Part 1. Overview Information

Key Dates

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.

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.

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.

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

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

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.

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.

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.

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

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

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

All instructions in the How to Apply- Application Guide must be followed.

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

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

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

All instructions in the How to Apply - Application Guide must be followed.

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. 

1. Study Timeline: Applicants should provide separate project performance timelines for the UG3 planning phase and the UH3 implementation phase of grant period. 
2. 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

All instructions in the How to Apply- Application Guide must be followed.

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.

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. 

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.

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.

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. 

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

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by appropriate Scientific Review Group(s) convened by the CSR, in accordance with NIH peer review policies and practices, 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 community/population merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 recipient 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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• All aspects of their 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 and community partners.
• Prior to the end of the UG3, submission of the transition package, which will include the UG3 progress report delineating progress toward achieving UG3 milestones.
• Close coordination and cooperation with NIDCR staff involved in those aspects of scientific and technical management of the study, including those outlined under "NIDCR Staff Responsibilities" and working cooperatively with other recipients and CEED when it is scientifically advantageous to pursue common methods and protocols.
• Participating in annual consortium meetings, supporting any committees, and community advisory board and partnership meetings, related to the project, as needed, and participating in regularly scheduled conference calls with the awarding agency. Project budgets should include travel for participation in these activities as appropriate.
• Participating in the SC. The SC will meet at least quarterly via a video conference, supplemented as deemed necessary by additional meetings, and the members may serve on working groups.
• Following the procedures required by the protocol regarding study conduct and monitoring and data collection.
• Making project-generated publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1 of the NIH GPS.
• Collaborating with community partners for the timely and broad dissemination of lessons learned, to inform researchers and relevant service systems as appropriate.
• Award recipients 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 DHHS, PHS, and NIH policies.

NIDCR staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• NIDCR staff who will serve as Program Official and Project Scientist will be responsible for the normal and/or above and beyond the normal scientific and programmatic stewardship of the award will be named in the award notice.
• NIDCR staff will interact with the PD(s)/PI(s) on a regular basis to help monitor progress. Monitoring may include regular communication with the PD(s)/PI(s) and their team and the reviews of fiscal, scientific, community engagement status, and other relevant stewardship matters. The review of scientific progress may include but not be limited to compliance with the study protocol, meeting subject enrollment and retention targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting to CEED.
• NIDCR staff will help facilitate and participate in consortium-level activities including the annual meetings in collaboration with CEED, the SC as non-voting member, and working groups and will advise on the selection of resources, data harmonization, and community engagement capacity building activities.
• NIDCR staff will help ensure the recipient demonstrates compliance with award terms and conditions. Failure to achieve minimally acceptable milestone recruitment levels and/or other critical aspects of the study may result in the withholding future support and/or negotiating an orderly close-out of this study.
• NIDCR staff will help assist and advise recipients with regard to various regulatory and compliance issues. For those studies that require additional oversight for the proposed human subject research, NIDCR will arrange the Medical Monitor or other appropriate monitoring body.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) provide, with assistance from the NIDCR staff, support necessary to ensure that sites and investigators, and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subject protection, informed consent, and reporting of adverse events.
• Recipients and NIDCR will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data and compliance with local cultures and norms regarding research data handling and governance.
• The SC (chaired and managed by CEED) is the primary governing body of the consortium. Recipients must participate in the SC. The SC reviews and approves common procedures and methodologies for guiding the consortium’s collaborative data collection, community engagement evaluation and capacity building, and coordination of communications.

Dispute Resolution:

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

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 prospective applications responding to this NOFO, regardless of the amount of direct costs requested for any one year, must submit a DMS Plan leveraging the NIH SCHARE platform. Specifically, each applicant should estimate cloud costs (for data storage and data analytics) for the proposed project and include the budget.  
• The applicants are also encouraged to use SCHARE data repository after the completion of the project (no cost/budget is required).

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

CEED will conduct community engagement evaluation periodically through quantitative and qualitative data collection from CBPR project researchers and community partners. Participation in such evaluation activities is required. 

Section VII. Agency Contacts

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

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

National Institute of Dental and Craniofacial Research (NIDCR)
Email: NIDCR-ADAPT@nih.gov

Office of Research on Women's Health (ORWH) 
Email: idr-orwh@mail.nih.gov

Office of Disease Prevention (ODP) 
Email: ODP-NOFO@mail.nih.gov

National Institute of Minority Health and Disparities (NIMHD)
Email: NIMHDDCHPSScientificTeam@mail.nih.gov

Office of AIDS Research (OAR)
Email: OARinfo@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

National Institute of Dental and Craniofacial Research (NIDCR)
Email: deeranotifications@nidcr.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.

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 2 CFR Part 200.