Part 1. Overview Information

Key Dates

It is critical that applicants follow the Training (T) 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 inSection IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applicationsthat do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

Purpose

The purpose of this funding opportunity announcement (FOA) is to invite applications to continue the NINDS Neurosurgeon Research Career Development Program (NRCDP). The NRCDP supports a national effort for mentored, research career development of junior neurosurgeon faculty at institutions nationwide that support neurosurgical research. The goal of this program is to increase the cadre of neurosurgeon investigators trained to conduct research into neurological disorders, making use of their neurosurgical skills and expertise. This research career development program should promote high quality, novel, creative research and innovative investigation by this cohort of individuals who possess unique clinical and research skills. As a result of this program, highly skilled neurosurgeons should be prepared to develop a successful, independent, well-funded research program, which they will combine with their clinical neurosurgery career to advance the understanding and treatment of neurological disorders. This FOA will fund the administration and infrastructure of one NRCDP for up to 5 years. It uses the K12 institutional career development mechanism, but is a single program, overseen by a PD/PI and a national cohort of renowned basic and clinical investigators, that is intended to fund highly promising junior neurosurgeon faculty regardless of their institution within the United States.

The involvement of neurosurgeons in cutting edge scientific research is critical, due to their unique ability to conduct research on human subjects with neurosurgical techniques. In addition, neurosurgeons have a unique perspective on neurological disorders based on their clinical experience that will be highly beneficial to basic research studies. Research into, for example, hydrocephalus, cerebrovascular disease, traumatic brain injury, spinal cord injury, brain tumors, stroke and many other neurological disorders, can benefit greatly from the involvement of neurosurgeons. However, the cohort of neurosurgeons conducting NIH-funded research is small, due to several obstacles. Among the most challenging obstacles is the ability to devote the time necessary for research career development to become a successful research scientist. Neurosurgery residencies are long and involve a heavy clinical load, which can preclude the ability to obtain individual support from NIH career development awards during residency. When neurosurgeons subsequently obtain a first faculty position at an institution different from their residency institution, clinical duties often prevent them from obtaining the protected time required to get a mentored research project to a stage where they can successfully compete for individual research funding. The goals of the NRCDP program are to 1) provide support for a prolonged period of mentored research and career development immediately following residency, 2) provide a venue for networking, collaboration and support of junior neurosurgeon researchers, and 3) facilitate the transition of neurosurgeons from mentored to independent research positions. Neurosurgeons in their last year of residency, in a fellowship year, or in their first year of an independent faculty position, can apply to the NRCDP program for support, which is intended to start during their first faculty year following residency. The program will primarily support neurosurgeons who leave their residency institution for a faculty position at another institution. Under some circumstances (see Program Scholars below), however, a candidate who remained at their residency institution for their faculty position may be supported. The NRCDP will provide the selected neurosurgeons with the experience, research support, and protected time for research and funding necessary to initiate a vigorous, sustainable research program. In addition, the NRCDP will create a support and mentoring network whereby scholars will have the opportunity to interact with both junior and senior neurosurgeon researchers.

Preparation of future leaders

The NRCDP is a research career development program designed to increase the size of the community of neurosurgeon researchers. Development of a successful dual career as a neurosurgeon researcher is a common path to leadership within the neurosurgery community (Flanigan et al., J. Neurosurg. 129:1342 1348, 2018). Thus, included in the mission of the NRCDP is to contribute to the preparation of junior neurosurgeon researchers supported by the NRCDP to becoming future leaders in the neurosurgery community. Therefore, the NRCDP should, as part of its career development mission, incorporate programmatic activities that are designed to prepare scholars for leadership positions. Similarly, the NRCDP should design a process within the NRCDP organizational structure to foster the transition of junior investigators who achieve individual research funding into faculty and/or leadership positions within the NRCDP.

Because of the importance of research in the fostering of future community leaders, and the opportunity for the NRCDP to contribute to the development of future leaders, the NRCDP should have a well-articulated plan for fostering the success of women and members of other underrepresented groups in research. This plan should include active efforts in recruitment, career development and fostering the transition to a successful research career and leadership opportunities as described above.

The NRCDP Program

The NRCDP K12 award provides five years of funding to the applicant organization to support a national research career development program. Although this K12 award is housed at the PD/PI's institution, it is not intended to support scholars specifically at that institution. The PD/PI(s) will recruit applications from eligible candidates at institutions from across the country, and selected scholars will proceed with their career development and research plan at their home institution, with a local mentor. The institution that houses this K12 is just one of these institutions at which research career development activities can occur. The leadership of the NRCDP consists of the PD/PI(s) and a committee of advisors (the National Advisory Committee, or NAC) selected by the PD/PI(s) to help guide the program. The PD/PI(s) may also choose to appoint program co-directors to help accomplish the goals of the program. The PD/PI(s), together with the NAC and if applicable, co-directors, will advise potential applicants and provide feedback on their applications, review candidates, make appointments to qualified individuals, monitor progress of each scholar, and ensure that program policies and requirements are followed. In general, the PD/PI(s), co-directors and NAC will define the process by which candidates apply for support. However, the application process for scholar candidates must include both a written application and an interview that takes place at the Annual NRCDP Meeting (see below).

Annual NRCDP Meeting

The PD/PI(s) will organize an annual meeting for applicants, scholars, the NAC, and appropriate faculty. The purpose of this meeting, in addition to serving as the venue for candidate interviews and selection, is to provide a forum for mentoring, evaluation of scholar progress, career development activities, development of scientific networks among scholars and other researchers and may serve other related purposes, at the PD/PI's discretion. This meeting should also include junior neurosurgeon researchers not affiliated with the NRCDP program, in order to broaden the scope of career development and networking within the neurosurgical research community. Thus, the PD/PI(s) may invite any neurosurgeon to the NRCDP program, regardless of institution or career stage, as long as they are a neurosurgeon researcher or will directly contribute to the goals of the meeting.

Preceptors/Mentors

Although the identity of future mentors will not be known at the time of application, the mentors of successful scholar applicants to the NRCDP should fulfill some general requirements. The primary mentor need not be a neurosurgeon; indeed, potential scholar candidates should be encouraged to obtain a mentor who is most appropriate to their scientific needs, regardless of degree or subspecialty. However, in such cases, all scholars should have a secondary mentor who is an accomplished neurosurgeon researcher. Members of the NAC may serve as secondary mentors to scholars, where an appropriate, local neurosurgeon scientist is not available.

Linkages of scholars to other departments, potentially through choice of mentors, should be encouraged, as they enhance career development and facilitate collaborative efforts. It is particularly encouraged that scholars develop interactions with neurologists and other non-neurosurgeons, as this can foster multidisciplinary research and the development of novel ideas and approaches. Although mentors must demonstrate a commitment to the NRCDC program and scholars, they cannot receive salary, fringe benefits or research support for this role on the K12 grant.

Scholar candidates should also be encouraged to include, as mentors, researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women as mentors, as this can provide a diverse perspective on their research approach and scientific thinking. The NRCDP as a community-wide program has an outstanding opportunity to increase the diversity of thinking in neurological research.

Program Scholars

Scholars funded by the NRCDP K12 must be conducting research that falls within the NINDS mission. All types of research, including basic, clinical and translational, are equally appropriate, but regardless of research type, it should be disease-relevant and potentially applicable to clinical practice. It is expected that this research will integrate with their clinical activities and that their clinical and research activities will inform each other. The program should strive to support individuals whose research might have a significant impact on patients with neurological disorders.

The metric by which the K12 will be judged is the extent to which scholars and, to a lesser extent, applicants, obtain future individual research funding and launch successful, dual careers as clinicians and researchers. Therefore, it is critical that scholar applications are clear regarding how their research and career development plans will help them launch a successful, individual research program. Similarly, the candidate selection process should be clearly described as including a written application and interviews by the PD/PI and members of the NAC.

As part of the recruitment effort, the NRCDP program should make every effort to broadly advertise the program. The program must actively seek out qualified women and individuals from diverse backgrounds.

For each scholar, a five-year career development program consists of two phases.

Phase I

In Phase I, the scholar receives up to two years of financial support directly from the K12 award (a third year is possible in highly unusual circumstances, at the discretion of the PD/PI and the NAC). During this phase, the scholar will embark on a focused career development program that will include research, skills development and any necessary education, under the auspices of a mentor who has an outstanding record of research productivity and training. In conjunction with the mentor, the scholar will develop a research and career development plan suitable to launch an independent research career to investigate a clinically significant research topic. This plan, and scholar progress, will be reviewed annually by the NRCDP PD/PI(s) and NAC. Provided they make appropriate progress during the first year, as judged by the PD/PI(s) and NAC, scholars are renewed for a second year of NRCDP support.

During each year of Phase I, in addition to conducting research and pursuing their research career development at their home institution, scholars will submit an annual progress report to the NRCDP PD/PI(s), will attend the NRCDP annual meeting, and will present their research in a public forum at the meeting. Scholars may engage in brief research activities at another institution if they are directly related to the purpose of the award. For research activities lasting longer than one month, scholars must obtain prior written approval from the K12 PD/PI. In addition, periods of leave from the program for greater than three months, for either professional or personal reasons, require prior written approval from the K12 PD/PI and the NINDS program official.

Phase II

In Phase II, the scholar begins to transition to independence. The scholar is highly encouraged to continue participating in the NRCDP program but must obtain research funds from sources other than the K12. As such, scholar selection should consider the likelihood that the candidate will be competitive for individual funding by the third year of the program. It is intended that the scholar will secure funds from an individual, mentored career development award, such as an NIH K08, K23 or equivalent. However, some scholars may be ready to obtain a large independent research grant, such as an NIH R01 or equivalent, or an independent career development award such as an NINDS K02. Scholars should generally apply for individual awards during Phase I, so that funding may be in place for the third year of the program. It is important that the scholar's research and career development plan be tailored to ensure that the candidate will be in a position to submit a competitive individual award by the end of the second year of the program. To this end, it is important that the scholar receive strong guidance and support from the mentor, the NRCDP PD/PI(s), the NAC and the Chair of the scholar's department, to provide the best possible opportunity for success.

Phase II scholars are highly encouraged to remain associated with the NRCDP program for an additional 3 years. Scholars are encouraged to provide progress updates to the NRCDP PD/PI(s) and present their research findings at NRCDP meetings during each year of the Phase II period. This attendance at NRCDP meetings during Phase II will help them with their own careers, will serve to facilitate their role as mentors to those who come behind them, and will serve to strengthen the network of neurosurgeon researchers, made up of K12 awardees, NINDS R25 participants, other neurosurgeons in the career development phase of their careers, and more established faculty.

The NRCDP program will support only candidates who make a minimum commitment of 6 person-months (50% full-time professional effort) per year to research for at least the 5-year period that covers Phases I and II. In the event that the candidate is making good progress during Phase I, makes appropriate efforts to obtain individual funding for the start of Phase II, but fails to do so by the start of the third year of the program, an ability to continue to devote 50% effort to research is critical to the scholar’s continued progress towards success. Thus, it is expected that the Chair of the scholar’s home department will commit to providing 50% protected time to the scholar during the entire Phase II period, when appropriate. Because protected time for research is critical for a candidate’s success, the NRCDP should ensure the home department’s clear 5-year commitment to the candidate’s research effort via an institutional commitment statement in the candidate’s application to the program and, if the candidate is selected for support, in an additional letter prior to funding. The NRCDP is generally not intended to provide financial support during the third year of the scholar's program. However, limited financial help during the third year may be provided in exceptional cases, at the discretion of the PD/PI(s), in consultation with the NAC.

For the first three new applicants supported each year, support from this program should be used only for individuals who move to a faculty position at an institution different from their residency institution. If more than three new scholars are chosen for support in a given year, these additional candidates may be selected from neurosurgeons who remain in a faculty position at their residency institution.

Educational Goals

Scientific achievement depends critically on conducting rigorous research studies with data being appropriately analyzed and interpreted. Moreover, success in research requires not only high-quality scientific conduct but an ability to clearly communicate, in both written and oral modes, for several purposes and to a variety of audiences. In addition, maintaining a successful research career requires knowledge of a variety of laboratory and research management skills, both with regard to immediate staffing and budgeting and building and maintaining collaborations. Finally, it has become increasingly apparent that unconscious bias, cognitive bias and ethical considerations influence study design, data interpretation and scientific reporting. Consequently, the NRCDP should ensure that scholars and others affiliated with the program receive education and/or training in these areas required for a successful and impactful research career.

Institutional Environment and Commitment to the Program

An important goal of the NRCDP is to ensure that scholars funded by the NRCDP obtain and retain critical institutional support. The Chair of the scholar's home department plays a key role in the success of the scholar. The NRCDP program is designed to directly support relatively few scholars, with the goal that all of those supported will go on to successful, dual careers as clinical neurosurgeons and productive, well-funded researchers. In order to launch such a career, scholars need a period of outstanding training and mentoring as well as resources and adequate protected time to successfully conduct high quality research and obtain independent funding. Consequently, for a successful application to the NRCDP program, Chairs must commit to allowing the scholar to devote 50% effort to research for 5 years, as described above under Phase II description. In addition, the NRCDP should ensure that chairs make every effort to provide appropriate resources and support, in whatever form needed, to facilitate success of the scholar.

The NRCDP program is expected to make at least one site visit to each scholar's home department to discuss with the scholar, mentor(s), Chair and others involved in the scholar's activities, the scholar's progress, needs and any other relevant issues. This would typically occur approximately 6 months after the start of scholar support but should be arranged as appropriate. All individuals associated with the scholar’s research career development at the scholar’s institution are expected to participate in the site visit.

Special Note: The PD/PI is strongly encouraged to work closely with the designated NINDS staff to maximize the success of the program in achieving the goals of this FOA. Potential applicants should contact the NINDS Director of Training and Workforce Development with any questions about this program, program planning or application for this award.

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

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

Section II. Award Information

Other Award Budget Information

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget. Funds may be used to support scholar salary and fringe benefits. In keeping with NINDS funding levels for K awardees, up to $100,000 salary per year, plus associated fringe benefits, may be provided to each scholar. In addition, up to $50,000 per year per scholar may be provided to support research expenses, such as supplies, equipment and travel. Funding may not be used for mentor salaries or other expenses incurred by mentors or scholar institutions.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Federal Governments

• U.S. Territory or Possession

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Eligible institutions must be affiliated with a medical school with a neurosurgery department that supports both clinical and funded research activities.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

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.

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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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 individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI(s) of the NRCDP should possess the scientific expertise, demonstrated leadership capabilities, stature in the neurosurgery community and administrative capabilities required to implement, coordinate and supervise a national, multidisciplinary research career development program for neurosurgeons. The PD/PI(s), together with the NAC and, if applicable, co-directors, will be responsible for the selection and appointment of scholars to the NRCDP, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day to day administration of the program and are responsible for appointing members of the NAC and using their recommendations to determine the appropriate allotment of funds. Any appointed co-directors should also have the qualifications necessary to guide an institutional training program designed for neurosurgeons.

If proposing an MPI leadership plan, each MPI should have a defined role in the program, in addition to sharing overall oversight responsibilities

2. Cost Sharing

3. Additional Information on Eligibility

Applicant organizations may submit only one application in response to this FOA.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

National Advisory Committee

A National Advisory Committee, the NAC, is a required component of the NRCDP program. The proposed NAC members must be selected in advance and listed in the application, as the appropriateness of the committee, both with respect to each individual selected and the overall composition of the committee, will be evaluated by the peer review process.

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Primary mentors must be tenure-track faculty (or equivalent) who have an established record of research productivity, competitive grant support and successful fostering of research expertise and accomplishment of clinician scientists. A primary mentor should have a strong research program in an area relevant to the NINDS mission. Mentors should have research expertise and experience relevant to the scholar’s proposed research and must be committed to continuing their involvement throughout the total period of the mentee’s participation in this award.

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars must devote a minimum of 6 person-months (50% of full-time professional effort) to their K12 research and research career development during the appointment on the K12 award.

Scholars to be supported by the NRCDP must be clinically practicing neurosurgeons. Eligible candidates for initial application to the program include those in the last year of residency training, fellowship training, and those who are within one year of starting their faculty position. It is intended that scholar support from this program will begin during the first year of a faculty appointment.

An individual who has served as a PD/PI on an NIH research grant (R01, R03, R21, P01, etc.), an individual career development award (K01, K02, K08, K23, K99, etc.), other non-training NIH grant (e.g. U-type or P-type grant, etc.),contract (N01) or Project Leads of program project (P01) grants may not be considered for support by the NRCDP.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) 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.

Page Limitations

All page limitations described in the SF424 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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the program designed to foster successful neurosurgeon-researchers. Indicate the planned duration of appointments, the projected number of scholars, including their levels (i.e. first year faculty) and intended scholar outcomes.

National Advisory Committee (NAC). The NAC, chaired by the PD/PI(s), is a select group of scientists who have established records of research and fostering of research expertise and accomplishment of clinician scientists. The committee should include approximately 12 established research investigators as members. This committee must be diverse in nature, with respect to scientific interests, geographic location and prior training affiliations. The NAC should also have appropriate representation of women and underrepresented minorities. Whereas it is appropriate that most members of the NAC be neurosurgeon researchers, at least one member of the NAC should be a PhD scientist with experience in fostering research expertise and accomplishment in clinician scientists, preferably neurosurgeons. In addition, the inclusion of leading physician scientists from other disciplines (e.g. neurology) with a strong, successful record of fostering research expertise and accomplishment and mentorship is desirable. The PD/PI(s) may also wish to add additional individuals who are more junior neurosurgeon scientists who are clearly outstanding for their career stage (i.e. individuals who have published high quality research and recently received their first R01). It is also recommended that prior NRCDP scholars who have developed successful, funded research programs, and especially women and URMs who have recently developed successful research programs, are included. Note that not all members of the NAC must have identical roles in the program. Whereas a minimum of 12 established investigator NAC members should contribute the review of NRCDP applicants, some NAC members may contribute as faculty and/or mentors but not be involved in applicant evaluation. The NAC evaluates all applicants to the program (this will include the evaluation of written applications and conducting interviews at the NRCDP meeting), monitors progress of current scholars and provides feedback to individuals as appropriate. NAC members may be asked to perform site visits at scholar institutions, and all except the "junior neurosurgeon scientists" should have the appropriate stature within the community to discuss program principles and policies with scholars, mentors and chairs. NAC members are expected to attend and participate in all annual meetings of the NRCDP program. The duration of service of individual NAC members to the NRCDP program will be negotiated between individual members and the PD/PI and should generally be a minimum of 3 years. NAC members may be primary mentors or secondary mentors but must avoid any conflict-of-interest in the scholar selection process.

The composition, including name, expertise, current affiliation and prior training affiliations (e.g. residency institution where they trained), as well as their roles and responsibilities, and other relevant information, should be included. Describe how the NAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment, selection and retention of candidates, and the evaluation of the overall effectiveness of the program. If any members of the NAC are to have special roles (e.g. serve as part of an executive committee or as co-directors or be responsible for specific functions of the program), this should be explained. A biosketch for each NAC member should be included in the application. Letters should be provided (in the Letters of Support section; see below) from each proposed NAC member confirming their understanding of the goals of the NRCDP and their willingness to serve on the NAC for a minimum of 3 years. Renewal applications should also include the names and affiliations of all committee members during the past project period. This information should all be uploaded as a separate pdf file attachment.

Please name your file Advisory_Committee.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

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

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide.

Research and Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

Follow all instructions provided in the SF424 (R&R) Application Guide.

The following modifications apply:

Data Tables are not required for this K12.

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Training Program

Program Plan

Program Administration:

Describe the strengths, leadership and administrative skills, scientific expertise and training experience of the NRCDP PD/PI(s). Particular attention should be paid to the qualifications of the PD/PI(s) to lead and oversee this national training program. Include discussion of PD/PI leadership activities at a national level. Describe the strategy and administrative structure planned that is designed to oversee and monitor the program and the scholar progress and research career development.

If the NRCDP program will have co-directors, these individuals should be identified, and their roles, and qualifications to carry out these roles, discussed. All proposed participating individuals, including co-directors and NAC members, should provide a letter documenting their willingness to serve in their proposed capacity. The letters should be included in the Letters of Support section.

Program Faculty:

Describe the expertise and experience expected of scholars mentors. Describe the plan for monitoring local mentorship and ensuring successful mentorship of scholars. If applicable, describe the plan for mentorship beyond the scholar’s local mentors, for example, by members of the NAC. Because the identity of local mentors cannot be known in advance, there is no need to name potential local mentors. For renewal applications, describe the nature of the oversight provided regarding previous scholar mentors.

Proposed Training:

Research Career Development. Describe the immediate and long-term objectives of the program, and describe training and/or career development activities that will be used by the national K12 to ensure that the objectives of the program are met. Include information about planned activities that will be incorporated into the overall NRCDP program, and what activities will be expected of the local institution. Describe how the NRCDP will prepare scholars to become future leaders within the community, and describe any specific career development activities designed to increase the number of women and members of other underrepresented groups in research and community leadership.

Specific Educational Goals

Scientific Methodology. Describe how, as a national program, the NRCDP will ensure that all scholars receive thorough training in experimental rigor with respect to experimental design, statistical methodology and data analysis and interpretation. Describe education in scientific methodology scholars are expected to receive at the home institution and how the NRCDP will monitor the quality and achievement of this education. Describe any planned activities that the NRCDP will provide directly to scholars in Scientific Methodology.

Unconscious Bias, Cognitive Bias and Ethics. Describe how the NRCDP will ensure that scholars and applicants have an understanding of the role of unconscious bias, cognitive bias and ethical issues in research studies and scientific reporting, with regard to both basic research and clinical research studies.

Communication. Describe formal activities intended to provide experience and facilitate excellence in both written and oral communication, for different scientific purposes and to different audiences.

Laboratory Management. Describe any other instruction the scholars are expected to receive, such as in laboratory, project, mentoring and time-management skills, and how this will be achieved under the auspices of the NRCDP (i.e., will the NRCDP program provide this education directly, and if not, how will the NRCDP ensure that scholars receive education in these areas at the local level or in another venue).

Renewal applications should describe past research career development activities related to these educational goals and describe planned changes to enhance the educational opportunities for scholars and applicants.

Annual Meeting. Applications should describe plans for the annual meeting. This description should include who would be invited, planned activities for current and past scholars, applicants and others who may be invited, approaches to using the meeting to build and/or strengthen a neurosurgery research community and any planned activities related to responsible conduct of research, becoming a successful researcher, rigorous scientific methodology, oral and written communication skills (including grant writing) and any activities designed to help scholars become future community leaders.

Site visits. Describe structural plans for site visits by the NRCDP program to each scholar's home department to discuss the scholar’s progress, needs and any other relevant issues with the scholar, mentor(s), Chair and others involved in the scholar's activities (i.e., who will do the site visit, how will it be organized, when will it occur, etc.). For renewal applications, list all site visits done for previous scholars. In general terms, describe what was learned from these visits, what problems were encountered, if any, and what, if anything, could make them more useful and/or successful.

Leadership. Describe the plan for using the NRCDP program to contribute to the development of future leaders within the neurosurgery community, with particular attention to fostering the success of women and members of other underrepresented groups in research.

Scholar Candidates:

A renewal K12 application must describe the activities in the previous funding period designed to recruit scholar applications to the NRCDP and to disseminate publicity intended to attract applications from outstanding candidates in diverse research areas from institutions around the country. The application should describe the perceived success of these efforts, any perceived limitations of these efforts, and any changes or enhancements that are planned based on prior experience.

New K12 applications must describe the approach to recruitment of outstanding scholar applicants to the program from nationally available candidates, including specific plans for achieving successful, comprehensive dissemination of the K12 opportunity. New applications should also provide a description of how it will address the issues in the above paragraph.

Define the process by which candidates will apply to the program. Describe how the program will select and appoint scholars who would most benefit from this program, and who hold strong promise of a successful, combined research and clinical career. Note that this process must include both a written and interview application component. The application should include a description of how the NRCDP will inform scholars, mentors and Chairs of their responsibilities, a plan for monitoring scholar progress, and a mechanism to ensure both progress and compliance with program policies.

Institutional Environment and Commitment to the NRCDP Program

The PD/PI’s sponsoring institution must assure support for the proposed NRCDP program including assurance that sufficient time will be allowed for the PD/PI(s) to contribute to the proposed program, and that full protected time for scholars selected for the program (a minimum of 6 person months, equivalent to 50%) will be maintained.

The application should describe plans for ensuring and monitoring appropriate commitments of the scholar's institution to the scholar, including appropriate research support, protected time for research, and opportunities for advancement given a combined research and clinical career.

Progress Report by Renewal Applications

Renewal applications should describe all relevant outcomes related to NRCDP activities over the past 10 years. This should include a detailed description of all previous scholars supported, including their institution, clinical specialty, research specialty, publications and other known funding obtained since the start of their NRCDP support, as well as any other relevant achievements. Renewal applications should also describe how the NRDCP program has evolved in response to changes in relevant scientific and technical knowledge, educational practices or experiences gained from previous program iterations. Renewal applications should describe efforts to evaluate the program, and any changes made to the program based on these evaluations. Discuss any perceived imbalances in subspecialties represented among applicants and scholars, and if needed, efforts to address these imbalances. Also, describe the yearly selection process, including the number of applicants, applicant demographics, comparisons of applicant and scholar demographics, any perceived deficits in the applicant pool and, if deficits were perceived, the plans to remedy them. Describe in general terms the makeup of the NAC, and what, if anything, will be changed to provide more optimal oversight of the program.

Renewal applications should describe the annual meetings held to date, with a detailed description of activities and goals. The application should describe how the meeting has evolved, what activities have been shown to be effective or ineffective, the perceived value of different aspects of the annual meeting and any changes or enhancements that are planned based on prior experiences.

?????Plan for Instruction in the Responsible Conduct of Research

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

Program Faculty.

If any mentors will supervise a Scholar proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

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 theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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.

Post Submission Materials

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.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as neurosurgeon-researchers?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Do the selection process, design of the proposed career development program, and processes for communicating with the scholars local mentors and Chairs, ensure effective career development of neurosurgeons regardless of their home institution?
• Is the proposed program likely to ensure that scholars will be prepared for successful and productive scientific careers?
• Is there a plan to ensure that all scholars obtain a thorough understanding of experimental rigor with respect to experimental design, statistical methodology and data analysis and interpretation?
• Is there a plan to ensure that scholars and others associated with the program receive education in oral and written communication skills and the roles of unconscious bias, cognitive bias and ethical issues in research conduct and reporting?
• Is there a plan to effectively coordinate career development activities between the NRCDP program and the scholars home institutions?
• Is there sufficient assurance that the required effort of the PD/PI(s), mentors and scholars will be devoted to their respective activities within the program?
• Does the program describe a detailed plan for an annual meeting that will serve to foster career development and success among neurosurgeon scholars and other junior neurosurgeon investigators?
• Is there a well-considered plan for inclusion of an appropriate number and type of attendees at this annual meeting, to include not only the K12 scholars but NINDS R25 neurosurgeon participants, neurosurgeons with individual K awards, other neurosurgeon scientists who are at a similar career stage and more established neurosurgeon researchers?
• Does the program describe a rigorous scholar selection plan, which includes a written and interview component, designed to select the very best applicants from a national pool of candidates?
• Does the scholar selection process provide a rigorous means for evaluation of the proposed research project, mentorship plan, career development plan and institutional environment and institutional commitment?
• Is there a thoughtful, affirmative plan for maximizing the potential number of applications from women and diverse individuals?
• Is there a plan for fostering leadership skills and opportunities for all scholars and are there any specific plans for helping women and individuals from underrepresented groups progress towards leadership within the community?
• Does the program have a sound and equitable process for evaluating candidates, monitoring scholar progress and enforcing program policies?

Advisory Committee (NAC)

• Is the constitution of the NAC appropriate, with regard to scientific expertise, training record, stature in the community, gender distribution and inclusion of underrepresented individuals?
• Are the members of the NAC appropriately diverse with respect to geographic distribution and prior training affiliations?
• Are the NAC members well qualified to serve as primary and secondary mentors?
• Do most members of the NAC have the necessary stature within the community to enforce the policies of the NRCDP?
• Is there a strong plan to include junior neurosurgeon-scientists, with appropriate attention to gender and diversity, who have launched successful research programs, who could provide insight and helpful advice to scholars as well as develop into future leaders in the neurosurgery-research community?
• Is there evidence that each member of the NAC has agreed to devote the time necessary to ensure success of the program as designed?
• Is there adequate documentation describing the responsibilities of the NAC with regard to the provision of input, guidance and oversight of the program?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Do the PD/PI(s) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
• For applications designating multiple PDs/PIs:
  • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

• Are there plans for ongoing evaluation of mentors chosen by the scholars? Will this evaluation process ensure high quality mentorship and successful research career development of the scholars?
• Is there evidence that the NRCDP PD/PI and NAC will be able to ensure appropriate and successful mentorship of the scholars?

Scholars

• What is the quality of plans to identify, recruit, and select candidates who have a commitment to research relevant to the mission of NINDS and the potential to develop as independent researchers?
• Is there evidence that the NRCDP program is designed to contribute significantly to the scientific and professional development of the scholars?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in this announcement?
• Does the scholar recruitment plan include a thoughtful process of disseminating information about the NRCDP opportunity to a national pool of candidates to enable selection of the best applicants from across the country?
• Does the recruitment and selection plan adequately address the need for fairness and diversity in selection of scholars, with respect to departmental affiliations, research areas and clinical subspecialties?
• Is there an appropriate, adequate and affirmative plan to successfully recruit scholars that will enhance gender and racial/ethnic diversity?

Scholar Outcomes

• Is there evidence of a successful past training record of the PD/PI(s) and senior NAC members, which includes success of former scholars in seeking independent research support and establishing productive scientific careers?
• For renewal applications, has the NRCDP program succeeded in fostering success among scholars in research careers?
• For renewal applications, is there evidence that the NRCDP program conducted site visits for each selected scholar and successfully monitored the mentorship and institutional commitment to the scholars over the course of the two supported years?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the program?

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s) and are the outcomes described indicative of a highly successful program? The application should also describe specific efforts that were made to recruit women and underrepresented individuals to the K12 program. Is there evidence of former scholars seeking and obtaining independent support and establishing productive scientific research careers? Has the program implemented a high-quality annual meeting, with clear objectives and activities to meet these objectives? Has the annual meeting, as implemented, successfully served a wider purpose than simply the selection of scholars for support? During the last funding period, did the program adequately monitor the quality of local mentorship and progress towards goals for each scholar? Are changes proposed that would improve or strengthen the career development experience? In the previous cycle, did the program implement an objective scholar selection process that ensured that the most meritorious candidates were identified and selected? Has the program been evaluated by external or internal reviewers, and if so, does the application describe how the program has evolved based on that evaluation?

Revisions

Revisions

Not Applicable.

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

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 specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

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 {LOCUS OF REVIEW} 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 will receive a written critique.

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.

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council.

• 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.

Section VI. Award Administration Information

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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, Recipients, and Activities, including of note, but not limited to:

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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.

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more. Scholars with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

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. Evaluation results should be included as part of the final RPPR.

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

Section VII. Agency Contacts

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, application errors and warnings, documenting system problems that threaten on-time submission, and 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)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

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

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

Section VIII. Other Information

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 and 2 CFR Part 200.