Part 1. Overview Information

Key Dates

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 Funding Opportunity Announcements (FOAs) 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.

The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives 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.

To support the best science, the NIH BRAIN Initiative encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs.

The BRAIN Initiative requires a high level of coordination and sharing between investigators. 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 such as the annual PI meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

NIH BRAIN Integrated Approaches Funding Opportunities

This RFA is one of a family of Integrated Approaches NIH BRAIN FOAs that range from small or exploratory, targeted brain circuits projects with specific research outcomes (R34, R01) to large, team-research projects with exploratory aims (U01) or with extensive and elaborated goals and a 5-plus year horizon of discovery (U19, this FOA). There is also a special RFA for doing investigative neuroscience in invasive research opportunities in humans (U01). In each case, the FOAs are guided by BRAIN 2025 A Scientific Vision: “The Application of Integrated Technologies to Study Fundamental Questions in Neuroscience: Numerous long‐standing problems in brain science will benefit dramatically from the integrated experimental approach made possible by the BRAIN Initiative.”

Potential applicants are encouraged to visit the NIH BRAIN Initiative website for information and guidance https://www.braininitiative.nih.gov/funding/initiatives.htm.

FOAs in this family of initiatives emphasize the use of cutting-edge methods of activation and recording to understand the behavior of circuits at cellular and sub-second levels of spatial and temporal resolution using human or non-human animal subjects. This family of initiatives also seek advances in theory and/or analytics and have a requirement of a data standards and management plan, as well as a data dissemination plan to facilitate use of the results by the research community.

Team-Research Brain Circuits Programs

Awards within this RFA require multiple PD/PI research programs with 3-5 Research Projects focused on a high impact topic and cutting-edge technologies in large-scale recording and manipulation of circuits in vivo in the context of measurable behaviors. Proposed research should not represent a collection of individual efforts or parallel projects. These research teams should offer resources and governance that bridge across institutional ‘silos.’ For example, research teams might comprise components across institutions or across colleges within a university. Projects should investigate neural function related to defined, ethologically relevant behaviors, well-defined neural systems, and/or biological mechanisms at an anatomic resolution of cells and circuits, and at a sub-second temporal resolution. We expect that awarded projects will become part of a consortium among BRAIN Initiative awardees in developing technologies, methods, expertise, and data and tools for sharing and reuse within the research community. There will be annual reviews by an External Advisory Board per award, with expanded programmatic site visits during years 2 and 4.

The proposed studies must relate to at least one of the seven major topic areas of the BRAIN 2025 report:

1. Discovering diversity: Identify and provide experimental access to the different cell types to determine their roles in the context of circuit function.

2. Maps at multiple scales: Generate structural and functional circuit diagrams that can span resolution from synapses to the whole brain.

3. The brain in action: Produce a dynamic picture of the functioning brain by developing and applying improved methods for large‐scale monitoring of neural activity.

4. Demonstrating causality: Link brain activity to behavior with precise interventional tools that change neural circuit dynamics.

5. Identifying fundamental principles: Produce conceptual foundations about circuit dynamics and functional connectivity for understanding the biological basis of mental processes through development of new theoretical and data analysis tools.

6. Advancing human neuroscience: Develop innovative technologies to understand brain circuits and ensembles of circuits that inform understanding of the human brain and mechanisms for treating its disorders.

7. From BRAIN Initiative to the brain: Integrate new technological and conceptual approaches produced in Goals #1‐6 to discover how dynamic patterns of neural activity are transformed into cognition, emotion, perception, and action in health and disease.

Specific Research Requirements

This RFA solicits applications from diverse interdisciplinary research teams that integrate theoretical models with innovative neurotechnologies for recording and manipulating neural circuits across multiple brain regions and scales. Studies of complex behaviors, including behavioral assays of freely-moving animals and objective measures of cognitive/perceptual processes, are encouraged. Applications may be submitted by teams with prior BRAIN technology and/or integrated approaches awards, and/or by new teams. The goal will be to support programs with a necessarily-synergistic, team-science approach that can realize meaningful outcomes within 5 and more years. Awards from this RFA will be made for no more than 5 years, with a possibility of one renewal.

Programs must include the following features:

• Teams: Multiple PD/PI teams should seek to cross boundaries of interdisciplinary collaboration by bridging fields– including neurobiologists, statisticians, physicists, mathematicians, engineers, computer scientists, and data scientists as appropriate - and linking theory and data analysis to experimental design. Teams must leverage appropriate multi-disciplinary expertise to develop new principles and methods for data acquisition, analysis, and interpretation. The application is required to be submitted as a multiple PD/PI application, with a minimum of 3 PDs/PIs.
• Content: The program should address overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. It should seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions.
• Experimental Design: The program should employ exceptionally innovative approaches to theory and analysis. It must incorporate theory-/model-driven experimental design and to create predictive models (quantitative or conceptual) that offer testable experimental results and/or theoretical concepts as deliverables. Definitive tests of competing theories or experimental outcomes, avoiding confirmation bias for preferred or prevailing concepts, are desired. It must employ approaches guided by specified theoretical constructs that incorporate theories about causal mechanisms of circuit functions, and are encouraged to employ quantitative, mechanistic models where appropriate.
• Innovative algorithmic approaches: Applicants are encouraged to include dynamic tracking of activity from continuous data and real-time signal processing, and to develop methods for interactive data exploration and visualization, and to accomplish innovative dimensionality reduction in high-dimensional data sets.
• Analytical methods and experimental approaches: Applicants are encouraged to link neural processes across multiple scales of structure and time (including the requirement of cellular recording resolution) (e.g., ion channels, to cell compartments/structures, to spike rates/timing, to LFPs/oscillations, to circuits/networks/ensembles, to brain states)
• Technology: The project should employ and/or develop new and emerging capabilities for large scale recording and manipulation of neural activity of specific circuits or systems, ideally across multiple brain regions.

• A cellular resolution of recording circuit activity, at sub-second temporal resolution, is required in order to address mechanistic understanding of circuit functions.
• Scale of recording should be sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome. This will be evaluated using species-appropriate considerations.
• The resolution of mechanistic manipulation of circuits is relaxed from that of single cells to that of cell type/location specificity (e.g., compatible with focal TMS, micro-stimulation, micro-injection, optogenetics/DREADDs, targeted viral vectors).

Some representative, but not exhaustive, examples of technology included in these projects are:

• Reporters of chemical and biochemical signals of brain activity
• Reporters of subthreshold and subcellular voltage signals
• Multi‐area population recording at cellular resolution
• Development of recording and manipulating methods that minimize tissue damage due to invasiveness
• Ability to identify and record from the same neurons over long periods of time
• Ability to anatomically identify recorded cells, including their genotype, phenotype and functional context
• Compatibility with quantitative measures of complex behavior at time resolution compatible with neural recording

Model system: The application should employ justified and appropriate model systems of study, including the possibility of multiple, “ideal” species. It should be made clear how the selected model species offer the best conditions for revealing general principles about the circuit basis of the specific behavior or neural system of interest.

Resource Components: In addition to multiple Research Projects, applications are allowed to propose well-justified Resource Cores that may include professional research staff that will serve the shared technical needs of the Research Projects. Resource Cores will serve technical needs of two or more Research Projects, and support opportunities for sharing technology and technology expertise with external investigators, where appropriate. A dedicated Data Science Resource Core is a requirement.

Data Science Resource: A Data Science Resource Core is a requirement for applications to this RFA. The proposed science in each awarded U19 (the brain circuit of focus) should drive the Data Science Plan (i.e., the research strategy for the Data Science Resource). Therefore, the plan should be customized to fit the science and the specific data science needs of the proposed collection of U19 research components. The Data Science Plan should be offered as a part of the Data Science Resource Core according to the Data Science Qualifications listed in the instructions in that section below. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

Applications must apply NIH standards of experimental and publication rigor (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html), should strive to promote ethnic, racial, gender and career stage diversity of the research teams, and must comply with NIH policy on reporting disaggregated sex-based data and other consideration of sex as a biological variable as elaborated in NOT-OD-15-102, NOT-OD-15-103 and NOT-OD-16-031.

The application is required to be submitted as a multiple PD/PI application, with a minimum of 3 PDs/PIs.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material. This FOA is among the first to require (PEDP) in the application and applicants are strongly encouraged to attend the Technical Assistance teleconference to ask for information on preparing a PEDP.

The (PEDP) mustbe submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Research Objectives

Applications should seek to demonstrate how new and unprecedented experimental capabilities can be used to transform general understanding of neural information processing within the context of specific systems or circuits. The list below includes representative, but not exhaustive, examples of topics that could be considered responsive to this RFA.

• Innovative approaches to understand network coding of sensory information and/or multisensory integration at multiple stages of processing, in response to diverse naturalistic inputs and perceptual contexts.
• New paradigms to assess motor coding during complex behaviors or freely-moving subjects.
• Novel approaches to understand neural circuitry associated with diverse social behaviors.
• Large-scale, dynamic changes in functional circuit connectivity underlying the brain's ability to store information and to learn new behaviors.
• Distributed circuits that contribute to the coordination of motivational states and reward behavior.
• New approaches to capture and assess information processing across brain regions during memory consolidation, memory retrieval, spatial/relational processing, attention, or planning.
• Large-scale approaches to assess distributed representations and the information processing underlying advanced mental processes such as decision making, numerical cognition, consciousness, reasoning, and metacognition.
• Empirical and analytical approaches to understand how behavioral states are emergent properties of the interaction of neurons, circuits, and networks.
• Research to advance principles of circuit function and neural systems in the central nervous system that regulate homeostasis, including biorhythms, and the balance of temperature, respiratory, energy and metabolic functions.
• Research for mechanistic understanding of circuits that spans stages of development.
• Research for mechanistic understanding of how non-neuronal cells support dynamic, functional circuits.

This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants.” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate ‘Clinical Trials Required’ or ‘Clinical Trial Optional’ FOA.

Applications Not Responsive to this FOA

Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:

• Applications for the study of specific disease mechanisms, or specific disease therapeutics and treatments will be considered nonresponsive to this BRAIN Initiative FOA. While fundamental basic research often generates insights relevant to disorders of the nervous system, this FOA is not intended to stimulate research that is explicitly disease-related. Studies for the investigation of specific diseases and disorders should be directed to the appropriate NIH Institutes.
• Applications with clinical trials that are not considered basic experimental studies involving humans (BESH).
• Applications that lack the required one-page PEDP attachment.

Prior Consultation with Scientific/Research staff

Consultation with relevant Scientific/Research staff is strongly recommended, preferably not later than the Letter of Intent due date. This is not the same as the Letter of Intent, and should be included as a separate communication to the Scientific/Research Contact, see Section VII. If requested by the applicants, staff can advise whether the proposed project meets the goals of this FOA 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 FOA. During the consultation phase, if the proposed project does not meet the programmatic needs of this FOA, applicants will be strongly encouraged to consider other Funding Opportunities.

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

Section II. Award Information

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

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government - including the NIH Intramural Program
• U.S. Territory or Possession

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.

• 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

James Gnadt, PhD

Telephone: 301-496-9964

Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall (required -1)
• Research Project (required, minimum 3 maximum 5)
• Administrative Core (required-1)
• Data Science Core (required-1)
• Resource Cores (optional, maximum 3, Resource Core needs to support two or more projects)

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities & Other Resources:

As part of the overall environment for research programs, the BRAIN 2025 report advises that “advances can then best move forward through partnership with other [academic,] clinical and industrial aspects of the research enterprise, which should shoulder some of the cost.”

In this section, describe aspects of the institutional environment that support team science. Describe the institutional and regional research resources that will be utilized to accomplish the goals of the program, and how access to these resources will be ensured for team members. Some examples of institutional environment could include recruitment and salary support of new faculty or professional staff positions to support the resource components, start-up packages, space renovations for team investigators, new facilities within the component projects, dedicated equipment for research and resource components, dedicated budget lines or facilities for a team consortium, dedicated use of commercial products and technologies, equipment and technology contributions from commercial collaborators, etc. Institutional environment can include evidence of pre-application institutional investments promoting and leveraging the NIH BRAIN Initiative interests from its 2014 date of inception, critical start up resources early in the award, or evidence of institutional annual support in the budget.

Other Attachments:

Applicants are required to include the following items: 1) Plan for Enhancing Diverse Perspectives (PEDP)and 2) Neuroethics consideration. These items must be uploaded as separate attachments in pdf format with filenames that correspondss to theindividual items. Applications lacking these required items will be deemed incomplete and will not be reviewed..

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.

Neuroethics Considerations

For the human studies compenents of the application, in an "Other Attachment" of up to three pages entitled "Neuroethical considerations", applications must include this section that describes and discusses in detail the process of informed consenting of research subjects who can expect no direct benefit from engaging in the investigative research proposed, considerations of FDA-defined conditions of non-significant risk/significant risk beyond established standards of clinical care, ethical and practical considerations of invasive device maintenance and ultimate removal, and other ethical issues specific to invasive human neuroscience research (e.g. compensation, informed consent, undue influence, therapeutic misconception and capacity, dual roles of clinician and investigator, etc). The consent methodology needs to address how the possibility of coercion or undue influence, and therapeutic misconception, will be minimized.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

The application must include Multiple Principal Investigators comprising the co-equal principals of the multicomponent research plan.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment of the Overall Component in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:

Provide a concise description of the overall program goals for an impactful and extended scope of work with a 5-plus year horizon. Outline how the approaches and goals of the componant Research Projects will address the requested 5 years of investigative research. In the Overall Specific Aims, the proposed research should be presented as an integrated and synergistic scientific program with specific aims organized to address the overall objectives rather than individual Research Projects. Make clear why the Program can only be accomplished as a collective Program of confederated Research Projects and Cores.

Research Strategy:

Provide a concise description of the goals of the entire program for an impactful scope of work. Briefly describe how the interdisciplinary team is structured, and how the represented areas of expertise will enhance the approach and outcomes of the project.

The Research Strategy should include a description of the scientific problems being addressed, the integration of the research and resource components, and why these components are essential for accomplishing the goals. The overall research strategy should be targeted to a broad audience and be concise. This section should lay out a compelling argument for why a team-research approach is needed to approach the aims, and how the synergy between projects and cores will interact and inform each other in ways not possible as separate research project grants, and at an economy of scale. Assessments of the program will focus on 1) Scientific merit of the neuroscience question(s) posed, 2) Expertise of the research team and technical feasibility of the methods, approaches and interpretations to successfully address the biological question(s) posed, 3) How the selected species and approaches offer the best conditions for revealing general principles about the circuit basis of the behavior or neural system of interest.

The overall research strategy should include:

1. Goals, relevant background, significance, and a description of the impact of the science proposed in relation to the state-of-the-art of the field. This section should also include an explanation of how the work proposed is innovative

2. A section should address how a team-research plan will allow a multidisciplinary approach necessary to accomplish the goals presented. The necessary expertise of each component should be justified, along with how the value of each component would contribute to the whole. This section should describe the working scientific and logistical design, as well as the resource support components necessary to implement the research.

3. The overall research strategy should include evidence for feasibility and can include general and background preliminary findings for the multiple research and resource components. This section should also present very clear evidence that the research team has been/will be able to work together effectively to accomplish the research proposed in the projects. Applicants should offer well-reasoned justifications for new and innovative approaches, including discussion of feasibility.

4. Applicants should include a project timeline in the form of a Gantt chart (or similar) that includes all major tasks to be performed during the project as well as critical benchmarks for success. The chart should also include estimated start and completion dates for those tasks, and should identify the contributions expected from each PD/PI toward accomplishing each task. For a truly integrated collaborative project, it is expected that most or all of the scientific aims will require substantial contributions from more than one PD/PI. This chart will aid reviewers in assessing the feasibility and likelihood that the work plan is adequate for achieving project objectives within the funding period. It will also aid in assessing the degree of integration and collaboration, and the availability of appropriate intellectual and technical expertise for each aim.

5. Describe how the program seeks to identify fundamental principles or produce conceptual foundations about circuit dynamics and functional connectivity.

6. Explain how the program offers potentially transformative and paradigm-shifting advances in understanding brain circuitry underlying complex behavior.

7. Describe how the projects and cores are synergistic, such that they will interact and inform each other in ways not possible as separate research project grants, and at an economy of scale.

8. Described how the Plan for Enhancing Diverse Perspectives will further the significance of the project.

9. Offer the program as a coherent and fully integrated set of specific aims or objectives. Offer a timeline and benchmarks appropriate for accomplishing the specific aims of the research, as neeeded. Explain how the combination of scientific expertise (represented by the PD/PIs) present a compelling case that collaborative, interdisciplinary research will enable scientific advance. Describe how the work plan makes adequate use of existing institutional and/or regional resources. If new resources or equipment are requested, justified them as not redundant with resources available elsewhere in the institution or region.

10. Describe the synergy of the research projects to the overall program objectives.

11. Address appropriate research designs to maximize the reliability and replicability of their findings.

12. Show how the use of cutting-edge methods of activation and recording to understand behavior or a neural system in terms of a mechanistic understanding of specific circuits at cellular and sub-second levels of spatial and temporal resolution.

13. Justify the scale and resolution of recording is sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome, explaining species-appropriate considerations.

14. Justify how the selected model species offers the best conditions for revealing general principles about the circuit basis of the specific behavior or neural system of interest.

15. Describe how the program will link theory and data analysis to experimental design, and explain how it will produce predictive models (quantitative or conceptual) as deliverables.

.

Letters of Support:

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section. There should be evidence of institutional buy-in for shared professional credit for team activities that is sufficient for professional advancement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010. A Resource Sharing Plan for the entire program should be included in the Overall Component, separate Resource Sharing Plans for other components are not necessary. The Data Sharing Plan for the entire program must be included in the Data Science Core.

Appendix:

Only 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 (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 1 - Basic Information

1.4 Clinical Trial Questionnaire

Applications to this FOA must propose a study that falls within the NIH definition of a clinical trial and also meets the definition of basic research. Consequently, applicants must answer "yes" to the four questions on 1.4 Clinical Trial Questionnaire and complete the subsequent form fields accordingly

3.1

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 (Overall)

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

Research Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

The Project Lead must commit at least a total minimum effort of 2.4 person-months per year to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims:

This section should provide a concise description of the aims for the research project.

Research Strategy:

Significance: This section should explain the necessity and contribution of the research project to the overall goals of the U19 program and how the component will interact with, and benefit from, the other participating components. Specifically, this section should describe how the proposed experimental capabilities and/or quantitative and/or theoretical frameworks will support the overall U19 goal. The choice of Project Lead and the key personnel for this component should be justified.

Innovation: Describe the unique and innovative contributions that will be made by this project. Explain how these contributions will be made possible by team synergy beyond the otherwise independent research projects.

Approach: Describe and offer evidence for the feasibility and rigor of the proposed experiments. Justify how the conceptual design, methods, and analyses are adequately developed, well integrated, and well-reasoned. Outline the advantages of any new methodologies, as well as the potential pitfalls and alternative approaches for the project and how these might impact overall progress of the project.

Describe how the proposed research Project Lead(s) are at the forefront of the area of science proposed, with a successful record of bringing novel and potentially high-risk projects to fruition as the principal investigator. Explain how individuals bring complementary and integrated expertise to the overall program.

Carefully relate and justify any proposed human studies (BESH) to the circuit-level mechanistic understanding required for these awards. Research involving humans must inform the overall program requirement of understanding specified behaviors or neural systems in terms of functional circuits.For example, as comparative projects that overlap or extend the cellular and sub-second spatio-temporal requirements to the coarser scales of multi-unit spikes and LFPs/oscillations of circuits, to functionally interconnected networks and ensembles, to brain states and percepts.

Letters of Support:

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section.

Resource Sharing Plan: Not Applicable for this component.

Appendix:

Only 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 (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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?” 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 a 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

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.

Administrative Core

When preparing your application, use Component Type ‘Admin Core’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments: If the application includes investigative human studies (BESH), applicants are required to include the following items: 1) Human Studies Team Management Plan

These items must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (Team Management Plan, and Clinical Protocol Synopsis). Applications lacking these required items will be deemed incomplete and will not be reviewed.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘CoreLead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The Administrative Core Lead must commit at least a total minimum effort of 1.2 person-months per year to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Provide a concise description of the goals of the Administrative Core.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, outreach, to foster synergy, and to support planning and evaluation activities.

Describe how each Project or Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Resource Core needs. The description of the Administrative Core should clearly indicate the, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be affected in a coherent manner.

Additional information required in the Administrative Core Research Strategy:

A Managing Director and an Internal Advisory Committee composed of membership from each contributing component should be described, along with a governance plan that will organize and direct efforts across components. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. (Documentation of these arrangements should be included in the Letters of Support section.) This section should include acknowledgement of establishing a to-be-named External Advisory Board to be convened annually to assess progress and accomplishments, and to advise the team governance. It is very important that potential advisory board members not be contacted before submission i in order to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration by review staff for the peer review panel.

Trainee Management Plan (required): The Trainee Management Plan must not exceed one page. An important and meaningful impact of the TeamBCP is in its role in shaping the next generation of neuroscientists. The U19 structure enables an expanded network to the trainees for collaborations and interactions. The resources and mentors that the trainees can access go beyond that available in their individual labs. Moreover, because of the multidisciplinary expertise, trainees are exposed to and can learn diverse scientific languages and methodologies, resulting in multi-faceted, early-stage investigators. In the Trainee Management Plan describe the efforts to expose trainees to diverse approaches afforded by the collective team program, including options such as multiple mentors, inter-lab meetings, all-hands tutorials, shared meeting and document space, inter-lab visits and trainee presentations, diversity and career advancement workshops. Describe how effort allocation within the U19 program and with other laboratory efforts will be managed, and how credit assignment of technical and intellectual contributions will be negotiated.

Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be affected in a coherent manner.

Describe how the Administrative Core will have the appropriate and effective administrative and organizational capabilities to support multidisciplinary research, outreach, to foster synergy, and to support planning and evaluation activities. Explain how the Administrative Core will clearly indicate how the collective operation of the whole program will be managed in a coherent manner. Describe how the Managing Director demonstrated leadership with a strong record of scientific achievements in the proposed area of science. Demonstrate the Team Director ability to organize, direct, and administer a complex, distributed research program. Offer an Internal Advisory Committee composed of membership from each contributing component, along with a governance plan that will organize and direct efforts across components. Describe how the Internal Advisory Committee is well positioned to foster synergy, Describe process for appropriate prioritization of research, appling strategic course corrections and identifying problems and appropriate solutions, overseeing effective sharing of resources, and conveying a high likelihood of effective, productive management of the program as a whole. Offer an organizational structure that will facilitate coordination and integration of progress ad processes to resolve disagreements within the collective program.

Letters of Support:

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section.

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section.Letters of Support:When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included. (Documentation of these arrangements should be included in the Letters of Support section.)

Resource Sharing Plan: Not appplicable for this component.

Appendix:

Only 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 (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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?” 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 a 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

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.

Data Science Core

When preparing your application, use Component Type ‘Core’

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

SF424 (R&R) Cover (Data Science Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Science Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Science Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Science Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘CoreLead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data Science Core)

Budget forms appropriate for the specific component will be included in the application package.

The Project Lead must commit at least a total minimum effort of 1.8 person-months per year to the project.

The Core should also include budget justified to support software engineering support and infrastructure.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Science Core)

Specific Aims: Provide a concise description of the goals of the Data Science Core.

1. Research Strategy:

   Significance: Describe overall goals of the science proposed in relation to the state of the field. This section should also explain the contribution of the data science core to the overall goals of the program and how the component will interact with and benefit from other components.

   Innovation: Describe the unique and innovative contributions that will be made by this component. Explain how these contributions will be made possible by team synergy beyond the otherwise independent research projects.

   Approach: Describe and offer evidence for the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls and alternative approaches for the project and how these might impact overall progress.

   ResourceSharing Plan:

   Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

   • The Data Science Core is designed to disseminate and share data, as required by the BRAIN data sharing policy. The data science core is responsible for (1) intra-team data sharing and dissemination, in addition to (2) sharing and dissemination to the public. It must include a Data Science Plan, with a timeline and a Data Sharing Plan. The goal of the Data Science Plan is to develop: 1) a service to the proposed U19 research components; and 2) a prototype data science framework for facilitating the workflow for data aggregation and analysis between the Research Components. The plan should be customized to fit the science and the specific data needs of the participating projects. The prototype framework will be shared with the other U19 awardees for further testing and refinement. Specifically, the Data Sharing Plan should be included here , and need not be repeated in the Resource Sharing Plan.
   • The Data Science Plan may include efforts to:Identify best practices, standards, tools, workflows, and computational infrastructures already in use by the research community
   • Adopt existing resources for use by the research components of the proposed U19 project
   • Define common data formats or create tools to harmonize disparate data formats within the U19 project
   • Facilitate the comparison of data across species, as appropriate
   • Provide robust and flexible data management and retrieval tools to function within the U19 project
   • Provide guidance for addressing data provenance
   • Integrate, when appropriate, predictive computational models and analytical tools for guiding experiments
   • Incorporate methods of uncertainty quantification to assess the robustness of model predictions and analytical methods
   • Formulate methods to ensure reproducibility and reusability of models and analytical (e.g., modular models, useable interfaces, etc.)
   • Integrate, when appropriate, formal statistical inference frameworks for causal analyses of data obtained in this project
   • Help determine the magnitude and type of "missing" data that need to be acquired to improve the causal analyses
   • Provide sufficient documentation, end-user training, and technical support for reuse and refinement of the prototype data science framework with other U19 awardees
   • Participate in a BRAIN Initiative U19 consortium to strategize on harmonizing the Data Science Plan and its implementation with other U19 awardees.

   The plan must comply with the Data Science Qualifications listed below:

   1) The data, algorithms, and workflows proposed in the Data Science Plan should consider the FAIR Guiding Principles for scientific data management and stewardship (Wilkinson, M. D. et al. 2016).

   2) The Data Science Plan should maximally leverage existing shared data, algorithms, workflows and computational infrastructure resources and capabilities at the institutional, regional, and national levels - in neuroscience and other scientific domains that can be adapted for the purposes of this U19. The use of these existing resources should be noted in the plan.

   3) The data used, collected, and subsequently managed in this project should be well-defined, utilizing reference data where possible. Investigators are encouraged to work toward consensus standards within the appropriate experimental subfield for representation of data in commonly used domains.

   4) The analytical methods, models, and tools to visualize and analyze the data should be optimized for the science, consistently annotated, and described for each project's own re-use and use by future users. Software services and tools, such as user interfaces and API's, are encouraged.

   5) The framework for integrating the data and analysis methods across the proposed Research Components should include workflows to expeditiously collect, manage, integrate, archive, and analyze the data. This framework should be developed as a prototype to be shared with other U19 awardees to be further refined and developed with input from within this consortium of investigators and the NIH, as described in the cooperative agreement terms and conditions (Section VI.2).

   Data scientists and dedicated, software engineering support may be incorporated into the data science plan. Applicants are welcome to consider editing this example data sharing plan, https://grants.nih.gov/grants/sharing_example_data_sharing_plan.doc to include the sharing of all the tool deliverables from this FOA (e.g. theories, models, methods, software, etc.). Awards made under this FOA must share data using appropriate standards in an appropriate repository.  For example, the NIH BRAIN Initiative will be supporting candidate activities and repositories through 3 BRAIN Informatics FOAs (RFA-MH-17-255, RFA-MH-17-256, and RFA-MH-17-257). Project-specific details will be established at the time of award. Budgets should include sufficient resources to prepare and disseminate data, as appropriate and consistent with achieving the goals of the program.

   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 participants 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. Investigators are encouraged to consult the NIH CDE Repository and describe in their applications any use they will make of NIH-supported CDEs in their projects, when applicable. 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 diseases), 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) Repository 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.

Letters of Support:

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section. Note that individuals providing letters of support will be ineligible as reviewers.

Appendix:

Only 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 (Data Science Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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?” 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 a 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

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.

Resource Core

When preparing your application, use Component Type ‘Core’

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

SF424 (R&R) Cover (Resource Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘CoreLead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

The Resource Core Lead must commit at least a total minimum effort of 1.8 person-months per year to the project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource Core)

Specific Aims:

Provide a concise description of the goals of the Resource Core.

Research Strategy:

Explain how the Resource Core will contribute to individual Research Projects

Significance: Describe overall goals of the science proposed in relation to the state of the field. This section should also explain the contribution of the data science resource core to the overall goals of the program and how the component will interact with and benefit from other components.

Innovation: Describe the unique and innovative contributions that will be made by this component. Explain how these contributions will be made possible by team synergy beyond the otherwise independent research projects.

Approach: Describe and offer evidence for the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls and alternative approaches for the project and how these might impact overall progress.

Describe how the Resource Cores will offer supporting services to two or more Research Projects, and operate independent of any and all research operations intrinsic to the Research Projects. Explain how each Resource Core addresses a critical need or technical barrier to progress in the Research Project components. Describe how each Resource Core will respond to Research Project needs and other Program needs like dissemination of resources, products and expertise to the greater research community. Offer how the Core Lead offers appropriate expertise and sufficient independence from the Research Project components to distribute efforts and resources equitably. Offer a detailed description of the cooperative administrative arrangements when multiple institutional sites are involved. Detail how the institutional support, equipment and other physical resources will be adequate for the Core proposed.

Letters of Support:

Statements of individual and Institutional Commitment, as appropriate to the overall application, should be included in this section. s.

Appendix:

Only 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 (Resource Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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?” 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 a 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

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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

The applicant organization must ensure that the unique entity identifier (UEI) provided on the application is the same number 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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 FOA.  Intellectual property will be managed in accord with 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.  

Post Submission Materials

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

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this FOA, note the following:

The entire research program will receive one Impact Score based on critical considerations of the Overall Program and the collective assessment of Research Projects and Cores. To guide the final scoring, reviewers will make interim assessment scores of the Overall Program and each Research Project (scores 1-9), along with evaluation of each Core (exceptional, adequate, or inadequate). The final Impact Score will reflect assessment of aggregate impact and synergies of the overall program that will balance the collective strengths and weaknesses of the overall goals and the individual components, and not necessarily the arithmetic average of the interim assessment scores.

The BRAIN Initiative invites fundamental basic applications that meet the goals outlined under Research Strategy and have high levels of innovation, which assumes some degree of risk. Reviewers should evaluate whether a sound rationale has been provided as to how and why the research is tractable and likely to generate an exceptionally high impact if successful. Although reviewers will consider feasibility, they will be instructed to not penalize unavoidable risks that are intrinsic to new and innovative approaches. While fundamental basic research often generates insights relevant to disorders of the nervous system, this FOA is not intended to stimulate research that is explicitly disease related.

The collective U19 team effort will be evaluated as an integrated research effort. The relationship and contributions of the Research Projects and Cores to the overall objectives will be discussed and evaluated. Is there synergy between the components that could not be achieved through individual NIH award mechanisms? Are there clear advantages of conducting the proposed research as a collective program rather than through separate efforts?

Individual Components will be assessed for relevant strengths and weaknesses in the context of the whole Program. Final Impact Score need not reflect a cumulative enumeration of minor weaknesses but should reflect a balance of both the quality of the individual components, and the collective synergies and impacts of all the components.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of 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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Does the program seek to identify fundamental principles or produce conceptual foundations about circuit dynamics and functional connectivity

Does the program offer potentially transformative and paradigm-shifting advances in understanding brain circuitry underlying complex behavior

Are the projects and cores synergistic, such that they will interact and inform each other in ways not possible as separate research project grants, and at an economy of scale?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

The application is required to be submitted as a multiple PD/PI application, with a minimum of 3 PDs/PIs.

Is the team diverse and interdisciplinary, such that it is comprised of appropriate content experts in their field? Are the team management plans clear and appropriate?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

Does the program involve innovative ideas or approaches that would be very difficult to pursue through independently funded individual or multiple PD/PI research project grants? Does the program involve innovative combinations of scientific fields and/or intellectual viewpoints to address its goals? Is innovation evident in the method that the established areas of science are combined? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

Is the program presented as a coherent and fully integrated set of specific aims or objectives? Are the timeline and benchmarks proposed appropriate for accomplishing the specific aims of the research? Does the combination of scientific expertise (represented by the PD/PIs) present a compelling case that collaborative, interdisciplinary research will enable scientific advance? Does the work plan make adequate use of existing institutional and/or regional resources? If new resources or equipment are requested, are they well justified and not redundant with resources available elsewhere in the institution or region?

Is there appropriate synergy of the research projects to the overall program objectives?

Have the applicants addressed appropriate research designs to maximize the reliability and replicability of their findings?

Does the program involve the use of cutting-edge methods of activation and recording to understand behavior or a neural system in terms of a mechanistic understanding of specific circuits at cellular and sub-second levels of spatial and temporal resolution?

Is the scale and resolution of recording sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome? This should be evaluated using species-appropriate considerations.

Does the program justify how the selected model species offer the best conditions for revealing general principles about the circuit basis of the specific behavior or neural system of interest?

Does this program aim to link theory and data analysis to experimental design, and will it produce predictive models (quantitative or conceptual) as deliverables?

How well does the Data Sharing Plan provide a summary of the shared data, a description of the data standards, a plan for the data archiving, and a timeline for data submission to the archive and sharing data with the research community?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Scored Review Criteria - Research Projects

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Does the project justify how its experimental capabilities and/or quantitative and/or theoretical frameworks will support the overall goal? Is the project necessary for success of the program? Would the program suffer if the project were flawed?

Does the project make an important contribution to the U19 program as a whole?

Is this project well integrated with the scientific objectives of the U19 program?

Is the project original and innovative?Is the project original and innovative?Is the project original and innovative?

Are the conceptual design, methods, and analyses adequately developed, well integrated, and well-reasoned?

Investigator(s)

Are the Project Lead(s), collaborators, and other researchers well suited to the program? If applicants are Early Stage Investigators or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Are the proposed research Project Lead(s) at the forefront of the area of science proposed, with a successful record of bringing novel and potentially high-risk projects to fruition as the principal investigator? Do the individuals bring complementary and integrated expertise to the overall program?

Innovation

Does the application challenge and seek to shift current research by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

Is the project original and innovative?

Approach

Are the strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be effectively managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) 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), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Have the applicants addressed appropriate research designs to maximize the reliability and replicability of their findings?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Review Criteria - Cores

Reviewers will not provide individual criterion scores for Cores and will assign overall ratings of exceptional, adequate or inadequate. The review criteria for the individual Cores are provided below.

Administrative Core

Does the Administrative Core have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, outreach, to foster synergy, and to support planning and evaluation activities? Does the Administrative Core clearly indicate how the collective operation of the whole program will be managed in a coherent manner? Has the Managing Director demonstrated leadership with a strong record of scientific achievements in the proposed area of science? Has the Team Director demonstrated his/her ability to organize, direct, and administer a complex, distributed research program? Is the Internal Advisory Committee composed of membership from each contributing component, along with a governance plan that will organize and direct efforts across components? Is the Internal Advisory Committee well positioned to foster synergy, ensure appropriate prioritization of research, apply strategic course corrections and identify problems and appropriate solutions, oversee effective sharing of resources, and convey a high likelihood of effective, productive management of the program as a whole? Is there an organizational structure that will facilitate coordination and integration of progress? Is a process to resolve disagreements within the collective program described?

Does the application include acknowledgement of establishing a to-be-named External Advisory Board to be convened annually to assess progress and accomplishments, and to advise the team governance?

Does the application include a Trainee Management Plan (required; not to exceed one page) that describes the efforts to expose trainees to diverse approaches afforded by the collective team program, including options such as multiple mentors, inter-lab meetings, all-hands tutorials, shared meeting and document space, inter-lab visits and trainee presentations, diversity and career advancement workshops. Does the application describe how effort allocation within the U19 program and with other laboratory efforts will be managed, and how credit assignment of technical and intellectual contributions will be negotiated. Is there evidence of institutional buy-in for shared professional credit for team activities that is sufficient for professional advancement? If shared research resources will be utilized, are plans adequate to ensure that all team members will have the access they require?

Data Science Core

Does the Data Science Core provide a reliable service to the proposed U19 research components? Does the Data Science Core provide a reasonable plan to optimally design a prototype data science framework for facilitating the workflow for data aggregation and analysis between the proposed Research Components? To what extent is the proposed data science framework development process incorporating risk to test new methodologies to produce generalizable approaches for the other BRAIN BCP efforts?

Does the application offer a Data Science Core that will identify best practices, standards, tools, workflows, and computational infrastructures already in use by the research community? Does the application provide robust and flexible data management and retrieval tools to function within the U19 project? Does the core integrate, where appropriate, predictive computational models and analytical tools for driving experiments? Does the plan incorporate appropriate data science staff and software engineering support? Have the investigators appropriately included plans to reuse existing best practices, standards, software tools, and computational infrastructures to manage their data, algorithms, and workflows? To what extent have the investigators proposed to develop new data standards, software tools for reusability, and computational infrastructures? Is this effort appropriate and well-justified for providing a prototype data science framework for this U19 project?

Resource Cores

Does each Resource Core offer supporting services to two or more Research Projects, and operate independent of any and all research operations intrinsic to the Research Projects? Does each Resource Core address a critical need or technical barrier to progress in the Research Project components? Does the application describe how each Resource Core will respond to Research Project needs and other Program needs like dissemination of resources, products and expertise to the greater research community?Does the proposed Core Lead offer appropriate expertise and sufficient independence from the Research Project components to distribute efforts and resources equitably? Does the application offer a detailed description of the cooperative administrative arrangements when multiple institutional sites are involved? Are the institutional support, equipment and other physical resources available adequate for the Core proposed?

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.

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Animal 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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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.

Applications from Foreign Organizations

Not Applicable

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).

Resource Sharing Plans

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

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)  convened by NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

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

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 appropriate national Advisory Council or Board. 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 including the PEDP.

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 theNIH Grants Policy Statement.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html 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 FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the NIH as defined below. The PD(s)/PI(s) will have the primary responsibility for:

• PDs/PIs will determine and coordinate the research approaches and procedures, conduct experiments, and analyze and interpret research data generated under this award.
• PDs/PIs will endeavor to meet the timeline stated in their application.
• Participate with an External Advisory Board including appointed research experts outside the research team and NIH staff.
• The PDs/PIs and other principals of the U19 will join other recipients of this RFA in a consortium to communicate across U19 projects and to facilitate common and collaborative efforts as determined by the Program Officer with the consortium.
• PDs/PIs will provide updates at least annually on implementation of the PEDP.
• PDs/PIs will agree to participate as a voting member in Research Consortia composed of other BRAIN Initiative recipients and NIH staff.
• PDs/PIs will share resources and data, final results, and technology with the broader research community as appropriate and consistent with achieving the goals of the program. PDs/PIs will ensure that results are published in a timely manner.
• PDs/PIs will submit data for quality assessment and/or validation in any manner specified by the NIH ProgramOfficer.
• PDs/PIs will submit periodic progress reports.
• PDs/PIs will provide updates at least annually on the implementation of the PEDP.
• PDs/PIs will accept and implement any other common guidelines and procedures approved by the Program Officer.
• PDs/PIs will attend BRAIN Initiative-related meetings. It is likely that there will be one in-person meeting per year and that other meetings will be by telephone or using internet-assisted meeting software.
• Recipientswill retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance and be named on the Notice of Award.
• A group of NIH program staff from the ICs contributing to the NIH BRAIN Initiative will form a Project Team for this award.
• The Project Team will be led by the Program Officer(s) for these BRAIN Initiative awards.
• The Project Team, led by the Program Officer(s) for these BRAIN Initiative awards, will review annual progress reports and other documents from the recipients and will advise the Program Officer about their view of the progress being made by the recipient as well as about progress being made by others in the field.
• One extramural NIH program staff member will be assigned as the Project Coordinator for this award. The same person may serve as the Project Coordinator for multiple BRAIN Initiative awards
• The Project Coordinator will provide technical assistance, advice, coordination, and other program actions supporting the Program Officer and recipients of these cooperative agreements during the conduct of an activity, which may be above and beyond the levels required normally for program stewardship of grants.
• The additional duties of the Project Coordinator may include attending and participating in meetings of Principle Investigators and NIH Staff, assisting in the development of the meeting agendas, assisting in evaluating achievement of proposed outcomes, and as needed, assisting with the establishment of a consortium for the purpose of sharing information and coordination of research activities among the recipients of these cooperative agreements.
• In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Areas of Joint Responsibility include: None; all responsibilities are divided between recipientsand NIH staff as described above. Dispute Resolution: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D, and DHHS regulation 45 CFR Part 16.

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.

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 FOAs 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 Part 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 75.113and 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 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

James Gnadt, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email:[email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email:[email protected]v

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

Section VIII. Other Information

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

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