Required Application Instructions

It is critical that applicants follow the 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 to all 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

The purpose of this FOA is to invite innovative research pre-applications from applicants who have an interest in submitting an application to "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT2)", companion announcement RFA-RM-16-003. This NIH Funding Opportunity Announcement (FOA) solicits pre-applications to develop new and/or enhance existing tools and technologies to be used to elucidate the neurobiology and neurophysiology underlying autonomic control of organs in health or disease, which will ultimately inform next generation neuromodulation therapies. These two-year projects will facilitate technology development for neural mapping activities through the NIH SPARC Common Fund program.

Background

The SPARC program (http://commonfund.nih.gov/sparc/index) is supported by the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The overall goal of the SPARC program is to provide the scientific foundation necessary to pilot new and/or improved closed-loop neuromodulation devices and stimulation protocols to treat diseases and conditions through precise neural control of end-organ system function. Significant advances in neuromodulation therapies to treat disease have led to industry-supported large, randomized and blinded, controlled trials. While the degree of efficacy of the neuromodulation devices has varied depending on the trial and condition under investigation, the data and approach show great promise for scientific and therapeutic development. In many cases, however, the detailed underlying physiology and mechanisms of action of these neuromodulation therapies are poorly understood. This poor understanding, in turn, limits improvement in neuromodulation therapy designs. Examples of areas where our understanding is incomplete include: what specific and diverse neural signals are carried by nerve fibers at different end organs; what are the functional relationships between neural signals and end-organ responses; whether there is altered peripheral nerve function in some conditions in which neuromodulators are currently utilized; what is the functional relationship between neural stimulation and unwanted side effects; what variability exists in expression/anatomical representation of the neural cell-types at each potential point of implantation; what are the optimal points of surgical intervention relative to the end-organ; what differences exist between animal models and humans with regard to neuroanatomy and control of organ activity by the nervous system; and the extent of variance in these functional mechanisms from subject to subject as they pertain to effects and side effects.

Through the SPARC program, the NIH plans to support multidisciplinary teams of investigators to deliver: foundational understanding of the physiological mechanisms of neural control of several major organs, novel electrode designs, minimally invasive surgical procedures, and stimulation protocols. Driven by end goals of improving existing, and developing new, neuromodulation therapies to relieve conditions, the program will be iterative and dynamic, with the technologies informing neural mapping efforts, and the mapping results defining new technology requirements.

The SPARC program will use recent advances in technology as well as anticipated new technological developments facilitated by the program to produce detailed, predictive, functional and anatomical neural circuitry maps of the autonomic and sensory innervation of multiple major organs in humans. These maps will provide a foundation for the development and testing of novel electrodes, stimulation protocols, and minimally invasive surgical procedures to improve existing, or develop new, neuromodulation therapies, and to test existing approved neuromodulation devices in new applications.

The SPARC program is envisioned as four components to be managed in an interactive manner as a consortium in order to achieve the overall SPARC program goals. To maximize progress, the NIH will actively manage needed expertise, technologies and shared information within the SPARC consortium by adding or subtracting research components as necessary.

The SPARC program will be supported through a combination of Cooperative Agreement and Other Transaction mechanisms. The projects to be submitted under the companion announcement RFA RM-16-003 to this OT1 announcement will use the Other Transaction (OT) mechanism (see SPARC Program Other Transaction Management, below).

The four components of the SPARC program are: 1) Anatomical and Functional Mapping of the Innervation of Major Organs, 2) Next Generation Tools and Technologies, 3) Use of Existing Market-Approved Technology for New Market Indications, and 4) SPARC Data Coordination.

Component 1, Anatomical and Functional Mapping of the Innervation of Major Organs, consist of two phases. The first phase will be addressed by four FOAs (RFA-RM-15-003, RFA-RM-15-018, RFA-RM-15-019 and RFA-RM-15-020) and which focus on anatomical and functional mapping using current state-of-the-art technologies. The second phase of the Anatomical and Functional Mapping component is planned to include application of next generation technologies to enhance and refine the functional mapping, and to design and pilot new therapies. The studies under this component are expected to develop the scientific foundation for more effective use of existing neuromodulation therapies and for development of additional neuromodulation therapies.

Component 2, Next Generation Tools and Technologies, started with the issuance of RFA-RM-15-002 on Exploratory Technologies to Understand the Control of Organ Function by the Peripheral Nervous System for SPARC (U18). That FOA was focused on developing exploratory tools and technologies needed to study function and establishing a quantitative scientific foundation for this overall program. The exploratory technologies solicited through that FOA were intended to address the gaps in understanding detailed underlying physiology and targeted mechanisms of action of future neuromodulation therapies.

Additional phases of Component 2, including this FOA, will include further technology developments to assist in mapping and future development of neuromodulation therapies. The next generation technologies developed will be responsive to, and freely shared with, other SPARC projects.

Component 3, Use of Existing Market-Approved Technology for New Market Indications, will encourage development of partnerships between industry and NIH-supported investigators to explore the utility of existing devices to address new indications. Future iterations of this component will make extensive use of information generated by the Anatomical and Functional Mapping component and the Next Generation Tools and Technologies component to determine possible new therapeutic opportunities and methodologies.

Component 4, SPARC Data Coordination, will support assembly of data from all projects into a SPARC data coordination center resource, including the detailed, integrated, predictive functional and anatomical neural circuit maps. Standardized methods, standard operating procedures, and other aspects of consortium coordination will be a part of this component.

Although the description above pertains to the entire SPARC program, and is included so potential applicants can consider formulation of their project with an overview of the entire program, THIS ANNOUNCEMENT APPLIES ONLY TO PRE-APPLICATIONS (OT1) for "Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System", described here and in companion announcement RFA-RM-16-003 (OT2).

This FOA supports the development of technologies to be used for understanding the neurophysiology underlying precise neural control of organ function, which will ultimately inform future neuromodulation therapies.

For this FOA, technologies of interest include, but are not limited to, those listed below:

• Modification of technologies, such as those previously developed to understand neural circuits in the Central Nervous System, to understand neural circuits in the Peripheral Nervous System; or technology used to understand neural circuits controlling one organ which can be modified for use with another target organ or multiple other organs
• Sensing techniques for relevant biomarkers to inform closed-loop response systems in organs (e.g., biomolecule sampling/measuring)
• Technologies for cell-class specific targeting and manipulation in peripheral nerves and ganglia, appropriate for animal models with clinical relevance (e.g., optogenetics)
• Activity sensors and associated imaging technologies suitable for peripheral nerve and end-organ monitoring (e.g., voltage probes)
• Reliable, wireless, high density technologies capable of simultaneous recording/stimulation of all neural signals going to and coming from a targeted organ; and or to facilitate functional mapping between multiple organs and nerves
• Biomimetic or biologically-active interfaces for chronic implants of electrodes and sensors that enhance our ability to chronically study the function of a target organ
• Invasive and non-invasive technologies for tunable stimulation/inhibition/block of nerve activity (e.g., ultrasound, magnetic fields, etc.)
• Tools for non-invasive tracing and functional imaging to facilitate minimally invasive surgeries in humans and anatomical mapping
• Computational platforms and predictive models that generate testable hypotheses of autonomic nervous system control of organs

Applicants are expected to describe the theoretical constructs justifying the logic of the proposed technology development. The proposed technology should be driven by the challenges of the targeted organ(s). SPARC will support projects to map neural circuits for a variety of organs; and thus, the development of technologies that are adaptable to multiple organs is welcome. Technologies used to understand neural control, supported by this FOA, can be different from technology used for neuromodulation therapies (e.g., in vitro model systems, animal models). This FOA accepts technology projects at all points of the technology development pipeline (early stage to late stage validation and translation to humans). All proposed projects must have a Resource Sharing Plan to make the technology delivered and useable to other SPARC research teams throughout the duration of the SPARC program.

Applicants are strongly encouraged to use quantitative models and methods to drive the design, development and validation of the proposed technologies. Theoretical methods, to model functional neuroanatomy as it pertains to organ function, and to predict effects and side-effects of electrical stimulation are strongly encouraged along with proposed strategies for their validation. Ideally, computational methods can be used to systematically promote multiscale data integration of neuronal, chemical, metabolic, and other organ activity markers. Finally, these integrative methods may facilitate a systems approach for understanding the mechanisms of action of current and future neuromodulation therapies for disease/symptom control.

The focus of the SPARC program is on peripheral neural control circuits for organ function in humans (excluding the brain and sensory organs of the head and the named voluntary muscles). There is interest, however, in understanding the basic connections within the brain and spinal cord to the extent necessary to understand the peripheral nervous system circuits for specific organs. For example, technologies to understand neural control of end organ function through spinal stimulation would be welcome.

This FOA will accept technology development tailored for the study of all relevant pathways pertaining to the organ of interest. Where organ function is dependent on a mixture of autonomic, sensory and voluntary innervation, investigation of any of these circuits is considered to be within the scope of the project. The specific project should be justified in the context of the critical technology it will supply to enable future comprehensive mapping of the nerves and the resulting function of the organ of focus. For example, if the sympathetic innervation is comparatively well understood but the parasympathetic innervation and the cellular targets of innervation are essentially unexplored, a future project could be proposed to fill this gap in fundamental data, using the technology developed through this FOA.

The proposed technology should be tailored appropriately for use in animals or humans. Significant steps in the understanding of peripheral nervous system control of organ function may require the use of animals. The animals planned for use must be justified in terms of the technologies to be employed and vice versa, the information to be gained, and eventual applicability of the information to humans. Accordingly, the research plan must include validation of results in humans to the maximum, feasible extent.

A main focus on healthy organs is anticipated for studies in this initial phase of SPARC. In some cases data collection on disease states may be necessary to further understand innervation or effects of innervation on normal organ function. Inclusion of such studies in a project will need to be justified in the application.

Successful projects for this FOA effort should utilize a multidisciplinary approach, consulting with experts in anatomical and functional mapping of innervation for each organ system in animal models, surgeons who routinely access the nerves for each organ system, technologists with expertise in multiple academic technologies, and translational engineers. The current state of knowledge of functional innervation as pertaining to control of each organ system is expected to vary widely. Recognizing that technologies currently being developed to study the brain may be modified to study the periphery, Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative researchers are encouraged to consider participating in collaboration with experts in the neurobiology and neurophysiology of the peripheral nervous system.

A goal of this FOA is for the resultant technologies to be capitalized upon by multiple SPARC research teams within the SPARC program duration. As the SPARC program develops, projects will interact with a broad range of other projects to accomplish the aims of the program. Technologies and information developed from projects supported under this FOA will be broadly shared within the context of the program in order to maximize progress and output of the SPARC program.

Responsiveness Criteria:

• Research on neuromodulation through central brain stimulation is not the appropriate focus of SPARC. As stated above, technologies to understand neural control of end organ function through spinal stimulation would be welcome to this FOA.
• Applications not proposing technology development, or applications in which the majority of the proposed aims do not focus on the development of technology, are not responsive to this FOA.
• Applications proposing to develop technologies that are not tailored to study neural control of targeted organ(s) are not responsive to this FOA.
• Applications proposing to develop new or modify existing technologies for use for any treatment therapy are not responsive to this FOA. This will be the subject of future FOAs.
• Applications primarily proposing SPARC data management infrastructures for broad sharing of neuroanatomical data and neuromodulation tools are not responsive to this FOA. Predictive models to be used by such an infrastructure are welcome to this FOA.

SPARC Program Other Transaction Management

The SPARC program will be a consortium of research projects managed by a SPARC Program Manager and an Agreement Officer, and will incorporate significant programmatic input into projects beginning with the OT1 pre-application process, before an OT2 application can be accepted, and throughout the life of the program.

The SPARC program will develop high resolution functional and anatomic neural circuit maps of the innervation of organs by integrating ideas and expertise from several disciplines, including anatomy, surgery, neuroscience, engineering, biotechnology, neuromodulation, physiology, data management and device design. In cases where additional or new expertise or approaches are required beyond those already included in the project, the SPARC program staff will aggregate the necessary expertise by adding or subtracting specific expertise, tools, technologies, and approaches to the problem of mapping peripheral neural circuits in relevant animal models and humans. A significantly different baseline of knowledge is expected in various organs/organ systems and expertise gained on one organ could be flexibly combined with projects focused on less-advanced areas to accelerate gains in knowledge across organs. Similarly, within the SPARC consortium, information, models, expertise, data and technologies will be shared in order to maximize progress.

The SPARC program will involve substantial risk, since entirely new technologies need to be developed and used to create an exceptionally complex data set. The specifications of the functional neural circuit map of the innervation of organs will be defined over time, as new data and technologies are established.

No award will be made in response to this announcement. Awards under the companion OT2 announcement (RFA-RM-16-003), specifically, will be made as OTs, which are not grants, contracts or cooperative agreements (as described in the NIH Other Transaction Award Policy Guide for the SPARC Program). For SPARC OT awards, NIH will use an active management structure to accommodate the need for flexibility in soliciting new collaborators as needed, for combining projects, for modified review processes, for rapid cessation of the high risk components that fail, and for adjusting the vision for the deliverables as new data are required. The planned review and management strategy will allow the addition or subtraction of aims and expertise to or from the research activities throughout the award period. Furthermore, NIH plans to develop hybrid projects, as needed, from multiple, independent applications to solve research problems for the SPARC program.

The funded projects in SPARC will be integrated across approaches to accelerate the research as a whole. Projects within SPARC must propose information sharing and include expertise for data exchange among research projects and with the SPARC data coordination center. It is anticipated that there will be two face-to-face meetings of the SPARC investigators per year, in addition to more frequent programmatic web-assisted meetings as deemed necessary by the SPARC Program Manager. Travel for these meetings is to be included in the project budget.

Applications must include project benchmarks that are quantitative, and with clear go-no-go criteria. Project goals, deliverables and benchmarks should be included in the Research Plan. A rigorous evaluation of benchmarks will occur at the end of year 1 of the award.

NIH policies as described in the NIH Other Transaction Award Policy Guide for the SPARC Program will apply to the applications submitted and awards made in response to this FOA.

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
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined here, are allowed:

The performance of any significant scientific element or segment of a project outside of the United States, either by the awardee or by a researcher employed by a foreign organization, whether or not funds are expended, is considered a foreign component. Activities that would meet this definition include, but are not limited to, (1) the involvement of human subjects or animals, (2) extensive foreign travel by project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the awardee that may have an impact on U.S. foreign policy through involvement in the affairs of environment of a foreign country. Examples of other award-related activities that may be significant are:

• Collaborations with investigators at a foreign site anticipated to result in co-authorship;
• Use of facilities or instruments at a foreign site; or
• Receipt of financial support or resources from a foreign entity.

Foreign travel for consultation is not considered a foreign component.

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. 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.

Not Applicable

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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov. SPARC OT applications will use the same electronic infrastructure as grant applications.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

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 along with the following additional instructions:

Type of Submission: Select "Pre-application"

Total Federal Funds Request: Enter 0

Total Federal and Non-Federal Funds: Enter "0"

Estimated Program Income: Enter "0"

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

All instructions in the SF424 (R&R) Application Guide must be followed. Along with the following additional instructions:

Are Human Subjects Involved: Answer "No". Note: no award will be made, or human subjects work performed, as a result of this OT1 FOA.

Are Vertebrate Animals Used: Answer "No".

All instructions in the SF424 (R&R) Application Guide must be followed. Key personnel must be included for data processing and for interfacing with the SPARC data coordination component.

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:

Specific Aims: Briefly state the specific aims of the project, indicating how the project will contribute to advancing neuromodulation science related to the organ(s) of focus.

Research Strategy:

Impact and Significance (up to two pages): Briefly describe the relevant major knowledge gaps and/or barriers the proposed technology will overcome. Highlight any conceptual, technical, and/or methodological innovations for the proposed project.

Preliminary Data (optional; up to one page): Provide a description of available Preliminary Data.

Benchmarks and Timeline (up to two pages): Include a description of the expected main 2-year outcomes and deliverables of the project and a summary of major benchmarks with estimated timeline under which these will be achieved. Include specific quantifiable metrics to facilitate a rigorous evaluation at the end of the first year. Include projected timelines for transmission of data associated with the developed technologies (such as predictive computational models) to the SPARC data coordination center. It may be helpful to reference examples of benchmarks/milestones at http://www.ninds.nih.gov/research/npp/example_milestones_advanced_neural-prosthetics_research_dev.htm

Investigators (up to one page): Include a table of effort for the key investigators and a statement of the multidisciplinary expertise needed to meet the various goals as appropriate for the stage of technology development proposed, and list investigators who fulfill the needed expertise. Explain how the environment and facilities will be leveraged to aid the multi-disciplinary approach to the proposed research.

Budget (up to one page): A total direct cost estimate for each year. This is not the final budget, but should be an informative estimate which may be revised in the OT2 application. A detailed budget request is not required in the OT1 application, but applicants should plan that 10% of total direct cost of the OT2 requested budget be set aside for future collaborating efforts within the SPARC program.

Letters of Support: Letters of support are NOT required for the OT1 pre-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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, must include a Resource Sharing Plan. This plan must include timely data release to the SPARC data coordination center, as well as to other projects within SPARC as determined by the SPARC Program Manager, and more broadly to the research community in general.

• All applications must commit to making data, biomaterials, models, reagents, tools, resources, methods and SPARC developed technologies useable and available to the other SPARC projects, including the SPARC data coordination center, and more broadly to the research community in general. The terms and timelines for sharing within SPARC; appropriate budget and costs associated with sharing; adjustments for coordination of research plans, validation of models, materials, methods and data; and sharing with the research community will be established by the SPARC Program Manager consistent with achieving the goals of the program and applicable NIH policies and all participants must adhere to these terms as a condition of award.
• The sharing plan must include an agreement that investigators will work collaboratively with the SPARC program to maximize research accomplished by the program, and to implement procedures (such as training on using the shared resources) to provide quality controlled data and information.
• In addition, applications must include plans for the form and method to make resources, materials and models available to other investigators consistent with achieving the goals of the program. These plans must include a strategy for release of data and information to the SPARC data coordination center, including timing of this release, and make materials and resources available to the research community.
• Upon completion or termination of the research projects(s), the awardees are responsible for making all study materials, data and procedures available to the SPARC data coordination center, as well as making them broadly available (e.g., putting them into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project. The resource sharing plan must include a plan to accomplish this availability and accessibility no later than at the end of the project period or as negotiated with the SPARC PM.

Appendix: Not Allowed. Appendix material is NOT allowed for the OT-1 pre-application.

Not Applicable

Not Applicable

Foreign (non-U.S.) institutions must follow policies described in the NIH Other Transaction Award Policy Guide for the SPARC Program, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants and SPARC OT 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.

This initiative is not subject to intergovernmental review.

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

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. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Not Applicable

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

For this particular announcement, OT1 applications will be reviewed according to the following criteria. The criteria below are not listed in order of relative importance and no weights are assigned.

Relevance and Justification

Will the proposed technology development fill a needed gap to facilitate our understanding of innervation of organs and nervous system modulation of organ function? Will the goals and outcomes significantly advance development of neuromodulation therapies by providing critical foundational knowledge that will be required to inform neuromodulation of one or more organs or through increased specificity, increased effectiveness, and decreased unwanted side effects compared to existing therapies?

Benchmarks and Deliverables

Are the proposed benchmarks and deliverables feasible and congruent with the goals outlined in the FOA? Are there quantifiable metrics at the end of the first year?

Expertise

Is the necessary expertise enlisted and the environment and facilities appropriate for a multi-disciplinary approach to the proposed research? Is expertise for data processing and communication to the SPARC data coordination center included? Is there evidence of sufficient commitment on the part of the key investigators for the project?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, but will not give separate scores for these items.

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

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not Applicable

Reviewers will comment on whether the following Resource Sharing Plans, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Not Applicable

Not Applicable

Applications will be evaluated by an appropriate review group convened by the Office of the Director, NIH, using the criteria described in Section V.1., above. Investigators on OT1 SPARC OTA pre-applications that are judged to be meritorious and align with the SPARC research mission will be invited to submit an OT2, SPARC Research Project -- Other Transaction Award application under RFA-RM-16-003.

As part of the objective review, all applications:

• will receive a written summary.

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

The following will be considered in making selections for OT2 applications:

• Merit of the proposed project as determined by objective review

Relevance of the proposed project to program priorities.

After the review of the application is completed, the PD/PI will receive the written summary of the review. No awards will be made under this FOA. The SPARC Program Manager will communicate the results of the review, including any potential Invitation to Submit an OT2 application. OT2 applications will ONLY be accepted if the applicant has received, and includes, an Invitation to Submit an OT2 application.

Not Applicable

Not Applicable

Not Applicable

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Grace C.Y. Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: SPARC_NextGen-Tools@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Irene Haas
National Center for Advancing Translational Science (NCATS)
Telephone: 301-435-0836
Email: haasi@mail.nih.gov

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 and other considerations described in the NIH Other Transaction Award Policy Guide for the SPARC Program.

Other Transaction awards are made pursuant to Other Transaction awards are made pursuant to the Consolidated Appropriations Act, 2016, P.L. 114-113, Division G, Title I .