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

The purpose of this FOA is to invite innovative research applications for Stimulating Peripheral Activity to Relieve Conditions (SPARC): Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs (OT2). These projects will use a multi-expertise approach to comprehensively understand the neuroanatomy and neurobiology of both afferent and efferent innervation of a major organ, as well as characterize nervous system regulation of function of that organ. Data from these projects will support the development of detailed, functional and anatomical neural circuit maps by the SPARC data coordination center with the long term goal of significantly advancing development of neuromodulation therapies. Target organs proposed for these projects must present significant opportunities for developing neuromodulation therapies.

An OT2 application is for an Other Transaction (OT) award, which is neither a grant, a contract, not a cooperative agreement (see NIH Other Transaction Award Policy Guide for the SPARC Program). Successful competition of an OT1 application in response to RFA RM-15-003, "Pre-application for Stimulating Peripheral Activity to Relieve Conditions (SPARC): Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs (OT1)", including a copy of the Invitation to Submit, is required for submission of an application in response to this announcement.

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 OT mechanisms. The projects to be submitted under this announcement will use the 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, will 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 will 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 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.

Two types of projects are envisioned during the first phase of the Anatomical and Functional Mapping component. This announcement applies only to Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs. Support for Foundational Functional Mapping of Neuroanatomy and Biology of Organs projects will be through separate announcements.

• Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs projects are appropriate when the knowledge base supports a full, multi-expertise approach to understanding both afferent and efferent components of nervous system control of organ function. These large projects will comprehensively provide data for the detailed, predictive functional and anatomical neural circuit map for neural control of medically relevant functions of a specific organ and its functionally-associated structures (for example, the bladder and associated sphincter). It is anticipated that Comprehensive Functional Mapping projects will enable later competitive high resolution mapping projects and pre-clinical testing for new therapies.
• Foundational Functional Mapping of Neuroanatomy and Neurobiology of Organs projects are smaller projects focused on major organs where it is necessary to fill current knowledge gaps in order to provide the foundational functional neuroanatomy and neurobiology data potentially leading to a subsequent large Comprehensive Functional Mapping project.

In addition to mapping and characterizing components of the nervous system involved in control of organ function, the SPARC Anatomical and Functional Mapping projects include development of methods to assess the related organ function.

The Anatomical and Functional Mapping projects will be integrated with other SPARC components described below in order to maximize progress and provide data for development of maps. The descriptions of the other SPARC components, below, are for information only. These components will be the focus of separate FOAs.

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). This 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 this FOA were intended to address the gaps in understanding detailed underlying physiology and targeted mechanisms of action of future neuromodulation therapies.

Additional phases of the Next Generation Tools and Technologies component will further technology developments to assist in mapping and future development of neuromodulation therapies. The next generation tools and technologies developed will be responsive to, and freely shared with other SPARC projects.

The third component, 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.

The fourth component, SPARC Data Coordination, will support assembly of data from all projects into a coordinated data 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 within the context of the entire program, THIS ANNOUNCEMENT APPLIES ONLY TO APPLICATIONS for Stimulating Peripheral Activity to Relieve Conditions (SPARC): Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs (OT2).

Data generated by these projects will be provided to the SPARC data coordination center, which in turn will generate detailed, functional and anatomical neural circuit maps for major organs and their functionally-associated structures. Projects will closely coordinate with the data coordination center in order to integrate data into the neural circuit maps.

Examples of target organs that would be considered appropriate for these mapping projects include the major internal organs (major viscera) such as the heart, lungs, liver, stomach, pancreas, duodenum, colon, bladder, adrenal gland, spleen or kidneys; and the skin. Examples of structures that would not be appropriate as the primary focus for these projects include the sensory structures of the head and the named voluntary muscles, except as allowed below.

While it is expected that most projects will focus on innervation of a single major organ, consideration will be given to incorporation of connections across organs. Examples include: cutaneous and subcutaneous afferent innervation which indirectly affect efferent input to internal organs, particularly where such novel inputs pose potentially minimally-invasive targets for eventual neuromodulation therapies; or circuits by which conditions of the duodenum may affect pancreatic function.

Each project will focus on both the afferent and efferent innervation of a single organ and its functionally, closely associated structures, and is expected to comprehensively collect data on innervation and nervous system regulation of function of that organ. The exact scope and data proposed for each project will likely depend on the base of knowledge already available and the specific organ of focus. Data for neural circuit maps may include, for example:

• detailed autonomic and sensory neuroanatomy including synapses, ganglia and interneurons
• molecular identity of neurons
• functional connectivity
• conduction properties of neurons
• functional and anatomic characterization of intrinsic innervation at the organ (for example, the enteric nervous system)
• organization of fibers and fascicles within nerves
• recordings of nerve activity
• potential points of surgical access
• other parameters of innervation that will be important to design and testing of neuromodulation therapies for the organ, such as neural plasticity in response to stimulation
• variability of all of the above animal-to-animal and patient-to-patient

In addition, research on organ function that is modulated by the nervous system will be expected, and may include, for example:

• identification of end-organ cells being innervated
• understanding of the minimum functional unit of nerve activity eliciting an organ function
• what organ functions result from different types of stimulation
• development of assays for assessment of changes in organ function due to nerve activity and neuromodulation
• other parameters of organ function that will be important to design and testing of neuromodulation therapies for the organ

Due to the comprehensive nature of these projects, it is expected that multiple areas of expertise will be needed. Projects should be developed to include investigators who have the outstanding, committed expertise in the areas required by the research that is to be proposed. A necessary consideration is that these projects will be conducted as part of a consortium of projects under SPARC and this consortium will be expected to develop common standards, formats, and means of communicating data between projects and to the SPARC data coordination center. Thus, each project must include expertise sufficient to develop and adhere to these data handling and communication processes.

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). However, there is interest 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. Research on neuromodulation through central brain stimulation is not the appropriate focus of SPARC.

Where organ function is dependent on a mixture of autonomic, sensory and voluntary innervation, investigation of all of these circuits is considered within the scope of the project.

It is anticipated that significant steps in the understanding of peripheral nervous system control of organ function will require the use of animals. The animals planned for use must be justified in terms of the technologies to be employed, 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.

The Comprehensive Mapping Projects may also include development of technology that is specific and necessary to the proposed Comprehensive Mapping Project. Such technology development, where justified, may be proposed for support as part of these projects but should not be the main focus of the project. The SPARC program, as explained above, includes a formal effort for Next Generation Tools and Technologies and these technologies will be exchanged and available for use among all projects in the program. Studies with a major focus on technology development related to SPARC should seek funding support through the appropriate SPARC component.

A main focus on healthy organs is anticipated for mapping 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 must be justified in the application.

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 autonomic and sensory innervation of organs will be defined over time, as new data and technologies are established.

Awards under this OT2 announcement 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, an active management structure will be used for this program 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.

Investigators must propose project benchmarks that are quantitative, and with clear go, no-go criteria that are aligned with achieving SPARC programmatic milestones (see below). The SPARC program staff will have the capability to discontinue support from aspects of the program that fail to meet performance requirements or benchmarks, and the flexibility to recruit new investigators to try new approaches.

The overall programmatic milestones for the first phase of the Anatomical and Functional Mapping component, Comprehensive Mapping Projects are:

Year 1: initiate mapping projects and collect initial anatomical and functional data; hold investigator meetings for planning, sharing of data and technologies, and development of parameters of research for mapping data; determine methods of data exchange with the SPARC data coordination center.

Year 2: continue investigator meetings and data exchange; for each particular organ, have a preliminary anatomical assessment, including variability of innervation at various potential intervention points; collect data on organ function regulated by innervation; begin or continue comparisons of animal model and human data; integrate new technologies for higher resolution data.

Year 3: complete functional mapping data using existing technologies; continue collecting higher resolution data with new technologies; complete initial development and validation of sensing technology and techniques to measure organ function, translate animal results into human, including subject-to-subject variance at logical surgical access points;

Potential applicants should develop project benchmarks commensurate with achieving these programmatic milestones. The programmatic milestones are listed here for planning purposes.

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.

This NIH Common Fund FOA is a limited competition for those who on the basis of objective review of RFA-RM-15-003 OT1 pre-applications have been invited to submit OT2 applications.

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. This FOA does not require matching or cost sharing as defined in the NIH Other Transaction Award Policy Guide for the SPARC Program.

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 download 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 30 pages. Reviewers will not have access to the corresponding OT1 SPARC pre-application, nor the summary from the OT1 review. Information in this Research Plan must be complete.

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:

A copy of the Invitation to Submit must be included in the Cover Letter attachment on the Cover form to demonstrate NIH concurrence with this submission in response to a successful OT1 application to announcement RFA-RM-15-003. The Cover Letter attachment should be addressed to the Division of Receipt and Referral.

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

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

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

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

A detailed budget and justification are required for all years of the application.

The budget must include travel costs to SPARC Consortium meetings twice per year in the Bethesda, Maryland region.

The budget should include expertise necessary for data exchange, as described above, and should be commensurate with the work and deliverables proposed.

Indirect costs on foreign awards will be reimbursed at a rate of 8% of total direct cost, less only equipment.

Indirect costs for domestic awards will be reimbursed using the applicant’s federal negotiated indirect cost rate. Any applicant that has never received a negotiated indirect cost rate may elect to charge a de minimis rate of 10% of modified total direct costs.

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

A detailed budget and justification are required for all years of the subaward.

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 of focus. Describe relevant major knowledge gaps and/or barriers for the neuromodulation of the proposed organ. Highlight any conceptual, technical, and/or methodological innovations for the proposed project.

Research Strategy: In addition to the SF424 (R&R) Application Guide Instructions, this section must include:

• Background information related to the need for understanding of neural circuitry of the organ; current knowledge related to the innervation of the organ; brief discussion of the strengths and weaknesses of the major approaches used for the anatomical and functional studies of the organ.
• Significance of the project and how this project will fill important gaps in information needed for effective future neuromodulation therapy.
• A description of the scope and goals of the project and how these relate to the SPARC program.
• A description of the expected main 3-year outcomes of the project and how these relate to the overall programmatic milestones for the first phase of the Anatomical and Functional Mapping component, Comprehensive Mapping Projects, described above in Section I Milestones and Individual Project Benchmarks .
• Project deliverables and benchmarks must be enumerated in the Research Plan in one section. The aims and subaims of the Research Plan that correspond to specific benchmarks and deliverables should be indicated through numbering, lettering or notations. Include projected timelines for transmission of data 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.
• A description of the proposed overall approach and methodology, including the outcome measures as well as assessment of current technologies for the study, and justification of any new technologies to be developed within the project. Describe how the outcome measures relate to the proposed organ function. Describe innovative aspects of the project and approaches and how they will yield the highest resolution possible.
• A description of anticipated problems and approaches to overcome them.
• A description of animal models to be employed and their relevance to human data. Describe plans to validate animal model data in humans.
• If the project is to be carried out in more than one department or institution, the collaborative plans and what parts of the project will take place at each different department or institution.

A statement of the expertise needed to meet the various goals and, without duplicating the biosketch, what each investigator will bring to the project to fulfill the needed expertise (two page maximum). This statement must include needed expertise to communicate data between projects and to the SPARC data coordination center timely and in a format agreed upon by the consortium.

• A plan for management of the project.
• A timeline for completion of the project.
• Optional element: The submitters are encouraged to describe technologies that would help to optimize future high resolution mapping and accelerate projects as a part of the overall Next Generation Tools and Technologies to be developed under SPARC, in addition to the technologies that they are planning to use for the proposed comprehensive mapping studies. This will be treated as program planning information.

Letters of Support: A letter of support from the applicant institution is required to demonstrate institutional commitment for the project, including for the Resource Sharing Plan.

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 sharing and making data, biomaterials, models, reagents, tools, resources and methods 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; 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 to provide quality controlled data and information.
• In addition, applicants 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 project(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 Program Manager.

Appendix: Not Allowed. Appendix material is NOT allowed for the OT2 application.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

All Other Transaction awards under SPARC are subject to the terms and conditions, and other considerations, described in the NIH Other Transaction Award Policy Guide for the SPARC Program.

Pre-award costs as described in the NIH Other Transaction Award Policy Guide for the SPARC Program are not allowed.

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.

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. Applications that are incomplete or non-compliant will not be reviewed.

Not Applicable

Reviewers will consider each of the criteria below and assign each a score of 1-9. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. The applicant shall include all information which documents and/or supports the criteria in the application.

Scientific and Technical Merit (6 X)

• Is there high potential for making substantial progress in a SPARC research area?
• Are the proposed project benchmarks feasible and congruent with the goals outlined in the specific call for applications?
• Are the proposed plans, methods, techniques, and procedures for the research sound, feasible, and valid?
• Are the proposed plans for dissemination of the resulting knowledge and/or technology suitable?
• Is the research methodology rigorous such that it would maximize reproducibility?

Personnel Qualifications (3 X)

• Do the past performance and experience of the Principal Investigator(s) and collaborators, demonstrated by the significance and impact of previous research, publications, professional activities, awards and other recognition, etc., indicate strong qualifications to lead the project?
• Is the necessary expertise committed to the degree required for the research project?
• Is the potential to collaborate effectively in a multidisciplinary environment strong? For example, is there strong evidence of:
• Ability to integrate diverse sources of information
• Experience in successful, high impact collaborations, including past leadership of collaborations;
• Commitment to executing effective strategies for accomplishing collaborative goals?

Institutional commitment (1X)

• Is there evidence of a long-term commitment by the institution to the applicant and the research in the form of a letter of support?

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 research that involves human subjects but does not involve one of the six 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 six 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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration 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, and should not consider them in providing an overall impact score.

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.

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).

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.

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

Applications will be evaluated for scientific and technical merit by an appropriate review group convened by the Office of the Director, NIH in accordance with the stated criteria above. Assignment to the review group will be shown in the eRA Commons.

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 awards:

• Scientific and technical merit of the proposed project as determined by objective review
• Availability of funds

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 through the SPARC Program Manager.

If the application is under consideration for funding, NIH will request pre-award information from the applicant.

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 Agreement 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.5. 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 will not be reimbursed by the NIH.

Any application awarded in response to this FOA will be subject to terms and conditions found in the NIH Other Transaction Award Policy Guide for the SPARC Program. Awards issued under this FOA will adopt the prescriptions and requirements of the Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212 https://grants.nih.gov/grants/bayh-dole.htm), including applicable portions of the related EO 12591 (April 10, 1987).

All Other Transaction awards under SPARC include the NIH Other Transaction Award Policy Guide for the SPARC Program as part of the NoA. For these terms of award, see the NIH Other Transaction Award Policy Guide for the SPARC Program Part II: Terms and Conditions of SPARC Other Transaction Awards.

The following special terms of award are in addition to, and not in lieu of, other HHS, and NIH Other Transaction administration policies.

The administrative and funding instrument used for this program will be the Other Transaction, OT2 mechanism, in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the OT, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients. The SPARC Program Manager provides overall direction for the SPARC program. The SPARC Program Manager and Agreement Officer will provide continuous monitoring of the OT awards to make certain that the aims of the awards are being addressed and proper business practices are employed. OTs offer considerable flexibility to renegotiate or terminate agreements when necessary to promote the overall objectives of the program. The award and post-award negotiations will reinforce program objectives and, if necessary, adjust conditions by which progress is assessed.

The SPARC Consortium will consist of research projects supported under this announcement as well as projects supported under additional announcements for the initiatives of the SPARC program, as well as the SPARC Program Manager, the SPARC Agreements Officer, and appropriate supplemental personnel, including Project Scientists.

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

• Awardee(s) will work with the SPARC Program Manager to define the research objectives and approaches; plan research; conduct analyses; and publish results, interpretations, and conclusions of studies conducted under the award.
• Investigators must adhere to the project benchmarks negotiated at the time of the award, and modified as necessary, by the SPARC Program Manager and Agreement Officer to ensure progress.
• The Program Director/Principal Investigator will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies (NIH Other Transaction Award Policy Guide for the SPARC Program).
• Awardees must function in accordance with processes and goals as delineated in the Funding Opportunity Announcement.
• All staff of the funded projects will be required to participate in a cooperative and interactive manner with NIH staff, one another and with the SPARC data coordination center.
• Awardees must share data, materials, models, methods, information and unique research resources that are generated by the projects as negotiated with the SPARC Program Manager in the resource sharing plan in order to facilitate progress of the SPARC program. When appropriate, and in accordance with direction from the SPARC Program Manager and as negotiated in the Resource Sharing Plan, awardees must collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other SPARC program awardees and Program Manager.
• Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to the terms of the award and Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies.
• Awardees must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community, the SPARC data coordination center and the NIH, consistent with NIH policies and achieving the goals of the FOA.
• Data are to be made available to the SPARC data coordination center in a timely manner and in a format agreed upon by the consortium and per the sharing plans.
• Upon completion or termination of the research project(s), the awardees are responsible for making all remaining study materials, data and procedures available to the SPARC data coordination center, as well as making them broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project.
• Investigators will work with the SPARC Program Manager and the SPARC Steering Committee to develop policies on information sharing and public information release consistent with approved resource sharing plans. In accordance with these policies on information sharing and release, all staff of the project will maintain the confidentiality of the information developed by the consortium investigations, including, without limitation, study protocols, data analysis, conclusions, etc., as well as any confidential information received by third party collaborators.
• The PD/PI will attend two consortium meetings per year to report on project progress. This is in addition to the annual written progress report. A summary of oral presentations at consortium meetings, or the slide set from the presentation, must be submitted to the official file to document progress. Additional reporting through conference call or other means may be required by the SPARC Program Manager.
• Awardee(s) agree that each industry collaboration should be governed by a research collaboration agreement (e.g., CTA, RCA, etc.) with terms that ensure the collaboration is conducted in accordance with the award, applicable NIH policies and procedures and any policies and procedures developed by the SPARC program.

SPARC Program Manager will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The SPARC Program Manager will coordinate and facilitate the research projects and attend and participate in all meetings of the consortium in order to achieve SPARC program goals.
• The SPARC Program Manager and Agreement Officer, with appropriate supplemental personnel, will establish, monitor and administer each OT award on an ongoing basis and correct issues as they arise.
• The SPARC Program Manager will have substantial scientific programmatic involvement in quality control, research coordination and performance monitoring. The SPARC Program Manager will have access and privileges to any data generated by the SPARC program.
• The SPARC Program Manager serves as a resource with respect to other ongoing NIH activities that may be relevant to the SPARC studies to facilitate compatibility and avoid unnecessary duplication of effort.
• The SPARC Program Manager or designee(s) may coordinate activities among awardees by assisting in the design, development, and coordination of common research protocol(s), new and existing technologies, and statistical evaluations of data. They may also coordinate across individual projects to combine, add to, or subtract from research being done in order to increase quality, accelerate the progress of research, realize economies, or discontinue duplicative or low-priority approaches.
• The SPARC Program Manager may review procedures for assessing data quality and monitor study performance.
• The SPARC Program Manager and Project Scientists may not be co-author(s) with SPARC investigators on study publications.

Areas of Joint Responsibility Include:

• A SPARC Steering Committee will be formed whose purpose is to transfer information between SPARC awardees in order to achieve the goals outlined in the overall SPARC program, and to establish policies for information and technology sharing, publication, and common protocols.
• The SPARC Steering Committee will be composed of PD/PIs (or the Contact PI in the case of multi-PI projects) and Project Scientist(s). The SPARC Program Manager will be a non-voting member, but will review and approve action plans developed by the Steering Committee.
• It is expected that most of the decisions on the activities of the SPARC Steering Committee will be reached by consensus. If a vote is needed, each project PI (or Contact PI in the case of multi-PI projects) will have one vote. The Project Scientists will designate a lead Project Scientist who will also have one vote. When a vote is required, at least 60% of the votes will be required for approval.

Termination

• NIH may also terminate for convenience. For example, in order to advance the goals of the SPARC program, NIH may terminate due to a change in programmatic needs or changes in the availability of funds for the project.
• In addition, if NIH determines that a recipient has failed to materially comply with the terms and conditions of award, NIH may take one or more enforcement actions which include disallowing costs, withholding of further awards, or wholly or partly suspending the Other Transaction award, pending corrective action. NIH may also terminate the award for cause.
• Records will be kept to document non-performance, establishing a history of failures to achieve benchmarks that has been well documented and clearly communicated to the awardee. The SPARC Program Manager and the Agreement Officer will make serious efforts to assist in performance of a project to meet or adjust benchmarks in order to achieve programmatic goals and protect the investment.
• NIH generally will suspend (rather than immediately terminate) an OT award and allow the recipient an opportunity to take appropriate corrective action before NIH makes a termination decision. However, NIH may decide to terminate the award if the recipient does not take appropriate corrective action during the period of suspension. NIH may immediately terminate an award when necessary, such as to protect the public health and welfare from the effects of a serious deficiency.
• If the NIH decides to terminate an award, the termination of the award will be considered a unilateral change and the recipient will not have the right to appeal. Unilateral changes will be based on Project Scientist, additional program staff, Steering Committee and external evaluators assessments and are subject to approval by the Director of the Division of Program, Coordination, Planning, and Strategic Initiatives. Although a decision is made to terminate an award, the recipient must continue to comply with the Record Retention and Access requirements contained in the NIH Other Transaction Award Policy Guide for the SPARC Program.
• An Other Transaction award also may be terminated, partially or totally, by the recipient. If the recipient decides to terminate a portion of an Other Transaction award, NIH may determine that the remaining portion of the award will not accomplish the purposes for which the Other Transaction award was originally awarded. In any such case, NIH will advise the recipient of the possibility of termination of the entire Other Transaction award and allow the recipient to withdraw its termination request. If the recipient does not withdraw its request for partial termination, NIH may initiate procedures to terminate the entire award for cause.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Other Transaction Award Policy Guide for the SPARC Program.

In addition, two reports on research progress will be made per year at SPARC Steering Committee meetings and slides and supporting materials will be made part of the permanent record.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Other Transaction Award Policy Guide for the SPARC Program.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://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
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

David Saslowsky, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-8179
Email: [email protected]

Patricia Greenwel, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-8179
Email: [email protected]

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: [email protected]

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 Section 480 (e)(3)(C) of the PHS Act, 42 U.S.C 287 a(e)(3)(C).