement, note the following: Only research proposing to examine social determinants of health (SDOH) that operate beyond the individual level of influence (as depicted in the National Institute on Minority Health and Health Disparities, https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html), in the context of their impact on oral health outcomes or oral health status will be considered for this FOA.

Research Strategy:

Applicants should address the following elements in the research strategy section of the Research Plan:

Significance:

  • Provide justification for the application’s focus on one or more specific SDOH that are hypothesized to act as a barrier to maintaining optimal oral health in the population/community of interest.
  • Provide information adequate to determine the significance and timeliness of, as well as the need to perform the study. This may include preliminary data, clinical and/or preclinical studies, or information in the literature.

Innovation:

  • Provide a compelling argument of how the proposed study will inform community, organizational, or public health practice paradigms or inform health policy as it relates to SDOH and improving oral health

Investigator(s):

  • Describe the expertise of the study team and the team’s ability to plan and implement the planned study and perform appropriate analyses of data collected.

Approach:

The Approach section should have a clear demarcation of the UG3 and UH3 portions of the application.

For the UG3 phase:

  • Describe the study development activities planned for the UG3 phase.
  • Define milestones for determining progress in the UG3 phase, and demonstrating readiness to progress to the UH3 phase.

For the UH3 phase, if the proposed study is a SMSS project:

  • Provide compelling justification as to the adequacy of the data source(s) being used to address the research question(s).
  • Address the data quality of data sources, including: the presence of relevant variables, completeness, bias, validity, feasibility of obtaining data, data harmonization and interoperability, and methods that will be used to account for data quality weaknesses.

For the UH3 phase, if the proposed study design is not a clinical trial (this may include observational clinical studies or SMSS studies):

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

For the UH3 phase, if the proposed study design is a clinical trial:

  • Address the feasibility of recruiting participants who are eligible for the proposed research.
  • Provide an overview of the proposed study design that must justify the selected trial elements provided in the Protocol Synopsis, including:
    • Rationale for the selected trial design/interventional model (e.g., single-group, parallel, cross-over, factorial) and allocation method.
    • Rationale for selection of the intervention to be tested and a description of how and at what frequency the intervention will be administered.
    • For behavioral interventions, demonstration that an intervention engages the mechanism of action target(s) it intends to, and that target engagement can be measured.
    • Justification for selection of the primary and secondary outcome measures and a description of how the outcome variables will be collected and the criteria for measuring the outcomes.
    • Description of the study population, including the sample size, pertinent demographic information, required health status or disease condition, and geographic location. Explain why the study population is an appropriate group to address the study objectives. Do not duplicate information described in Section 2 (Study Population Characteristics) of the Study Record: PHS Human Subjects and Clinical Trials Information form.
  • Discuss potential biases or challenges in the proposed trial and how they will be minimized and/or addressed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, should address: 1) A Data Sharing Plan describing the plan to make final datasets available in the public domain, managed by the grant applicant institution, and 2) a plan to make study materials and procedures manuals (data collection instruments, study protocols) available in the public domain.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Only add one study record for the UH3 study.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

The Data and Safety Monitoring Plan should include a description of data monitoring activities, such as:

Plans to ensure that validated systems and controls are in place to assure the integrity of the clinical trial data being collected.

Proposed methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification and data validation. Describe the data query process and query frequencies and any planned mitigation strategies in the event of noncompliance with data collection processes.

The process for locking the final trial datasets for analysis.

Do not name members of any oversight board in the application. The NIDCR will appoint members of any oversight committees after consultation with the clinical trial investigator team.

Delayed Onset Study

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to this FOA:

Does the application provide:

  • Justification for the focus on one or more specific SDOH that operate beyond the individual-level and that are hypothesized to act as a barrier to maintaining optimal oral health in the population/community of interest?
  • Information adequate to determine the significance and timeliness of, as well as the need to perform the study? This may include preliminary data, clinical and/or preclinical studies, or information in the literature.

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

Specific to this FOA:

Does the application provide:

  • A description of the expertise of the study team and the team’s ability to plan and implement the planned study and perform appropriate analyses of data collected?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

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

Specific to this FOA:

Does the application provide:

  • A compelling argument of how the proposed study will inform community, organizational, or public health practice paradigms or inform health policy as it relates to SDOH and improving oral health?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

Study Milestones

Are appropriate, evaluative milestones clearly defined for the UG3 and UH3 phases? Does the application provide a compelling proposal that the study is likely to meet these milestones within the proposed project period? For the UG3 Phase Milestones, are all key aspects of planning for the subsequent clinical trial included as Milestones, and/or is there compelling justification for why certain planning activities are not needed?

Study Timeline

Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 will receive a written critique.

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.

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

Applications will be assigned to the National Institute of Dental and Craniofacial Research. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

The PD(s)/PI(s) will have the following primary responsibilities:

* 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. The NIDCR policy related to monitoring is available at: https://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DataandSafetyMonitoring.htm. The NIDCR full policy about terms and conditions of awards supporting clinical research 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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIDCR Program staff member(s) acting as a Project Scientist(s) will be assigned to have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NIDCR staff members may be designated to have substantial involvement. The NIDCR Project Scientist(s) and any other substantially involved staff members will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NIDCR waiver according to the NIDCR procedures for management of conflict of interest. Some Program Officials will also have substantial programmatic involvement. In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek an NIDCR waiver as stated above.

The main activities of the NIDCR substantially involved staff members include but are not limited to the following aspects:

* Providing input on experimental and clinical approaches, assisting in designing protocols, and consulting on updates to project milestones;

* Assisting and advising awardees with regard to various regulatory and compliance issues;

* Participating in monthly teleconferences with PDs/PIs to monitor progress and facilitate cooperation;

* Monitoring progress of the trial towards meeting its primary outcome;

* Tracking monthly accrual of participants; and

* Reviewing 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 subject enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

An NIDCR Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. An NIDCR Medical or Dental Officer will monitor the studies and serve as the Medical Monitor.

Areas of Joint Responsibility:

None, all responsibilities are divided between awardees and NIH staff as described above.

Administrative Review Committee:

The NIDCR will establish an Administrative Review Committee to assist in determining the transition from the UG3 phase to the UH3 phase. In addition to the Project Scientist and Program Official, the Administrative Review Committee will contain NIH staff not assigned to the award.

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 will be convened, and will vote to resolve the dispute. The Dispute Resolution Panel will have three members (with one vote each): a designee of the award governing body chosen without NIH staff input, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two Panel members. 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. NIDCR's final decision on whether a UG3 project may transition to the UH3 phase is not disputable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Hiroko Iida, DDS, MPH

National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7404
Email: hiroko.iida@nih.gov

Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Telephone: 301-480-1161
Email: melissa.greenparker@nih.gov

Elizabeth Anne Barr
Office Of Research On Women's Health (ORWH)
Phone: none
E-mail: none

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Diana Rutberg, MBA

National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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