National Institutes of Health (NIH)
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)
UM1 Research Project with Complex Structure Cooperative Agreement
- November 2, 2023 - BRAIN Initiative Connectivity across Scales Data Coordinating Center (BRAIN CONNECTS DCC) (U24 Clinical Trial Not Allowed). See Announcement RFA-NS-24-028
- August 29, 2023 - Notice of Intent to Publish a Funding Opportunity Announcement for BRAIN Initiative Connectivity across Scales Data Coordinating Center (BRAIN CONNECTS DCC) (U24 Clinical Trial Not Allowed). See Notice NOT-NS-24-009
- NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
- NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
- June 01, 2022 - Notice of Informational Webinar for BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) Funding Opportunity Announcements. See Notice NOT-NS-22-100
RFA-NS-22-049 , U01 Research Project (Cooperative Agreements)
This Funding Opportunity Announcement (FOA) solicits applications for Comprehensive Centers to develop the research capacity and technical capabilities to map mouse brain connectivity, with goals of brain-wide coverage and comprehensive mapping of local and long-range cell-to-cell connectivity at the level of synaptic connections. Proposals may focus on a sub-volume of the central nervous system (CNS), provided the volume is sufficiently large to demonstrate feasibility of collecting, reconstructing, analyzing, integrating, disseminating, and interpreting synapse-level connectivity maps of 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. Applications may propose limited testing and optimization using additional species beyond mouse for testbed technology development, if strong scientific and cost justification is provided.
Applications must address the following five required research activity elements: (1) Sample Processing and Data Acquisition, (2) Data Processing and Management, (3) Integration and Dissemination, (4) Research Discovery, and (5) Feasibility Metrics and Milestones. Successful Centers will establish and scale complete pipelines from sample collection through data integration and dissemination, using state-of-art methods. They will automate and streamline processes for sample collection and data acquisition, optimize protocols for data management, and develop solutions for highly accurate circuit reconstruction. They will incorporate toolsets and infrastructure for seamless integration with other datasets of the same and different modalities, and for easy-access dissemination to the research community for collaborative annotation and analyses. They will apply their data to address research questions of high significance for understanding the relationship between structure and function of brain circuits.
Centers will be integrated into the BRAIN CONNECTS Network, consisting of projects from this FOA and its companion announcements, as a coordinated effort aimed at developing wiring diagrams that can span entire brains across multiple scales.
May 13, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 13, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
| June 13, 2023 | Not Applicable | Not Applicable | November 2023 | January 2024 | April 2024 |
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
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 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 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.
This FOA and its companions have been developed in response to one of the transformative projects suggested bythe Advisory Committee to the NIH Director BRAIN Initiative Working Group 2.0, which called for a complete nanometer-level reconstruction of an entire mouse brain as a potential revolutionary project for the second phase of the BRAIN Initiative. The BRAIN 2.0 WG Report indicated that such an endeavor will provide a roadmap for the organizing structures of the human brain, revealing worlds of circuitry that are currently unattainable. Acknowledging that a synapse-level connectome of the human brain is presently out of reach, the report suggested that human and non-human primate (NHP) brains should be pursued at the level of axonal projections. To further refine this concept, NIH partnered in Spring 2021 with the Department of Energy Office of Science to co-host the Brain Connectivity Workshop Series, five workshops and a town hall that brought together members of the scientific community and other stakeholders to explore the significance, the state-of-art, and the challenges and opportunities associated with producing and analyzing whole brain wiring diagrams at the level of synapses ( connectomes ) and long-range axonal projections ( projectomes ) to drive scientific discovery.
The BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) Network
This FOA is one of three companion FOAs initiating the BRAIN CONNECTS Network, a coordinated effort aimed at developing the research capacity and technical capabilities to generate wiring diagrams that can span entire brains across multiple scales. The initiating FOAs represent the first phase of an anticipated 10-year program. The overarching objective of the first five years is to develop these capabilities through innovation and iterative engineering of the required technologies, including tissue processing and sample handling, data acquisition, data analysis, dissemination, and application to fundamental questions of nervous system function. The FOAs will support multiple approaches for imaging and reconstructing brain connectivity, which are expected to be complementary to one another, with different technologies suited for different types of research questions and use-cases.
Through these initiating FOAs, the program will support:
- A portfolio of complementary approaches for data acquisition and reconstruction of brain connectivity, with metrics for comparing and choosing approaches
- Teams with diverse perspectives from a variety of disciplines, including but not limited to neuroscience, engineering, computational and molecular biology, chemistry and physics, mathematics, computer and data sciences, and bioethics
- Engineering and innovation efforts aimed at scale-up to map entire brains with high throughput and precise fidelity
- Demonstration of lossless acquisition and accurate reconstruction, validated with ground truth data, across large distances required for whole-brain mapping
- Proof-of-concept datasets, representing large and unprecedented sub-volumes within the brain or spinal cord, aimed at understanding the wiring principles of specific circuits and their implications for neural function
- New approaches and toolsets for mining and integrating into the neuroscience knowledge base, including morphological, functional, and molecular data
- New infrastructure for the research community to discover cell types, circuit motifs, wiring principles and circuit elements, and to develop new computational and conceptual models based on these rich new sources of data
The Network will be supported by the following three FOAs. A fourth FOA supporting a Data Coordinating Center will be released after awards from the first FOAs are made.
RFA-NS-22-047 - Comprehensive Centers for Human and Non-Human Primate Brain
RFA-NS-22-048 - Comprehensive Centers for Mouse Brain
RFA-NS-22-049 - Specialized Projects for Scalable Technologies
Comprehensive Centers will use the UM1 activity code, which supports cooperative agreements involving large-scale research activities with interdependent components. For human and NHP, Centers will demonstrate region-to-region connectivity at the level of axonal projections. For mouse, Centers will demonstrate local and long-range cell-to-cell connectivity at the level of synaptic connections. Although the focus of Comprehensive Centers must be on human, NHP, or mouse, applications may propose limited testing and optimization using additional species for testbed technology development, if strong scientific and cost justification is provided. Centers will establish full production pipelines, from sample collection through data integration, analysis, and dissemination, applied to CNS sub-volumes that are sufficiently large to prove feasibility of whole-brain mapping, chosen to test specific hypotheses relating circuit structure to function. They will 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 Projects will use the U01 activity code for cooperative agreements to support development of current or emerging technologies for scalable mapping of brain connectivity. Efforts are expected to complement the Comprehensive Centers with distinct capabilities and competencies, applied to any aspect(s) of the pipeline, from tissue processing to imaging, alignment, segmentation and annotation, error correction, analysis, integration into the larger neuroscience data environment, and dissemination to the research community. Although the focus of the BRAIN CONNECTS Network is on human, NHP, and mouse brain, Specialized Projects may use other species for validation if well justified.
In all cases, the expectation is that technologies and approaches will be sufficiently scalable to enable brain-wide connectivity mapping in a subsequent five-year follow-on period, if not earlier.
Throughout the funding period, all CONNECTS Network awardees will work cooperatively to further common goals and identify collaborative opportunities, as described in Section VI.2, below. The CONNECTS Network will develop shared data standards, consensus policies for data and resource sharing, and metrics for comparison between approaches and for assessing feasibility and cost of scaling to entire brains.
Objectives and Requirements for this FOA
This FOA solicits applications for Comprehensive Centers to develop the research capacity and technical capabilities to map mouse brain connectivity, with goals of brain-wide coverage and comprehensive mapping of local and long-range cell-to-cell connectivity at the level of synaptic connections. Proposals may focus on a sub-volume of the CNS, including brain or spinal cord, provided the volume is sufficiently large to demonstrate metrics establishing feasibility of collecting, reconstructing, analyzing, integrating, disseminating, and interpreting synapse-level maps of entire brains. The resulting feasibility data from these awards are expected to inform NIH decisions on program continuation in a subsequent five-year funding period for production of brain-wide wiring diagrams. Applications may propose limited testing and optimization using additional species beyond mouse for testbed technology development, if strong scientific and cost justification is provided.
Detailed requirements for the FOA are included in the application instructions (Section IV, below), with five required research activity elements: (1) Sample Processing and Data Acquisition, (2) Data Processing and Management, (3) Integration and Dissemination, (4) Research Discovery, (5) Feasibility Metrics and Milestones.
Successful Centers are expected to:
- Establish complete pipelines whose components synergize to advance state-of-artmethods for collection, reconstruction, analysis, integration, dissemination, and interpretation of brain connectivity and associated data.
- Automate and streamline processes for highly reproducible tissue collection and preparation, followed by ultra-low-loss sample processing and data acquisition.
- Optimize protocols for efficient data transfer, storage, and security across different stages of the pipeline.
- Develop solutions for high-capacity, high-accuracy circuit reconstruction, annotation, and error correction validated with efficient ground truth human assessments.
- Provide capabilities for comprehensive, efficient statistical representations of diverse cellular features and circuit-level structure.
- Incorporate toolsets and infrastructure for seamless integration with other datasets of the same and different modalities, and easy-access dissemination to the research community for collaborative analyses.
- Apply the collected data to one or more research questions chosento demonstrate the significance of the approach for understanding the functional implications of circuit connectivity. If appropriate, additional experiments may be proposed to record and/or perturb neural circuit activity, provided the experiments are well-justified and are limited to complementing and further framing the significance of the corresponding connectivity data, to elucidate fundamental principles of neural function.
- Provide performance metrics to demonstrate the feasibility of scaling to entire brains, to enable whole brain mapping in a potential subsequent five-year production phase.
- Work closely with other awardees of the BRAIN CONNECTS Network to synergize and harmonize data generation and analysis workflows, establish data standards for joint analysis and publications, and develop appropriate policies for data and resource sharing.
Plan for Enhancing Diverse Perspectives (PEDP)
This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material. 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.
Applications Not Responsive to this FOA
Proposed research that is not responsive to this FOA and will not be reviewed includes the following:
- Projects not aimed at comprehensive pipelines for synapse-level connectivity in mouse brain.
- Technologies not expected to provide comprehensive mapping of local and long-range cell-to-cell connectivity at the level of synaptic connections.
- Technologies not expected to demonstrate feasibility of scaling to enable collection, reconstruction, analysis, and dissemination of synapse-level atlases of entire mouse brains in a potential subsequent five-year funding period.
- Applications lacking a PEDP submitted as Other Project Information as an attachment.
Applicants considering related technologies that may not meet requirements for this or companion FOAs should consider other BRAIN Initiative FOAs, and in particular the following:
RFA-MH-21-175, BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed).
RFA-MH-22-115, BRAIN Initiative: Development of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in Human and Non-Human Primate Brain (UG3/UH3 Clinical Trial Optional)
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 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.
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 FOA.
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 FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The NIH BRAIN Initiative intends to commit an estimated total of $30M in FY2023 for this and companion funding announcements to fund approximately 15 awards.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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 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 (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.
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.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; 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. 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 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).
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 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Edmund Talley
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
For this specific FOA, the Research Strategy is limited to 30 pages, exclusive of the specific aims page. It should consist of the following two sub-sections with the indicated page limits:
Center Overview (6 pages)
Research Activities and Milestones (24 pages)
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 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.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
At least 3 person-months per year must be devoted by the PD(s)/PI(s) to the project for the duration of the award.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
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).
BRAIN CONNECTS Network Semi-annual In-person Meeting Costs:
- Applications may include allowable costs for participating in semi-annual in-person BRAIN CONNECTS Network meetings.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 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.
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 Comprehensive Center, explaining how the different research components will be developed and scaled over the project period to demonstrate feasibility of scaling to entire brains, which would occur in a potential subsequent five-year funding period for production of whole brain wiring diagrams.
Research Strategy:
Center Overview (6 pages)
- Overall Research Aims and Strategy
- Summarize the different components of the project and how they will integrate and synergize towards a complete pipeline for collection, reconstruction, analysis, integration, dissemination, and interpretation of brain connectivity and associated data.
- Describe how the chosen strategies will advance state-of-art technologies and address current gaps and challenges, and why the approaches offer advantages over alternative methods.
- Explain the significance of the proposed dataset for understanding neural circuit structure and function, and how the project will result in novel capabilities and capacity for new discoveries by the research community.
- Organizational Structure
- Describe the organization and leadership for the different project components. Include an overview of the production workflow, and information on performance sites, staffing and responsibilities of each Center segment. A graphical representation is recommended.
- Administrative Support Plan
- Describe plans for Center administration, communication, and production management.
- Explain how the Center will maintain and manage production goals, including quality assurance, performance assessment, and milestone reporting.
- Describe plans to ensure efficient coordination, communication, and decision support within the Center and with the other entities of BRAIN CONNECTS Network.
Research Activities and Milestones (24 pages)
For each of the following elements, detail the strategies and specific innovations that will enable scaling to high-throughput and will serve as a platform for mapping entire brains. Explain how the chosen methods will advance the field beyond current state-of-art. Include preliminary data and information on the team and its qualifications to demonstrate suitability and readiness to address the associated challenges.
- Sample Processing and Data Acquisition
- Provide details on tissue collection, processing, and sample handling, as well as imaging and/or other data acquisition modalities.
- Explain how these processes will be automated and scaled for high-throughput, including quality assurance and risk mitigation strategies. Additional species beyond mouse may be proposed for limited testing and optimization for testbed technology development. In such cases, strong justification must be provided in terms of scientific and cost benefits.
- Data Processing and Management
- Describe the plan for data transfer, storage, and security across the different stages of the pipeline. Explain how performance will be assessed and optimized, including as appropriate, innovations from computer science and the information technology industry. Where possible, compatibility with existing resources should be prioritized.
- Detail the strategy for processing steps such as 3D registration and segmentation, annotation, error correction, and statistical representation. For automated analyses, explain how ground truth benchmarking will be accomplished and used for algorithm development, optimization, and accuracy assessment.
- Explain how the approach is well suited for efficient and cost-effective data processing and analysis, and how it will enable data integration into a wider data ecosystem within the BRAIN CONNECTS Network and beyond.
- Integration and Dissemination
- Provide strategies and/or software toolsets for integrating separately collected data of the same modality into the Center platform. Describe how new data will be incorporated and will serve to extend the analytic horizon of the overall dataset, through additional detail and/or comparative information from additional subjects/animals.
- Provide strategies and/or software toolsets for crossing modalities to integrate Center data into the wider neuroscience knowledge base, including molecular, morphological, connectivity, and/or functional data. Explain how the Center data will complement other modalities for a unified understanding of brain cells, circuits, and networks.
- Describe how the Center data will be made available for easy accessto the research community, including software toolsets for collaborative proofreading, error correction, annotation, mining and discovery.
- Research Discovery
- For the chosen brain or spinal cord volume, apply one or more key research use-cases to demonstrate the value of the data and the significance of the approach. Choose a scientific question(s) of high importance to the neuroscience community, for which understanding anatomical structure and connectivity will elucidate fundamental principles of neural function.
- If appropriate, functional experiments may be included (but are not required) to record and perturb circuit activity, provided the experiments are well-justified. The functional experiments must be limited in scope to complementing and further framing the significance of the corresponding connectivity data, and should be integrated via computational and/or conceptual models with predictive outcomes.
- Feasibility Metrics and Milestones
- For each of the first three research components of this section (Sample Processing and Data Acquisition, Data Processing and Management, Integration and Dissemination), provide performance metrics that can be used to demonstrate feasibility of scaling to entire brains in a subsequent five-year funding period, and that will allow comparison to other approaches. Include expectations of cost, time, and any ancillary requirements that would affect decisions on project continuation in a potential subsequent funding period.
- For the first four components of this section (including Research Discovery), provide a timeline and annual milestones using SMART criteria (Specific, Measurable, Attainable, Relevant, and Time-bound). Milestones should be delineated into aspirational but realistic goals for the project, vs. go/no-go criteria representing minimally acceptable progress for project success.
Letters of Support:Include as appropriate letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants.
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 following modifications also apply:
In the Resource Sharing Plan attachment, all applications, regardless of the amount of direct costs requested for any one year, must include the following two sections detailed below: (A) Data Sharing and (B) Resource Sharing.
A. Data Sharing
The general data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010. A central goal of this FOA is to enable data resources that will be widely used throughout the research community. To reap the maximum value from this program, data, experimental protocols, tools, and instrumentation design are expected to be made publicly available. Open dissemination is also expected for computational methods, software, and analytic workflows, for unrestricted redistribution and modification. The Data Sharing section should include the following key elements:
- A description of project management of data sharing
- A summary of specific data to be shared
- Archives and repositories that will house the data and associated resources
- Schedule/timeline for submission to the relevant archive(s) and release to the research community
- A description of data standards that will be used and/or developed
B. Resource Sharing
Research resources should be made rapidly available to the research community, including assay protocols, technology platforms, tools, reagents, user manuals, and preprints. The Resource Sharing section should provide specific information on distribution via repositories such as protocols.io, Addgene, GitHub, bioRxiv, or other open repositories.
After the initial peer review, program staff will be responsible for any additional administrative review of the plan for sharing data and research resources, and may negotiate modifications of the Resource Sharing Plan with the prospective awardee prior to award. The final negotiated version of the Resource Sharing Plan will become a term and condition of the award of the cooperative agreement. After all awards have been made, the BRAIN CONNECTS Network Steering Committee (described in Section VI.2, below), of which all awardees will be members, will develop a common plan for data and resource release as appropriate for the project that will address the interests of the data producers, analysts, and end-users of the BRAIN CONNECTS datasets. The Resource Sharing Plan in the application proposal should indicate willingness to participate in the development of such a plan and to accept the final terms.
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.
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.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) 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 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 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.
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.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
This FOA solicits applications for Comprehensive Centers to develop the research capacity and technical capabilities to map mouse brain connectivity, with goals of brain-wide coverage and comprehensive mapping of local and long-range cell-to-cell connectivity at the level of synaptic connections. Proposals may focus on a sub-volume of the CNS, including brain or spinal cord, provided the volume is sufficiently large to demonstrate metrics establishing feasibility of collecting, reconstructing, analyzing, integrating, disseminating, and interpreting synapse-level maps of entire brains. The resulting feasibility data from these awards are expected to inform NIH decisions on program continuation in a subsequent five-year funding period for production of brain-wide wiring diagrams. Applications may propose limited testing and optimization using additional species beyond mouse for testbed technology development, if strong scientific and cost justification is provided. Successful Centers will establish and scale up complete pipelines, from sample collection through data integration and dissemination, advancing state-of-art methods and applying the data to research use-cases of high importance to the neuroscience community.
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 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 announcement:
To what extent will the components of the project integrate and synergize towards a complete pipeline for collection, reconstruction, analysis, integration, and dissemination of brain connectivity and associated data? Will the chosen strategies advance state-of-art technologies and provide capabilities of value to the field? To what extent will the project contribute to increasing the scale and feasibility of mapping the connectivity of entire brains? Will the proposed dataset be a resource for new discoveries by the neuroscience community?
Will the proposed research use-case(s) demonstrate the value of the data and the significance of the approach for understanding anatomical structure and connectivity to elucidate fundamental principles of neural function? 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), 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 announcement:
Do the PD(s)/PI(s) and other key personnel devote sufficient time/effort to achieve the Center goals? Is the organizational and leadership structure appropriate to achieve the Center goals?
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 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 announcement:
To what extent do the proposed developments represent innovative advances over current state-of-art and address current gaps and challenges for brain connectivity mapping? To what degree do the approaches offer advantages over alternative methods? To what extent will the availability of the proposed data and toolsets serve as a platform for novel capabilities and capacity for new discoveries by the research community?
To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
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?
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 announcement:
Does the plan for Sample Processing and Data Acquisition provide an appropriate approach, with evidence that processes will be automated and sufficiently scaled for high-throughput? Are the strategies for quality assurance and risk mitigation well-considered and suitable for success of the project? If additional species beyond mouse are proposed for for testbed technology development, are the scientific and cost benefits well justified?
Does the application adequately describe Data Processing and Management, with plans and justification for testing and optimization across different stages of the pipeline? Are plans for transfer, storage, and security adequate for managing the proposed data? Are processing steps appropriate, and are there adequate plans for benchmarking against ground truth data? Is the approach well suited for efficient and cost-effective data processing and analysis, and will it enable data integration into a wider data ecosystem within the BRAIN CONNECTS Network and beyond?
Do plans for Integration and Dissemination provide appropriate strategies for integrating data of the same modality, such that the collected dataset is extended with additional detail and/or comparative information from additional subjects/animals? Are appropriate strategies provided for crossing modalities to integrate Center data into the wider neuroscience knowledge base, including molecular, morphological and/or functional data? Do plans for making Center data available to the research community provide a path for easy access, and collaborative mining and discovery?
Is the plan for Research Discovery well-reasoned, feasible, and designed to demonstrate the value and significance of the corresponding data? If functional experiments are proposed, are they well-justified in terms of complementing and further framing the significance of the corresponding structural data?
Do the Feasibility Metrics and Milestones provide performance benchmarks to demonstrate feasibility of scaling to entire brains in a subsequent five-year funding period? Do they provide sufficient information to allow comparisons to other approaches in terms of cost, time, and any ancillary requirements that would affect decisions on project continuation in a subsequent funding period? Are the current project timeline and annual milestones reasonable and well-considered?
Are the plans for Center administration, communication, and production management well-reasoned and appropriately resourced?
Do the Data Sharing Plan and Research Resource Sharing Plan provide reasonable strategiesfor management of data/resource sharing, including information on applicable archives/repositories and standards, and schedules/timelines for submission and sharing with the research community?
Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
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 announcement:
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.
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
Not Applicable
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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).
Resource Sharing Plans
Not Applicable
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{LOCUS OF REVIEW}, 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.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this 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.
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:
- 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 identify, 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 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 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.html and https://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 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 45 CFR Part 75 and 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 FOA. 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.
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 FOAs.
- NIH intramural scientists involved in the BRAIN CONNECTS Network will have the same rights and responsibilities as comparable extramural scientists involved in the Network. Any participation of NIH intramural scientists is independent of and unrelated to the roles of NIH extramural Program Officer or the NIH Project Team.
Areas of Joint Responsibility include:
BRAIN CONNECTS Network Steering Committee:
The Steering Committee will consist of the PDs/PIs of awards of the BRAIN CONNECTS FOAs (as listed in Section 1), along with one NIH extramural program representative. Itwill 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 have one vote. 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.
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.
3. 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.
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 $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.
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]
Edmund Talley
National Institute of Neurological Disorders and Stroke | 301-496-1917
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
and Human Services (HHS)
