Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Mental Health (NIMH)
Funding Opportunity Title	NIMH Career Transition Award for Tenure-Track and Tenured Intramural Investigators (K22)
Activity Code	K22 Career Transition Award
Announcement Type	Reissue of PAR-09-246
Related Notices	September 02, 2014 - This PAR has been reissued as PAR-14-330. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	PAR-12-201
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.281
FOA Purpose	The primary goal of the NIMH Career Transition Award for Tenure-Track and Tenured Intramural Investigators (K22) Program (hereafter abbreviated as the NIMH Career Transition K22 Program) is to provide support for career intramural investigators at NIMH who aim to transition from the Division of Intramural Research Programs (DIRP) to an independent research faculty position in the extramural community. Principal investigators will have a demonstrated record of meritorious research in mental health-related fields.

Posted Date	June 8, 2012
Open Date (Earliest Submission Date)	July 9, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Applications are due on the 9th of each month, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Applications are due on the 9th of each month by 5:00 PM local time of applicant organization.
Scientific Merit Review	Applications will be handled on an expedited external peer review and award basis to meet the goals of this program.
Advisory Council Review	Applications will be handled on an expedited review basis to meet the goals of this program.
Earliest Start Date(s)	Applications will be handled on an expedited basis to meet the goals of this program.
Expiration Date	New Date September 3, 2014. (Original Expiration Date: July 10, 2015)
Due Dates for E.O. 12372	Not Applicable http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch10.htm#construction_grants_intergovernmental_review

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The 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 (K22) 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.

The NIMH DIRP has undergone a Blue Ribbon Panel evaluation (see the report at: http://www.nimh.nih.gov/about/director/updates/nimhbrpreport.pdf). In this report, the Blue Ribbon Panel applauded the numerous vital contributions that NIMH DIRP investigators have made to mental health research and the emphasis on translational research and high risk-high yield projects that spur innovation. In order to maintain and even expand on these contributions 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 (K22) 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.

Nature of the Career/Research Transition Opportunity

Each application to the NIMH Career Transition (K22) Program must reflect the individual needs of the Candidate (PD/PI). Phase 1 of the award will be sponsored by the NIMH DIRP while Phase 2 will be sponsored by the domestic, extramural institution to which the Candidate will transition. The application will be submitted for peer review of the 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 the primary 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 the 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.

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.

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. Recipients of a NIMH K22 award may hold concurrent research support and salary support from their K22 award and a competing NIH research project grant when recognized as a PD/PI or Subproject Director of the research project grant. See NOT-OD-08-065.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period	The total project period may not exceed 3 years..

Salary	NIH will contribute funds for up to 6 person months' effort per year toward the salary of the career award recipient. The salary may not exceed the current NIH extramural salary cap. The funds for salary and fringe benefits are included within the annual, direct cost cap of $300,000 for the NIMH Career Transition Award (K22) Program. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Other Program-Related Expenses	NIMH will contribute up to $300,000 per year toward the total direct costs (salary, fringe benefits, and research costs) of the award recipient. Research costs must be justified and consistent with the stage of experience of the candidate and the proportion of time to be spent in research activities. Salary for secretarial and administrative assistants, etc. is not allowed.
Indirect Costs	Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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 Institution for Phase 1:

For Phase 1 of the NIMH Career Transition (K22) Program, only NIMH intramural laboratories are eligible to apply on behalf of tenured or tenure-track investigators in the NIMH DIRP.

Eligible Applicant Institutions 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

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.

Agencies of the federal government and foreign institutions are not eligible to apply for 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 not allowed.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

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

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

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any tenured or tenure-track NIMH Intramural Scientist who has been in that intramural position for at least 5 years and who has the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with the NIMH Division of Intramural Research Programs to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple Principal Investigators are not allowed.

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 the 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 5 years. Individuals are NOT eligible to apply if they have already accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere.

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.

Candidates for this award must have earned a terminal 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.

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

At the time of the Phase 2 award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. 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.

Phase 2 awardees must devote an effort of at least 6 person-months (equivalent to 50% full-time professional effort) to mental health-related research.

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

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

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

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

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

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

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

This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to conduct in Phase 2 of the award.

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

Candidate’s Background (Component of Candidate Information)

• Describe prior training and research efforts, and how they relate to the objectives and long-term career goals of the Candidate.
• 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.
• Explain how the career award will contribute to career goals, and further the Candidate’s research career and ultimate impact on science.
• Describe the Candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH.

Career Goals and Objectives (Component of Candidate Information)

• Describe the Candidate’s career goals and objectives under this award, including prior experience and current research support.

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

• The Candidate should describe any new or enhanced research skills and knowledge he/she will acquire, if applicable to the Candidate's career goals, during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research program as an independent scientist.
• The Candidate should also 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.

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

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

Statements by Consultants, Contributors (Component of Statements of Support)

• Signed statements must be provided by each collaborator and/or consultant 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 that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.

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

The NIMH Division of Intramural Research Programs must document a strong, well-established research program related to the candidate's area of interest, including a high-quality research environment.

• Describe the scientific environment, including resources and facilities, that will be available to the candidate during Phase 1 (intramural) of the K22.

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

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

Research Strategy (Component of Research Plan)

• Describe a sound research project that is consistent with the candidate’s level of research experience and objectives of his/her continued career advancement. The description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach as well as the ability of the candidate to carry out the proposed research.

Appendix

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

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.

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

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

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 faciliate 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 for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

Has the candidate demonstrated the capacity to carry out independent research? Does the candidate have the potential to make significant contributions to the field? Is there evidence of past and present research productivity as evidenced by contributions to the scientific literature, and success in obtaining independent funding? Has the candidate demonstrated the ability to conceptualize and organize a long-term research approach? Is the candidate’s level of experience and competence commensurate with the purposes of the award?

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

What is the likelihood that the award will contribute substantially to the continued scientific advancement and productivity of the candidate? Are the career goals and objectives under this award consistent with the candidate’s career goals?

Research Plan

Is the research plan of high quality, and does it have potential for advancing the field of study? Is the scientific and technical merit of the proposed research plan significant? Is the proposed research relevant to the candidate's career objectives? 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 research and scientific literature associated with the mission of the NIMH?

Consultant(s), Collaborator(s)

Has the candidate demonstrated effective use of collaborations during his/her tenure in the DIRP? Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration during the K22 project period? Have the proposed consultant(s) and/or collaborator(s) provided evidence of commitment to the Candidate and the Candidate’s project? Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?

Environment & Institutional Commitment to the Candidate

Does the application document a strong, well-established research program in the DIRP related to the candidate's area of interest and a high-quality research environment? 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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups that the candidate will participate in? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety? Do the plans adequately describe the candidate s role in the participation in instruction in RCR? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction? Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to NIMH. 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.

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

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

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

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

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

There will not be a formal Notice of Award (NoA) associated with Phase 1 of the NIMH K22 award conducted in the NIMH intramural program. The NIMH will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIMH K22 award, as well as expectations for the transition to Phase 2 of the award.

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.

Individuals must have been offered and accepted a research faculty position at an eligible institution with appropriate infrastructure to support the proposed research program and a history of external research funding. Transition to Phase 2 is not automatic. Approval of the transition will be based on an administrative review by NIMH staff evaluating the faculty position the Candidate has accepted. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of six person-months (50% full-time professional effort) protected research time, space, and resources needed to conduct the proposed research project. A plan that will enable the candidate to successfully compete for NIH research support is essential.

To avoid potential problems, applicants are strongly encouraged to contact their NIMH Program Official as soon as plans to assume an extramural position develop, to discuss plans for transition to, and the application for, the Phase 2 award.

The Phase 2 institution will submit an application on behalf of the candidate for the NIMH Career Transition K22 award using the PHS398 Application.

This application must include:

• A new face page signed by the Phase 2 institutional representative;
• A new project description page (the project summary or abstract should be updated to reflect current plans for the Phase 2 award);
• Detailed budget pages for a non-modular budget and budget justification for all requested funds (direct cost cap of $300,000);
• Biographical Sketches for the PD/PI and any additional Key Personnel;
• A new Resources page;
• An updated research plan (the Specific Aims should be updated to reflect current plans for Phase 2, and the updated research plan should be briefly described in less than 5 pages);
• An updated Protections for Human Subjects, Inclusion of Women, Minorities, and Children and/or Vertebrate Animals section, as appropriate; and
• A new Checklist.
  

In addition, a letter from the Department or Division Chairman describing the institution’s commitment to the candidate and plans for his/her continued career advancement should be submitted (see below).

These materials should be submitted directly to the NIMH. The original application plus one copy (preferably in a PDF format) are to be submitted to the NIMH Financial or Grants Management contact person listed in the PD/PI's eRA Commons account. The Phase 2 K22 application will be evaluated administratively by NIMH staff for completeness and responsiveness to the program.

An institutional commitment agreement will be required at the time of the Phase 2 award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424 (R&R) Application Guide.

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 6 person-months [50% full-time professional effort]) at least for the duration of the K22 award. The start-up package and other institutional support must be described and should be comparable to that given to other faculty recently hired. 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 faculty who are hired without grant support. The sponsoring institution should describe the candidate’s academic appointment. The Phase 2 institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support.

The NIMH Career Transition (K22) Program requires that a minimum of 6 person-months (50% full-time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the K22 award period. NIH staff may review start-up packages and other commitments between the institution and candidate. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the NIMH Program Official prior to submission of the K22 application. NIH will not make a K22 award if the institutional commitment is deemed inadequate. K22 awardees will receive a Notice of Award for the K22, the dollar amount, and the new recipient organization.

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

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

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

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program 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.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-3107
Email: ndesmond@nih.gov

David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6150, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov.

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: rclaycam@mail.nih.gov

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

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