It is critical that applicants follow the instructions in the Career Development Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH 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. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision, which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This FOA and other FOAs issued in Fiscal Year 2017 are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.

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

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.

The BRAIN Initiative will require a high level of coordination and sharing between investigators. While this FOA does not use a cooperative agreement mechanism, it is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.

Educational goals for the NIH component of the BRAIN Initiative (see BRAIN 2025: A Scientific Vision) include acquisition of quantitative skills, the appropriate use and integration of newly developed tools, technologies and methods developed under the BRAIN Initiative, and consideration of the ethical implications of neuroscience research. The BRAIN 2025 Report notes that individuals should obtain robust grounding in quantitative reasoning, principles, and techniques during their training. A special focus is training in quantitative neuroscience; i.e., theory and statistics for biologists, and exposing physicists, engineers, and statisticians to experimental neuroscience. The BRAIN 2025 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.

This FOA is related to the education recommendations in Section II.7 of the BRAIN 2025 Report. Specifically, this FOA invites applications for mentored career enhancement (K18) awards in research areas identified by the BRAIN 2025 Report as high-priority research areas. This career enhancement program will support development of research capability for the BRAIN Initiative, with specific emphasis on training independent investigators in a cross-disciplinary area to the candidate's established research program and central to the BRAIN Initiative. The career enhancement program should provide the investigator with cutting-edge research skills and conceptual knowledge to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative.

For BRAIN Initiative awards to date, see http://www.braininitiative.nih.gov/funding/fundedAwards.htm.

This purpose of this award program is to provide up to two years of protected time to independent investigators to augment or redirect their research programs through the acquisition of cutting-edge research skills and conceptual knowledge to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative. The applicant must propose a mentored career enhancement plan that includes a collaborative research project in any high-priority research area identified by the BRAIN Initiative long-term scientific plan, BRAIN 2025: A Scientific Vision, and will meet the above-stated goal.

Applications are strongly encouraged from individuals seeking training in a cross-disciplinary area to the candidate's established research area and central to the BRAIN Initiative. A neuroscientist may propose to extend training in a substantively different area of neuroscience, neuroethics, or in a quantitative and physical discipline (e.g., physics, chemistry, engineering, computer science, mathematics); and vice versa, an investigator trained in a quantitative or physical discipline may propose to gain in-depth training in an area of neuroscience highly relevant to the BRAIN Initiative using state of the art neuroscience technologies. For example, an independent investigator trained in cognitive and behavioral neuroscience may propose a career enhancement program in electrophysiology using next-generation multi-electrode arrays; and just as appropriate for this FOA, an independent geneticist and developmental neuroscientist may propose a program in experimental optical physics with high applicability to the goals of the BRAIN Initiative. The proposed program is expected to develop sufficient depth in the cross-discipline to allow the investigator to provide significant contributions to collaborative projects as an independent investigator.

For the purpose of this FOA:

• The applicant must propose a mentored career enhancement plan that includes a collaborative research project in any high-priority research area identified by the BRAIN Initiative long-term scientific plan, BRAIN 2025: A Scientific Vision.
• The research project must take place in a host laboratory, whether in the applicant institution (i.e., candidate's home institution, where (s)he holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career enhancement experience. In both cases, the tutelage of a well-qualified sponsor/mentor (or team of mentors/sponsors) is required.
• The host laboratory must be actively engaged in research with high relevance to the goals of the BRAIN Initiative, as articulated in the 2014 report to the Advisory Committee to the Director, BRAIN 2025: A Scientific Vision.
• The research enhancement program proposed should have the potential to substantially augment the research capabilities and conceptual knowledge of the candidate in areas highly relevant to the BRAIN Initiative in order to enhance the candidate's ability to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative.

The career enhancement plan may include an academic enrichment plan of coursework, seminars, journal clubs, etc., if appropriate. The candidate and the proposed primary mentor will not have current well-established and long-standing research collaborations candidates are expected to either establish new collaborative arrangements or strengthen and enhance relatively new or developing collaborations on a research project of high relevance to the BRAIN Initiative. A new or relatively new collaboration may be determined by an absence of publications on which both the candidate and mentor are listed as senior authors.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• 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)
• 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

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

Applicant Organizations

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

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

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

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

Any 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(s) and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

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

Candidates must have a research or health-professional doctoral degree or equivalent. The research doctoral degree may be in neuroscience or in a quantitative or physical discipline. The candidate should have demonstrated professional accomplishments consonant with his or her career status.

Eligible candidates are independent investigators at any faculty rank or level, from the research assistant professor to the senior faculty level, who have shown clear evidence of productivity and research excellence in the field of their training, and who propose to expand their research capability, with the goal of making significant contributions to the goals of the BRAIN Initiative.

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

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. 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 NOT-OD-11-101).

If applicable, candidates may submit research project grant (RPG) applications concurrently with a career award (K) application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the K application.

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.

At the time of award, the candidate must have a "full-time" appointment at an eligible institution. Candidates must commit a minimum of 3 person-months of full-time professional effort over the duration of the project period, regardless of whether the effort is expended consistently throughout the academic or calendar year, be focused during the summer months, or be split over two summers. Since the depth of knowledge that is to be acquired is considerable, 6 person-months (or more) of full-time professional effort over the course of the project period is encouraged.

This award is intended for independent investigators at all career stages, but it requires the commitment of an experienced mentor from the proposed new discipline. The mentor should be recognized as an accomplished investigator in the proposed research area, which must be aligned with at least one of the high-priority goals identified in the BRAIN 2025 Report. The mentor should have evidence of successfully mentoring faculty and productive collaborations, and be committed both to the career enhancement of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support to conduct the proposed research, in excess of the research development funds provided through this award. Candidates may identify more than one mentor, i.e., a co-mentor or mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career enhancement program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The candidate must have independent, peer-reviewed research support (e.g., R21, R01, DP1, DP2, P01, P50) as PD/PI at the time of submitting the application, with the exception of investigators from quantitative disciplines, such as mathematics, who have an established research program evidenced by peer-reviewed publications and the mentorship of graduate students. Training (T and D43) and research education (R25, R90), fellowship (F32, F33), clinical trial or research project planning (R34), Pathways to Independence (K99/R00), or other career development (K) awards are not considered eligible research support for this FOA. It is not a requirement that the candidate or the proposed mentor receive his/her primary research funding from the NIH. Further, it is expected that the candidate and/or the mentor has sufficient research funding to support the proposed mentored research project, in excess of the allowable costs of this award.

Institutional Environment

The home institution is the applicant institution, and may be a different institution than the host institution. Both institutions must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors. The host institution must in addition have well-qualified faculty and a strong record of research in areas relevant to the goals of the BRAIN Initiative.

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

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

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

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

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

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

The letter of intent should be sent to: [email protected]

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

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

Other Attachments: Attach a one-page description of the relationship of the proposed career enhancement program to one or more of the specific goals stated in the BRAIN 2025 Report. The first sentence of this description should state which of the seven, high-priority goals enumerated in this Report is addressed by your program. Name this file: Program Relationship to BRAIN.

Attach a separate one-page description of the relevance of the host laboratory's active research projects to the goals of the BRAIN Initiative. Include only the projects that have high relevance to one or more of the specific goals in the BRAIN 2025 Report. Name this file: Host Lab Relationship to BRAIN.

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

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

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

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

The PHS 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
• Human Subjects Sections
• Other Research Plan Sections
• Appendix

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

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

Candidate Information and Goals for Career Enhancement

Candidate s Background

• Describe the candidate's commitment to a career in research areas of high relevance to the goals of the BRAIN Initiative.
• Describe the candidate’s current research program and research expertise, and how these are complementary for the proposed program in the cross-disciplinary area.
• Present evidence of the candidate’s success as an independent investigator and his/her potential to acquire the skills and conceptual knowledge to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative.
• Present evidence of the candidate's ability to interact and collaborate with other scientists.

Career Goals and Objectives

• Describe the candidate’s immediate and long-term career objectives.
• Describe the candidate's career goals and objectives under this award.
• Explain how the K18 award will contribute to these goals, and further the candidate’s research career and ultimate impact on the goals of the BRAIN Initiative.
• Candidates are encouraged to provide a timeline for accomplishing these goals.

Candidate s Plan for Career Enhancement Activities During Award Period

• Describe any cutting-edge research skills and conceptual knowledge he/she will acquire during the career award period, and how this will be accomplished by the proposed research project.
• As relevant, describe how the proposed short-courses, seminars, and other academic enrichment activities will contribute to the skills and conceptual knowledge to be gained.
• Provide a timeline for planned activities, milestones and other benchmarks. Although submitting a subsequent grant application is not an expectation of this award, any plans for a subsequent application on a topic of high relevance to the K18 research project or the BRAIN Initiative should be detailed in the timeline.

Research Plan Section

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

Research Strategy

• Provide a sound research plan that is designed to enhance the candidate's ability to provide significant contributions or lead future collaborative projects in areas of high relevance to the BRAIN Initiative.
• Provide a Statement of Hypothesis and Specific Aims; Background; Preliminary Data, if applicable; Significance and Rationale; and Research Design and Methods. Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show how the candidate's established research program will be enhanced according to the goal of this FOA.

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 candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• Describe the peer-reviewed research support of the mentor at the time of submitting the application and whether this funding, in conjunction with the candidate's research support in excess of the allowable costs of this award, is adequate to support the proposed mentored research project.
• Describe how the expertise of the mentor is relevant to the research project and to the goals of the BRAIN Initiative.
• If the applicant and mentor have previously collaborated, describe the nature and recency of the collaboration and justify the need to further develop this collaboration.
• Provide evidence of successfully mentoring faculty and productive collaborations, and describe the commitment to the career enhancement of the candidate.
• Describe the nature of the supervision and mentoring that will occur during the proposed award period.
• Describe a plan for career enhancement that will provide the candidate with the cutting-edge skills and conceptual knowledge in the research area proposed.
• Provide a plan for monitoring the candidate’s research and progression towards the goals of this FOA in addition to annual evaluations of the candidate’s progress as required in the annual progress report.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.

Letters of Support from Collaborators, Contributors and Consultants

• Each collaborator and/or consultant must provide a signed statement that confirms his/ her participation, describes his/her specific role, and documents the expertise he/she will contribute. These individuals generally do not need to provide their biographical sketches. These individuals also are not directly involved in the development of the candidate's career enhancement program.
• The host institution must provide a letter of support. It should ensure the candidate has the appropriate resources within the host laboratory and access to facilities to carry out the proposed research project. The host institution must provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career enhancement plan. The host institution must provide a statement of assurance that the candidate will be able to devote the proposed number of person-months of full-time professional effort to this research career enhancement program, which must be a minimum of 3 person-months over the course of the project period. The host institution must provide a statement of commitment to the development or enhancement of the candidate's research capability for the BRAIN Initiative. Note that this letter should not duplicate the letter from the home instiutiton, submitted as part of the Institutional Commitment to the Candidate’s Research Career Development attachment. .

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

• Separate from the mentor's letter, the host institution must document a strong, high-quality research program in an area that is highly relevant to the BRAIN Initiative, including key faculty members and other investigators capable of productive collaboration and mentoring of the candidate.

Institutional Commitment to the Candidate’s Research Career Development

• The Commitment letter from the home institution, which is the applicant institution, should be submitted here.
• The candidate's home institution must provide statements of assurance that the candidate will be able to devote the proposed number of person-months of full-time professional effort to this research career enhancement program, which must be a minimum of 3 person-months over the course of the project period. The letter from the home institution must be signed by the relevant administrators (e.g., department chairs, deans) and provide a clear and unambiguous assurance that, during the active period of the K18 award, the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award. The home institutional representatives should also indicate what, if any, duties or commitments the candidate will continue to maintain, including grant-related responsibilities.
• The candidate's home institution must provide a statement of commitment to the development or enhancement of the candidate's research capability for the BRAIN Initiative.
• If the host laboratory is at the candidate's home institution, but in a different department or division from the candidate's department, signed statements of commitment and assurances of professional effort toward the career enhancement award are required from both (i.e., all relevant) departments. The host department or division commitment letter should be submitted as the host institutional letter via "Letters of Support from Collaborators, Contributors, and Consultants."

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the BRAIN Initiative, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

To be considered responsive to this FOA, the proposed career enhancement program must include a mentor and include a research project in a high-priority research area identified by the BRAIN Initiative long-term scientific plan (BRAIN 2025: A Scientific Vision). In addition, the research project must take place in a host laboratory that is actively engaged in research with high relevance to the goals of the BRAIN Initiative.

Applicants are required to follow our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: The purpose of this award program is to provide up to two years of protected time to independent investigators to augment or redirect their research programs through the acquisition of cutting-edge research skills and conceptual knowledge to significantly contribute to or lead projects that investigate questions central to the goals of the BRAIN Initiative. The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. The proposed program is expected to develop sufficient depth in a cross-discipline to allow the investigator to provide significant contributions to collaborative projects as an independent investigator.

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

• Does the candidate demonstrate potential to attain the deeper knowledge of the proposed research area to be able to significantly contribute to or lead future projects in accordance with the goals of this FOA?
• Does the candidate demonstrate a record of productivity in his/her field of expertise, as evidenced by contributions to the scientific literature?
• Is there evidence of current, independent, peer-reviewed research support?
• Does the candidate show evidence of his/her ability to interact and collaborate successfully with other scientists?

Career Enhancement Plan/Career Goals and Objectives

• Are the candidate's career enhancement goals and objectives under this program consistent with the candidate's immediate and long-term career objectives?
• Is the proposed career enhancement program in a cross-discipline relative to the candidate's current expertise, and would development in this new area complement the investigator's research program?
• Is the program likely to develop the candidate's knowledge in the cross-discipline in sufficient depth for the candidate to be able to provide significant contributions to collaborative projects as an independent investigator?
• Does the addition of the research skills and conceptual knowledge to be gained from the proposed program significantly enhance the candidate's research capability in accordance with the goals of this FOA?
• Are the structured activities such as seminars or technical workshops, if applicable, appropriate for the research area and likely to substantially enhance progression in the research area and project?
• Are the content, scope, and duration of the career enhancement plan likely to achieve the goals of this FOA? Is a timeline for planned activities, milestones and benchmarks clear?
• Is there evidence that the candidate will be able to devote the proposed number of person-months of full-time professional effort to this research career enhancement program, which must be a minimum of 3 person-months over the course of the project period?

Research Plan

• Is the research project plan appropriate for developing the research skills and conceptual knowledge described in the career enhancement plan?
• Are the proposed research question, design, and/or methodology innovative, and of significant scientific and technical merit to be likely to have a significant impact on the investigator's ability to contribute or lead future projects in accordance with the goals of this FOA?
• Is the research question significant? Does the research project have the potential to substantially change the way the brain is investigated, or does it develop or employ novel concepts, approaches, methodologies, tools, or technologies?
• 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, and authentication of key biological and/or chemical resources?

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

• Are the qualifications and experience of the mentor(s) and collaborator(s) in a high-priority area as identified by the goals of this FOA?
• Does the mentor(s) demonstrate commitment to the career enhancement of the candidate and to the mentoring of the candidate’s research?
• Do collaborators, if applicable, also demonstrate commitment to the project?
• Does the mentor have a successful track record of mentoring faculty and successful collaborations?
• If the candidate and mentor have previously collaborated, is the collaboration sufficiently recent and/or under-developed that a continuing or renewing collaboration or mentoring relationship would develop new skills and knowledge base in the proposed cross-disciplinary area?
• Is the mentor's proposed role likely to enhance the candidate's development of cutting-edge skills and conceptual knowledge in the proposed area?
• Is there evidence of the mentor's current research productivity, and does the mentor have sufficient research support and facilities for the mentored research project?
• Is active research grant funding between the candidate and mentor sufficient to support the proposed research project?
• Are there adequate plans for monitoring and evaluating the candidate's progress toward the goals of this FOA?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the host institution to ensure that a minimum of 3 person-months of full-time professional effort will be devoted directly to the research and career enhancement activities described in the application? Is there documentation of any requisite commitments of the candidate at the host institution during the career enhancement program?
• Are the research facilities and resources adequate and appropriate for the career enhancement program, including productive faculty with relevant expertise for productive collaboration and mentorship with the candidate?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., unique collaborative arrangements, subject populations, or access to facilities or equipment?
• Does the candidate’s home institution provide an assurance that the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award so that he/she will be able to devote the proposed number of person-months of full-time professional effort to this research career enhancement program, which must be a minimum of 3 person-months over the course of the project period?
• Does the home institution indicate what, if any, duties or commitments the candidate will continue to maintain, and do the extent of these commitments seem reasonable for the level of effort that the candidate needs to expend on this program?

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

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

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

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

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

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.

Not Applicable

Not Applicable

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.

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the 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.

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

As part of the scientific peer review, all applications:

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

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

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 Council on Drug Abuse. The following will be considered in making funding decisions:

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

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

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

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

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

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

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

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

When multiple years are involved, awardees 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. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Michele Rankin, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-3832
Email: [email protected]

Mark Swieter, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5844
Email: [email protected]

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6685
Email: [email protected]

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

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