Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this initiative is to support intervention research aimed at equipping the dental workforce in meeting the unique needs of people living with HIV (PLWH) or at risk of contracting HIV. This initiative aligns with the United States Department of Health and Human Services (DHHS) plan, “Ending the HIV Epidemic: A Plan for America,” which identifies four broad goals: 1) Diagnose individuals infected with HIV as soon as possible after infection; 2) Treat HIV infection rapidly and effectively to achieve sustained viral suppression; 3) Protect people at risk for HIV using potent and proven prevention strategies, including Pre-exposure Prophylaxis (PrEP); and 4) Respond rapidly to detect growing HIV clusters and to prevent new HIV infections. Dental care providers may have unique opportunities to contribute to these efforts, but there are also significant challenges. Among the most commonly-cited challenges are concerns about patient acceptability, the need for appropriate provider training and support, fitting HIV-related services into the dental clinic workflow, complex and variable laws related to HIV service-provision, and billing and reimbursement systems necessary for sustainability. This FOA encourages research to develop evidence-based approaches that allow members of the dental workforce to contribute to ending the HIV epidemic, and that address one or more challenges currently preventing such efforts. Applications in response to this FOA should propose to develop, adapt, and/or test interventions to equip dental care providers to participate in and/or to provide HIV-related services, consistent with those identified in the DHHS plan. Proposed interventions should address one or more challenges currently preventing greater participation by dental care providers, and may aim to overcome barriers at any relevant socioecological level (e.g., providers, patients, communities, clinics, care organizations). 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 of up to five years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase.

Background

There are 1.1 million people living with HIV in the U.S., 14% of whom are unaware of their infection status. Infection rates are not distributed equally in the population. Among the 40,000 newly diagnosed HIV infections in 2017, 21% occurred in young people, 13-24 years old. Men who have sex with men (MSM) bear the greatest burden of HIV, with the majority of new infections occurring among members of this group who are Black/African American or Hispanic/Latino. There are also notable disparities in the geographic distribution of HIV infection. Of the 3,007 counties in the United States, over 50% of new HIV infections in 2016-2017 occurred in only 48 counties along with Washington, DC and San Juan, Puerto Rico. These densely populated areas of concentrated HIV infection are paralleled by notable disparities in rural areas, especially 7 states in the Southeast with a high burden of HIV.

Fortunately, powerful tools already exist to detect, treat, and prevent HIV infection. In the realm of screening, rapid tests can produce a reliable result in as little as 30 minutes using a saliva sample, and self-test kits have made at-home testing possible. Current treatment strategies for HIV include many FDA-approved, Anti-Retroviral Therapies (ART) that increase the life expectancy of newly diagnosed subjects by an average of 53 years. Beyond their capacity for extending life, when treatment regimens are taken as prescribed, ARTs can suppress viral load to such an extent that risk of sexual transmission to others is essentially eliminated., inspiring the message that “undetectable equals untransmissible” (U=U). Individuals who are not HIV positive but are at risk may be candidates for pre-exposure prophylaxis (PrEP) regimens that are more than 95% effective in preventing HIV infection if taken daily.

Dental care providers have played important roles in addressing the HIV epidemic, recognizing patterns of oral disease among affected patients early in the epidemic, and developing practice guidelines that consider HIV status in treatment planning. Dental care providers are well-positioned to contribute to even broader efforts, potentially by providing HIV testing, supporting individuals in preventive care or treatment, or working to coordinate care in HIV “hot spots” where needs are greatest. Early empirical research points to specific opportunities to improve both HIV control and dental care, but also finds significant challenges, including acceptability to patients, preparedness of providers, legal liability, and cost. This FOA encourages research to develop evidence-based approaches appropriate for the dental setting and dental scope of practice, that allow members of the dental workforce to contribute to ending the HIV epidemic, and that address one or more challenges currently preventing such efforts.

Specific Areas of Research Interest

HIV-Related Services. Applications responding to this FOA must clearly identify the HIV-related service(s) or activities in which they aim to engage dental care providers. Interventions are expected to engage dental care providers in HIV-related services that are relevant to at least one of the four main goals identified in the DHHS plan listed below, with just a few examples (offered for illustration; not a comprehensive list) of how these activities might translate into the dental setting:

1. Diagnose HIV as quickly as possible after infection (e.g., recommending HIV testing to all eligible patients; providing rapid HIV screening to all eligible dental patients; screening under-served individuals who may not have other interactions with healthcare providers);
2. Treat HIV infection (e.g., coordinating care with other providers for HIV+ patients; supporting adherence to HIV treatment regimens; extending the reach and effectiveness of HIV treatment among under-served communities to address health disparities or inequities);
3. Prevent HIV infection (e.g., screening for HIV risk, providing brief advice intervention, and referring for pre-exposure prophylaxis (PrEP) treatment, sometimes called an SBIRT approach; increasing awareness and access to HIV prevention among under-served communities) and/or
4. Respond rapidly to HIV infection “hotspots” (e.g., participating in community surveillance or health/wellness campaigns; coordinating HIV testing and referral activities with other community leaders and care providers; assist in identifying and responding to emerging health disparities and HIV-related community needs).

Barriers to Participation of Dental Care Providers. Interventions are expected to address one or more barriers to participation of dental care providers in HIV-related services or activities. These barriers may be documented in prior research, or may be newly-identified (e.g., unique to a specific geographic region or clinic setting). Common barriers cited in the literature include those below, but applications may propose to address any barriers, with sufficient justification:

• Concern about patient acceptability of HIV screening in the dental setting;
• Need for provider training in how to deliver rapid HIV testing, including pre- and post-test counseling;
• Time constraints during a dental visit, and/or questions about how to fit HIV-related activities into the clinic workflow;
• Cost of supplies, staff time, analysis of samples, documentation, etc., and/or no clear mechanism for reimbursement;
• Legal liability and uncertainty about mandates related to HIV testing and care (e.g., variability in laws regarding informed consent, requirements for pre- and post-test counseling, mandatory reporting, HIV-specific criminalization).

Stage of Intervention Research. Research on the role of dental care providers in different HIV-related activities is at different stages of development, with the most attention given to integrating HIV testing into dental clinics. As such, depending on the availability, nature, and results of prior research, applications may propose intervention research at any stage of intervention development. Applications must indicate the stage of intervention development characterizing the proposed study, and proposed research activities are expected to be appropriate for the designated stage, using the NIH Stage Model as a guide:

• Stage I - Development of novel brief screening tools or provider interventions; Adaptation of brief behavioral interventions used in other settings or fields for use with dental providers addressing HIV
• Stage II – Fully-powered efficacy testing of promising behavioral or social intervention, delivered by research interventionists
• Stage III – Fully-powered efficacy testing of established behavioral or social intervention, delivered by practitioner-interventionists, maximizing internal validity
• Stage IV - Fully-powered effectiveness testing of established behavioral or social intervention, delivered by practitioner-interventionists, maximizing external validity
• Stage V – Implementation science studies testing how to incorporate an established intervention into dental practice, focusing on aspects of the care delivery system

Scope of the UG3/UH3 Mechanism

Clinical Trial Planning Phase (UG3)

The UG3 award will provide up to 2 years of support for scientific and operational planning activities necessary—and not yet completed--to prepare for conduct of a subsequent clinical trial. When not yet already completed, at a minimum, the following UG3 planning activities are required, and must be included as UG3 milestones:

• Acceptability and feasibility of the study intervention(s) or 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 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.
• If applicable, finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, electronic health records systems, etc.
• 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) ), required documentation will include a clinical protocol, clinical quality management plan, data quality management plan, and participant consent/assent forms and procedures.
• Fidelity monitoring procedures. Monitoring the degree to which a study intervention is delivered as it is 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 must include the development of these methods. For interventions delivered by computer, smartphone, or other technologies, fidelity of intervention delivery may be assured by the platform. However, fidelity of intervention receipt may need to be tracked (e.g., were text messages read? Were prompts in the electronic health record accessed?)
• Completion of data management system(s).
• Finalization of all materials required for regulatory approvals (IRB and applicable oversight committees).
• Finalization of all documents necessary to implement the trial (e.g., case report forms, etc.).

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 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 must 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
• 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

UG3/UH3 Transition

At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request to progress to the UH3 clinical trial implementation phase. UH3 transition requests will undergo administrative review by NIH staff to determine whether the study will be awarded the implementation phase (UH3). Transition decisions will be based on success in meeting study milestones, readiness to conduct the UH3 clinical trial, feasibility of completing the UH3 clinical trial, availability of funds, and program priorities.

Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 clinical trial implementation phase. 

Additional Information

Awardees are required to comply with the NIDCR Clinical Terms of Award for any planning phase activities that involve human subjects and all subsequent UH3 implementation phase studies. It is recommended that applicants use the NIDCR tools and templates for development of the clinical trial documents. The details can be found at the following websites: NIDCR Clinical Terms of Award and NIDCR Toolkit for Clinical Researchers.  Implementation of the Clinical Terms of Award ensures that the conduct of the clinical trial meets widely-accepted standards for ethical and rigorous research.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant organizations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

Letter of Intent

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

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

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

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Telephone: 301-594-5593
Email: [email protected]

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

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.

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

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

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

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

Milestone Plan

The filename "Milestone Plan" should be used to name this attachment. 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:

• 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;
• Finalization of agreements for use of resources available within CTSAs, practice-based research networks, patient registries, electronic health records systems, etc.;
• Finalization of the clinical protocol and other required study documentation;
• Finalization of intervention fidelity monitoring procedures;
• Completion of data management system(s);
• Finalization of all materials required for regulatory approvals (IRB and applicable oversight committees);
• Finalization of any other documents necessary to implement the trial, such as case report forms.

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

• 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.

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.

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

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

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

Applicants are encouraged to address the following elements in the research strategy section of the Research Plan:

• A rationale for why dental care providers might contribute to/provide the HIV service(s) proposed in the application.
• An explanation of how the proposed HIV service(s) fit(s) with at least one of the four goals in the DHHS plan, “Ending the HIV Epidemic: A Plan for America”.
• A justification for the application’s focus on one or more specific challenges that currently make it difficult for dental care providers to contribute to/provide HIV services.
• A justification for the intervention proposed in the application, and how it is hypothesized to overcome current challenges to dental care providers’ contribution to/provision of HIV services.
• A description and justification of the stage of intervention research, using the NIH Stage Model as a guide (e.g., Stage I Early intervention development/adaptation to Stage V Implementation science).
• 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 for how it is hypothesized to produce its effect(s), at a level of specificity that makes the rationale falsifiable.
• Plans for testing whether the intervention “worked” (i.e., produced its effects) in the way hypothesized, as well as testing for efficacy, effectiveness, or implementation outcomes.
• Plans for monitoring and/or ensuring fidelity of intervention delivery and/or receipt.
• Rationale for the intervention study design (e.g., single case study, multiple baseline, adaptive/SMART design, factorial) and allocation method.
• 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).

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:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

The following modifications apply:

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, questionnaires or surveys with instructions, observational coding systems, fidelity monitoring checklists and rating tools, and draft or sample intervention manuals. These appendices must not include results or data from previous uses of the materials.

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.

For projects that involve more than one clinical trial during the UH3 phase, add a separate study record for each proposed clinical trial. The research strategy section of the application should provide justification for each proposed trial, including justification for the proposed intervention and the barrier(s) it is hypothesized to address, the stage of intervention research, intervention fidelity procedures, and the causal model or mechanisms to be tested.

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.

The delayed onset designation does not apply to this FOA. While human subjects recruitment may not start immediately after successful transition from the UG3 to the UH3, this is considered a delayed start study, and not a delayed onset study.

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.

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.

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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Section V. Application Review Information

1. Criteria

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

In addition, for applications involving clinical trials:

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

For this particular announcement, note the following: For example, a Clinical Trial application could propose to adapt an evidence-based intervention from another discipline or health condition that is relatively new to the field of dental, oral, or craniofacial health. In addition, a proposed intervention need not be widely generalizable or sustainable in its current form in order to have merit. This FOA recognizes the value of multiple approaches to intervention research, including approaches that aim to maximize efficacy with future streamlining in mind, those that aim to develop interventions that fit the current limitations of the care delivery system, and those that aim to test interventions as a way to understand the principles of tailoring and implementation in different settings.

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).

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?

In addition, for applications involving clinical trials

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

In addition to the standard review criteria, the following criteria should be assessed for applications responding to this FOA:

Does the application provide:

• A clearly-articulated rationale for why dental care providers might contribute to/provide the HIV service(s) proposed in the application?
• A compelling explanation of how the proposed HIV service(s) fit(s) with at least one of the four goals in the DHHS plan, “Ending the HIV Epidemic: A Plan for America”?
• A strong justification for the application’s focus on one or more specific challenges that currently make it difficult for dental care providers to contribute to/provide HIV services?
• A strong justification for the intervention proposed in the application, and how it is hypothesized to overcome current challenges to dental care providers’ contribution to/provision of HIV services?

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?

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

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

Approach

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

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

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

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

Data Management and Statistical Analysis

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

Specific to this FOA:

Does the application provide:

• An appropriate description and justification of the stage of intervention research, using the NIH Stage Model as a guide (e.g., Stage I Early intervention development/adaptation to Stage V Implementation science)?
• A compelling scientific justification for the selection of an intervention's "dose" or number of sessions, frequency, and modality of administration?
• A compelling rationale for the intervention and for how it is hypothesized to produce its effect(s), at a level of specificity that makes the rationale falsifiable?
• Rigorous plans for testing whether the intervention “worked” (i.e., produced its effects) in the way hypothesized, as well as testing for efficacy, effectiveness, or implementation outcomes?
• Appropriate plans for monitoring and/or ensuring fidelity of intervention delivery and/or receipt?
• A compelling rationale for the intervention study design (e.g., single case study, multiple baseline, adaptive/SMART design, factorial) and allocation method?
• Strong 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)?

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?

Environment

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

In addition, for applications involving clinical trials

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

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

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

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

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

Study Milestones

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

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

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

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 to the National Institute of Dental and Craniofacial Research. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

Any application awarded in response to this FOA will be subject to 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: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

2. Administrative and National Policy Requirements

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

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

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

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

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

• The PD(s)/PI(s) will meet NIDCR policy requiring that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study (NOT-DE-19-008, August 28, 2019).
• Upon implementation of the protocol, each study, whether a single entity or a consortium of entities, will follow the procedures required by the protocol regarding study conduct and monitoring, participant management, data collection, and quality control.

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

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

NIH staff will have 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 awardees with regard to various regulatory and compliance issues;
• Participating in monthly teleconferences with PDs/PIs to monitor progress and facilitate cooperation;
• Monitoring progress of the trial towards meeting its primary outcome;
• Tracking monthly accrual of participants; and
• Reviewing the progress of the study, and of each participating component, through consideration of the annual reports, site visits, logs, etc. This review may include, but not be limited to, compliance with the study protocol, meeting subject enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.

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

Areas of Joint Responsibility:

As appropriate to a funded clinical trial, the following collaborative responsibilities will be incorporated in the grant award:

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.

3. 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.

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

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

Section VII. Agency Contacts

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

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: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Melissa Riddle, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: [email protected]

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]

Diana Rutberg, MBA

National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

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 45 CFR Part 75.