Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIDCR recognizes that behavioral and social factors play a role in many dental, oral and craniofacial (DOC) disorders and conditions, and that behavioral and social interventions have the potential to improve these conditions by targeting key behavioral and social factors. The NIDCR is committed to supporting the development and testing of behavioral and social interventions to improve DOC health, and to supporting careful planning for these intervention studies. The purpose of this FOA is to provide support for planning well-designed, rigorously-conducted behavioral or social intervention studies relevant to DOC health.

The NIDCR will only support behavioral or social intervention clinical trials that are developed using rigorous, designs, with full written documentation of all procedures necessary for study implementation. The quality of the planning, design, and documentation products for such studies are given key consideration when the NIDCR considers supporting a clinical trial. To help grantees meet these essential standards, the NIDCR encourages investigators proposing investigator-initiated interventional clinical trials to utilize a two-part grant process: (1) a behavioral or social intervention study planning grant (R34) followed by (2) a clinical trial implementation cooperative agreement (U01) award. The intent of the R34 planning phase is to provide support for the planning activities required to prepare for a rigorous clinical trial. This FOA, NIDCR Behavioral or Social Intervention Planning Grant (R34), addresses the R34 grant; a companion FOA, PAR-11-339 "NIDCR Clinical Trial or Biomarker Clinical Validation Study Implementation Cooperative Agreement (U01)", addresses the clinical trial or study implementation cooperative agreement. Applicants planning for a non-behavioral clinical trial, or a biomarker clinical validation study, should respond to the appropriate NIDCR announcement. For activities to plan for a clinical trial testing drugs and devices, or to conduct a biomarker validation study, applicants should consult the announcement entitled NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant PAR-14-346.

The NIDCR expects that receipt of an R34 planning grant will lead to the timely submission of an application for U01 grant support to conduct a study of the proposed behavioral or social intervention, incorporating the elements developed under the planning grant. However, prospective applicants should note that funding of an R34 planning grant does not guarantee or imply funding for a subsequent clinical intervention implementation application. For NIDCR policies and procedures about the acceptance, peer review, and funding of investigator-initiated clinical trials, see NOT-DE-08-002 "New NIDCR Policy: Investigator-Initiated Clinical Trials".

This R34 announcement is appropriate for applicants planning for a behavioral or social intervention clinical trial. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Studies proposing to test the efficacy or effectiveness of behavioral or social interventions are considered clinical trials, regardless of whether the intervention is in early stages of development (e.g., Stage I, iterative testing for acceptability and feasibility, etc.), or has demonstrated efficacy and effectiveness (e.g., Stage IV, ready for dissemination and implementation research).

Clinical studies conducting basic behavioral or social sciences research are not considered clinical trials. For the purposes of this announcement, the NIDCR uses the definition of basic behavioral and social sciences research developed by the Office of Behavioral and Social Sciences Research (OBSSR), National Institutes of Health: Basic research in the behavioral and social sciences is designed to further our understanding of fundamental mechanisms and patterns of behavioral and social functioning, relevant to the Nation’s health and well-being, and as they interact with each other, with biology and the environment. As is the case with basic biomedical research, basic behavioral and social sciences research does not address disease outcomes per se. Rather, it is designed to elucidate knowledge about underlying mechanisms and processes Examples of such studies include laboratory-based studies in which behavioral or social probes are used to evoke participants responses (e.g., emotional regulation, dental fear, social norms) under varied conditions, and for which proximal behavioral or social outcomes but not disease outcomes--are assessed. Such studies are sometimes referred to as Type 1 translation studies, or studies that seek to ensure that a particular manipulation actually engages the behavioral or social target it intends to engage. Applications that propose a basic behavioral or social clinical study should apply for support via the parent R21 or R01 FOAs. Applicants are encouraged to contact the NIDCR to discuss which FOA is appropriate for any particular study.

The R34 planning grant process is designed to:

• permit early peer review of the rationale for the proposed behavioral or social intervention clinical trial;

• permit early assessment of the design of the proposed trial; and

• provide support for the development of a complete behavioral or social intervention manual, clinical protocol and associated documents, and other elements necessary to prepare for a clinical trial.

The R34 grant award will provide one year of support for activities directed towards the planning and design of a behavioral or social intervention clinical trial study. For this announcement, planning activities may include the development of a behavioral or social intervention manual; a comprehensive clinical trial protocol and manual of procedures (MOP); a draft of materials for Institutional Review Board (IRB) evaluation; the tools for data analysis and management, participant safety and operational oversight; certain feasibility and acceptability testing; and other activities necessary to prepare for a subsequent clinical trial. The different documents developed during the planning phase serve different purposes, but each is an important part of study planning.

Behavioral or Social Intervention Manual. The intervention manual is a document that describes in detail the content and delivery of the intervention. The intervention manual should describe how to conduct the intervention, how to train the interventionists, how to monitor fidelity in delivering the intervention, and the rationale for the specified intervention. A clear statement of the rationale for the intervention will include the hypothesized:

• explanation of the problem;

• behavioral or social targets the intervention is intended to engage;

• rationale for why the intervention is expected to engage the target(s); and,

• rationale for why engaging these targets is expected to contribute to solving the problem.

Clinical Trial Protocol and Manual of Procedures. The clinical trial protocol is a document that describes in detail how the study will be conducted, and is expected to follow the NIDCR clinical trial protocol template format, which adheres to International Conference on Harmonisation (ICH) E6 Good Clinical Practice Consolidated Guidance. The manual of procedures is a companion document to the protocol containing site-specific instructions for study operations, and other standard operating procedures. Please see the NIDCR website for protocol and MOP templates and instructions: http://www.nidcr.nih.gov/Research/toolkit/#startup2).

Institutional Review Board (IRB) Application(s). The R34 planning grant supports the development of applications to IRBs that will be responsible for reviewing and approving subsequent clinical trials. The NIDCR recognizes that IRB requirements and documentation vary across institutions, and supports investigators in providing the documentation required by any particular IRB. In cases where approval from more than one IRB will be required, the R34 planning phase will support the development and harmonization of applications across institutions.

Feasibility and Acceptability Testing. Where applicable, this announcement will support small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated methods. Data collection instruments used during the R34 project period should be limited to those that assess feasibility and/or acceptability of a planned behavioral or social intervention. Collection of data for the purposes of determining efficacy or effectiveness of an intervention, whether on a small or large scale, will not be supported under this funding opportunity announcement (FOA). Also, activities associated with developing new instruments, or establishing reliability or validity of measures, will not be supported during the R34 planning grant. Examples of activities supported by this announcement include, but are not limited to:

• Delivery of the planned behavioral or social intervention to a small number of participants, sufficient to determine the acceptability of the intervention to the target participants.

• Delivery of the behavioral or social intervention in the target setting, with collection of data about feasibility of conducting the study in that setting.

• Comparison of assessment measures delivered via different modalities, using a sample size adequate for understanding participant preference and performance.

• Training of a sample of interventionists in the planned behavioral or social intervention, with assessment of fidelity in delivering the intervention after training.

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

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)

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)

• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
Telephone: 301-594-5593
Fax: 301-480-8303
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.

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.

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

Specific Aims: The application should state clearly both the specific aims of the R34 planning period, and the goals of the proposed future behavioral or social intervention trial. At a minimum, one specific aim for the R34 planning period should include development of the clinical protocol and other supporting documentation required for the future trial. The application should clearly describe how the proposed R34 planning activities prepare for the future trial, including R34 activities required to finalize the design or methods of the future trial. For behavioral and social intervention studies, appropriate outcomes may be one or more dental, oral or craniofacial (DOC) health behavior(s); outcomes need not be clinical measures of DOC health if DOC health is expected to be a distal outcome of an intervention to change behavior.

Research Strategy:

• Significance

• The application should describe the significance of the proposed clinical trial, with a clear explanation of the importance of the proposed behavioral or clinical endpoints. There should be a discussion of the need for the trial or study, and how the trial or study will test the proposed hypothesis(es).

• The application should describe the rationale for selection of the proposed behavioral or social intervention, including the hypothesized cause of the problem to be addressed, the hypothesized behavioral targets of the proposed intervention, and the hypothesized result of intervening on those targets.

• The application should describe the major findings of basic and applied behavioral, social and other studies that support the proposed clinical trial.

• The application should describe the potential of the clinical trial results to improve our knowledge of behavioral or social contributions to the clinical condition, improve clinical outcomes or change health care policy, and/or to change clinical practice.

• If the application prepares for an effectiveness study, efficiency study, or dissemination and implementation study, the generalizability of potential findings should be discussed. This includes describing how findings from studies conducted at foreign sites will impact health care delivery or policy in the US, if that is the intent of the trial or study.

Innovation

• The application should challenge and seek to shift current research or clinical practice paradigms, either: 1) by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions; or: 2) by translating and applying concepts or methodologies from other fields to DOC health. The application should present a compelling argument of how the proposed clinical trial will shift behavioral or social interventions for DOC health, clinical practice paradigms, or health care policy.

Approach

The application should state clearly both the planning activities that will be accomplished during the R34 period, and the preliminary approach for the future clinical trial. The following aspects of the R34 planning approach and subsequent trial approach should be included:

• A description of and justification for the design of the proposed future study;

• Rationale for the selected behavioral or social intervention;

• Preliminary primary and secondary outcome variable(s) and data to be collected, including relevance to the clinical and statistical hypothesis being tested;

• Preliminary statistical plan and sample size estimate;

• Preliminary organizational structure for the administration and management of the subsequent trial, especially where multiple sites are involved; and

• Justification that conducting a study at foreign sites will change health care practices or policy in the U.S., if that is the intent of the future trial.

• Plans to develop the behavioral or social intervention manual, interventionist training procedures, and methods for monitoring intervention fidelity;

• Plans to develop a leadership structure appropriate to the complexity of the clinical trial;

• Plans to develop the clinical protocol, draft manual of procedures, quality management processes, etc.;

• A plan for the selection of potential clinical sites, including how they will be evaluated for inclusion in the future study;

• A discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed;

• A projection of the initial time line for implementing and completing the trial or study.

Although the R34 planning grant supports planning activities, the application should provide sufficient detail about the subsequent clinical trial to allow early assessment of the proposed rationale and dosing of the clinical trial. Planning activities such as evaluating the potential study population to determine the number of subjects at a site that would fulfill eligibility criteria for the future trial is allowed. Applicants are encouraged to clearly distinguish between activities proposed for the R34 planning phase, and those proposed for the subsequent U01 implementation phase. Applicants are also encouraged to identify those R34 activities that are necessary in order to finalize aspects of the subsequent U01 clinical trial application. For example, the R34 planning phase may be necessary to determine who should deliver an intervention (dental office staff, research staff), how data should be collected (by computer, by phone, in person by interview), and whether the proposed schedule of study visits is acceptable to participants. In such cases, study procedures for the subsequent U01 project depend on the results of the R34 planning phase, and so should be described as tentative in the R34 application.

All R34 applications (regardless of whether they involve HS in the planning phase or not) should provide a plan and documentation for HS protection in a subsequent U01 for all behavioral or social intervention clinical trials. Applicants should include a description of the requisite study population with preliminary estimates of its availability, and describe plans to develop recruitment, outreach, follow-up and retention strategies. In addition, plans for addressing any ethical and safety issues, and challenges anticipated regarding the proposed intervention should be included.

Human Subjects Protections: R34 applications that involve human subjects to test for feasibility and/or acceptability of a behavioral or social intervention should fully address the HS protections. Applicants are encouraged to distinguish clearly between HS involvement during the R34 phase, and HS involvement proposed for the subsequent U01 clinical trial implementation or application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 Applying Electronically.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following 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? 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?

• Is the significance of the proposed behavioral or social intervention clinical trial clearly supported?

• Is there clear rationale for selecting the proposed behavioral or social intervention, including the hypothesized cause of the problem to be addressed, the hypothesized behavioral targets of the proposed intervention, and the hypothesized result of intervening on those targets?

• Is there a compelling description of why the study is needed and is not duplicative of existing research?

• For applications preparing for an effectiveness study, efficiency study, or dissemination and implementation study, is there adequate discussion of the generalizability of potential findings, including, if applicable, how findings from studies conducted at foreign sites will impact health care delivery or policy in the US?

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?

For multidisciplinary projects, does the investigator team have sufficient range and depth of expertise to design, conduct and complete the proposed study? Is there appropriate professional experience in administration of complex projects, development of an appropriate study design, study team, and committee structure appropriate to the complexity of the trial or study?

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 application present a compelling argument of how the proposed clinical trial will shift behavioral or social interventions for DOC health, clinical practice paradigms, or health care policy?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

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 children, justified in terms of the scientific goals and research strategy proposed?

For activities proposed as part of the R34 approach:

• Are there clear plans to develop the behavioral or social intervention manual, interventionist training procedures, and methods for monitoring intervention fidelity?

• Are the clear plans to develop a leadership structure appropriate to the complexity of the clinical trial?

• Are there clear plans to develop the clinical protocol, draft manual of procedures, quality management processes, etc.?

• Are there appropriate plans for the selection of potential clinical sites, including how they will be evaluated for inclusion in the future study?

• Is there an adequate discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed?

• Is the projected time line for implementing and completing the trial or study feasible?

• For any aspect of the clinical trial approach that depends on results of the R34 planning activities, is there an adequate description of the planning activity/ies that will inform the clinical trial approach?

For the proposed approach for the future clinical trial:

• Is the description of, and rationale for, the proposed future study design appropriate to the research question(s) posed?

• Is the rationale for the selected behavioral or social intervention compelling?

• Is there an adequate justification for preliminary primary and secondary outcome variable(s) and data to be collected, including relevance to the clinical and statistical hypothesis being tested?

• Is the preliminary statistical plan and sample size estimate appropriate to the research question(s) and study design? and

• Is there strong justification that conducting a study at foreign sites will change health care practices or policy in the US, if that is the intent of the future trial?

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? Are adequate facilities in place to conduct clinical trials or biomarker clinical validation studies? Is there a plan to determine if study populations required for the proposed study are available at the proposed clinical site(s)?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Children

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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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) Genome Wide Association Studies (GWAS).

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.

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

As part of the scientific peer review, all applications:

• 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.

• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the 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.

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.

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

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 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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]

Dave Clark, DrPH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
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]

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 Parts 74 and 92.