Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund Initiative through the NIH Office of the NIH Director, Office of Strategic Coordination. The FOA will be administered by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on behalf of the NIH.

Funding Opportunity Title

Stimulating Peripheral Activity to Relieve Conditions (SPARC):  Foundational Peripheral Neuroanatomy and Functional Neurobiology in Under-Studied Organs (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-17-003

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.310

Funding Opportunity Purpose

This NIH Funding Opportunity Announcement (FOA) is part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) Common Fund program. This FOA solicits applications for support of research to gather critical data and answer critical questions on functional peripheral neuroanatomy of organs and reveal the organ function controlled by neural circuits.   Organs of interest include those where the peripheral neuroanatomy and functional neurobiology of the organ have been understudied, and which are not the subject of existing SPARC funding under RFA-RM-15-018 (see below).  

Key Dates

 

Posted Date

January 26, 2017

Open Date (Earliest Submission Date)

March 3, 2017

Letter of Intent Due Date(s)

March 3, 2017

Application Due Date(s)

April 3, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this Funding Opportunity Announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2017

Advisory Council Review

August 2017

Earliest Start Date

September, 2017

Expiration Date

April 4, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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 that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) is to solicit applications for support of research to gather critical data and answer critical questions on functional peripheral neuroanatomy of organs and reveal the organ function controlled by neural circuits.   Organs of interest include those where the peripheral neuroanatomy and functional neurobiology of the organ have been understudied, and which are not the subject of existing SPARC funding under RFA-RM-15-018.  Thus, organs that are not of interest under this announcement include:  heart, lungs and airways, intestine, and stomach (see https://commonfund.nih.gov/sparc/index for a listing of all projects funded to date by SPARC under specific announcements).  Organs that are of interest under this announcement include, but are not limited to:  bone, bone marrow, liver, esophagus, kidney, male and female reproductive organs, and spleen.

Proposed projects must overcome key roadblocks to understanding the peripheral innervation of the target organ through investigation of neuroanatomy and functional neurobiology of the organ.  Studies should be designed to significantly advance knowledge of peripheral neuroanatomy and neurobiology controlling organ function in the target organ, including the response of the organ to signals from the nervous system.  The project should establish a base of knowledge, and lead to data that will enable understanding of whether this organ presents an opportunity for future development of neuromodulation therapy.

Background

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 approaches. The goal of the SPARC program is to transform the study of the neural control of organ function by addressing these gaps. 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:

  • 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 organ systems in order to develop predictive computational models of peripheral nerve 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 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, mapping of the temporal structure of nerve activity to postsynaptic organ function, 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 for the PNS

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, system engineering, virology and genomics, device design and manufacture, surface chemistry, tissue engineering, and more. A list of priorities may be accessed via the SPARC website once available [https://commonfund.nih.gov/sparc/index].

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 integrative online hub facilitating open science via three Core functionalities: Data Coordination, Map Synthesis, and Simulation. This corpus of information and collaboration tools will serve as a critical resource for the peripheral neuromodulation community both during and after the SPARC Program.

Current SPARC projects can be browsed, by organ system, at the SPARC website. All SPARC 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. A key aspect of the Consortium governance is described in the SPARC Material Sharing Policy, available here (https://commonfund.nih.gov/sparc/materialsharing). SPARC is actively managed, and the Consortium will continually be adjusted by adding or subtracting research projects to achieve the overall SPARC goal.

About the NIH Common Fund

SPARC (https://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 described below.  These projects will address gaps in the understanding of peripheral neuroanatomy and functional neurobiology of organs where innervation of the organ is under-studied (see Specific Objectives, below).

Specific objectives for foundational peripheral neuroanatomy and functional neurobiology in under-studied organs (u01) projects (this FOA)

This FOA solicits applications for support of research to gather critical data and answer critical questions on functional peripheral neuroanatomy and neurobiology of organs and reveal the organ function controlled by neural circuits.   Organs of interest include those where the peripheral neuroanatomy and functional neurobiology have been understudied, and which are not the subject of existing SPARC funding under RFA-RM-15-018.  Potential applicants are strongly advised to consult with the Scientific/Research Contact listed below to discuss the interests of the SPARC program under this announcement.  Organs that are the focus of current Comprehensive Functional Mapping of Neuroanatomy and Neurobiology of Organs projects under RFA-RM-15-018 and which are non-responsive under this announcement include:  heart, lungs and airways, intestine, and stomach (see https://commonfund.nih.gov/sparc/index for a listing of all projects funded to date by SPARC under specific announcements). Furthermore, examples of structures that would not be appropriate as the primary target for SPARC projects include the sensory structures of the head and the named voluntary muscles, except as allowed below. Organs that are of interest under this announcement include, but are not limited to:  bone, bone marrow, liver, esophagus, kidney, male and female reproductive organs, and spleen.

Data from research supported by the Anatomical and Functional Mapping of the Innervation of Major Organs component of the SPARC program will be used to develop comprehensive maps of the neural circuitry controlling function of major organs.  In many cases, comparatively little is understood of the neural control of organ function, either from the perspective of the circuits involved or the ability to assess the nerve involvement in control of organ function, or both.  In some organs, although innervation is present, the nature of the nerve fibers, the information transmitted, and the cells in the organ that are affecting or being affected by the nerves are unclear.  These limitations in the foundational knowledge may inhibit full development of targeted neuromodulation therapies.

The foundational peripheral neuroanatomy and functional neurobiology in under-studied organs projects to be supported under this FOA are intended to provide support to gather critical data and answer critical questions on peripheral functional neuroanatomy of understudied organs, and organ function controlled by those neural circuits. A project focused only on characterization of organ biology is not acceptable without a functional neuroanatomy component.  The research proposed must be justified in the context of what is known, and what is needed to increase understanding of neuroanatomy and neurobiology of organ function in organs of interest, as defined above.  The project must clearly address the need described. 

Consistent with achieving the goals of the program, data generated by these projects are expected to be made available to the SPARC data coordination center, and to the research community to assist the SPARC program and the community in developing next stage understanding of peripheral neurobiology and neuroanatomy of organ function in these under-studied organs.  Projects will closely coordinate with the data coordination center in order to integrate data.

Projects must focus on innervation of a single organ.  Depending on the knowledge gaps associated with innervation of the target organ, projects may consider both the afferent and efferent peripheral innervation of a single organ and its functionally, closely associated structures, as well as related organ function.  The exact scope and types of data proposed for each project will likely depend on the base of knowledge already available and the specific organ of focus.  However, data to be collected is expected to contribute to our ability to construct a visual map of the circuits innervating the organ including nerves and branches to the organ, as well as a dose-response understanding of the relationship between neural input and organ function.  Data of interest could include, for example:

-Detailed autonomic and sensory neuroanatomy including synapses, ganglia and interneurons

-Molecular identity of neurons

-Conduction properties of neurons

-Functional and anatomic characterization of intrinsic innervation at the organ

-Organization of fibers and fascicles within nerves

-Recordings of nerve activity

-Variability of parameters of innervation across individuals of the same species, and across species

Multiple areas of expertise will be needed for these projects.  Thus, projects should be developed to include investigators who have 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 the SPARC Consortium, and this consortium will be expected to develop common standards, formats, and means of communicating data between projects and to the data center.  Thus, each project must include expertise 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 directed at enabling 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 any of these circuits is considered to be potentially within the scope of the project.  The specific project should be justified in the context of the critical data it will supply to enable continued research leading to peripheral neuromodulation therapy. 

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, including any sex differences to be explored. Accordingly, the research plan must account for validation of results in humans to the maximum feasible extent. 

These projects are not intended for technology development except as a minor component to enable the particular study.  Such technology development, where justified, may be proposed for support as part of these projects but should not be a major 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 studies under this announcement.  In some cases data collection on disease states may be necessary to further understand innervation or effects of innervation on normal organ function.  Inclusion of such studies in a project will need to be justified in the application.


SPARC Program Management

The SPARC program consists of a consortium of research projects managed by a SPARC Program Manager as well as Program Officers and Project Scientists, and will incorporate significant programmatic input into projects.  The cooperative agreement projects under this FOA will participate in this consortium, which includes other Cooperative Agreement and Other Transaction awards.    Information on Other Transactions and the Material Sharing Policy for Other Transactions can be found on the SPARC web site at https://commonfund.nih.gov/sparc/index.

The funded projects in SPARC will be integrated across approaches to accelerate the research as a whole.   Projects within SPARC are expected to propose information sharing and include expertise for data exchange among research projects and with the data coordination center, consistent with achieving the goals of the program.  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. 

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to fund an estimate of 6-8 awards, corresponding to a total of $2.5 Million for fiscal year 2017. Future year amounts will depend on annual appropriations.

Award Budget

The maximum request per project is $250,000 in direct costs per year

Award Project Period

The project period may be up to 3 years 

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Required Registrations

Applicant Organizations

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

  • 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.

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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).
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Jill Carrington
Telephone: 301-402-0671
Fax: 301-480-8300
Email: SPARC_Biology@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. In addition the budget must include travel costs for the PD/PI to SPARC Consortium meetings twice per year in the Bethesda, Maryland region.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Provide the following information.

  • State the expected main 3-year outcomes of the project and how it will advance knowledge of peripheral neuroanatomy and neurobiology controlling organ function in an organ. As part of this reasoning, explain how the project will expand current knowledge and understanding of organ function and possible neuromodulation therapy targets.
  • Describe the animal models to be employed and their relevance to human data. As part of this reasoning, provide detailed plans to validate animal model data in humans, including any sex differences to be explored.
  • Provide the project milestones along with the aims and subaims that correspond to specific milestones and deliverables. Indicate these elements through numbering, lettering or notations.
  • Propose projected timelines for transmission of data to the SPARC data and resource center.

Describe the project milestones and provide an estimated timeline under which these will be achieved. Each milestone should include the quantitative criteria for success with go/no-go criteria that are aligned with achieving SPARC programmatic goals. It may be helpful to reference examples of milestones at https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/Neural-Prosthetics-Milestones and https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library//CounterACT-Milestone-Example. Milestones should be S.M.A.R.T.: specific, measurable, accurate, relevant, and timely.

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, should address a Data Sharing Plan.  This plan is expected to 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 are expected to 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 is expected to 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 are expected to 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 are expected to 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 is expected to 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:

 Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

Foreign Institutions

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

 
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Will the results of this study significantly advance knowledge of peripheral neuroanatomy and neurobiology controlling organ function in an organ?  Will the project establish a base of knowledge, and lead to data that will enable understanding of whether this organ presents an opportunity for development of neuromodulation therapy?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   Does the project include personnel who will serve as a liaison with the data coordination center for communication of data?  

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?  Does the study propose validation of animal model-derived data to the maximum feasible extent?

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

N/A

Renewals

N/A

Revisions

N/A

Additional Review Considerations

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.

Applications from Foreign Organizations

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.

Select Agent Research

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

Resource Sharing Plans

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).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

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

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

Awardees 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 may be reimbursed only to the extent considered allowable pre-award costs.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

 The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The SPARC network consists of both Cooperative Agreement and Other Transaction awards.  The awards to be made under this FOA will consist of 6-8 Cooperative Agreements.  These awards will have the opportunity to interact with each other, per the below, and to interact with other components of the SPARC network under the leadership of the Program Manager.

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

  • Awardee(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
  • The Program Director/Principal Investigator (PD/PI) 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 (FOA) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
  • Awardee(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
  • Awardees are responsible for their staff in maintaining confidentiality of the information as developed by the consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
  • 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 and the NIH, consistent with NIH policies and achieving the goals of the FOA.
  • Awardee(s) will be required to participate in a cooperative and interactive manner with members of the consortium including designated NIH staff (e.g., Program Officer(s), Project Scientist(s) and SPARC Program Manager).
  • Awardees are expected to share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with SPARC Consortium policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, awardees will be expected to 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 members.
  • Awardee(s) agree to establish agreements amongst themselves that address the following issues as needed: (1) procedures for data sharing among consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
  • 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 Cooperative Agreement, applicable NIH policies and procedures.
  • Awardees must agree to comply with the processes and goals as delineated within the FOA.
  • Upon completion or termination of the research project(s), the awardees are expected to make all study materials and procedures 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, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this at the end of the study.
  • Awardee(s) agree to the governance of the study through a Steering Committee:
  • The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
  • Each full member will have one vote.
  • The awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees.
  • Awardees must serve on SPARC subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the biannual meetings.

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

  • SPARC Program staff will designate NIH Program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.
  • An NIH IC Project Scientist(s) and SPARC Program Manager will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
  • The NIH Project Scientist(s) and SPARC Program Manager will coordinate and facilitate the research projects, and attend and participate in all meetings of the Consortium Steering Committee
  • The NIH Project Scientist(s) and SPARC Project Manager will be a member(s) of the Steering Committee and, as determined by that committee, its Subcommittees as needed. Only one NIH Project Scientist will vote on the Steering Committee. Other designated NIH program staff attending the steering committee meetings will be an ex officio (non-voting) member(s).
  • The NIH Project Scientist, SPARC Program Manager, and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
  • The NIH Project Scientist(s) and Program Official, as well as the SPARC Program Manager will review the scientific progress, cooperation in carrying out research, and maintenance of high quality research in each of the individual research project(s), and review the project(s) for compliance with operating policies developed by the Consortium (Steering Committee), and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the Consortium (Steering Committee). Review of progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.
  • The SPARC Program team reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.
  • The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and the Steering Committee in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, regardless of the number of NIH personnel involved.
  •  The Project Scientist(s) and SPARC Program Manager will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist(s) will have the same access and privileges to any data generated by the grantee. The dominant role and primary responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist(s).
  • The NIH Project Scientist(s) serve 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 NIH Project Scientist(s) and SPARC Program Manager, or designee, may coordinate activities among awardees by assisting in the design, development, and coordination of (a) common research protocol(s) and statistical evaluations of data and in the publication of results.
  • The NIH Project Scientist(s) and SPARC Program Manager may review procedures for assessing data quality and monitor study performance.
  • The NIH Project Scientist(s) may be (a) co-author(s) on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.  The SPARC Program Manager may not co-author publications.

Areas of Joint Responsibility include:

  • Steering Committee (SC)
  • The Steering Committee (SC) composed of each of the PD/PI(s) for each SPARC Cooperative Agreement and Other Transaction award, or Contact PD/PI(s) in the case of multi-PD/PI grants, of the study (including research projects and Coordinating Center), the NIH Program Officer(s), Project Scientist(s), SPARC Program Manager and one other member of the Project Team. The Steering Committee will be the main governing board of the study (Consortium). It is expected that most of the decisions on the activities of the SPARC Steering Committee will be reached by consensus. Each full Steering Committee member will have one vote, and the Project Scientist(s) will each have a vote. The number of NIH votes will not exceed one-third of the total votes, since the expectation is that one or more Project Scientists will serve that role on more than one award. The Program Officer(s) and the other member of the Project Team will be non-voting participants.
  • All major scientific and policy decisions will be determined by voting and policies as established by the Steering Committee at the initial meeting. When a vote is required, at least 60% of the votes will be required for approval. This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project.
  • SPARC Program staff, in concert with the SC, will have the option to redirect research activities within the U01 grant(s) if it is considered beneficial to the overall program.
  • The Steering Committee may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the Steering Committee when necessary.
  • There will be (an initial) meeting and two Steering Committee meetings annually, held in conjunction with the two investigator meetings.
  • Each research project awardee agrees to the governance of the U01 through the SC.
  • The NIH Program Officer(s), Project Scientist(s) and SPARC Program Manger may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.

Dispute Resolution:

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

3. Reporting

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 Grants Policy Statement.

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 Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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: support@grants.gov

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

Scientific/Research Contact(s)

David Saslowsky, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-8179
Email: SPARC_Biology@mail.nih.gov

Patricia Greenwel, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-8179
Email: SPARC_Biology@mail.nih.gov

Peer Review Contact(s)

Robert Elliott, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-3009
Email: elliotro@csr.nih.gov

Financial/Grants Management Contact(s)

Sharon Bourque
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8846
Email: bourques@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


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