Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Complementary and Integrative Health (NCCIH)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Center for Advancing Translational Sciences (NCATS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

This Funding Opportunity Announcement (FOA) is developed as a NIH Blueprint for Neuroscience Research initiative (https://neuroscienceblueprint.nih.gov/)

Funding Opportunity Title
NIH Blueprint for Neuroscience Research: Functional Neural Circuits of Interoception (R01, Clinical Trial Not Allowed)
Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-AT-21-003
Companion Funding Opportunity
None
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.213; 93.350; 93.867; 93.866; 93.273; 93.286; 93.865; 93.279; 93.121; 93.113; 93.242; 93.361; 93.853

Funding Opportunity Purpose

The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

The goal of this FOA is to enhance our fundamental understanding of interoception with a specific focus on dissecting and determining the function of neural circuits that connects peripheral organs/tissues with the central nervous system (CNS) via peripheral ganglia. For this FOA, interoception science includes studies of the processes by which an organism senses, interprets, integrates, and regulates signals originating from within itself. This FOA encourages projects that combine diverse expertise and use innovative approaches to delineate interoceptive mechanisms at the molecular, cellular, circuitry, functional, and/or behavioral levels. Outcomes of this research will lay a critical foundation for future translational and clinical research on interoception as well as its roles in nervous system disorders. Studies of interoceptive neural circuits exclusively within the CNS may be more appropriate for The BRAIN Initiative funding opportunities. Applications in response to this FOA should budget for an annual investigator meeting organized by the NIH Blueprint for Neuroscience Research. Human subject research is not allowed for this FOA.

Key Dates

Posted Date
September 02, 2020
Open Date (Earliest Submission Date)
November 18, 2020
Letter of Intent Due Date(s)

November 18, 2020

Application Due Date(s)

December 18, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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)

December 18, 2020

 

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Scientific Merit Review

March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
December 19, 2020
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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 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. You must use one of these submission options to access the application forms for this opportunity.

  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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

The goal of this FOA is to enhance our fundamental understanding of interoception with a specific focus on dissecting and determining the function of neural circuits that connect peripheral organs/tissues with the central nervous system (CNS) via peripheral ganglia. . For this FOA, interoception science includes studies of the processes by which an organism senses, interprets, integrates, and regulates signals originating from within itself. The FOA encourages projects that combine diverse expertise and use innovative approaches to delineate interoceptive mechanisms at the molecular, cellular, circuitry, functional, and/or behavioral levels. Outcomes of this research will lay a critical foundation for future translational and clinical research on interoception as well as its roles in nervous system disorders. Studies of interoceptive neural circuits exclusively within the CNS may be more appropriate for The BRAIN Initiative funding opportunities. Applications in response to this FOA should budget for an annual investigator meeting organized by the NIH Blueprint for Neuroscience Research. Human subject research is not allowed under this FOA.

Background

Neuroscience has gained a tremendous understanding of how we sense and interact with our external world through research into the primary exteroceptive sensory systems of vision, audition, olfaction, taste, and somatosensation. We know less about the interoceptive system - the nervous system’s ability to sense and regulate our own internal milieu. On April 16-17, 2019, the National Institutes of Health, Blueprint for Neuroscience Research convened a 2-day workshop on “The Science of Interoception and Its Roles in Nervous System Disorders.” At the workshop, a distinguished group of investigators highlighted recent findings and discussed a wide range of topics critical to the future of interoception research. This workshop addressed some of the key issues in interoception research, including the definition of interoception, the scope of interoception science, interoceptive signaling via specialized “interoceptors,” specialized ascending and descending neuroanatomical pathways, normative functions and disease implications, and potential interventions, as well as the integration of internal and external representations of the world from an experimental and computational modeling perspective.

The workshop also identified many critical knowledge gaps and challenges not currently tackled by major NIH research initiatives such as the BRAIN Initiative and the NIH Common Fund Stimulating Peripheral Activity to Relieve Conditions (SPARC) Initiative or by individual NIH neuroscience institutes and centers via their regular programmatic activities. These critical areas include: 1) characterization of functional circuits and interaction dynamics between central and peripheral nervous systems in physiological conditions; 2) delineation of the interaction between interoceptive networks involved in basic physiological processes (e.g. respiration, thirst, feeding, urination, metabolism, etc.) and other sensory, motor, reward, emotional, cognitive/memory, and social circuits to regulate brain diseases and disorders; 3) determining the impact of central or peripheral disorders on interoceptive networks and the effects of modulating interoceptive processes on associated diseases and disorders; and 4) the need for objective and quantitative assessments of interoception as well as effective technologies and approaches to measure and modulate interoceptive processes. As part of a coordinated effort to address the critical knowledge gaps in interoception research, this FOA intends to support interoception science research focused on functional neural circuit analysis of interoceptive processes in animal models, although ex vivo studies may be included to enhance the mechanistic understanding. Research supported under this FOA will provide the critical neural basis for future translational and clinical studies of interoception.

Terminology for Interoception Research

For the purposes of this FOA:

Interoceptive signals are signals that originate within an organism and include at least three major types: 1) biochemical signals ranging from inorganics, such as acidic ions, to organic molecules and small peptides; 2) mechanical forces altering structures, such as cellular shape, through stretch or tissue extension; and 3) thermal and electromagnetic signals, which may be delivered in various forms across the electromagnetic spectrum.

Interoception science includes the study of the processes by which an organism senses, interprets, integrates, and regulates interoceptive signals. Here, the action of “sensing” denotes communication from other physiological systems to the CNS through the ascending pathways; the action of “regulating” refers to the communication from the brain to other physiological systems via the descending pathways. The CNS, especially the brain, is primarily responsible for interpreting and integrating these signals into a representation of the internal state.

Interoceptors are molecular sensors or receptors in neurons that directly detect these various interoceptive signals, and transduce them into electrical, hormonal, or other non-neural signals to be integrated and interpreted by the brain. Interoceptors include chemoreceptors, humoral receptors, specialized mechanoreceptors, and free nerve endings or nociceptors. The location of the interoceptors may determine whether the interoceptive signals are transmitted through the peripheral nervous system or the non-neural humoral pathway.

Central interpreters and integrators of interoception include neurons in the CNS (spinal cord and brain) involved in processing, interpreting, and/or integrating interoceptive signals. They may include substructures throughout the brain, including within brainstem, hypothalamus, thalamus, and insula and other cortical regions.

Central regulators of interoception include neurons in the CNS (spinal cord and brain) involved in generating signals to regulate interoceptive processes.

Regulating signals refer to signals generated by the CNS to regulate interoceptive processes. The regulating signal can be transmitted via non-neural (e.g. humoral) pathways or descending neural pathways (cranial/vagal or spinal efferents) to effector organs/tissues to modulate their function or their interoceptive signaling. Most regulating signals may be in biochemical or electrical forms.

Peripheral interoceptive neural pathways include both ascending and descending neural connections between the peripheral organs/tissues and the CNS. The ascending connections primarily transmit interoceptive signals from the periphery to the brain via two major types of peripheral sensory ganglia. One type resides in the cranial/vagal pathways, such as nodose or jugular ganglia, and often projects to nucleus tractus solitarii (NTS) of the brainstem. The other type consists of dorsal root ganglia that project into the brain through the spinal cord. The descending connections primarily transmit regulating signals from the brain to the peripheral organs/tissues via cranial/vagal or spinal efferents. In the descending neural pathways, the final effecting neurons or effectors are also commonly called sympathetic or parasympathetic ganglion neurons and directly synapse with the peripheral organ/tissue non-neural cells.

Research Objectives and Scope

This FOA will focus on delineating interoceptive neural circuits via peripheral ganglia in appropriate model organisms. Ex vivo studies may be included to complement the in vivo analysis. While human subject research is not allowed under this FOA, studies in mammalian model organisms building on observations from relevant human research to provide novel mechanistic insights or critical neural basis for future clinical studies are considered high priorities. Applicants are encouraged to incorporate state-of-the-art molecular, cellular, genetic, imaging, physiological, and behavioral technologies and approaches. Research employing neuroanatomical tract tracing with cell type specificity in combination with physiological and/or behavioral analyses that may include gain- and/or loss-of-function experiments to analyze the vagal/cranial or spinal interoceptive pathways via the peripheral ganglia is strongly encouraged. Applications aiming to study the pathophysiology of specific disease mechanisms or specific disease therapeutics and treatments will be considered nonresponsive to this FOA. Disease models may only be used to help contrast relevant normal versus abnormal interoceptive processes. Similarly, therapeutic approaches should only be used to manipulate specific interoceptive processes..

The proposed studies should include analysis of both brain and at least one specific peripheral organ/tissue. Peripheral organs included within the purview of this FOA include internal organs in cardiovascular/circulatory, respiratory, endocrine, renal, urinary/excretory, reproductive, digestive, and skeletal systems, oral and craniofacial complex, as well as connective tissues associated with the internal organs. Studies of the auricular vagal pathway in the context of its connections with other interoceptive pathways may also be appropriate. Although the lymphatic and immune systems play important roles in interoception, studies focusing exclusively on the connections between these two systems and the brain are considered to be outside the scope of this FOA. Studies including muscular systems involved in voluntary motor action/movement are not responsive to this FOA.

This initiative seeks applications in areas including, but not limited to:

  • Functional neural circuit analysis using neural anatomical tracing in combination with physiological and/or behavioral analysis of the proposed neural circuits through gain- and/or loss-of-function experiments in appropriate model organisms
  • Cell-type characterization of the peripheral ganglia involved in ascending and/or descending peripheral interoception neural pathways
  • Identification of the role of specific ganglia in interoceptive signaling as well as interoceptors in the peripheral ganglia
  • Anatomical mapping of neural circuits and peripheral ganglia involved in interoception, spanning between the peripheral organs/tissues and the brain
  • Delineation of sex differences in interoceptive neural circuits at the molecular, cellular, functional and behavioral levels
  • Study of the interactions between the lymphatic/immune systems and other interoceptive systems via spinal or vagal neural networks
  • Cross-species studies elucidating variations in interoception at the molecular, cellular, circuitry, functional and behavioral levels
  • Delineation of the auricular vagal pathway and its connection with other vagal or spinal pathways

Applicants interested in studies of interoceptive neural circuits exclusively within the CNS or brain circuits involved in processing interceptive signals delivered to the brain through non-neural pathways or humoral systems may consider seeking for BRAIN INITIATIVE funding opportunities

Special Requirements

Anatomical and functional data are expected to be deposited into an appropriate database. Annual travels to NIH or an NIH-designated location for investigator meetings organized by the NIH Blueprint for Neuroscience Research are expected and should be budgeted appropriately.

Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goal of this FOA.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH Blueprint for Neuroscience Research Institutes intend to commit approximately $3.6 million in total costs for FY 2021 to fund 6 - 8 awards.

Award Budget

Application budgets need to reflect the actual needs of the proposed project. The budgets are limited to $375,000 direct costs annually.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)

Local 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)

Federal Governments

  • 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 not 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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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 instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.

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:

Martina Schmidt, PhD
Telephone: 301-594-3456
Email: schmidma@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.

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:

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and its plan to deposit the data in an appropriate database.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

PHS Assignment Request Form

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

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NCCIH Referral Office by email at SchmidMa@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

This FOA aims to support applications that use innovative approaches and combine diverse expertise to delineate functional neural circuits involved in interoception. Thus, in their assessment reviewers will evaluate the innovation of the proposed work, which may utilize cutting-edge techniques and methods to significantly advance our understanding of the functional circuits of interoception. In addition, the reviewers will evaluate how the circuit components that are proposed to be studied will enhance our fundamental understanding of interoception and whether the data will be collected in a manner conducive to proposed database deposition.

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 the prior research that serves as the key support for the proposed project rigorous? 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?

For this particular announcement, note the following:

Does the circuit components proposed to be studied enhance our fundamental understanding of interoception? Will interoceptive mechanisms at the molecular, cellular, circuitry, functional, and/or behavioral levels be delineated that will lay a critical foundation for future translational and clinical research on interoception as well as its roles in nervous system disorders?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

For this particular announcement, note the following:

Does the project include the diverse expertise needed to allow for the use of innovative approaches to delineate interoceptive mechanisms at a variety of different levels?

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?

For this particular announcement, note the following:

Are state-of-the-art molecular, cellular, genetic, imaging, physiological, or behavioral technologies and approaches proposed to gain novel mechanistic insights or novel details regarding critical neural bases of interocepton?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?

For this particular announcement, note the following:

Will observations from previous relevant human studies build a basis for the proposed studies that would provide novel mechanistic insights or critical neural basis for future clinical studies? How will anatomical and functional data generated be deposited into an appropriate database?

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

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Please bring any concerns to the attention of the Scientific Review Officer.

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

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 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 NCCIH, 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 will receive a written critique.

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.

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. 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

Not Applicable

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 RPPR, 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 funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Primary Contact for FOA:

Wen G. Chen, M.MSc., Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-451-3989
Email: wen.chen2@nih.gov

IC Specific Contacts:

Cheri Wiggs, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Cheri.Wiggs@nih.gov

Coryse St. Hillaire-Clarke, Ph.D.
Phone: 301-496-9350
Email: coryse.sthillaire-clarke@nih.gov

Changhai Cui, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-1678
Email:Changhai.cui@nih.gov

Guoying Liu, Ph.D.
National Institute of Biomedical Imaging & Bioengineering (NIBIB)
Telephone: 301-594-5220
Email: liug@mail.nih.gov

Joe Bonner, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-8303
Email: joe.bonner@nih.gov

Yolanda F. Vallejo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: (301) 827-4655
Email: yolanda.vallejo@nih.gov

Steve Grant, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 443 8869
Email:sgrant@nida.nih.gov

Johnathan Hollander, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:984-287-3269
Email: jonathan.hollander@nih.gov

Siavash Vaziri, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-594-2924
Email: siavash.vaziri@nih.gov

James Gnadt, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email:BRAINCircuits@nih.gov

Dana M. Schloesser, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-3975
Email: dana.schloesser@nih.gov

Peer Review Contact(s)

Martina Schmidt, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov

Financial/Grants Management Contact(s)

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@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.


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