Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Dental and Craniofacial Research (NIDCR)
Funding Opportunity Title	NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22)
Activity Code	K22 Career Transition Award
Announcement Type	New
Related Notices	January 8, 2015 - This PAR has been reissued as PAR-15-084. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	PAR-12-004
Companion FOA	NoneNone
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.121
FOA Purpose	The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to provide highly-qualified dentists in NIH Intramural postdoctoral fellowship positions with an opportunity to receive further mentored research experience in the NIH Intramural program, and then to provide them with independent funding to facilitate the transition of their research programs as new investigators at extramural institutions. To achieve these objectives, the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators will support two phases of research: a mentored intramural phase of up to two years, and an independent extramural phase of up to three years. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee s research program as determined by an NIDCR progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

Posted Date	October 21, 2011
Open Date (Earliest Submission Date)	January 12, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply
AIDS Application Due Date(s)	Standard dates apply
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	January 8, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists are 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 purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to provide highly-qualified dentists in NIH Intramural postdoctoral fellowship positions with an opportunity to receive further mentored research experience in the NIH Intramural program, and then to provide them with independent funding to facilitate the transition of their research programs as new investigators at extramural institutions. To achieve these objectives, the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators will support two phases of research: a mentored intramural phase of up to two years, and an independent extramural phase of up to three years. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee s research program as determined by an NIDCR progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

Following the mentored phase, the individual may request up to 3 years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track (or equivalent) full-time assistant professor position (or equivalent). This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for NIH research grant (R01) support.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget (Applicable to Extramural Independent phase only)	Award budgets are composed of salary and other program-related expenses, as described below. Up to $249,000 in direct costs per year is allowed during the extramural independent phase. This amount includes salary, fringe benefits, research support allowance and applicable indirect costs (8%).
Award Project Period	The total extramural phase project period may not exceed 3 years.

Salary	Phase 1 (Intramural): Mentored candidates in the NIH Intramural Program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions. Phase 2 (Extramural): The total salary requested must be based on a full-time independent tenure-track (or equivalent) faculty 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. NOTE: NIDCR does not require that full salary support be derived from the K22 award. If no salary funds are requested in the Phase 2 application, a statement should be included indicating the source and amount of salary support.
Other Program-Related Expenses	For the independent extramural phase, research development support costs may include salaries for technical support, consultant costs, equipment, supplies, travel to scientific meetings and training, statistical services, and other research-related expenses. These costs 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	For the extramural phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Phase 1 (mentored)

The application must be submitted on behalf of the candidate by an NIH Division of Intramural Research laboratory or branch.

Phase 2 (independent, extramural):

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

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

The extramural institution (Phase 2 of the award) may be private (profit or nonprofit) or public.

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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

Only individuals affiliated with an NIH Intramural Laboratory may apply (specific information is available for intramural candidates on the Electronic Submission Intranet link available only to users internal to NIH).

Candidates for this award must have earned a clinical dental doctoral degree (DDS, DMD or equivalent), or a combined dental and research doctoral degree (PhD or equivalent).

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).

Former PD(s)/PI(s) on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K awards), or the equivalent are not eligible. Former principal investigators of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.

Applicants should contact the NIDCR program staff (Section VII.) for guidance and additional information.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not duplicate the provisions of the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD(s)/PI(s) on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

Individuals are eligible for a K22 award if they have been, or currently are the PD(s)/PI(s) of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) and Center Grant (P50), or a non-NIH equivalent to these grants/awards.

At the time of selection for the Intramural mentored phase, the candidate must have a full-time appointment in an NIH Intramural Scientific Program.

At the time of award for the independent extramural phase, the awardee must have a full-time appointment at an eligible institution. Awardees who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the Phase 2 extramural institution. 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.

Before submitting the application, the candidate must identify a mentor(s) in an NIH Intramural Laboratory who will supervise the proposed career development and research experience of the first phase of the K22. 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(s) should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The mentor and any co-mentors are also expected to provide an assessment of the candidate s qualifications and potential for a research career. 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. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

Sponsoring Extramural Institution: To obtain support for Phase 2 of the award, the Phase 1 awardee must receive and accept a formal tenure-track (or equivalent) offer at an extramural institution. The institution must demonstrate a commitment to the individual by providing protected research time, as well as space, equipment and facilities needed to conduct the proposed research.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

Project Summary/Abstract (Component of the Other Project Information Component)

This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to continue in the independent phase.

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

Candidate’s Background (Component of Candidate Information)

• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.
• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIDCR.

Career Goals and Objectives (Component of Candidate Information)

• Describe a systematic plan that shows a logical progression from prior research and training experiences to the research and training experiences that will occur during the K22 award period and then to independent investigator status.
• Candidates for the mentored phase should select a mentor with whom the candidate can consult in preparing and submitting the application for the intramural mentored phase of the award. Individuals working at an NIH laboratory may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent research career. Suggested activities include, but are not limited to, those designed to improve skills and understanding in grant writing, clinical trials methodology, research design and management, statistical analysis, and bioethics.
• The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a researcher.
• Candidates must justify the need for both the mentored phase and the independent phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored scientist followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem.
• Describe professional responsibilities/activities including other research projects that are beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress during the career development program. If an advisory committee is planned, describe and justify the scientific composition, and the role and responsibilities of the committee to the candidate.
• The candidate and K22 Intramural phase mentor must describe the plan for evaluation of the candidate’s progress during the mentored phase and plans for the transition to the independent phase.

Training in the Responsible Conduct of Research (Component of Candidate Information)

• Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

• The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• Each mentor and co-mentor(s) must provide a statement of his/her areas of expertise and responsibility. Co-mentors should clearly describe how they will coordinate mentoring of the candidate. If any of the co-mentors 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 personal meetings.
• Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles. Collaborators and consultants generally 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. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the Candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research career development, including any formal course work; and 4) a plan for transitioning the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award.
• The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• 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 the sponsoring institution’s scientific environment including the resources and facilities that will be available to 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 and progression to the independent phase.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

• The NIH Intramural laboratory or branch must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.
• The NIH Intramural laboratory or branch must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• The NIH Intramural laboratory or branch must provide assurances that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.

Research Strategy (Component of Research Plan)

• The candidate should describe his/her research that is relevant to the proposed independent phase research plan. Ideally, this would include a brief description of research performed prior to the mentored phase, a description of the research planned during the mentored phase and a detailed description of the research planned for the independent phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved). The application must include a description of how the mentored phase research will lead to the independent phase research.
• The application must describe a sound independent phase research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan. The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.

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.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate required reference letters will not be reviewed (more details in the Notice). This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the Chief, Scientific Review Branch by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name, and title of the application.

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

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/priority score.

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

• Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field? Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project? Do the letters of reference from at least three well-established scientists address the candidate’s potential for becoming an independent investigator?
  

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

• What is the likelihood that the proposed career development activities will contribute substantially to the continued scientific development and productivity of the candidate? Is the career development plan consistent with the candidate’s prior research experience and current research career goals? Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence?
• To what extent are the plans for evaluating the candidate s progress adequate and appropriate for guiding him/her towards a successful transition to the independent phase of the award? Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and for the career development activities proposed for the mentored phase of the award?

Research Plan

• Is the proposed research project appropriate for the candidate s stage of research development and as a vehicle for development of research skills described in the career development plan?
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience? Is the proposed research relevant to stated career objectives?
• Is the proposed independent phase research scientifically sound and a logical extension of the Intramural mentored phase research? Is there evidence of long-term viability of the proposed independent phase research plan?
• To what extent is the proposed independent phase research project likely to foster the career of the candidate as an independent investigator in biomedical research?
• 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 evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of the mentor's previous research productivity?
• Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work, adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
• Does the mentor have a comprehensive plan to support the proposed mentored phase career development and research plans as well as the candidate s efforts to transition to independence? Is this plan adequate and appropriate?

Environment & Institutional Commitment to the Candidate

• Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty? Is the environment of high quality and relevance for scientific and professional development of the candidate? Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is there clear commitment of the NIH Intramural laboratory or branch to ensure that the required effort of the candidate will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans?
• Is sufficient evidence provided that the Intramural program is strongly committed to fostering the candidate’s development and transition to the independent phase?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, 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? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? 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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCR, and in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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/priority score.
• Will receive a written critique.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH Intramural Program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH Intramural K22 award, as well as expectations for the transition to the independent phase of the award.

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.

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.

Transition from the mentored phase to the independent phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, space and resources needed to conduct the proposed research project and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. NIH will conduct a formal scientific progress review no later than two months before the end of the mentored phase.

Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the candidate.

Form PHS 2590 must include the following:

• A description of the proposed research.
• A description of the institutional environment, including: research facilities and the availability of appropriate educational opportunities, including collaborating faculty, when necessary; quality and relevance of the environment for scientific and professional development of the candidate.
• Information about the sponsoring institution’s commitment to the candidate and to the candidate’s scientific independence, including: commitment to ensuring that the candidate’s effort required by the K22 program will be devoted directly to the research and career development activities described in the proposed career development and research plans; institutional commitment to fostering the career development of the candidate.
• Position Description: the institution should provide a detailed description of the candidate’s position, responsibilities, and duties. The institution’s tenure-track policy should be defined or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track.
• Budget in detail, including justification for all requested funds:
• List the name, role on project and percent effort for all project personnel (salaried and unsalaried) and provide a narrative justification for each person;
• Identify all consultants by name and organization affiliation and describe the services to be performed;
• Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project;
• Describe specific resources committed by the sponsoring institution to support the Candidate’s research.

Consistent with NIH Policy, the extramural institution must ensure that:

• all sites engaged in research involving human subjects have an appropriate OHRP-approved Assurance and an IRB approval of the research, and
• all sites are operating in accordance with an approved Animal Welfare Assurance and provide verification that the IACUC has reviewed and approved those sections of the application that involve use of vertebrate animals, in accordance with the requirements of the Policy.

If IRB and/or IACUC approval has not been obtained in time for the transition application, a restricted award will be made until such approvals are granted and documentation is provided to NIDCR.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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.

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. Accordingly, recipients are hereby notified that they 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.

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

Special Note: Prospective applicants should consult the Program Contact to make sure that their applications comply with the requirements of NIDCR. Prior consultation with NIDCR staff is strongly encouraged.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

James E. Melvin, DDS, PhD
Clinical Director
National Institute of Dental and Craniofacial Research (NIDCR)
10 Center Drive MSC 1470
Bldg 10/Rm 5-2531
Bethesda, MD 20892
Phone: 301-402-1706
Email: [email protected]

Lynn Mertens King, PhD
Chief, Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
1DEM, Room 690, MSC 4878
6701 Democracy Boulevard
Bethesda, Maryland 20892
(Courier 20817)
Telephone: 301-594-5006
Fax: 301-480-8303
Email: [email protected]

Yasaman Shirazi, PhD
Chief, Scientific Review Branch
NIDCR, NIH
6701 Democracy Boulevard, Suite #662
Bethesda, Maryland 20892
(Courier 20817)
Tel: (O)301-594-5593, (c)301-335-6233
Fax: 301-480-8303
Email: [email protected]

Dede Rutberg, MBA
Lead Grants Management Specialist
Grants Management Branch
National Institute of Dental and Craniofacial Research (NIDCR)
6701 Democracy BLVD, RM 656
Bethesda MD, 20892
Phone: 301-594-4798
Email: [email protected]

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

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