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

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

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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. 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 this NINDS Career Transition Award (K22) is to provide support to outstanding, newly trained basic or clinical investigators to develop their independent research skills through a two phase program; an initial period involving an intramural appointment at the NIH and a final 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.

This funding opportunity is available to licensed neurologists and neurosurgeons in the NINDS intramural program, who are within 4 years of completion of residency or clinical fellowship. For this award, awardees may spend up to 2 years in the intramural phase, with the balance (3 years or more) in the extramural phase. The entire award is intended to be mentored, but a transition to independence is strongly encouraged during the extramural phase of the award (see: Transition to the Extramural Phase). In order to transition to the extramural phase, awardees must obtain a faculty position at an academic institution. This position should either be a tenure-track or equivalent position, or a faculty position with a strong institutional commitment to facilitate progress towards a successful dual career as clinician and research scientist in a secure faculty position. In order to obtain the 5th year of K22 funding, awardees must submit a competitive NIH R01 or R21 application, as PD/PI, by the end of the 4th year of the K22 award.

This FOA is intended to facilitate the transition of NINDS intramural clinician-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. As such, awardees should develop, with their mentors, a comprehensive, coherent career development program to achieve the knowledge and skills required to succeed in such a position. Applicants should have a well-conceived research plan that investigates a highly significant scientific problem within the NINDS mission. The proposed initial phase of the research to be conducted at the NIH intramural program should be designed to continue at an extramural academic institution during the second phase of the research. Projects that require special resources available only at the NIH intramural program are acceptable if 1) collaborative efforts with NIH staff can be maintained, 2) it is clearly feasible to continue timely research activity that requires these resources, and 3) collaborators and the NINDS scientific director commit to the continued collaboration. In addition, regardless of whether special NIH resources are necessary for conduct of the project in phase II, a significant portion of the project proposed should belong to the applicant, such that he/she can pursue the project in phase II without competition from the mentor(s) at NIH.

In addition to the specific research plan, applicants should develop a plan to obtain the skills and experiences that 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. Regardless of research question or approach, applicants should obtain a fundamental understanding of the requirements for experimental rigor (see, for example, NOT-NS-11-023 and the related NINDS Transparency in Reporting guidance) and build such rigorous processes into their research project. Experiences might include 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, which may include, as applicable, managing a laboratory, managing a budget, managing personnel, recruitment of human subjects, organizing multiple sites for clinical research activities, etc.

As this is a mentored, career-development award, applicants should have one or more mentors who will fulfill all of the applicant's career development needs. Mentors are expected to contribute to the successful completion of all career development components, as well as provide guidance on choosing, and negotiating for, an appropriate extramural position.

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.

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (PAR-18-711).

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

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

Only NINDS may apply for the initial mentored phase of the K22 mechanism on behalf of intramural neurologists or neurosurgeons. They are not eligible to apply for phase 2 of the award. Public and private institutions of higher education, as well as For-profit and Non-profit institutions affiliated with a medical school, may serve as institutions for phase II of the award.

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.

Applicant Organizations

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

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

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

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

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

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

Candidates for the K22 award must have a clinical doctorate (including MD, DO, or equivalent doctoral degree), or a combined clinical and research doctoral degree.

Individuals must be licensed neurologists or neurosurgeons within the NINDS Intramural Program to be eligible (see specific information available for intramural candidates on the Electronic Submission Intranet link available only to users internal to NIH). Individuals must be in the career development phase of development; individuals who are independent researchers are not eligible for this award.

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

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

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

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

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 pending an 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 during the mentored phase. 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-09-036 for more details.

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 diverse 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 and clinical trial.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

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

It is critical that applicants follow the Career Development (K) 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.

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

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

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

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

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

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the extramural phase.

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

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

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

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate

Research Plan

Other Candidate Information

Mentor, Co-Mentor, Consultant, Collaborators

Environment & Institutional Commitment to the Candidate

Other Research Plan Sections

Appendix

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

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

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 NINDS.
• For individuals in postdoctoral and similar positions (i.e. still in training), 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.
• Describe all of the candidate's professional responsibilities at NINDS and elsewhere and show their relationship to the proposed activities on the career award.
• Describe the candidate's clinical experience and ability to combine a research and clinical career.
• Describe the candidate's plan for transition to an extramural position that combines clinical and research opportunities.
• If applicable, describe the candidate's prior clinical trials research efforts, research interests and experience.

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.
• Describe the candidate's current and long-term research and career objectives.
• 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

• A systematic plan should be presented for obtaining the background, research experience, and career development activities necessary to launch an independent research career. Describe current activities and how they relate to the candidate's career development plans and career goals. 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 the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) for neurologists; 6 person-months (50% full time professional effort) for neurosurgeons 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.
• Describe planned didactic components, workshops, meetings, collaborative activities and other relevant research and educational activities that will contribute to the research career development of the candidate. Describe specific activities, in detail, 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 the breadth of statistical methodologies relevant for different types of biomedical research.
• Describe the specific activities designed to obtain a 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, etc.
• 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 development of the program of study and to monitor the candidate's progress during the career development program. 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) what the applicant expects to obtain scientifically, clinically or both, during the intramural phase, that will enable successful transition, 4) what special resources would be required at the extramural institution for the successful continuation of the research and what resources, if any, might be unique and require collaboration with NINDS (if no unique resources are needed this should be clearly stated), and 5) 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 Strategy 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 mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).

The application must also describe the relationship between the mentor's research and the candidate's proposed research project. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. Both the candidate and mentor(s) should clearly describe which aspects of the research proposed belong to the candidate, such that once the candidate transitions to an extramural position, the mentor(s) will not continue with, or compete in, this part of the project.

The application must include a description of how the mentored phase research will lead to the independent phase research.

If a patient population is required for the research, details should be provided regarding the pool of patients available, access to the patient population, recruitment strategies, any potential obstacles, any relationship between the clinical and research activities of the applicant that involves these patients, and any special problems that may be encountered because of the population being studied. The applicant should also describe how the project will be continued during the extramural phase of the award if the intramural phase requires a specific patient population.

If patient-oriented research is proposed, the application should clearly describe the expected clinical impact of the research.

If unusual or special equipment, available during the intramural phase of the application, is required for the proposed research, applicants should address the availability, or lack of requirement, for this equipment during the extramural phase of the award. The application should make clear the planned research accomplishments during the first 4 years of the K22 that will support a competitive application for an NIH R01 or R21 by the end of the 4th year of the K22 award.

The application should describe collaborative arrangements required for the research, and how these collaborative arrangements will be continued after the transition to the extramural phase of the award.

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 study to an ongoing 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 or ancillary study, 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 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).

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 (sponsor), 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 primary 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(s) 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 primary mentor's statement should provide, in narrative form: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan describing the nature of the supervision and mentoring that will occur during the proposed K22 award period, including how the candidate's scientific and professional progress to independence will be promoted; 3) a description of the training needs of the applicant (candidates who are already independent are not appropriate for this award); 4) a description of the elements of the planned research training and career development, including any formal course-work; 5) a plan for transitioning the candidate from the intramural phase to the extramural phase of the award and a description of how the mentor will help the candidate progress towards scientific independence from his/her mentor(s); and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the applicant to the extramural phase of the award. In addition, the mentor must specifically identify what elements of the proposed research the K22 applicant can take when he/she transitions to the extramural phase and provide assurance that he/she will not directly compete with the applicant with regard to these specific elements. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included.
• If more than one mentor is proposed, the specific contributions of each mentor and co-mentor to the research and career development plan should be described by the applicant. In addition all mentors should describe their expertise and their understanding of their roles in the candidate's research and career development. A plan should be provided that clearly describes how mentors will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution (i.e. the NIH campus), a statement should be provided by the mentor(s) describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The primary mentor must (and ideally, all mentors will) agree to assist the candidate in transitioning to an extramural research position by guiding the candidate during the job search and negotiation process.
• 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. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. 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 sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe the resources and facilities that will be available to the candidate.
• Describe the sponsoring institution's scientific environment including the resources and facilities that will be available to the candidate.
• Describe the specific community that will contribute to the candidate's career development. This community may include faculty, postdocs, students, technicians and any other contributing personnel (do not list the entire intramural staff; discuss only those that are directly relevant to the candidate and candidate's research project and career development plan). If applicable, list activities that foster scientific interaction within the community.
• Describe the resources and facilities that will be available to the candidate, including 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 sponsoring institution 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) to carry out the proposed research plan.
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.
• The sponsoring institution must include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) for neurologists, 6 person-months (50% full-time professional effort) for neurosurgeons, to the career development program and related career development activities, and explain explicitly (i.e. with time requirements) how all non-K22 activities combined will require 25% or less (50% or less for neurosurgeons) of the candidate's professional effort. Note that NINDS evaluates time commitment as follows: 1/2 day per week = 10% effort, 1 month per year = 8% effort, periods with on call responsibilities are not considered protected time for research.

If special resources available only at NIH intramural program are required, the K22 application should clearly state this, describe how collaborative efforts with NIH staff will be maintained, and provide all necessary commitments (from the collaborators(s) and NINDS Scientific Director) attesting to the feasibility, willingness and provision of any financial requirements on the part of the NINDS intramural program, to collaborate. If no special resources are required that would limit award portability to an extramural institution, this should be stated, and if appropriate, explained.

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.

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 a 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

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

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

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.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Important Update: See NOT-OD-18-229 for updated review language for due dates on or after January 25, 2019.

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

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 K 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?
• Has the candidate demonstrated that he/she can perform significant, high quality scientific research?
• Did the candidate's prior research and training experiences prepare him/her to pursue the proposed research using state-of-the-art approaches?
• 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?

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 independent phase of the award?
• Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate's current stage of scientific and professional development and the career development proposed for the independent phase of the award?
• Is the career development plan consistent with the candidate's research and career goals?
• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Is the career development plan, combined with the applicant's prior experience, appropriate for the timeline proposed for transition to the extramural phase, and for the expectation that a competitive NIH R01, or R21 application will be submitted by the end of the 4th year of the K22 award period?
• Does the career development plan adequately address skills and experiences required for successful independent research other than those directly related to the research (e.g. grant writing, networking, oral presentation, leadership, lab management, etc.)?
• Based on the specific details provided, will the candidate obtain appropriate expertise in principles of experimental design, a solid understanding of the breadth of statistical methodology utilized for biomedical research and sophistication with respect to data analysis?
• Is there adequate assurance that the candidate will receive at least 75% protected time (50% for neurosurgeons) for research career development? Are the non-research commitments of the candidate clearly described in terms of the actual time commitment required to fulfill them?

Research Plan

• Is there a strong scientific premise for the project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the proposed research project appropriate for the candidate's stage of research development and as a vehicle for development of the research skills described in the career development plan?
• Is the proposed research relevant to stated career objectives?
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience?
• Does the research plan describe methodology to achieve adequate scientific rigor?
• Will the research project address an innovative hypothesis, challenge existing paradigms or otherwise make a highly significant contribution to the field? Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies? Does the project make use of, or lead to, a unique set of skills of the candidate?
• Does the research plan include an adequate description of data analysis, expected results, approach to data interpretation, alternative hypotheses, potential problems and solutions to those problems?
• If human subjects are involved, does the research plan adequately address issues related to recruitment, potential obstacles related to the particular population, and transportability of the research to the extramural phase of the award?
• If the research plan requires special, NIH-specific resources (e.g. equipment, expertise, patient population, etc.), is there adequate evidence that the research plan can be continued during the extramural phase?
• Is the proposed research designed to lead to a highly successful independent line of research for the candidate? If the proposed research discipline requires team-based approaches, will the candidate develop skills to play a major leadership role in the chosen research field?
• Is the research project adequately distinct from the mentor's research to allow transition of the project to the exclusive control of the candidate?
• 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?
• 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 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, consultant's, and/or collaborator's previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's current research productivity and peer-reviewed support?
• Is active/pending support for the proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee's progress toward independence?
• Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate's project?
• Do the proposed consultant(s)/collaborator(s), along with the mentors, provide the required expertise for successful conduct of the research project?
• Do the applicant and mentor provide an adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate for the proposed research and career development?
• If applicable, do co-mentors describe their role in the research and career development plan, as well as the frequency and expected plans for meeting with the candidate?
• Are the research career development activities, and mentoring plan, tailored to, and adequate to achieve the candidate's needs?
• Does the mentoring team have appropriate research and training experience to successfully guide the applicant in his/her research, career development and transition to independence?
• Does the mentor, or member of the mentoring team, have adequate experience to guide the candidate in skills required to obtain research funding?
• Is the mentor currently a productive scientist? Is support specifically for the proposed research project appropriate and adequate?
• Does the mentor describe his/her expectation for the transition of the candidate to the extramural phase of the award, including the projected timing of this transition, and the guidance he/she will provide to facilitate this transition?
• Does the mentor clearly and explicitly describe the portion of the project the candidate can take with him/her to the extramural phase of the award and the resources, if any, the candidate can take to the extramural phase of the award,? Does the mentor clearly state that he/she will not compete with the candidate in pursuit of this portion of the project?
• If applicable, does the mentor adequately address the ability of the candidate to access any special NIH resources that are needed during the extramural phase of the award? If applicable, does the mentor adequately address his/her willingness to continue collaborating with the candidate, and the expectation for this collaboration?
• 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, or feasibility study and help him/her to meet timelines?

Environment & Institutional Commitment to the Candidate

• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research training, 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 scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?
• Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty?
• Is the environment suitable for the candidate's success in the proposed scientific and career development goals of the candidate?
• Does the environment include an oversight mechanism to ensure the successful progress of the candidate towards his/her research and career development goals?
• Does the letter of commitment from an appropriate individual clearly state what the candidate's non-research commitments during the intramural phase will be, and describe the calculation to demonstrate that they will consume 25% or less of the candidate's full time effort?
• 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 feasibility or ancillary 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?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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)?

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

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

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

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

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

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

Not Applicable

Not Applicable

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

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

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

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

Authentication of Key Biological and/or Chemical Resources

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

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned 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. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter that 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.

Specific to applications proposing clinical trials, ancillary or feasibility studies

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA.

For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.

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, or a new ancillary study to an ongoing clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator 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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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).

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

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

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

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

Transition from the intramural phase to the extramural phase is not automatic, and requires administrative approval by NINDS extramural program staff. Approval of the transition will be based on several factors. The awardee's progress during the intramural phase will be determined from a progress report included in the request to transfer the award (see below). The awardee's research and career development plans for the extramural phase, included in the request to transfer the award, will be evaluated in light of the progress already made. The sponsoring institution must provide either a tenure-track or equivalent position, or a faculty position with a strong institutional commitment to facilitate progress towards a successful dual career as a clinician and research scientist in a secure faculty position. The sponsoring institution must provide a minimum protected time for research of nine person-months (75% full time professional effort) for neurologists, six person-months (50% full time professional effort) for neurosurgeons (as in the initial application, the extramural institution must provide a detailed explanation of the non-research responsibilities, and the time required for them, that leads to the calculation of protected time). The institution must also provide the space and resources needed to conduct the proposed research project, as well as a description of startup funds provided. Careful attention should be paid to appropriate mentoring at the extramural institution. The extramural institution should have an appropriate scientific mentor for the project, and the candidate should include any additional mentors required for comprehensive guidance in the candidate's career path. It is essential that the request to transition include a plan for career development that will lead to research independence, the ability to successfully compete for research support, and a commitment from the extramural mentor and institution to support the candidate's progress towards a successful research program and independent funding. NINDS must have appropriate documentation no later than two months before the end of the intramural phase (e.g. no later than two months before the end of the 2nd year of the K22 award) in order to avoid a potential interruption in funding. Except in rare, extenuating circumstances, if the awardee does not secure an extramural position by the end of the 2nd year of the K22 award, the K22 award will be terminated.

The application for the extramural phase of the award must be submitted no later than 2 months prior to the proposed activation date of the award by extramural grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact the Director, Office of Training, Career Development and Workforce Diversity, NINDS as soon as plans to assume an extramural position develop, and not later than 6 months prior to the end of the intramural phase of the award, to discuss plans for transition to, and the application for, the extramural phase.

An eligible extramural institution for this K22 must have the appropriate infrastructure to support the proposed research program and a history of external research funding.

Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the candidate.

Form PHS 2590 must include the following:

• A new face page signed by the Phase II institutional representative.
• A description of the proposed research.
• A description of the institutional environment, including: research facilities and the availability of appropriate educational opportunities, including collaborating faculty, when necessary; quality and relevance of the environment for scientific and professional development of the candidate.
• Information about the sponsoring institution's commitment to the candidate and to the candidate's scientific independence, including: commitment to ensuring that the candidate's effort required by the K22 program will be devoted directly to the research and career development activities described in the proposed career development and research plans; institutional commitment to fostering the career development of the candidate.
• In addition to the narrative provided by the mentor (described above), a biosketch with a complete description of the mentor's funding should be provided.
• Although the protected time requirement only extends to the end of the K22 award, the extramural institution is encouraged to continue to provide adequate protected time beyond the K22 award period to allow the applicant to successfully launch a vigorous, independent research program. Any such allowance is an encouraged part of the extramural application.
• Position Description: the institution should provide 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.
• Budget in detail, including justification for all requested funds:
• List the name, role on project and percent effort for all project personnel (salaried and unsalaried) and provide a narrative justification for each person;
• Identify all consultants by name and organization affiliation and describe the services to be performed;
• Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project;
• Describe specific resources committed by the sponsoring institution to support the Candidate's research.
• An estimate of the cost of the proposed research should be provided. If more funding is required than provided in the K22 award to conduct the proposed research, the source of available funds should be identified, and an appropriate letter attesting to the availability of these funds provided.

The extramural institution must provide the space, facilities, resources, and other support needed to conduct the proposed research, as well as the required protected research time for neurologists and neurosurgeons, at least for the duration of the K22 award. Any 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 the equivalent faculty position. The K22 sponsoring institution must describe the candidate's academic appointment. The K22 institution must describe the awardee's ability to apply for and secure independent research grants, including an NIH RPG or equivalent.

These materials should be sent, via an email attachment (preferably pdf format), directly to both the Scientific Contact and Grants Management Contact listed below.

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 Application Guide.

The K22 award is intended to facilitate successful transition to an independent dual, clinician-scientist career. Moreover, funding of the 5th year of the K22 award requires the candidate to submit a competitive NIH R01 or R21 application by the end of the 4th year of the K22. Consequently, a requirement for approval of the transfer of the K22 to the extramural institution is the commitment of the extramural institution, including the provision of adequate resources, for successful progress of the candidate to research independence.

Candidates for whom transfer to the extramural institution is not approved 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 transfer application.

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

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

A final 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.

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

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

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

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

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

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

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

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

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