About this file

This is a Notice of Funding Opportunity (NOFO) for the Community-Based Participatory Research to Advance Data and Practice Transformation (ADAPT) initiative, soliciting UG3/UH3 phased cooperative agreement applications from the National Institute of Dental and Craniofacial Research (NIDCR) with co-funding from the Office of AIDS Research, National Institute on Minority Health and Health Disparities, Office of Research on Women's Health, and Office of Disease Prevention. The funding opportunity (FON PAR-27-015) seeks research proposals to evaluate, implement, and test population-based interventions addressing oral disease burden in communities through cross-sector partnerships that integrate healthcare and non-healthcare services. The application period opens September 16, 2026, with rolling submission deadlines occurring October 16, November 16, and annually thereafter through November 17, 2028. The UG3 Phase 1 supports up to two years of developmental and feasibility activities with awards up to $300,000 per year in direct costs, while the UH3 Phase 2 provides up to five additional years of implementation at up to $650,000 per year, contingent upon meeting specified Go/No-Go transition milestones. Total project period is seven years maximum.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, tribal organizations, and faith-based organizations operating domestically. Applications must include specific aims for both UG3 and UH3 phases, annual and transition milestones, meaningful community engagement with cross-sector partners, theory-driven conceptual frameworks addressing social and chronic disease risk factors, and budgets for travel to a mandatory in-person inaugural meeting in Bethesda, Maryland, CEACR expert consultation fees ($6,000 per consultation), and SCHARE cloud platform data storage costs. Applicants must demonstrate existing community partnerships with documented letters of support, participate in the ADAPT Consortium steering committee, and leverage existing data systems for efficiency. Applications not including both UG3 and UH3 specific aims, transition milestones, cross-sector partners in key roles, or budget for community-centered activities will not be reviewed. The award is issued as a cooperative agreement under CFDA numbers 93.121, 93.307, 93.310, and 93.313, with substantial NIH programmatic involvement throughout the project period.

PAR-27-015-Full-Announcement.html

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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)

Office of AIDS Research (OAR)

National Institute on Minority Health and Health Disparities (NIMHD)

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

Community-Based Participatory Research to Advance Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All (UG3/UH3 Clinical Trial Optional)

Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type

New

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-27-015

Companion Funding Opportunity

RFA-DE-27-001

, U01 Research Project (Cooperative Agreements)

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.121, 93.307, 93.310, 93.313

Funding Opportunity Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit UG3/UH3 phased, cooperative agreement research applications to evaluate, implement, and/or test population-based interventions to policies, programs, and/or practices for promoting integration of services, systems, and/or values by leveraging cross-sector partnerships in communities. Such interventions must address social and chronic disease common risk factors and/or barriers driving oral disease burden in communities. Projects funded through this funding opportunity and a separately funded Community Engagement Evaluation and Data Coordination hub (CEED) will form a Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT), which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people across the lifespan.

Funding Opportunity Goal(s)

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan.

Key Dates

Posted Date

April 27, 2026

Open Date (Earliest Submission Date)

September 16, 2026

Application Due Dates
Review and Award Cycles
New
Renewal / Resubmission / Revision (as allowed)
AIDS - New/Renewal/Resubmission/Revision, as allowed
Scientific Merit Review
Advisory Council Review
Earliest Start Date

October 16, 2026

November 16, 2026

Not Applicable

March 2027
May 2027

July 2027

October 16, 2027

November 16, 2027

Not Applicable

March 2028
May 2028

July 2028

October 16, 2028

November 16, 2028

Not Applicable

March 2029
May 2029

July 2029

All applications are due 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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

November 17, 2028

Required Application Instructions

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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.
Use the NIH ASSIST system to prepare, submit and track your application online.
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.
Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) solicits UG3/UH3 phased, cooperative agreement research applications to evaluate, implement, and/or test population-based interventions to policies, programs, and/or practices that promote the integration of services, systems, and/or values by leveraging cross-sector partnerships in communities. Such interventions must address social and chronic disease common risk factors and/or barriers driving oral disease burden in communities. The projects awarded through this NOFO, together with the separately funded Community Engagement Evaluation and Data Coordination hub (CEED), will form a Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT). ADAPT will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people across the lifespan.

Key Definitions for this NOFO Community: A social group of any size whose members reside in a specific locality, share government, and often have a common cultural and historical heritage. Community may be self-defined or defined by the catchment areas of local government or service providers (e.g. residents served by a county school district or community clinic). Examples of communities include but are not limited to neighborhoods, towns, cities, counties, school districts, reservations or Tribal communities, military bases, and college campuses. Virtual or other communities that do not reside in the same geographic location are not the focus of this initiative.

Community-Based Participatory Research (CBPR): A highly-evolved collaborative approach in research that expects researchers and groups of people affiliated by, for example, geographic proximity or other defining characteristics to identify and address issues affecting the well-being of those people as equivalent partners in all aspects of the research process. Community engagement in research can be viewed in the context of a continuum, ranging from consultation with community partners to community-driven research. Moving along the continuum, as the relationships between community partners and researchers grow, meaningfulness to community partners and the impact of research to community health increase. Applicants are encouraged to incorporate at least one established framework of community engagement for proposed CBPR projects submitted to this NOFO.

Cross-Sector Partnerships: A collaborative partnership between two or more community-based service sectors with the goal of leveraging the resources and expertise of the partners to achieve a mutually beneficial outcome. In this NOFO, cross-sector partnerships must include healthcare-related (e.g. businesses that provide dental and medical services, equipment/supplies, insurance) and non-healthcare-related organizations and individuals from these service sectors.

Levels of Influence: The socio-ecological levels, such as individual, interpersonal, organizational, community, and societal levels, at which specific domains of factors (e.g., biological, behavioral, physical/built environment, sociocultural environment, healthcare system) operate to influence risks and resilience for subsequent health outcomes. For this NOFO, the proposed intervention(s) must directly address factors at the community and/or societal levels, not merely be implemented at these levels.

Background Despite considerable advances in science and the practice of preventing and controlling oral diseases over the last 20 years, oral diseases such as dental caries and periodontal disease remain among the most common chronic diseases across the lifespan. In the United States, approximately one in four preschool children reportedly have experienced caries in their primary teeth, and nine in ten adults ages 20-64 years have either treated or untreated caries in their permanent teeth. Periodontal disease is more common as people age, and more than 40% of US adults 30 years or older have some form of periodontitis. Chronic oral diseases such as dental caries and periodontal diseases progress silently over the lifespan, influenced by various individual and contextual factors, resulting in pain and loss of teeth, supporting tissues, and basic functions of the mouth such as eating and speaking thus impairing a person’s health and psychosocial and economic well-being. Among US adults 65 years and older, approximately 25% have lost eight or fewer teeth, and the prevalence of complete tooth loss is more than 15%. Poor oral health and untreated oral diseases are particularly common among populations with low socioeconomic status.

The mouth is a portal to chronic disease risk, with tobacco use and an unhealthy diet also contributing to poor oral health outcomes and America's chronic disease crisis. The mouth, which is home to over 700 microbial species, often shows early signs of physiological challenges such as altered immunity and inflammation while untreated oral diseases and sustained localized inflammation in the mouth can trigger the initiation of systemic inflammatory responses and multimorbidity.

The conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of upstream factors shaping the conditions of daily life (e.g., systems and policies affecting social, economic, educational, neighborhood conditions, and health care access and quality) can improve, maintain, or hinder health through multiple direct, indirect, and interacting mechanistic pathways. They may also interact with downstream factors to influence disease risks and resilience to further promote or compromise health across the life-course. Enhanced access to high-quality, affordable, and evidence-based oral health services is an important step towards improving oral health in communities. Nevertheless, multi-level common risk factors giving rise to oral and systemic multimorbidity must be considered to increase the efficiency and value of oral health care delivery for optimizing oral and overall health for all people.

CBPR utilizes a collaborative approach that engages community members as equivalent partners with scientists throughout the research process. The NIH has supported research using CBPR strategies for several decades to accelerate the translation of scientific discovery into communities. Despite progress, gaps remain in the level of community engagement within NIH-funded research, presenting opportunities to deepen community-researcher partnerships and enhance the impact of research in improving community health.

The ADAPT Consortium Structure The ADAPT consortium comprises the UG3/UH3 research projects awarded through this NOFO and a separately funded Community Engagement Evaluation and Data coordination hub (CEED). The consortium will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform. CEACR, which was established within the NIH Community Engagement Alliance (CEAL), provides curated expert consultations tailored to the needs of each consultee by using a panel of community and academic experts in community engagement. In this initiative, CEACR will be available to provide up to three episodic, expert panel consultations for each project, as proposed and budgeted in the application. CEACR will also provide longitudinal consultative services (e.g. targeted consultations, office hours, and webinars etc.) that are aligned with CEACR objectives and scope of work supported by NIDCR-co-funding to promote adherence to the principles of community-partnered research approaches and enhancing participant representation in CBPR projects. SCHARE, a cloud-based platform developed by a collaboration of several NIH Institutes, includes datasets relevant to population health science to enable researchers to link, analyze, and export data within a secure and collaborative workspace that is equipped with advanced computational tools. In this consortium, CEED will manage the ADAPT workspace provided by SCHARE, and each CBPR project will have its own SCHARE workspace. CEED will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains: 1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Consortium Infrastructure and Operational Support. CEED will chair the ADAPT Steering Committee (SC) which will serve as the primary governing body of the consortium and will include at least two representatives from each research project (e.g. one from research institutions and the other from partner community organizations) and non-voting members such as NIDCR Program staff and representatives from SCHARE and CEACR. The ADAPT SC will meet quarterly and engage in a range of planning and evaluation activities for the consortium including data harmonization, assessing needs and priorities for community engagement capacity building, and reviewing and planning of manuscripts or other resources/products. In addition to the SC, an external expert committee may be convened by NIDCR. Applicants are encouraged to review the CEED NOFO (RFA-DE-27-001) to fully understand the consortium structure, objectives, and activities.

CBPR Research Projects (UG3/UH3 Phased Awards) In this milestone-driven, transition phased award, the UG3 award (Phase 1) will provide up to two (2) years of funding support for a developmental/exploratory study and/or cross-sector community engagement activities to demonstrate feasibility of and capacity for the proposed CBPR project to be implemented in the UH3 phase (Phase 2) that leverages transformational community partnerships. The UH3 (Phase 2) award will provide support for up to five (5) additional years to test and/or evaluate population-based interventions/strategies that promote the integration of services, systems, and/or values aimed at reducing the burden of oral disease and optimizing oral health for all people. Funding of the UG3 phase does not guarantee support of the UH3 phase. Transition to the UH3 phase will be evaluated toward the end of the UG3 phase and determined by availability of funds and success in meeting UG3 phase Go/No-Go transition milestones. Not all funded UG3 projects may transition to the UH3 phase, and appeals of the transition decision will not be accepted.

Research projects planned in the UG3 phase and implemented in the UH3 phase are expected to have the following features:

Evaluate, implement, and/or test interventions at community- and or societal-level(s) independently or with other levels (individual- and/or interpersonal-levels) that address one or more social and chronic disease common risk factor(s) and/or barrier(s) driving disproportionate burden of oral health diseases.
Examine whether and how the intervention mitigates oral disease burden in communities, guided by a theory-driven conceptual framework/model.
Attain scientific rigor by using appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. 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 of individual participants are analyzed for between-group effects, special methods are required for sample size determination and data analysis. Methods consistent with plans for assignment of participants and delivery of interventions must be documented in the application.
Collect SCHARE core common data elements (CDEs), available in the NIH CDE Repository, and employ a common set of tools and resources that will promote the collection of comparable oral and general health and contextual data across studies (e.g. PhenX Toolkit as appropriate) for promoting reproducibility.
Focus on populations/communities experiencing chronic oral disease burden such as dental caries, periodontal disease, and oral or oropharyngeal cancers in the US.
Be guided by a theory-driven conceptual framework/model identifying hypothesized multi-level pathways among the intervention, risk factors and barriers to be modified, and outcome(s) at individual- and population-levels as well as economic outcomes as appropriate.
Cultivate equivalent and meaningful partnerships with new and existing cross-sector community representatives (i.e. representation of healthcare and non-healthcare sectors is required) and outreach to the population(s) experiencing oral disease burden for research projects guided by the principles/frameworks of community partnered research to accelerate dissemination and implementation of study findings in communities.
Leverage existing data systems and community resources (e.g. Clinical and Translational Science Award Hubs, electronic medical records, existing surveillance and/or administrative databases, or patient registries), as appropriate, for efficient project data collection and community transformation.

Research objectives for CBPR projects include but are not limited to:

Adapt and test evidence-based and community-informed intervention strategies across systems/sectors in the community to reduce economic barriers and/or enhance oral health literacy to prevent oral diseases and facilitate effective use of oral health care.
Implement comprehensive/multipronged interventions for reducing social and chronic disease common risk factors using whole person health approaches that enhance community resources and culture/norms for preventing oral diseases in the context of multimorbidity.
Evaluate and/or test community-based strategies to integrate healthcare and non-healthcare sector services for promoting healthy lifestyles, uptake and cost-effectiveness of evidence-based oral disease screenings, prevention and management approaches, and access to care to mitigate multifaceted challenges faced by the populations experiencing oral disease burden.
Evaluate existing or upcoming population-based interventions (e.g. policy changes, changing social or practice norms, program integrations) to address upstream factors and/or barriers contributing to downstream chronic disease risks and outcomes impacting oral health across the lifespan.
Integrate primary and dental care at safety-net care delivery systems through care navigation/coordination, co-location, and/or integrated care to address gaps of scientific evidence impeding US Preventive Service Task Force (USPSTF) recommendations on primary care clinician-based oral health interventions and facilitate comprehensive dental care access for asymptomatic yet at-risk populations with or without limited access to dental services in the US.

Activities supported during the UG3 phase may include but are not limited to the following, expressed as UG3 milestones:

Meet with NIH Program staff regularly to discuss milestone progress and obstacles.
Execute necessary agreements with community partners for committed financial and/or human resources in CBPR project.
Organize and regularly meet with a community advisory board (CAB) and establish a bidirectional feedback loop between researchers and cross-sector community partners for project decision-making, planning, evaluation, and dissemination.
Receive at least one expert consultation(s) on a community engagement plan and finalize strategies and milestones for outreach and cross-sector partnerships. CEACR will be available to provide up to three episodic consultations during the project period as proposed and budgeted.
Participate in consortium-wide data-related planning activities organized by CEED to identify/finalize common data elements including oral health outcomes that will be used across different projects and demonstrate capacity for achieving research objectives collaboratively and sustainably.
Acquire data to be used in the proposed project and establish necessary agreements.
Demonstrate ability to recruit appropriate individual and/or organizational population samples and conduct data collection and implement a community-informed data management and sharing plan that supports shared governance and shared intellectual property, as appropriate.
Pilot research activities and materials and develop near final study documents including a community- and expert-informed community-engagement plan.
Build research capacity in community partners and empower the community to be a full partner in CBPR.
Participate in the kick-off orientation on using the SCHARE platform, cloud workspace, and resources.
Participate in an inaugural consortium meeting in person in the Bethesda, Maryland area, virtual ADAPT consortium meetings (once a year) thereafter, and capacity building activities planned by the ADAPT SC (virtual and no more than two activities per year) to share progress, strengthen CBPR capacity, and network with other consortium members.

UH3 activities may include the following operational activities, expressed as UH3 milestones:

Finalization of data management system(s).
Completion of regulatory approvals.
Study activation.
Registration of clinical trials in ClinicalTrials.gov, as appropriate.
Enrollment of the first study participant and randomization of 25%, 50%, 75% and 100% of the projected study population, as appropriate.
Completion of data collection.
Completion of primary outcome data analyses.
Reporting results to communities and, as appropriate, in ClinicalTrials.gov.
Demonstration of ongoing cross-sector engagement for the CBPR project and community engagement and intervention outcomes.
Participation in the annual consortium meetings, ADAPT SC meetings, and community engagement evaluation and capacity building activities.

Applications Not Responsive to the NOFO

Applications that do not include specific aims for both a UG3 and a UH3 phase.
Applications that do not specify Go/No-Go transition milestones for the UG3 phase and annual milestones for the UH3 phase.
Applications that do not include cross-sector partners in key roles, budget proposals for community-centered activities, and/or a widespread dissemination plan.
Projects that focus on interventions and intervention effects that only target the individual and/or interpersonal levels.
Projects that are exclusively qualitative.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the Scientific/Research Contact for this NOFO to discuss whether a planned application is responsive.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance 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 NOFO.

Application Types Allowed

New

Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

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

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

Award Budget

Application budgets are limited to $300,000 per year in direct costs for UG3 (Phase 1), and $650,000 per year in direct costs for UH3 (Phase 2).

Award Project Period

The maximum project period is 7 years. This includes 2 years for the UG3 (Phase 1) and 5 years for the UH3 (Phase 2).

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

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

Multiple project directors/principal investigators (MPD/MPI) applications that include both researcher PD(s)/PI(s) and community partner PD(s)/PI(s) is strongly encouraged.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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 their organization to develop an application for 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 How to Apply-Application Guide.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

For multi-PD/PI project proposals involving both community partner PD(s)/PI(s) and researcher PD(s)/PI(s), each must contribute equivalent effort during the project period.

R&R Budget

Costs should include, but are not limited to, costs for the following:
Travel costs for selected project team members to an inaugural in-person meeting in the Bethesda, Maryland area.
Community engagement expert consultation cost. If applications propose to receive tailored expert consultation(s) on community engagement from CEACR during the project period, the episodic consultation cost ($6000 per consult) must be included in the budget.
Cloud costs for data storage and data analytics in the SCHARE workspace.
If co-funding or in-kind support is planned from non-NIH sources, it must be described in the budget justification.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Separate sections that describe the research strategy for the UG3 and the UH3 phases are required, but it is not necessary to repeat information or details that are described in the UG3 section in the UH3 section. Applications should clearly describe:
Population(s) and communities of focus and the chronic oral disease burden affecting them; priority and assets in the community; existing and planned cross-sector partnerships.
The conceptual model that depicts 1) how community- and/or societal-level systems/policy/practice of interest drive oral disease burden in populations, 2) how the intervention of interest would promote oral health well-being for all, and 3) how relationships between oral health and the intervention are influenced by social and/or chronic disease common risk factors and/or by barriers.
The non-healthcare sector(s) involved in the project, the roles of collaborators within those sectors, and the roles of other community-based or research collaborators and upstream factors impacting community health that will be addressed through the partnerships.
Strategies for leveraging existing community resources and data systems to enhance efficiencies in project data collection and community transformation.
The scientific, operational, and/or collaborative planning activities for the UG3 phase.
The scientific, operational, and/or collaborative implementation activities for the UH3 phase.
The plan for dissemination and sustainability of the proposed project to benefit the population/community of focus through cross-sector partnerships.
A plan for participating in the ADAPT consortium (e.g., participation in SC meetings, data harmonization, cross-site collaboration in community engagement capacity building, etc.) and the SC. Describe how the project team will work with CEED, considering CEED’s role to provide data planning, consultation and technical assistance on methodologies and analytics, and community engagement evaluation for planning capacity building activities.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of community partners, collaborators, and others. Letters of support should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, must be included in the Letter(s) of Support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.
All applications responding to this NOFO are encouraged to leverage the NIH SCHARE platform for data storage during the project period (cloud costs must be budgeted) and also for data repository (no cost/budget is required) after the completion of the project.
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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

Section 2 - Study Population Characteristics

2.7 Study Timeline

The filename “Study Timeline and Milestone Plan” should be used to name this attachment, which should include both the Study Timeline and Milestone Plan.

Study Timeline: Applicants should provide separate project performance timelines for the UG3 planning phase and the UH3 implementation phase of grant period.
Milestone Plan: A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Go/No-Go transition milestones for the UG3 phase and annual milestones for the UH3 phase must be included in the Milestone Plan. These milestones must be specific to the project being proposed, discrete and measurable, and must be clearly defined. Applications should also address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies. Milestones may be refined and finalized in consultation with NIDCR Program Staff at the time of the UG3 phase award and the UH3 phase award, if funded. The Terms and Conditions for an award under this NOFO will include Milestones that are mutually agreed upon by the investigators and NIDCR. Annual milestones will be carefully assessed, and future support of the CBPR project under this NOFO is contingent upon meeting projected milestones, including meeting adequate participant enrollment, retention targets, and meaningful community engagement.

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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described 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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Significance
Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
Specific to this NOFO:
Evaluate how well the populations of focus are specified and justified.
Assess the completeness and appropriateness of the conceptual model for the proposed study, including the risk factors to be addressed and the upstream contextual factors to be modified for optimizing oral health for all people.
Assess the potential for sustainability of the intervention after the project is over and the scalability to other settings.
Evaluate the extent to which the proposal explains pre-application community engagement in development of the research topic, questions, approach, and outcomes ensuring the research addresses the population’s priorities, needs, and assets/experiences.
Evaluate whether the proposed engagement strategies/structures support equivalent decision-making between researchers, cross-sector collaborators, and other community stakeholders.
Assess the extent to which the proposed intervention includes novel cross-sector partnerships or approaches to address chronic oral disease burden in communities.

Factor 2. Rigor and Feasibility (Approach)

Approach
Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

Evaluate the potential to produce unbiased, reproducible, robust data.
Evaluate the rigor of experimental design and whether appropriate controls are in place.
Evaluate whether the sample size is sufficient and well-justified.
Assess the quality of the plans for analysis, interpretation, and reporting of results.

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