Participating Organization(s)
National Institutes of Health (NIH)

National Endowment for the Arts (NEA)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

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 on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

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)

Funding Opportunity Title
Promoting Research on Music and Health: Fundamentals and Applications (R01 Clinical Trials Optional)
Activity Code
R01 Research Project Grant
Announcement Type
New
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-NS-19-008
Companion Funding Opportunity

RFA-NS-19-009, R21 Exploratory/Developmental Research Grant

RFA-AT-19-001, R61/ R33 Exploratory/Developmental Phased Award

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.213; 93.853; 93.867; 92.866; 93.273; 93.173; 93.121; 93.242; 93.361
Funding Opportunity Purpose

This broad spectrum FOA is intended to: (1) increase our understanding of how music affects the brain, body, and behavior and (2) use that knowledge to develop evidence-based music interventions to enhance health or treat specific diseases and disorders.  Proposed R01 projects can investigate how music is processed by or modifies the brain, or how it affects specific biological functions during childhood development and learning, adulthood, and aging.  Projects can also include preliminary interventions that provide a basis for therapeutic interventions. When appropriate, collaborations among basic researchers, technology developers, music intervention experts, or other clinical researchers are highly encouraged.

Posted Date
October 30, 2018
Open Date (Earliest Submission Date)
January 28, 2019
Letter of Intent Due Date(s)
January 15, 2019
Application Due Date(s)
February 28, 2019

No late applications will be accepted for this Funding Opportunity Announcement.

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
May 2019
Advisory Council Review
August 2019
Earliest Start Date
September 2019
Expiration Date
March 01, 2019
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

Background

Music has the remarkable ability to enhance child development, improve adult function and well-being, and optimize the quality of life during aging.  Many studies have shown that music can also ameliorate the symptoms of a broad range of diseases and disorders that occur throughout the lifespan and be utilized effectively in delivering palliative care during serious advanced illness and at the end of life. Recent scientific breakthroughs, including the development of new technologies, are providing the community with opportunities to understand the mechanisms through which music acts, and to develop new music interventions for a variety of human conditions.  To capitalize on these opportunities, the NIH is issuing three related funding initiatives intended to: i) promote our understanding of the basic mechanisms through which music is processed by the brain and body; ii) explore how music can impact health and disease, and iii) facilitate rigorous music intervention studies to help treat disease.

 

In 2016, the NIH, John F. Kennedy Center for the Performing Arts (KC), and National Endowment for the Arts (NEA) formed a collaborative partnership ( Sound Health) and in early 2017 organized a workshop to evaluate the state of basic and applied music research ( Music and the Brain). In this meeting, a diverse panel of experts discussed three overlapping periods of life (childhood, adulthood and aging) and made recommendations for enhancing research in each of these domains ( NIH report). The group developed a set of recommendations intended to highlight research opportunities and promote the rigor of future research. These recommendations centered around four broad areas: 1) Basic and Mechanistic Research, 2) Translational and Clinical Research, 3) Methods and Outcomes and 4) Capacity Building and Infrastructure.

 

In 2017, a trans-NIH Music and Health working group was formed to capitalize on these recommendations and promote their implementation. To achieve this, the NIH is issuing three related announcements. The first two FOAs are related and will support R01 and R21 awards respectively that are within the interests of the participating NIH components (see below) and that address the recommendations of the 2017 workshop.  This R21 FOA emphasizes exploratory projects which may have a unique potential for moving an important aspect of the science of music and health. The companion FOA utilizes the R01 mechanism and is intended to support studies with a sound premise and potentially strong impact on the science of music and health. Projects for either the R01 or R21 FOAs could potentially range from basic foundational studies to clinical trials that provide a basis for better therapeutic interventions. The third FOA will utilize a phased R61/R33 mechanism to support research that can best be facilitated through milestone-driven awards on music and health geared towards music intervention. While no preliminary data is needed for the R61 phase, transition to the R33 phase is contingent on successful completion of agreed upon Go/No-Go milestones.

 

Potential applicants for any of the three FOAs are strongly encouraged to reach out to the chief contact listed near the end of announcement to discuss any questions about the most suitable FOA, as well as questions about scope and clinical trials. For questions about the specific interests of a participating institute, center or office, applicants should contact the appropriate contact listed at the end of the appropriate document.

Investigators are expected to participate in an annual meeting held at the National Institutes of Health to review progress of the funded research and highlight advances on the science of music and health and should therefore budget accordingly.

 

Scope of Research

This R01 FOA proposes to build upon the rapidly expanding evidence base linking music and health and to address the broad research recommendations that emerged from the NIH workshop referenced above. Both basic and applied studies are within the scope of this RFA. Applications that propose multidisciplinary research and collaborative studies involving musicians, music therapists, biomedical, behavioral, and/or social scientists are encouraged. 

All proposed projects should have the potential to increase our understanding of the science of music and health, and inform music interventions to enhance normal function and improve health.

All projects should be rigorously designed, reproducible and within the mission of the participating institutes, centers and offices. Projects that are responsive to this FOA include but are not limited to categories and bullets below from the NIH workshop that produced research recommendations for the field.

Basic and Mechanistic studies

  • Defining which neural circuits are involved in the interaction between music and the brain or body
  • Investigating which physiological pathways are enhanced by both active and passive musical training
  • Examine commonalities between music and language processing

Translational and Clinical studies

  • Integrating mechanistic understanding with music therapy approaches
  • Developing and validating biomarkers for music interventions
  • Better defining the issue of “dosing” in music interventions
  • Developing methods to better understand and predict individual differences in response to music interventions

Methods and Outcomes

  • Developing methods that integrate brain- and other relevant organ system-based measurements with musical activities
  • Conducting longitudinal and ancillary studies to assess outcomes of music interventions.
  • Establishing standardized and/or personalized outcome measures
  • Establishing evidence-based best practices for music interventions intended to enhance wellness or treat/ameliorate specific health conditions

Critical Notes for Applicants Proposing Clinical Trials or Work with Human Subjects

Potential applicants are strongly encouraged to interact with the scientific contacts listed below to discuss possible clinical trials and other clinical studies. Applicants are also encouraged to see the current NIH Definition of a Clinical Trial, the sub-definition of an “intervention,” and the numerous case studies provided. For example, administering a stimulus (such as music) for the purposes of measuring or describing brain activity but NOT to modify it, is not considered an intervention under the NIH definition, and would thus not be a clinical trial (see case study 18b as an example). The NIH sub-definition of an intervention states that an intervention is a manipulation of a subject or their environment with the intent to modify a health-related outcome.

 

Health-related outcome is defined very broadly and ranges from changes in protein levels to changes in behavioral outcomes for example, and essentially covers most of the NIH’s research portfolio. The type of health-related outcomes that will be assessed determines what type of clinical trial the application would be considered, and this is critical to know and understand prior to submission, as not all participating institutes and centers support all types of trials under this FOA. There are two main types of clinical trials relevant to this FOA: Mechanistic clinical trials and Clinical Outcome Clinical Trials. 

 

Mechanistic clinical trials are studies with primary outcomes designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Clinical outcome clinical trials are studies with primary outcomes designed to assess the safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, surgical, or device interventions.

 

It is imperative for an applicant to determine whether they are proposing a clinical trial, and if so, which of the above categories it falls within. The scientific contacts listed can help with this determination, and ascertain whether the application would fit within the requirements listed by the relevant participating institutes, centers, and offices below.

 

IC and NIH Office Interest Areas and Specific Requirements:

Understanding the basic science of music and exploring its potential to enhance health and treat disease is relevant to the mission of the NIH Institutes participating in this FOA. Below is a list of areas that are of particular interest to participating ICs:

 

NINDS: The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting basic and applied research that is within its mission and focused on understanding the effects of music on the brain.  This includes investigating the effects of music on neural circuits and pathways, sensorimotor processing, proprioception, motor function, and skill learning.  Approaches involving either music listening or music production, in the contexts of music experience, training, or practice are welcome. NINDS is also interested in studies that inform the understanding, management, and/or treatment of neurological diseases and disorders, and/or accompanying symptoms.  This includes studies to facilitate recovery processes (e.g. after injury or stroke) or maintain function (e.g. slow cognitive decline). Music interventions may be studied alone, in conjunction with, or in comparison to other interventions.

 

NCCIH: The National Center for Complementary and Integrative Health (NCCIH) is broadly interested in supporting research aimed at understanding the mechanisms by which music and music interventions impact symptom management in high-priority topics such as pain, stress-related disorders, sleep disorders.  NICCH is also interested in how music and music intervention could be used to address opioid misuse and enhancement of emotional well-being. In addition to basic animal model work, NCCIH supports mechanistic clinical trials under this FOA.  However, NCCIH will not support grant applications proposing efficacy or effectiveness research with primary clinical outcomes under this FOA.  Investigators who are ready to propose a fully powered efficacy or effectiveness clinical trials can apply to PAR-18-662 with a companion application to PAR-18-663 for an independent data coordinating center. Investigators are strongly encouraged to contact program staff to discuss their aims prior to submission.

 

NEI: The National Eye Institute (NEI) supports research that addresses blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind. Under this FOA, NEI will accept applications that propose to examine how music affects the fundamental mechanisms of visual function or loss of vision, which may inform development of music-based interventions for the visually impaired.  Topics of interest include, but are not restricted to, the role of music in neural reorganization and plasticity in the visually impaired; the impact of music on sensory substitution, navigation/mobility, and functional strategies in the visually impaired; and music integration in low vision rehabilitation.
 

NIAAA:
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in supporting research within the mission of NIAAA. Example research areas of interest to NIAAA include 1) How does music modulate negative emotion states associated with alcohol dependence and withdrawal? What are the biological and neurological underpinnings of the modulation? 2) How does alcohol exposure across the life span, during early development, adolescent stage, adult, and aging, impact music processing? 3) Can music facilitate cognitive recovery following heavy chronic alcohol use, and what are the underlying neurocircuit mechanisms? 4) How does music impact recovery from alcohol use disorders? Which types of music might promote sustained abstinence?

NIA:
The National Institute on Aging (NIA) is interested in research to increase our basic understanding of how music affects the brain, body and behavior with aging. Of specific interest is research to investigate the neural pathways and circuits involved in music processing and how these may be altered in aging, the mechanisms by which the experience of music may affect brain structure and function in aging and the potential for music to induce neural and behavioral plasticity in aging and the underlying mechanisms. NIA is also interested in behavioral intervention development,  in accordance with the  NIH Stage Model (please see https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development) that capitalizes on and integrates basic research on music to inform the development of efficacious interventions for individuals as they age.   The purpose of the interventions to be developed may be, for example, to promote health and well-being, promote behaviors associated with health and well-being (e.g., exercise), cope with stress (e.g., dementia caregivers), improve the emotional/behavioral status of care providers of individuals with dementia, help individuals deal with age-related disorders (e.g., Parkinson’s), help older individuals with declining memory improve their memory.  Applications to NIA proposing behavioral intervention development research are encouraged to use NIH Science of Behavior Change experimental medicine methodology (for more information about the SOBC program, please see: https://commonfund.nih.gov/behaviorchange).  
 

NIDCD: The National Institute on Deafness and Other Communication Disorders (NIDCD) seeks to conduct and support biomedical and behavioral research in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language.  With respect to this RFA, NIDCD is particularly interested in supporting research to investigate the neuroscience of music as a complex auditory stimulus, and to understand the basic processing mechanisms as they relate to communication disorders through voice, speech, and language processing. Well-designed and controlled investigations of music interventions, and interactions, on areas such as voice, speech, language, balance, or the processing of complex sounds may also be of interest. These studies could result in clinical outcomes and/or explore the mechanisms underlying music interventions through human studies. The immediate or long-term focus of these investigations should be to ameliorate conditions such as disordered communication, poor hearing, or balance disorders. Applicants are strongly encouraged to contact NIDCD program staff to discuss their aims prior to submission. 
 

NIDCR:
The National Institute of Dental and Craniofacial Research (NIDCR) is interested in music research that has the potential to improve dental, oral, and craniofacial health. Areas of interest include, but are not limited to, investigations of mechanisms by which music may: i) Decrease anxiety, stress, and/or fear levels at the pre-treatment and treatment stages as well as influence levels of these during recall (memory) of the experience in pediatric and adult dental patients; including special needs populations, and ii) Modulate the experience of acute and chronic orofacial pain conditions including temporomandibular joint disorders, trigeminal neuropathies, burning mouth syndrome, oral cancer pain, dental pain, and other conditions.  The effects of music on neuroplasticity, connectivity, endogenous opioids, and differences in affective states that may exist between healthy individuals and those that suffer from chronic orofacial pain conditions are of interest. Clinical trials designed to answer specific questions about the safety, tolerability, efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device interventions will only be supported by NIDCR if submitted to an NIDCR clinical trials-specific FOA https://www.nidcr.nih.gov/research/clinical-trials. Awardees will be required to comply with the  NIDCR Clinical Terms of Award for activities that involve human subjects. Investigators are encouraged to contact NIDCR program staff to discuss potential research projects prior to application submission to determine alignment of the planned studies with priorities of the Institute mission and strategic plan.

 

NIMH: The National Institute of Mental Health (NIMH) supports neuroscience research to discover the causes of mental illness and to develop more effective and safer treatments. For applications proposing clinical trials, the NIMH only accepts applications proposing mechanistic studies that meet NIH’s definition of a clinical trial (see NOT-OD-15-015) through this FOA. A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. NIMH is interested in applications proposing to develop and test novel potential biomarkers of treatment response to advance understanding of the neurobiological effect of target engagement in healthy subjects and/or in patients. However, trials that include as goals the determination of safety or clinical efficacy of interventions are outside of the scope of this FOA. Applicants interested in evaluating treatments for clinical efficacy should apply through one of the FOAs listed at the NIMH clinical trials website, which includes links to the NIMH CT FAQs. NIMH strongly encourages applicants to consult with NIMH Program Officials when developing plans for an application. This early contact will provide an opportunity to clarify NIMH policies and guidelines and identify whether the proposed project is consistent with NIMH program priorities, and to determine which available FOA would best support the proposed research. This is particularly important if there is doubt as to whether or not the submission is determined to be an NIH-defined clinical trial, and if found to be a clinical trial, whether it is a mechanistic study as described by NIMH.

  

Data Sharing

To support the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA by NIMH are expected to share those data via the National Institute of Mental Health Data Archive (NDA; https://data-archive.nimh.nih.gov). Established by the NIMH, NDA is a secure informatics platform for scientific collaboration and data sharing that enables the effective communication of detailed research data, tools, and supporting documentation. A cost estimation tool for data sharing is available at https://ndct.nimh.nih.gov/preplanning/budget and can be used when preparing budgets for applications.

 

Recruitment Reporting

NIMH requires reporting of recruitment milestones for participants in all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size (see https://grants.nih.gov/grants/guide/notice-files/NOT-MH-16-013.html). All NIMH funded mechanistic clinical trials funded under this FOA must report recruitment milestones, including those with fewer than 150 subjects. This expectation will be stated in the notice of grant award.

 
NINR: The National Institute of Nursing Research (NINR) supports research in areas that explore strategies to prevent, reduce, or comfort the symptoms of advanced illness across the lifespan, particularly developing and testing strategies to minimize the physical and psychological burdens on individuals and their caregivers. In doing so, NINR promotes and improves the health of individuals, families, and communities across the lifespan, in a variety of clinical settings and within diverse populations. 
 
As the lead NIH Institute for end of life research, NINR recognizes palliative care as a critical component of high-quality, evidence-based care that includes advanced symptom management and informed decision-making support for both individuals and their family caregivers.
 

NINR will consider studies involving the evaluation of the efficacy or effectiveness of music-based interventions in the clinical management of individuals with serious, advanced illness and their families/caregivers that are consistent with the NINR's research goals. Of particular interest are studies in end-of-life and hospice care, palliative care, pediatric palliative care, diverse populations, and settings.

 

OBSSR:  The Office of Behavioral and Social Sciences Research (OBSSR) is interested in behavioral neuroscience and social science research that:

  • Investigates how music affects the brain and behavior and/or the pathways/neural circuits involved in the interaction between music, brain, and behavior
  • The mechanisms that underlie music-based interventions for the improvement and/or maintenance of health and well-being, or the prevention and/or treatment of behavioral and/or neurological disorders
  • Develops methods and measures that integrate brain and behavioral measurements with musical activities/interventions
  • Performs longitudinal and ancillary studies to assess outcomes of music interventions
  • Establishes standardized and/or personalized outcome measures
  • Is multidisciplinary research and capacity building through collaborative studies involving neuroscientists, music therapists, musicians, and biomedical, behavioral, or social scientists
  • Establishes evidence-based best practices for music interventions intended to enhance wellness or treat/ameliorate specific health conditions.

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

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.

Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH with its participating institutes, centers, and offices, intend to commit up to $5,000,000 in FY2019 to promote research on music and health via this intended FOA as well as the related FOAs. 9-12 totals awards are anticipated between all three related FOAs.

Award Budget

The R01 award will be limited to $250,000 in direct costs in any given year.

 

Award Project Period
The maximum period allowed in five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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.

3. Additional Information on Eligibility

 

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)

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

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

 

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:

Robert Riddle, PhD

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone:301-496-5745

Email: riddler@ninds.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.

 

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

modular budgets are allowed.

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.

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
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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.

 

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?

Will the results of the proposed study substantially and fundamentally increase our understanding of the science of music as it pertains to human health? How will the project:  1) increase our understanding of music's effect on the brain and body?, 2) inform interventions to enhance normal function and/or development, and/or 3) enhance its use to better treat disorders and disease?

In addition, for applications involving clinical trials:  

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

 

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?

Does the proposed research team include appropriate interdisciplinary expertise for the proposed experiments and aims? Are partnerships and collaborations among basic researchers, technological development researchers, music intervention experts, and/or other clinical researchers appropriate and clearly laid out, understanding that a long history of collaboration between these investigators might not always exist considering the scientific focus of this funding announcement?    

In addition, for applications involving clinical trials: 

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

 

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?

What specific areas of music and/or health-related research will especially advance from these studies?

 

In addition, for applications involving clinical trials:

 

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

 

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?

In addition, for applications involving clinical trials

 

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

 

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

 

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

 

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

 

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?

In addition, for applications involving clinical trials

 

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

 

Specific to applications involving clinical trials 

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

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

 
Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

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

 

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

 

Not Applicable

 

Not Applicable

 

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.

 

Not Applicable

 

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

 

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

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NINDS, 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. 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.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all 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.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

2. Administrative and National Policy Requirements

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

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

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.

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

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.

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 on-time submission, 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 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:

Robert Riddle, Ph.D.

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone:301-496-5745

Email: riddler@ninds.nih.gov

 

IC Contacts:

Wen G. Chen, Ph.D.

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-451-3989

Email: chenw@mail.nih.gov

 

Cheri Wiggs, Ph.D.

National Eye Institute (NEI)

Phone: (301) 451-2020

Email:  wiggsc@mail.nih.gov

 

Coryse St. Hillaire-Clarke, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-827-6944
Email:
sthillaireclacn@mail.nih.gov

 

Changhai Cui, Ph.D.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Telephone: 301-443-1678

Email: changhai.cui@nih.gov

 

Amy Poremba, Ph.D. 

National Institute on Deafness and Other Communication Disorders (NIDCD) 

Telephone: 301-496-1804 

Email:porembaa@mail.nih.gov

 

Yolanda F. Vallejo, Ph.D.

National Institute of Dental and Craniofacial Research (NIDCR)

Telephone: 301-827-4655

Email: yolanda.vallejo@nih.gov

 

Lynn Adams, Ph.D.

National Institute of Nursing Research (NINR)

Telephone:  301-594-8911

Email:  lynn.adams@nih.gov

 

Mi Hillefors, M.D., Ph.D.

National Institute of Mental Health (NIMH)

Telephone: 301-443-2738

Email: mi.hillefors@nih.gov

 

Dana M. Greene-Schloesser, Ph.D.

Office of Behavioral and Social Sciences Research

Email: dana.schloesser@nih.gov

Phone: 301-451-3975

Peer Review Contact(s)
Dr. Ernest Lyons
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-4056
Email:LyonsE@ninds.nih.gov
Financial/Grants Management Contact(s)
Dr. Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9231
Email:decostert@ninds.nih.gov

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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