It is critical that applicants follow the Research (R) 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 to this limited competition FOA must include an Invitation to Submit, in response to a successful OT1 pre-application. Applications that do not include and Invitation to Submit will not be accepted for review. 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 applications for Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT2). Applications are only accepted after successful competition of the corresponding OT1 pre-application (See RM-17-009, an Other Transaction funding opportunity) and receipt of an invitation to submit an OT2 application.

Successful applications to this FOA will be funded via an Other Transaction (OT) award, which is neither a grant, nor a contract, nor a cooperative agreement (see NIH Other Transaction Award Policy Guide for the SPARC Program).

Peripheral nerve stimulation to modulate organ function is rapidly developing as a therapeutic approach to a wide range of conditions. Rigorous clinical studies have yielded both promising successes and puzzling failures, highlighting an urgent need for clearer anatomical and physiological understanding of the neural control of organ function. While rough outlines are emerging, significant gaps exist which demand innovative programmatic approaches. The goal of the SPARC program is to transform the study of the neural control of organ function by addressing these gaps with primary focus on a few organs. By constructing an open atlas of comprehensive anatomy and functional peripheral nerve connectivity with organs, SPARC teams will provide the scientific foundation for the next generation of therapeutic closed-loop neuromodulation devices and protocols.

Specific major gaps to be addressed include, but are not limited to:

• Understanding the specific and diverse peripheral neural signals carried by nerve fibers to or from end-organs;
• Understanding the functional relationships between neural signals and end-organ cellular activity;
• Developing tools, techniques, and mechanisms to functionally modulate specific portions of peripheral nerves;
• Validating particular animal models to human neuroanatomy and functional neurobiology of organs;
• Characterizing the anatomical and physiological variability at potential peripheral nerve therapeutic access points and organ targets;
• Integrating anatomical and functional mapping data across methodologic approaches, animal models, and organs in order to develop predictive computational models of peripheral nerve and end-organ activity.

SPARC is composed of four interdependent components, as follows:

SPARC1: Anatomical and Functional Mapping of the Innervation of Major Organs

SPARC1 supports the creation of new anatomical and physiological data sets in able to generate and address hypotheses areas such as the coursing and branching of nerves and the distribution of axon terminals, the structure of nerve-organ synapses, the cross-sectional organization of nerves, the organ functional effects mediated by firing patterns, and the relevance of particular animal models to human systems. These studies will proceed in relevant animal models and in humans, including cadaveric tissue when necessary.

SPARC2: Next-generation Tools and Technologies

SPARC2 supports the development of tools and technologies to facilitate the progress of other components, particularly SPARC1. The scope encompasses a wide range of capabilities, spanning the fields of photonics, systems engineering, virology and genomics, device design and manufacture, surface chemistry, tissue engineering, neural interfacing, biomarker sensing, and more. A list of SPARC OT Priorities will be posted on the SPARC website and frequently updated.

SPARC3: Translational Partnerships for Human Functional Mapping and New Indications

SPARC3 supports translational partnerships between industry and SPARC investigators to produce proofs of concept for new nerve stimulation indications and to study functional neuromodulation in the context of human clinical studies.

SPARC4: Data and Resource Center

SPARC4 supports the creation of a multifunctional online hub facilitating coordination, synthesis, and prediction via three Core functionalities: Data Coordination, Map Synthesis, and Modeling & Simulation.

Current SPARC projects can be browsed, by organ, at the SPARC website. All funded teams are part of the SPARC Consortium. All teams are expected to frequently interact with each other, sharing data, protocols, and tools within the Consortium and, as rapidly as possible, with the broader scientific community. Consortium governance is described in the SPARC OT Award Policy Guide and Material Sharing Policy. All members of the Consortium are required to agree to these policies. SPARC is actively managed, and the Consortium will continually be adjusted by adding or subtracting research elements to achieve the overall SPARC goal.

About the NIH Common Fund

SPARC (http://commonfund.nih.gov/sparc/index) is a program of the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. Common Fund programs 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 scientific progress.

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 applications for Stimulating Peripheral Activity to Relieve Conditions (SPARC): Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (OT2).

Specific Objectives for Technologies to Understand the Control of Organ Function by the Peripheral Nervous System (This FOA)

This FOA solicits applications for Other Transaction awards to develop tools and technologies to support physiological, anatomical, and/or functional mapping of the peripheral nervous system.

The applicant’s Invitation to Submit will indicate which SPARC Priority the applicant is allowed to propose.

Because SPARC supports projects investigating a variety of organs, each supplied by nerves having a variety of properties and courses across individuals and species, it is desirable that proposed technologies are adaptable to multiple needs. Single-purpose solutions for specialized high-value needs are also acceptable. Technologies are not required to be on a pathway towards translation to human use, unless specifically stated in the SPARC Priorities.

If appropriately justified, any degree of preliminary technology maturity is acceptable, from theoretical and unproven to integration or improvement of commercial off-the-shelf (COTS) products. Applicants are strongly encouraged to demonstrate use of quantitative models and methods to drive the design, development and validation of the proposed technologies.

SPARC is not part of the BRAIN Initiative https://www.braininitiative.nih.gov; however, technologies to study brain and spinal circuits may be in scope for SPARC to the extent that their study is necessary to a first- or second-order understanding of organ-specific peripheral nerve circuits. Examples might include tools to functionally assess a particular nerve-organ connection via spinal cord stimulation, or to study the alteration of peripheral nerve responsiveness by synaptic plasticity in the brainstem.

With respect to peripheral nerves, this FOA will accept technology development tailored for the study of all relevant pathways pertaining to an 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 program. Applicants must provide justification, and must describe the relevance of proposed technologies to the SPARC Mission.

With regard to tool development and validation, the specific choice of animal or human model must be justified. The proposed technology should be tailored appropriately for use in said animal or human model. The sample size and sex distribution, the technology verification plan and expected knowledge to be gained from its use, and the eventual applicability of these results to humans must be justified.

Tool validation strategies making use of preparations outside the scope of currently funded SPARC organs will be accepted, provided the applicants justify the tool's relevance to a system under investigation by SPARC awardees. Applicants may propose to develop tools intended for organs or nerves not currently under investigation in the SPARC program, but must justify the importance of the organ or nerve for potential inclusion in SPARC and explain why current tools prevent its study.

It is expected that applicants will utilize a multidisciplinary team approach when needed, for example: 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 varies based on the scientific foundation underlying each organ. Technologies currently being developed to study the brain may be adapted to study the periphery.

It is expected that final deliverables (and interim deliverables if possible) will be mature enough to share with the SPARC Consortium, or be collaboratively developed with them. Data, designs, and services developed by SPARC2 projects will be made available to the SPARC Data and Resource Center, and to the research community to assist the SPARC program and the community.

Finally, it is important to note that innovation is not the primary objective of this FOA. Applicants are encouraged to instead focus on the utility of their developments to address the SPARC mission.

Please see the FAQ for clarifications to common questions.

Responsiveness to this FOA:

Applications with an emphasis on the following will be considered not responsive to this FOA:

• Major deliverables which are not new technologies.
• Development of tools or technologies solely justified by a treatment or therapeutic strategy.
• Deliverables which are outside the SPARC Priorities for the receipt date.
• Tools and techniques to neuromodulate sensory organs of the head, named voluntary muscles, and central nervous system above the spine.
• Applications that do not address concerns raised in the Invitation to Submit are not responsive to this FOA.

SPARC is focused on understanding healthy organ function. Study of disease states may be necessary to further understand innervation or the effects of modulation on normal organ function. Inclusion of such studies in a project must be justified in the application.

For the purposes of this FOA, preganglionic neurons of the autonomic nervous system located in the brainstem or spinal cord, as well as dorsal and ventral roots of neurons coming from or going to the spinal cord are considered part of the PNS and are thus responsive.

SPARC Program Other Transaction Management

Awards under this FOA will be made as Other Transactions, which are not grants, contracts or cooperative agreements. The NIH Other Transaction Award Policy Guide for the SPARC Program describes the OT mechanism, and describes other policies that all awardees must comply with.

SPARC OT awards are actively managed by SPARC Program and Project Managers and an Agreements Officer. This active management allows for flexibility in soliciting new awardees, combining projects, and modifying review processes. SPARC Program and Project Managers will have significant programmatic input into awarded activities, providing substantial scientific programmatic involvement in quality control, research coordination, performance monitoring, technical assistance, and final decisions for award directions. The Program Manager will also oversee coordination 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.

Projects within SPARC must propose information sharing and include expertise for material exchange among teams and with the Data and Resource Center. The SPARC Material Sharing Policy defines these expectations. Awards issued under this FOA will adopt the prescriptions and requirements of the Bayh-Dole Act of 1980, which pertains to the ownership of intellectual property.

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 face-to-face meetings must be included in the project budget.

Additional Project Funding

This FOA is intended to support the development of technologies to support the SPARC program. It is recognized that some projects may warrant further development beyond the original deliverables. NIH may choose to provide additional funding to projects awarded under this FOA and extend the duration of the award, subject to availability of funds.

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

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

This FOA is a limited competition for applicants, who on the basis of objective review of RM-17-009 OT1 pre-applications, have been invited to submit OT2 applications.

Applicant Organizations and Unaffiliated Individuals 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.

Individuals not affiliated with an organization, or who want to submit an application independently of their current organization, may apply. Applicants do not have to be U.S. citizens or permanent residents but must have a U.S. tax payer identification number. Applicants may be subject to financial analysis and risk assessment conducted by NIH staff. Individual applicants not affiliated with an organization or who want to submit an application independently must complete all the required registrations as though they are an organization. There should NOT be any cost associated with ANY of these registrations .

• 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 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. Unaffiliated individuals will be registered as independent scholars and will also act as the SO, with the same authority in eRA Commons that the Authorized Organizational Representative(s) has in Grants.gov.

Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

The eligible individual(s) should have technical expertise directly related to the scientific area in which the application is targeted and be capable of providing both administrative and scientific leadership to the development and implementation of the proposed project, monitoring and assessing the project, and submitting all documents and reports as required.

This FOA does not require cost sharing as defined in the NIH Other Transaction Award Policy Guide for the SPARC Program. Applicants may voluntarily choose to propose a financial plan that includes non-federal resources. The OT2 budget submission must clearly identify and justify the use of these resources. Any voluntary cost share must be supported by a letter of support from the providing organizations/individual. All voluntary cost share provided is also required to adhere to the SPARC OT Award Policy Guide.

• Applicant organizations and unaffiliated individuals may submit only one application in response to an Invitation to Submit an OT2 application for this FOA (RFA-RM-17-010). The NIH will not accept applications that do not have an Invitation to Submit an OT2 application.The Invitation to Submit is derived from an OT1 pre-application to companion funding opportunity RM-17-009
• After objective review of the OT1 pre-application, successful applicants will receive an Invitation to Submit an OT2 application.
• OT2 applications submitted after the receipt date specified in the Invitation to Submit must be submitted again following issuance of a new Invitation to Submit an OT2 application.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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 12 pages. Reviewers will not have access to the corresponding OT1 SPARC pre-application, nor the summary from the OT1 review. Information in this Research Strategy 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:

Cover Letter Attachment: 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 pre-application to funding opportunity RM-17-009. 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 an estimate for the total cost for each task per year of the project (see the Research Strategy section below for an explination of "task"). In addition, a summary of the direct costs for each major task must be included in the Research Strategy. The table below is provided as an example of one way in which this information may be submitted

Description

Year 1

Year 2

Year 3

Total Cost (Direct + Indirect)

Task 1

Brief description & identify benchmarks

$ 177,386

Task 2

Brief description & identify benchmarks

$ 210,987

Task 3

Brief description & identify benchmarks

$ 225,782

Task 4

Brief description & identify benchmarks

$ 315,761

Task 5

Brief description & identify benchmarks

$ 433,889

Task 6

Brief description & identify benchmarks

$ 291,592

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 interface with the SPARC Data and Resource Center, as described above, and should be commensurate with the work and deliverables proposed. Applicants must include costs associated with their Resource Sharing Plan, such as costs associated with training on using the shared resources.

Applicants should allocate 10% of total direct cost of the OT2 requested budget for future collaborating efforts within the SPARC program. This is in addition to the costs to support interaction with the Data and Resource Center and other resource sharing activities.

Indirect costs on foreign awards will be reimbursed at a rate of 8% of total direct costs, 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: Do not consider this to be a traditional Specific Aims page for hypothesis-driven research. This page should provide an outline of the project. Briefly state the objective of the project and how the deliverable addresses the currently posted SPARC Priorities. As appropriate, describe target nerve(s) and/or organ(s). Provide a summary of major tasks to be accomplished with milestones and benchmarks, a timeline, and deliverables.

Research Strategy: Do not consider this to be a traditional Research Strategy. The objective of this FOA is to identify projects and teams who can provide needed tools and technology to the SPARC Consortium and the broader research community. This section should be structured to provide sufficient information to gauge the applicant’s likelihood of producing the deliverables and achieving their objectives.

• Impact and Significance: Identify the SPARC Priority being addressed in this application and the organ(s) being targeted. Briefly describe the relevant major knowledge gaps and/or barriers within that Priority that the proposed technology will overcome. Highlight any conceptual, technical, and/or methodological innovations for the proposed project. Compare your technology to existing state-of-the-art approaches, quantitatively if possible.
• Preliminary Data: Provide a description of the technology's maturity. One approach is to use Technology Readiness Levels. Describe the Preliminary Data, if available. Preliminary data is not required for a successful application.
• Development Plan: Describe in detail the approach and methodology to develop the technology. Be sure to account for biocompatibility, changes in physiology as a result of the technology, measurement uncertainty, and calibration processes. The plan should demonstrate deep understanding of the technical challenges and present a credible plan to achieve the goals. Define the specifications of your technology, quantitatively if possible. Justify the relevance of these specifications to the SPARC Priority.
  
  
• Validation Plan: Justify the appropriateness of animal or human model. Justify sample size and sex distribution. Justify the knowledge to be gained from use of the technology and the eventual applicability of this knowledge to humans.
  
  
• Risk Analysis: Provide a description of potential pitfalls and limitations, and approaches to retire and/or mitigate them.
• Tasks, benchmarks, timeline: For each major task, describe the expected outcomes and deliverables. Include benchmarks for each task that can be used to evaluate interim and final progress towards the deliverables. Benchmarks should include quantifiable criteria for success (i.e. go/no-go), and should aggressively address major risks in the first year of the project. The criteria for success and benchmarks should be based on quantitative estimates, if possible. The timeline must include benchmarks, deliverables, and transfer of material to the SPARC Data and Resource Center. A Gantt chart may be included (see the Budget section above for an explination).

Examples of benchmarks are available at https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/Neural-Prosthetics-Milestones

• Investigators: Describe past collaborations between the key personnel, if any. Responsibility for interfacing with the SPARC Data and Resource Center must explicitly be assigned to one or more individual(s) planned contributions.
• Project management: Describe the management plan. If the project is to be carried out in more than one department or institution, identify what parts of the project will take place at each organization and which senior/key individuals will be responsible for each portion.

Letters of Support

A letter of support from the applicant’s organization (if any) is required to demonstrate institutional commitment for the project. For university-based applicants, this is a letter from a senior administrator indicating support of this proposed project and a commitment to ensuring your access to any necessary facilities.

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 sharing of material to the SPARC Data and Resource Center, as well as to other projects within SPARC, and more broadly to the research community in general. All award recipients will be required to comply with the SPARC Material Sharing Policy provided at https://commonfund.nih.gov/sparc/materialsharing.

Appendix:

Not Allowed

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

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

Foreign (non-U.S.) organizations must follow policies described in the NIH Other Transaction Award Policy Guide for the SPARC Program, and procedures for foreign organizations 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.

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

No post-submission materials will be accepted, except video files less than two minutes in duration. NOT-OD-12-141 provides guidelines, unless superceded by the following. Files must be converted into MPEG4 (.mp4) format and emailed to [email protected] no later than 5:00 PM local time on the receipt date. This address only accepts attachments less than 25 MB. If the video file is larger than 25 MB, the NIH file-sharing service (SEFT) must be used. Once the video has successfully been downloaded, you will be emailed to confirm that it has been received.

Please note: applicants submitting files greater than 25 MB must first register for a SEFT account by calling the NIH IT Service Desk (+1-301-496-4357 or +1-866-319-4357 toll free or +1-301-496-8294 TTY). Once registerd, notify SPARC staff that you have a SEFT account by emailing [email protected]. Applicants are then able to reply and attach videos greater than 25 MB to NIH-initiatted SEFT emails. Additional information and system requiremnts is available through the EES-Enterprise Email Service website.

Only the criteria described below will be considered in the review process. For this particular announcement, reviewers will consider each of the criteria below in the determination of scientific merit and assign each an impact score of 1-9. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Note that innovation is not a scored criterion.

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 Priority, as defined https://commonfund.nih.gov/sparc/FOApriorities?
• 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?
• Is the Resource Sharing Plan suitable?
• Is the research methodology rigorous such that it would minimize bias in experimental design and reporting?
• Are anticipated risks and challenges associated with the technology development adequately addressed? Are the proposed mitigation plans acceptable?
• Is it possible to generate quantitative estimates for the criteria for success? If so, are these included in the application, feasible, and a meaningful measure of achieving the SPARC Priority?
• Is the timeline of deliverables feasible?
• Is the breakdown of tasks, task-based budgets, and deliverables clearly defined and reasonable?

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?
• If this is a Multiple PD/PI application, is the Leadership Plan reasonable?

Institutional Commitment (1X)

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

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 the responses to comments from the previous scientific review group, concerns raised in the Invitation to Submit an OT2 application, and changes made to the project.

Not applicable

Not applicable

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.

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, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

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 by an appropriate review group convened by the Office of the Director, NIH, using the criteria described in Section V.1. by a group of NIH Program staff and outside experts. Assignment to the review group will be shown in the eRA Commons.

As part of theobjective review , all applications:

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

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

• (add bullet) Scientific and Technical Merit of the proposed project as determined by objective review(add bullet) Availability of funds

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.

All Other Transaction awards under SPARC include the NIH Other Transaction Award Policy Guide for the SPARC Program and the SPARC Material Sharing Policy 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."

Other Transaction (OT) Terms and Conditions of Award".

The following special terms of award are in addition to, and not in lieu of, other HHS, and NIH Other Transactions 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, with appropriate supplemental personnel, 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 responsibilities:

• 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(s)/Principal Investigator(s) will assume responsibility and accountability to the applicant’s officials (if any) 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 and SPARC Material Sharing Policy).
• Awardee(s) 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, other members of the SPARC Consortium, and with the SPARC Data and Resource center.
• Awardee(s) 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, technologies, devices, 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.
• Awardee(s) 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 and Resource Center and the NIH, consistent with NIH policies and achieving the goals of the FOA (SPARC Material Sharing Policy).
• Data are to be made available to the SPARC Data and Resource 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 awardee(s) are responsible for making all remaining study materials, data and procedures available to the SPARC Data and Resource 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.

Intellectual Property

The successful development of technologies from SPARC require either substantial investment and support by private sector industries, and/or may involve collaborations with other organizations such as academic, other government agencies, and/or non-profit research institutions not directly involved in the NIH-funded SPARC Program. NIH recognizes that intellectual property rights may play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:

• The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
• Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
• The prescriptions and requirements of the Bayh-Dole Act will govern any inventions made by the awardee in the performance of the project, and the awardee is required to report to the U.S. Government all such inventions, as specified by 35 U.S.C. Sect. 202.

Awardees are expected to make new information and materials known to the research community in a timely manner through sharing with the SPARC Data and Resource Center and SPARC Consortium, publications, presentation, and/or other mechanisms.

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, with appropriate supplemental personnel, 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 or designee(s) will have substantial scientific programmatic involvement in quality control, research coordination and performance monitoring.
• The SPARC Program Manager or designee(s) 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 or designee(s) will enforce general statutory, regulatory, or policy requirements.
• 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 publication, dispute resolution policies, 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 Program Manager(s) and Scientist(s) as well as designated NIH staff.
• 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 Program Manager(s) and Scientists(s) will designate a lead NIH representative who will also have one vote. When a vote is required, at least 60% of the votes will be required for approval.
• Publication collaboration is encouraged among award recipients and partners.
• The SPARC Program Manager, OT Project Manager and Project Scientists may not be co-author(s) with SPARC investigators on publications of original SPARC-funded research.

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.
• 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.

If 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.

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 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 Center Telephone: 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

Michael B. Wolfson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-301-451-4778
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

Awards are made under the Other Transaction Authority (OTA) as authorized and appropriated by the Consolidated Appropriations Act, 2016, Division H, Title II, Sec. 215 (P.L. 114-113).Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.