Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34)
Activity Code	R34 Clinical Trial Planning Grant Program
Announcement Type	Reissue of PAR-08-195
Related Notices	September 19, 2014 - This PAR has been reissued as companion FOAs PAR-14-342 and PAR-14-346. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 19, 2013 - See Notice NOT-DE-14-001. Notice to Clarify Allowable Planning Activities for Behavioral and Social Interventions. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PAR-11-338
Companion FOA	PAR-11-339, U01 Research Project Cooperative Agreements
Number of Applications	Applicants may submit more than one application, provided that each application is scientifically distinct. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.121
FOA Purpose	The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical evaluation studies. The R34 grant award will provide support for activities that include, but are not limited to: the establishment of the research team; the development of the clinical protocol and Clinical Investigators Brochure (or equivalent); the development of tools for data management, safety and operational oversight of the research; the definition of recruitment strategies; and all essential elements of the study such as a Manual of Procedures for the clinical trial or biomarker clinical evaluation study, or a draft of the manualized behavioral, community, or services intervention. (See Scope for more detail.) The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant is not designed for the collection of preliminary data (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study.

Posted Date	September 16, 2011
Open Date (Earliest Submission Date)	September 16, 2011
Letter of Intent Due Date	Four weeks before standard due dates.
Application Due Date(s)	Standard dates apply by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Standard dates apply by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	September 8, 2014
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

Purpose:

The NIDCR is committed to identifying effective approaches to address dental, oral and craniofacial diseases and disorders. Improving associated health through the generation of robust data from well-designed and executed clinical trials and clinical studies is a high priority for the NIDCR. Significant planning is required before submitting an application to conduct a clinical trial or biomarker clinical evaluation study.

As announced in NOT-DE-11-002, the NIDCR will support investigator-initiated interventional clinical trials or biomarker clinical evaluation studies through a two-part grant process: (1) a clinical trial or biomarker clinical evaluation study planning grant (R34) followed by (2) a clinical trial or biomarker clinical evaluation study implementation cooperative agreement (U01) award. This FOA, NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34) addresses the R34 grant; a companion FOA, NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Implementation Cooperative Agreement (U01), PAR-11-339 addresses the clinical trial or study implementation cooperative agreement.

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 or behavioral 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, drug use or abuse, family functioning, stress and coping, chronic disease management), or care provider behavior (e.g., provider-patient communication, provider referral patterns) fits this definition of a clinical trial. Clinical research to develop or evaluate clinical laboratory tests (e.g., imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or if the test itself imposes more than minimal risk for subjects. Most clinical trials supported by the NIDCR are investigator-initiated Phase I, II, III or IV interventional clinical trials, conducted as single trials or within clinical research networks or centers. These networks / centers are composed of coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources. This combination of collaborating organizations and specialists ensures that all elements of the planning and design of clinical trials can be addressed and fully documented before a decision is made to implement a trial.

A biomarker clinical evaluation study is designed to validate candidate biomarker(s) for their specificity, sensitivity, robustness and utility in an independent prospectively recruited cohort for prognostic or diagnostic purposes. Biomarker clinical evaluation studies are an integral part of the biomarker and diagnostics development pathway and, similar to clinical trials, they are time-consuming, labor-intensive, complex, and costly. As such, NIDCR will consider these studies to be logistically equivalent to clinical trials and subject to the same peer review and funding policies as investigator-initiated clinical trials submitted for NIDCR funding.

The NIDCR has determined that any clinical trial or prospective biomarker clinical evaluation study it supports must be developed using rigorous standards for planning, design, documentation and implementation. Furthermore, the quality of the planning, design, and documentation products for such studies are given key consideration when the NIDCR considers supporting a clinical trial implementation or biomarker clinical evaluation study application. The NIDCR believes that a two-part grant process that separates planning and design of a clinical trial or study from the implementation of a trial or study will help grantees meet these essential standards.

Overview of the NIDCR program for investigator-initiated clinical trials or biomarker clinical evaluation studies:

Part 1: NIDCR Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34). The NIDCR will support clinical trial or biomarker clinical evaluation study planning grants (R34) for comprehensive planning, design and documentation of investigator-initiated Phase I, II, III, or IV interventional clinical trials, or biomarker clinical evaluation studies that involve prospective collection of specimens and clinical outcomes. Interventional behavioral studies, sometimes referred to as Stage I, II, III or IV studies, are included. The goal of the R34 grant program is to give investigators the time and funds necessary to complete detailed clinical trial or study planning and written supporting documentation prior to U01 funding and full implementation of a clinical trial or study. The R34 grant will provide up to one year of support. R34 awardees who complete their planning activities and have compelling justification to proceed to a clinical trial or biomarker clinical evaluation study can submit a cooperative agreement application (U01) for clinical trial implementation or biomarker clinical evaluation study (details are presented in PAR-11-339). If the investigators conclude that a clinical trial or biomarker clinical evaluation study is not warranted, the reasons for not proceeding with the U01 implementation application must be documented in the final progress report to the NIDCR that summarizes the R34 award activity.

Part 2: Clinical Trial Implementation or Biomarker Clinical Evaluation Cooperative Agreement (U01)

The NIDCR will accept, peer review, and consider for funding applications for Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreements (U01) from R34 awardees only. The material in the implementation grant application must be sufficient to allow initiation of study staff training, followed by subject recruitment upon award of an implementation cooperative agreement and approval of the study protocol by the oversight committee and the NIDCR. This material will be developed using funding from the R34 award. An applicant who can demonstrate that all activities needed for submission of a Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01) application were completed with other funding may request from the NIDCR an exception for the R34 award prerequisite.

The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant (R34)

The R34 grant award will provide one year of support for activities directed towards the planning and design of a clinical trial or biomarker clinical evaluation study. The Clinical Trial or Biomarker Clinical Evaluation Study Planning Grant is not designed for the collection of preliminary data (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. It is expected that receipt of an R34 grant will lead to the timely submission of an application for support of the implementation of the clinical trial or biomarker clinical evaluation study, 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 trial implementation or biomarker clinical evaluation study application.

Scope

The R34 planning grant process is designed to:

• permit early peer review of the rationale for the proposed clinical trial or biomarker clinical evaluation study;
• permit early assessment of the design of the proposed trial or study; and
• provide support for the development of a complete study protocol and associated documents and support the development of other essential elements of a clinical trial or biomarker clinical evaluation study.

Examples of activities supported by the R34 include, but are not limited to, developing the following:

1. A clinical protocol following International Conference on Harmonisation (ICH) E6 Good Clinical Practice Consolidated Guidance using the standard NIDCR protocol template (refer to http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/);

2. The Manual of Procedures (MOP) including details, validation, and quality control for any non-standard clinical or laboratory/mechanistic testing which will be performed;

3. The statistical analysis plan and statistical programming plan;

4. The consent form(s) and, if applicable, assent form(s);

5. The Clinical Investigators Brochure (CIB) or equivalent, if applicable;

6. A plan for the acquisition and administration of study agent(s), if applicable;

7. Detailed description of Roles and Responsibilities of study personnel;

8. Detailed timeline or Gantt Chart;

9. Quality management plan;

10. Recruitment and retention plan, including strategies to put in place should enrollment or follow up not meet specified metrics;

11. A complete set of suitable documents for submission to the appropriate regulatory authorities with a product development plan if study product will be under Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).

Investigators planning a biomarker clinical evaluation study are expected to undertake most of these activities during the planning phase, including the development of a clinical protocol using the standard NIDCR protocol template, a Manual of Procedures, consent / assent forms, a complete statistical analysis plan, recruitment and retention plans, a detailed study timeline, and a quality management plan. NIDCR clinical research policy and guidance information as well as NIDCR templates are available at the following website: http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/)

The NIDCR issued an NIH Guide notice concerning the conduct of clinical trials and biomarker clinical evaluation studies (NOT-DE-11-002 published on July 14, 2011). In addition, awardees are required to comply with these Clinical Terms of Award. The details can be found at the following websites: NIDCR Clinical Terms of Award and NIDCR Guidance for Clinical Terms of Award (refer to http://www.nidcr.nih.gov/ClinicalTrials/ToolkitClinicalResearchers/PoliciesGuidance/NIDCRClinicalTermsofAward.htm The implementation of the clinical terms of award ensures that the conduct of the clinical trial or clinical study meets widely-accepted standards.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Direct costs for planning and designing a Phase I clinical trial may not exceed $75,000 over a one-year period. Direct costs for planning and designing a Phase II, Phase III, or Phase IV clinical trial or a biomarker clinical evaluation study may not exceed $150,000 over a one-year period.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed one year.

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 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 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 be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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(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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) 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 may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

A letter of intent is not required for the funding opportunity.

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:

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, Maryland 20892
(Courier 20817)
Telephone: 301-594-5593
Fax: 301-480-8303
Email: [email protected]

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.

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

Specific Aims: The goals of the clinical trial or biomarker clinical evaluation study, and the expected outcome(s) should be stated concisely. The specific objectives of the proposed trial or study must be clearly and concisely presented.

Research Strategy:

Significance

• The significance and biological relevance of the proposed clinical trial or biomarker clinical evaluation study must be stated clearly, with a clear explanation of the importance of the proposed 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 major findings of the pre-clinical and clinical studies that led to the proposed clinical trial or biomarker clinical evaluation study, and the rationale for selection of the intervention or biomarker should be presented. Data from pre-clinical and pilot studies demonstrating the need for and the feasibility of the trial or study should be included so the overall strategy and proposed methodology are clearly justified.
• For biomarker clinical evaluation studies, analyses of available evidence on the analytical performance of the biomarker assay; the known associations of the biomarker and disease states, and the proposed future use of the biomarker should be included;
• The potential impact or how the results of the trial or study will advance our knowledge or clinical practice should be articulated.
• If the application proposes a future Phase III trial or multi-center biomarker clinical evaluation study, the generalizability of potential findings should be discussed.

Innovation

• A compelling argument of how the proposed clinical trial or biomarker clinical evaluation study will shift clinical practice paradigms or inform health care policy should be presented.

Approach

The approach for the future clinical trial or biomarker clinical evaluation study should be presented briefly. The following should be covered:

• A description of and rationale for the proposed study design;
• Translation of the clinical question into a statistical hypothesis;
• 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;
• The plan for the acquisition and administration of study agent(s) with the rationale for the chosen route of administration, if appropriate;
• Rationale for the dose of an interventional agent, if appropriate;
• Preliminary organizational structure for the administration and management of the trial or study, including the administrative center, data coordinating center, participating enrollment centers / sites, and the laboratory/ testing center;
• For multidisciplinary projects, proof that the investigator team has adequate expertise in necessary clinical specialties to design and conduct studies that will inform policy;
• Plans to develop the committee structure appropriate to the complexity of the clinical trial or biomarker study;
• A discussion of activities and outcomes that will be achieved during the planning phase;
• A discussion of potential challenges that are anticipated during planning and study implementation, and how they will be addressed; and
• An initial time line for implementing and completing the future clinical trial or biomarker study.

Human Subjects Section

Although human subjects will not be involved during the planning period, the application should provide 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 adherence to the proposed intervention protocol should be included.

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(s)/PI(s) 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(s)/PI(s) 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, NIH. Applications that are incomplete will not be reviewed.

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.

For this particular announcement, note the following:

The NIH R34 is designed to support planning activities in preparation for a clinical trial or a clinical study. These activities are primarily logistical, conceptual, and/or technical in nature. They do not involve the collection of data typical of research-related activities supported by the traditional NIH research project grant. As such, the evaluation of R34 applications will focus on the justification of, or need for, the proposed trial or study, along with the appropriateness of the proposed planning activities and qualifications and completeness of the proposed team.

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 the significance of the proposed clinical trial or biomarker clinical evaluation study supported by the following?

• A clear statement of the question(s) that the trial or study will address and its importance;
• Information adequate to determine the significance and timeliness of, as well as the need to perform, the trial or study;
• Preliminary data or the literature supporting the need for a clinical trial or biomarker clinical evaluation study to test the proposed hypothesis or intervention and the choice of the particular intervention;
• For biomarker clinical evaluation studies, analyses of available evidence on the analytical performance of the biomarker assay; the known associations of the biomarker and disease states, and the proposed future use of the biomarker;
• The biological mechanisms and clinical data that support conducting the trial or study;
• The potential of the outcome to change clinical practice, improve clinical outcomes, community behaviors or health care policy; and
• The generalizability of potential findings if this is a Phase III clinical trial or a biomarker clinical evaluation.

Investigator(s)

Are the PD(s)/PI(s), 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the key members of the research team named, and does the team possess the following:

• An appropriate and qualified PD(s)/PI(s) and, for multicenter trials, potential clinical center investigators with professional training, clinical expertise and previous research record in the field of the clinical problem under study;
• For multidisciplinary projects, an investigator team with sufficient range and depth of expertise to design, conduct and complete the proposed study;
• Qualified data coordinating center investigators with expertise to implement and monitor the study; and
• The 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?

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? For all proposed clinical trials or biomarker clinical evaluation studies, evaluate the following:

• Translation of the clinical question into a statistical hypothesis;
• Proposed primary and secondary outcome variable(s) and data to be collected, including relevance to the clinical and statistical hypothesis being tested;
• Criteria for evaluating outcome variables;
• Clinical significance of the outcome variable(s) and appropriateness of a composite outcome if multiple outcome variables are combined;
• Plans to obtain any study agent;
• Initial sample size and duration of the trial or study;
• The plan to organize a research team (e.g., statisticians, data managers, study coordinators and project managers) and committee structure (e.g., Planning, Steering, and Executive committees) appropriate for the complexity of the trial or study.
• Activities that will be accomplished during the planning phase, such as developing a clinical protocol, basic elements of a Manual of Procedures, and if applicable, documents required for Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).
• Potential challenges that are anticipated during planning and study implementation and how they will be addressed and overcome during the planning period; and
• Reasonableness of the initial time line for implementing and completing the trial or study.

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 evaluation 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/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

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

Renewal applications are not allowed for this FOA.

Revisions

Revision applications are not allowed for 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 NIDCR, (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 will be discussed and assigned an overall impact/priority score.
• Receive a written critique.

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 l. 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.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Because clinical trials and clinical biomarker evaluation studies are costly and time-intensive, NIDCR anticipates funding only those studies of the highest priority and mission relevance. Investigators considering preparing and submitting an application are strongly encouraged to contact NIDCR staff prior to beginning the application process.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Jane Atkinson, DDS
Director, Center for Clinical Research
Division of Extramural Research
National Institute of Dental and Craniofacial Research
1DEM, Room 634, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: (301) 435-7908
Fax: (301) 480-8319
Email: [email protected]

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
NIDCR, NIH
6701 Democracy Boulevard, Suite #662
Bethesda, Maryland 20892
(Courier 20817)
Tel: (O)301-594-5593, (c)301-335-6233
Fax: 301-480-8303
Email: [email protected]

Mary Greenwood
Chief, Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 658, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: 301-594-4808
Fax: (301) 480-3562
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.