Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title
Harnessing Technologies to Support Oral Health Promotion and Management Outside the Dental Setting (UG3/UH3 Clinical Trial Required)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices
  • October 19, 2022 - Notice of Corrected Application Forms for RFA DE-23-009 Harnessing Technologies to Support Oral Health Promotion and Management Outside the Dental Setting (UG3/UH3 Clinical Trial Required). See Notice NOT-DE-23-001
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • August 19, 2022 - Notice of Change in Receipt Date for Applications to Harnessing Technologies to Support Oral Health Promotion and Management Outside the Dental Setting (RFA-DE-23-009). See Notice NOT-DE-22-012.

Funding Opportunity Announcement (FOA) Number
RFA-DE-23-009
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.121
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research that develops and/or adapts and tests technology-facilitated behavioral, social, and organizational tools for use in oral health promotion and management outside the dental setting. Of particular interest are tools that harness mobile, web, sensor, or other technology-based platforms with the potential to improve oral care at home or in the community; to facilitate needs assessment, treatment planning, and engagement; and to expand access to quality care for those who are under-served. This FOA focuses on tools that are adjunctive to, or extensions of, clinical care, rather than clinical tools meant to diagnose or treat oral disease. This FOA uses a UG3/UH3 phased cooperative agreement funding mechanism, inviting applications to plan and implement behavioral and social intervention clinical trials. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

Key Dates

Posted Date
July 01, 2022
Open Date (Earliest Submission Date)
October 10, 2022
Letter of Intent Due Date(s)

October 10, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 21, 2022 Not Applicable November 21, 2022 March 2023 May 2023 July 2023

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.

Expiration Date
New Date November 22, 2022 per issuance of NOT-DE-22-012. (Original Expiration Date: November 11, 2022 )
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PURPOSE

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research that develops and/or adapts and tests technology-facilitated behavioral, social, and organizational tools for use in oral health promotion and management outside the dental setting. Of particular interest are tools that harness mobile, web, sensor, or other technology-based platforms with the potential to improve oral care at home or in the community; to facilitate needs assessment, treatment planning, and engagement; and to expand access to quality care for those who are under-served.

BACKGROUND

Oral Health Promotion

Recommendations to maintain good oral health typically advise regular toothbrushing with fluoridated toothpaste, flossing or cleaning between teeth daily, eating a healthy diet that limits sugary foods and beverages, and visiting a dental care provider regularly for prevention and treatment services. Additional recommendations target specific conditions, such as prevention of oral cancers by not using tobacco products and following guidelines for HPV vaccination; prevention of craniofacial injury through use of mouthguards, face shields, and helmets; and management of temporomandibular joint and muscle disorders (TMD) with self-care strategies and temporary use of appliances. These and other oral health recommendations make clear that behaviors enacted outside of the dental setting are a major component in preventing dental, oral, and craniofacial diseases and promoting health. What these recommendations don’t acknowledge explicitly is that the recommended behaviors are not always a matter of individual choice, but rather are shaped or even determined by multiple social, physical, and economic factors. These factors are sometimes referred to as social determinants of oral health (SDOH), and include family traditions and priorities, access to--and costs of--resources and services, relevant health care policies, and other potential determinants. Further, because of persistent inequities in behavioral and social determinants of oral health across individuals and communities, inequities in oral disease have been troublingly persistent.

Oral health promotion is an approach to public health that recognizes the many potential behavioral and social determinants of oral health, and the need for disease prevention and health promotion activities, both in the dental setting, and outside the clinic. While definitions of oral health promotion vary, they tend to share core principles of empowering individuals and communities to achieve good oral health, focusing on the behavioral and social determinants of oral health, and working toward equity in access to care and care delivery. A wide variety of oral health promotion programs have been implemented in community settings, such as school-based supervised toothbrushing, oral screenings, and nutritional programs; community-based educational and motivation-based programs for individuals and families; media campaigns to encourage tobacco cessation, HPV vaccinations, and oral cancer screening; and community water fluoridation programs.

Use of Technology for Oral Health Promotion

Some oral health promotion programs are already making use of technology, with exponential growth in smartphone- and web-based health promotion programs in recent years. In addition, oral-health related sensor and remote communication technologies are increasingly available, potentially allowing for skill-building, patient self-monitoring, and use by clinicians for tailored recall and treatment planning. Efforts to develop integrated electronic health record systems add to the promise of technology-facilitated oral health promotion, empowering patients to direct their own health care, for example by having access to their health records, scheduling, and other resources.

While the use of technologies to support oral health promotion is not new, the COVID-19 pandemic has generated renewed interest in the use of such technologies in dentistry as well as other health care sectors. Since physical distancing was recommended to prevent spread of the virus, both clinical and oral health promotion activities have made use of remote technologies, such as videoconferencing, web-based programs, and smartphones. By necessitating greater use of remote technologies, the pandemic likely increased familiarity with and confidence in web-based communication technology and in use of telemedicine for many users, and also exposed some of the challenges still to be addressed. Among these important challenges are: the need for empirical testing of technology-based oral health promotion tools, including understanding for whom and under what circumstances they “work”, and the essential components of these tools; the need for these tools to meet accepted standards for technology design and behavior change principles; and the imperative to ensure that increasing reliance on technologies does not increase oral health disparities or inequities.

SCOPE

This FOA intends to support research that develops and/or adapts and tests technology-facilitated behavioral, social, and organizational tools for use in oral health promotion. Of particular interest are tools that harness mobile, web, sensor, or other technology-based platforms with the potential to improve oral care at home or in the community; to facilitate needs assessment, treatment planning, and engagement; and to expand access to quality care for those who are currently under-served.

This FOA focuses on tools that are adjunctive to, or extensions of, clinical care, rather than clinical tools meant to diagnose or treat oral disease. Technology-facilitated clinical tools aiming to make diagnostic or treatment claims, e.g., those that fall within the regulatory purview of the Food and Drug Administration in the United States, are outside the scope of this FOA. Applications may propose research on tools that facilitate access to care; however, tools solely meant to facilitate real-time (synchronous) communication with a dental care provider for diagnostic or treatment purposes (sometimes called teledentistry) are outside the scope of this FOA. Applicants wishing to propose research on such technology-facilitated teledentistry approaches are encouraged to consider submitting to NIDCR’s Clinical Trial Planning and Implementation Cooperative Agreement Funding Opportunity (PAR-21-160).

This FOA solicits clinical trials of oral health promotion approaches spanning from Stage I (early intervention development) to Stage V (dissemination and implementation research), following the NIH Stage Model of Intervention Development Research (for more information, please see the National Institute on Aging website). Tests of hypothesized mechanisms of action and monitoring of intervention fidelity should be included at each stage, as appropriate to the stage of intervention development. Although this FOA does not impose specific requirements about the type of technologies proposed in applications, potential applicants should consider carefully the clinical readiness of their technologies to fully respond to this FOA; technologies that require extensive, early prototype-development and testing may not be appropriate.

Applications in response to this FOA must include the following two analyses, in addition to any study-specific analyses proposed:

  1. An analysis of the degree to which the proposed oral health promotion tool(s) adheres to standards for technology design and behavior change principles; and
  2. An analysis of the degree to which use of the technology-facilitated oral health promotion tool(s) affects disparities or inequities in key outcomes or access to care.

Selected Examples

Examples of oral health promotion tools relevant to this FOA include, but are not limited to:

  • Smartphone apps or web-based programs to support oral hygiene or other behaviors relevant to oral health (e.g., tobacco cessation, self-management of chronic oral or craniofacial conditions, healthy nutrition)
  • Virtual reality or other immersive technology for mitigating dental fear or anxiety, sensory sensitivities, or other barriers to seeking dental treatment
  • Technology-facilitated tools for training caregivers and care partners in effective oral hygiene support for individuals needing assistance
  • Tools that assist in oral health needs assessment, treatment planning, and engagement in care
  • Tools that build community capacity for oral health promotion (e.g., by addressing SDOH challenges, or by harnessing community strengths)
  • Communication or other technologies to increase access to oral health promotion resources for under-served individuals or communities
  • User-friendly data search, integration, and/or visualization tools for identifying oral-health related community resources or needs
  • Data collection and integration tools to equip policymakers and other stakeholders with data needed for oral-health related decision making

Clinical Trial Planning Phase (UG3)

The UG3 award will provide up to 2 years of support for scientific and operational planning activities necessary to conduct the clinical trial. The UG3 planning phase should incorporate all activities required—and not yet completed--to prepare for conduct of a subsequent clinical trial.

When not yet already completed, at a minimum, UG3 planning activities should include the following activities, included as UG3 milestones:

  1. Adherence to good technology design and behavioral/social/organizational intervention principles: If not already developed, applications must include a milestone that develops plans for ensuring that the proposed study methods adhere to accepted principles for technology design and behavioral/social/organizational intervention design and testing. The application should identify the specific technology and intervention design principles that will guide the study methods; this milestone allows for developing plans to assess adherence to the principles, but should not include work to identify accepted design principles.

  2. Oral health disparities and/or inequities: When not already developed, applications must include a milestone that involves developing a robust plan for evaluating any changes to disparities or inequities caused by one or more study intervention(s).  
  3. Measurement of target engagement: Applications should include plans to measure the proposed intervention target(s) and the degree to which the intervention engaged (e.g., changed) the target(s). For instance, in planning for a study to test a tool meant to teach oral hygiene skills, the UG3 phase should demonstrate that oral hygiene skills can be accurately measured.
  4. Acceptability and feasibility of the study intervention(s) and procedures: If acceptability and/or feasibility of the intervention has not yet been established in the study population, the UG3 phase should propose activities necessary to ensure acceptability and feasibility. Relevant Stage I activities may include consultation with stakeholders, delivery of the intervention to gather feedback from participants and providers, and/or other activities. In addition to the acceptability and feasibility of the study intervention(s), planning activities should establish the acceptability and feasibility of proposed study procedures. If not already established, the UG3 planning phase should include pilot-testing of study procedures, such as participant recruitment, methods of data collection, interventionist training procedures, and other key aspects of study conduct.
  5. Finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, etc., as applicable.
  6. Finalization of the clinical protocol and other required study documentation: To ensure adherence to the principles of Good Clinical Practice (International Conference on Harmonisation (ICH) E6), required documentation will include a clinical protocol, clinical quality management plan, data quality management plan, and participant consent/assent forms and procedures. For some studies, additional documentation may be required; for instance, a Manual of Operations is typically required for multi-site studies where site-level procedures may vary. Applications should describe plans for developing relevant study documentation that will require NIDCR review and approval before progressing to the UH3 phase.
  7. Development of fidelity monitoring procedures: Monitoring the degree to which a study intervention is delivered as it was intended to be delivered (i.e., with fidelity) is expected at every stage of intervention development; although the way fidelity data is used differs depending on the stage of intervention development and the associated research question(s). For instance, in stages of intervention development where efficacy is being established, fidelity monitoring is used to ensure intervention fidelity, and to identify interventionists who may need re-training. For studies in later stages of intervention development where efficacy has already been established, and research questions concern effectiveness or implementation, fidelity data may be used to identify challenges to intervention delivery. If methods for monitoring the fidelity of intervention delivery are not already established, UG3 planning activities should include the development of these methods.
  8. Completion of the data management system
  9. Near-final drafts of all materials required for regulatory approvals (IRB and applicable oversight committees) and any other documents necessary to implement the trial

Clinical Trial Implementation Phase (UH3)

The UH3 award will provide up to 5 years of support to conduct the clinical trial in accordance with activities planned in the UG3 phase, and is contingent upon successful completion of the UG3 milestones. The NIDCR expects clinical trials supported during the UH3 phase to be hypothesis driven, milestone-defined, and to contribute meaningfully to a cumulative science of behavior change and public health research within the research mission of the NIDCR. The clinical trial must meet all applicable NIH, and Office of Human Research Protections (OHRP) policy requirements.

At a minimum, UH3 activities should include the following operational activities, expressed as UH3 milestones:

  • Completion of regulatory approvals and site activation
  • Registration of clinical trial in ClinicalTrials.gov
  • Enrollment of the first subject
  • Regular clinical and data quality management activities, including ongoing confirmation of intervention fidelity
  • If applicable, enrollment and randomization of 25%, 50%, 75%, and 100% of the projected study sample
  • Completion of data collection
  • Completion of primary study analyses
  • Completion of the final study report

Additional Information

The proposed clinical trial must meet all applicable NIH and Office for Human Research Protections (OHRP) policy requirements. Awardees are required to comply with the NIDCR Clinical Terms of Award and the NIDCR Policy on Data and Safety Monitoring for any planning phase activities that involve human subjects and all UH3 studies. It is recommended that applicants use the NIDCR tools and templates for development of the clinical trial documents, located in the NIDCR Toolkit for Clinical Researchers.

Potential applicants are encouraged to review the NIDCR interventional protocol template or the NIH e-Protocol Writing Tool both of which provide guidance for developing a comprehensive clinical protocol for behavioral, social, or organizational research. These protocol templates have further information about elements that should be included in a clinical trial and described in the Research Strategy and Protocol Synopsis of the grant application.

Applications developing and/or testing oral health promotion tools that meet the U.S. Food and Drug Administration (FDA) of a medical device are outside the scope of this FOA. Such applications may be submitted through NIDCR's Clinical Trial Planning and Implementation Cooperative Agreement Funding Opportunity (PAR-21-160). The NIH and the FDA use the term "digital therapeutics" to describe behavioral, social, and organizational tools that meet the definition of medical devices "digital therapeutics", and they differentiate these from tools meant to support general health and wellness. Investigators proposing the development of digital therapuetics are strongly encouraged to reach out to the appropriate FDA Center for Devices and Radiological Health (CDRH) office via the Pre-Submission process, to discuss plans for development and clinical validation: Q Submission Process.

Applications that propose multi-site studies with multiple domestic sites are subject to the NIH Single IRB policy as indicated in NOT-OD-16-094 and the Revised Common Rule cooperative research provision 45 CFR 46.114.

Applications proposing the following activities are considered outside the scope of this FOA, and will be returned without peer review:

  • Proposals to develop drugs, devices, or products that are regulated by the FDA
  • Proposals to develop tools solely meant to facilitate real-time communication for diagnostic or treatment purposes
  • Proposals of clinical studies that have delayed onset

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIDCR intends to commit $1.5 million in FY 2023 to fund 4-6 awards.

Award Budget

Application budgets are limited to less than $200,000 in direct costs per year for the two-year UG3 phase, or less than $300,000 in direct costs for a one-year UG3. Application budgets are not limited in the UH3 phase but need to reflect the actual needs of the proposed project.

Award Project Period

The UG3 phase may be up to 2 years, and the UH3 phase may be up to 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

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

Other

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

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

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

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

Required Registrations

Applicant Organizations

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

  • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • 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 full SAM and 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

In addition to the standard information described in the application guide, applications to this FOA must also include the following details, identified by header in the Research Plan section:

Introduction to the Application: The significance of the proposed trial must be stated clearly, and must be supported by the following:

  • A compelling argument of how the proposed study will contribute to a cumulative science of behavior change, and/or advance clinical practice.
  • A description of any novel theoretical concepts, approaches or methodologies, instrumentation or interventions that will be used in the proposed clinical trial.
  • For Stage V trials (i.e., implementation research), a strong rationale for why the intervention(s) is/are ready for implementation, including how efficacy of the intervention(s) has been established. .
  • A compelling rationale for the need to conduct the study, as well as the timeliness of the study. This may include preliminary data, clinical and/or preclinical studies, information in the literature, or knowledge of behavioral, social or biological mechanisms.

Research Strategy: The Research Strategy  must provide justification for the trial, including the following:

  • Proposed Stage of Intervention Research (e.g., Stage I Early intervention development or adaptation to Stage V Implementation research). For example, if proposing a Stage V Implementation study, provide evidence from previous trials that an intervention is efficacious.
  • The scientific rationale and justification for the selection of an intervention's "dose" or number of sessions, frequency, and modality of administration.
  • Rationale for the intervention and the behavioral or social targets it is hypothesized to engage, at a level of specificity that makes the rationale falsifiable.
  • Plans for testing whether the intervention engaged the hypothesized target(s), as well as efficacy or effectiveness.
  • Where applicable, plans for testing and/or ensuring that the study procedures and intervention(s) are feasible and acceptable to the target population and interventionists.
  • Plans for monitoring and/or ensuring fidelity of intervention delivery.
  • Justification for selecting the study variables, including a specific explanation of the hypothesized relevance of each to the clinical and statistical hypothesis being tested (i.e., the hypothesized role each variable plays in the causal chain; specification of variables as hypothesized moderators, mediators, or outcomes).
  • Identification and justification of accepted principles of technology design and behavioral/social/organizational intervention design that will guide the study methods.
  • Plans for evaluating the degree to which the study methods adhere to accepted principles for technology design and behavioral/social/organizational intervention design. If plans are to be developed during the UG3 phase, the application should describe activities proposed to develop these plans.
  • Plans for evaluating the degree to which the proposed technology-facilitated oral health promotion tool affects disparities or inequities in key outcomes or access to care. If plans are to be developed during the UG3 phase, the application should describe activities proposed to develop these plans.

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

The following modifications also apply:

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

The NIH announced a policy limiting allowable appendix materials (NOT-OD-17-098); however this FOA allows specific materials to be included as appendices that are otherwise disallowed by the general policy. Applications may include as appendices the following materials: focus group guides, structured interview schedules, blank questionnaires or surveys with instructions, observational coding systems, fidelity monitoring checklists and rating tools, and screenshots or wireframe diagrams of proposed interventions. These appendices should not include results or data from previous uses of the materials.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 2 - Study Population Characteristics

2.7. Study Timeline

Required Attachment: Study Timeline and Milestone Plan

For this specific announcement, applications should include an attachment describing both the Study Timeline and Milestone Plan, and should be saved as filename "Study Timeline and Milestone Plan".

Study Timeline. The Study Timeline should describe the proposed trial's schedule of events, capturing time points and planned activities at study visits or data collection events. Applicants are encouraged to use the Schematic of Study Design (Section 4) in the NIDCR Interventional Protocol Template. The Study Timeline should include acceptable time windows for each activity.

Applications that lack the Study Timeline are considered incomplete and will be withdrawn without peer review.

Milestone Plan. The Milestone Plan must describe separate milestones for the UG3 and UH3 phases.

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

  • Development of plans to ensure the study intervention(s) adhere to accepted principles of technology design and behavioral/social/organizational intervention design and testing;
  • Development of plans to assess changes in oral health disparities or inequities as a result of one or more study intervention(s);
  • Development of plans to measure intervention target engagement during the subsequent trial;
  • Collection and analysis of any data to assess the acceptability of the study intervention(s) or other procedures to the target population and feasibility of operations in the target setting;
  • Development of a late-stage draft of the clinical protocol;
  • Development of fidelity monitoring procedures;
  • Completion of the data management system;
  • Finalization of all materials required for regulatory approvals (IRB and applicable oversight committees);
  • Finalization of any other documents necessary to implement the trial.

Milestones to be completed during the UH3 phase should include:

  • Completion of regulatory approvals and site activation;
  • Registration of clinical trial in ClinicalTrials.gov.
  • Enrollment of the first subject;
  • If applicable, enrollment and randomization, of 25%, 50%, 75% and 100% of the projected study population;
  • Completion of data collection;
  • Completion of primary study analyses;
  • Completion of final study report.

Applications that lack the Milestone Plan are considered incomplete and will be withdrawn without peer review.

Delayed Onset Study

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

Delayed onset studies will not be supported by this FOA. Do not enter a delayed onset study, as the UH3 trial should not be considered a delayed onset study.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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 FOA 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

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

Investigator(s)

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

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

Innovation

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

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

Approach

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

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

Specific for this FOA:

For this particular announcement, note that the following additional review criteria related to the Approach will be evaluated:  

Are the proposed research activities described in terms of Stage of intervention research, and are the activities appropriate and justified given the Stage of intervention research?

Are the scientific rationale and justification compelling for the selection of an intervention's "dose" or number of sessions, frequency and modality of administration?

Is there a strong rationale for the intervention and the behavioral or social target(s) it is hypothesized to engage? Is the rationale described at a level of specificity that makes it potentially falsifiable? Are there sufficient plans for testing and/or ensuring intervention target engagement?

Where applicable, are there rigorous plans for testing and/or ensuring that the study procedures and study intervention(s) are feasible and acceptable to the target population and interventionists?

Does the application propose acceptable plans for monitoring and/or ensuring fidelity of intervention delivery?

Does the application adequately justify the selection of study variables, including a specific explanation of the hypothesized relevance of each to the clinical and statistical hypothesis being tested (i.e., the hypothesized role each variable plays in the causal chain; specification of variables as hypothesized moderators, mediators, or outcomes)?

Does the application identify compelling principles for technology design and for design of behavioral, social, or organizational interventions? Are there robust plans for ensuring the study methods adhere to accepted principles, or if plans are to be developed during the UG3 planning phase, are the development activities likely to yield robust plans?

Does the application include a strong evaluation of the degree to which the study intervention(s) affect oral health disparities or inequities, or if the evaluation will be developed during the UG3 planning phase, are the development activities likely to yield a strong plan?

Does the application include a strong Data Sharing Plan describing how and when final research data and study materials will be available in the public domain, managed by the grant applicant institution, and consistent with applicable NIH data sharing policies?

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

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

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

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

Additional Review Criteria

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

Milestone Plan

Does the application describe separate milestones for the UG3 and UH3 phases of the project? Do the milestones include the required milestones for each phase of the project? Are the milestones appropriate and feasible for the research proposed? Do the UG3 milestones describe the major planning activities required to prepare for the UH3 phase?

Study Timeline


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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

* All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators are the PD(s)/PI(s) responsibilities. The recipient agrees to accept close coordination, cooperation, and participation of NIDCR staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.

  • The PD(s)/PI(s) will meet NIDCR policy requiring that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study (NOT-DE-21-014, September 24, 2021).
  • Upon implementation of the protocol, each study, whether a single entity or a consortium of entities, will follow the procedures required by the protocol regarding study conduct and monitoring, participant management, data collection, and quality control.

The PD(s)/PI(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

  • The PD(s)/PI(s) will manage involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIDCR.
  • The PD(s)/PI(s) will make study materials and procedure manuals available in the public domain, consistent with NIH policies on resource and data sharing, intellectual property, and other relevant considerations. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDCR/NIH.
  • The PD(s)/PI(s) will obtain prior written approval of the NIDCR Grants Management Specialist, in consultation with the NIDCR Program Officer, for changes in any of the key personnel identified in the Notice of Grant Award.

NIH staff will have the following primary responsibilities:

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

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

  • Providing input on experimental and clinical approaches, assisting in designing protocols, and consulting on updates to project milestones;
  • Assisting and advising recipients with regard to various regulatory and compliance issues;
  • Participating in monthly teleconferences with PDs/PIs to monitor progress and facilitate cooperation;
  • Monitoring progress of the trial towards meeting its primary outcome;
  • Tracking monthly accrual of participants; and
  • Reviewing the progress of the study, and of each participating component, through consideration of the annual reports, site visits, logs, etc. This review may include, but not be limited to, compliance with the study protocol, meeting subject enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

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

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

Dispute Resolution:

With the exception of the decision about transitioning to the UH3 phase, any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Members will be: a designee chosen by the PD/PI, 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 DHHS regulation 45 CFR Part 16.

3. 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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

Melissa W. Riddle, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 451-3888
Email:riddleme@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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

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