Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the SF424 (R&R) 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 Application Guide and the NOFO) 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.

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.



Table of Contents
Part 1. Overview Information
Key Dates
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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about career programs may be found at the NIH Extramural Research Training and Career Development website.

The objective of the NIH BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is to help outstanding postdoctoral researchers from diverse backgrounds with the opportunity to complete needed, mentored training and transition in a timely manner to independent, tenure-track or equivalent faculty positions. The BRAIN Initiative Diversity K99/R00 program is intended to foster the development of creative, independent researchers that will be competitive for subsequent independent funding and that will help advance the mission of the NIH and BRAIN Initiative research areas in particular. Applicants must have no more than 5 years of postdoctoral research experience at the time of the initial or the subsequent resubmission application. The K99/R00 award is intended for individuals who require at least 12 months of mentored research training and career development (K99 phase) before transitioning to the R00 award phase of the program. Consequently, the strongest applicants will require, and will propose, a well-conceived plan for 1 2 years of substantive mentored research training and career development that will help them become competitive candidates for tenure-track faculty positions and prepare them to launch robust, independent research programs. An individual who cannot provide a compelling rationale for at least one year of additional mentored research training at the time of award is not a strong candidate for this award.

Individuals must be in mentored, postdoctoral training positions to be eligible to apply to the K99/R00 program. If an applicant achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 period.

NIH and BRAIN Initiative Interest in Diversity

Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. Promoting diversity in the extramural scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from underrepresented groups, is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. See the Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, including those from underrepresented groups, who will help to further NIH's mission.

In spite of tremendous advancements in scientific research, information educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from diverse backgrounds, including those from groups underrepresented in the biomedical, clinical, behavioral and social sciences (see the Notice of NIH's Interest in Diversity; NOT-OD-20-031).

The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through (NASEM, 2018) encourages NIH and research institutions to diversify their postdoctorate and faculty populations to enhance the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences. In addition, women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines including those relevant to the BRAIN Initiative (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially the table describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank (Table 9-23 of Special Report NSF 13-304 from 2013.).

There is a large loss of talented researchers during the transition from postdoctoral training to junior faculty positions, particularly those from underrepresented groups. Evidence from several reports demonstrates that an intervention designed to facilitate successful transition at this point would benefit the research community and scientific teaching environment and would provide, in particular, needed role models for students from underrepresented groups (Expanding Underrepresented Minority Participation: America's Science and Technology Talent at the Crossroads, National Academy of Sciences, 2011; Beyond Bias and Barriers: Fulfilling the Potential of Women in Academic Science and Engineering, NASEM, 2007; Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, National Research Council, 2005; and Advancing the Nation's Health Needs: NIH Research Training Programs, National Academy of Sciences, 2005). In addition to fostering a diverse pool of trainees, including those from underrepresented groups, targeted programs that focus on transition points along the postdoctorate to junior faculty career path could prevent the loss of highly trained scientists (The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through). For example, women make up more than half of biomedical science undergraduate (58%) and postgraduate (53%) degrees but only 18% of full professors in the biomedical sciences (www.nces.ed.gov/programs/digest/2013menu_tables.asp; https://www.nsf.gov/statistics/2017/nsf17310/static/downloads/nsf17310-digest.pdf). Specifically for underrepresented neuroscience early career researchers, there is a decrease in the proportion of trainees from underrepresented groups from postdoctoral (9%) to tenure-stream neuroscience faculty (5%); 2011 Survey Report Neuroscience Departments and Programs. A diverse faculty is critical for providing role models for aspiring scientists from all backgrounds and achieving a research agenda that benefits the nation. Moreover, surveys reveal that a diverse faculty is important for attracting students to research and has a positive impact on retention and career mentoring for students from diverse backgrounds.

This Notice of Funding Opportunity (NOFO) is designed to assist transition to secure faculty positions, enhance the diversity of the pool of available faculty researchers, and enhance the skills needed to progress to independent NIH or other independent research support. As demonstrated in a 2011 NIH Individual Mentored Career Development Awards Program Evaluation, receipt of support under an individual mentored career development award had a measurable and significant impact on program participants, as seen in their publication records and subsequent applications for and receipt of NIH grants. Collectively, researchers who participated in a NIH K program had a significantly higher R01 success rate than those with no prior career development support. The BRAIN Initiative Diversity K99/R00 also aligns with the vision of NIH Leadership to "focus on the system's nodes where attrition is most common, which means focusing on retention, continuity, flexibility, and innovation across branch points in the career pathway" CBE Life Sci Educ. 2016 Fall; v.15(3). It is envisioned that funding support from this K99/R00 will enhance the pool of well-trained researchers who are available to compete competitively for research opportunities available under the auspices of the BRAIN Initiative.

Next Generation Researchers in the BRAIN Initiative

Since 2014, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN Initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notice of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.

The NIH BRAIN Initiative recognizes that teams comprised of individuals with a diversity of experiences and perspectives that work together often outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031.

Postdoctoral scientists are a critical component of the U.S. workforce. Trained in the latest research practices, they bring new knowledge and techniques into the research workforce. This NOFO is related to the education recommendations in Section II.7 of the BRAIN 2025 Report, as was underscored in the BRAIN 2.0 report. Specifically, this NOFO solicits applications from advanced-stage postdoctorates to acquire mentored research training using cutting-edge tools, theories and/or approaches in one or more of the high-priority areas of the BRAIN Initiative, including neuroethics. The NIH BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) is a trans-NIH effort to promote retention and advancement of a diverse pool of individuals, including those from underrepresented groups in the biomedical and behavioral sciences in BRAIN Initiative research careers.

Both the initial BRAIN 2025 Report and the BRAIN 2.0 Report strongly encourages scientists to cross traditional areas of expertise to conduct interdisciplinary research and acknowledges the need to attract investigators and faculty recruits to neuroscience from quantitative disciplines, e.g., statistics, computer science, physics, mathematics, and engineering. Given the expressed need to bring those trained in quantitative disciplines to neuroscience research, applications from individuals in quantitative disciplines are strongly encouraged.

In addition to the National BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research and research training. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research and research training efforts through investigator-initiated applications as well as through specific NOFOs. Potential applicants to this NOFO are strongly encouraged to contact Scientific/Program staff if they have any questions about the best NOFO for their career development.

For BRAIN Initiative awards to date and examples of research areas funded, see: http://www.braininitiative.nih.gov/funding/fundedAwards.htm.

Specific Objectives of the Career/Research Transition Opportunity

Individuals must be in mentored, postdoctoral training positions to be eligible for support under the K99/R00 program. If a candidate achieves independence (any faculty or non-mentored research position) before a K99 award is made, neither the K99, nor the R00 award, will be made. The K99/R00 award will provide up to 5 years of support in two phases. The initial (K99) phase will provide support for up to 2 years of mentored postdoctoral research training and career development. The second (R00) phase will provide up to 3 years of independent research support, which is contingent on satisfactory progress during the K99 phase and an approved, independent, tenure-track (or equivalent) faculty position. The two award phases are intended to be continuous in time. Therefore, although exceptions may be possible in limited circumstances, R00 awards will generally only be made to support those K99 PDs/PIs who accept independent, tenure-track (or equivalent) faculty positions by the end of the K99 award period.

Applicants for the NIH BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00) program are expected to propose a research project and training plan in a scientific area relevant to one or more of the goals of the BRAIN Initiative, including neuroethics (see http://braininitiative.nih.gov). The integrated program of research and training is expected to provide candidates with training using cutting-edge tools, theories and/or approaches that will prepare them to launch independent research careers in areas that will advance the goals of the BRAIN Initiative. To be considered responsive to this NOFO, the proposed research training plan must be relevant to the scientific goals of the BRAIN 2025 Report and BRAIN 2.0 Report, as described in the required Other Attachment for this application. Applications that are not relevant to one or more goals of these two BRAIN reports will not be reviewed.

Prior Consultation with Scientific/Research Staff

Consultation with Scientific/Research Contact staff listed in Section VII is strongly recommended, at least three weeks before the application due date. NIH staff can advise on candidate eligibility for this NOFO, and whether the proposed project meets the goals of this NOFO and the mission of the BRAIN Initiative and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project does not meet the programmatic needs of this NOFO, applicants will be strongly encouraged to consider other Funding Opportunities.

Applications Not Responsive to this NOFO

Applications solely focused on the study of specific disease mechanisms, or existing disease therapeutics and treatments, will be considered nonresponsive. If an application focuses on the study of a disease or disorder of the CNS, the work must be primarily aimed at the development, optimization, testing, or novel use of technology where application to the disorder or disease is essential for demonstration of the technological approach. Studies for the investigation of specific diseases and disorders, or the mechanisms of such diseases should be directed to the appropriate NIH Institutes.

Proposed research that is not responsive to this NOFO will not be reviewed.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this NOFO are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion NOFO (RFA-MH-22-330).

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government -Including the NIH Intramural Programs

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored (K99) and independent (R00) phase, with the following exceptions: (1) Eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase; and (2) Eligibility of organizations, other than institutions of higher education, for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.

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

Applicant Organizations

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

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

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

K99/R00 candidates for this specific NOFO must have no more than 5 years of postdoctoral research experience as of the relevant application due date regardless of whether it is a new or resubmission application. Individuals must be in mentored, postdoctoral training positions to be eligible for support under the K99/R00 program. If an applicant achieves independence (i.e., any faculty or non-mentored research position) before a K99 award is made, neither the K99 award, nor the R00 award, will be issued.

NIH considers requests for extension of the K99 eligibility window for various reasons, including medical concerns, disability, family care, extended periods of clinical training, natural disasters, and active-duty military service. Each of these requests is reviewed on a case-by-case basis. Consistent with the NIH Extension Policy for Early Stage Investigator Status (ESI), NIH will approve an extension of one year for childbirth within the 5 year BRAIN Initiative K99 eligibility window. Candidates who will be PD/PIs on a K99 application must provide the child’s date of birth in the extension request justification submitted to IC program officials and/or scientific/research contacts listed in the NOFO at least 12 weeks before submitting an application. Please refer to NIH Extension Policy for Eligibility Window for Pathway to Independence Awards (K99/R00).

In addition, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 5-year research training eligibility limit. Only time dedicated to research activities would count toward the 5-year limit

Additional clarifications are provided under Frequently Asked Questions. Potential candidates are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying.

Candidates for the K99/R00 award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians (including those with MD, DDS, DVM and other licensed health professionals) in a clinical faculty position that denotes independence in clinical responsibilities but not in research may also be eligible for the K99/R00 award. Funding decisions will be made consistent with applicable law.

Individuals are NOT eligible if they:

• Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Have more than 5 years of related postdoctoral research training at the time of initial application or resubmission; or
• Have been an independent PD/PI on NIH research grants (e.g. R01, R03, R21), received an NIH individual career development award (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leaders on sub-projects of program project (P01) or center (P50) grants or the equivalent.

Ph.D. (or equivalent research doctorate degree) candidates in positions other than postdoctoral fellow positions: It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent, mentored training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility from the relevant IC before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that his or her position complies with the intent of this eligibility requirement. If a potential applicant is in a position that is not clearly identifiable as a postdoctoral training position, candidate should provide the relevant NIH Institute or Center an official statement of the institution’s policy (e.g. published position description in an official institutional document) which documents the position as a mentored, postdoctoral training position.

Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions: Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. Such individuals may also wish to consider other career awards (see K Kiosk) available for junior faculty development.

The following is provided as an aid to distinguish independent from non-independent positions: However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

• The candidate’s research is entirely funded by another investigator’s grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
• According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
• The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

Conversely, evidence for independence, and therefore lack of eligibility, includes:

• The candidate has a full-time faculty position.
• The candidate received a start-up package for support of their independent research.
• The candidate has research space dedicated to their own research.
• The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
• The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research grant.

2. Cost Sharing

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

3. Additional Information on Eligibility

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (See 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details

R00 Phase. Although candidates are required to devote no less than 75% of their full-time, 12-month professional effort to research (i.e., full-time for 9 person-months), the required 9 person-months of research effort need not be devoted exclusively to the R00-supported research.

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. Candidates holding a clinical doctorate should include at least one individual with a clinical doctorate on the mentoring team. Candidates also are encouraged to propose a mentoring team that will provide additional guidance typically towards professional aspects of the candidate's career development.

The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should also be included. Where feasible, the recruitment of women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities as potential mentors is encouraged, given their ability to serve as role models.

For this NOFO, at minimum, the primary mentor should have research expertise relevant to one or more of the goals described in the BRAIN 2025 Report or BRAIN 2.0 Report.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in BRAIN Initiative research areas.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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 instructions in the Career Development (K) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

The following additional instructions apply:

Facilities & Other Resources: Include a description of how the scientific environment is specifically conducive to the proposed research training in one or more of the high-priority areas described in the BRAIN 2025 Report.

Project Summary/Abstract: Include a description of your current research and the research you propose to continue in the independent phase.

BRAIN Initiative Relevance: Attach a one-page description of the relationship of the proposed Research Plan to one or more of the specific goals stated in the BRAIN 2025 Report or BRAIN 2.0 Report. The first sentence of this description should state which of the eight, high-priority goals enumerated in these reports is addressed by the Research Training Plan. Name this file: BRAIN Relationship.pdf. The filename provided for each "Other Attachment" will be the name used for the bookmark in the electronic application in eRA Commons.

Institutional Letter: Applicants are required to attach a letter from the institution explaining how the candidate's participation would further the goals of the BRAIN Initiative Postdoctoral Career Transition Award. The letter from the institution must be on institutional letterhead and scanned so that an institutional official signature is visible. Name the PDF-formatted letter "Institutional_Ltr.pdf". This letter is limited to 1 page.

Project Summary/Abstract

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

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

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

R&R Budget

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

Provide itemized budget information for each budget period covered under the K99 phase.

Itemized budget information is not required for the R00 phase; a total requested amount for each budget period is acceptable. However, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period of the R00 phase:

• • Select the appropriate Budget Type
  • Provide the Budget Period Start Date and End Date
  • In Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, $0 for Requested Salary and $0 for Fringe Benefits
  • In Section F: Other Direct Costs add a line item titled 'R00 Independent Phase' and provide the total request for that period (up to $249,000).

At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

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

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a career in a biomedical, behavioral, or clinical research field relevant to advancing the goals of the NIH and the BRAIN 2025/BRAIN 2.0 Repor
• Describe the candidate’s potential to develop into a successful, independent investigator.

Career Goals and Objectives?

• Describe the candidate’s current and long-term research and career objectives.
• Present a scientific history that: (1) shows a logical progression from the candidate’s prior research and career development experiences to the training and research experiences proposed for the mentored phase of the award (K99) and subsequently to the independent phase of the award (R00); and (2) justifies the need for further mentored career development to become an independent research investigator.
• If currently supported by an institutional training grant or individual fellowship award (such as provided through the Ruth L. Kirschstein NRSA program), describe the candidate’s current research training or fellowship program.
• Describe how the candidate plans to separate scientifically from his/her mentor and advance to research independence.

Candidate’s Plan for Career Development/Training Activities During Award Period

• A systematic plan should be presented for obtaining the biomedical, behavioral, or clinical science background, research experience, and career development activities necessary to launch an independent research career. Describe current activities and how they relate to the candidate’s career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as related skills such as grant-writing, communication, leadership, and laboratory management. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher.
• Describe how the skills and knowledge obtained during the mentored phase will enhance research productivity and facilitate the development of new approaches and directions for investigation. Describe how the career development plan will promote the candidate’s success and transition to scientific independence. Candidates must justify the need for the award, particularly the mentored (K99) phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored candidate followed by up to 3 years as an independent scientist) will substantially enhance their career and/or will allow the pursuit of a novel or promising approach to a particular research problem. Candidates should make clear why additional mentored research and career development are critical before transitioning to research independence and pursuit of the proposed independent phase research.
• The candidate must describe a plan, including a timeline with milestones, for evaluation of their progress during the mentored phase and for the transition to the independent phase.
• The candidate and K99-phase mentor (see below) must describe a specific plan for the transition to the independent phase.
• Describe how the proposed training and research help launch the candidate’s independent research career in an area that will advance the goals of the BRAIN Initiative.

Research Plan Section

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

Research Strategy

• The research strategy must span both phases of the K99/R00 award and relate to the BRAIN Initiative for both phases. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).
• The research plan should state the significance, innovation and approach of the proposed research during the K99 and R00 phases of the award. The research plan should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. Although it is anticipated that candidates will be best able to describe their current and past research, the research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this component of the application.
• Describe the relationship between the mentor’s research and the candidate’s proposed research. Describe how the candidate will gain independence from his/her mentors and separate his/her scientific research program from that of the mentor(s).
• If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.
• Describe how the proposed research will help advance the mission of the NIH and BRAIN Initiative research areas in particular.
• Describe how the proposed research is within a scientific area relevant to one or more of the goals of the BRAIN Initiative, including neuroethics.
• Describe how the proposed R00 phase research is likely to foster the career of the candidate as a successful, independent investigator in BRAIN Initiative-relevant research.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

Plans and Statements of Mentor and Co-mentor(s)

• The application must include a statement from the primary mentor that provides: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan describing the nature of the supervision and mentoring that will occur during the proposed K99 award period, including how the candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research training and career development, including any formal course-work; 4) a plan for transitioning the candidate from the mentored phase to the independent phase of the award and a description of how the mentor will help the candidate achieve scientific independence from their mentor(s); 5) a statement identifying the components of the proposed research that the K99 applicant can take when they transition to research independence and that can be part of their independent (R00) phase award; and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the applicant to the independent phase of the award.
• The mentor should have sufficient independent research support to cover the costs of the proposed K99 research project in excess of the allowable costs of this award, and should state that needed costs will be covered. If funds are needed beyond what will be provided by the mentor, the source of additional funds should be identified and documented in a letter signed by the responsible individual.
• Similar information must be provided by all co-mentors. If more than one mentor is proposed, the respective areas of expertise, the responsibility of each, and the nature of the involvement with the candidate should be explicitly described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate to provide an integrated mentoring effort.
• The primary mentor must agree to write and provide annual evaluations of the candidate’s progress for the initial mentored phase as required in the annual progress report.
• The mentor must agree to assist the candidate in transitioning to an independent research position by guiding the candidate during the job search and negotiation process and by commenting on the R00 phase application.

• If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or co-mentor of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator, i.e. conducting the proposed mentored research and career development during the K99 phase and competing for, and transitioning to, a tenure-track assistant professor position at an academic institution. While the K99 phase sponsoring institution is not responsible for sponsoring the applicant during the R00 phase, it should be supportive of the candidate prior to initiation of the R00 phase.
• Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
• Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs during the K99 award period.
• Provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be available during the K99 award period.
• For individuals in postdoctoral positions with other titles although still in non-independent, mentored training positions, provide evidence of eligibility for the K99/R00 program.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to the NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information). Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied.For more guidance on submitting data to NDA refer to the NDA website and give the link to the following site https://nda.nih.gov/contribute/contribute-data.html NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved?&##148; on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Delayed Onset Study

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

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

PHS Assignment Request Form

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

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

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

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

4. Submission Dates and Times

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

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

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

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

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.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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. See Section III of this NOFO for information on registration requirements.

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 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.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed according to established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Sharing for Applicants and Awardees

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

Reviewers should evaluate the candidate's potential for obtaining a tenure-track or equivalent faculty position and developing an independent research program that will make important contributions to the BRAIN Initiative research field. Reviewers should consider in their evaluation the likely value of the proposed K99 phase research and career development in facilitating transition to research independence, and the feasibility of the proposed research project as a vehicle for developing a successful, independent research program after transition to the R00 award phase.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

• Based on the candidate’s prior research and training experience, track record, referee’s evaluations, and the quality and originality of prior research and the current application, what is the candidate’s potential to become a highly successful, independent investigator who will contribute significantly to his/her chosen field of biomedical, behavioral, or clinical related research?
• Considering the years of postdoctoral research experience to date, what is the candidate’s record of research productivity, including the quality of peer-reviewed scientific publications?
• What is the quality of the candidate's pre- and postdoctoral research training, with respect to development of appropriate scientific and technical expertise?
• Given the candidate’s prior training, proposed career development plan, and the referees evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent faculty position within the time period requested for the K99 phase of this award?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

• Are the content and duration of the proposed components of the career development plan appropriate and well-justified for the candidate’s current stage of scientific and professional development and proposed research career goals?
• To what extent does the proposed career development plan enhance or augment the applicant’s research training and skills acquisition to date?
• Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate, and facilitate his/her successful transition to independence?
• To what extent are the plans for evaluating the K99 recipient’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?
• Is the timeline planned for transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development, anticipated productivity, and the career development proposed for the K99 phase of the award?
• If proposed, will the clinical trial experience contribute to the applicant's research career development?
• To what extent will the proposed training and research help launch the candidate’s independent research career in an area that will advance the goals of the BRAIN Initiative?

Research Plan

• Is the prior research that serves as the key support for the proposed project rigorous?

Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support of the proposed project?

Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the proposed K99 phase research significant and scientifically sound?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Are the scientific and technical merits of the K99 research appropriate for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program?
• Is the proposed R00 phase research significant, scientifically sound, and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan?
• Does the R00 phase project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
• To what extent will the proposed research help advance the mission of the NIH and BRAIN Initiative research areas in particular?
• To what extent is the proposed research within a scientific area relevant to one or more of the goals of the BRAIN Initiative, including neuroethics?To what extent is the proposed R00 phase research likely to foster the career of the candidate as a successful, independent investigator in BRAIN Initiative-relevant research?
• To what extent is the proposed R00 phase research likely to foster the career of the candidate as a successful, independent investigator in biomedical, behavioral, or clinical research?
  • If proposed, will the clinical trial experience contribute to the research project?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• To what extent does the mentor(s) have a strong track record in training future independent researchers?
• To what extent are the mentor’s research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant’s career development needs?
• Is the supervision proposed for the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant’s career development appropriate and sufficient?
• Does the mentor provide an appropriate plan that addresses the candidate’s training needs, and that is likely to foster the candidate’s continued development and transition to independence?
• Does the mentor describe an acceptable plan for clear separation of the candidate’s research and research career from the mentor’s research, including identifying the components of the research plan that the K99 candidate may take to an independent research position?
• If applicable are the consultants /collaborators research qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment?
• If applicable, are the Advisory Committee members qualifications appropriate for their roles in the proposed K99 phase of the award? Do they provide letters of support that affirm their commitment?
  • If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

• To what extent does the institution provide a high quality environment appropriate for the candidate’s development during the K99 phase of the award?
• To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate’s research and career development goals during the K99 phase of the award? Is adequate evidence provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and preparation for transition to independence?
• Is there adequate assurance that the required minimum of 9 person months (75% of the candidate’s full-time professional effort) will be devoted directly to the research training, career development, and research activities proposed for the K99 phase of the award?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

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.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Training in the Responsible Conduct of Research

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

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).

Authentication of Key Biological and/or Chemical Resources

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

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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the R00 phase of the award.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accomodations and making services accessile to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment; see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Transition to the Independent Phase

Transition from the mentored phase to the independent phase is intended to be continuous in time and, except in unusual, extenuating circumstances, the awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year limit. ICs may, at their discretion, make exceptions to this time limitation when individuals have been invited for faculty job interviews but final decisions have not yet been made by the potential R00 institution or, rarely, because of unusual, extenuating circumstances. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full-time assistant professor position (or equivalent) by the end of the K99 project period.

An eligible R00 institution will have appropriate infrastructure to support the proposed research program and a history of external research funding. K99 candidates are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated. This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards. Eligibility of for-profit organizations for the R00 phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH R01 or R01-equivalent research grants. PIs are encouraged to discuss job offers at for-profit organizations with NIH Program staff well in advance of accepting such an offer.

To avoid potential problems in activating the independent phase, candidates are strongly encouraged to contact their NIH program official as soon as plans to apply for and, assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award.

At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase recipient organization.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:

• A new face page signed by the R00 phase institutional representative;
• A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);
• Detailed budget pages for a non-modular budget;
• Biographical sketches for the PD/PI and any other Key Personnel;
• A new Resources page;
• A brief description of progress made during the K99 phase that will serve as the Final Progress Report for the K99 phase;
• An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages);
• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals across the Lifespan (as appropriate);
• Authentication of Key Biological and/or Chemical Resources (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards (as appropriate); and
• A new checklist.

These materials should be sent directly to the awarding Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.

Two additional documents are included with the R00 application. A letter from the R00 Department or Division Chairman must be submitted that describes the R00 institution’s commitment to the candidate and plans for their career development (see below). If not already provided, the final evaluation statement by the K99 phase mentor, must be provided.

In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 9 person-months or 75% of the candidate’s full time professional effort) at least for the duration of the R00 award. The start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into tenure-track or equivalent faculty positions. Institutions must provide a startup and salary package equivalent to that provided to a newly hired faculty member who does not have a grant; R00 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for tenure-track (or equivalent) assistant professors who are hired without grant support. The R00 sponsoring institution must describe the candidate’s academic appointment, bearing in mind that it must be tenure-track assistant professor (or equivalent), and confirm that the appointment is not contingent on the transfer of the award to the institution. The R00 phase institution must describe how the recipient’s ability to apply for and secure independent research grant (R01) support will be fostered and supported during the R00 phase of the award.

The R00 award requires that a minimum of 9 person months (75% of the candidate’s full time professional effort) be devoted to research activities. Consequently, teaching, clinical duties and other non-research activities should be minimal during the R00 award period. NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. It is suggested that the applicant and/or the hiring institution discuss the institutional commitment with the relevant NIH institute Program Official prior to finalizing the offer. NIH will not activate the independent phase if the institutional commitment is deemed inadequate. Candidates who are approved to transition will receive a Notice of Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).

The K99/R00 award is intended to facilitate successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. K99 candidates are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research. It is important for all candidates, but especially so for those who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence. Candidates are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the R00 application.

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

Termination of the K99 award phase

If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition at an extramural institution occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

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.

Within ten years of making awards under this program, the NIH BRAIN Initiative Working Group will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

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

• Subsequent participation in research or employment in a BRAIN Initiative relevant research field
• Authorship of scientific publications in a BRAIN Initiative relevant research 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 on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-326-8800
Email:[email protected]

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email:[email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
Email: tjarosik@mail.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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.