National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Planning Grants for Dental, Oral and Craniofacial Tissue Regeneration Consortium Resource Centers (R34)
R34 Planning Grant
New
None
RFA-DE-15-005
None
93.121
This Funding Opportunity Announcement (FOA) invites Planning Grant applications to articulate a vision, roadmap, organizational structure and operational procedures for establishing Resource Centers (RCs). These planning grants are intended to enable the institutions to develop the necessary partnerships and infrastructure needed to be competitive for establishing successful RCs. It is envisioned that the RCs will provide technical support and research capacity for a future Dental Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC).
September 4, 2014
December 29, 2014
December 29, 2014
January 29, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
May/June 2015
August 2015
September 1, 2015
January 30, 2015
Not Applicable
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:
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:
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIDCR intends to commit $1.8M in FY2015 to fund 8-10 awards.
Applications may not exceed $125,000 in direct costs, and the budget should reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 1 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
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
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.
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:
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:
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:
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:
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
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
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
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
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:
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:
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.
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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.