Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	Innovative Approaches and Technologies for Examining the Uncultivable Bacteria of the Oral Microbiota (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-DE-14-003
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.121
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) seeks to stimulate innovative research that will increase our understanding of the role that uncultivable bacterial species play in the microbial ecology of the human oral microbiota during states of health and disease. The effective integration of current technologies and the development of new tools and innovative methods are especially encouraged. Due to the wide spectrum of possible experimental approaches and the multidisciplinary tools that will be required to study this unique microbial population, this FOA is designed specifically to encourage team science that will leverage innovation, broad expertise and multiple technological platforms to answer hypothesis-driven questions regarding these bacteria. Consistent with this approach, the use of a multiple Program Directors/Principal Investigators (PDs/PIs) model is encouraged that will recruit complementary and collaborative research teams to conduct these studies.

Posted Date	May 20, 2013
Open Date (Earliest Submission Date)	August 18, 2013
Letter of Intent Due Date(s)	August 18, 2013
Application Due Date(s)	September 18, 2013, by 5:00 PM local time of applicant organization. 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.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	January 2014
Advisory Council Review	May 2014
Earliest Start Date	June 2014
Expiration Date	September 19, 2013
Due Dates for E.O. 12372	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 goal of this Funding Opportunity Announcement (FOA) is to stimulate innovative research that will increase our understanding of the role that uncultivable bacterial species play in the microbial ecology of the human oral microbiota during states of health and disease. The effective integration of current technologies and the development of new tools and innovative methods are especially encouraged. Due to the wide spectrum of possible experimental approaches and the multidisciplinary tools that will be required to study this unique microbial population, this FOA is designed specifically to encourage team science that will leverage innovation, broad expertise and multiple technological platforms to answer hypothesis-driven questions regarding these bacteria. Consistent with this approach, the use of a multiple Program Directors/Principal Investigators (PDs/PIs) model is encouraged that will recruit complementary and collaborative research teams to conduct these studies.

The human oral microbiota is estimated to contain over 600 individual bacterial taxa with approximately 200 being formally named species but only about 100 members representing laboratory-cultivable isolates or strains. This lack of cultivability of the majority of the population represents an enormous diversity of organisms for which we still know very little particularly with regard to the molecular and metabolic interactions that occur in relation to their host or the role they may play in oral health or disease. Although cultivable species in pure culture can validate Koch s postulates and replicate specific oral diseases in carefully controlled model systems, some oral diseases are more complex and are recognized as being polymicrobial in origin. Periodontitis is one ecological disease with a polymicrobial etiology. While the causative organisms produce a myriad of virulence factors and induce a destructive inflammatory host response, much remains to be determined with regard to their role in disease initiation, progression, or their role in normal or non-disease ecology. What role the uncultivable species may play in these processes is equally enigmatic. Uncultivable species could be envisioned to have multiple roles from helping to maintain the commensal flora, acting as overt pathogens, or participating in some unknown covert capacity. Or, they simply could be by-standers that persist harmlessly in various states of oral health or as a consequence of a disease state. While recent technological advances have revolutionized individual aspects of oral microbiology, this FOA strives to encourage systems integration by combining diverse specialties to answer complex questions regarding uncultivable bacteria. It is recognized that additional tool development may be needed to assist with the integration or expansion of existing technologies. But development work must be in the context of answering a hypothesis-driven question regarding the biology of these organisms and should not specifically be devoted to new tool development.

Multidisciplinary research teams including those outside of recognized dental research institutions capable of achieving the objectives of this FOA are strongly encouraged to apply. These teams should possess a collective skill set that can provide a broad range of innovative enabling technologies such as biofilm modeling and quantitative imaging, direct in situ non-destructive measurement of cell viability, metagenomics, metabolomics, domestication and handling of fastidious organisms, and in vivo animal modeling where appropriate. Applicants are strongly encouraged to build teams that will provide a complete skill set resulting in a strong data package addressing the hypothesis-driven question(s) specific for each project.

Projects should be of sufficient complexity to address these five key objectives:

1) Expand the catalog of cultivable oral bacteria by capturing presently uncultivable species via the development of new technologies and culture strategies. These technologies may involve novel domestication strategies, culture media or techniques requiring co-cultivation with various microbial partners or the use of host-derived cells or factors. Projects must not be limited solely to increasing the collective numbers of new oral bacterial isolates but directed specifically toward the development of a knowledge base that will answer basic questions about the physical state of uncultivability. Hypothesis-driven questions such as what makes one species easily cultivable over another or why one closely-related species is cultivable while a genetically similar strain is uncultivable are of particular interest. Also of specific interest is whether domesticated isolates require compensatory mutations, genome rearrangements or other types of genomic changes for adaption to in vitro culture conditions or whether some reversible stochastic mechanism is involved allowing a previously uncultivable isolate to revert back to an uncultivable state.

2) Integrate and optimize recent technological advances in biofilm modeling and cell quantitation using miniaturized flow-cell systems that will enable high through-put analysis of oral biofilm communities under a variety of long-term culture conditions. Multiple variables could be considered in these studies such as the effects of population complexity, nutrient flow, potential for interspecies metabolic cooperation, cell-cell signaling (either through direct cell contact or via diffusible small molecule mediators), role of host-derived factors or surfaces and population dynamics that will increase our understanding of community resilience and long-term maintenance. These investigations must make use of newly isolated uncultivable species either by using domesticated forms or through concomitant co-culturing strategies with cultivable partners. Projects must make full use of culture miniaturization technologies that will limit the need for high volume saliva-based culture media.

3) Utilize current state-of-the-art technologies or further develop and refine techniques for molecular labeling, biofilm imaging, non-destructive in situ measurement of cell viability and metabolite detection to discover and quantify metabolic interactions between community members and to demonstrate the ability to monitor these interactions in real time during long-term culture conditions. Test systems must prove to be tractable and capable of recapitulating essential dynamic functions believed to be present under in vivo conditions in the human oral cavity. They must have clearly defined quantitative experimental read-outs or end-points that can leverage the depth and breadth of current metabolome and microbiome datasets.

4) Configure mock communities composed of various combinations of known cultivable species recognized as being present in situations of oral health or known pathological states of disease, together with newly identified uncultivable species, in order to understand metabolic and molecular interactions required for maintenance of the uncultivable species and to determine their overall role in the composition of the oral microbiota and their role in disease. Test platform technologies also may be expanded to include in vivo animal modeling to ascertain virulence attributes of domesticated pure isolates or mixed communities containing uncultivable species as long as the models are directly relevant and applicable to diseases of the human oral cavity. If utilized, animal models must directly address an essential hypothesis-driven question relative to some aspect of uncultivability and how a particular uncultivable species may contribute to virulence either directly or through a pathogenic consortium. Primate models of infection will not be considered.

5) Provide an adequate mechanism for the assembly and open dissemination of complex data sets and biological materials that arise from these studies under the context of the NIH Data Sharing Policy through a well-defined Project Data and Resource Sharing Plan. Although a stand-alone data analysis and coordination center or activity is not specifically envisioned for this FOA, a convenient and end user-friendly informatics model for rapid data release must be an essential component of each project. All microbial taxonomic data should conform to the Oral Taxon System as specified under the Human Oral Microbiome Database (HOMD). Newly discovered oral taxon designations should be coordinated and fully integrated into the HOMD as well as other world-wide nucleic acid and protein sequence repositories appropriate for direct access by the oral research community. Reagents, such as microbial isolates or strains to be sequenced should be deposited at the BEI Resources Repository or another approved public repository directly accessible by the oral research community. Prior to deposition, the strategy and criteria for isolate selection should be outlined in the project plan. Other resources and reagents to be shared should be released rapidly to promote the principles expressed above and described as part of a comprehensive Project Data and Resource Sharing Plan.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDCR intends to commit $2,000,000 in total costs in FY2014 to support one to two awards in response to this FOA.
Award Budget	Application budgets are not limited, but need to reflect the actual needs of the proposed project.
Award Project Period	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

• 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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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

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 (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for 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, 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
National Institute of Dental and Craniofacial Research (NIDCR)
6701 Democracy Blvd., Suite 662
Bethesda, MD 20892 (Courier 20817)
Telephone: 301-594-5593
FAX: 301-480-8303
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required 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 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.

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:

• Address technology innovation and how the project will integrate existing technologies together with any new technologies that may be required for total system integration in order to move the field forward.
• State clearly the criteria that will be used to evaluate the ability of the project to define the state of bacterial uncultivability and how uncultivable organisms differ from cultivable organisms.
• Address as appropriate each of the five key objectives as outlined in the Section I., Funding Opportunity Description.

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 modifications as outlined in a comprehensive Project Data and Resource Sharing Plan:

• Applicants should provide a precise description of how they will organize and implement a convenient end user-friendly informatics system for rapid data release preferably via a World Wide Web (WWW)-based data base application.
• For relevant microbial taxonomic data on new microbial isolates, applicants should describe how they will conform to the Oral Taxon Classification System as specified under the Human Oral Microbiome Database (HOMD) and coordinate new taxa designations between their individual systems and the HOMD.
• For new microbial isolates, strains or other biological materials, applicants should describe their deposition criteria and strategy for depositing materials into the BEI Resources Repository.

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.

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 the National Institute of Dental and Craniofacial Research (NIDCR), NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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?

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 considerations will include:

Will the members of the research team be able to work together to address the specific aims of the project?

Is there prior evidence of the members working together on complex multi-component research projects or through prior scientific collaboration between separate projects?

Is there an adequate description of how management problems will be addressed if they were to arise within the project team?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

How will the project increase our understanding of the natural state of bacterial uncultivability in the oral cavity?

Will the work lead to new technologies or approaches for the recovery of uncultivable bacterial isolates from the oral cavity either through domestication, co-cultivation or novel techniques?

How will test systems be capable of recapitulating essential dynamic functions believed to be present under in vivo conditions in the human oral cavity and how will these systems significantly contribute to understanding the state of uncultivability?

Are the proposed quantitative read-outs or end-points from the test systems clearly defined and reasonable based on the current technical state of the field?

Will the essential methods and technologies described for each specific aim be adequately covered by a member of the project team?

If previously uncultivated isolates will be required in the early stages of the project (either for comparative purposes or to allow for initial establishment and testing of mock communities or systems), will those materials be readily available to the investigators?

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?

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 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 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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDCR, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

• 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 the DUNS, SAM 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

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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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]

R. Dwayne Lunsford, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-2421
Email: [email protected]

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected]

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

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