Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The National Institute of Dental and Craniofacial Research (NIDCR) is firmly committed to facilitating clinical translation of the most promising scientific and technological advances in tissue engineering and regenerative medicine (TE/RM) to safely and effectively regenerate and reconstruct dental, oral and craniofacial (DOC) tissues. Toward achieving this goal, NIDCR will establish a multidisciplinary DOC Tissue Regeneration Consortium (DOCTRC) that will conduct  pre-clinical studies leading to the submission of Investigational New Drug (IND)/Investigational Device Exemption (IDE) applications to the U.S. Food and Drug Administration (FDA) to develop safe, predictive and effective clinical strategies for regeneration of functional tissues of the human DOC complex, including vascularized and innervated craniofacial bone and musculoskeletal complex, periodontium, tooth, cartilage, salivary gland and temporomandibular joint (TMJ). The DOCTRC will be built through a three-stage process.  This FOA will support activities in the first stage, the opportunity to plan for Resource Centers (RCs), which will be the foundation for the DOCTRC. The overall outcome of the DOCTRC effort will be the development of TE/RM products, including combination products, based on cells, biologics and/or devices and associated protocols ready for the initiation of clinical trials.

To meet the demands of the accelerated translational timeline of this effort, the DOCTRC will employ those TE/RM tools and strategies that have been tested previously in small or large animal models, and have already demonstrated significant translational potential and readiness to advance through the translational pipeline.

The three stages of DOCTRC effort are outlined below:

• Stage 1, Planning Stage (solicited through this FOA): This stage will be implemented under an R34 Planning Grant funding mechanism to provide up to one year of support to develop an overall vision, roadmap, organizational structure and operational procedures for centralized RCs. The goal of stage 1 will be to develop detailed plans for establishing interactive interdisciplinary teams of biologists, bioengineers, clinicians and other technical experts to function as RCs. While participation of the academic clinicians is welcomed, inclusion of the practicing clinicians involved in everyday patient care is required for building a successful RC infrastructure.  Industry expertise may also be added to the RC teams, as needed.
• Stage 2, Resource Centers Stage: Following the completion of the R34 planning stage, awardees will be able to compete for the establishment of the RCs in stage 2 through a second FOA. The duration of stage 2 will be three years. On the basis of peer-review assessment and programmatic considerations, NIDCR will select 1-3 most meritorious teams from stage 1 to establish the centralized RCs. The goals of the RCs will be to 1) develop a robust infrastructure to deliver uniform high-quality technical support and research capacities for pre-clinical studies and 2) organize, recruit and integrate several Interdisciplinary Translational Project (ITP) teams into the RC. Each of these ITP teams will have identified and developed a specific TE/RM approach for regeneration of a functional DOC tissue that synergizes with the expertise of the RC. In order to effectively support the ITPs, the RCs will improve, optimize, validate and standardize tools and technologies for DOC tissue regeneration in the following areas: (i) cells and biomaterials; (ii) disease and injury -relevant large animal models; (iii) functional assays and endpoints; and (iv) interactions with the FDA. To successfully compete for inclusion in the final stage of DOCTRC, the RCs and the ITP teams must establish productive collaborations by the completion of the RC development stage, and demonstrate their capacity to collectively advance the most likely to succeed tissue engineering/regenerative medicine (TE/RM) products through the translational pipeline. Productive collaborations between different RCs in the areas of complementary expertise will be highly encouraged. 
• Stage 3, Consortium Stage: The RCs and their ITP teams will compete for the final stage through a third FOA to establish DOCTRC. The duration of stage 3 will be four to five years. The ITP teams will utilize resources developed by the RCs during stage 2, and will work in continuous close collaboration with the RCs while seeking advice from the FDA in advancing specific TE/RM clinical applications. The DOCTRC will complete validation, manufacturing, and preclinical testing of the most likely to succeed TE/RM products and will develop INDs/IDEs for submission to FDA. The outcome of the DOCTRC will be TE/RM products and associated protocols ready for initiation of Phase I clinical trials. 

Many promising scientific and technological advances have emerged from the investment that NIDCR and NIH have made in TE/RM over the years.  These include scaffolds that can guide functional maturation of the engineered constructs in vitro and facilitate tissue regeneration in vivo. Such scaffolds can be designed to deliver active biomolecules to cells, degrade at a pre-determined rate, control inflammatory responses, and exhibit many other useful characteristics. Further, substantial progress has been made in isolation and characterization of DOC tissue-specific stem and progenitor cells, functional assays have been developed for testing safety and efficacy of TE/RM products, and new cell and tissue tracking and imaging modalities have been derived to monitor tissue regeneration in vivo. Despite this progress, only a few TE/RM-based prospective therapies for DOC and other tissues have reached the stage of clinical trials.

NIDCR carried out a comprehensive analysis of the nature of obstacles interfering with TE/RM translation, and on the basis of this analysis, developed a plan to establish the translation-targeted DOCTRC. One of the key features to ensure the success of DOCTRC in advancing TE/RM products to the clinic will be a strong alignment between the clinical needs for DOC tissue regeneration and the available TE/RM tools and technologies that have sufficiently matured in discovery research. Achieving this alignment will require robust interdisciplinary partnerships among practicing clinicians, biologists, bioengineers, regulatory experts and other technical professionals. In this partnership, the clinicians will define the areas of clinical needs and will establish product design criteria, and on the basis of these recommendations, the technical and regulatory experts of the DOCTRC will develop specific products and technical strategies to meet these needs.

Given a multitude of the available TE/RM-based biomaterials, scaffolds, cell sources, functional assays, and animal models, a preparatory stage will be required before specific products and protocols can be advanced through the translational pipeline for preclinical testing. Specifically, it will be necessary to conduct side-by-side quantitative comparisons, and to standardize, optimize and validate the available materials, cells and protocols in DOC disease and injury -relevant large animal models with respect to their safety, efficacy, and other functional outcome parameters.  The outcome of this effort will be the identification of those candidates that are most likely to succeed in clinical settings. Moreover, effective scale up, Good Manufacturing Practices (GMP) protocols and Standard Operating Procedures (SOPs) will need to be developed before the products can be effectively advanced toward clinical trials. The DOCTRC will systematically address these issues during its two initial stages while the third stage will focus on advancing the most-likely to succeed products and protocols toward Phase I clinical trials.

This FOA encourages applications for Planning Grants (R34) from interdisciplinary groups of investigators to propose plans for establishing the RCs. x.  Prior involvement in advancing TE/RM products and technologies to clinical trials is highly desired.  Other types of technical expertise can be added, as needed. Multiple Program Director/Principle Investigator (multi-PD/PI) applications are strongly encouraged.

This FOA is designed to support the development of the overall vision, roadmap, organizational structure and operational procedures of the RCs, as well as to define specific approaches and practices that will be employed by the RCs. This FOA is not designed to support the collection of preliminary data or to conduct pilot studies to support a rationale for the RCs.

Examples of the activities supported by this FOA include, but are not limited to the following:

• Outlining scientific, technical, manufacturing and regulatory issues to be addressed by the RC for advancing DOC TE/RM products and protocols toward clinical trials.
• Planning the structure, the composition and other characteristics of the RC, such as focus areas, specific types of expertise to be included and other capabilities. This plan should describe how the proposed RC structure would insure a broad coverage of clinical needs.
• Outlining the dynamics of interdisciplinary collaborative interactions among the different members of the RC team with a particular emphasis on the interactions among clinical, technical and regulatory experts.
• Planning specific strategies to be employed for quantitative side-by-side comparisons, standardization and functional validation of different biomaterials, cell sources and other components of TE/RM products to allow selection of the candidates that have high probability to succeed in the translational pipeline.
• Defining functional assays, specific metrics and endpoints to be used in side-by-side comparisons, standardization and validation of the TE/RM products.
• Defining protocols and an organizational framework for selecting TE/RM candidate products that have a high probability to succeed in translational pipeline.
• Defining animal models, particularly large DOC disease and injury -relevant animal models to be used for testing the efficacy of the TE/RM products. If new models are proposed, specific approaches for the development and validation of these models should be described.
• Outlining potential strategies for scaling up and GMP manufacturing of the TE/RM products.
• Defining specific milestones and timelines for the RC’s productivity and output.
• Outlining possible alternative strategies to be used for overcoming technical, organizational and other types of obstacles encountered during RC development.
• Planning and development of training materials, Standard Operating Procedures, and management protocols for the RC staff.
• Outlining product development plans for IND/IDE submissions to the FDA.

The listed examples only serve to illustrate the types of activities that should be addressed in applications. The applicants can expand on these examples, and provide additional ideas and plans for building functional RC infrastructure.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

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

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

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

Each interdisciplinary group of applicants must include practicing dental/surgical/clinical, biological, bioengineering and regulatory expertise

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

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

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

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

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

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
NIDCR, NIH
6701 Democracy Blvd., Rm. 662
Bethesda, MD 20892-4878 (20817 for express deliveries)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

Applicants should budget to travel to the NIDCR-organized DOC Tissue Regeneration Symposium that will take place in the fall of 2015.

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

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

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

Research Strategy: The Research Strategy should address the elements specified in Section I of this FOA. The description of the planning activities should be captured under the following elements:

• Overall vision for the RC
• Organizational Structure of the RC
• Strategies for defining clinical needs of the RC
• Collaborations and communications with a particular emphasis on interdisciplinary collaborations, communications with clinicians and interactions with FDA
• Strategies for establishing collaborations with ITPs
• Technical approaches, statistical methods and power analysis, SOP and protocol development
• Validation, standardization and quality control
• Milestones and timelines
• Planning activities regarding Vertebrate Animals protocols and procedures for future RCs
• Planning activities regarding Human Subject protection for future RCs

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing Plan) as provided in the SF424 (R&R) Application Guide enomic Data Sharing Plan) are expected, but they are not applicable for this FOA.

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

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

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

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

Consultation with NIDCR Program staff at least 10 weeks prior to the application due date is strongly encouraged for submission of R34 Planning Grant applications. The NIDCR staff will consult on whether the proposed application meets the goals of the FOA.  NIDCR staff will not evaluate the technical and scientific merits of the proposed planning grant; technical and scientific merits will be determined during peer review using the review criteria indicated in this FOA.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

This R34 FOA is designed to support planning activities in preparation for the development of the Resource Centers (RCs) to support a Dental Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC). These activities are primarily logistical, conceptual, and technical in nature. They do not involve the collection of data typical of research-related activities supported by the traditional NIH research project grants. As such, the evaluation of applications in response to this FOA will emphasize the appropriateness of the proposed planning activities and the qualifications and the completeness of the proposed RC teams.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA

• Is the rationale for establishing the proposed RC well-justified, and the proposed RC goals and objectives adequately defined?
• Is there a clear statement of the technical areas that will be addressed by the RC?
• Does the application provide proper justification for selecting the proposed infrastructure of the RC? Is there sound clinical, biological and technical data to support selection of the particular infrastructure of the RC?
• Would the proposed RC infrastructure effectively support the general goals and the specific objectives of the DOCTRC, to conduct  pre-clinical studies leading to the submission of IND/IDE applications to FDA to develop safe, predictive and effective clinical strategies for regeneration of functional tissues of the human DOC complex. Is there a high likelihood that the proposed RC infrastructure can support collaborations and interactions between different RCs?

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 

Specific to this FOA

• Is the team of investigators appropriately qualified and well-suited for the proposed RC?
• Does the team of investigators include practicing clinicians who manage patient care on a regular basis? 
• Is the expertise of the individual investigators adequate for achieving the goals of the RC? Do they have a proven track record in the areas to be addressed by the RC?
• Is the overall composition of the RC personnel sufficiently balanced for achieving the RC's goals?
• Is there a plan in place to insure proper training of the technical personnel of the RC?
• Will the interdisciplinary composition of the RC promote productive collaborations within the RC and forging collaborations with ITP teams?
• Are the plans adequate to ensure productive collaborations?
• Is the time commitment of all team members appropriate?
• Are the communication plans within the RC adequately described?
• Is there an evidence of effective leadership plan?

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? 

Specific to this FOA

Are functional assays, DOC disease-relevant animal models, scale up and manufacturing strategies and the overall infrastructure of the RC built on innovative principles and are they expected to be effective in meeting the translational goals of the RC?

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? 

Specific to this FOA

• Will the proposed RC employ TE/RM tools and strategies that have been tested previously in small or large animal models, and have already demonstrated significant translational potential and readiness to advance through the translational pipeline?
• How well would the proposed RC infrastructure effectively support the general goals and the specific objectives of the DOCTRC, to conduct pre-clinical studies leading to the submission of IND/IDE applications to FDA to develop safe, predictive and effective clinical strategies for regeneration of functional tissues of the human DOC complex??
• Does the application present a detailed description of the activities to be conducted and completed during the planning period, including milestones and timelines for Stage 2 competition?
• Are the activities proposed for the planning period adequate and sufficient for the timely and effective establishment of the RC?
• Will the proposed activities anticipate obstacles and barriers that might be encountered by the RC? Are there adequate plans in place to overcome these obstacles and barriers?
• Are the proposed approaches and methodologies for building RC infrastructure scientifically/technically sound, and will they be realistically executed within the duration of the RC development project period?
• Is appropriate expertise included to address quantitative side-by-side comparison, standardization, functional validation and quality control of the TE/RM products?
• Is appropriate statistical expertise included in the research team? 
• Does the application present a detailed description of the interdisciplinary interactions between clinical, technical, and regulatory components of the RC?
• Does the application outline plans for establishing collaborations with ITP teams and with the other RCs?
• Does the application outline plans for interactions with the FDA and preparation of IND/IDE submissions?
• Does the application include detailed milestones and timelines? Are the proposed timelines and milestones appropriate for achieving the goals of the project?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

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? 

Specific to this FOA 

• Are adequate facilities in place to establish an RC?
• Are there adequate plans for the development of an effective organizational structure and the communication plan between different components of the organizational structure of the RC and between the RC and ITPs?

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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 NIDCR Special Emphasis Panel (SEP), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned   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’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

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

Nadya Lumelsky, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7703
Email: nadyal@nidcr.nih.gov

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.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.