Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov on behalf of the NIH.

Funding Opportunity Title
SPARC Human Open Research Neural Engineering Technologies (HORNET) Initiative (U41 Clinical Trial Not Allowed)
Activity Code

U41 Biotechnology Resource Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-RM-21-024
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

This U41 opportunity will fund Centers to create interoperable open-source modules that can be combined into custom profiles for new exploratory and clinical neuromodulation studies in the peripheral nervous system, and for potential applicability in the central nervous system. The centers will disseminate the open-source neuromodulation resources broadly.

Key Dates

Posted Date
October 07, 2021
Open Date (Earliest Submission Date)
December 13, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
January 12, 2022 Not Applicable Not Applicable March 2022 May 2022 August 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
January 13, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance toall requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applicationsthat 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. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program seeks to accelerate development of therapeutic approaches that modulate electrical activity in peripheral nerves to improve organ function. SPARC is generating maps, tools, and models to identify and influence therapeutic targets that exist within the neural circuitry of a wide range of visceral organs and tissues.

Advancement of such therapeutic approaches from early-stage development to successful clinical translation requires the availability of clinical-grade neuromodulation platforms. Currently, such platforms are either costly to develop from the ground up or difficult to access for exploratory use from large medical device companies (SPARC Stage Two Strategic Planning Summary). These barriers to translation have hindered the research community from bringing innovative therapeutic approaches to the patients who need them most. Creating an open-source technology ecosystem will help to eliminate these hurdles and accelerate the translation of new therapies into the clinic. Motivated by the observation that most neuromodulation approaches utilize the same technology elements (e.g., hardware, signal processing algorithms, software, and firmware), SPARC seeks to develop neuromodulation systems that can be applied across biomedical applications. The development of interoperable modules and full neuromodulation systems should ultimately lower regulatory hurdles to better facilitate translation of new therapies to humans.

The primary goal of the SPARC Human Open-Research Neural Engineering Technologies (HORNET) initiative is to advance the clinical translation of neuromodulation therapies in humans by supporting the development of this open-source ecosystem. Awardees of the HORNET program will develop open-source neuromodulation libraries that include multiple “templates” that describe combinations of individual technology modules necessary to construct complete, fully functional neuromodulation systems. Modules may include any hardware, firmware, and software elements that are combined to define a neuromodulation system. The neuromodulation systems should be applicable to a variety of peripheral nervous system applications, with potential applicability in the central nervous system as well. The open-source neuromodulation libraries should include engineering designs, regulatory documentation, technical specifications, manufacturing and assembly processes, testing and validation reports, firmware designs, software code, etc. Examples of hardware include, but are not limited to, electrodes, leads, connectors, electronics, telemetry components, batteries, enclosures, hermetic technologies, and insulation layers. Firmware may include digital informatics, machine learning, analytical algorithms, cloud computing, wireless communication, etc. Software-design considerations may include supporting different use cases, setting optimal stimulation parameters, enabling closed-loop control techniques, ways to adapt to multiple types of biomedical applications, and integration of a device into clinical workflows. Designed technology modules should be integrated into a functional neuromodulation system suitable for a specific translational research need. By requiring that these systems are designed for compliance with the regulatory expectations of the FDA, the regulatory burden of translating a technology will be significantly eased.

HORNET Centers and Components

A HORNET Center will assemble technological and other resources to develop open-source, modular neuromodulation systems for use in human clinical research. This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the Center and with others outside of the Center.

A HORNET Center is composed of three parts:

1) an Administrative Core,

2) three to five Nested Elements for SPARC Technologies (NEST) Projects, and

3) a Technology Integration and Dissemination (TID) Core.

The Administrative Core will manage the center, coordinate and oversee the NEST Projects, monitor integration and dissemination activities in the TID Core, and oversee the bridge between NEST Projects and the TID Core. The Administrative Core will also co-organize HORNET consortium meetings with other HORNET Centers and coordinate the development of regulatory templates.

Each NEST Project within a HORNET Center will be tasked with the design and development of one or more modular neuromodulation technologies. NEST Projects should be at the cutting edge of their technological field and develop the open-source modules for the HORNET Center. The TID Core will work with the NEST Projects to ensure integration and interoperability of the developed modules across the HORNET Center. The NEST Projects will work with the TID Core to validate the integrated NESTs in benchtop, computational, and/or animal models for future use in neuromodulation applications. Working in an iterative relationship with NEST Projects, the TID Core will need to drive the integration of modules and facilitate systems testing to validate the functionality of the full neuromodulation system.

The collection of NEST Projects within a Center should represent a variety of technological areas (e.g., hardware, firmware, and software) necessary to develop a fully functional neuromodulation system. Technology validation activities focused on advancing aspects of a NEST Project should be included within the relevant NEST Project.

Through the TID Core, a HORNET Center must develop and carry out a technology integration and dissemination plan to achieve a wide impact on biomedical research. The TID Core will be responsible for studies to fully integrate modules from NEST Projects towards a functional neuromodulation system. The TID Core should also coordinate with other Centers in support of integration and interoperability of modules across Centers, as applicable. Dissemination plans should detail the TID Core’s approach to disseminate the Center’s neuromodulation system templates to the research community. Such plans should be geared toward researchers and end-users at various levels of clinical and technical expertise, such as clinicians, scientists, engineers, industry, graduate students, postdocs, and junior faculty. Efforts of the TID Core should include establishing and facilitating a user community for technology dissemination and collaborations both during and after the end of the award. These efforts necessitate the commitment of greater financial and personnel resources to non-research activities than is typical for other types of research efforts. Industrial partnerships are not required, but they are welcome when appropriate.

Through the Admin Core, the Center may appoint external representatives to provide objective advice to the HORNET Center on its system concepts, designs, and integration and dissemination plans throughout the duration of the Center’s functions. The advisory representatives should be available to the Center as needed to discuss progress, challenges, and provide guidance to the Center on future directions, particularly in planning future funding and/or additional grant applications.

Center PDs/PIs will represent their Center at bi-annual HORNET Grantee meetings (one in-person, one virtual), which will take place to facilitate collaboration across Centers, and to allow the NIH and NIH-appointed HORNET Steering Committee members to evaluate progress towards the Centers’ goals and milestones.

In addition to developing, testing, and validating modules in support of an open neuromodulation ecosystem, awardees are expected to complete the following by the end of the HORNET program in three years:

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

Leveraging STRIDES for Cloud Computing Activities

The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) initiative has established partnerships with commercial cloud service providers (CSPs) Google and Amazon Web Services (AWS) to provide favorable pricing for cloud-based costs. The NIH Common Fund, managed by the Office of Strategic Coordination, is using the STRIDES partnerships to provide in-kind support for CSP costs. For more details, please see NOT-RM-20-009.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The NIH Common Fund intends to commit approximately $7,500,000 per year for three years. Approximately two to five awards are anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

Project periods may not exceed three years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Other

Foreign Institutions

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

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

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

Required Registrations

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.

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.

Eligible Individuals (Program Director/Principal Investigator)

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

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

The letter of intent should be sent to:

Eric Hudak, Ph.D. and Brooks Gross, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: SPARC-O@od.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Admin Core Admin Core 6 Required 1 1
NEST projects Projects 6 Required 3 5
Technology Integration and Dissemination Core Core 6 Required 1 1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

When preparing your application, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Include a succinct and accurate description of the overall HORNET Center goals. Describe how the PD(s)/PI(s) of the Center and the staff will be organized with respect to the Center components: administrative core, NEST projects, and Technology Integration and Dissemination core. Describe the overall working dynamics of the Cores and NEST Projects. Include a summary of overall program management and coordination of the different Cores and Projects.

Research Strategy: Describe the overall goals of the proposed HORNET Center and explain why the team is well positioned to accomplish these goals. Describe how the modules from the proposed NEST Projects could function together in an interoperable open neuromodulation ecosystem. Include a table of milestones with clear go/no-go criteria for each Core and Project in the Center. Timelines for the release of module designs must be described, with milestones indicating intermediate accomplishments along the path to that goal.

Milestone Plan (Required):

Within the page limit of the Research Strategy, provide detailed project performance and timeline objectives. Applications that lack a Milestone Plan are considered incomplete and will be withdrawn. Applications must include a timeline and quantitative milestones for completion of key stages of the project. Milestones should include minimum success criteria that define a successful progression of system development, integration, and dissemination.

Suggested milestones are as follows:

Format: Milestone No. (Year#Quarter#): Description

Letters of Support: Applications should include letters necessary to demonstrate the support of participating institutions and collaborators for the Center (Cores and Projects), such as Senior/Key Personnel and Other Significant Contributors included in the grant application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

Data Sharing is the only component of the Resource Sharing Plan that must be included.
Other components of the Resource Sharing Plan are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administration Core Component

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Admin Core)

Complete only the following fields:

 

PHS 398 Cover Page Supplement (Admin Core)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Admin Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Admin Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Admin Core)

 

Budget (Admin Core)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: The budget should include a detailed justification for key personnel. The PD/PI must devote at least 3.0 person months to the entire Center, within which 1.2 person months must be devoted to the Administration component. For Multiple PD/PI applications, all PDs/PIs must devote a minimum of 3.0 person months each to the entire Center. From within this time commitment, the PDs/PIs in a multiple PD/PI application must devote a combined minimum of 1.2 person months to the Administration component. Applications that do not propose to devote these minimums will be considered ineligible and not go forward to review.

External Advisors & HORNET Grantees Meetings:

Funds should be requested for the PI/PD and any external advisory representatives to attend an annual HORNET Grantee meeting in-person. Additionally, funds should be requested to support travel for six to eight experts that will serve as the HORNET Steering Committee to attend the annual in-person HORNET Grantee meeting. Each Center will host one in-person HORNET Grantee Meeting, and should budget for these costs accordingly.

Additionally, there is generally an Annual Consortium Meeting to share progress and promote collaboration across the SPARC program. It is expected that the PD/PI and one other senior member of the SPARC HORNET Center will attend this meeting. Funds to support travel to this meeting should be requested in the budget.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Admin Core)

Specific Aims: State concisely the goals of the Admin Core. Include a succinct summary of the core and its relevant experience to the stated objectives of this solicitation.

Research Strategy: The application should describe the administrative structure of the Center. This section should be broken down into: Organizational Structure and Staff Responsibilities, Center Operating Procedures, External Advisory Committee, and Institutional Support.

Organizational Structure: Describe the Organizational Structure and provide an organization chart of the Center.

Team Management: Describe the governance of the leadership team and the research projects, processes for making decisions on scientific direction, intellectual property, and procedures for resolving conflicts.

Center Operating Procedures: Describe Center Operating Procedures. Include criteria and mechanisms for how progress on modules will be tracked and plans adjusted, how information will be shared with other HORNET Centers, and how final designs will be released, including open-source license plans. Describe the plans for any policies/procedures to address the ordering and recognition of authors of manuscripts, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable).

External Advisors: Each Center may appoint external advisory representatives. The representees should be knowledgeable about the Center's technologies and/or the science it serves but must not be a member of the Center staff, a significant collaborator of the Center, or be affiliated with applicant and/or partnering institutions.

The external advisory representatives should provide written reports of their recommendations addressed to the PD(s)/PI(s) and shared with the NIH within two weeks of providing to the PD(s)/PI(s). The application should explain how advice, feedback, and guidance will be solicited from external advisors and their recommendations implemented.

Potential advisors must not be contacted before completion of the review process, to avoid potential conflicts of interest; however, the scientific disciplines of anticipated individuals should be described.

Bi-annual HORNET Grantee Meetings: The Admin Core should plan to attend and prepare materials for bi-annual HORNET Grantee Meetings (alternating between in-person and virtual every six months) to facilitate collaborations across HORNET Centers and provide progress updates and discuss challenges with external advisors, the NIH, and the NIH-appointed Steering Committee. Each funded HORNET Center will be responsible for hosting, coordinating, and organizing (in collaboration with the other Centers and NIH) one in-person Grantee Meeting during the three-year award period. The Admin Core should plan to provide materials from all Centers to meeting attendees three weeks in advance of the meetings and provide a meeting summary to the NIH and other Centers within three weeks after the meeting.

Sustainability Plan: The HORNET Center must describe long term plans and availability of modules to the scientific community that goes beyond providing designs and open-source license plans. This should include plans for establishing manufacturing services (e.g., by through agreements with vendors).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Data Sharing is the only component of the Resource Sharing Plan that must be included.

Other components of the Resource Sharing Plan are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Nested Elements for SPARC Technologies Project (NEST Project) Component

When preparing your application, use Component Type ‘NEST Project’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (NEST Project)

Complete only the following fields:

PHS 398 Cover Page Supplement (NEST Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (NEST Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (NEST Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (NEST Project)

ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

 

Budget (NEST Project)

Budget forms appropriate for the specific component will be included in the application package.

The budget should include a detailed justification for key personnel under this NEST project component. The person months for each member of the Center staff related to this NEST project should be included here. Support for graduate students and postdoctoral fellow can be requested only if they are active participants in NEST projects. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire Center.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (NEST Project)

Specific Aims: State concisely the goals of the proposed NEST Project

Research Strategy: Since it is expected that these projects will involve multidisciplinary science and engineering, the projects are not required to be physically located at a single site. If more than one site is involved, provide a plan to ensure strong communication and collaboration among distant sites.

The plan should describe the design, testing, and public description of each module proposed in the NEST Project. Applicants should show how the NEST project would contribute to an interoperable open neuromodulation ecosystem. Describe plans for collaborating with the TID for iterative development during validation studies of integrated modules.

Unique aspects of the research and technology development should be clearly outlined.

Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data.

List the investigator(s) who will be primarily responsible for each project and describe the relationship between the NEST projects and the overall goals of the Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Data Sharing is the only component of the Resource Sharing Plan that must be included.
Other components of the Resource Sharing Plan are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (NEST Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

 

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

 

Technology Integration and Dissemination Core (TID Core) Component

When preparing your application, use Component Type ‘TID Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (TID Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (TID Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (TID Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (TID Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (TID Core)

Budget (TID Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (TID Core)

Specific Aims: State concisely the goals of the proposed Technology Integration and Dissemination Core Component

Research Strategy: Plans for technology integration and dissemination should be described. The choice of approaches should be informed by the special constraints and opportunities of the Center.

Technology Integration: Technology Integration is generally necessary to ensure the new technology developed in the NEST projects are compatible modules that integrate into an overall neuromodulation system. Describe the TID Core’s approach to demonstrate the functional integration and interoperability of the technology modules developed in the Center’s NESTs. Information sharing and coordination across HORNET Centers should be described, in support of integration of interoperability of modules across all Centers.

Dissemination: Dissemination activities should have two overall objectives: informing the scientific community about the technical capabilities and accomplishments of the Center and promoting and enabling a broader use of the technologies. A multi-faceted approach to reaching these goals should be described. Types of approaches include but are not limited to publishing articles, books, newsletters, annual reports, or special issues of technical journals; issuing press releases; presenting research results at meetings; conducting workshops, short courses, and conferences; distributing software products; transferring technologies to other laboratories; licensing technologies to industry; and web-based training modules and tutorials. All Center dissemination activities must acknowledge SPARC grant support and reference the SPARC grant number. Applicants should describe how the TID core will work with the SPARC Data and Resource Center to share the open neuromodulation libraries with the broader scientific community via the SPARC Portal (https://sparc.science/).

In Centers that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software that is readily available and has user support. SPARC encourages sharing of source code, consistent with the NIH data-sharing policy and achieving the goals of this program. Software is required to be open source and released under a permissive license (e.g., Creative Commons, MIT, Apache 2.0, or BSD).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Data Sharing is the only component of the Resource Sharing Plan that must be included.
Other components of the Resource Sharing Plan are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions, with the following modification: all applications should address an Open Neuromodulation Library Sharing Plan, leveraging the SPARC Portal as appropriate.

PHS Human Subjects and Clinical Trials Information (TID Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

 

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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 Involving the NIH Intramural Research Program

Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, 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 Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

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

Post Submission Materials

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.

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.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed). The Overall Impact score should not simply be the average of the individual scores of the components, but rather should consider the review criteria listed here and under each of the elements of the Center listed below. Given the state of open source neuromodulation platforms is very limited, reviewers should anticipate that starting maturity will be low and should focus on the anticipated outcomes of the application, if successful. Accordingly, the evaluation will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance human health.

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed Center rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this announcement:

All of the above should be considered in light of the overall goal of the initiative: to advance the clinical translation of neuromodulation therapies in humans by supporting the development of an open-source modular ecosystem.

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the Center?

Specific to this announcement:

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this announcement:

• If the proposed technology is designed to improve over early generations, are potential advantages identified? Are the changes in the proposed technology likely to succeed where the predecessor did not?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

 

 

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this announcement:

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this announcement

Additional Review Criteria - Overall

As applicable for the Center 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.

Milestone Plan: Milestones will be negotiated prior to issuing the notice of award. Are the timelines and quantitative milestones for completion of the key stages of the technology module development below sufficiently detailed and feasible?

Review Criteria for the Admin Core

Review Criteria for NEST Projects

Address the following for each NEST Project:

Review Criteria for the TID Core

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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 VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH Grants Policy Statement.

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

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

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

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

 

2. Administrative and National Policy Requirements

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 Part 75, 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 recipient 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 recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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

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

Collaborative Responsibilities:

Clarifying and negotiating the milestones and timelines.

Coordination of site visits, if needed, at critical milestones or transition points of the award

The members of this collaborative effort are all made aware of the requirement for confidentiality due to the intent of the recipient to pursue commercialization of any qualified outcomes. Contractors and consultants of NIH will be made aware of the confidential nature of work done under this collaborative effort. The handling and disposition of this confidential data and business privileged information may be covered by the Trade Secrets Act, 18 U.S.C. Section 1905.

Dispute Resolution:

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

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Eric Hudak, Ph. D
Brooks Gross, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: SPARC-O@od.nih.gov

Peer Review Contact(s)

Center for Scientific Review
Email: FOA_ReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

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.

Authority and Regulations

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, 45 CFR Part 75 and 2 CFR Part 200.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.