BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) Program - Specialized Projects (U01 Clinical Trial Optional)

BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) Program - Specialized Projects (U01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This program seeks transformative and innovative research to understand brain circuit function and its contributions to behavior. It supports the development of technologies to generate comprehensive atlases of brain connectivity.

RFA-NS-27-015: BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Specialized Projects for Scalable Technologies (U01 Clinical Trial Not Allowed) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Neurological Disorders and National Eye Institute ( NEI ) 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 ) Funding Opportunity Title BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Specialized Projects for Scalable Technologies (U01 Clinical Trial Not Allowed) U01 Research Project – Cooperative Agreements Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 372, 93. 853, 93.

242, 93. 866, 93. 867, 93.

173, 93. 279, 93. 273, 93.

286, 93. 213, 93. 865 Funding Opportunity Purpose This funding announcement, issued by the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, seeks transformative, cutting-edge, and innovative research that embraces new technologies, ideas, and approaches to understand brain circuit function and contributions to behavior.

It is a component of the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) Program, which aims to lay the scientific foundation for the next generation of neural circuit-based approaches for preventing and treating devastating brain disorders.

This Notice of Funding Opportunity (NOFO) supports Specialized Projects to develop current or emerging technologies to generate comprehensive atlases of brain connectivity, with an emphasis on human, non-human primate (NHP), and mouse. Projects using other species are also permitted, if their use is well justified and the goal is to test and validate approaches that can be generalized across species.

Applications may address any aspect(s) of brain connectivity and associated data pipelines, including data collection, reconstruction, analysis, integration, dissemination, and interpretation, to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams.

Funded projects will be integrated into the BRAIN CONNECTS Network consisting of projects funded under this and preceding BRAIN CONNECTS NOFOs, as a coordinated effort aimed at developing the capabilities to generate wiring diagrams that can span entire brains across multiple scales.

Funding Opportunity Goal(s) To provide extramural research support for the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative's aim of revolutionizing our understanding of the brain and its function in unprecedented detail.

The NIH BRAIN Initiative's focus is foundational development of new technologies and tools to map, monitor, and modulate brain circuits in model systems and humans – toward the ultimate goal of treating and curing human brain disorders.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description 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. The NIH BRAIN Initiative recognizes innovative ideas require creativity, scientific expertise, and experience.

There are many benefits that flow from a scientific workforce with broad participation including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, and enhancing public trust. 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. The BRAIN Initiative requires a high level of coordination and sharing between investigators.

It is expected that BRAIN Initiative recipients 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 BRAIN Initiative Biennial Conference. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010 .

BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) 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 RFA-NS-24-028 U24 Data Coordinating Centers Comprehensive Centers funded under RFA-NS-22-047 and RFA-NS-22-048 use the UM1 activity code for large-scale research activities with interdependent components.

Funded projects aim to 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, and chosen to test specific hypotheses relating circuit structure to function.

Specialized Projects ( RFA-NS-22-049 and this re-issue) use the U01 activity code for cooperative agreements to develop current or emerging technologies for scalable mapping of brain connectivity. Data Coordinating Centers ( RFA-NS-24-028 ) facilitate and organize the activities of the BRAIN CONNECTS Network.

Through these awards, 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 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 Objectives and Requirements for this Announcement Applications to this announcement may address any aspect(s) of the production and analysis pipeline – from data collection, reconstruction, analysis, integration, dissemination, and interpretation of brain connectivity and associated data.

The proposed development must aim to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams. Projects may develop and optimize current technologies or propose entirely new, disruptive, and potentially risky approaches.

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. Applications to this announcement are expected to complement existing BRAIN CONNECTS awards with distinct capabilities and competencies.

Applicants are strongly encouraged to use NIH RePORTER to retrieve information on awards from each of aforementioned announcements. The focus of the BRAIN CONNECTS Program is on human, NHP, and mouse brain. For mouse, technologies must demonstrate feasibility of local and long-range cell-to-cell connectivity at the level of synaptic connections.

For human and NHP, technologies must demonstrate region-to-region connectivity at the level of axonal projections. Other species are permitted, if their use is well justified and the goal is to test and validate approaches that can be generalized across species.

The BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) Network Awards funded under this announcement will be integrated into the BRAIN CONNECTS Network for project coordination and program integration. Throughout the funding period, all CONNECTS Network recipients will work cooperatively to further common goals and identify collaborative opportunities.

The CONNECTS Network will develop and harmonize common data processing pipelines, integrate and disseminate data analytic tools and capabilities, initiate efforts towards a unified knowledge base for connectivity data from a variety of modalities, and organize and implement outreach and engagement to the wider research community and the general public.

Applications Not Responsive to this Announcement Proposed research that is not responsive to this announcement and will not be reviewed includes the following: Projects not aimed at developing or improving technologies that can serve as components of scalable pipelines for brain-wide connectivity. Projects using approaches that will not be applicable to mammalian brain.

Technologies not expected to support mapping of region-to-region connectivity at the level of axonal projections in human or NHP, or local and long-range cell-to-cell connectivity at the level of synaptic connections in mouse.

RFA-MH-26-170 , BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed) Prior Consultation with Scientific/Research Staff See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Cooperative Agreement: A financial assistance 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 The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The NIH BRAIN Initiative intends to commit an estimated total of $10M in the first year for this funding announcement to fund approximately 3-6 awards. Application budgets are not limited but need to reflect the actual needs of the proposed project. The maximum project period is 3 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 Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Intellectual property will be managed in accord with established policy of 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. Intramural scientist cannot be MPIs on extramural awards. Foreign Organizations/International Collaborations 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 not allowed. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information. 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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 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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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.

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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. BRAIN Initiative and CONNECTS Network In-person Meeting Costs: Applications may include allowable costs for participating in annual in-person BRAIN CONNECTS Network meetings.

The budget should include funds necessary for travel for up to two key personnel to participate in the BRAIN Initiative Biennial Conference. All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: In the Specific Aims section, explain how the project will contribute to scalable pipelines for brain connectivity and associated data, and how it will result in new or improved capabilities that can be scaled to whole brains.

In the Research Strategy section, detail how the project will contribute to scalable pipelines for brain connectivity and associated data, and how it will result in new or improved capabilities that can be scaled to whole brains.

Applications may address any aspect(s) of data collection, analysis, and dissemination pipelines, from tissue processing to data acquisition, alignment, segmentation and annotation, error correction, analysis, integration into the larger neuroscience data environment, and dissemination to the research community.

The proposed development must aim to enable faster, more precise, and more cost-effective generation, analysis, and interpretation of brain-wide wiring diagrams. 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.

For entirely new, disruptive, and potentially risky approaches, explain how success of the project will lead to quantitative and/or qualitative gains in brain mapping capabilities.

If a new dataset will be generated or analyzed to validate the approach, explain the significance of the data and/or resulting analysis for understanding neural circuit structure and function, and indicate how availability of the proposed data or toolsets will contribute to novel research findings and/or new capabilities for the field.

If producing or analyzing data from species other than mouse, NHP, or human, provide justification for the choice of species and explain how the approach can be generalized more broadly.

Funded awards will be integrated into the BRAIN CONNECTS Network, consisting of other Specialized Projects, Comprehensive Centers, and Data Coordinating Centers as a coordinated effort aimed at developing the capabilities to generate wiring diagrams spanning entire brains across multiple scales.

Accordingly, proposals should include plans to ensure efficient coordination, communication, and decision support with the other entities of BRAIN CONNECTS Network. Feasibility Metrics and Milestones : In a separate section of the Research Strategy, provide performance metrics that can be used to demonstrate feasibility of scaling to entire brains and/or comparison to other approaches.

Include information on expectations of cost, time, and any ancillary requirements that would affect decisions on project continuation in a potential subsequent funding period. In addition, provide a project timeline and annual milestones using SMART criteria (Specific, Measurable, Attainable, Relevant, and Time-bound).

Milestones should be delineated into aspirational but realistic goals 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 How to Apply - Application Guide . All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data.

Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.

An updated listing of BRAIN Initiative archives is provided at the BRAIN Informatics website. Currently established archives that may be relevant to this funding opportunity include, but are not limited to: Distributed Archives for Neurophysiology Data Integration (DANDI; https://www. dandiarchive.

org ; R24MH117295) for cellular neurophysiology data; The Neuroscience Multi-omic Data Archive (NeMO; https://nemoarchive. org /about ; R24MH114788) for data from -omics experiments; The Brain Image Library (BIL; https://www. brainimagelibrary.

org ; R24MH114793) for confocal microscopy data; Data Archive for the BRAIN Initiative (DABI; https://dabi. loni. usc.

edu ; R24MH114796) for data related to human invasive device research; OpenNeuro ( https://openneuro. org ; R24MH117179) for magnetic resonance imaging and other neuroimaging data; and Block and Object Storage Service (BossDB; https://bossdb. org ; R24MH114785) for electron microscopy and x-ray microtomography data.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide . No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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 How to Apply - Application Guide must be followed.

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 How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

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. 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 How to Apply-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 Section 7.

9. 1 Selected Items of Cost. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply – 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. 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 How to Apply – 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure