Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34)
Activity Code	R34 Clinical Trial Planning Grant Program
Announcement Type	New
Related Notices	December 3, 2010 - Notice of Informational Web Seminar for RFA-DE-12-001. See NOT-De-10-005.
Funding Opportunity Announcement (FOA) Number	RFA-DE-12-001
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.121
FOA Purpose	The purpose of the NIDCR Behavioral or Social Intervention Planning and Pilot Data Grant (R34) program is to support the planning, design, documentation, and pilot data collection for investigator-initiated studies of behavioral or social interventions relevant to oral, dental or craniofacial health. This program is intended to provide support for the development of a comprehensive clinical trial protocol (i.e., behavioral or social intervention study protocol), associated documents, and collection of pilot data. The complete protocol, associated documents, and pilot data are required components of any subsequent clinical trial implementation (U01) application. The product of successful R34 funding will be either an application for a clinical trial implementation cooperative agreement (U01), or a report summarizing the work completed and the reasons for not proceeding to a clinical trial implementation application.

Posted Date	November 16, 2010
Open Date (Earliest Submission Date)	December 10, 2010
Letter of Intent Due Date	December 10, 2010
Application Due Date(s)	January 10, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review	June, 2011
Advisory Council Review	August, 2011
Earliest Start Date(s)	September, 2011
Expiration Date	January 11, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

1) Purpose

The NIDCR recognizes that behavioral and social factors play a role in many oral and craniofacial disorders and conditions, and that behavioral and social interventions can improve these conditions. The NIDCR is committed to supporting the development and testing of behavioral and social interventions to improve oral health, and to supporting careful planning for these intervention studies. The purpose of this NIDCR BEHAVIORAL OR SOCIAL INTERVENTION PLANNING AND PILOT DATA GRANT (R34) is to provide support for planning a well-designed, rigorously-conducted behavioral or social intervention study relevant to oral, dental or craniofacial health.

This R34 grant mechanism is intended to provide support for the development of a comprehensive clinical trial protocol (i.e., for this FOA, a behavioral or social intervention manual and study protocol), associated documents, and collection of pilot data. The behavioral or social intervention manual is a document that describes in detail the content and delivery of the intervention. The study protocol is a document that describes in detail how the study will be conducted (please see the NIDCR website for templates of minimal risk and more-than-minimal risk protocols: http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/ClinicalTrialsProtocolTemplate/. For studies involving human subjects, other required associated documents include an IRB application and participant consent or assent forms (to be submitted before the full-scale trial is implemented); a detailed data and safety monitoring plan; and letters of agreement from clinic sites or other collaborators (where applicable). The behavioral or social intervention manual, complete study protocol and these other associated documents are required components of any subsequent clinical trial implementation (U01) application. 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 behavioral or social intervention, incorporating the elements developed under the planning grant. However, prospective applicants should note that funding of a R34 planning grant does not guarantee or imply funding for a subsequent clinical intervention implementation application. For NIDCR policies and procedures for the acceptance, peer review, and funding of investigator-initiated clinical trials, see NOT-DE-08-002 New NIDCR Policy: Investigator-Initiated Clinical Trials http://grants.nih.gov/grants/guide/notice-files/NOT-DE-08-002.html. )

2) Distinctions between this announcement and the standard R34 NIDCR CLINICAL TRIAL PLANNING GRANT

Features that distinguish this NIDCR BEHAVIORAL OR SOCIAL INTERVENTION PLANNING AND PILOT DATA GRANT (R34) announcement from the standard NIDCR CLINICAL TRIAL PLANNING GRANT (R34) (PAR-08-195) are the focus on behavioral or social interventions, the allowable project length and budget, the waiving of the requirement for prior approval, and the allowed support of primary pilot data collection.

This FOA announcement solicits applications to plan for behavioral or social intervention trials that address oral, dental or craniofacial diseases or conditions. Applicants wishing to plan for clinical trials that are not behavioral or social in nature (e.g., those testing dental or medical procedures, dental materials, pharmacological treatments for oral conditions, etc.) should respond to the standard R34 NIDCR CLINICAL TRIAL PLANNING GRANT (R34) ANNOUNCEMENT: http://grants.nih.gov/grants/guide/pa-files/PAR-08-195.html.

This R34 NIDCR BEHAVIORAL OR SOCIAL INTERVENTION PLANNING GRANT is a unique NIDCR program. It differs from the standard R34 NIDCR CLINICAL TRIAL PLANNING GRANT because it supports collection of specific kinds of pilot data needed for launching a successful behavioral or social intervention trial. Depending on the nature of the intervention to be tested, this R34 planning grant allows for the collection of pilot data that establishes the theoretical rationale for the intervention; ensures the acceptability and/or feasibility of the intervention for the target population; prepares for a full-scale test of the mediators, moderators and/or mechanisms of action of the intervention (i.e., why and for whom the intervention works); and tests the sustainability of the intervention in the setting(s) in which the intervention is meant to be implemented.

3) Types of primary pilot data collection supported via this R34 announcement

In cases where pilot data are not already available, planning projects submitted to this R34 announcement should incorporate pilot testing related to the theoretical rationale of the intervention; the acceptability and feasibility of the intervention; the monitoring of fidelity in the intervention study; the incorporation of tests of mediators, moderators and/or mechanisms of action of the intervention; and where applicable, sustainability of the intervention.

• Theoretical rationale: For behavioral or social intervention studies, it is especially important that interventions are based on a strong theoretical rationale and are well-specified. If a behavioral or social intervention is not yet fully developed, the development of an intervention manual that specifies very clearly why a behavioral or social problem exists, and why the intervention being developed is expected to change that behavioral or social problem should be proposed. There is no requirement that interventions need to be based on existing behavioral or social theories. Given the limitations of existing theories in explaining some oral health challenges, it is expected that new theories and rationales will need to be developed in some cases. Planning activities could include lab-based, qualitative or other pilot studies to establish the plausibility of a proposed theoretical rationale. A separate health planning model, such as Precede-Proceed, RE-AIM, or ON-PRIME may be especially useful in planning activities, from theory development through dissemination.
• Acceptability to the target population: The NIDCR expects that investigators developing behavioral and social interventions to improve oral health will ensure that these interventions are acceptable to the target population and to the intended providers. The NIDCR does not mandate any particular approach to ensuring acceptability (e.g., through community-based participatory research, community-involved research, community-based research, etc.). If acceptability of the intervention has not yet been established, this R34 planning grant will support the activities necessary to ensure acceptability.
• Feasibility of conducting the intervention study: The NIDCR also expects that investigators will establish the feasibility of testing a behavioral or social intervention in a particular population or setting. If not already established, this R34 planning grant will support the collection of pilot data related to the feasibility of testing the behavioral or social intervention in a clinical trial.
• Monitoring fidelity of intervention delivery: Behavioral or social intervention studies must ensure that the intervention is delivered as intended (i.e., delivered with fidelity ). If methods for monitoring the fidelity of intervention delivery are not established, this R34 award will support the development of these methods.
• Mediators, moderators, and/or mechanisms of action of the intervention: The NIDCR expects behavioral and social intervention research to investigate why, how and for whom interventions work, in addition to whether they work. Sound measures of the mediators, moderators, and mechanisms of action of behavioral and social interventions are essential in answering these questions. Intervention study designs that allow for identifying mediators, moderators and mechanisms are also essential. Unless mediators, moderators, and/or mechanisms are already established for the intervention, the R34 will support activities to prepare for rigorous tests of these variables or processes. Planning activities could include (but are not limited to): the development and pilot-testing of measures to capture mediators, moderators, and/or mechanisms; the development and pilot-testing of methods to be used in a subsequent clinical trial to test mediators, moderators and/or mechanisms; and lab-based, qualitative, or other studies to pilot-test hypothesized mediation, moderation or mechanisms of action.
• Sustainability of the behavioral or social intervention: Researchers use the term sustainability to describe the degree to which a behavioral or social intervention can be delivered in a lasting way for the target population(s) by the intended providers and in one or more delivery systems. The NIDCR recognizes that there are different perspectives regarding how behavioral and social intervention research should approach sustainability, with some advocating for building sustainability into interventions from an early stage, and others seeing benefit in developing efficacious interventions even if they are not sustainable under existing conditions. Planning activities for an intervention trial may include preparations to test the sustainability of a behavioral or social intervention, if a test of sustainability is an integral aspect of the research. It is expected that the more established a behavioral or social intervention is for oral health, the more likely planning activities are to focus on sustainability. There is no requirement, however, that planning activities include preparations for a test of sustainability of the behavioral or social intervention.

4) Overview of the NIDCR Policy for Investigator-Initiated Clinical Trials and Requirements of this R34 Behavioral or Social Intervention Planning and Pilot Data Grant

As announced in NOT-DE-08-002, the NIDCR will support investigator-initiated clinical trials through a two-part award process: (1) a planning grant (R34) followed by (2) a clinical trial implementation cooperative agreement (U01) award.

A funded NIDCR BEHAVIORAL OR SOCIAL INTERVENTION PLANNING AND PILOT DATA GRANT (R34) would fulfill the R34 component of the two-part process. The companion FOA, NIDCR CLINICAL TRIAL IMPLEMENTATION COOPERATIVE AGREEMENT (U01), PAR-08-196 (http://grants.nih.gov/grants/guide/pa-files/PAR-08-196.html) describes the clinical trial implementation requirements for a subsequent investigator initiated clinical trial cooperative agreement application.

For this FOA, the NIDCR will support behavioral or social intervention planning grants (R34) for comprehensive planning, design and documentation of interventional behavioral or social studies, including studies developing new interventions (i.e., Stage I research), studies testing established interventions (i.e., Stage II research), studies testing adaptations of interventions to be community-friendly (i.e., Stage III research), and studies testing the implementation of established interventions in community settings (sometimes referred to as Stage IV research).

A clinical trial is defined by NIH 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). Clinical trials are used to determine whether biomedical, behavioral or social interventions are safe, feasible, acceptable, efficacious, and effective. Clinical research involving an intervention to modify individual, family or group behavior (e.g., oral hygiene, nutrition, tobacco or drug use, family functioning, stress and coping, pain or chronic disease management, care-seeking behavior, etc.), or care provider behavior (e.g., provider-patient communication, behavioral screening practices, provider referral behavior, etc.) fits this definition of a clinical trial.

Studies developing approaches to train or educate dental, dental hygiene or other students in behavioral or social interventions are not considered clinical trials. These studies are of interest to the NIDCR, but are not responsive to this FOA. Applications for these type of studies may be submitted through the regular R03, R21 or R01 NIH omnibus announcements.

The NIDCR will accept, peer review, and consider for funding applications for Clinical Trial Implementation Cooperative Agreements (U01) from R34 awardees only, unless an exception is granted by the Institute. The material in the implementation grant application must be sufficient to allow the applicant to initiate the study in a manner that meets the highest standards of rigorous clinical research. An important element of rigorous clinical research is the development of a protocol that guides the conduct of the intervention trial. Templates of protocols for minimal risk and more than minimal risk intervention studies are available at the NIDCR website: http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/ClinicalTrialsProtocolTemplate/. For guidance about whether a study is minimal risk or more than minimal risk, please contact NIDCR staff listed in this announcement.

This R34 behavioral or social intervention planning grant is designed to:

• permit early peer review of the rationale for the proposed clinical trial
• permit early assessment of the design of the proposed trial
• provide support for the collection of pilot data for development of a behavioral or social intervention manual, complete study protocol and associated documents.

The main activities supported by the R34 include, but are not limited to, the following:

Development of a study protocol, which includes the following basic elements:

• Description of study population including inclusion and exclusion criteria;
• Adequate plans for recruitment and retention of participants;
• Study design;
• Clear definition of the research hypothesis and outcome measures;
• Quality control/assurance procedures including development of adherence and competence measures;
• Analytical techniques and statistical analysis plan;
• Sample size estimates with justification;
• Administrative procedures (including regulatory approvals if necessary);
• Handling of clinical specimens including collection, inventory, processing and shipping;
• Collaborative arrangements;
• Duties and responsibilities of the principal investigator(s), project manager, staff at clinical sites, and other central resource centers such as a central data coordinating center, laboratory or radiographic center;
• Monitoring plans to assure subject protection and safety oversight (i.e., a Data and Safety * Monitoring Board, Safety Monitoring Committee and/or an Independent Scientific Monitoring plan); and
• The data management plan that assures data integrity and confidentiality.

Development of an intervention manual with sufficient detail is necessary to guide the systematic delivery of the behavioral or social intervention. The manual should be based on a strong rationale or theory of the problem, and of how the intervention is intended to address the problem.

Note: external members of a proposed Data and Safety Monitoring Board, Safety Monitoring Committee and/or individuals involved in an Independent Scientific Monitoring plan must not be contacted or named in the application. Only the scientific areas required to provide the necessary expertise on these advisory/monitoring boards is required. External members are individuals not listed as PD/PI and senior/key personnel in the application.

For behavioral and social intervention research, planning for a rigorous intervention trial involves several additional elements:

• Strong support for the theoretical rationale on which the behavioral or social intervention is based, e.g., from proof-of-concept laboratory-based studies, qualitative investigation, epidemiologic research, etc.;
• Evidence, even if preliminary, that the behavioral or social intervention is, or will be, acceptable to the target population;
• Indications of feasibility, including documentation of sufficient numbers of potentially-eligible participants, documentation of established relationships or agreements with partner-sites, documentation of participant interest in the study, and/or other indicators of feasibility;
• Procedures to train and monitor study staff and interventionists, including methods to ensure that behavioral or social interventions are delivered with fidelity;
• Psychometrically-sound measures of the key constructs or variables in the study, including hypothesized mediators, moderators and/or mechanisms of action of the intervention;
• Depending on the behavioral or social intervention to be developed, and the goals of the research, planning activities may also include indications of how sustainable the intervention will be for the target population, intended providers or delivery system.

The NIDCR issued an NIH Guide notice concerning the conduct of clinical trials (NOT-DE-08-001 published on March 27, 2008:http://grants.nih.gov/grants/guide/notice-files/NOT-DE-08-001.html). Standard NIDCR Terms and Conditions of Award for clinical studies and trials were updated. Awardees are required to comply with these Clinical Terms of Award. The details can be found at the following website: NIDCR Clinical Terms of Award and NIDCR Guidance for Clinical Terms of Award http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/PoliciesGuidance/. The implementation of the clinical terms of award ensures that the conduct of the clinical trial meets widely-accepted standards.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	For this funding opportunity, the NIDCR intends to make available up to $3 million to fund approximately 8-10 awards
Award Budget	Applicants may request up to $350,000 in direct costs for the total project period for planning and pilot data collection for a behavioral or social intervention trial.
Award Project Period	The R34 grant will provide up to two years of support

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

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 Organizations)

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

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, 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
NIDCR-NIH
6701 Democracy Blvd RM:662
Bethesda, MD 20892-4878 (20817 for courier deliveries)
Telephone: 301-594-5006
FAX: 301-480-8303
Email: Lynn.King@nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Research Strategy section is limited to 12 pages.

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

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Supplemental R34 Submission Instructions

Applicants are strongly encouraged to contact a NIDCR Behavioral and Social Sciences Research Branch Program staff member before the application receipt date to discuss the proposed trial (http://www.nidcr.nih.gov/Research/DER/BSSRB).

The following general instructions supplement the SF424 Research & Related (R&R) form instructions to highlight the requirements for this FOA. This information should be included in the Research Strategy section of the application, and must fit within the required page limit of 12 pages.

Planning Activities: Specify how the planning period will be used. The application must include the specific aims and rationale for the planning period, and descriptions of the activities to be carried out. Enough information should be provided to allow reviewers to evaluate how the clinical trial documents will be developed, and to evaluate the feasibility of a subsequent clinical trial after the proposed planning activities.

Investigators: The application must include a description of the leadership and proposed organization of the clinical trial, but letters of commitment are not required at this stage. Describe the roles of the members of the research team in the development of the planned clinical trial and their experience in related studies. The ability of the PD/PI(s) to bring together the necessary clinical trial organization must be addressed as well as the process for the identification and selection of additional investigators and/or collaborators.

Monitoring: Individual members of a Data and Safety Monitoring Board or Safety Monitoring Committee and/or an Independent Scientific Monitoring plan must not be contacted or named in this planning and pilot data grant application, but if these committees are planned, the scientific expertise required for these oversight groups must be described.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115,

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/priority 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 there a clear statement of the question(s) that the trial will address and its importance? Are the hypothesis(es) and the specific aims/study objectives well defined?
• Does the application provide adequate rationale and justification for a future clinical trial that is timely and significant?
• How would trial results affect health care policy, community behaviors or practice in the specific area of research?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

* Are all members of the team of investigators involved in the organizational structure of the proposed clinical trial appropriately identified? To what extent do they have the expertise, training, ability and experience to organize, coordinate and manage the project?

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?

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

• To what extent are the activities proposed for the planning period adequate and sufficient to allow for a timely clinical trial implementation application? Are the activities sufficiently detailed and is the timeline for completion reasonable?
• Do the proposed planning activities address potential barriers to a future clinical trial? Is the proposed pilot data collection appropriate to maximize success of a future clinical trial?
• Is the selection of intervention and mode of delivery, including details such as dose or a particular intervention, adequately justified?
• If oversight committees are planned, are the scientific expertise of the proposed membership adequate for the function of the committee and the behavioral or social intervention?

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?

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Resubmissions are not allowed in response to this FOA.

Renewals

Renewals are not allowed in response to this FOA.

Revisions

Resubmissions are not allowed in response to this FOA.

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/priority 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 (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

• 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/priority score.
• Receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the 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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

Although applicants responding to this FOA are not required to seek prior approval from the NIDCR before submitting an application, prospective applicants are encouraged to speak to appropriate NIH staff for technical assistance prior to submitting an application. Applicants responding to the standard R34 announcement (PAR-08-195, http://grants.nih.gov/grants/guide/pa-files/PAR-08-195.html) are required to have prior approval from the NIDCR (refer to http://www.nidcr.nih.gov/GrantsAndFunding/PoliciesandGuidance/ClinicalResearch/InvestigatorInitiatedClinicalTrials/R34RequestToSubmit.htm for information about the pre-approval process).

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

David Clark, Dr.P.H.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: David.Clark2@nih.gov

Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
NIDCR-NIH
6701 Democracy Blvd RM:662
Bethesda, MD 20892-4878 (20817 for courier deliveries)
Telephone: 301-594-5006
FAX: 301-480-8303
Email: Lynn.King@nih.gov

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

Mary Daley Greenwood
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4808
Email: md74u@nih.gov

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.