Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Effectiveness of Treatment for Oral Diseases in Medically Compromised Patients (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DE-12-007

Companion FOA

RFA-DE-12-006, R01 Research Project Grant

Number of Applications

Applicants may submit more than one application, provided that each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic
Assistance (CFDA) Number(s)

93.121

FOA Purpose

This Funding Opportunity Announcement encourages exploratory / developmental clinical research related to determining outcomes of prevention and treatment strategies for oral diseases in persons with medical conditions known to severely compromise oral health.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

October 18, 2011

Letter of Intent Due Date

October 18, 2011; August 18, 2012

Application Due Date(s)

November 18, 2011 and September 18, 2012 , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

February-March 2012; December 2012

Advisory Council Review

May 2012; May 2013

Earliest Start Date(s)

July 2012

Expiration Date

September 19, 2012

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research that addresses gaps in our knowledge of how best to treat the oral diseases of medically compromised patients, to identify risk factors that further compromise treatment outcomes in these selected patient groups, and to generate evidence for treatment guidelines. 

Background:

Systemic diseases and disorders such as Sjögren’s syndrome, head and neck cancers, cleft lip/palate, Ectodermal Dysplasias (ED), and diabetes severely compromise factors that maintain oral health. Consequently, oral diseases are more prevalent and severe in these patients.  Most evidence supporting treatment for caries or periodontal diseases is derived from clinical trials/studies in relatively healthy subjects, and the long term success of different treatment and restorative approaches for oral diseases has not been assessed in individuals with the highest risk for poor oral health.  Patients with certain systemic diseases or disorders can spend significant time and resources maintaining their oral health. For example, a recent case-control study of Sjögren’s syndrome patients found out-of-pocket spending for dental care was two to three fold higher in Sjögren’s patients as compared with peer controls.  A survey of ED patients found costs for dental treatment could exceed $40,000 for those with severe hypodontia, and over 50% of patients paid for all dental services out of pocket.  Small studies suggest some standard treatments for oral diseases are not as successful in compromised patient groups. For example, glass ionomer and composite resin restorations placed in post head-and-neck radiation cancer patients are reported to have very high two-year failure rates.  A recent review of the literature concerning the success of dental implants in patients with ED and tooth agenesis concluded the evidence to support treatment guidelines was scarce, and studies lacked long term outcomes.  Children born with oral clefts have multiple reparative procedures from birth through early adulthood, but there is little evidence to support the use of many cleft treatment protocols. 

Scope:

The objective of this FOA is to support effectiveness research to inform prioritization of evidence-based treatment for patients with disorder or disease-related compromised oral health, and suggest appropriate adaptations (in timing, frequency, procedure or material) of recommended preventive and restorative guidelines for these patients.  This Funding Opportunity will not support epidemiological studies of disease prevalence without assessment of treatment outcomes.  It also will not support randomized clinical trials.  Investigators proposing clinical trials must use the R34 / U01 mechanism (see http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm).

Study designs considered responsive would be case-control studies, survey studies, 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), or cross-sectional or longitudinal studies, provided sufficient numbers of subjects and meaningful clinical outcomes can be evaluated within the grant timeframe.  Topics could include comparative effectiveness studies of dental procedures, reconstructive interventions or maintenance therapies, and cost-effectiveness assessments of existing interventions with demonstrated effectiveness. The research should identify best procedures, devices, drugs or other interventions that restore oral health.  Also considered responsive would be studies identifying procedures that reduce treatment costs without compromising treatment outcomes. There must be existing evidence that the disease or condition selected for study (such as Sjögren's syndrome) is associated with an increased risk of oral disease or developing more severe forms of oral disease. 

All study subjects must have the condition or disease of interest (such as post head-and-neck radiation), but analyses may examine the contribution of co-morbid conditions on treatment outcomes.  Patient groups of interest would include, but are not be limited to, head-and-neck radiation patients, those with Sjögren’s syndrome, transplant patients, patients born with cleft lip / palate, individuals with rare syndromes such as the Ectodermal Dysplasias, and inherited immunodeficiencies. 

Applications that propose to utilize existing records and subjects at specialized treatment centers are encouraged to apply.  Any application planning to use existing data should provide a compelling argument as to the adequacy of the database or records to address the question.  There must be sufficient clinical data to determine the relative positive and negative impacts of prevention/therapy in the patient population of interest compared to an otherwise healthy population. Discussion of the database or existing records should address data quality, missing data, bias and any methods that will be used to control or account for deficiencies. 

Examples of research that could be supported through this FOA include, but are not limited to:

1.  Dental restoration, implant, crown or prosthetic survival in post head-and-neck radiation patients, patients with Sjögren's syndrome or individuals with Ectodermal Dysplasias;

2.  Impact of early interventions (such as those for babies born with oral clefts) on later clinical outcomes;

3.  Effectiveness of prophylactic interventions (such as hyperbaric oxygen therapy) to prevent post-surgical complications; and

4.  Outcomes of grafting or particular techniques for facial reconstruction after major surgery or trauma.

Applications must clearly document either the lack of published information describing the outcomes for treatment of the condition of interest, or the need to update information due to developments in treatment that have altered the condition’s epidemiology.  Projects must describe which outcomes are being used and how each will be measured.  Applicants should describe if and how current treatment guidelines and quality of care measures may need to be adjusted as a result of their findings.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New submissions only for the November 18, 2011 receipt date;

New and resubmissions will be accepted for the September 18, 2012 receipt date.

The OER Glossary and the SF 424 (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. NIDCR intends to support approximately 5-6 R21 applications solicited through this Funding Opportunity Announcement. A companion Funding Opportunity Announcement, RFA-DE-12-006, will support approximately 4-5 R01 additional grant applications. NIDCR intends to commit up to $4 million to support meritorious projects solicited through these two announcements.

Award Budget

Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with a maximum of $200,000 in direct costs allowed in any single year..

Award Project Period

The total project period for an application submitted in response to this funding opportunity 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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

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

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.  

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted to the September 18, 2012 receipt date, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.    

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
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
1DEM, Room 662, MSC 4878
6701 Democracy Boulevard
Bethesda, Maryland 20892
(Courier 20817)
Telephone: 301-594-5593
Fax: 301-480-8303
Email: yasaman.shirazi@nih.gov

Required and Optional Components

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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Research Plan Research Strategy Section

Significance

Provide the evidence that the disease group selected for study has an increased risk for the prevalence or severity of a particular oral disease.   

Describe the significance and clinically relevant outcome(s) of the proposed research.

Document either the lack of published information describing the outcomes for treatment of the condition of interest, or the need to update information due to developments in treatment that have altered the condition’s epidemiology.

Describe if and how current treatment guidelines and quality of care measures may need to be adjusted as a result of the proposed research.

Approach

Provide evidence that all study subjects have in common the condition or disease of interest (note: analyses may examine the contribution of co-morbid conditions on treatment outcomes) and describe how the diagnosis will be established.

The application must address the feasibility of recruiting subjects who are eligible for the proposed research. Specifically, applicants must provide evidence that each recruiting clinical center has access to a sufficient number of study participants who meet the eligibility criteria. For multi-site applications, information must be provided for each participating clinical site.

Describe the outcomes being used, how each will be measured, and provide the analysis plan.

For longitudinal studies, provide evidence that meaningful clinical outcomes can be evaluated within the proposed duration of the project and the plan for subject retention.

For retrospective data analyses, provide a compelling argument as to the adequacy of the database or records to address the question. The proposed dataset must have sufficient numbers of the target patient group and measurable oral health outcomes.  Discussion of the database or existing records should address data quality, missing data, bias, and any methods that will be used to control or account for deficiencies.  Provide evidence that the study team has access to the data needed to complete the research. If data will be extracted from individual medical records, describe how the data will be collected uniformly and how data will be validated.

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.

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, with the following modifications:

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.  

6. Other Submission Requirements and Information

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/PIs 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, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

This R21 exploratory/developmental grant supports investigation of scientific ideas that have the potential for significant impact on clinical care.  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.

Overall Impact

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).

Scored Review Criteria

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? Is there evidence that the condition or disease group selected for study is associated with an increased risk for the prevalence or severity of a particular oral disease?  Does the proposed investigation address a clinically meaningful outcome? Will the outcomes of the research generate new evidence that could answer a meaningful clinical question rather than simply confirming findings of other studies?  Do the investigators articulate how the results of the proposed research will impact existing treatment guidelines?

Investigator(s)    

Are the PD/PIs, 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?  

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? Do all subjects in the target patient group have the disease or condition of interest?  How will the diagnosis or condition be established?  If proposing retrospective data analyses, does the data set have sufficient numbers of the target patient group and do oral health outcomes exist in the data set? Does the application discuss the quality of existing data, missing data bias and any methods that will be used to control or account for deficiencies? 

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? Do the investigators have access to sufficient numbers of potential subjects or subject records to complete the research within the grant period?

Additional Review Criteria

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

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.

Additional Review Considerations

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDCR  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will be assigned to the NIDCR.  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 l. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 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.      

2. Administrative and National Policy Requirements

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

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Jane Atkinson, DDS
Director, Center for Clinical Research
Division of Extramural Research
National Institute of Dental and Craniofacial Research
1DEM, Room 634, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: (301) 435-7908
Fax: (301) 480-8319
Email: jatkinso@mail.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
NIDCR, NIH
6701 Democracy Boulevard, Suite #662
Bethesda, Maryland 20892
(Courier 20817)
Tel: (O)301-594-5593, (c)301-335-6233
Fax: 301-480-8303
Email: yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Mary Greenwood
Chief, Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
1DEM, Room 658, MSC 4878
6701 Democracy Boulevard
Bethesda, MD 20892-4878
Telephone: 301-594-4808
Fax: (301) 480-3562
Email: daleym@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.


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