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 in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose and Background Information

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.

This FOA encourages applications for the continuation of a national program that will provide support, mentoring, oversight, knowledge and skills required for the research career development of child neurologists in the mission area(s) of the NINDS.

The purpose of this funding opportunity announcement (FOA), issued by the NINDS, is to invite applications for the Child Neurologist Career Development Program (CNCDP). The CNCDP supports a national effort for mentored career development and training of child neurologists at institutions nationwide that support research relevant to the mission of NINDS. The goal of this program is to increase the cadre of child neurologists 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 FOA 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 child neurologists 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 dearth of child neurologists 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 pediatric 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 K12 award provides five 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 diverse representation 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 his/her 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 his/her 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 child neurologists, the CNCDP will include the following critical components:

• An advisory committee to the CNCDP PD/PI(s) that consists of both child neurologists 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 appropriate gender-balance and should contain diverse representation with regard to racial/ethnic background, geographic location of their home institutions, residency/fellowship training institutions and area 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 in diverse 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.
• A plan to recruit women and individuals from diverse backgrounds into this program, as well as a plan for including members of these groups in mentoring and program administration.
• 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: http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf 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. Child Neurologists 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 in-person 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 Funding Opportunity Announcement (FOA) 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.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

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

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.

• Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
• Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

It is anticipated that a foreign component for a scholar's research career development project will be rare. However, a limited foreign component is allowable when it provides an outstanding opportunity for the scholar's research program that cannot be obtained at a domestic institution.

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.

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 child neurologists 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.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

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.

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 child neurologist 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.

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 child neurologists 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 FOA 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 child neurologists, 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.

Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program. Details on citizenship requirements are available in the NIH Grants Policy Statement.

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.

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Stephen Korn, Ph.D.
Email: [email protected]

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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 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. 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. This committee should be diverse in nature, with respect to scientific interests, geographic location and prior training affiliations. The advisory committee should also have appropriate representation of women and underrepresented minorities. Whereas it is appropriate that most members of the advisory committee be child neurologist-researchers, 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. Applicants should 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 his/her 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.

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.

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

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

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

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

• The R&R Budget Component must be used instead of the Training Budget Component.
• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Do not complete the section on Participant/Trainee Support Costs.
• Domestic travel costs for the annual retreat may be requested.

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 with the following additional modifications:

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.

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.

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.

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 child neurologists 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.

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 any specific efforts to be made to recruit underrepresented minorities to the CNCDP program. 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.

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 SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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.

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.

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.

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

• Are the guidelines proposed for oversight of didactic, training-related, and research-related activities of the program appropriate?
• Is the institutional commitment to the proposed program clear and appropriate?
• Are appropriate oversight mechanisms in place to ensure timely, scholar career progression and transition to independence?
• Does the program have a cogent, feasible plan to ensure that all appointed scholars will obtain strong training in scientific rigor, research design and statistics?
• If multiple sites are participating in administration of the program, is this adequately justified and is it feasible?
• Is there a strong, feasible plan to ensure that appointed scholars will obtain the required research career development protected time and that scholar's mentors will devote the time necessary for superior mentoring of the scholar?
• Are the responsibilities of the CNCDP advisory committee described and adequate with regard to the provision of candidate selection, input, guidance and oversight of the program?
• Are the CNCDP advisory committee members, as a whole and individually, appropriate for the needs of the program, with regard to scholar selection, career development guidance, the conduct of site visits, scientific breadth, and other committee responsibilities?
• Is the advisory committee appropriate, with respect to research accomplishments, diversity of research expertise, training track record, stature in the community, geographic representation, gender balance and racial/ethnic diversity?
• Is a well-thought out annual retreat proposed that will significantly aid in the development of successful physician-scientist careers of the supported scholars?

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

• Do the PD/PI(s) and co-directors (if applicable) have the experience, expertise, knowledge and stature to develop, direct and administer the proposed program?
• Does the leadership team bring complementary, synergistic and/or 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?
• Is there sufficient assurance, in the form of institutional and departmental letters of support, that the required effort of the PD/PI(s), co-directors and advisory committee members will be devoted directly to the career development, and related activities of the CNCDP?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) of the leadership team appropriate for the proposed career development program?
• Are the PD(s)/PI(s) and, if applicable, co-directors, currently (or recently) 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

• Is there an appropriate plan to ensure that primary mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
• Is there an appropriate plan to ensure that each scholar will have a mentorship team that covers all needed aspects of the scholar's research and career development?
• Is there an appropriate plan to ensure that the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars are acceptable?
• Is there an appropriate plan to ensure that the research productivity, research quality and funding of proposed mentors is suitable for the development of successful scholar research careers?
• Is there a plan to ensure that projects proposed by candidate scholars can be pursued by the scholars via an independent funding mechanism without competition from the mentor?

Candidates/Scholars

• Is a well-defined and justified recruitment plan proposed with strategies likely to attract high quality scholar candidates from a national pool, and not just from selected institutions?
• Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
• Is there a well-conceived plan for a rigorous application to the program, which includes both written application and interviews?
• Does the plan ensure that scholars appointed to the CNCDP will have, before appointment, a well-designed research and career development plan, which could be expected to lead to individual funding after approximately 3 years of CNCDP support?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
• Does the program have a plan to provide guidance to ensure that the content, phasing, and proposed duration of the career development plan will be appropriate for transitioning scholars to individual awards by the end of the CNCDP support period?
• Is an appropriate set of qualifications expected of applicants for support, and if exceptions to these qualifications are permitted, is the plan for making exceptions clear and appropriate?
• Is there a thoughtful, feasible timeline of applicant recruitment and appointment that includes solicitation of applications, preparation of candidate applications, submission of applications to the program, selection of applicants, and applicant support?

Training Record

• Is there evidence of a successful past training record of the PD/PI(s), co-directors and advisory committee members, including the success of former scholars in seeking independent support and establishing productive scientific careers?
• Does the program have rigorous evaluation plans, utilizing internal and/or external advisors, to assess the quality and effectiveness of the program?

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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.

Resubmissions

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

Renewals

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)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past record of the program, including the success of former scholars in seeking independent support and establishing productive scientific research careers? Did the program implement a scholar selection process that was fair, effective, designed to receive applications from a broad swath of institutions, and which involved both written and interview components? Did the program create a robust, well thought out annual retreat that met the goals of the FOA (e.g. providing activities related to career development, mentorship, oral and written presentation skills, becoming rigorous scientists, etc.)? Is there evidence that the design of the annual retreat, and potentially other programmatic activities, contributed towards the development of a community from which both CNCDP-supported and non-supported child neurology researchers benefit? Did the program implement an evaluation process, either internally or involving an external panel, and if so, did the program act on recommendations? Did the CNCDP leadership implement an approach to evaluating the members of the advisory committee? Did the program implement site visits that provided useful information? Did the program implement an approach to ensuring appropriate protected time and mentorship for scholars over the course of their CNCDP support?

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 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 training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training 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 training 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 NINDS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted 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 l. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Not Applicable

When multiple years are involved, awardees 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 grantee 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 trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees 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.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

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

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

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, 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 instructions, 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)
Telephone: 301-496-9223
Email: [email protected]

Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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

Awards are made under the authorization of 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.