Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This FOA is a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by a trans-NIH team led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) on behalf of the NIH Common Fund Program on Stimulating Peripheral Activity to Relieve Conditions (SPARC) http://commonfund.nih.gov/sparc/index.

Funding Opportunity Title

Exploratory Technologies to Understand the Control of Organ Function by the Peripheral Nervous System for SPARC (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-RM-15-002

Companion Funding Opportunity

None

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

93.310

Funding Opportunity Purpose

This NIH Funding Opportunity Announcement (FOA), supported by funds from the NIH Common Fund (Common Fund) and managed by the Office of the Director and participating NIH Institute(s) and Center(s) of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program, solicits U18 Research Demonstration Cooperative Agreement applications to develop new and/or enhance existing tools and technologies tailored to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease, which will ultimately inform next generation neuromodulation therapies. These awards will establish feasibility for further technology development in any future SPARC initiatives.  Additionally, the technologies developed through these awards are expected to lay the groundwork for more systematic facilitation of biological mapping activities in any future SPARC initiatives.  

Key Dates
Posted Date

January 26, 2015

Open Date (Earliest Submission Date)

March 14, 2015

Letter of Intent Due Date(s)

March 14, 2015

Application Due Date(s)

April 14, 2015, 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-July 2015

Advisory Council Review

August 2015

Earliest Start Date

September 2015

Expiration Date

April 15, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The specific goal of this FOA is to promote exploratory studies to develop new and/or enhance existing tools and technologies tailored to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease, which will ultimately inform next generation neuromodulation therapies. These awards will establish feasibility for further technology development in any future SPARC initiatives.  Additionally, the technologies developed through these awards are expected to lay the groundwork for more systematic facilitation of biological mapping activities in any future SPARC initiatives.

Background

This announcement is part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program (http://commonfund.nih.gov/sparc/index) supported by the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The overall goal of the SPARC program is to provide the scientific foundation necessary to pilot new and/or improved closed-loop neuromodulation devices and stimulation protocols to treat diseases and conditions through precise neural control of end-organ system function. This FOA is focused more narrowly on developing the tools and technologies needed to establish a quantitative scientific foundation for this overall program. Subsequent announcements will likely address technology development for functional stimulation and feasibility studies.  

Significant advances in neuromodulation therapies to treat disease have led to industry-supported large, randomized and blinded, controlled trials. While the degree of efficacy of the neuromodulation devices varies depending on the trial and condition under investigation, the data and approach show great promise for scientific and therapeutic development. The detailed underlying physiology and mechanisms of action of these neuromodulation therapies, however, are poorly understood in many cases. This poor understanding, in turn, limits improvement in neuromodulation therapy designs.  Examples of areas where our understanding is incomplete include: the specific and diverse neural signals carried by nerve fibers at different end organs;  the functional relationship between neural signals and end-organ responses; evidence for altered peripheral nerve function in some conditions in which neuromodulators are utilized; the functional relationship between neural stimulation and unwanted side effects; and variability in expression/anatomical representation of the neural cell-types at each potential point of implantation along the axis; the optimal points of surgical intervention relative to the end-organ; and the variance in these functional mechanisms from subject to subject as they pertain to effects and side effects.  The technologies solicited through this FOA are intended to address these gaps.

Through the SPARC program, the NIH plans to support multidisciplinary teams of investigators to deliver foundational understanding of the physiological mechanisms of neural circuit maps of several organ systems, novel electrode designs, minimally invasive surgical procedures, and stimulation protocols. Driven by end goals of improving existing and developing new neuromodulation therapies to relieve conditions, the program will be iterative and dynamic, with the technologies informing mapping efforts, and the mapping results defining new technology requirements.  This first SPARC FOA focuses on developing technologies that can be used to study function. The later initiatives will likely focus on use of these technologies and others to understand function, and the development of improved technologies for functional neuromodulation.  Projects in response to this FOA must be justified within the context of these goals of the SPARC program, overall.

Scope of this Funding Opportunity

This FOA is the first step in the SPARC program, supporting exploratory studies to develop technologies tailored for understanding the neurophysiology underlying precise neural control of end-organ system function, which will ultimately inform future neuromodulation therapies. 

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

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

Under the U18 mechanism, NIH will have substantial programmatic involvement that is above and beyond the normal stewardship role for planning, directing, and executing the proposed projects.  Preliminary data are not expected nor needed for the U18 application.  It is expected, however, that, theoretical constructs will be provided justifying the logic of the proposed technology development.

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

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

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

Responsiveness Criteria:

  • Applications primarily proposing SPARC data collection, curation, integration and broad sharing of neuroanatomy data and neuromodulation tools will not be considered responsive to this FOA.
  • Projects developing new technologies, or modifying existing technologies without a targeted use case to study a mechanism of neural control of end organ function (i.e. general purpose platforms) will not be considered responsive to this FOA.

Applications deemed to be non-responsive will not proceed to review.  

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.

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 5 to 7 awards, corresponding to a total of $2.1M for fiscal year 2015, and $2.1M for fiscal year 2016.

Award Budget

Direct costs are limited to $200,000 per year.

Award Project Period

The project period may not exceed 2 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:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

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:

Grace C.Y. Peng, Ph.D.
Telephone: 301-451-4778
Fax: 301-480-1614
Email: grace.peng@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.

The PD/PI and up to one other key personnel with complementary expertise are required to attend four workshops organized by the NIH during the award period. There will be an initial kick-off meeting and subsequent meetings at 6 month intervals in the Washington DC Metro region.  Funds to attend these workshops should be budgeted in the application.

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

  • Applicants must describe how the proposed technology will be tailored to investigate the mechanisms of neural control of end organ function, and how the technology will be appropriately designed to achieve these specific goals.
  • Applicants interested in developing technologies specific to animal models must justify the model as one that will potentially have broad use for the SPARC program overall, within the next four years.
  • Applicants are required to define the specific technology challenge(s) that is being addressed in this exploratory project, the final end product of the proposed technology design, and how it is envisioned that the outcomes will integrate with the SPARC program - that is to inform the mechanism of neural control of end organs which will drive the design of next generation neuromodulation therapy. 
  • Applicants must provide a timeline and milestones that describe the work that will be completed during the project period. Each milestone should include the criteria for success and the rationale.

The application should describe consultation with diverse expertise.

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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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? 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?

To what degree would the proposed technology be catalytic for understanding how cellular and tissue-based responses to peripheral neural stimulation and inhibition may contribute to end-organ function? 

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?

To what degree have the investigators consulted with diverse experts to develop this exploratory project? 

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?

If the application is building on previous technology, how are the investigators using innovative methods to target the technology to elucidate specific physiological and biological mechanisms of neural control of end organ function? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? 

To what degree does the application provide a strong theoretical justification that the proposed exploratory technology will be appropriately designed for the targeted neurophysiological studies?  Does the project provide a convincing technical plan to achieve the desired outcome in two years?  Are the proposed milestones and timeline feasible for the proposed work?

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 appropriate national Advisory Council or Board. 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

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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 PD(s)/PI(s) will have the primary responsibility for:

  • Determining experimental approaches, designing protocols, setting project milestones and conducting experiments;
  • Submitting quarterly progress reports during the two year funding period, in a format as agreed upon by the NIH SPARC Steering Committee, described below under Areas of Joint Responsibility;
  • Participate as a voting member of the Steering Committee and join relevant subcommittees;
  • Ensure that the data produced meets the quality standards and costs agreed upon at the time of award, or any improved quality standards and costs negotiated during the award period;
  • Adhering to the NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program policies regarding intellectual property, data release and other policies that might be established during the course of this activity;
  • Accepting and implementing any other common guidelines and procedures developed for the SPARC Program and approved by the NIH SPARC Steering Committee;
  • Accepting and participating in the cooperative nature of the coordinated NIH SPARC Program;
  • Attending four workshops organized by the NIH during the award period. There will be an initial kick-off meeting and subsequent meetings at 6 month intervals in the Washington DC Metro region.  The PI and up to one other key personnel with complementary expertise are required to attend these meetings.  Funds to attend these workshops should be budgeted in the application. 

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

  • A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance.
  • An NIH Project Team composed of NIH Program Staff of the ensuing awards as well as other Program staff of the SPARC ICs, will be created to ensure communication and continuity among the interested NIH ICs related to coordination among SPARC awards and with other grant or contract activities by NIH.
  • The Project Team will include and be led by the Program Officer(s) assigned to these SPARC awards.
  • One extramural NIH program staff member will be assigned as the Project Scientist for an award. The same person may serve as the Project Scientist for multiple SPARC awards, or others may serve as Project Scientist
  • The Project Scientist will also be a member of the Project Team.
  • The Project Scientist for an award will interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research.
  • The Program Officer(s), the Project Scientist(s), and one member of the Project Team will be members of the SPARC Steering Committee, as described below under Areas of Joint Responsibility.
  • The Project Scientist interacts scientifically with the SPARC Steering Committee, described below under Areas of Joint Responsibility, and may assist in research planning, may present experimental findings to the Steering group from published sources or from relevant contract projects, may participate in the design of experiments agreed to by the Steering group, may participate in the analysis of results, and may help ensure that duplication is avoided.
  • In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Areas of Joint Responsibility include:

  • A SPARC Steering Committee is formed whose purpose is to transfer information between SPARC awardees in order to achieve the goals outlined in the overall SPARC program.
  • The SPARC Steering Committee is composed of PD/PIs, Project Scientist(s), the Program Officer(s) and one other member of the Project Team.
  • 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 awardee 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. When a vote is required, at least 60% of the votes will be required for approval. The Program Officer and the other member of the Project Team will be non-voting participants.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Grace C.Y. Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: grace.peng@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)

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8521
Email: kellis@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 Parts 74 and 92.

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