It is critical that applicants follow the instructions in the Career Development Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

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 (DIRP) in achieving their research career goals. The specific goals of this program are to: 1) support tenure-track and tenured scientists conducting research in the NIMH DIRP who aim to transition to independent research positions in the extramural community where they intend to continue already successful 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 DIRP investigators to mental health research and to strengthen further the innovative research that is conducted in the DIRP, the NIMH DIRP must maintain a steady turnover of tenured and tenure-track investigators. In seeking to attract outstanding, early-stage scientific talent to the NIMH DIRP, there is a need to maintain a steady flow of DIRP 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 tenured and tenure-track investigators in the DIRP to transition their research programs to the extramural community. This Program should enable tenured and 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.

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 DIRP 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 tenured or tenure-track investigator in the NIMH DIRP. 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 fundable score after peer review of the initial application, she/he will be notified in writing of NIMH's 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. 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 (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 is thus submitted in two phases in order to allow 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.

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

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

Eligible Applicant Organizations for Phase 1:

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

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)

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, and laboratory) at which the Candidate has been recruited, offered and has accepted an independent research faculty position. Only successful Phase 1 Candidates may proceed to Phase 2.

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

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 DIRP and must have been a tenured or tenure-track investigator in the NIMH DIRP 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 this 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.

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

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

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

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

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

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 the Phase 2 award, the candidate must have a full-time appointment at the academic institution. Phase 2 awardees are required to commit a minimum of 50% of full-time professional effort (i.e., a minimum of 6 person-months) to their mental-health research. 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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Institutional Environment

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.

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

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

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

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

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

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

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

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

Project Summary/Abstract: Include a description of your current research and the research you propose to conduct during Phase 2 of the award.

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

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

All instructions in the SF424 (R&R) 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
• Human Subjects Sections
• Other Research Plan Sections
• Appendix

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

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

Candidate Information and Goals for Career Development

Candidate s Background

• Describe the Candidate’s commitment to a career 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 accquired 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 DIRP 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 SF424 (R&R) 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 SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

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. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution (the NIMH DIRP) must document a strong, well-established research 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 must provide a statement describing the DIRP's commitment to facilitate the candidate’s transition to a faculty position in the extramural community. The sponsoring institution (DIRP) must provide the Candidate with the appropriate facilities and other resources necessary to facilitate the Candidate's transition.

Protection of Human Subjects Section

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and Data and Safety Monitoring Plan should reflect the policies and guidance in this Notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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 SF424 (R&R) Application Guide, with the following modification: To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-09-005, NOT-MH-14-015 and NOT-MH-15-012), as appropriate. Established by the NIMH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.

Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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.

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

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

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 Phase 2 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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

NIH encourages 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.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: the goal of the NIMH Career Transition (K22) Award Program is to facilitate the transition of a tenured or tenure-track intramural investigator from the NIMH DIRP (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 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.

Candidate

• Has the candidate demonstrated the capacity to carry out independent research?
• Based on the Candidate’s demonstrated capacity to conduct independent research, evidence of past and present research productivity (contributions to the scientific literature), and success in obtaining independent funding, is the Candidate likely to continue to make significant contributions to the field?
• Has the Candidate demonstrated the ability to conceptualize and organize a long-term research program?
• Is the Candidate’s level of experience and competence commensurate with the purposes of this award?

Career Development Plan/Career Goals and Objectives

• To what extent are the Candidate’s stated career goals and objectives consistent with the proposed career development/training activities?
• To what extent do the plans for career development and training activities during the award period position the Candidate for successful transition and to continue as an independent and productive scientist in the extramural community?

Research Plan

• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the proposed research project appropriate for the candidate's stage of research development and as a vehicle for development of the reearch skills described in the career development plan?
• Is the proposed research relevant to the stated career objectives?
• Is the research plan significant and of high quality, and does it have high potential for advancing the field of study?
• Does the proposed research demonstrate innovation and creativity, i.e., does the plan develop or employ novel concepts, approaches or methodologies, tools, or technologies for the specific area of research?
• Is there strong potential for the proposed research to contribute significantly to the mental health-related research and scientific literature?

Consultant(s), Collaborator(s)

• Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?
• Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
• Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project?
• Has the Candidate demonstrated effective use of collaborations during his/her tenure in the DIRP?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution (NIMH DIRP) to ensure that the required effort of the candidate will be devoted directly to the research activities described in the proposed career development and research plans?
• Is there strong institutional commitment to fostering the career development of the candidate?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty at the NIH?
• Based on the statement of the Scientific Director, NIMH, is there a strong and appropriate commitment by the DIRP to facilitate the Candidate's transition to a research faculty position in the extramural community?

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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

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

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). Reviewers will comment on whether the plan for sharing data via the NIMH Data Archive, or the rationale for not sharing via this archive, is reasonable.

Authentication of Key Biological and/or Chemical Resources

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:

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

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

NIMH requires reporting of recruitment milestones for participants in clinical trials as noted at https://grants.nih.gov/grants/guide/notice-files/NOT-MH-05-013.html. While trials in response to this FOA might not seek 150 subjects or more (the level at which this reporting has been required), all trials funded under this FOA must report recruitment milestones, including those with fewer than 150 subjects. This expectation will be stated in the NoA.

The NIMH expects the registration and results reporting in ClinicalTrials.gov for all NIMH-supported clinical trials, regardless of whether they are subject to FDAAA (see https://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm). This expectation will be stated in the NoA.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

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

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

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

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 Children, Planned Enrollment Report and Cumulative Inclusion Enrollment Report (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards and Select Agents (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.

These materials should be sent directly to the NIMH. The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) directly to the NIMH Financial or Grants Management contact person listed in the PD/PI's eRA Commons account. The Phase 2 application will be evaluated by extramural NIMH 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 NIMH communicating the rationale for the disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application.

Although the financial plans of the NIMH provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.