Part 1. Overview Information

Key Dates

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 the How 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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall 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.

The National Institutes of Health (NIH) believes that the creativity and innovation of independent investigators at all career stages play an integral role in addressing our Nation's biomedical, behavioral, and clinical research needs. The intent of the NIMH Career Transition Program is to assist investigators in the NIMH Division of Intramural Research Programs (IRP) in achieving their research career goals. The specific goals of this program are to: 1) support tenure-track scientists conducting research in the NIMH IRP who aim to transition to independent research positions in the extramural community where they intend to continue already productive biomedical research careers as independent scientists; and 2) foster the further career advancement of these independent scientists and enable them to expand their potential to contribute significantly to mental health-related research.

In order to maintain and expand on the many contributions of IRP investigators to mental health research and to strengthen further the innovative research that is conducted in the IRP, the NIMH IRP must maintain a steady turnover of tenure-track investigators. In seeking to attract outstanding, early-stage scientific talent to the NIMH IRP, there is a need to maintain a steady flow of IRP investigators to the extramural community. To foster and aid that transition, the NIMH Career Transition Program will provide fiscal support for up to three years to enable tenure-track investigators in the IRP to transition their research programs to the extramural community. This Program should enable tenure-track intramural investigators to compete successfully for academic positions, make successful career changes, and compete for R01 or R01-like research grant support from the NIH and other agencies.

Nature of the Career/Research Transition Opportunity

Each application to the NIMH Career Transition (K22) Program must reflect the individual needs of the Candidate (PD/PI). The K22 award is conducted in two phases: Phase 1 takes place at the NIMH IRP while Phase 2 takes place at the domestic, extramural institution to which the Candidate will transition.

The application will be submitted for peer review of scientific and technical merit while the Candidate is a tenure-track investigator in the NIMH IRP. The research proposed must span both phases of the award. The outcome of this review will be a key determinant of whether the application will be supported. However, it is the Phase 2 application that will be awarded. If the Candidate receives a meritorious score after peer review of the initial application, the candidate will be notified in writing of NIMH's initial commitment to make an award. The Candidate will then have a period of no more than 18 months (Phase 1) to identify a suitable, independent research position at a domestic research institution/organization and negotiate a start-up package while continuing their independent research program in the IRP. As soon as negotiations between the Candidate and the institution are complete, the Phase 2 application must be submitted by the extramural institution for administrative review and award (see below).

Phase 2 of the NIMH Career Transition (K22) award will provide up to three years of support to conduct research as an independent scientist at a domestic, extramural institution/organization to which the Candidate has been recruited, been offered and has accepted an independent research position. The institution sponsoring the Phase 2 award must demonstrate a commitment to provide the environment, resources, and at least 6 person-months (equivalent to 50% full-time professional effort) of protected time during the Phase 2 award period for the Candidate to conduct the proposed research. This commitment will enable the Candidate to maintain and develop further an independent research program and to prepare a competitive application for research grant support (e.g., R01) during the K22 award period. NIMH K22 award recipients are expected to apply for NIH or other independent research grant support during the second year of the extramural phase (Phase 2) of the K22 award.

The NIMH Career Transition (K22) application allows the project to be peer-reviewed for scientific and technical merit (Phase 1) before the Candidate begins an independent research position at an extramural institution (Phase 2). Phase 2 funding is NOT automatic and is subject to several conditions described in Section VI. Transition to Phase 2. Once the independent research position has been secured, NIMH will administratively review the Phase 2 application to ensure that all programmatic requirements are met prior to award.

Candidates are encouraged to consult with the appropriate staff person in Section VII - Agency Contacts, prior to submitting an application, to discuss eligibility and program requirements.

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.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Applicant Organizations for Phase 1:

For Phase 1 of this NIMH Career Transition Program, only NIMH intramural laboratories are eligible to apply on behalf of tenure-track investigators in the NIMH IRP

Eligible Applicant Organizations for Phase 2:

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local 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)

The application for the extramural phase (Phase 2) of the award will be submitted by the domestic, for-profit or non-profit, academic institution/organization (e.g., university, college, hospital, or laboratory) at which the Candidate has been recruited, offered and has accepted an independent research faculty position. Eligibility of organizations, other than institutions of higher education, for Phase 2 depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants. Only successful Phase 1 Candidates may proceed to Phase 2.

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.

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For more information, see Notice of NIH’s Interest in Diversity, NOT-OD-20-031 and also 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).

At the time an application is submitted (or resubmitted) for peer review, the PD/PI must currently be conducting research in the NIMH IRP and must have been a tenure-track investigator in the NIMH IRP for at least five years. At the time an application is submitted (or resubmitted), individuals are NOT eligible to apply if they are negotiating and/or have accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere.

Candidates for the K22 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined clinical and research doctoral degree.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

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

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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (See NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Phase 2 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.

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 50% of full-time professional effort (i.e., a minimum of 6 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 50% 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.

Both Phase 1 and Phase 2 applicant institutions must have strong, well-established records of research and career development activities and faculty qualified to serve as collaborators and/or consultants in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Page Limitations

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.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

Other Project Information

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 conduct during Phase 2 of the award.

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

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

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.

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate’s commitment to a career in a biomedical, behavioral, or clinical research field relevant to the mission of the NIMH.
• Describe prior training and research efforts and experience, including publications and inventions, and how they relate to the objectives and long-term career plans of the candidate.
• Describe current professional responsibilities (e.g., teaching, service, editorial review service, role in professional societies) and their relationship to the activities proposed during the transition award. Describe any prior and current research support that the Candidate has obtained.
• Present evidence of the Candidate’s success as an independent investigator and his/her potential to make future contributions to the chosen field of research.

Career Goals and Objectives​

• Explain how the award and associated transition to an extramural research position will foster the Candidate's ability to make future contributions to the chosen field of research. 

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

• Describe how any new or enhanced research skills and knowledge acquired during the K22 award will significantly enhance the Candidate’s ability to continue his/her research program as an independent scientist.
• Describe any new and/or enhanced professional skills that will be acquired during the career award period, e.g., refining grantsmanship skills as appropriate for an extramural scientist, and any other skills that may be germane to a future career in the extramural research community.
• Describe past and current collaborations during the Candidate’s tenure at the IRP and how these collaborations contributed to the Candidate's training and research.
• Describe any collaborations that are anticipated to continue in Phase 2 of the award.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

• The research plan must span both phases of the award. The candidate should clearly indicate the research planned for each phase.
• Describe a sound research project that is consistent with the Candidate’s level of research experience and the objectives of his/her continued career advancement. The project should demonstrate the quality, novelty, significance, creativity, and approach of the candidate’s research thus far, as well as the Candidate's ability to carry out the proposed research.

Training in the Responsible Conduct of Research

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

Mentor, Co-Mentor, Consultant, Collaborators Section 

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

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

Do not include.

Letters of Support from Collaborators, Contributors and Consultants

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

Environmental and Institutional Commitment to the Candidate

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
• Describe the scientific environment including the resources, facilities, and access to clinical and/or other research populations (if applicable) that will be available to the Candidate during Phase 1 (intramural) of the K22. 
• Describe the scientific environment including the resources, facilities, and access to clinical and/or other research populations (if applicable) that will be needed during Phase 2 of the K22 award.

Institutional Commitment to the Candidate’s Research Career Development

• The Scientific Director of the NIMH Division of Intramural Research Programs (IRP) must provide a statement describing the IRP's commitment to facilitate the candidate’s transition to a faculty position in the extramural community. The sponsoring institution (IRP) must provide the Candidate with the appropriate facilities and other resources necessary to facilitate the Candidate's transition.

Other Research Plan Sections

Resource Sharing Plan(s):

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

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:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied.  For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary. 

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.

PHS Human Subjects and Clinical Trials Information

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.

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

Delayed Onset Study

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.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Reference Letters

Important Note: Letters of Reference are not required for this K22 program. The Candidate should ignore any notification from NIH indicating that letters are required and were not received.

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

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

4. Submission Dates and Times

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, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

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

Generally, Phase 1 is for 18 months; however, award recipients may transition earlier than 18 months when the recipient has been offered an acceptable position. It is expected that award recipients will generally benefit from a Phase 1 period of no less than 12 months in duration before transitioning to Phase 2.  If an applicant is negotiating and/or has accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere prior to notification of the Institute’s intent to make a K22 award, then no award will be made.

Award recipients are expected to apply for NIH or other independent research grant support during year 2 of the Phase 2 K22 award.  Funding of year 3 of the Phase 2 K22 award may not be approved should the PD/PI not have applied for independent research grant support during year 2 of this award.  

7. Other Submission Requirements and Information

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 organization’s 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Management and Sharing for Applicants and Awardees.

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]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following: the goal of this NIMH Career Transition (K22) Award Program is to facilitate the transition of a tenure-track intramural investigator from the NIMH IRP (Phase 1) to an extramural research faculty position (Phase 2).  The first year of the Phase 2 award at the extramural institution is likely to include time to establish the new laboratory and to recruit, hire and train personnel.

Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s 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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review 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:

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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.

• 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

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 applicant’s 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 applicant’s 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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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 recipient’s 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 Phase 1 of this NIMH K22 award conducted in the NIH intramural program. The NIMH will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIMH Phase 1 K22 award, as well as expectations for the transition to Phase 2 of this award.

Award recipients are expected to apply for NIH or other independent research grant support during year 2 of the Phase 2 K22 award.  Funding of year 3 of the Phase 2 K22 award may not be approved should the PD/PI not have applied for independent research grant support during year 2 of this 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.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690).To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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. 

Transition to the Independent Phase

Transition to Phase 2

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 obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIMH programmatic review of the faculty position the Candidate has accepted and the institutional commitment to the Candidate. From the date of the approval letter transmitted to the Candidate, the Candidate has a period of no more than 18 months (Phase 1) to identify a suitable, independent research faculty position at an eligible, domestic research institution/organization, negotiate a start-up package, and accept a position. Generally Phase 1 is for 18 months; however, award recipients may transition earlier than 18 months when the recipient has been offered an acceptable position. It is expected that award recipients will generally benefit from a phase 1 period of no less than 12 months in duration before transitioning to phase 2. If an applicant is negotiating and/or has accepted an independent faculty position, or its equivalent, in academic, industry, or elsewhere prior to notification of the Institute’s intent to make a Phase 1 K22 award, then no Phase 2 award will be made. In order to submit a Phase 2 application, an individual must have been offered and accepted a research faculty position at an eligible institution that has both appropriate infrastructure to support the proposed research program and a history of external research funding.

To avoid potential problems, Candidates are strongly encouraged to contact their NIMH Program Official as soon as plans to accept an extramural position develop. At that time, individuals should discuss plans for transition to, and the application for, 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 Phase 2 institution will submit an application on behalf of the Candidate using the PHS398 Application. The application must include:

• A new face page signed by the Phase 2 institutional representative;
• A new project description page (the original project summary or abstract should be updated to reflect current plans for the Phase 2 award period);
• Table of contents;
• Detailed budget pages for a non-modular budget and narrative justification for all requested funds for each budget year, including:
• The name, role on project, and level of effort for all project personnel (salaried and unsalaried) and a narrative justification for each person;
• The name and organizational affiliation of all consultants and a description of the services to be performed;
• Biographical Sketches for the PD/PI and any other Key Personnel;
• A new Resources page including a description of specific resources committed by the sponsoring institution to support the Candidate’s research; research facilities; and the availability of appropriate educational opportunities, including collaborating faculty, if appropriate.
• Updated Specific Aims that reflect current plans for the Phase 2 project;
• An updated Research Plan (not to exceed 5 pages);
• A Letter of Institutional Commitment from the Department or Division Chairperson that describes the sponsoring institution's commitment to the candidate’s scientific independence (see additional details below);
• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals Across the Lifespan, Planned Enrollment Report and Cumulative Inclusion Enrollment Report (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards and Select Agents (as appropriate);
• Updated Authentication of Key Biological and/or Chemical Resources (as appropriate);
• Letters of Support (e.g., Consultants): if previously unnamed consultants/collaborators are added, provide letters of commitment from these individuals;
• Updated Resource Sharing Plan (as appropriate);
• Updated plan for Instruction in the Responsible Conduct of Research; and
• A new checklist.

Letter of Institutional Commitment: A letter of institutional commitment is required at the time of the Phase 2 application and is typically provided by the Department or Division Chairperson. This letter should satisfy the criteria described in the Career Development Award Section of the SF424 (R&R) Application Guide. The letter should describe the following:

•  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. The start-up and salary package and other evidence of institutional support must be described and must be comparable to that provided to other, recently hired faculty who did not have a grant at the time they were hired. K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for faculty who are hired without grant support.
• Commitment to providing adequate resources, an appropriate institutional environment, and protected research time. Describe the quality and relevance of the institutional environment for the scientific and professional development of the Candidate. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must demonstrate a commitment to the Candidate by providing a minimum of six person-months (50% full-time professional effort) of protected research time for at least the duration of the K22 award. Consequently, teaching, clinical duties and other non-research activities should be reduced during the K22 award period.
• Institutional commitment to fostering the Candidate's career development including how the institution will foster and support the Candidate's efforts to secure independent research grant (R01) support during the K22 award period. A plan is essential because NIMH K22 award recipients are expected to apply for NIH or other independent research grant support during year 2 of the Phase 2 K22 award.

NIMH staff may review start-up packages and other commitments between the institution and Candidate. The applicant and/or the hiring institution are encouraged to discuss the nature of the institutional commitment with the NIMH Program Official prior to finalizing the offer and submission of the K22 application. NIMH will not make a Phase 2 K22 award if the institutional commitment is deemed inadequate.

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 NIMH communicating the rationale for the disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application.

3. Data Management and Sharing

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.

4. Reporting

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. The Mentor's Report is not applicable for this K22.

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.

5. Evaluation

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.

Section VII. Agency Contacts

.

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]

Ashlee Van't Veer, PhD
National Institute of Mental Health (NIMH) 
Telephone: 301-443-3107 
Email: [email protected]

Additional Scientific/ Research Contact(s)

See http://www.nimh.nih.gov/funding/training/contacts-for-research-training-and-career-development-programs.shtml for current Scientific/Research Contacts

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: [email protected]

Section VIII. Other Information

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

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.