It is critical that applicants follow the 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 Ruth L. Kirschstein National Research Service Award (NRSA) 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. NRSA fellowships support the training of pre-and postdoctoral scientists, dual-degree investigators, and senior researchers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

This NINDS F32 is designed specifically to support postdoctorates who are just beginning a postdoctoral training period in a given laboratory or research environment (support from this F32 FOA may be requested for either a first or second postdoctoral mentored training position, but a second position will only be supported if the laboratory, research environment and mentor(s) are completely different from those of the applicant's first postdoctoral position). The window during which applicants are eligible to apply (from approximately 12 months prior to starting in the proposed postdoctoral position to within 12 months of starting the postdoctoral position) precludes the expectaion of applicant-generated preliminary data, and thus encourages original projects that rely on creative, innovative ideas that address highly significant questions. Because of the early application, it is expected that there will be no preliminary data in the application and applicants are encouraged to NOT include preliminary data in the application. Further, this F32 will only support postdoctorates who are within the first 3 years of training in a specific laboratory or scientific environment (or with a specific mentor). Candidates seeking support that focuses on advanced postdoctoral career development can apply for a new NINDS postdoctoral K01 (see NOT NS-16-013), and candidates seeking support for completion of postdoctoral career development and transition to a faculty position can apply for a K99/R00.

Projects are encouraged at all levels of investigation, including basic science that is targeted to understanding central and/or peripheral nervous system processes but may not have direct disease-relevance, basic science with direct relevance to one or more neurological diseases or disorders, clinical (patient-oriented) research or translational research (studies designed to move compounds or devices towards clinical use). The integrated program of research and training is expected to provide applicants with training at the forefront of science that will prepare them to launch independent research careers in areas that will advance the goals of the NINDS mission.

The application should consist of a well-conceived scientific project, integrated with a comprehesive training plan, designed by a collaborative discussion between candidate and mentor that begins prior to the start of the candidate's training in the laboratory. In addition to preparing the candidate to be a subject matter and technical expert, both the project and training plans are expected to provide the candidate with a profound understanding of quantitative principles of experimental design and analysis. Moreover, the candidate's approach should consider the experimental system quantitatively to ensure a deep understanding of the potential significance of experimental results.

The proposed research and training plan should focus on a research area and/or skill set that complements the applicant's existing research expertise and skills. The research should differ substantially from the applicants prior research and training experience, and should not occur in a training environment already experienced by the candidate. A significant contribution to training potential is not only the novelty of the research project and skills obtained but the interaction with different investigators, in a different environment, to learn additional ways of approaching both scientific and procedural problems.

The proposed research and training plan should enhance the individual’s potential to develop into a productive, independent researcher by providing strong mentorship, appropriate training and career development opportunities, and strong institutional support and commitment. The training plan should explain how the proposed mentored research and training plan, in combination with the candidate's prior training and experience, will contribute to the individual’s research career goals. The training plan should be explicitly designed to facilitate the fellow’s transition to the next career stage.

It is expected that the mentored training experience will provide, in addition to high quality, published data and expertise in a research area:

• A strong foundation in quantitative reasoning, research design, methods, statistics and analytic techniques appropriate to the proposed research;
• An understanding of, and adherence to, the principles of strict scientific method that ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results.
• An expert understanding of the tools and methods used
• Opportunities to present research findings, and interact with members of the scientific community, at national meetings as the work progresses;
• The opportunity to publish the research findings as first author; and
• Professional skills and scientific credentials needed to transition to the next stage of the applicant’s research career

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

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• Eligible Agencies of the Federal Government

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Before submitting a fellowship application, the applicant must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the applicant. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. All institutions with the appropriate resources and commitment are encouraged to apply.

An individual may request support for training abroad. In such cases, the applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

The Kirschstein-NRSA F32 fellowship is designed to support research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. In most cases, therefore, the sponsoring institution should be a site other than where the applicant trained as a graduate student. However, if the applicant is proposing postdoctoral training at his/her doctoral institution, the application must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background and to acquire new knowledge and/or technical skills that will enhance his/her potential to become a productive, independent investigator. Applications that propose postdoctoral experiences in the same lab, in fundamentally the same research environment, or with the same mentor(s) that supported the candidate's predoctoral experience, or other postdoctoral experiences, will not be considered for funding.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor 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).

Applicants are strongly encouraged to apply for the NINDS F32 before they have joined the proposed laboratory, and if it is a first postdoctoral experience, before they have completed their terminal doctoral degree requirements. This will ensure thoughtful and comprehensive planning before the start of the postdoctoral period and will maximize this award's training potential. However,

candidates are also eligible to apply if they are within the first 12 months of joining the proposed laboratory or research environment. Early applications are strongly encouraged, however, as the NINDS F32 cannot be used to support candidates beyond the 3rd year in a laboratory or research environment. Thus, successful applications submitted earlier will result in a longer support duration, up to a maximum of 3 years. Moreover, very early submission may facilitate the ability to resubmit applications within the eligibility window, if necessary (the eligibility window above applies to both new and resubmission applications).

In addition to standard, automatic NIH leave policies, fellows who have children while supported by this FOA, either through childbirth or adoption, are encouraged to consider requesting a six-month extension of their fellowship. NINDS may provide one six-month extension to ensure that fellowship research and training can be completed. Requests must be submitted in writing, following the procedures described in the NIH Grants Policy Statement, Section 11.2.6.

Before a Kirschstein-NRSA postdoctoral fellowship award can be activated, the individual must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. A Kirschstein-NRSA fellowship may not be used to support the clinical years of residency training. However, these awards are appropriate for the research fellowship years of a residency program. Research clinicians must devote full-time to their proposed research training and confine clinical duties to those activities that are part of the research training program; the latter may constitute no more than 25% of full time effort.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the 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 may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Applicant fellows must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

Before submitting the application, the applicant must identify a sponsor(s) who will supervise the proposed mentored training experience. The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the applicant’s research training and to direct supervision of his/her research. The sponsor must have sufficient research funds and resources for high-quality research training of this applicant on the proposed project. The sponsor, or a member of the sponsor team, should have a successful track record of mentorship. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for providing expert advice in all aspects of the training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the applicant’s overall training. The applicant is expected to work with the sponsor(s) in preparing the application. In many cases, the proposed research will be closely related to an ongoing project of the sponsor. Importantly, however, the proposed research project should derive from the collaborative intellectual input of both applicant and sponsor(s), and cannot merely be a research project previously devised by one or more sponsors.

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

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

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (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.

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

The PHS Fellowship Supplemental Form is comprised of the following sections:

• Fellowship Applicant
• Research Training Plan
• Sponsor(s), Collaborator(s), and Consultant(s);
• Institutional Environment & Commitment to Training
• Other Research Training Plan Sections
• Additional Information
• Budget
• Appendix

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

Applicants are strongly encouraged to identify their individual contributions, for example, by using the first person singular narrative, when describing their hypotheses, contributions and work to be done. Ideas, hypotheses and work done by others should be attributed appropriately.

Fellowship Applicant Section

Applicant s Background and Goals for Fellowship Training

The applicant should describe how his/her background has prepared him/her for the proposed project. The applicant should describe the skills gained from previous training, and aspects of prior research project(s), that will contribute to the applicant's ability to conduct the project successfully. Applicants should also describe the skills required for successful completion of the project that the applicant does not yet have but will gain from the proposed training program. Applicants should describe the activities planned that will provide him/her with a strong foundation in quantitative reasoning, research design, methods, statistical methodology and analytic techniques appropriate not only to the proposed research but which will also support the ability of the applicant to conduct outstanding, quantitatively rigorous research in the future. This narrative should include a description of how the planned methodological, intellectual and professional skills to be obtained will help the applicant to transition to the next career stage. The applicant should describe long term research and career goals, and the role of the proposed research and training plan in helping the candidate to achieve his/her goals.

Research Training Plan Section

Research Strategy

Applicants must describe a well-defined research project (typically hypothesis-driven) that is well-suited to his/her stage of career development. The applicant should describe the background leading to the proposed research, the significance of the research, the proposed approach (design and methods) for achieving the Specific Aims and the rationale for the proposed approach. Furthermore, applicants should clearly and specifically address the expected outcomes, potential pitfalls, and alternative approach and/or direction should the expected outcomes not occur.

Because it is desirable for applicants to submit applications before or very soon after beginning their postdoctoral positions, applicants are strongly discouraged from including preliminary data in the application. However, applicants should nonetheless address technical feasibility, as well as the strengths and weaknesses of previously published (or unpublished) work that supports the project significance and approach taken. Given the lack of preliminary data in the application, it is especially important to include a discussion of the planned course of action should the proposed approach(es) be unsuccessful.

Training in Responsible Conduct of Research

Applicants and sponsors are encouraged to devise a formal approach to RCR that goes beyond the minimal NIH requirements. This may be based in a single lab or with multiple labs, and ideally would include regular, planned meetings to discuss topical issues.

Sponsor(s), Collaborator(s), and Consultant(s) Section

Sponsor and Co-Sponsor Statements

The Sponsor and any Co-Sponsors should describe their qualifications to train a postdoctoral fellow who seeks mentored training in a research area relevant to the proposed project. Describe the plan of mentored research training, and include a discussion of any didactics or other formal training necessary to ensure that the applicant acquires robust grounding in quantitative reasoning, principles, and techniques. Describe the guidance mechanism by which any necessary course-correction will be achieved to ensure that the applicant makes substantial progress towards the proposed research and career development goals. Describe a specific plan by which the applicant's transition to the next step of his/her research career will be facilitated.

The Sponsor should also describe his/her contribution to the research plan, the portion of the research ideas and plan that originated with the applicant, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.The sponsor must document the availability of sufficient research funds and resources for high-quality research training of this applicant on the proposed project.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

Describe the institutional opportunities available to the applicant to develop professional skills, e.g., communication, grant-writing, laboratory management and leadership skills. Describe the contribution of the sponsor and sponsor's research environment to development of these skills and describe the opportunities available to the applicant that are independent of the sponsor.

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.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

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 with the following additional instructions:

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

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

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

Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference 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 Reference Letter link and not through Grants.gov.

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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). 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. Add 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. The National Research Service Award (NRSA) policies apply to this program. A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

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) and sponsor(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 our Post Submission Application Materials policy.

Important Update: See NOT-OD-18-227 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the applicant s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

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.

Fellowship Applicant

• Are the applicant’s academic record and research experience of high quality?
• Was the applicant appropriately productive during the predoctoral training period?
• Does the applicant have the potential and commitment to develop into an independent and productive researcher?
• Did the applicant demonstrate strong logic and reasoning capabilities in preparation of the application?
• Does the research project reflect a significant contribution of the candidate to the originality of the project idea, approach and/or hypotheses?

Sponsors, Collaborators, and Consultants

• Is there evidence of a match between the research interests of the applicant and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the applicant’s training needs as well as the ability and commitment to assist in meeting these needs?
• Is there evidence of adequate research funding to support the applicant’s proposed research project and training for the duration of the fellowship? Did the sponsor identify the source of the funds to be available for the applicant's project?
• If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project?
• Does the sponsor's research and training record, as well as mentoring statement, indicate that the applicant will receive outstanding training in the proposed research area, methodology relevant to the project and quantitative reasoning and principles of experimental design and data analysis?
• Does the sponsor's record support the requirement that the applicant will have the opportunity to publish high quality papers as first author and present research data at national meetings as the project progresses?

Research Training Plan

• Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
• Is the research project consistent with the applicant’s stage of research development?
• Is the proposed time frame feasible to accomplish the proposed training?
• Will the training plan provide a strong foundation in quantitative reasoning and analytic techniques appropriate to the proposed research?
• Will the training plan ensure an understanding and application of the principles of strict scientific methods that ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results?
• Will the training plan provide the applicant with an expert understanding of the tools and methods used?
• Does the training plan provide adequate opportunities to present research findings and meet with scientists in the community at national meetings as the work progresses?
• Does the training plan explicitly describe the opportunity for the applicant to publish the research findings as first author?
• Will the training plan provide the professional skills needed for the applicant to transition to the next stage of his/her research career?
• Is the applicant's proposed research sufficiently distinct from the sponsor's ongoing research to suggest that the applicant contributed to the development and design of the project?
• Did the discussion of expected results and potential pitfalls and alternatives provide confidence that, if an important component of the research is unsuccessful, the applicant has a viable path for continuation of the project, or appropriate re-direction to another aspect of the project?

Training Potential

• Are the proposed research project and training plan likely to provide the applicant with the requisite individualized and mentored experiences in order to obtain outstanding skills for a research career?
• Does the training plan take advantage of the applicant s strengths and address gaps in needed skills? Does the training plan document a clear need for, and value of, the proposed training?
• Does the proposed training have the potential to serve as a sound foundation that will clearly enhance the applicant’s ability to develop into a productive researcher?

Institutional Environment & Commitment to Training

• Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations), and training opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?
• Is the institutional environment for the applicant’s scientific development of high quality?
• Is there appropriate institutional commitment to fostering the applicant’s mentored training?
• Does the institutional and/or lab environment provide appropriate and sufficient opportunities for the applicant to gain the professional skills needed for a successful research career?

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.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

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

Revisions

Not Allowed

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.

Training in the Responsible Conduct of Research

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 sponsor(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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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) Genomic Data Sharing Plan.

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 NINDS 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 committee 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 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.

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.

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.

As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; applicants may also wish to review Frequently Asked Questions for more details. The taxability of stipends is described in the NIH Grants Policy Statement.

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

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.

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
• The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Kirschstein-NRSA Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, NIH may grant an extension of the activation period upon receipt of a specific request from the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
• For the individual's initial 12 months of Kirschstein-NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.
• At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the NIH within 30 days of termination. Fellows with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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: nindsreview.nih.gov

Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.