Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) 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 Application Guide and the NOFO) 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.

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
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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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. 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 Extramural Training Mechanisms website.

The objective of the Career Transition Award (K22) is to provide support to outstanding, 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 successful, independent research career.

The objective of this Mentored Career Transition Award (K22) is to provide support to outstanding 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 specific goals of this NIMH K22 program are to 1) support the career development of postdoctoral fellows conducting research in the NIMH Division of Intramural Programs (DIRP); and 2) foster their career advancement to an academic faculty positions in the extramural community where they will develop their independent research programs. This K22 program offers NIMH intramural fellows a funding opportunity comparable to those available to their extramural counterparts (see https://www.nimh.nih.gov/funding/training/funding-opportunities-for-early-career-investigators.shtml). The 6-year K22 eligibility window should be of particular benefit to clinical fellows, whose clinical responsibilities often compete with research training activities.

This NIMH Mentored Career Transition Award for NIMH Intramural Fellows will support two phases of mentored research career development: a mentored intramural phase no less than one year, and up to two years, in duration, and a mentored extramural phase up to three years in duration, for a total maximum of five years of support. Transition from the intramural to the extramural phase is not automatic. In order to transition to the extramural phase, recipient's must obtain a tenure-track or equivalent faculty position at an academic institution, with strong institutional commitment to their development as independent investigators and with appropriate faculty to serve as the extramural mentor.

This Notice of Funding Opportunity (NOFO) is intended to facilitate the transition of NIMH intramural fellows to independent, extramural faculty positions. Applicants should propose a well-conceived research plan that investigates a significant scientific problem within the NIMH mission. The research plan must span both phases of the award. Regardless of the research question or approach, applicants should obtain a fundamental understanding of the requirements for experimental rigor and build such processes into their research project. In addition to the specific research plan, applicants should develop, with their intramural phase mentors, a comprehensive, individualized career development plan to obtain the skills and experiences that will facilitate a successful, independent research career. Skills should include grant-writing and oral presentation skills, specialized coursework if needed, and expertise in experimental design and statistics. The career development plan should also include activities such as networking with key researchers in their field, both nationally and internationally, attendance at workshops designed to enhance specialized knowledge and skills, and presentations at national and international meetings. Applicants should also receive guidance on administrative skills associated with an independent research career, such as laboratory management.

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 candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PAR-23-149).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• Eligible Agencies of the Federal Government - Including the NIH Intramural Program

Only NIMH intramural laboratories are eligible to apply for the intramural phase of the K22 mechanism on behalf of intramural candidates. Transition to the extramural phase requires an extramural appointment.

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 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.

• 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 NIMH DIRP postdoctoral fellow 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

K22 applicants must have no more than 6 years of postdoctoral experience at the time of the initial or the subsequent resubmission application, and must currently be conducting research as a postdoctoral fellow (i.e., clinical fellow, research fellow, IRTA postdoctoral fellow) in the NIMH DIRP (see https://oir.nih.gov/sourcebook/personnel/ipds-appointment-mechanisms). Time spent in clinical training during residency or clinical specialty is not counted towards K22 eligibility. Time spent in research training during these periods is counted toward K22 eligibility. Parental leave or other well-justified leave for personal or family situations of generally less than 12-months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 6-year eligibility limit. Part-time postdoctoral research, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly. In addition, time spent conducting required postgraduate clinical activities that do not involve research is not considered part of the 6-year eligibility limit.

The K22 award is intended for individuals with career-stage appropriate research experience, and who require up to an additional five years of mentored research and career development. Consequently, the strongest applicants will require, and will propose, a well-conceived plan for substantive mentored research and career development that will help them become competitive candidates for tenure-track or equivalent faculty positions and to launch robust, independent research programs. If an applicant achieves research independence (any faculty or equivalent independent research position) before the intramural phase K22 award is made, neither phase of the K22 award will be made.

Candidates for the K22 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, 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.

3. Additional Information on Eligibility

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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

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

At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research. Mentors are expected to contribute to the successful completion of all career development components, as well as provide guidance on choosing and negotiating an appropriate extramural position.

During the transition to the extramural phase, the candidate must identify an extramural mentor who is qualified to oversee the candidate's research activities and promote their career development.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

The intramural phase applicant institution must be the NIMH DIRP. Both the intramural phase and extramural phase applicant institutions must have strong, well-established records of research and career development activities and faculty qualified to serve as mentors 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity 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.

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Project Summary/Abstract

Include a description of the proposed intramural phase research and the research you propose to continue at the extramural institution during the extramural phase.

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

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

R&R Budget

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

For period of support, indicate the total period of support being requested for the extramural phase: up to 3 years.

PHS 398 Cover Page Supplement

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

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

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives?

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.

• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

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

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful.
• The mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study or to monitor the candidate's progress through the career development program.

• A systematic plan should be presented for obtaining the background, research experience, and career development skills necessary to launch an independent extramural research career.
• Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as necessary professional skills such as grant-writing, communication and leadership. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher.
• Describe planned didactic components, workshops, meetings, collaborative activities and other relevant research and educational activities that will contribute to the candidate's research career development.
• Describe specific activities that will provide a solid understanding of the fundamentals of experimental design, statistical methodology, data analysis and scientific rigor. This description must include formal activities, engaged in previously or planned, that will provide the candidate with strong expertise in experimental design and statistical methodologies relevant to the proposed research.
• Describe the specific activities planned to obtain practical knowledge of the administrative skills associated with an independent research career, which may include, as applicable, managing a laboratory, managing a budget, managing personnel, recruitment of human subjects, organizing multiple sites for clinical research activities, clinical research experience, etc.
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career award.
• The time required for these non-K22 activities should be explicitly described, with the time devoted to each explicitly stated. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
• A timeline, including the expectations for publication of results, is strongly encouraged. This timeline should include expectations for activities that will be completed in the first phase (intramural) and the second phase (extramural) of the award.
• Although not required, applicants are strongly encouraged to form an active advisory committee (or mentoring team) to assist with the candidate's career development and to monitor progress. If such a team is formed, applicants should describe the planned frequency of meetings and group vs. individual expectations for advisory committee members.
• Describe the specific plan for transition to the extramural phase of the award. This plan should include information on 1) the expected timing of the transition; 2) the type of position that will be sought; 3) the specific activities designed to prepare the applicant for a successful job search; 4) the qualities and qualifications desired in the extramural mentor; and 5) any other information the applicant deems pertinent.

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. This narrative should describe what the candidate will accomplish during the intramural phase research that will enable him/her to launch an extramural research program (i.e., what does the candidate still need to accomplish during the intramural phase in order to compete successfully once they have moved into the extramural phase).
• The research plan should describe the significance, innovation and approach of the proposed research during the intramural and extramural phases of the award. The research plan should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the extramural phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application.?
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• The application must include a description of how the research during the intramural phase will lead to the proposed extramural phase research.
• If unusual or special equipment, facilities, patient populations or resources, available during the intramural phase of the application, are required for the proposed research during the extramural phase, applicants should address the availability or plans for access to these resources during the extramural phase
• For trials focusing on clinical or public health endpoints, describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study). For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, describe how the proposed clinical trial will advance scientific understanding.
• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
• If proposing an ancillary clinical trial, provide a brief description of its relationship to the larger clinical trial.
• If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.

• Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

Training in the Responsible Conduct of Research

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

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

• The candidate must name a primary mentor, who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The primary mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
• The application must include a statement from the mentor providing: (1) information on their research qualifications and previous experience as a research supervisor; (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the candidate’s scientific and professional independence will be promoted; (3) a description of the elements of the planned research career development, including any formal coursework; and (4) a plan for transitioning the candidate to move from the mentored stage of their career to the independent research investigator status during the project period of the award
• The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

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

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The NIMH DIRP 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 NIMH DIRP scientific environment including the resources and facilities that will be available to the candidate, any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

• The Scientific Director of the NIMH DIRP must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan.
• Provide assurances that the candidate will be able to devote a minimum of 75% full-time professional effort to the development of a research program.

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 SF424 (R&R) 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 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 web site 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 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 SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Reference Letters

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

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.

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

7. Other Submission Requirements and Information

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

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

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

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.

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.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.

Candidate

• Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field?
• Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project?

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

• Has the candidate demonstrated that he/she can perform significant, high-quality scientific research?
• Given the candidate’s prior training, proposed career development plan, and the referees evaluations, is it reasonable to expect that the candidate will be able to achieve a tenure-track or equivalent extramural faculty position within the time period requested for the intramural phase of this award?

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

• To what extent are the plans for evaluating the awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the extramural phase of the award?
• Is the timeline planned for the transition to the extramural phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the intramural phase of the award?
• Are the content and duration of the proposed components of the career development plan appropriate and well-justified for the candidate’s current stage of scientific and professional development and proposed research career goals?
• To what extent does the proposed career development plan enhance or augment the applicant’s research training and skills acquisition to date?
• Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate his/her successful transition to independence?
• Does the proposed career development plan include specific activities that will provide a solid understanding of the fundamentals of experimental design, statistical methodology, data analysis and scientific rigor?

• Where applicable, to what effect will the clinical trial experience contribute to the applicant's research career development?

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, if applicable?
• Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of the research skills described in the career development plan?
• Is the proposed research relevant to stated career objectives?
• If the research plan requires special, NIH-specific resources (e.g., equipment, expertise, patient populations), is there adequate evidence that the research plan can be continued during the extramural phase?
• Are the scientific and technical merits of the research appropriate for developing the research skills described in the career development plan, and appropriate for developing a highly successful research program?
• Is the proposed extramural phase research significant, scientifically sound, and a logical extension of the intramural phase research? Is there evidence of long-term viability of the proposed extramural phase research plan?
• Does the proposed research address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
• To what extent is the proposed research likely to foster the career of the candidate as a successful, independent investigator in biomedical, behavioral, or clinical research?
• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• For trials focusing on clinical or public health endpoints, is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention? Or in the case of a feasibility study necessary to establish feasibility of a future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

• Are the scientific rationale and need for a clinical trial, ancillary clinical trial, or feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• Is the clinical trial or ancillary clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
• Is the mentor’s description of the elements of the research career development activities, including formal course work, adequate?
• Is there evidence of the mentor's current research productivity and support?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
• Does the mentor describe an acceptable plan for clear separation of the candidate’s research and research career from the mentor’s research, including identifying the components of the research plan that the candidate may take to an extramural research position?
• Are the consultants /collaborators research and/or mentoring qualifications appropriate for their roles in the proposed intramural phase of the award? Do they provide letters of support that affirm their commitment?

• Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary clinical trial, or feasibility study and help him/her to meet timelines?

Environment & Institutional Commitment to the Candidate

• Are the intramural research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is there clear commitment of the NIMH DIRP to ensure that the required effort of the candidate will be devoted directly to the research skill development, career development, and 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 DIRP scientific environment that benefit the proposed research; e.g. useful collaborative arrangements or subject populations? If so, can the research be continued productively following transition to the extramural environment?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?

• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial, ancillary clinical trial, or feasibility study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

Study Timeline for Clinical Trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Revisions

Not Applicable

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Training in the Responsible Conduct of Research

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

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 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

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 VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 NOFO 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 K22 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an insitution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accomodations and making services accessile to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment; see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 and 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.

Transition to the Extramural Phase

Transition from the intramural phase to the extramural phase is not automatic. Approval of the transition will be based on the success of the recipient's research program as determined by annual scientific reviews, by the evaluation of the research and career development plan to be carried out at the extramural institution, and the strength of the commitment of the extramural institution to the recipient/.

Transition from the intramural phase to the extramural phase is intended to be continuous in time and, except in unusual, extenuating circumstances, NIMH will not extend the intramural phase beyond the 2-year limit. NIMH may, at its discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews, but final decisions have not yet been made by the potential extramural institution or, rarely, because of unusual, extenuating circumstances. To activate the extramural phase of this award, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the intramural project period.

An eligible extramural institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. Applicants are free to apply for positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the extramural phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Such outcomes are consistent with the goals of this NOFO. Eligibility of for-profit organizations for the extramural phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.

To avoid potential problems in activating the extramural phase, applicants are strongly encouraged to contact their NIMH program official to discuss transition to the extramural phase as soon as plans to apply for an extramural position develop, and not later than 6 months prior to the termination of the intramural phase of the award. The application for the extramural phase of the award should be submitted no later than 2 months prior to the proposed activation date of the extramural K22 award by the extramural phase grantee organization.

The extramural phase institution will submit an application on behalf of the candidate for the K22 award using the PHS 398 Application. The extramural phase application must include:

• A new face page signed by extramural institutional representative;
• A new project description page (the project summary or abstract should be updated to reflect current plans for the extramural phase);
• Budget pages, including justification for all funds requested;
• Biographical Sketches for the PD/PI and any other Key Personnel for the K22 PI, the proposed extramural mentor and any co-mentors for the extramural award period;
• A new Resources page;
• A brief description of progress made during the intramural phase that will serve as the Final Progress Report for the intramural phase;
• An updated Candidate's Plan for Career Development/Training Activities;
• An updated Research Plan (the Specific Aims should be updated to reflect current plans for the extramural phase, and the updated research plan should be described in no more than 5 pages);
• An updated Plan and Statement of Mentor and Co-Mentor(s)
• Updated PHS Human Subjects and Clinical Trials Information form (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards (as appropriate);
• Updated Select Agent Research (if applicable);
• Updated Resource Sharing Plan(s) (if applicable);
• Updated Authentication of Key Biological and/or Chemical Resources (if applicable);
• A new Checklist;
• A letter from the extramural Department or Division Chair describing the institution’s commitment to the candidate and plans for his/her career development, as well as 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; and
• A final evaluation letter from the intramural phase mentor (if not already provided).

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) to the Financial or Grants Management contact person at NIMH listed in the approval letter. The extramural phase K22 application will be evaluated by NIMH extramural staff for completeness and appropriateness to the program.

An institutional commitment agreement will be required at the time of activation of the extramural phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424(R&R) Application Guide.

The Mentored Career Transition Award for NIMH Intramural Fellows (K22) is a mentored award during both the intramural and extramural phases. As such, a mentor at the sponsoring extramural institution must be identified to facilitate the candidate's continued career development and research goals. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (or advisory committee), if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage.

In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months, 75% of the candidate’s full-time professional effort) for the duration of the K22 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The sponsoring institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The extramural phase institution must describe how the recipient's’s ability to apply for and secure independent research grant (R01) support will be fostered and supported during the extramural phase of the award.

NIMH staff may review start-up packages and other commitments between the institution and candidate prior to activating the extramural phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIMH Program Official prior to finalizing the offer. NIMH will not activate the extramural phase award if the institutional commitment is deemed inadequate. Applicants who are approved to transition will receive a Notice of Award reflecting the grant mechanism dollar amount, and the new recipient organization.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the extramural phase 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.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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. 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 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

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

Section VII. Agency Contacts

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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: GrantsInfo@nih.gov (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: support@grants.gov

Ashlee Van't Veer
National Institute of Mental Health (NIMH)
Telephone: 301-443-3107
Email: dnbbstrainingbranch@mail.nih.gov

Mark Chavez, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-443-8942
Email: Mark.Chavez@nih.gov

Anita Bechtholt, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-480-8368
Email: ?anita.bechtholt@nih.gov

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tamara.kees@nih.gov

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.