and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Dental and Craniofacial Research (NIDCR) |
|
Funding Opportunity Title |
Design and Development of Novel Dental Composite Restorative Systems (U01) |
Activity Code |
U01 Research Project - Cooperative Agreement |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-DE-13-001 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.121 |
Funding Opportunity Purpose |
The intent of this Funding Opportunity Announcement (FOA) is to support the design and development of novel dental composite restorative systems that demonstrate superiority in material properties and endurance in the oral environment over the currently used bisphenol A glycidyl methacrylate/triethylene glycol dimethacrylate (Bis-GMA/TEGDMA)-based systems. The goal is not to incrementally improve the currently utilized dental composite restorative systems, but rather to develop a novel, new composite polymer as part of a complete dental composite restorative system. It is expected that the clinical service life of these novel dental composite restorative systems will exceed current commercial materials by at least a factor of two. |
Posted Date |
September 12, 2012 |
Open Date (Earliest Submission Date) |
December 31, 2012 |
Letter of Intent Due Date |
December 31, 2012 |
Application Due Date(s) |
January 31, 2013, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
May/June 2013 |
Advisory Council Review |
|
Earliest Start Date(s) |
September 2013 |
Expiration Date |
February 1, 2013 |
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
The focus of this funding opportunity announcement (FOA) is to support the design and development of novel dental composite restorative systems that demonstrate superiority in material properties and endurance in the oral environment over the currently used bisphenol A glycidyl methacrylate/triethylene glycol dimethacrylate (Bis-GMA/TEGDMA)-based systems. It is understood that the composite polymer is only the initial step in the development of a dental composite restorative system and that this composite polymer will be an integral part of all the intricate interfaces correlated with the filler, enamel, dentin, and adhesive components. Multidisciplinary approaches are strongly encouraged from research areas traditionally and/or not currently focused on composite polymers. Investigators involved with polymer development such as polymer chemists, organic chemists, computational polymer scientists, materials scientists, chemical engineers, bioengineers, clinicians, and microbiologists, as well as those engaged in bone cement fabrication, in vitro, in vivo, animal, and clinical studies are strongly encouraged to collaborate. The novel dental composite restorative system must include assessment in a physiologically relevant oral microbial, physical/chemical environment. Other properties of the novel dental composite restorative system such as the ability to self-heal, be biomimetic, and be directly integrated with the host dentin/enamel interface without an adhesive would add significant value to the design.
This novel dental composite restorative system should ultimately meet the following criteria: biocompatibility; aesthetics; low shrinkage; mechanical superiority to existing commercial products; resistance to degradation in the oral cavity (not susceptible to esterase or other enzyme attack); satisfactory handling properties; limited leaching of polymer components; and have a significantly longer service life than current dental composite restorative systems. With the development of a new composite polymer, the corresponding coupling agents, fillers, and dentin/enamel bonding agents may also need to be redesigned. It is expected that the clinical service life of these novel dental composite restorative systems will exceed current commercial materials by at least a factor of two.
This FOA seeks novel research. Accordingly, innovation will be emphasized in the review criteria.
The initial phase of the composite polymer development will need to meet the following goals and conditions (Please include timelines):
1)Successful demonstration of reduced enzymatic, hydrolytic, and/or oxidative degradation (minimum testing duration 90 days)
2)Physical and mechanical properties comparable with or exceeding current composite polymers
3) Description of how the fillers and adhesive system will be developed/incorporated into the novel composite polymer.
4) A plan which shows how U01 awardees of composite polymer development and research advances will work cooperatively and share data and resources among these U01 awardees to achieve the goals of this program.
The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve oral, dental and craniofacial health through research and research training. The objective of this initiative is consistent with the NIDCR Strategic Plan 2009-2013, Objective I-5: Facilitate reconstruction and regeneration of diseased or damaged oral and craniofacial tissues and organs through biological, bioengineering and biomaterials research approaches. The increasing use of dental composites restorative systems and the associated dentin/enamel bonding agents is approaching approximately 65-70% of dental restorations placed in the United States. These restorations are currently a combination of three main components: a Bis-GMA/TEGDMA polymer (20-25% by weight), glass or ceramic filler particles (75-80% by weight), and a silane coupling agent to bind the composite polymer to the filler particles. The dental restoration is attached to the surrounding tooth structure using a dentin/enamel adhesive. The composite polymer allows for convenient manipulation and handling, properties valued by dentists, and the filler provides strength and aesthetics. This dental composite restorative material is placed within a tooth as a paste mixture of its components and polymerized using a 400-480 nm curing light. Unfortunately, the lifespan of these materials may be limited depending on tooth location and restoration size. Although improvements have been made in the composite polymer and filler properties, the polymer chemistry is fundamentally unchanged since its introduction in the early 1960s. Current research on developing new improved materials has been concentrated on incremental modifications of the Bis-GMA/TEGDMA polymer to reduce polymerization shrinkage and residual polymerization stress. The current dental composite restorative system has been shown to alter the metabolism of caries-related bacteria and biofilm, such that secondary caries juxtaposing dental restorations may have a different microbial environment than initial caries on enamel-dentin surfaces. For example, leached unreacted monomers and other degradation products from dental composite restorative systems and sealants have been associated with a muted immune response, possibly also eliciting changes in bacterial responses.
From the 2005-06 Survey of Dental Services Rendered, an estimated 122.7 million dental composite restorations were placed in 2006 and the current trends in clinical dentistry indicate that this number is likely to increase. The advance of a new, longer-lasting composite polymer and corresponding filler and adhesive components is an urgent dental and oral health need which could have a significant positive impact on the oral health of the US population.
This FOA will not accept clinical trial applications. Applicants who wish to conduct clinical trials must use the R34 / U01 mechanism under the NIDCR Clinical Trials Program (see http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm).
Applications will be considered nonresponsive if:
a) assessment of the composite polymer is not evaluated in a physiologically relevant oral microbial, physical/chemical environment;
b) the design/incorporation of filler and adhesive system are not proposed for the novel composite polymer; and
c) a plan which shows how U01 awardees of composite polymer development and research advances will work cooperatively and share data and resources among these U01 awardees to achieve the goals of this program is not provided.
It is recognized that the 5 year project period supported by this FOA may not be sufficient for complete development of a dental composite restorative system, and in this case investigators are asked to briefly outline their chosen objectives in a framework of the overall research plan. Objectives should describe proposed specific, measureable and achievable progress throughout the project period which can be used as an indicator of success towards the end-goal of a novel dental composite restorative system.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
NIDCR intends to commit up to $3 million dollars in total costs in FY2013 to support 5-6 U01s solicited through this FOA. The actual number of awards is contingent upon receiving a sufficient number of meritorious applications and the availability of funds. |
Award Budget |
Applications are limited to $350,000 direct costs per year for a total of $1.75 million direct costs over five years. A detailed budget is required. The nature and scope of the proposed research will vary among applications; thus it is anticipated that the size and duration of each award will also vary. |
Award Project Period |
The total project period for an application submitted in response to this FOA is limited to no more than five years. |
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 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.
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 4-6 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 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 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.
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.
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
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd, Room 662
Bethesda, MD 20892-4878
Telephone: (301) 594-5593
Fax:(301) 480-8303
Email: shiraziy@mail.nih.gov
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. 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.
A detailed budget is required.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
The Research Plan should include: 1) a section addressing novelty; 2) a section addressing the criteria to evaluate the composite and evidence for a two fold increase in composite service life; 3) a section addressing goals; 4) future plans for the research in the context of the 5 years proposed here; and 5) specific discussion about the multidisciplinary team.
The initial phase of the composite polymer development will need to meet the following goals and conditions (Please include timelines):
1)Successful demonstration of reduced enzymatic, hydrolytic, and/or oxidative degradation (minimum testing duration 90 days)
2)Physical and mechanical properties comparable with or exceeding current composite polymers
3) Description of how the fillers and adhesive system will be developed/incorporated into the novel composite polymer.
4) A plan which shows how U01 awardees of composite polymer development and research advances will work cooperatively and share data and resources among these U01 awardees to achieve the goals of this program.
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
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) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDCR. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applications will be considered nonresponsive if:
a) assessment of the composite polymer is not evaluated in a physiologically relevant oral microbial, physical/chemical environment;
b) the design/incorporation of filler and adhesive system are not proposed for the novel composite polymer; and
c) a plan which shows how U01 awardees of composite polymer development and research advances will work cooperatively and share data and resources among these U01 awardees to achieve the goals of this program is not provided.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
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? To what is extent is the multidisciplinary team of investigators complementary? Does the composition of the team support the development of a novel composite polymer? Is there evidence for appropriate communication and collaboration plans?
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? To what is extent is the proposed composite polymer novel and not and an incremental step in development?
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? To what extent are the evaluation criteria for the composite polymer addressed? Is there evidence that the proposed composite polymer will increase service life by a factor of two? To what extent are the goals described comprehensively and realistic and is there evidence that these goals can be achieved in the proposed time period? Are there clear future plans to address the further development of the dental composite restorative system in the context of the 5 year funding period?
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? Is there evidence that the environments of the multidisciplinary team are diverse and complementary? To what extent will these environments add to the proposed research?
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
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/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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 National Institute of Dental and Craniofacial Research) 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 Institute of Dental and Craniofacial Research Advisory Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) 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 the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and other HHS, PHS,
and NIH grant administration policies.
The administrative and funding instrument used for this program will be the
cooperative agreement an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The Program Director/Principal Investigator will have the primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the FOA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below:
The Program Director/Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance in coordination, cooperation and participation of NIDCR staff in scientific and technical management of the project in accordance with the terms formally and mutually agreed upon prior to the award. The responsibility for the planning, direction, and execution of the proposed project will be solely that of the Principal Investigator. The Program Director/Principal Investigator agrees to provide NIDCR with the design, methods, and procedures to be employed in the conduct of studies and to comply with requirements prescribed by NIDCR for study development, conduct, and independent scientific review.
Regular telephone and written/email communication with the NIDCR Program Official is considered to be very important and is strongly encouraged.
Publications: The Program Director/Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the cooperative agreement award and supported in part or in total under this Agreement. Publications or oral presentations of work performed under this Agreement are the responsibility of the Program Director/Principal Investigator and will require appropriate acknowledgement of NIDCR support. Timely publication of major findings is encouraged.
Data: While the NIDCR Project Scientist/Program Official has a right of access to the data (see NIDCR staff responsibilities below) the awardee will retain custody of and right to the data. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIDCR Project Scientist/Program Official will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NIDCR Project Scientist/Program Official will serve as a liaison/facilitator between the awardee and other government agencies, and will serve as a resource of scientific and policy information related to the goals of the awardee's research. The NIDCR Project Scientist/Program Official will facilitate coordination of project activities during the course of the project. The NIDCR Project Scientist/Program Official will assist the awardee with access to other NIDCR-supported resources and services.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
However, the NIDCR Conflict of Interest Management strategy for Cooperative agreements will apply to this award. It is anticipated that the Project Scientist/Program Official will refrain from activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication. Should the extent and nature of staff involvement evolve to the level where conflicts of interest arise, NIDCR will carefully re-evaluate the alignment of duties among staff and implement specific strategies to manage the conflicts of interest.
Areas of Joint Responsibility include:
The specific timelines,
interim objectives and funding levels agreed to by the awardee and the NIDCR
shall be included in the terms and conditions of award. Given the nature of designing
and developing a novel composite polymer and corresponding dental composite restorative
system, it is recognized that timelines and interim objectives may require
revision and renegotiation during the course of the project period. The
Principal Investigator and NIDCR must agree to all such revisions. Release of
each funding increment by NIDCR will be based on a NIDCR review of progress
towards achieving the previously agreed upon interim objectives. Where
scientifically appropriate, NIDCR may ask the awardee to collaborate or
cooperate with other NIDCR-funded projects and/or US government agencies.
Dispute
Resolution
Any disagreements that may arise in scientific or programmatic matters (within
the scope of the award) between award recipients and the NIH may be brought to
Dispute Resolution. A Dispute Resolution Panel composed of three members will
be convened. It will have three members: a designee of the awardee chosen
without NIH staff voting, one NIH designee, and a third designee with expertise
in the relevant area who is chosen by the other two. This special dispute
resolution procedure does not alter the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with PHS regulations 42 CFR
Part 50, Subpart D and HHS regulations 45 CFR Part 16.
The awardee will be required to provide the NIDCR with biannual periodic reports reflecting project progress. There will be an administrative review organized by the NIDCR after approximately four years of the project period to determine if the awardee has performed as envisioned. Based on this review, a decision may be made by the NIDCR about continuing research activities as planned, refocusing activities, or ending the research activities.
Awardees will be required to submit biannually the Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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.
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.
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]
James L. Drummond, DDS, PhD
Director, Dental Materials and Biomaterials Program
Integrative Biology and Infectious Diseases Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health, DHHS
6701 Democracy Blvd., Rm. 612
Bethesda, MD 20892-4878
Telephone: (301) 402-4243
Email: [email protected]
Yasaman Shirazi, PhD
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd, Room 662
Bethesda, MD 20892-4878
Telephone: (301) 594-5593
Fax: (301) 480-8303
Email: shiraziy@mail.nih.gov
Dede Rutberg, MBA
Lead Grants Management Specialist
Division of External Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
6701 Democracy Blvd, Room 656 MSC 4878
Bethesda, MD 20892-4878
Telephone: (301) 594-4798
Fax: (301) 480-3562
Email: [email protected] or [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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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