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 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.

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 the "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 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.

The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

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

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

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

The BRAIN Initiative requires a high level of coordination and sharing among 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 annual PD/PI meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

This NOFO is related to the recommendations in Priority Areas 3 and 6 of the BRAIN 2.0 of the BRAIN working group.  Specially, this NOFO solicits applications that will address the recommendations on “The Brain in Action” and “Advance Human Neuroscience”. 

Development of Next Generation Sensor Technologies and Bioelectronic Devices

This program capitalizes on the development of new sensor technologies that will allow synchronization with brain recordings that will allow the generation of new models of human or animal behavior. Key aspects of sensor development include low or zero battery usage, miniaturization, and wireless configurations. For example, at nano-scale, harnessing quantum physics design principles has brought on new kinds of transistors in which fundamental limitations of their operating characteristics are now overcome and enable smaller designs. The delivery of related nanosensors into the cellular milieu has also opened up possibilities for sensing in the cellular environment with extremely low power consumption. With the development of next generation micro-and nano-scale fabrication coupled with high-performance computing, the brain research community is ripe to develop next generation sensor designs.

Research Objectives 

Key Features for the Development of Sensors and Bioelectronics to support the BBQS research community

What are the desired features of the next-generation of sensors and bioelectronics? Sensors and bioelectronic designs should include but not be limited to electrochemical, micromechanical, optical, fiber-optic, electromagnetic, radiation, temperature, inertial, acoustic and ultrasound modalities. They may also be remote in overall design, for example with LiDAR or microwave sensing to measure position or movement.  Oxygen or other gas sensors are another type of sensor to be included for monitoring of physiologic activity. Sensors need to perform with minimal or zero energy consumption, preferably with energy harvesting.  Sensors need to be next-generation with demonstration of improved performance over other previous and similar designs; the demonstration of novelty will be dependent on the particular type of sensor proposed.  Justification or rationale for the proposed design will need to show that sensor performance would exhibit high reliability and repeatability in output, to ensure the most accurate measurements.  Sensors would also need to collect data in real-time, and their performance needs to be maintained over long periods, i.e. for 48 hours or longer. Combinations of multiple sensor modalities are highly encouraged to promote compact designs. There are no limitations on materials to be used in fabrication.

How will sensor data be integrated into the BRAIN Behavior Quantification and Synchronization research?  In the era of micro-electromechanical systems (MEMs) and nanotechnology, and with the goals of the BBQS Program in mind, researchers need to include several features.  Next generation sensing technology needs to include the acquisition of data with the highest spatial and temporal resolution possible.  Sensor data may come from within or the edge, (that is, close to where the data originates) keeping in mind the collection of only meaningful data, to minimize data storage and compute time.

Sensor data in this NOFO will need to be combined with other data streams including neural recordings, either from surface or intracranial brain recordings. Last, in the context of invasive sensing, biocompatibility and or low toxicity effects are key issues that need to be addressed.

The "BRAIN 2025: A Scientific Vision" report enumerated several core principles, including that "new methods should be critically tested through iterative interaction between tool?makers and experimentalists. After validation, mechanisms must be developed to make new tools available to all."  As such, this NOFO will foster close interaction between engineers and behavioral neuroscientists, computational and data scientists in a research consortium. The BBQS Consortium will promote rigorous sensor technology design, testing, validation, and dissemination and aid in quantification and synchronization of data to improve our understanding of behavior.

Research Scope

The aims of the NOFO are to develop novel sensor technologies and/ or bioelectronic devices that will enrich existing sensor or other data streams to improve our understanding of human and organismal behavior. Applicants to this NOFO should propose technologies or devices with superior performance and reliability to achieve real-time data acquisition of physiologic, physical, chemical, or electrical data. The proposed projects should demonstrate the potential to achieve as many of the following goals as possible. Applicants must address goals 1, 2, 3, 4, 5 and 6:

GOALS (Required 1-6):

1. Next-generation and compactness in design, with the expectation that this will contribute to very low or zero power consumption. Proposed sensors/devices must not consume more power than current sensors/devices.

2. High reliability and repeatability in performance and accuracy of measurement beyond what has been previously demonstrated.

3. Sensor design with stability in battery power, and long-term performance greater than 48h, to be able to capture naturalistic behavior in real time from human or animal subjects.

4. Collection of data in real time.

5.  Biocompatibility should be high and toxic effects of sensors (either noninvasive or invasive) to cells, tissues, and organisms are quantitatively low.

6.  Demonstration of synchronization of the sensor(s) data with brain recordings, including surface or  intracranial recordings.

7.  Intracranial recordings to be included wherever possible within the research team.

8.   Energy harvesting capability.

9.   Combinations of multiple sensors or bioelectronics into a single compact design.   

10.  Devices that are easily produced and could be widely disseminated in the engineering and scientific community.

11.  Development of computational models of behavior using all data, including sensor data.

Applicants are strongly encouraged to form multidisciplinary teams to develop a new type of sensor or bioelectronic device, using the above goals for design, fabrication, testing, validation, and dissemination. Successful applicants will become part of a research consortium (see further below) encompassing other recipients. The NIH expects the consortium to operate as a cooperative network to promote collaboration and coordination and to achieve the program's overall goals. This will include regular meetings and other coordinated activities within the Consortium as well as in the BRAIN Initiative more broadly.

During the funding period, applicants must develop novel sensing technology or bioelectronics to be utilized in the quantification and synchronization of data, to be combined with brain recordings.

Working Together in the BBQS Research Consortium

Supported U01 recipients are expected to work closely together and benefit from membership in the BBQS Consortium of researchers, including other BBQS recipients from this NOFO, and several others including from the BBQS Organismal Research Community RFA-DA-24-042, the BBQS Human Research Community RFA-MH-26-100, the Data and Artificial Intelligence Coordination Center for the BBQS program RFA-MH-23-130 and a NOT-MH-23-115. Coordination among Consortium members is expected to include sharing of protocols, technologies, and data to improve the optimization process of novel sensors and their integration into BBQS experimental and modeling efforts, as well as cooperation in publication and development of best practices to integrate the best technologies into the behavioral research. To promote coordination, applications can include requests for travel funds to the Brain PI Annual Meeting.

 This NOFO seeks applications in areas including, but not limited to:

• Design, fabrication and validation of next generation or optimized sensors including but not limited to collection of data in the following domains: MEMS, nanotechnology or nanosensor development designed to function in noninvasive, minimally invasive, or invasive applications with a plan to quantify and synchronize data for behavioral study; 
• Combination of sensors into a single sensor design;
• Combination of sensor data with brain recordings, including intracranial or surface methods;
• Artificial intelligence or machine learning approaches for managing sensor or bioelectronics data that improve efficiency of data transmission;
• Use of sensor data to generate computational models of behavior;
• Mechanical (force, pressure, piezoelectric);
• Thermoelectric;  
• Potentiometric (Solutes, Metabolites, Hormones, Neurotransmitters etc);
• Inertial (velocity, angular acceleration);
• Optical (Near-infrared (NIRS), photonic, etc.);
• Acoustic / Ultrasound;
• O₂ and CO₂ blood gas sensing;
• Remote (Doppler radar, LiDAR etc.) sensing;
• Quantum

Proposed Milestones and Timeline

Applications must include Proposed Milestones and Timeline submitted as Other Project Information as an attachment (see Section IV). The Proposed Milestones and Timeline should explain critical indicators of progress for Sensor and Bioelectronic device development to enhance our understanding of behavior. The Proposed Milestones and Timeline will be evaluated as part of the review process, but final versions will be agreed upon at the time of award. If justified by scientific and/or technological needs, future year milestones may be revised, upon request, based on data and information obtained in the current year.

Non-responsive Areas of Research

Applications will be considered non-responsive and will not be reviewed if they propose:

• Devices that are bulky, cumbersome or would need to be carried with respect to organism size and which would interfere with naturalistic behavior
• Devices that require hard-wired configurations for data acquisition
• Devices with short battery life less than 48 hours
• Magnetic resonance and other imaging technologies with relatively low spatial resolution
• Devices with low temporal resolution
• Sensing measurements that require invasive imaging approaches
• Studies primarily focused on technology development that do not propose a sensor device
• Applications that do not address goals 1-6 in the Research Scope section
• Devices that will not develop novel sensing technology or bioelectronics to be utilized in the quantification and synchronization of data, to be combined with brain recordings

For projects focused on using  existing tools, technology or devices to quantify and synchronize data for understanding organismal or human behavior, potential applicants should consider responding to other BRAIN Initiative NOFOs (RFA-DA-24-042, RFA-MH-26-100 or reissued versions).

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

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, 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 encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be 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 materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

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)

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

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

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

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 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.
  • 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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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 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:

Email: [email protected]. 
 

Page Limitations

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.

SF424(R&R) Cover

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.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• 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 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Consortium Annual In-Person Meeting Costs:

• Applications may include allowable costs for participating in the Consortium annual in-person meetings.

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.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

The following items must be addressed:

Applications must describe plans for the development of next generation sensors and bioelectronics beyond their initial stages into working tools for understanding behavior in ways that are currently unachievable. The intended outcome, by the end of this award, will be bold, high-impact, and transformative technologies to enhance our understanding of organismal and human behavior.

The specific goals to be achieved by the project must be stated in the application for the proposed project, including an explanation of how the proposed activities will serve to transform our understanding of behavior beyond what can be achieved through existing methods. 

Applications must provide information regarding how their U01 application will: 

• Advance sensors beyond the state-of-the-art, in their timing, spatial and temporal resolution capabilities, sensitivity and overall performance through the use of optimal materials and scale 
• Build devices that will function for long recording times, that is for 48 hours and longer 
• Optimize battery life and include considerations for energy harvesting where possible
• Optimize device weight to record naturalistic behavior in organism(s) or human subjects 
• Conduct testing and validation to demonstrate improvements over existing sensor designs
• Adapt sensor(s) into easily produced and applied formats for behavioral neuroscience users
• Utilize sensors in behavioral neuroscience frameworks
• Combine multiple sensors in the same device where possible
• Integrate sensor data with neural recordings
• Integrate all data into computational models of behavior

Consistent with NIH BRAIN Initiative goals, applications must balance innovation and advanced thinking and methodology with convincing tractability and potential impacts.

Additional Considerations for the Activities Supported by This U01

• The project team must develop, generate, integrate and work towards the development of computational models of behavior and must be multi-disciplinary, including the expertise of scientists, clinicians, and engineers from fields including but not limited to: electrical engineering, bioengineering, chemical engineering, physics, materials science, computational neuroscience, neurology, neurosurgery, psychiatry, neuroethology, evolutionary biology, cognitive neuroscience, neurocognitive development, biokinetics and data science. Team members must bring diverse technical and scientific  expertise in observing, measuring, and modeling behavior.
• Neural recordings must be included and may be of either surface or ideally intracranial in nature.  
• For projects using multiple species, describe how the sensor will be adapted to collect behavioral data 
• If the planned project will involve human subjects or data, the plan must consider the analytical and ethical challenges of collecting, archiving and analysis of subject-level data, including privacy.

Current State-of-the-Art Statement: Investigators must specifically define the current state of technology as a benchmark against which their proposed new sensor technology performance will be measured. A sound rationale should be provided as to why the approach proposed is the most appropriate and, if successful, likely to generate an exceptional improvement in the way sensor technology and bioelectronics development for the study of behavior is conducted in the future.

Timeline and Milestones: A timeline must 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 should be tailored to the unique scope of each project and details must be provided to permit a thoughtful evaluation of precisely what will be achieved throughout the duration of the project. This should include descriptions that will indicate how the proposed approaches will be tested and validated along with alternative strategies should an effort fail to perform as expected. Investigators should describe how our current state of sensor technology, synchronization of neural data, and subsequent computational models of behavior will be transformed by the proposed project.

Animal Research/Development Inclusion: This NOFO allows animal studies that are clearly justified as necessary for the proposed development of next generation sensors and bioelectronic devices. Applications proposing animal research before scaling up to humans must provide clear rationale as to how the findings from the proposed studies will translate up the scale and lead to the development of working tools for the study of behavior, with the intention that the technologies are capable of being used practically and ethically in healthy humans.

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): 

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.
• The data sharing expectations for BRAIN Initiative awards require that the data is deposited to relevant data archives developed by the BRAIN Initiative. Applicants can refer to NOT-MH-19-010, for more information about BRAIN Initiative data sharing information.

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.

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.

PHS Assignment Request Form

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

Foreign Organizations

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.

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 co-investigators in accordance 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.

6. Funding Restrictions

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

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

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 administratively withdrawn before review.

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

Applications must include 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 before review.

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 Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

For this particular NOFO, note the following:

This NOFO specifically seeks applications to develop novel sensors and bioelectronic interfaces, therefore, the NIH expects that many applications will be clearly technology development-based.  

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 scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the plan to enhance diverse perspectives affects the scientific merit of the project.

Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions, consistent with applicable law.

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

Please note that reviewers will not consider race, ethnicity, age, or gender (including gender identify, sexual orientation or transgender status) of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial’s data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

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

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

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

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Optimize design of a sensor for use in the behavioral neuroscience field to quantify and synchronize with brain recordings.
• Determine and coordinate the research approaches and procedures, conduct experiments, and analyze and interpret research data generated under this award.
• Meet or exceed the timeline stated in their application.
• Agree to participate as needed as a voting member in a Consortium composed of other recipients from this NOFO and other BBQS NOFOs, NIH staff, and an external expert group.
• Share protocols, technologies, and unpublished data with Consortium members.
• Ensure that results are published in a timely manner.
• Coordinate with other Consortium members the publication of research results, dissemination of sensors and bioelectronic devices, and dissemination of data.
• Submit devices and data for use, quality assessment, and/or validation in any manner specified by the Steering Group and the NIH Project Scientist.
• Submit annual milestone reports to the NIH with completeness that include experimental design with rigor, including assumptions for the design of any experiments, the results of the investigations, interpretations of the results, and for concluding whether milestones have been met or not.
• Provide updates at least annually on implementation of the PEDP.
• Accept and implement common guidelines and procedures approved by the Consortium. This may include common file formats for output data.
• Attend Consortium meetings. It is likely that there will be one in-person meeting per year and that other meetings will be held by telephone or using internet-assisted meeting software.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• A Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award..
• Prior to award, the Program Officer will negotiate final milestones with the PD/PIs that will be incorporated in the Notice of Award.
• A group of NIH program staff from the ICs that make up the NIH BRAIN Initiative will form a Project Team for this award.
• The Project Team will include the Program Officer for these BRAIN Initiative awards.
• The Project Team will review annual progress reports and other documents from the recipients and will advise the Program Officer about their view of the progress being made by the awardee as well as about progress being made by others in the field.
• One or more extramural NIH program staff member will be assigned as Project Scientist for this award. The same person may serve as a Project Scientist for multiple BRAIN Initiative awards.
• The Project Scientist(s) will interact scientifically with the PDs/PIs of the cooperative agreement and other named key personnel as a partner in the research activities.
• The Program Officer and the Project Scientist(s) will be members of the Steering Group.

Areas of Joint Responsibility include:

• The purpose of the Steering Group is to transfer information and technologies among the recipients of this NOFO, and several others including from the BBQS Organismal Research Community RFA-DA-23-030, the BBQS Human Research Community RFA-MH-22-240, and the Data and Artificial Intelligence Coordination Center for the BBQS program RFA-MH-23-130 and a NOSI and between the recipients and the BRAIN Initiative more broadly in order to achieve the goals outlined in the BRAIN 2025 and BRAIN 2.0 reports.
• The Steering Group will be comprised of the PDs/PIs of the awards of this NOFO, and several others including from the BBQS Organismal Research Community RFA-DA-23-030, the BBQS Human Research Community RFA-MH-22-240, and the Data and Artificial Intelligence Coordination Center for the BBQS program RFA-MH-23-130, the Project Scientist(s), the Program Officer, and a group of external experts.
• The PDs/PIs and Program Officer will invite a group of external experts to attend Steering Group meetings.
• A chair of the Steering Group, who is a recipient of this NOFO, or one from the BBQS Organismal Research Community RFA-DA-23-030, the BBQS Human Research Community RFA-MH-22-240, and the Data and Artificial Intelligence Coordination Center for the BBQS program RFA-MH-23-130 will be designated by the Steering Group on a rotating basis as needed.
• It is expected that most of the decisions on the activities of the Steering Group will be reached by consensus. A steering committee member can, however, request that a vote is needed, at which time each Committee member will have one vote and the Project Scientist(s) collectively will have one vote.
• The Project Scientist may assist in research planning, may present experimental findings from an award from published sources or from relevant award projects, may participate in the design of experiments agreed to by the group, may participate in the analysis of results, may help ensure that duplication is avoided, and will interact scientifically with the Steering Group.
• The Program Officer and the external expert group members will attend Steering Group meetings as non-voting participants.
• In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• 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 Section 8.6 Closeout. 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.

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]

Yvonne Bennett, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-222-7094
Email: [email protected]

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
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.