National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
See Notices of Special Interest associated with this funding opportunity
See Section III. 3. Additional Information on Eligibility.
The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentist scientists from NIH Intramural postdoctoral research positions to extramural, academic tenure-track or equivalent faculty positions at eligible U.S. institutions. The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution.
This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.
NIDCR extramural research provides research funds to support basic, translational, and clinical research in dental, oral, and craniofacial health and disease through grants, cooperative agreements, including small business research through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and contracts that support scientists working in institutions throughout the United States and internationally.
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 12, 2025 * | March 12, 2025 * | May 07, 2025 * | July 2025 | October 2025 | December 2025 |
June 12, 2025 * | July 12, 2025 * | September 07, 2025 * | November 2025 | January 2026 | April 2026 |
October 12, 2025 * | November 12, 2025 * | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
February 12, 2026 * | March 12, 2026 * | May 07, 2026 * | July 2026 | October 2026 | December 2026 |
June 12, 2026 * | July 12, 2026 * | September 07, 2026 * | November 2026 | January 2027 | April 2027 |
October 12, 2026 * | November 12, 2026 * | January 07, 2027 * | March 2027 | May 2027 | July 2027 |
February 12, 2027 * | March 12, 2027 * | May 07, 2027 * | July 2027 | October 2027 | December 2027 |
June 12, 2027 * | July 12, 2027 * | September 07, 2027 * | November 2027 | January 2028 | April 2028 |
October 12, 2027 * | November 12, 2027 * | January 07, 2028 * | March 2028 | May 2028 | July 2028 |
All applications are due by 5:00 PM local time of applicant organization.
Applications are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in theHow to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The overall purpose of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development website.
The goal of the Career Transition Award (K22) is to provide support to newly trained basic or clinical investigators to develop their research skills through a two phase program: an initial period involving an intramural position at the NIH and a subsequent period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a productive, independent research career.
To achieve this goal, the NOFO is structured to provide up to two years of mentored research training as a postodoctoral NIH intramural investigator (Phase 1) followed by three years support (Phase 2) as an independent scientist. During the intramural training phase of the K22 (Phase 1), support will be provided by the candidate's NIH intramural laboratory or branch. Funds from the K22 award may be used to support Phase 2 at an extramural sponsoring institution/organization to which the individual has accepted a tenure-track full-time assistant professor position (or equivalent). This allows the individual to continue to work toward establishing his/her own independent research program and prepare an application for research grant support, such as an R01, or equivalent award.
Candidates should select a mentor from the NIH Intramural Research Program with whom the candidate can consult in preparing and submitting the application for the NIH intramural mentored phase of the award. Candidates may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidates dental, oral, and craniofacial research career. Candidates are also encouraged to include co-mentors or collaborators from extramural institutions to assist with the transition from the NIH Intramural Research Program to an extramural research institution.
The K22 application should describe the research planned during both the mentored and independent phases of the program. This research should align with NIDCR extramural research areas. The application will be peer reviewed and receive an overall impact score. Applications approved for funding will receive an approval letter from the NIDCR to initiate the intramural NIH research training (Phase 1) that will be supported through NIH intramural funds. The approval letter will include the terms and conditions to activate the funds from the K22 award at an extramural institution/organization (Phase 2).
A transition application from the extramural institution/organization on behalf of the K22 awardee will be required to begin the activation process. Activation of the extramural phase of the award is not automatic. Approval to activate the extramural phase will be based on an administrative review of the transition application by the NIDCR and will consider the recipients research performance progress during the intramural phase and the achievement of an independent tenure-track (or equivalent) position at a United States extramural institution.
Note: This Notice of Funding Opportunity (NOFO) is designed specifically for proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provides details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials.
Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Intramural Phase 1:
Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch. Support for the intramural phase may not exceed two years in duration. The salary support will be consistent with that provided by the NIH intramural program for other investigators in the same position and with similar levels of postdoctoral experience.
Extramural Phase 2:
Support for the extramural phase will be provided to the extramural institution. Support for the extramural phase may not exceed three years in duration. The total cost for the extramural phase may not exceed $249,000 total cost per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below).
The total NIH contribution to salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
Intramural Phase 1:
Research-related expenses for the intramural phase are provided by the candidate's NIH intramural laboratory or branch.
Extramural Phase 2:
Total expenses for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see Indirect Costs below).
Salary for mentors, secretarial and administrative assistants, etc., is not allowed.
For the extramural phase award, 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 from this NOFO.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Only NIH Intramural Programs are eligible to apply for the mentored Phase I of the K22 program on behalf of intramural candidates. For the independent phase, the sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs. Federal laboratories, including the NIH Intramural Programs, are not eligible to apply for the independent phase.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.
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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
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 their mentor and organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
The K22 award is intended for individuals with career-stage appropriate research experience, and who require up to an additional two years of mentored research and career development. Consequently, the strongest applications will have a well-conceived plan for substantive mentored research and career development that will help them become competitive candidates for tenure-track or equivalent faculty positions and to launch robust, independent research programs. If an applicant achieves research independence (any faculty or equivalent independent research position) before the intramural phase K22 award is made, neither phase of the K22 award will be made.
Candidates for the K22 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined clinical and research doctoral degree. Individuals for the K22 award not affiliated with an organization may also apply (specific information is available for unaffiliated candidates).
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
Candidates may submit research project grant (RPG) applications concurrently with K applications. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application, and ishould an RPG be awarded the K22 application would be withdrawn. During the independent phase of the K22, the K22 award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI 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, currently a the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aims or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have a pending 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 PD/PI on an NIH research grant (such as R01, P01) or a subproject leader on an NIH multicomponent grant or cooperative agreement (e.g., P01, U19, P20, P30, P50, U54, UM2), or an equivalent NIH or non-NIH award.
At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.
Before submitting the application, the candidate must identify a mentor in the NIH Intramural Research Program who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidates research. The mentor must document the availability of sufficient resources for high-quality research. 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 primary mentor who will coordinate the candidates research. If the candidate's primary mentor is not based in the NIDCR Intramural Research Program, the candidate should include a co-mentor with expertise in dental, oral, and craniofacial research. This mentoring team may include investigators in NIH Intramural Research Laboratories and investigators at extramural institutions. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidates career stage. Women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be recruited to serve as mentors.
The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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.
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the independent phase.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
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 How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidates Background
Career Goals and Objectives
Candidates Plan for Career Development/Training Activities During Award Period
The candidate and the mentor are jointly responsible for t preparing the career development plan. A timeline, including publications, is strongly encouraged. The mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of the candidate's program of study or to monitor the candidate's progress through the career development program.
The career development plan must be tailored to the needs of the individual candidate, incorporating the candidate's goals, current activities, prior experience, and the ultimate goal of achieving independence as a researcher. 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 research or trials methodology, research design and management, statistical analysis, and bioethics. Candidates must justify the need for both the mentored phase and the independent phase, and 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 their career and/or will allow the pursuit of a novel or promising approach to a particular dental, oral or craniofacial research problem . The candidate and intramural mentor must describe a plan, including a timeline with milestones, for evaluation of the candidate's progress during the intramural mentored phase and plans for the transition to the independent extramural phase.
Research Plan Section
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Research Strategy
Training in the Responsible Conduct of Research
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultants
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Institutional commitment is provided by the Scientific or Clinical Director of the NIH Intramural Institute or Center in which the candidate is based. This statement should:
N/A
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Reference Letters
Candidates must carefully follow the How to Apply - Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. 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.
See Part 2. 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
Part I. 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, NIHs 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply – Application Guide.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .
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 How to Apply - 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Any instructions provided here are in addition to the instructions in the policy.
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.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidates potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact 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.
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Not Applicable
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.
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 or 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
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.
Not Applicable
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
All applications for support under this NOFO 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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate’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 NOT-OD-22-055.
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, 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:
Appeals for initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
There will not be a formal Notice of Award (NoA) associated with the K22, Phase I of the 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Successful recipients under this NOFO agree that:
Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.
Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.
Transition from the intramural phase (Phase 1) to the extramural phase (Phase 2) is intended to be continuous in time. Support for Phase 2 is not automatic and is contingent upon the K22 awardee obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIDCR programmatic review of the transition application. In order to submit an independent Phase 2 application, individuals must have been offered and accepted a research faculty position at an eligible institution that has an appropriate infrastructure to support the proposed research and a history of external research funding. To avoid potential problems, candidates are strongly encouraged to contact their NIDCR Program Official as soon as plans to apply for, or assume, an independent position develop. At that time, individuals should discuss plans for transition to the Phase 2 award. The application for the Phase 2 award should be submitted no later than 2 months prior to the proposed start date of the Phase 2 award. The extramural phase institution will submit an application on behalf of the candidate using the PHS 398 Application. The application must include:
Institutional Support: A letter from the K22 Department or Division Chairman must be submitted that describes the K22 Phase 2 institutions commitment to the candidate and plans for his/her career development. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months: 75% of the candidates full time professional effort) at least for the duration of the K22 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The sponsoring institution must describe the candidates academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The K22 Phase 2 institution must describe how the awardees ability to apply for and secure independent research grant (R01) support will be fostered and supported during the independent phase of the K22 award.
The K22 award requires that a minimum of 9 person-months (75% full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the K22 award period. NIDCR staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss institutional commitment with the relevant NIH institute Program Official prior to finalizing the offer. NIDCR will not make a K22 award if the institutional commitment is deemed inadequate.
The K22 Phase 2 transition application (preferably in PDF format) is to be e-mailed directly to the
NIDCR Financial/Grants Management specialist identified in the PD/PI's eRA Commons account.
The K22 Phase 2 transition application will be evaluated by extramural NIDCR Program staff for completeness and responsiveness to the program. Applicants who are approved to transition will receive a Notice of Award reflecting the dollar amount and the recipient organization. Candidates who are not approved to transition will receive written notification from the NIDCR communicating the rationale for disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentors Report must include an annual evaluation statement of the candidates progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.
In carrying out its stewardship of human resource-related programs, 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Shoba Thirumangalathu, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
Telephone: (301) 594-0652
Email: [email protected]
Janice Lee, DDS, MD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4591
Email:[email protected]
Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: [email protected].
Gabriel Hidalgo, M.B.A.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
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.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.
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 2 CFR Part 200.