Department of Health and Human Services

Part 1. Overview Information
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.

Key Dates
Posted Date
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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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.

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:

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:

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:

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.  

Section II. Award Information
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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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

Required Registrations

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.

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.

Eligible Individuals (Project Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

Descriptive title of proposed 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  

Required and Optional Components

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.

Page Limitations

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:

 
PHS 398 Research Plan Component

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 Organizations

 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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

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? 

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?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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.

Additional Review Considerations

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

2. Review and Selection Process

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:

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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.  

Section VII. Agency Contacts

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).    

Application Submission Contacts

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 301-435-0714
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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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).

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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