Part 1. Overview Information

Key Dates

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.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Background

Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notices of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.

The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of 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 historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

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

For applications proposing a collaboration with an industry partner, a successful application will be contingent on the applicant's ability to provide the NIH with documentation of company interest in allowing access to the selected device and associated data needed for conducting the proposed non-clinical studies and for filing an investigator-sponsored IDE in order to conduct the proposed exploratory clinical research study (e.g., an executed Collaborative Research Agreements (CRA) or letter from the partner). Final negotiations need not be completed at the time of submission, but an executed CRA may be required before issuance of grant award.

CRA and Confidential Disclosure Agreement templates can be found here: https://braininitiative.nih.gov/research/neural-recording-and-modulation/public-private-partnerships-program. These templates can be used as common starting points for negotiations of agreements between the device manufacturer, researcher, and research institution. These agreements have been developed to streamline interactions among the parties and expedite the formation of partnerships to conduct exploratory clinical research by creating a reasonable starting point for negotiations. The NIH recognizes that specific terms and clauses may need to be altered for specific projects by consensus agreement of the two parties.

A. Purpose

This Notice of Funding Opportunity (NOFO) is part of a coordinated effort to develop "innovative technologies to understand the human brain and treat its disorders" as recommended in Section III of the BRAIN 2025 Report. This NOFO seeks applications for the translation of novel recording and modulation technologies in the human central nervous system (CNS), from device proof of concept up to the stage of readiness for first in human (FIH) studies. 

B. Scope

The scope of this program, beginning with establishing proof of concept, may include efforts for technology development, optimization and pre-clinical testing that will advance next-generation human CNS recording and/or modulation devices along the translational path up to the stage of readiness for clinical studies. Proof of concept is the initial exploration phase where the feasibility and viability of an innovative device concept are evaluated. It involves creating a prototype to demonstrate the basic functionality and potential of the idea, often without the full range of features. Applications should propose design-directed development of a new technology and not be hypothesis-driven. Devices may be non-invasive, minimally invasive, implantable, or a combination thereof. Technologies may incorporate any signal modality such as electrical, optical, magnetic, acoustic, or any combination thereof. Devices may be used in combination with drugs, biologics, and/or small molecules. Activities that incorporate the ability to synchronize the device with other technologies in real time are strongly encouraged.

Examples of activities that are within the scope of this NOFO include, but are not limited to:

• Demonstrate basic functionality and potential of the idea (i.e., generate proof of concept data).
• Scaling device features for future human use.
• Activities that work towards preparing for future GLP testing or clinical studies for regulatory approvals.
• Activities to bring the development process under Design Control and Quality Systems processes.
• Device, software, and firmware design verification and validation activities.
• Development of packaging, connectors, surgical tools, and other accessories.
• Regulatory activities (e.g., pre-submission meetings with FDA).

C. Entry Criteria

Projects must begin at the device proof of concept stage and have scientifically sound assays to test the device. It is expected that by the end of the project period, recipients will have validated the technology or approach in vivo and demonstrated a viable pathway to a first in human study. Preclinical activities supported by this NOFO include those that generate preliminary evidence of device safety and effectiveness. Applicants are encouraged to provide this safety and effectiveness data to the FDA in a pre-submission meeting during the supported project to determine the scope of research needed for a future pilot clinical study.

Expected Project Activities: 

• Develop a technology or approach that is on a credible path towards use in humans within 5 years.
• Have a plan to continue developing the device after successful completion of the proposed project.
• "Begin with the end in mind," using design-driven development principles, such as gathering input from stakeholders and manufacturing partners, and safe, consistent, and reliable operation.
• Follow FDA guidance for Design Control and Quality Systems processes as appropriate for the proposed device and with respect to data that will be required to obtain regulatory approval for future clinical studies.
• Provide letters of support from industrial partners, if applicable.
• Consider, where appropriate, multi-PD/PI applications that integrate various domains of expertise, including engineering (e.g., biomedical, electrical, mechanical, industrial), computational (e.g., modeling, control theory, and statistical analysis), and scientific.
• The anatomical target to be affected or measured should be identified (i.e., brain and/or spinal circuit).
• There should be supporting data that the device will focally interact with the anatomical target.
• There should be a clear plan to evaluate the progression and ultimate success of the project. Specifically, projects must have a clear timeline, quantitative benchmarks, and deliverables.
• There should be a description of the design practices that will be used to manage the project.
• There should be a justification of support for all resources and expertise (e.g., manufacturing partner, regulatory consultant, neuroanatomist).
• There should be a justification of the budget and duration of the project within context of the maturity upon entry, anticipated maturity upon exit, needed resources, and project risks, in addition to standard criteria.

Applications that include the following activities will be considered non-responsive and will be withdrawn and not reviewed: 

• Clinical Trials are not allowed for this NOFO. 
• Development of technologies intended exclusively for implant outside the CNS that do not treat or diagnose CNS disorders or provide knowledge about CNS function, including dorsal root ganglion, peripheral, or cranial nerve modulation for the treatment of peripheral nervous system disorders. 
• Delayed onset studies are not responsive and will not be accepted.

Applications that are missing parts are deemed to be incomplete and will be withdrawn and not reviewed: 

• Include a Needs Assessment as an attachment, as described in Section IV.2.
• Include an Intellectual Property (IP) Strategy as an attachment, as described in Section IV.2.
• Include a Team Management Plan as an attachment, as described in Section IV.2.
• Include a Gantt chart as an attachment, as described in Section IV.2.
• Include a Current-State-of-the-Art-Statement as described in Section IV.2.
• Include a Plan for Enhancing Diverse Perspectives (PEDP) as an attachment, as described in Section IV.2.
• Attachments that exceed the maximum page limits listed for each attachment in Section IV.2 will be considered non-responsive and will be withdrawn.

Plan for Enhancing Diverse Perspectives (PEDP) (Required)

This NOFO 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 NOFO 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.

Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goals of this NOFO and the BRAIN Initiative.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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:

Brooks Gross, Ph.D.
Telephone: 301-496-1779
Email: [email protected] 

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:

Gantt Chart (Required – 1- page max):

Applications that exceed this limit or do not include this attachment will be withdrawn. This attachment should be entitled "Gantt.pdf". Applicants must include a project timeline in the form of a Gantt chart (or similar) that includes all major tasks to be performed during the project. The chart should also include estimated start and completion dates for those tasks.

Needs Assessment (Required – 3 pages max).  This attachment should be entitled "Needs Assessment.pdf". The needs assessment should establish performance requirements with clear, quantifiable metrics and identify significant issues faced by stakeholders (e.g., patients, clinicians, caregivers, customers), which is a key step in the design control process and will be evaluated for adequacy.

The Needs Assessment should:

• provide strong, systematic evidence for the most efficient and effective route to addressing an unmet need;
• critically evaluate primary or secondary data that have been used to identify deficiencies in current capabilities and the origins of the problem or critical barrier;
• describe the beneficiaries of the proposed work and how their needs have been identified;
• distinguish "wants" from "needs" and outline the involvement of those who will benefit in the development of a solution;
• describe how finite resources can best be deployed to develop and disseminate a feasible and applicable solution; and
• identify any human factors incorporated into the proposed research that optimize usability.

Intellectual Property (IP) Strategy (Required – 3 pages max). This attachment should be entitled "IP Strategy.pdf". The program strongly encourages the recipients and/or their collaborators to obtain and retain any IP developed around the device during the project period. Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, if applicable. Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the device development process. The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project.

• Applicants should describe the IP landscape surrounding their device. Applicants should describe any known constraints that could impede their technology development (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies that are under patent protection and/or on the market, etc.) and how these issues could be addressed.
• If the applicant proposes using a component or method whose IP is not owned by the applicant's institution, the applicant should address any limitations imposed on the studies or the project (including IP generation) which would impede achieving the goals of the funding program, such as impeding robust licensing opportunities at project completion. Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the technology, if there are any limits on the studies that can be performed with that technology, and agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.
• If patents pertinent to the device being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, application status, and associated USPTO links, if applicable.
• Applicants should discuss future IP filing plans. For a multiple-PD-PI and/or multiple-institution application, applicants should describe how IP will be shared or otherwise managed, and the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions.

Team Management Plan (Required – 2 pages max). NIH strongly encourages applicants to form multidisciplinary teams able to define the overall device development plan to ensure gaps that need to be filled can clearly be defined and addressed during this funding period, to design the details of the plans and experiments, and to execute the research strategy. An organizational structure that clearly defines the team structure and relationships among the various components should be described in the team management plan and illustrated in an organizational chart. This plan should also describe the governance and organizational structure of the leadership team and the research project, including communication plans, processes for making decisions on scientific direction, intellectual property, and procedures for resolving conflicts. For publications, policies should be presented that address decisions about what material to publish and the ordering and recognition of authors.

Plan for Enhancing Diverse Perspectives (PEDP) (Required - 1 page max)

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

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

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

Schematics (Optional – 1 page max):

Applications that exceed this limit will be withdrawn. This attachment should be entitled “Schematics.pdf”. This attachment may include images, photos, drawings, engineering schematics, design specifics, and associated labeling and captions.

Other Clinical Study-related Attachments

Communications with the IRB (Optional): For projects requiring limited human studies (e.g., usability), applicants may provide official communications with their IRB.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The budget should include funds necessary for travel for up to two key personnel to participate in a BRAIN Initiative investigator meeting, lasting not more than two days and including up to two overnight stays, for each year of the project.

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).

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

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:

Research Strategy:

The research strategy must primarily focus on technology development rather than mechanistic, hypothesis-driven research or biological aims. Applications should propose target and minimum device specifications as a measure of successful progress at the completion of the R18. The device should take a unique approach to target the relevant anatomy while limiting confounds or side effects. If the proposed device is for the diagnosis and/or treatment of a central nervous system disorder, the investigators should consider the phenotype, physiology, and feasibility of treating the target clinical population in the design of the technology. While it is expected that research supported by this NOFO may not have fully been designed prior to submitting the application, applicants are nonetheless expected to provide initial target specifications that describe the intended capabilities of the device to be developed. Supporting data may be preliminary (i.e., unpublished). Supporting data should adequately describe the rigor of prior studies. Applicants should compare their candidate device’s expected capabilities against commercially available technology approved for human use.

Target specifications are encouraged to be quantitative (e.g., “prototype survives 32 days under accelerated aging at 80 degrees C with less than 5% degradation in any one operational parameter”). Quantifiable (e.g., “we will measure how long it survives in accelerated aging”) or subjective (e.g., “our device will survive aging tests”) specifications are significantly less desirable. If a quantitative target specification is a “best guess estimate”, then applicants are encouraged to describe their assumptions and degree of confidence in the planned value. Applicants should furthermore provide a rationale for each criterion, such as a comparison against the state of the art.

Applicants should describe the engineering design principles to be used to manage their projects. These principles should specify how design requirements will be developed, refined, and validated; how risks and timelines will be managed; how the team will be managed; and how resource allocations will be modified if obstacles are encountered during execution of the project. 

Details on methods, assumptions, experimental designs, and data analysis plans should be included in the application. These details should be incorporated into the overall project timeline, which should also be reflected in a Gantt chart. Ultimately, the project timeline should be designed to provide confidence that the device will meet its target specifications, achieve a specific level of maturity at exit, and perform preclinical safety and effectiveness testing to inform, where appropriate, at least one pre-submission meeting with the FDA.

Experiments should be formulated to validate the technology and to demonstrate its capabilities on the bench or preclinically, rather than advancing the state of biological knowledge. Applicants should justify the specific techniques to be utilized for validation and should relate them to the target condition(s) and population(s). Ensure the experimental design is rigorous. This includes, but is not limited to justification for model systems, endpoints, adequacy of controls and sample sizes, description of statistical analyses, inclusions of measures to reduce bias, and plans for replication, if applicable.

A thorough risk analysis should be included. It is expected that among the analyses, applicants will describe the maturity and limitations of existing components to be integrated into the device, the maturity and limitations of scientific knowledge about the biological mechanistic basis for the treatment, factors that may adversely affect the timeline, and factors that may limit translation into clinical use. Applicants are encouraged to use a hazard analysis to inform the risk analysis.

Applicants are expected to consider barriers to translation, such as regulatory, reimbursement, IP, and commercialization factors. Applicants should describe the preliminary capabilities and maturity of any device or component to be integrated into the project and describe other resources, technologies, or capabilities to be incorporated into the system design. For each component to be developed within the project, applicants should justify why off-the-shelf components are inadequate. Applicants should also describe the anticipated plan after conclusion of the grant period, if successful.

Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the research activity the proposed interaction occurs. Describe how the team, including consultants, has already been engaged and a plan as to how they will continue working together over the course of the project (e.g., recurring team meetings, review and report of data across disciplines, decision-making, participate in meetings with NIH, communication, etc.).

If the applicant has any material from a preliminary needs assessment, it should be included in the separate Needs Assessment attachment as a part of your application package, and not in the Research Plan.

Current State-of-the-Art Statement: 

A current state-of-the-art statement must be included as part of the Research Strategy. Investigators should specifically define the current state of technology as a benchmark against which their proposed new technology or improvements will be measured. Preliminary/feasibility data are not required or expected for early-stage, high-risk projects. However, a sound rationale is required to provide as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful. In these cases, more emphasis is expected to be placed on details of the approach, particularly feasibility-testing. Applicants are expected to explain the specific assay(s) to be utilized in the application to validate the new technology in proof-of-concept testing.

Timeline: 

A timeline should be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes indicators of progress at critical junctures. These are expected to be tailored to the unique scope of each project and written concretely enough to evaluate what exactly will have been achieved (e.g., crucial steps in technology development) during the course of the project. Given that projects are likely to be early stage and high-risk in nature, it is required to include the specific proof-of-concept test(s) that will indicate whether/how a proposed technology actually “works”, along with alternative strategies should that effort fail to perform as expected. Tests should include a comparison against existing benchmark technologies; if a technology is truly first-in-class, comparisons may be done against a nearest neighbor technology. Investigators are expected to briefly note how results will be used to inform future phases of technology development.

Letters of support:

The following letters of support should be provided:

• If applying from an academic institution, include a letter of support from the technology transfer official who will be managing intellectual property associated with this project.
• If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.
• If collaborating with a private entity, include a letter of support that addresses any agreement to provide a device or technology, any limits on the studies that can be performed with said device or technology, any limitations on sharing of data (including negative results), and whether a licensing agreement(s) will be needed and in place once the project is funded. This letter should come from a high official within the private entity who has authority to speak on these issues.
• If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NIH, other governmental or non-governmental entities, include letters of support detailing the terms of collaboration, data sharing, and intellectual property.

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. 

Other Plan(s):

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• 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.
   
• Consistent with authorities under the 21st Century Cures Act, all applications to BRAIN Initiative NOFOs must include a Data Management and Sharing Plan. The BRAIN Initiative data sharing policy (NOT-MH-19-010) establishes the expectation that this plan should include:

1. a summary of the data that will be shared;
2. a description of the standard(s) that will be used to describe the data;
3. the archive(s) that will house the data; and
4. the proposed timelines for submitting data to the archive and for sharing data with the  research community.

• 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:

1. Distributed Archives for Neurophysiology Data Integration (DANDI; https://www.dandiarchive.org; R24MH117295) for cellular neurophysiology data;
    
2. The Neuroscience Multi-omic Data Archive (NeMO; https://nemoarchive.org/about; R24MH114788) for data from -omics experiments;
    
3. The Brain Image Library (BIL; https://www.brainimagelibrary.org; R24MH114793) for confocal microscopy data;
    
4. Data Archive for the BRAIN Initiative (DABI; https://dabi.loni.usc.edu; R24MH114796) for data related to human invasive device research;
    
5. OpenNeuro (https://openneuro.org; R24MH117179) for magnetic resonance imaging and other neuroimaging data; and
    
6. Block and Object Storage Service (BossDB; https://bossdb.org; R24MH114785) for electron microscopy and x-ray microtomography data.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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.

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 How to Apply - Application Guide must be followed.

Delayed onset studies are not responsive and will not be accepted 

All instructions in the How to Apply - Application Guide must be followed.

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

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.

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.

Important reminders:

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

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

Plan for Enhancing Diverse Perspectives (PEDP)

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn.  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.

Applications Involving the NIH Intramural Research Program

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

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Intramural Scientist may not serve as PD/PI on extramural awards. 

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.

In addition to the items described in the policy, letters and documentation of additional communications with regulatory bodies, including the FDA or IRB, may be submitted as post-submission materials (NIH post-submission policy applies).

IRB Communications (Optional – 5 pages max):

• Submissions that exceed this limit will not be accepted.
• This attachment should be entitled “IRB Communications.pdf”.
• Applicants should submit relevant approval letters and associated attachments.

FDA Communications (Optional - 10 pages max):

Applicants should include a summary (1-page max) of interactions with the FDA, supported by the following associated and attached documentation:

• approved minutes from all pre-submission meetings
• notice of IDE approval and any associated attachments
• notification of risk determination
• breakthrough device designation
• 513(g) letter (if applicable)
• communications on official FDA letterhead
• email communications with substantive information regarding the device, review, or outcome.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the 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?

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

Specific to this NOFO:

• How significant of an advantage will the candidate device offer over commercially available scientific and/or clinical technologies approved for human use?
• What is the strength of the rationale for the biological target (if applicable)? 
• If the proposed device is for the diagnosis and/or treatment of a central nervous system disorder, have the investigators considered the phenotype, physiology, and feasibility of treating the targeted clinical population in the design of their technology?   

Needs Assessment (attachment):

• Is the needs assessment adequate and complete?
• Does the needs assessment incorporate input from relevant stakeholders (e.g., researchers, clinicians, caregivers)?
• Were the beneficiaries of the proposed research described and were their needs identified?

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?

Reviewers must consider the “Team Management Plan” in addition to standard application materials.

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

Specific to this NOFO: 

• Does the Team Management Plan strongly encourage a multidisciplinary team and describe how the team will work together (description provided in section IV.2)?

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?

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

Specific to this NOFO: 

• Does the device take a unique approach to target the relevant anatomy while limiting confounds or side effects?
• How significant of an advantage does the proposed device offer over existing approaches for the same scientific and/or clinical purpose regardless of technology class (e.g., device, drugs, biologics)?
• If the proposed device is designed to improve over early generations that may or may not have been marketed, are the potential advantages truly novel so the technology might succeed where others did not?
• Is the Current State-of-the-Art statement well-reasoned and appropriate (description provided in section IV.2)?

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?

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

Specific to this NOFO: 

• Is a sound rationale provided as to why the approach proposed is the most appropriate and is likely to generate an exceptionally high impact if successful?
• Is the plan for device development reasonable, including the plan after conclusion of the grant period?
• Are design criteria informed by input from stakeholders and include clear and justifiable metrics for verification?
• Is the regulatory plan reasonable in terms of the path to market?
• Are the experiments formulated to validate the technology and demonstrate safety and effectiveness for the specified condition and population(s), rather than advancing the state of biological knowledge?
• Have the applicants considered the critical factors that might limit adoption?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

If the project involves human subjects (e.g., usability, wearability), are the plans to address

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

2) inclusion (or exclusion) of individuals based on 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?  

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?

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?

Specific to this NOFO: 

1) Is there sufficient translational experience (e.g., regulatory, manufacturing, commercialization) to guide development of the device towards human use within 10 years? 

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.

Specific to this NOFO:

Timeline

Is the timeline realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps?

Gantt Chart (Attachment)

Does the Gantt chart provide sufficient detail on the timing and duration of key project tasks? Are the timelines proposed for achieving project goals realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps?

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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 the Center for Scientific Review , in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned 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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council . The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

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

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

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

2. Administrative and National Policy Requirements

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

• Federal-wide Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

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

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 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.

Additionally, in accordance with the Notice of Data Sharing Policy for the BRAIN Initiative (NOT-MH-19-010), recipients of BRAIN Initiative awards will be required to share the data they collect using the BRAIN Initiative informatics infrastructure (both data archives and relevant data standards), consistent with authorities under the 21st Century Cures Act and these awards authorized under that Act. Recipients will be expected to coordinate with Program Staff to select appropriate BRAIN Initiative data archives and to submit data to the selected archives every 6 months of the award period. Submitting data to an archive is distinct from sharing that data with the research community. Submitted data will be held in a private enclave until the data are shared with the research community. After the data have been submitted to the appropriate data archive, it will be shared with the research community when papers using the data have been published or at the end of the award period, whichever occurs sooner.

4. Reporting

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

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Brooks Gross, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Center for Scientific Review  
Email: [email protected]

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

Section VIII. Other Information

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

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