Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	Establishing Outcome Measures for Clinical Studies of Oral and Craniofacial Diseases and Conditions (R21)
Activity Code	R21 Exploratory/Developmental Grant
Announcement Type	New
Related Notices	July 17, 2015 - This PA has been reissued as PAR-15-298. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PAR-13-380
Companion Funding Opportunity	PAR-13-379 , R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.121
Funding Opportunity Purpose	The goal of this funding opportunity announcement is to support the development of well-founded outcome measures, including establishing their reliability and validity, for clinical studies of oral and craniofacial diseases and conditions.

Posted Date	October 23, 2013
Open Date (Earliest Submission Date)	January 16, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, 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)	Standard AIDS dates apply 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.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	September 8, 2015
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

Study outcomes or endpoints used in a clinical trial or study must provide reliable and valid signals for the efficacy of the intervention being tested or to reliably document disease prevalence and/or progression. The lack of defined, valid outcome measures has limited clinical studies of some oral and craniofacial diseases and conditions. This funding opportunity announcement (FOA) aims to address this problem by supporting research that will establish well-founded clinical outcome measures to be used in oral and craniofacial research. The R21 activity code is intended to encourage new exploratory and developmental research projects. For example, projects could assess the feasibility of a using a new experimental outcome measure that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing method of assessing one disease to explore the method’s ability to measure another. An R21 grant application need not have extensive background material or preliminary information.

The developed outcome assessment(s) may be used to characterize a disease, its progression or its severity, or it may serve as a clinical endpoint to measure treatment efficacy in future studies. This FOA also encourages development of clinician-reported, patient-reported or observer-reported (i.e., parent- or caregiver-reported) outcome measures to capture clinical differences that are meaningful to individuals affected by a disease or condition.

Acceptable methodologies for developing or validating measures may include observational or natural history studies designed to collect essential data for future studies, such as establishing the frequency of treatment complications in a population, as long as the study proposed in the application also develops or validates companion outcome measures. These could include patient-centered outcomes or clinical measures. It is expected that multi-disciplinary teams with the necessary expertise (such as experts in oral health, behavioral sciences, epidemiology, biostatistics and/or clinical studies design) will be needed to design and conduct successful studies. Any treatments would be standard of care provided by regular caregivers and observed. Applications can include assessments of multiple measures. This announcement does not allow for interventional research or longitudinal studies proposing to validate biomarkers of disease progression.

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve oral, dental and craniofacial health through research, research training, and the dissemination of health information. The objective of this initiative is consistent with the NIDCR Strategic Plan 2009-2013, Objective III-1: Conduct well-designed, definitive clinical research studies that improve oral, dental and craniofacial health and support more effective care delivery and health policies. The NIDCR recognizes the need to develop new approaches and technologies to meet this objective. Areas of interest include improved measures to monitor pre-malignant oral lesions, assessing outcomes after endodontic treatment or implant placement, establishing outcomes for studies of children who undergo surgery or receive orthodontic treatment for cleft lip/cleft palate, reliably defining and assessing the natural history of osteonecrosis and osteoradionecrosis of the jaw, and documenting periodontal disease progression in a less burdensome manner.

To obtain definitive evidence in clinical trials or studies, study endpoints must provide reliable and valid signals for the efficacy of the intervention being tested. For some diseases and conditions, such endpoints are not easily identified because appropriate outcome assessments have not been defined or existing outcome assessments are too insensitive or too variable. In some cases, potential outcome assessments have not been tested adequately to prove their utility. For example, while recent technical advances have made it possible to visualize craniofacial structures in ways that were unimaginable 30 years ago, few studies have evaluated their usefulness in assessing outcomes of treatment or reliably documenting disease progression.

Development of a new outcome measure or modification/refinement of an existing measure must begin with a clear description of what is intended to be measured and why it is meaningful. The clinical outcome assessment must be sensitive enough to detect clinically meaningful differences in severity and yet differentiate treatment-related changes from inherent variability of a disease or condition. To be useful in clinical studies, an outcome measure must also be reliable, valid, reproducible, readily interpretable, and able to capture a clinically interpretable change. In addition, the data collection process for the new outcome measure must be acceptable to study participants and research staff.

Well-defined, reliable, and valid measures to assess disease severity or progression or to evaluate therapeutic effects in clinical trials are lacking for some oral and craniofacial diseases and conditions. For example, improved measures are needed for monitoring pre-malignant oral lesions and oral mucosal diseases, assessing outcomes after endodontic treatment or implant placement, determining outcomes in children who undergo surgery or receive orthodontic treatment for cleft lip/cleft palate, reliably defining and assessing the natural history of osteonecrosis and osteoradionecrosis of the jaw, and documenting periodontal disease progression. The usefulness of newer technologies such as three-dimensional imaging or functional MRI in measuring disease progression or response to therapy has not been established for many craniofacial diseases and conditions. There are multiple oral and craniofacial diseases and conditions that could be supported through this FOA.

In addition to the development and testing of new measures to describe disease status, assess disease progression or determine efficacy of an intervention, this FOA will support studies designed to validate measures that have previously been proposed but have not yet been validated and/or adopted by researchers in the field.

Incorporating the patients voice into clinical research studies as outcome measures is widely recognized as essential to fully capture both benefit and harm to the patients, as well as assess their health-related quality of life (HRQoL). This is especially true for individuals with rare diseases. Patient-reported outcomes (PRO) can often provide data that traditional lab-based or provider-reported information cannot. Establishing clinical outcome measures that have meaning for patients is critical for evaluating treatment benefit, as biomarkers and other measurement tools may not adequately capture the symptoms and functional impacts of a disease or condition. A patient, an observer or a clinician may report observable concepts (e.g., signs, events, behaviors) that define a disease or are affected by the disease. Only a patient can report unobservable concepts (e.g., symptoms, feelings, perceived functional deficits, sensations such as pain).

Applicants are encouraged to explore options for initially validating patient-reported outcomes measures, provided they are assessed in conjunction with clinical outcomes. Applicants should take care not to re-create existing validated PRO instruments found in the NIH-funded PROMIS (Patient Reported Outcomes Measurement Information System, www.nihpromis.org) or NeuroQoL (www.neuroqol.org). The NIH-funded PROMIS and NeuroQoL contain banks of validated PRO instruments. Investigators who are interested in developing patient-reported outcome measures are highly encouraged to utilize the rigorous methodologies used in PROMIS and NeuroQoL to validate their measures.

Acceptable methodologies for developing or validating measures may include observational or natural history studies designed to collect essential data for future studies, such as establishing the frequency of treatment complications in a population, as long as the study proposed in the application also develops or validates companion outcome measures. This Funding Opportunity will not support epidemiological studies with a primary goal of establishing disease prevalence and/or risk factors for acquiring the disease. Acceptable study designs would be cross-sectional or longitudinal studies of well-defined cohorts, case-control studies, survey studies, and database analyses beyond the scope of NIDCR Small Research Grants for Data Analysis and Statistical Methodology (R03) such as those proposing extraction of data from individual health records with adjudication of findings. Investigators proposing a longitudinal study should consider the companion R01 Funding Opportunity Announcement that provides up to five years of support.

Applications that propose a clinical trial or any other study designed to test and administer an intervention, or propose to correlate biomarkers with disease progression or disease activity are not appropriate for this FOA. Applicants who wish to conduct clinical trials or biomarker validation studies must use the R34 / U01 mechanism under the NIDCR Clinical Trials Program (see http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm. Biomarker discovery studies may be proposed using the parent R03, R21 and R01 announcements http://www.nidcr.nih.gov/GrantsAndFunding/FundingOpportunityAnnouncements/ByTopic.htm.

If the application proposes to validate a measure using a device that is experimental or currently marketed, the investigators must follow all applicable FDA regulations and guidance. Consolidated guidance is presented at http://www.fda.gov/RegulatoryInformation/Guidances/ucm122046.htm.

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 Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
Award Project Period	The total project period may not exceed two 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 not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account 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
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research (NIDCR)
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.

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.

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

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

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

The application should describe how any valid outcomes developed from the research will be shared. This would include sharing of instruments such as questionnaires for collection of the outcomes.

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, NIH. Applications that are incomplete will not be reviewed.

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

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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? If successful, is the proposed new measure or validation of the existing measure likely to exert a powerful influence on future dental, oral, and/or craniofacial research? If the application is to establish reliability and validity of an existing measure, is there sufficient justification and/or scientific premise for continued research on this measure in dental, oral, and/or craniofacial research? If the application is to develop a new measure, is there a description of the gap in measurement and sufficient justification for why existing measures are inadequate?

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? If the application is proposing development of a new measure, do the investigators have the knowledge, skills and abilities to develop a new measure? Do the investigators have experience with assessing validity and reliability of the proposed instrument(s)?

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? If proposing to establish reliability and validity of an existing measure, does that measure show promise to move the research forward? If developing a new measure, is it sufficiently different from existing methods of measuring outcomes to warrant its development? Will the new measure capture a clinically-meaningful change?

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? Is there a clear description of what is intended to be measured and why it is meaningful? If proposing to develop patient centered outcomes, are they assessed in conjunction with clinical outcomes? Is the proposed approach and statistical plan sufficient to rigorously test the specificity/sensitivity, validity and/or reliability of the proposed measure(s)?

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?

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.

• If proposing to use a device, does the clinical study meet all applicable NIDCR, NIH, Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) policy requirements?

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 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 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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), 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.

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. 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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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 Telephone: 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]

Jane C. Atkinson, DDS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: [email protected]

David B. Clark, Dr PH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: [email protected]

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

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

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.