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

Short-term Mentored Career Enhancement Award in Dental, Oral and Craniofacial Research for Mid-Career and Senior Investigators (K18)

Activity Code

K18 Career Enhancement Award

Announcement Type

New

Related Notices
  • 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-14-039

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) encourages applications for short-term mentored career enhancement (K18) awards in dental, oral and craniofacial research with a focus on behavioral and social sciences, and genetic and genomic research. The intent of this K18 program is to provide mid-career or senior investigators with short-term training in the theories, tools, methods or approaches of another scientific area, in order to enhance their existing research program. Two categories of candidates are targeted: (a) established dental, oral, and craniofacial research investigators who seek training with investigators from another field, in order to enrich their existing dental, oral and craniofacial research program; and (b) established investigators in other fields who seek training with dental, oral and craniofacial research investigators in order to facilitate the introduction of dental, oral and craniofacial research into an existing research program.

Key Dates
Posted Date

December 13, 2013

Open Date (Earliest Submission Date)

January 12, 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)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

February 13 , 2017

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, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), 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.


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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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of this NIDCR Short-Term Mentored Career Enhancement Award in Dental, Oral and Craniofacial Research for Mid-Career and Senior Investigators (K18) is to provide mid-career or senior investigators with salary and research support over a short-period of time to support a mentored career enhancement experience in the theories, tools, methods or approaches of a scientific field different from their own, in order to enrich and expand an existing research program in dental, oral and craniofacial research, or to bring dental, oral and craniofacial research to existing research in other scientific fields.

This FOA focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent, peer-reviewed Federal or private research grant funding. Candidate are not required to have active research grant support at the time of application. The purpose of the award is to provide candidates with support for short-term, intensive mentored research experiences over a period of two and a half to twelve months to acquire new research capabilities within the NIDCR research mission. Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are established, well-qualified, and willing to sponsor the short-term research career development experience. It is expected that the proposed career enhancement plan will represent a novel extension of the research of the candidate. Such experiences will afford candidate investigators protected time to 1) seek training with established investigators from another field, in order to enrich their existing dental, oral and craniofacial research program; and 2) seek training with established dental, oral and craniofacial research investigators in order to facilitate the introduction of dental, oral and craniofacial research into the candidate's existing research program.

The research career enhancement experience may be conducted in a different department within the candidate's  home institution or different institutional setting from the location where they hold their primary appointment. The host mentoring laboratory/research program is expected to demonstrate appropriate research and resources to provide a new research direction for the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate the goals of this FOA in a manner that could not be achieved solely through a research grant or current collaborative arrangement.

Research Scope

This FOA supports short-term mentored research training in two general areas: behavioral and social sciences, and genetic and genomic research. Applications must be consistent with the research priorities of the NIDCR Behavioral and Social Sciences Research Branch (BSSRB) and/or the NIDCR Translational Genomics Research Branch (TGRB).  Additional information about the priorities of NIDCR's Behavioral and Social Sciences Research Branch can be found at: http://www.nidcr.nih.gov/Research/DER/BSSRB.htm. Additional information about the priorities of NIDCR's Translational Genomics Research Branch can be found at http://www.nidcr.nih.gov/Research/DER/TGRB/ ). Prospective applicants are encouraged to contact an NIDCR program official from either of these branches to discuss their research goals,  NIDCR specific programmatic information,  and the research priorities listed below. Applications addressing other areas of research will not be be considered for funding. 

This FOA does not support clinical intervention studies. NIDCR guidelines for investigators who wish to propose a clinical intervention study are found at http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm.

Behavioral and Social Sciences Research Priorities for this FOA

The NIDCR behavioral and social sciences program supports both basic and applied research to promote oral health, to prevent oral/dental diseases and related disabilities, and to improve management of craniofacial conditions, disorders and injury. Mentored experiences are encouraged that facilitate the application of theories, tools, methods or approaches from the behavioral or social sciences to oral health challenges. Examples of candidate-mentor pairings, and associated projects, are listed below for illustrative purposes. This list does not imply preference for these specific example projects:

* An investigator with expertise in analyzing national oral health data seeks mentorship from an investigator in causal modeling; the candidate learns innovative statistical techniques and methodologies to identify causal relationships, and the two work together on a simulation study that allows testing alternative causal hypotheses.

* An investigator in oral health disparities seeks mentorship from an investigator in systems science; the candidate learns the methods and tools of system science, and the candidate analyzes the mentor's data set, asking an oral health or health disparities question.

* An investigator in adherence to asthma medication seeks mentorship from a dentist-scientist; the candidate learns the adherence challenges in dentistry, and the two collaborate on a small project in which they identify ways in which adherence principles could be applied in the dental clinic.

* An investigator in children's oral health seeks mentorship from an investigator with expertise in research on parenting; the candidate learns the theories, measures and methods of family research, and the two work together on a project to develop and test a measure to capture potentially relevant family dynamics in the dental clinic.

* An investigator who studies peer influence among adolescents seeks mentorship from a pediatric dentist-scientist; the candidate learns about the parameters of pediatric dentistry, and the two collaborate on a study that identifies sources of peer influence that might be leveraged in a subsequent oral health study.

* An investigator with a strong track record in dissemination and implementation science seeks mentorship from a clinical investigator who works in dental practice-based research; the candidate learns about the clinical, organizational and policy challenges in dental practice, and the two design a survey to better understand how evidence based practices are adopted in dental practice.

Genetics/Genomics Research Priorities for this FOA

Scientific areas of highest priority for Genetics/Genomics applications are laboratory and/or statistical analysis and interpretation of genetic and genomic data which may include DNA genotyping and/or sequencing, epigenetics/epigenomics, and/or gene expression.

Examples may include but are not limited to:

* A clinical researcher studying an oral disease seeks mentorship from an investigator in genomic laboratory methods, and the two collaborate on a project that makes use of stored samples from a previous study.

* An epidemiologist working with a national oral health database seeks mentorship from an investigator with expertise in statistical analysis of genetic/genomic data, and the two complete a project using data available thru the NIH's database of Genotypes and Phenotypes (dbGaP).

* An investigator in DNA sequencing seeks mentorship from an investigator with expertise in a particular oral disease, and the two design a study to identify potential genetic markers for the oral disease.

* A dentist-scientist seeks mentorship from an investigator with expertise in bioinformatics, and the two pilot-test an innovative approach to analyzing clinical and genomic data.

Section II. Award Information
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

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

A project period from 2.5 months to 12 months may be requested.

Other Award Budget Information
Salary

NIDCR will contribute a minimum of 2.4 up to a maximum of 6 person-months of full-time professional effort  per year toward the salary of the career award recipient.  

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIDCR will contribute $25,000  per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grant 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 Institutions

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.

Required Registrations

Applicant Organizations

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

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

All PD(s)/PI(s) must have an eRA Commons account 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.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for this award must have a research or health professional doctoral degree, or a combined health-professional and research doctoral degree.  The award is intended for well-established investigators at the academic rank of Associate Professor or Professor, or the equivalent in non-academic settings, who have established records of independent, peer reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.

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 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:

Level of Effort

At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.   

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.   

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed. 

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Other program-related expenses: Applicants may request up to $25,000 in direct costs to cover other program-related expenses, such as tuition and fees for short-term courses, travel to scientific meetings or training, consultant fees, and research-related costs, primarily supplies and technical or computational services. Salary for research assistants, laboratory technicians, or equivalent research staff may be appropriate.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate’s Background

Career Goals and Objectives

Candidates’ Plan for Career Development/Training Activities During Award Period

Training in the Responsible Conduct of Research

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

Letters of Support from Collaborators, Contributors and Consultants

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Description of Institutional Environment

Institutional Commitment to the Candidate’s Research Career Development

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series), must be followed, with the following additional instructions:

Research Strategy

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Letters of Reference

Letters of reference are not required.

3. Submission Dates and Times

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.

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.

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 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify Dr. Yasaman Shirazi, Chief of the Scientific Review Branch, NIDCR by email at shiraziy@nidcr.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria


Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

Research Plan

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Environment & Institutional Commitment to the Candidate

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 score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is  justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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 score.

Training in the Responsible Conduct of Research

 Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups that the candidate will participate in?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety?  Do the plans adequately describe the candidate’s role in the participation in instruction in RCR? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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), convented 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:

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:

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’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.

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. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed.

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. 

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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: 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

Scientific/Research Contact(s)

Lynn Mertens King, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: Lynn.King@nih.gov

David Clark, DrPH
Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: David.Clark2@nih.gov

Emily L. Harris, PhD, MPH
Translational Genomics Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4846
Email: emily.harris@nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov .

Financial/Grants Management Contact(s)

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@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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