Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The overall goal of the NIH Research Career Development programs is to help ensure that a 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.

This Notice of Funding Opportunity (NOFO) encourages applications from organizations that propose innovative institutional research career development programs in the mission area(s) of NINDS. 

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

The purpose of this NOFO, issued by the NINDS, is to invite applications for the Child Neurology Career Development Program (CNCDP). The CNCDP supports a national effort for mentored career development and training of physicians specialized in Child Neurology at institutions nationwide that support research relevant to the mission of the NINDS. The goal of this program is to increase the small population of physicians specialized in Child Neurology trained to conduct outstanding research into neurological disorders of children, taking advantage of their clinical training 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 knowledge and experience. As a result of training and career development activities in this program, highly skilled individuals should be prepared to develop a successful, individual, well-funded research program, which they will combine with their clinical career to advance the understanding and treatment of neurological disorders of children and neonates. This NOFO will fund a 5-year award that will support the administration and infrastructure of one CNCDP. It uses the K12 Career Development mechanism, to be overseen by a single or multiple PD/PI(s) or multiple co-directors (at least one of whom is the PD/PI), together with an advisory committee composed of basic and clinical investigators who have a strong record of funded research and successful training of clinician scientists.

Under this award, newly trained physicians are to be selected and appointed to this program by the PD/PI(s) and co-directors (if applicable), in consultation with the CNCDP advisory committee (together, the PD/PI(s), co-directors and advisory committee will be referred to as the "CNCDP leadership"). The program is intended to provide up to 3 consecutive years of support for each scholar appointed, although the duration of support may be shorter or longer for a specific individual at the discretion of the CNCDP leadership. It is expected that scholars selected will be committed to dual careers as clinicians and researchers, and that they will subsequently apply for their own individual, Mentored NIH Career Development Award (K08, K23 or K99/R00), an NINDS Research Scientist Development Award (K02) or a Research Project Grant (R01 or equivalent), to continue their career development and/or research program.

The program should accommodate research scholars with varying levels of research experience. For example, candidates with significant prior research experience may need little didactic training and two or fewer years of K12 support in order to develop a research program that is competitive for individual funding. In contrast, a prospective research candidate with less experience in a given field of research may require a more structured program, which includes some didactic training as well as supervised research experience, and may require 3 years of K12 support in order to be competitive for individual funding. Regardless of previous experience, however, each individual's plan should be designed to develop a significant research project, which, before the end of year 3 of CNCDP support, will be competitive for an individual career development or major research award and subsequent transition to an independent research program.

The CNCDP is intended to remedy the small number of physicians specialized in Child Neurology who are conducting outstanding, innovative research into the understanding and treatment of neurological disorders of children and neonates. Consequently, an additional critical purpose of the CNCDP will be to create a support and mentoring network whereby scholars will have the opportunity to interact with both junior and senior researchers who conduct basic and clinical research that addresses childhood disorders. To facilitate this purpose, the CNCDP will support an annual retreat for CNCDP applicants and scholars. As a major purpose of this retreat is to build a strong community of Child Neurology researchers, the retreat may be made available to others at a similar career stage who are devoted to the understanding and treatment of childhood neurological diseases and disorders.

The CNCDP

The CNCDP K12 award provides 5 years of funding to the applicant organization to support a national research career development program. Although this K12 award will be administered from the PD/PI's institution, it is not intended to support scholars solely 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 or mentoring team. The institution that is awarded this K12 is just one of the institutions at which research career development activities can occur. The scholar's home institution will be expected to have the infrastructure to support an outstanding career development program for the scholar, which would include resources, faculty and research expertise appropriate for the scholar. Moreover, the scholar-applicant's Chair and Institution must commit to providing the candidate with 75% of their full-time professional effort (e.g., 9 person-months) towards the research and career development outlined in their application for CNCDP support.

The CNCDP leadership will define the application process, review candidates, make appointments to qualified individuals, conduct site visits at scholar institutions, monitor progress of each scholar, organize and implement an in-person annual retreat for all scholars, and ensure that program policies and requirements are followed. There is no limit to the number of scholars that may be supported at a particular institution, but it is expected that CNCDP leadership will be cognizant of the need for a broad range of institutions at which scholars are supported.

The program is intended to fund approximately 30 new scholars over a 5-year period. Scholars may be appointed in any of the 5 years of the award for a maximum of 3 years each. At the discretion of the CNCDP leadership, a scholar who has made great progress and applied for a major NIH grant award (e.g. K08, K23, K02, R01) by the end of the third year may receive additional support beyond the 3rd year (details below). Except in extremely rare and unusual circumstances (e.g. related to a leave of absence for health or family needs), scholars should only be appointed in consecutive years, to ensure continuity of research progress.

In conjunction with their mentor(s), the scholar will develop a research and career development plan suitable to launch an independent research career for the study of a clinically significant research topic. This plan, and scholar progress, will be reviewed annually by the CNCDP leadership, with continued funding dependent on appropriate scholar progress and adherence to program requirements. For example, scholars must be guaranteed a minimum of 75% protected time for research by their Chair and home institution. Failure to maintain 75% of full-time professional effort on their research project while appointed to the K12 program is expected to result in lack of reappointment to a subsequent year of K12 support.

The scholar's home environment must have a well-established record in research and clinical career development, and qualified faculty to serve as mentors. The scholar will acquire knowledge and research skills in scientific areas relevant to their career development goals. This may include relevant didactic and laboratory experiences, as well as participation in relevant activities outside of the scholar's home institution, which will promote development of an outstanding research program for the scholar. A specific research and career development plan must be developed in advance of obtaining support. The plan must explicitly describe the anticipated accomplishments that will lead to the transition to individual funding on an appropriate schedule.

The scholars supported by this program may conduct basic, clinical and/or translational research. All research supported by this program must fall within the NINDS mission. (Research projects should be suitable for submission to NINDS for subsequent individual awards. For questions about project suitability, the CNCDP leadership may consult with the Director, NINDS Office of Training and Workforce Development. It is further expected that each scholar's research can be successfully integrated with their clinical responsibilities to enable a successful career as a clinician-scientist.

As a single national program designed to foster the development of dual clinical and research careers of physicians specialized in Child Neurology, the CNCDP will include the following critical components:

• An advisory committee to the CNCDP PD/PI(s) that consists of both experts in Child Neurology and experts in the training of clinician-scientists who are not affiliated with Child Neurology. At least 1/4 of the advisory committee members should be outside of the field of Child Neurology. The advisory committee should have expertise in both basic and clinical research, should include clinician and non-clinician scientists, should include scientific leaders in the field of Child Neurology, should contain a range of backgrounds, geographic location of their home institutions, residency/fellowship training institutions, and areas of expertise. Members of the advisory committee should have a history of research funding and the stature necessary to conduct site visits to scholar's institutions and effectively carry out the CNCDP oversight function.
• A plan for negotiation and coordination with participating institutions, departments and chairs to ensure that scholars obtain appropriate research support, appropriate protected time for research (a minimum of 75% of full-time professional effort) and opportunities for appropriate career advancement given a combined research and clinical career.
• A plan for recruitment of applicants and dissemination of publicity intended to attract applications from the best candidates across all research areas from institutions around the country.
• A plan for selection of applicants who would most benefit from this program and who hold strong promise of a successful, combined research and clinical career. It is expected that the program will utilize a rigorous, fair and effective procedure for application to the program and selection of individuals to be funded. The application process should include both a written document and in-person interviews with multiple advisory committee members at the annual retreat supported by the CNCDP.
• A plan for monitoring progress of the scholars and a mechanism to ensure both progress and compliance with program policies. The program should have a transparent and appropriate plan for granting or denying reappointment for a second and third year of support, based on appropriate yearly progress and compliance with program policies.
• A plan for an annual retreat with scholars, others affiliated with the program and appropriate faculty mentors for research presentations, professional development, skills development, mentoring, career counseling and networking.
• Guidelines for didactic activities and research career development. All scholars should obtain, early in their CNCDP career development, a comprehensive appreciation of the principles of experimental design, statistics and scientific rigor (see, for example: https://www.ninds.nih.gov/funding/preparing-your-application/preparing-research-plan/rigorous-study-design-and-transparent-reporting.html and http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-023.html). It is critical that the CNCDP include activities designed to provide foundational education on these principles and not rely exclusively on scholars' prior experience or planned coursework to cover these topics. In addition, the CNCDP must ensure that all scholars complete responsible conduct of research training, in accordance with the NIH policies expressed in (NOT-OD-10-019), at their home institution.
• A plan to have the CNCDP program regularly evaluated internally and rigorously evaluated by an expert external panel at least once. Moreover, the program is expected to have a defined process by which the comments and recommendations that result from these evaluations will be considered for the purpose of iteratively improving the program.

The components and activities to be included in proposed CNCDP are described in more detail in Section IV below.

Continuation of the CNCDP will depend on the progress made by scholars, productivity of scholars, and whether supported scholars applied for and/or obtained their own individual NIH Career Development awards or subsequent R01 or equivalent grants. Whereas NINDS recognizes that important contributions to the NINDS mission can be made by scholars as contributors to research programs of other investigators, the explicit purpose of the NINDS CNCDP is to prepare supported scholars for a competitively funded research career by the end of, or shortly following, the 3rd year of support.

Role of the PD/PI(s). 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 Advisory Committee. In addition, the PD/PI(s) are responsible for determining, to the extent possible, that scholars to be appointed to the CNCDP K12 intend to develop research programs supported by individual career development (e.g. NIH K08, K23 or NINDS K02 awards) or research grants that they pursue as PD/PI. The PD/PI(s) will organize and implement the CNCDP annual retreat and ensure that at least one site visit per scholar will be conducted by a PD/PI or advisory committee member, preferably within the first 6-12 months of scholar appointment.

It is expected that the PD/PI(s) will provide detailed information about the specific goals and expectations of the CNCDP to each primary mentor, and when appropriate, Department Chairs, and ensure that the mentors and Chairs are in agreement with the goals, expectations and requirements of the CNCDP. The PD/PI(s) will provide necessary oversight to ensure that scholars, mentors and Chairs work to achieve the goals of the CNCDP. It is also expected that the PD/PI(s) will have a strong, formal mechanism in place to ensure that the scholar maintains the required yearly protected time for research career development.

The PD/PI(s) may wish to assign significant programmatic roles to faculty members (e.g., name co-directors) who do not serve as PD/PI(s). These individuals should agree to perform the described duties and should have documented, sufficient time to commit to the program.

Scholar selection to the CNCDP. Physicians specialized in Child Neurology  from any educational institution or professional organization in the U.S. that combines both clinical and research activities are eligible to apply for support as scholars. The CNCDP leadership will define the professional levels required for eligibility (e.g., fellow, years in faculty position, type of faculty position, etc.), but generally, individuals will have finished residency/fellowship training no more than 3 years prior to applying to the program. In order to be selected for support by the CNCDP, scholars must have a well-thought out research plan that, (1) is relevant to the NINDS mission, (2) has intrinsic research significance, (3) is founded on strong scientific premise (see relevant sections of http://grants.nih.gov/reproducibility/faqs.htm for a discussion of rigor and scientific premise), (4) will serve as a suitable vehicle for learning the methodology, theories, and concepts required of a well-trained, independent clinician-researcher and (5) will provide data and/or publications that will be useful in the submission of subsequent individual research applications. Moreover, strong consideration should be given to selection of scholars for whom the CNCDP is likely to provide the critical mentored research experience that will enable them to successfully compete for subsequent independent funding.

Didactic courses should be limited to those needed to meet the goals of the CNCDP award, which is to develop a research program and provide the skills and knowledge necessary to pursue the proposed research plan and achieve individual funding. When possible, NINDS recommends that extensive coursework, such as that required for additional advanced degrees, be delayed until the scholar obtains an individual career development award, such as an NIH K08 or K23. This will allow the scholar to devote as much time as possible to development of a robust research project that will facilitate transition to an individual award. It is not appropriate for the CNCDP to support individuals who are spending significant time towards attainment of advanced degrees. Advanced degrees may be pursued when supported by individual mentored career development awards.

The CNCDP should have an anticipated timeline by which scholars will apply for the program, be selected, and receive funding. The program should utilize a selection approach, and subsequent oversight process, to ensure that, prior to appointment to the CNCDP, and continuing through the period of support, scholars have a well-articulated research project and career development plan that would reasonably be expected to lead to transition to an individual funding mechanism by the end, or shortly after the end, of the CNCDP support period. Ideally, the CNCDP would include a method to monitor scholar progress on a semi-annual basis as an aid to the scholar's continuing progress and to ensure that obstacles to success are overcome quickly.

Scholar commitment to the CNCDP. Scholars must devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award pursuing research, career development and research-related activities consonant with the intent of the CNCDP award. The remaining time should be devoted to clinical and teaching pursuits that contribute to their development as successful clinician-researchers. Although the CNCDP is intended to support up to 3 years of research career development activities for each scholar, the program should encourage scholars to transition to individual awards as soon as they are ready. For scholars with significant prior training, it is desirable for scholar research career development plans to aim for individual funding after approximately two years of support. If scholars have made excellent progress in their research and have submitted an application for major individual funding (such as an NIH K award or R01 equivalent) within the first 3 years of CNCDP support, up to one additional year of CNCDP support may be provided at the discretion of the CNCDP leadership.

For the purpose of calculating protected time for research, the following is provided as guidance. For a 12-month period, one-half day is 10% of a week. 1 month is 8% of a year. Time spent with on call responsibilities is not time protected for research. Given this formula, all scholar applicants to the CNCDP must provide a letter from their Departmental Chair, which should be co-signed by any individual with clinical duty assignment authority over the scholar, that explicitly identifies the applicant's non-research responsibilities, expressed according to the above time calculation. Scholars should not be appointed to the program without this explicit written description from the scholar's Chair and potentially, clinical supervisor. As part of its oversight function, the administrative leadership of the CNCDP should have a mechanism in place to ensure that supported scholars maintain the minimum required research effort each year.

Local Advisory Committee for the Scholar. Each scholar supported by this program should have a local advisory committee to provide input and guidance to the scholar, and to provide local oversight of the scholar's progress (this advisory committee is unrelated to the CNCDP advisory committee). The scholar's local advisory committee would be expected to be composed of experts in all areas necessary to ensure the success of the scholar(s) in research, career development and ultimately the creation and management of an independent research lab. Composition, responsibilities, frequency of meetings, and other relevant information should be included in the document submitted by the applicant when applying for support from the CNCDP.

CNCDP Advisory Committee for the Scholar. The CNCDP should appoint one or more individuals from the CNCDP advisory committee to serve as a program mentor/advisor to selected scholars. The CNCDP program should define the goals and minimum frequency of interaction between CNCDP mentor and the scholar.

The CNCDP Annual Retreat

The CNCDP will organize and implement an annual retreat for all scholars supported by the program. Although this retreat may be a stand-alone meeting or held in conjunction with the Annual Child Neurology Society Meeting, it is critical that the meeting be held at a time that is free of potential distractions associated with other events (i.e. either before or after any Society Meeting activities that involve CNCDP faculty, applicants or scholars). The annual retreat should be used for scholar selection activities (e.g. application review, interviews, the "study section" at which selection occurs), scholar research presentations, mentoring and career development activities (including, for example, critical review of grant application proposals, critical reviews of oral presentations, discussions of issues pertaining to clinician-scientist careers, etc.) and formal activities designed to strengthen participant understanding of experimental design, the principles of statistics and rigor, and networking. Each appointed scholar, as well as each member of the CNCDP advisory committee, is expected to attend the CNCDP annual retreat every year. The CNCDP leadership may choose to invite other relevant participants to the meeting, including, but not limited to, other clinician-scientists at a similar career level, established clinician-scientists and scholars' mentors.

A critical career development component of the CNCDP annual retreat will be for all scholars to present their research projects orally each year. This will serve not only as a public report on research progress but will foster excellence and improvement in oral communication and the ability to respond to critical examination of their results in a public forum. Moreover, at least once before the end of their third year of support (or prior to a planned grant submission), scholars should have the opportunity to discuss the anticipated specific aims of their expected individual career development or research grant application with a mentor or group at the CNCDP annual retreat.

This Notice of Funding Opportunity (NOFO) does not allow appointed scholars 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.

Special Note: Potential applicants should contact the Director, NINDS Office of Training and Workforce Development with any questions about this program, program planning or application for this award.

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

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)

Local Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

Federal Governments

• Eligible Agencies of the Federal Government
• 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.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any 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 their organization to develop an application for 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 How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of scholars to the approved career development program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

Each PD/PI must be an established physician-scientist in Child Neurology who has the experience to provide both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI(s) should have a demonstrated track record in both research and the successful training of clinician-scientists for a dual research and clinical career. In addition, the PD/PI(s) should have the stature in the Child Neurology community appropriate for an individual charged with oversight over a single national program designed to fulfill the critical need of developing the careers of physician-scientists specialized in Child Neurology to conduct significant research intended to find cures and better treatments of childhood neurological diseases.

Each PD/PI must have sufficient time to devote to the CNCDP.

The PD/PI may want to designate an individual as a pre-application advisor to the candidates. This advisor may advise potential applicants on any aspect of their application, including aspects of the research and/or career development plan or choice of mentor(s). This individual should not be a voting member of the selection committee.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

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

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. 

Scholars should have an appropriate mentorship team, with each mentor having a role to play in the scholar's development as a physician-scientist (note that, as in all institutional career development programs, the CNCDP's leadership does not select the scholar's mentors; each scholar chooses his/her mentorship team. The CNCDP evaluates the appropriateness of the mentorship team as part of the scholar's application to the program for support). Each scholar appointed in the program must have a primary mentor who: (1) is recognized as an accomplished investigator, (2) is actively involved in basic or clinical research, (3) has a successful record of providing the type of training required under this award and (4) will dedicate the time and resources required to foster the scholar's success. The primary mentor should be at the scholar's institution, should be appropriate for providing guidance for the research career development of the scholar, must be aware of the goals of the CNCDP, and is expected to provide the guidance appropriate for helping the scholar transition to individually funded research. Ideally, each scholar will have at least one mentor who is a physician specialized in Child Neurology with a record of successful research experience, who can provide guidance on successfully navigating a career that combines clinical and research activities in Child Neurology. Scholars may also choose to have additional mentors for specific purposes, such as methodological expertise and career guidance.

Scholars

Individuals to be supported by the CNCDP must be at the career level for which the planned program is intended, which, except under unusual circumstances, is within the first 3 years after completion of clinical fellowship. The NINDS expects scholars appointed to the CNCDP to have demonstrated potential to develop into successful researchers. Individuals should not be appointed as scholars unless the CNCDP leadership and advisory committee has confidence that the individual will be competitive for an individual award (e.g. NIH K or R01) by the end of the 3-year CNCDP support period.

An explicit goal of the CNCDP is to facilitate the transition of physician-scientists in Child Neurology to an NINDS Mentored Career Development Award (K08 or K23), an NINDS Research Scientist Development Award (K02) or a Research Project Grant (R01) within, or shortly after, the CNCDP support period. Therefore, scholar candidates for support under this NOFO must have the following: (1) a clinical degree or its equivalent, (2) residency training (or its equivalent), (3) a license to practice medicine in the U.S.A., (4) at least one mentor who has extensive and well-funded research experience and a successful track record of training clinician-scientists, and (5) the intent to continue in a dual research/clinical career, supported by an individual career-development or research award that they obtain as PD/PI.

Note: Although primarily intended to support physician-scientists in Child Neurology, the CNCDP may be used to support a limited number of physician-scientists from closely related disciplines, who are similarly situated with respect to their career progression, who are conducting research to advance the understanding and treatment of neurological disorders of children.

Individuals who are, or have been, principal investigators on NIH individual mentored or non-mentored career awards (e.g. K01, K02, K08, K22, K23, K99), major research project awards (e.g. R01, DP2, U01 or equivalent), sub-projects of program project (P01) or center grants (P50), or equivalent, non-federal career development awards or major research grants, are not eligible for appointment under this program. Scholar candidates who have been supported by other NIH institutional K awards (e.g. KL2, K12) may not be supported by the CNCDP K12. Scholar candidates who were former or who are current principal investigators on NIH small grants (R03) or exploratory/developmental grants (R21) remain eligible. Scholar candidates may not concurrently hold any other award that duplicates the provisions of this award (e.g. federal or non-federal career development award) and must terminate support by the CNCDP K12 immediately upon obtaining a federal or non-federal K08/K23-equivalent or R01-equivalent research grant.

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - 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 How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

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.

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 How to Apply - Application Guide must be followed.

SF424 (R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Project Summary/Abstract. Provide an abstract of the entire application. Include the goals, objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., year of fellowship, year of faculty position, etc.), and intended scholar outcomes.

Other Attachments. An Advisory Committee is not a required, but a highly recommended component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. 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 How to Apply - Application Guide.

PHS 398 Cover Page Supplement

Follow all instructions provided in the How to Apply - Application Guide.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the How to Apply - Application Guide.

Research and Related (R&R) Budget

Follow all instructions provided in the How to Apply - 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 NOFO specifically instructs applicants to do so.

Follow all instructions provided in the How to Apply - Application Guide.

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.

No NIH training tables are required. However, applicants are encouraged to include data in table form that portrays CNCDP faculty training qualifications. In addition, for a renewal application, the applicant is encouraged to include, in table format, information that indicates characteristics of the applicant and scholar pool. This may include, but is not limited to, yearly number of applicants to the program, relevant applicant and scholar characteristics from prior years (e.g. years since clinical training, research experience) and scholar achievements and outcomes (e.g. scholar publications, awards, career progression, etc.). This tabular information must be provided within the 25-page limit.

Training Program

Program Plan

Program Administration.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by Scholar(s).

Proposed Training.

The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in laboratory and project management. 

In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed Scholar(s).

Program Administration.

Describe the strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the career development program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

Describe the plan for monitoring progress of the scholars, and the approach to ensuring both progress and compliance with program policies. Describe the process by which continued support of a scholar by the program will be granted or denied.

Describe the plan for communicating detailed information about the goals and expectations of the CNCDP program to primary mentors and departmental chairs. Describe the plan for ensuring that scholars maintain the required yearly protected time and obtain expected and adequate resources to accomplish their research and career development goals.

For all PD/PIs and co-directors, describe the anticipated responsibilities of each individual in the context of the effort they will devote to the program.

CNCDP Advisory Committee. The Advisory Committee to the CNCDP co-directors is a select group of scientists who have established records of research and research training of clinician-scientists. The committee should be composed of 12-15 members from a range of geographic locations. The committee should possess a variety of perspectives, scientific interests, and prior training affiliations. Whereas it is appropriate that most members of the advisory committee be physician-scientists in Child Neurology, at least 1/4 of the advisory committee members should be from disciplines outside of Child Neurology. These could include leading physician-scientists from other disciplines (e.g. Adult Neurology, Pediatrics, etc.) and PhD scientists with a successful track record in training clinician-scientists. The advisory committee and co-directors evaluate all applicants to the program (which will include the evaluation of written applications and conducting interviews), monitor progress of current scholars and provide feedback to the PD/PI(s), co-directors and scholars as appropriate. Advisory committee members may be asked to, and should agree to, perform site visits at scholar institutions, and should have the appropriate stature within the community to discuss program principles and policies with scholars, mentors and department chairs. The CNCDP advisory committee members are expected to attend and participate in all annual retreats of the CNCDP. The duration of service of individual CNCDP advisory committee members will be negotiated between individual members and the PD/PI(s) and should generally be a minimum of 3 years. Advisory Committee members may be primary or secondary mentors to scholars, but must avoid any conflict-of-interest, real or apparent, in the scholar selection process. A complete cohort of advisory committee members should be selected in advance of submission and proposed in the application.

Describe the strengths of, and rationale for choosing, each advisory committee member as well as the rationale for the specific composition of the advisory committee as a whole. The application should include letters from each advisory committee member confirming their willingness to participate. If this is a renewal application, the previous members of the advisory committee should be listed, with an explanation for the evolution of the panel to its proposed future membership.

Proposed Career Development Activities.

Provide an overview of the proposed program. Outline the objectives of the program and the programmatic activities that will be used to meet these objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the academic and research background needed to pursue the proposed career development, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about any planned courses, mentored research experiences, and activities conducted by the national program itself, which are designed to develop specific technical skills or other skills essential for the proposed research career development.

Skills. Describe how the CNCDP will ensure that all scholars develop skills for high quality oral and written presentations and skills needed to successfully apply for individual grant support. Describe any potential plans for education of scholars in ancillary skills required for a research career, such as overseeing laboratory research or a clinical research program, project and budget management and personnel management. The PD/PI(s) may choose to incorporate this career development component into the annual retreat agenda (see below). Alternatively, the PD/PI(s) should have a mechanism to ensure that scholars obtain this instruction at their home institutions or elsewhere.

Expectations for local activities. Describe anticipated guidelines for participation of scholars in didactic activities and research career development activities at the scholar's local institution. Describe activities, if any, that will be mandated by the CNCDP, and how the CNCDP leadership will determine whether individual scholars are obtaining the local career development guidance that is expected for their research career success. Describe the plan to ensure that all appointed scholars obtain, early in their CNCDP career development, a comprehensive appreciation of the principles of experimental design, statistics and scientific rigor (for examples of critical elements of a well-designed study see http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf). Conversely, describe how the CNCDP will ensure that scholars do not become involved too heavily in didactic activity that will detract from their ability to progress in their research sufficiently to obtain individual funding by the end of the CNCDP support period.

Oversight of local scholar support. Describe the plan for negotiation and coordination with participating institutions, departments and chairs to ensure that scholars obtain appropriate research support, appropriate protected time for research and opportunities for appropriate career advancement given a combined research and clinical career. The CNCDP leadership is encouraged to provide scholars, mentors and department chairs and supervisors with a document that outlines program expectations, in addition to listing expectations on a CNCDP website.

Describe the process by which the CNCDP will ensure timely scholar career progression and transition to independence, as well as ensuring that scholars, once supported, obtain the full protected time for research that is required for CNCDP support. Describe the plan by which the CNCDP will ensure that a scholar's mentor(s) have the necessary expertise to cover scholar's needs, and will commit sufficient time to the scholar's career development, to facilitate scholar success in obtaining the goals of the CNCDP-supported activities.

Annual retreat. Describe the plans for the annual retreat. This retreat should be used for the PD/PI(s) and CNCDP advisory committee members to interview applicants, evaluate their written applications to the program and select scholars to be supported. This meeting should also include, at a minimum, opportunities for supported scholars to 1) improve their oral and written presentation skills, 2) sharpen their analytical skills with regard to data gathering and interpretation, as well as an understanding of the clinical significance/relevance of their research at a granular level, 3) obtain knowledgeable advice regarding the specific aims of planned future grants and 4) obtain career guidance. The CNCDP is encouraged to include in the annual retreat a comprehensive, general discussion of experimental design and rigor. In addition to supported scholars and advisory committee members, who are expected to attend each meeting annually, describe, in principle, other anticipated invitees to the meeting and the goals of their attendance at the meeting.

The annual retreat is also intended to serve as an infrastructure for building a community of physicians specialized in Child Neurology who are dedicated to a research component to their careers. The application should describe any approach or activities anticipated to facilitate the success of CNCDP applicants who are not selected for salary support by the program.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program. Given the recent startup of the CNCDP program, such evolution might be expected to involve all aspects of the program, including scholar selection, national advisory committee composition and involvement, oversight strategies, annual retreat activities, monitoring of scholar progress, etc. Provide the agenda for a recent retreat, and describe anticipated changes to be made based on the experience.

One-time program evaluation by an external panel. Describe plans for a rigorous, comprehensive external review of the program. The evaluation panel should be made up of outstanding research scientists with highly successful records in training clinician-scientists. The panel should consist of individuals from outside the child neurology subspecialty.

Program Faculty.

If any mentors will supervise a Scholar proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of their 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.

Scholar Candidates and Retention Plans.

If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study. If the event that a clinical trial may be proposed, discuss the potential of prospective Scholars to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Institutional Environment and Commitment to the Program

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.

Mentors.

The application must include information about the characteristics of mentors who would be appropriate to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences expected of proposed mentors, including active research and other scholarly activities in which the mentors are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). Describe whether and how, if at all, the CNCDP program will evaluate each scholar's mentor choices and advise on suitability and potential changes. Describe what, if any, requirements the CNCDP will have for the makeup of a scholar's mentorship team.

Scholar Candidates.

Describe, in general terms, the size and qualifications of the pool of scholar candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective scholars. Describe specific plans to recruit candidates and explain how these plans will be implemented. Describe the process to be used to select candidates who would be offered support from the program and criteria for scholar reappointment to the program. Describe the minimum expected qualifications (e.g. research experience, publications, institutional support, faculty positions, etc.) required for appointment to the CNCDP, and if exceptions to these qualifications are possible, the anticipated bases for exceptions. Describe the anticipated components of the application process, including written documents, personal interviews, reference letters, institutional commitment, etc. To be eligible for support, the institution must commit to 75% protected time for research for the duration of CNCDP support. Describe the plans for ensuring that the candidates have this institutional commitment and that the scholars' supervisors understand the sanctity of this commitment. In addition, describe any planned expectation for commitment by the scholar's institution to foster a successful transition of the scholar from the CNCDP to individual research support.

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.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Letters of Support

The application should include letters, on institutional letterhead, for each PD/PI, co-director and advisory committee member which confirms support for the time needed for each person's respective role in the program.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost. 

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex of program candidates, scholars, or faculty may not, be used as factors in the evaluation of applications.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development program will prepare individuals for successful, productive scientific research careers, 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 career development impact.

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.

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.

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

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 Announcement. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council.

The following will be considered in making funding decisions, consistent with applicable law:

• 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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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.

After the peer review of the application is completed, the PD/PI will be able to access their 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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 must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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. 

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Not Applicable.

A Data Management and Sharing Plan is not applicable for this NOFO.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. Continuation support will not be provided until the required forms are submitted and accepted. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 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 Section 8.6 Closeout. 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.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving undergraduate students:

• Successful completion of an undergraduate degree in a STEM field
• Pending application for and/or enrollment in an advanced degree program in a STEM field
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field

For programs involving graduate students:

• Successful completion of a STEM graduate program
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source 

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 submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Office of Training and Workforce Development
National Institute of Neurological Disorders and Stroke (NINDS)
Email: NINDSTrainingOffice@ninds.nih.gov  

NOFOReviewContact@csr.nih.gov

Examine your eRA Commons account for additional review assignment and contact information (information normally appears two weeks after the submission due date). 

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Section VIII. Other Information

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

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 2 CFR Part 200.