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 support for an intensive period of mentored research experience to acquire new research capabilities 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. It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are established, well-qualified, and agree to sponsor the candidate’s short-term research career development experience. It is expected that the proposed career enhancement plan will represent a novel extension of the candidate’s current research program and provide protected time to 1) seek training with established investigators from another field, in order to enrich his/her existing dental, oral and craniofacial research program; or 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 the same or different department/school within the candidate's home institution where the candidate holds a primary appointment, or at a different institution. The host mentoring laboratory/research program must have appropriate research facilities and resources to provide a new research direction for the candidate. The candidate and the mentor(s) may or may not have had any previous research collaborations. However, in either case, the candidate must justify why this program will facilitate the goals of this NIDCR K18 program in a manner that could not be achieved solely through a research grant or current collaborative arrangement.

This FOA supports short-term mentored research training in two general areas: i) behavioral and social sciences, and genetics, genomics, bioinformatics and computational biology research. The proposed research 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 these NIDCR programs can be found at https://www.nidcr.nih.gov/grants-funding/grant-programs. Prospective applicants are strongly encouraged to contact an NIDCR program official from either of these branches to discuss their research goals, specific programmatic information, and the research priorities listed below.

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, Bioinformatics, and Computational Biology Research Priorities for this FOA

Of highest priority for genetics, genomics, bioinformatics, and computational biology studies are those that look for genetic factors, environmental factors, and regulatory pathways underlying phenotypes of interest using genomic technologies, statistical approaches, bioinformatic methods, and/or computational modeling. Projects may involve research on inherited susceptibility or normal variation related to oral and craniofacial health and disease, the human microbiome or somatic changes in oral cancer. Generation and analysis of phenotype and multi-omics data, and computational modeling of gene regulatory networks and gene-environmental interaction, may be entailed.

Examples may include but are not limited to:

* A clinical researcher with expertise in phenotyping studying an oral disease seeks mentorship from a genomics investigator, and the two collaborate on a genomic data generation and analysis project that makes use of stored and well-phenotyped samples to identify the underlying genetic loci and regulatory pathway.

* A bioinformatician who has identified a putative regulatory pathway underlying a craniofacial disorder using machine learning partners with a clinical researcher to validate the finding in well-phenotyped patients by generating and analyzing genomewide multi-omics data and, in turn, further improve the machine learning algorithm.

* 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 NIDCR-funded FaceBase and/or the NIH's database of Genotypes and Phenotypes (dbGaP).

*A dentist-scientist and genomic investigator partner to study the oral microbiome, its interaction with the human host, and its role in oral health and disease.

Other Award Budget Information

1. Eligible Applicants

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)

• U.S. Territory or Possession

• 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

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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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 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.

2. Cost Sharing

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Other Research Plan Sections

Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a career as a health related research scientist.
• Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support.
• Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress through this career enhancement plan.
• Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines.

Career Goals and Objectives?

• Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed dental, oral and craniofacial research career development enhancement program.
• Justify the need for further career enhancement in order to achieve the candidate's future research goals.
• Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

Candidate’s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team.
• Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program.
• Provide a systematic plan for progression of activities for the period of the award and beyond, emphasizing the potential to enhance an existing research program in dental, oral and craniofacial research, or to bring dental, oral and craniofacial research into another scientific field.
• Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.
• If the candidate proposes to work with a mentor with whom they have had previous research collaboration, include justification as to why this mentored experience will facilitate career development that could not be achieved solely through a research grant or collaborative arrangement.

Research Plan Section

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

Research Strategy

• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.
• Describe a research project in the behavioral and social sciences or in bioinformatic, computational, and genetics/genomics research that is consistent with the goals and objectives of this NIDCR K18 career enhancement program.

• If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor must be recognized as an accomplished investigator in the proposed research area and have a track record of success in training independent investigators.
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a plan that describes the nature of the mentoring that will occur during the proposed award period, including how the candidate’s research career enhancement objectives will be promoted; and (3) the ongoing research activities and research grant support of the mentor(s), along with how the candidate’s new research activities will dovetail with the mentor's research program.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Describe the host institution's research environment, including the resources and facilities (e.g., equipment, laboratory space, computer time) that will be available to the candidate to carry out the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development

• The candidate’s home institution must provide a statement of commitment and assurance that the candidate will be able to devote a minimum of 2.4 to 6 person-months of full-time professional effort to the research career enhancement program during the period of K18 support.
• The candidate’s home institutional statement must describe any duties or commitments the candidate will continue to maintain during the K18 award, including how any grant, teaching or administrative responsibilities will be managed, if applicable.
• The mentor's (host) institution must provide assurances that appropriate time and support will be provided for any proposed mentor(s) and/or other staff consistent with the career enhancement plan.
• The mentor’s institution must provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities to carry out the proposed research plan.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

• For FOAs that do not allow independent clinical trials, do not complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

Reference Letters

Letters of reference are not allowed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

6. 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.

7. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

• Has the candidate provided evidence of excellence as an independent investigator, including a record of research support and peer-reviewed publications?
• Does the candidate show evidence of a high level of commitment to meeting the program's career enhancement objectives?
• Does the candidate have high potential for successfully augmenting his/her research career capabilities and becoming an outstanding contributor to the research field relevant to the proposed research enhancement experience?

• For candidates new to dental, oral and craniofacial research, does the candidate have the potential to develop as an independent and productive researcher in dental, oral and craniofacial research?
• For candidates established in dental, oral and craniofacial research, does the candidate have the potential to successfully expand his/her existing research program to incorporate new theories, tools, methods or approaches?

Career Development Plan/Career Goals and Objectives

• Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
• What is the likelihood that the career enhancement and mentoring plans will contribute substantially to the scientific development of the candidate leading to rigorous dental, oral and craniofacial research?
• Is an appropriate level of the candidate's professional effort to the career development plan documented in the application?

• If proposed, will the clinical trial experience contribute to the applicant’s research career development?

• Is there an adequate description of the need for further career enhancement of the candidate as it relates to rigorous dental, oral and craniofacial research?

Research Plan

• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Are the proposed research question(s), design and methodology of significant scientific and technical merit?
• Is the research plan relevant to the candidate’s research career objectives?
• Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career enhancement plan?
• Is the research plan appropriate in developing a rigorous research program in dental, oral and craniofacial research?
• Is the proposed research a novel extension of the research of the candidate? In cases where the candidate and the proposed host laboratory/research program have previous research collaborations, is there sufficient justification as to why this program will facilitate career development that could not be achieved solely through a research grant or current collaborative effort?
• If proposed, will the clinical trial experience contribute to the research project?

• If proposed, will the clinical trial experience contribute to the research project?

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

• Are the mentor's research qualifications in the area of the proposed research appropriate?

• Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?

• To what extent are the mentor's research qualifications, experience, scientific stature and mentoring track record appropriate for the candidate's career development needs?

• Is there evidence of the mentor's previous experience in fostering the development of independent investigators?

• Is there evidence of the mentor's research productivity and peer-reviewed support?

• How well do the research activities of the candidate dovetail with the mentor's research funding and ongoing activities?

• Is the source(s) of funding, beyond what is provided by the K18 award, described and adequate for the proposed research and career enhancement activities?

• If co-mentors, consultants, and/or collaborators are identified, is there adequate description of roles and how each person will contribute to the career enhancement of the candidate? Is the coordination of mentoring reasonable? Will there be adequate communication and personal meetings with the candidate?

• Do the statements from consultants/contributorsclearly state their role(s) in the career development of the candidate?

• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration, adequate, appropriate, and available to the candidate?
• Is there strong institutional commitment to fostering the candidate’s advanced research career development? Are there unique features of the scientific environment of the institution(s) that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?
• Is there a strong commitment from the candidate's home institution to ensure that 2.4-6 person-months of the candidate’s full-time professional effort will be dedicated to the research career enhancement plan during the active period of the award?
• Is there a strong commitment for the success of the mentored experience, including the proposed research project, from the mentor's (host) institution?
• Are the host laboratory/research program and institution well suited for the advanced development of the candidate’s research career and the pursuit of the proposed career enhancement activities and research plan?
• Is the environment for scientific and professional development of the candidate of high quality?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals across the Lifespan

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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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) Genomic Data Sharing Plan (GDS).

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction MUST occur during each career stage and at least once 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.

See also: NOT-OD-10-019 and note the additional guidance for middle or senior career level applicants.

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).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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), 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.

• 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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Reporting

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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.

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Leslie Frieden, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: Leslie.frieden@nih.gov

Melissa Riddle, PhD
Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 451-3888
Email:riddleme@nidcr.nih.gov

Lu Wang, PhD
Translational Genomics Research Branch
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 594-4846
Email:wanglu@mail.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

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