The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is a Presidential initiative aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This report can be found at http://braininitiative.nih.gov/ . This FOA and other FOAs issued in Fiscal Year 2015 are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group (http://braininitiative.nih.gov/MCWG-Roster.pdf ), which held its first two meetings in 2014 and 2015 (see http://videocast.nih.gov/summary.asp?file=18555&bhcp=1 and http://videocast.nih.gov/Summary.asp?File=18880&bhcp=1 ) .

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/ ) support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research.

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

This RFA encourages applications from diverse teams of investigators, including team members that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.

To achieve the goals of the program, the BRAIN Initiative will require a high level of coordination and sharing between investigators. By involvement as a cooperative agreement mechanism, it is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.

This RFA is related to the Recommendations in Section III. 6 of the Final Report (http://www.nih.gov/science/brain/2025/index.htm ) of the BRAIN working group. Specifically, this RFA solicits applications that will address the recommendations on "ADVANCING HUMAN NEUROSCIENCE" (Section III Implementation: Goals, Deliverables, Timelines and Costs, Part 6) of the Final Report.

Background

The BRAIN Initiative seeks to understand the circuits and patterns of neural activity that give rise to mental experience and behavior, which will provide a foundation for understanding and treating diverse neurological, psychiatric, and behavioral disorders. Dynamic activity of ensembles of neurons in specially organized networks gives rise to the internal states we experience as sensations, perceptions, emotions, thoughts, and memories and to observable motor behavior. The activity of these networks is the substrate of cognitive processes such as attention, intention, reasoning and decision making; of emotional states of happiness, sadness, and fear; of sensation such as touch, pain, hearing, olfaction, taste, and vision; and to motor behaviors such as balance, motor control. Dysfunction of these large systems of neurons due to disease, injury, or developmental anomaly is the basis of neural and mental disorders. Furthermore, investigative studies of neural circuits in human subjects offer unique opportunities for mechanistic understanding of complex capabilities especially advanced in humans.

While research using non-invasive imaging and stimulation methods is typically considered non-significant risk by Institutional Review Boards and does not require an Investigational Device Exemption (IDE) from the FDA, opportunities for research involving invasive, higher-resolution stimulating/recording devices for human neuroscience research often have limited time windows. These opportunities are mostly restricted to patients undergoing neurosurgical procedures or implantation for less than 30 days with devices such as ECoG/EEG grids and indwelling penetrating arrays. There are few stimulating/recording devices that are FDA market-approved for implantation for greater than 30 days. These inherent challenges associated with research using invasive devices in the human nervous system therefore require a greater degree of planning and interdisciplinary collaboration.

RFA Research Objectives

Investigations within the human brain offer revolutionary, but challenging, opportunities for experimental investigation of how the human brain senses, thinks, perceives, remembers, plans, registers emotions, activates movements, and makes decisions. Invasive surgical procedures provide the unique ability to record and stimulate neurons within precisely localized brain structures in humans. However, human studies using invasive technology are often constrained by a limited number of patients and resources available to implement complex experimental protocols and are rarely aggregated in a manner that addresses research questions with appropriate statistical power. Therefore, this RFA seeks applications to assemble diverse, integrated, multi-disciplinary teams that cross boundaries of interdisciplinary collaboration to overcome these fundamental barriers and to investigate high-impact questions in human neuroscience. Projects should propose prospective testing and validation of explicit or model-driven hypotheses. Studies that offer deployment or development for high temporal resolution of behavioral quantification integrated with invasive recording of brain activity is encouraged, especially those that would transition to use in naturalistic environments outside of strict laboratory settings.

Projects should engage diverse, multidisciplinary teams consisting of clinicians, scientists, device engineers, data/computational scientists, regulatory specialists, and/or ethics specialists. Teams may be assembled within a single institution, but because of the likelihood of a limited number of patients at any single research center, integration of research teams across sites is strongly encouraged.

Awardees are expected to actively participate in a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community. In the interest of iterative models of discovery, support for complementary animal studies are allowed if they validate or inform these empirical studies of human physiology. Applicants are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate.

We anticipate that implantable devices for most of these applications will rely on existing technology sufficiently advanced for an IRB Non-Significant Risk designation, or an FDA IDE without needing significant additional pre-clinical testing on the device. We also anticipate that newly IDE-approved devices may become available over the course of these awards. NIH BRAIN is supporting new device development and regulatory approval through other NIH BRAIN initiatives, including the availability of template Memoranda of Agreements (MOUs), Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) with various private and commercial device providers that may facilitate awardees to adopt novel technologies to fit their needs (see http://braininitiative.nih.gov/ for up to date information and NIH Scientific/Research contacts). Where appropriate, applicants are encouraged to anticipate potential and alternative plans for adopting newly available technologies. Furthermore, use of the cooperative agreement mechanism will allow awardees to negotiate the incorporation of new technologies by working through NIH Program staff in collaboration with technology providers.

Activities Supported

The list below includes representative, but not exhaustive, examples of activities that could be considered responsive to this RFA . Applications may:

• propose statistically-powered hypothesis testing.
• integrate non-invasive technologies to image and/or perturb the nervous system for use in conjunction with the invasive implants in order to cross spatial and temporal scales.
• combine multi-modal techniques.
• offer a combination of quantitative psychophysics and behavioral assays in combination with brain recording or stimulating that tests mechanistic hypotheses.
• utilize approved, chronic implants, (e.g., DBS implants; FDA-approved indwelling electrodes) to address mechanistic hypotheses about brain function, plasticity, etc.

Topics supported

The list below includes representative, but not exhaustive, examples of topics that could be considered responsive to this RFA.

• Human research studies as mechanistic investigations. A mechanistic investigation is designed to understand a biological or behavioral process, or the mechanism of action of an intervention.
• Investigative studies for understanding the neurobiology of cognitive functions specially advanced in humans.
• Approaches to understanding network coding of sensory information.
• Paradigms to assess motor coding during complex behaviors.
• Approaches to understand neural circuitry associated with diverse social behaviors.
• Changes in circuit functions underlying the brain's ability to store information and to learn new behaviors (plasticity).
• New approaches to capture and assess information processing across brain regions during memory consolidation, memory retrieval, spatial/relational processing, attention, or planning.
• Assessment of distributed representations and information processing underlying advanced mental processes such as language, decision making, numerical cognition, reasoning, consciousness, and metacognition.
• Investigation of distributed circuits that contribute to the coordination of motivational states and reward behavior.
• Empirical and analytical approaches to understand how behavioral states are emergent properties of the interaction of neurons, circuits, and networks.

The following are non-responsive for this program:

• Human research studies that include clinical trials designed to answer specific questions about safety, tolerability, efficacy, and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions (e.g., phase 1, phase II, phase II, or pivotal clinical trials).
• Studies designed primarily to develop or improve disease/disorder therapeutics or devices.
• Studies for which the primary goal is to achieve regulatory approval of neurotechnology (see http://braininitiative.nih.gov/ for other BRAIN FOAs supporting this activity, and the NIH bioengineering grant program http://www.ninds.nih.gov/research/bioengineering/index.htm) or the peripheral nervous system (see NIH SPARC http://commonfund.nih.gov/sparc/index).
• Imaging approaches not coupled with intra-cranial recording or stimulating.
• Implementing rehabilitation therapies.
• Definitive clinical trials of therapeutic devices, such as a traditional feasibility study and/or pivotal trial (see http://www.fda.gov/downloads/MedicalDevices/DeviceRegulati%20onandGuidance/GuidanceDocuments/UCM279103.pdf2 for the definition of an early feasibility study, feasibility study and pivotal trial).
• Projects focused on augmentation of neural function in healthy individuals.

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)

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)

• 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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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. 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 NOT-OD-11-101)

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:

James Gnadt, PhD
Telephone: 301-496-9964
6001 Executive Blvd
North Bethesda, MD 20892
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments:

Applicants are required to include the following items: Team Management Plan and Clinical Protocol Synopsis. These items must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (Team Management Plan, and Clinical Protocol Synopsis). Applications lacking these required items will be deemed incomplete and will not be reviewed.

Team Management Plan: The team management plan must not exceed one page; applications that exceed this limit will be withdrawn. NIH strongly encourages applicants to form diverse, multidisciplinary teams that consist of clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory specialists and/or ethics specialists, as appropriate. This multidisciplinary team should be able to address the details of the plans and experiments, to execute the research strategy, and to dedicate resources and personnel to participate in and contribute to consortia activities, which include coordinating data science and analysis within and across BRAIN teams, integrating data into the BRAIN data archives, and identifying consensus standards of practice. An organizational structure that clearly defines the team structure and relationships among the various components must 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, without repeating information from the Multiple PD/PI Plan if submitted, and the research project, including communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable), should be presented.

The team management plan should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the team management plan, who together would have the intellectual and leadership responsibilities, would likely be members of the Scientific Steering Group. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.

Clinical Protocol Synopsis: The clinical protocol synopsis must not exceed six pages; applications that exceed this limit will be withdrawn. The clinical protocol synopsis must include the following information:

• Compliance with HIPAA and informed consent must be explicitly described.
• A list of participant eligibility criteria
• How recruitment and retention plans will accommodate access to the appropriate brain areas of recording, including a discussion of the availability of participants for the proposed study and the ability of enrollment sites to recruit and retain the proposed number of participants, including women and minority participants.
• Participant recruitment and retention plans, including a discussion of the availability of participants for the proposed study and the ability of enrollment sites to recruit and retain the proposed number of participants meeting the eligibility criteria, including women and minority participants. Data supporting recruitment and retention estimates must be provided.
• A description of all assessments including clinical, laboratory, physiological, behavioral, patient-centered, or other outcomes addressing the primary and secondary research questions.
• Discussion of the potential biases in the study and how they will be addressed
• Statistical Methods: Discussion of sample size and power calculations where hypothesis testing is explicit, study outcome measures, plans for interim and final analyses, methods of bias control, and methods for handling missing data. Examples of the critical elements of a well-designed clinical study are summarized on the NINDS website. http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf.
• Data Management and Quality Control: Details of efficient data management and methods for monitoring quality, methods for monitoring the quality and consistency of intervention administration, and methods for ensuring participant confidentiality. Applicants are expected to incorporate data elements from the NINDS Common Data Elements (CDE) Project in their data collection forms (see http://www.commondataelements.ninds.nih.gov)
• Discussion of the challenges expected in implementing the studies and how these might be overcome

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy: Harmonization of recruitment and methods (including collection, curation, and analysis) across multiple sites should be well planned and described as appropriate and consistent with achieving the goals of the program. The aims of this application must investigate fundamental questions in human neuroscience. While fundamental basic research often generates insights relevant to disorders of the nervous system, this RFA is not intended to generate research that is explicitly disease-therapeutic.

All applications are required to include the following points, which must be incorporated within the page limits of the Research Strategy:

• Statement of the neurobiological, neurological or mental health questions to be addressed, including the theoretical and conceptual framework that drives the research design and questions, and discussion of the analytical methods for interpreting the results.
• Description of how studies in the brain tissues potentially affected by the disease or disorder can adequately address the research questions and mechanisms posed, including comparison to complementary studies in animals if appropriate and feasible.
• Description of recording/manipulation methods that will be employed or developed to approach the questions as a functional system, and how the invasive intervention and/or the implantation of foreign (device) materials may confound the interpretation of results.
• If complementary animal studies are proposed, then anticipated, non-human, experimental components must be adequately described and justified.
• Where the adoption of newly developing technology pending FDA-approved is anticipated, reasonable description as an alternative methodology (to the extent that details are available), along with potential advantages and pitfalls, is required.
• Description of a timeline for completion of tractable research goals, strategic goals, and key stages of progress for the project, especially in terms of participant accrual.
• Applicants must address the technical, procedural, and ethical aspects specific to invasive studies in human patients, and the strategic plans for addressing functional studies of a specified neural system in the context of patients with neural dysfunctions and invasive device interventions.
• Description of resources and personnel dedicated to active participation in a consortium work group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

Neuroethical considerations: Applications must include this section that describes and discusses in detail the process of informed consenting of research subjects who can expect no direct benefit from engaging in the investigative research proposed, considerations of FDA-defined conditions of non-significant risk/significant risk beyond established standards of clinical care, ethical and practical considerations of invasive device maintenance and ultimate removal, and other ethical issues specific to invasive human neuroscience research.

Protection of Human Subjects: Assurance of the protection of human participants and the biohazard safety of employees (if applicable) must be provided for the overall study and for each clinical site. The applicant must discuss any issues which might lead to concern for the welfare of participants. Additionally, the human subjects section of the application must address data security measures and confidentiality.

Please note that The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46 (NOT-OD-16-094).

Long-Term Plan for Patients: Applicants must describe a plan for the care of patients at the end of the study and after the study period, if appropriate. These plans may vary from project to project, but examples might include 1) explant of indwelling devices once the approved study period is complete, 2) surgical removal of batteries and capping the exposed metals from leads/IS-1 connectors, 3) manufacturer-supported device maintenance for patients responding to therapy, 4) manufacturer support for filing of compassionate use exemptions for device maintenance, etc.

Data and Safety Monitoring Plan: For minimal- to no-additional risk studies, it generally will be acceptable for the data and safety monitoring to be conducted by an investigator-appointed Study Monitoring Committee (SMC), an Independent Medical Monitor (IMM), or, for single-site studies involving low risk, the Program Director/Principal Investigator and his/her IRB. However, NIH may decide to establish an independent Data and Safety Monitoring Board (DSMB) depending on the score and risk of the study. Applicants should refer to NIH’s policy on data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) as well as the NINDS Guidelines for Data and Safety Monitoring (http://www.ninds.nih.gov/research/clinical_research/policies/data_safety_monitoring.htm).

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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.

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 (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. The PD(s)/PI(s) will have the primary responsibility for:

• PDs/PIs will determine and coordinate the research approaches and procedures, conduct experiments, and analyze and interpret research data generated under this award.
• PDs/PIs will endeavor to meet or exceed the timeline stated in their application.
• PDs/PIs will agree to participate as a voting member in Research Consortia composed of other BRAIN Initiative awardees and NIH staff.
• PDs/PIs will share resources and data, as appropriate and consistent with achieving the goals of the program.
• PDs/PIs will ensure that results are published in a timely manner.
• PDs/PIs will submit data for quality assessment and/or validation in any manner specified by the NIH Program Director.
• PDs/PIs will submit periodic progress reports.
• PDs/PIs will accept and implement any other common guidelines and procedures approved by the Program Director.
• PDs/PIs will attend BRAIN Initiative-related meetings. It is likely that there will be one in-person meeting per year and that other meetings will be by telephone or using internet assisted meeting software.
• Awardees 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 Director will be assigned to this award. The Program Director will be responsible for normal scientific and programmatic stewardship and guidance.
• A group of NIH program staff from the ICs contributing to the NIH BRAIN Initiative will form a Project Team for this award.
• The Project Team will be led by the Program Director(s) for these BRAIN Initiative awards.
• The Project Team will review annual progress reports and other documents from the awardees and will advise the Program Director about their view of the progress being made by the awardee as well as about progress being made by others in the field.
• One extramural NIH program staff member will be assigned as the Project Officer for this award. The same person may serve as the Project Officer for multiple BRAIN Initiative awards
• The Project Officer will also be a member of the Project Team.
• The Project Officer will interact scientifically with the PDs/PIs of the cooperative agreement and other named key personnel as a partner in the research.
• The Project Officer may assist in research planning, may present experimental findings from the group from published sources or from relevant contract projects, may participate in the design of experiments agreed to by the group, may participate in the analysis of results, and may help ensure that duplication is avoided.
• In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include: None; all responsibilities are divided between awardees and NIH staff as described above. Dispute Resolution: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

James Gnadt, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

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

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