Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Funding Opportunity Title
BRAIN Initiative Connectivity across Scales Data Coordinating Center (BRAIN CONNECTS DCC) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type
New
Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

Related Notices
  • January 30, 2024 - Notice of Change: Extension of RFA-NS-24-028 - BRAIN Initiative Connectivity across Scales Data Coordinating Center (BRAIN CONNECTS DCC) (U24 Clinical Trial Not Allowed). See Notice NOT-NS-24-025
  • December 22, 2023 -Notice of Change to Allow Post-Submission Materials for RFA-NS-24-028 and RFA-NS-22-049. See Notice NOT-NS-24-046.
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
  • February 22, 2022 - BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Comprehensive Centers for Human and Non-Human Primate Brain (UM1 Clinical Trial Not Allowed). See NOFO RFA-NS-22-047.
  • February 22, 2022 - BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Comprehensive Centers for Mouse Brain (UM1 Clinical Trial Not Allowed). See NOFO RFA-NS-22-048.
  • February 22, 2022 - BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Specialized Projects for Scalable Technologies (U01 Clinical Trial Not Allowed). See NOFO RFA-NS-22-049.
Notice of Funding Opportunity (NOFO) Number
RFA-NS-24-028
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.853, 93.273, 93.213, 93.286, 93.865, 93.866, 93.173, 93.242, 93.867, 93.279
Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) solicits applications for one or more Data Coordinating Centers (DCCs) to support BRAIN CONNECTS, a networked consortium of Comprehensive Centers and Specialized Projects funded under RFA-NS-22-047, RFA-NS-22-048, and RFA-NS-22-049. The goals of BRAIN CONNECTS awards are to develop the research capacity and technical capabilities for comprehensive brain-wide connectivity mapping in mouse, human, and non-human primate (NHP). BRAIN CONNECTS projects will collect and process unprecedented volumes of anatomical data by scaling up cutting-edge acquisition modalities and analysis methods, to demonstrate the feasibility and potential impact of production, analysis, dissemination, and interpretation of connectivity maps from entire brains. The resulting feasibility data from these awards are expected to inform NIH decisions on program continuation in a potential subsequent five-year funding period for production of brain-wide wiring diagrams.

Through this NOFO, NIH expects to fund one or more BRAIN CONNECTS DCCs, which will collaborate with the technology development projects to (1) coordinate activities of the BRAIN CONNECTS Network, (2) develop and harmonize common data processing pipelines, (3) integrate and disseminate data analytic tools and capabilities, (4) establish a unified knowledge base for connectivity data of diverse modalities, and (5) organize and implement outreach and engagement to the wider research community and the general public. Awards will be integrated into the BRAIN CONNECTS Network as a coordinated effort aimed at developing the ability to generate whole-brain wiring diagrams across multiple scales and species.

Key Dates

Posted Date
October 30, 2023
Open Date (Earliest Submission Date)
December 29, 2023
Letter of Intent Due Date(s)

December 29, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
January 29, 2024 Not Applicable Not Applicable July 2024 October 2024 December 2024
August 21, 2024 Not Applicable Not Applicable December 2024 January 2025 February 2025

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

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

Expiration Date
New Date August 22 2024 (Original Date: January 30, 2024) per issuance of NOT-NS-24-025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of 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 Notices of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.

The NIH BRAIN Initiative recognizes that 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 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 historically 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 can consider applying for BRAIN Initiative SBIR/STTR funding (see NOT-MH-21-125).

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO will require a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. 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. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material as described in NOT-MH-21-310.

BRAIN CONNECTS

The BRAIN CONNECTS DCC(s) will be charged with supporting awards from the following NOFOs:

RFA-NS-22-047 UM1 Comprehensive Centers for Human and Non-Human Primate Brain

RFA-NS-22-048 UM1 Comprehensive Centers for Mouse Brain

RFA-NS-22-049 U01 Specialized Projects for Scalable Technologies

Details and PI contact information can be found by searching NIH RePORTER for awards from each of the three NOFOs.

Comprehensive Center UM1 awards will establish full production pipelines, from sample collection through data integration, analysis, and dissemination, applied to sub-volumes that are sufficiently large to prove feasibility of whole-brain mapping. From these sub-volumes, specific hypotheses will be tested to understand relationships between circuit structure and function and the neural substrates for complex behaviors. Centers will also incorporate toolsets and infrastructure for integrating additional data of the same and different modalities, and for enabling the neuroscience community to interact with and mine the data for new research questions.

Specialized Project U01 awards are expected to complement the Comprehensive Centers with distinct capabilities and competencies, to develop and scale up any aspect(s) of the pipeline, from sample processing, data acquisition and analysis, to integration with the larger neuroscience data environment and dissemination to the research community.

The funded CONNECTS awards include diverse mapping technologies and associated data processing and analytic approaches. For human and NHP, the common goal is to establish high-resolution region-to-region connectivity at the level of axonal projections. For mouse, the goal is local and long-range cell-to-cell connectivity at the level of synaptic connections. A variety of acquisition and analysis methods will be scaled to unparalleled throughput and unprecedented tissue volumes.

The BRAIN CONNECTS Network

BRAIN CONNECTS DCC(s) will be responsible for coordinating consortium efforts of the BRAIN CONNECTS Network. All CONNECTS award recipients contribute to the activities of the Network, which is governed by a Steering Committee consisting of award PIs and an NIH representative. Expectations and requirements for each project are published in the Cooperative Agreement Terms and Conditions of each NOFO and include agreement to accept and implement common policies and guidelines as approved by the Steering Committee. The DCCs will coordinate the following requirements of CONNECTS Network members to:

  • Optimize data production and analysis across various modalities, including dissemination of best practices and collective evaluation of procedures, resources, and emerging technologies.
  • Establish common data release and resource sharing policies, develop uniform procedures for data standardization and quality assurance, and agree on consensus metrics for assessing scalability, benchmarking performance, and comparing between approaches.
  • Submit data for quality assessment to ensure scientific rigor, and share algorithms and software source code with other Network members for scientific evaluation, while maintaining confidentiality and adhering to NIH intellectual property policies.
  • Coordinate and collaborate with other U.S. and international groups that may be generating complementary datasets, and as needed, establish working groups including outside experts to address specific issues of high importance to the broader field.

BRAIN CONNECTS DCC Requirements

Detailed requirements for the NOFO are included in the application instructions (Section IV, below). The BRAIN CONNECTS DCC(s) will be integrated into the BRAIN CONNECTS Network and will collaborate with CONNECTS technology development projects to accomplish the following five Critical Elements.

1. Coordinate activities of the BRAIN CONNECTS Network.

The DCC(s) will coordinate the efforts of the Network consortium, including the requirements outlined above and any relevant activities agreed upon by the Network Steering Committee during the course of the project.

2. Develop and harmonize common data processing pipelines.

DCC applications must propose to harmonize and optimize processing, analysis, and dissemination of data from one or more of the following data acquisition and analysis modalities:

  • Electron microscopy and automated segmentation and classification of cells and synapses, integrated with transcriptomic cell-type data by positional and morphological correlation.
  • Fluorescence microscopy and tracing of axonal projections, densely labeled by antibodies to endogenous markers, or sparsely labeled by injection of fluorescent tracers or virally expressed fluorescent proteins.
  • Nucleotide barcode library expression, followed by bulk sequencing of micro-dissected tissue, or by in-situ sequencing of cell bodies and axons combined with transcriptomic cell-type identification of single barcoded cells.
  • Axonal projection and fiber orientation data collected from the same brains using multiple imaging modalities, including high-gradient-strength diffusion MRI, polarization-sensitive optical coherence tomography, and high-energy coherent phase-contrast X-ray tomography.

On an ongoing basis, the DCC(s) will convene projects producing and analyzing data of the same modality, to develop consistent data and metadata standards and practices, to agree on quality assurance protocols, and to implement shared archiving and dissemination strategies. This effort will leverage the BRAIN Initiative Data Infrastructure as appropriate, which is funded under RFA-MH-20-600 and related NOFOs (for more information see https://braininitiative.nih.gov/research/data-science-and-informatics/informatics-program), for data sharing and development of cloud-based analytic tools. The DCC(s) will also be responsible for developing metrics and implementing processes for assessing scalability and comparing between approaches. In addition, the DCC(s) will coordinate planning and assessment of future capabilities for processing datasets approaching exabyte scale, including new approaches to data compression, as well as protocols and consensus policies for sharing reduced derivative data to the neuroscience research community.

3. Integrate and disseminate data analytic tools and capabilities.

For each data modality, DCC(s) are expected to instantiate a unified environment for cooperative or competitive development of visualization and analysis toolsets, and for online algorithms with potential to scale up to brain-wide capabilities. The resulting software tools and analysis products will be broadly distributed for democratized access and analysis by the neuroscience research community. Online platforms must be compatible and interoperable with data submitted to the BRAIN Initiative Data Archives, and must include architecture for data validation, shared annotation, error correction and ground truth comparisons, as well as query and statistical analysis of embedded features.

4. Establish a unified knowledge base for connectivity data of diverse modalities.

Collectively, the DCC(s) will engage and extend the integration goals of the technology development projects, to bridge modalities and initiate a unified representation of brain connectivity data. Strategies might include development of standards and data models at points of intersection between modalities, such as common coordinates and similarity matching algorithms. The DCC(s) are expected to leverage as appropriate the efforts and products of the BRAIN Initiative Cell Atlas Network (BICAN), including cell-type taxonomies and common coordinate frameworks, as well as the standards development efforts of the BRAIN Initiative Data Archives and associated projects.

5. Organize and implement outreach and engagement to the wider research community and the general public.

The DCC(s) will organize and enhance ongoing and new efforts by the technology development projects to disseminate their products to the broader research community. In addition, they will extend and synergize efforts to engage and develop a new and diverse generation of biomedical researchers, as proposed in each project’s research strategy, and as elaborated in each Plan for Enhancing Diverse Perspectives. Engaging investigators and scholars from Minority-Serving Institutions (MSIs) and IDeA-eligible institutions is strongly encouraged. The DCC(s) will also develop resources and a vision for disseminating BRAIN CONNECTS aspirations and outcomes to the general public, to enhance scientific literacy and to fully leverage the impact of new understanding of the brain’s wiring principles and the implications for treating brain disorders.

Applications Not Responsive to this NOFO

The following proposed research is not responsive to this NOFO and will not be reviewed :

  • Projects that do not meet the NOFO requirements as described under "BRAIN CONNECTS DCC Requirements" and as detailed in the application instructions.
  • Projects not aimed at accomplishing all five of the Critical Elements listed above. Applicants proposing to address a subset of data needs for the BRAIN CONNECTS pipeline are encouraged to consider applying to RFA-NS-22-049 (BRAIN CONNECTS Specialized Projects for Scalable Technologies).
  • Applications that do not propose to harmonize and optimize processing, analysis, and dissemination of data from one or more of the data modalities listed above. Applicants proposing to address data needs not associated with the BRAIN CONNECTS Program are encouraged to consider applying to RFA-MH-23-270 (Integration and Analysis of BRAIN Initiative Data) or RFA-DA-23-039 (BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain).
  • Applications lacking a PEDP submitted as an Other Attachment. As described in the application instructions below, the PEDP should summarize strategies as viewed and supported throughout the application.

Prior Consultation with Scientific/Research Staff

Consultation with Scientific/Research Contact staff listed in Section VII is strongly recommended, preferably well before the Letter of Intent due date. If requested by the applicants, staff can discuss questions of responsiveness, and advise whether the proposed project is likely to meet the goals of this NOFO and the mission of the BRAIN Initiative. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project does not meet the programmatic needs of this NOFO, applicants will be strongly encouraged to consider other Funding Opportunities.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The BRAIN Initiative intends to commit $6M in FY 2025 to fund 1-3 awards.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The maximum project period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 Government

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Organizations)
Foreign Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. 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.

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.

2. Cost Sharing

This NOFO 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 NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Kari Johnson, PhD
National Institute of Neurological Disorders and Stroke
Email: BRAIN-CONNECTS-Inquiries@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments

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 historically 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/vision/plan-enhancing-diverse-perspectives.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

BRAIN CONNECTS Network Meeting Costs:

  • Applications are expected to include allowable costs for organizing, implementing, and attending virtual and in-person meetings associated with activities of the CONNECTS Network, including semi-annual meetings of the full Network consortium.

PEDP Implementation Costs:

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

Provide a summary of the overall goals for the Data Coordinating Center, outlining how it will coordinate the activities of the BRAIN CONNECTS Network and fulfill the requirements of the five Critical Elements listed in Section I and below.

Research Strategy:

Follow the PHS 398 Research Plan instructions for Significance, Innovation, and Approach, with the following additional instructions.

In the Significance Section, explain how coordination and support for the chosen acquisition and analysis modalit(ies), from the list in Section I above, will benefit the BRAIN CONNECTS Program and the broader field. Include a summary of how the team’s expertise specifically addresses each chosen modality, and how their commitment to serving a coordinating role will further the goals of the Network and provide lasting impact for the field. In the Innovation Section, briefly describe any novel organizational concepts and management strategies, if applicable, and how these features will enhance the overall Network development platform and serve as a paradigm for future efforts. In addition, describe any innovations associated with proposed solutions to current and upcoming challenges for processing, analyzing, and disseminating large-scale connectivity data of the chosen modalit(ies). In the Approach Section, for each of the five Critical Elements listed in Section I, describe the goals, strategies, and key metrics for success. Provide details addressing the following:

1. BRAIN CONNECTS Network coordination

  • Explain how the DCC will coordinate the overall efforts of the Network consortium and will facilitate the requirements for Network projects outlined in Section I and indicated in the Cooperative Agreement Terms and Conditions of the BRAIN CONNECTS NOFOs.
  • Describe priorities and procedures for governance, with particular attention to collective decisions on data release, data and resource sharing, standardization, quality assurance, and consensus metrics for assessing scalability and comparing approaches.
  • Describe plans for coordination with other U.S. and international groups to benefit the overall field, including the establishment of working groups to address specific issues of critical importance.

2. Common data processing pipeline development and harmonization

  • Applications must address one or more of the required data acquisition and analysis modalities listed in Section I (electron microscopy and cell-type data, fluorescence tracing, barcode expression, axonal projection/fiber orientation imaging).
  • Explain how the DCC will convene projects focused on the chosen modalit(ies) to develop consistent data and metadata standards and practices, to agree on quality assurance protocols, and to implement shared archiving and dissemination strategies.
  • Describe potential interactions with ongoing efforts, including the BRAIN Initiative Informatics Infrastructure (described in RFA-MH-20-600 and related NOFOs) to achieve data sharing and cloud-based analysis.
  • Explain how metrics and processes for assessing scalability and comparing between approaches will be developed and implemented.
  • Describe strategies for pipeline modification and optimization to accommodate datasets approaching exabyte scale in a potential second 5-year phase of BRAIN CONNECTS, including new data structures, efficient processing pipelines, and novel compression methods, together with policies and protocols to streamline sharing of derived data with the neuroscience research community.

3. Integration and dissemination of data analytic tools and capabilities

  • For the chosen data modalit(ies), describe the unified environment for cooperative or competitive development of visualization and analysis toolsets, including online algorithms with potential to scale up to brain-wide capabilities.
  • Detail the architecture for data validation, shared annotation, ground truth comparisons and error correction, as well as query and statistical analysis of embedded features.
  • Explain how the capabilities and toolsets will be provided to the neuroscience research community for broad dissemination, and for democratized access to reproducible analyses of brain-wide connectivity data.
  • Indicate how the tools will be compatible with data formats and standards used by the BRAIN Initiative Archives and other relevant efforts, including cloud operability as appropriate.

4. Unified knowledge base for connectivity data

  • Describe how the chosen modalit(ies) for the DCC will integrate and bridge with other modalities to initiate a unified representation of brain connectivity data.
  • Include strategies for integrating points of intersection, for example by standardization of data models for compatibility with common spatial coordinates, algorithms for similarity matching within and across modalities, or object classifiers based on shared feature sets.
  • Explain how ongoing efforts, such as cell-type taxonomies and common coordinate frameworks under development by the BRAIN Initiative Cell Atlas Network (BICAN), will be leveraged.

5. Outreach and engagement to the research community and general public

  • Describe how the DCC will organize and enhance efforts of Network projects to disseminate their products to the wider research community.
  • Explain how efforts to engage and train a new and more diverse generation of biomedical researchers will be extended and unified across BRAIN CONNECTS projects, and how these efforts are consistent with the PEDP included as an Other Attachment in this application.
  • Elaborate the vision and the resources to be developed for disseminating BRAIN CONNECTS aspirations and outcomes to the general public. Indicate how they will enhance scientific literacy and public recognition of the impact of understanding the brain’s wiring principles and the implications for treating brain disorders.

Annual Milestones

For each of the five Critical Elements sections in the Approach, provide annual milestones with clear outcomes and actionable criteria for evaluating progress and decisions on project continuation and direction. Include plans for ongoing feedback and critical evaluation by the CONNECTS Network Steering Committee and NIH Program Staff. For Year 1, include interim milestones for integrating efforts with the CONNECTS Network projects and with other DCCs that may be awarded through this NOFO.

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.

The Resource Sharing Plan will be considered by reviewers in determining scientific and technical merit and in providing an overall impact score.

The Resource Sharing Plan should include information on plans for Center dissemination of open source code for processing and analyzing data from the Network and other relevant efforts. In addition, consistent with instructions in the Research Strategy and requirements in the Cooperative Agreement Terms and Conditions, the Resource Sharing Plan should include plans for coordinat ing resource sharing activities of projects in the Network, following policies and protocols agreed upon by the Network Steering Committee .

Other Plan(s):

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

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

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

the Data Management and Sharing Plan will not be included in the application materials provided to reviewers and will not be considered by reviewers in determining scientific and technical merit and in providing an overall impact score.

Specific for this and other BRAIN Initiative NOFOs (as referenced in NOT-MH-19-010 ), the plan must include a summary of the data that will be shared, a description of the standard(s) that will be used to describe the data, the archive(s) that will house the data, and the proposed timelines for submitting data to the archive and for sharing data with the research community.

In addition, consistent with instructions in the Research Strategy, the Data Management and Sharing Plan should describe plans for coordination of data release by the projects in the Network , including software needed for data replication or reuse, following policies and protocols agreed upon by the Network Steering Committee . The plan should address challenges and opportunities for managing and sharing data from novel and emerging acquisition and analysis technologies, including strategies and policies for disseminating unprecedented volumes of anatomical data across diverse data modalities.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

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

Applications 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 before review.

Applications Involving the NIH Intramural Research Program

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

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed 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.

As a note- A Notice of Award will not be issued for grants to NIH Intramural Scientist who will participate as PDs/PIs. Funding for those awards will be provided by the NIH Intramural Program. NIH staff cannot participate as PD/PIs on extramural awards.

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

1. Criteria

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

The BRAIN CONNECTS DCC(s) will coordinate efforts of the BRAIN CONNECTS Network, a cooperative consortium funded under RFA-NS-22-047, RFA-NS-22-048, and RFA-NS-22-049. Project details can be found by searching NIH RePORTER for awards from each of the three RFAs. BRAIN CONNECTS projects will collect and process unprecedented volumes of anatomical data by scaling up cutting-edge acquisition modalities and analysis methods, to demonstrate the feasibility and potential impact of production, analysis, dissemination, and interpretation of connectivity maps from entire brains. The resulting feasibility data from these awards are expected to inform NIH decisions on program continuation in a potential subsequent five-year funding period for production of brain-wide wiring diagrams.

The BRAIN CONNECTS DCC(s) will be integrated into the BRAIN CONNECTS Network and will collaborate with CONNECTS technology development projects to accomplish the five Critical Elements detailed in the application instructions.

Overall Impact

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).

Scored Review Criteria

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 proposed Center address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this NOFO:

To what degree will the proposed coordination and support for the chosen acquisition and analysis modalit(ies) benefit the goals of the BRAIN CONNECTS Program (as described in this NOFO)? Will the proposed activities provide lasting impact for the broader field?

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

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research relevant to the BRAIN CONNECTS Network? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center?

Specific to this NOFO:

How well-matched is the team’s expertise to the specific data needs and development goals of the proposed acquisition and analysis modalit(ies)? Is there sufficient evidence of commitment to serving a coordinating role to further the goals of the Network?

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

Innovation

Does the application propose novel organizational concepts and management strategies in coordinating the research network consortium the Center will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Specific to this NOFO:

In addition to the organizational concepts and management strategies, how innovative are the proposed solutions to current and upcoming challenges for processing, analyzing, and disseminating large-scale connectivity data of the chosen modalit(ies)?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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 NOFO:

BRAIN CONNECTS Network coordination: To what degree will the DCC facilitate the requirements for the Network, including priorities and procedures for governance and collective decisions on data policies? To what extent do the plans for coordination with outside efforts synergize with the goals of the Network and benefit the broader field?

Common data processing pipelines: To what extent do the plans to develop and harmonize data processing pipelines represent advances for the field? For the chosen data modalit(ies), are high-impact but realistically attainable endpoints proposed for consensus standards, quality assurance protocols, and strategies for shared archiving and dissemination? To what degree will the metrics and processes for assessing scalability result in clear benchmarks and meaningful comparisons between approaches? Are the strategies for scalability well-conceived and sufficient to accommodate datasets approaching exabyte scale?

Integration and dissemination of analytic tools and capabilities: Will the proposed environment for visualization and analysis toolsets provide a valuable resource for shared development activities, interoperability, and/or common standards? To what degree is there a clearly described and compelling architecture for data annotation and associated validation, and for query and statistical analysis of embedded features? To what level will the capabilities and tools be broadly disseminated and provide democratized access to reproducible analyses of brain-wide connectivity data?

Unified connectivity data knowledge base: To what extent do the plans for bridging across modalities provide appropriate strategies for unifying brain connectivity data? Is sufficient detail provided for integrating points of intersection, for example by standardization of data models? Are relevant ongoing efforts appropriately leveraged?

Outreach and engagement to the research community and general public: To what extent will the plans for disseminating products to the research community result in broad and democratized access for maximal benefit to the field? Are there thoughtful plans for engaging and training a new and more diverse generation of biomedical researchers, consistent with the application PEDP, that will extend and unify efforts across the CONNECTS Network? To what degree will the outreach to the general public enhance scientific literacy and public recognition of the potential impacts of understanding the brain’s wiring principles?

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

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network consortium it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO:

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?

Additional Review Criteria

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.

Milestones

Specific to this NOFO:

Do the milestones provide clear outcomes and actionable criteria for evaluating progress and decisions on continuation and project direction?

Research Resource Sharing

Specific to this NOFO:

Does the Research Resource Sharing Plan provide reasonable strategies for managing and sharing resources generated by the DCC, and for coordinating policies and practices for sharing resources by the Network?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Authentication of Key Biological and/or Chemical Resources:

For programs 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 policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NINDS Advisory Council. 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.
  • Programmatic balance, in particular considering the overall mix of capabilities serving the range of acquisition and analysis modalities represented in the Network, as described in Section I.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of the 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 2 CFR 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibilities as described below:

  • Define the details for the project within the guidelines of this NOFO. Oversee and perform the scientific activities and administratively manage the project.
  • Accept close coordination, cooperation, and participation of NIH program staff consistent with the goals of the BRAIN CONNECTS Network.
  • Serve as a member of the BRAIN CONNECTS Network Steering Committee (described below) and participate in BRAIN CONNECTS Network activities, including periodic meetings to report project progress, develop shared metrics and standards, and identify opportunities for collaboration and coordinate publication of research results.
  • Accept and implement the common guidelines and procedures approved by the Steering Committee and NIH. Agree to project modifications consistent with the shared goals of the BRAIN CONNECTS Network, as agreed upon by the BRAIN CONNECTS Steering Committee, with concurrence from NIH program staff.
  • Share data and resources according to data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the program.
  • Fully disclose algorithms and software source code to the other members of the Network for the purpose of scientific evaluation.
  • Maintain confidentiality of information obtained from other members of the Network.
  • Submit data for quality assessment and/or validation in a manner specified by the Steering Committee and/or NIH Program staff to ensure scientific rigor.
  • Adhere to NIH policies regarding intellectual property and other NIH policies that might be established during the course of this activity.
  • Coordinate and collaborate with other U.S. and international groups that may be generating complementary datasets.
  • Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding 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 named in the award notice and will be responsible for normal scientific and programmatic stewardship and guidance for the overall project. The Program Officer will be responsible for milestone negotiations and reporting, to ensure that benchmarks are being achieved and project goals are met, and for monitoring the agreed data and resource sharing plans. The Program Officer may attend Steering Committee meetings as a non-voting participant.
  • A group of NIH extramural program staff from the ICs contributing to the NIH BRAIN Initiative will form a Project Team for this award. The Project Team will review annual progress reports and other documents from this and other BRAIN CONNECTS awards and will assist the Program Officer in the evaluation of progress and coordination of Network activities.
  • One or more extramural NIH program staff member(s) will be assigned as Project Coordinator(s), and will provide technical assistance, advice, coordination, and other program actions supporting the Program Officer and award recipients during the conduct of research activities, which may be above and beyond the levels normally required for program stewardship of grants. The same person may serve as the Project Coordinator for multiple awards under this and other BRAIN CONNECTS NOFOs.

Areas of Joint Responsibility include:

BRAIN CONNECTS Network Steering Committee:

The Steering Committee will consist of the PDs/PIs of awards of this and other BRAIN CONNECTS NOFOs (as listed in Section 1), along with one NIH extramural program representative. It will plan and design activities, review and discuss progress, and establish priorities and policies for the BRAIN CONNECTS Network. A chair will be designated on a rotating basis as needed. PDs/PIs will have one vote for each project and the NIH representative will serve as a non-voting member. The frequency of meetings will be determined jointly with NIH program staff. Recipient members of the Steering Committee will be required to accept and implement policies and common guidelines approved by the Steering Committee.

The Steering Committee will:

  • Coordinate and improve connectivity data production, for example by reporting progress, disseminating best practices, and collectively evaluating new procedures, resources, and technologies.
  • Assess feasibility metrics for establishing scalability, benchmarking performance, and comparing approaches.
  • Facilitate the development of uniform procedures and policies, for example for data standards, quality measures and assessment, nomenclature and annotation conventions for data depositions, and so forth.
  • Establish working groups as needed to address particular issues and interests. Working groups will include representatives from the BRAIN CONNECTS investigators, NIH program staff, and possibly outside experts by mutual agreement. Working groups may be formed to: 1) develop and implement data production and analysis standards; 2) address data submission, management, and analysis issues; 3) develop quality standards and methods for quality control and assurance; and 4) develop and benchmark shared informatics tools. In these cases, common policies, uniform practices (as needed), and data exchange will be critical to the success of the effort and will enable harmonization and eliminate duplication/overlap.

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.

3. Data Management and Sharing

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

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Recipients will provide updates at least annually on implementation of the PEDP.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Kari Johnson, PhD
National Institutes of Neurological Disorders and Stroke (NINDS)
Email: BRAIN-CONNECTS-Inquiries@nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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

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