Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

National Endowment for the Arts (NEA)

Components of Participating Organizations

National Center for Complementary and Integrative Health (NCCIH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)

National Institute on Aging (NIA)

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: Phased Innovation Award for Music Interventions (R61/R33, Clinical Trial Optional)

Activity Code

R61/R33 Exploratory/Developmental Phased Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AT-19-001

Companion Funding Opportunity

RFA-NS-19-008, R01 Research Project Grant

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

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

 93.213; 93.866; 93.273; 93.173; 93.242; 93.853

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications with little or no preliminary data. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged. The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions. The R61 phase will provide funding to either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or can be used to develop innovative technology or approaches to enhance music intervention research. The second R33 phase will provide support for further mechanistic investigations, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research. Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.

Key Dates

 

Posted Date

October 30, 2018

Open Date (Earliest Submission Date)

January 28, 2019

Letter of Intent Due Date(s)

 Although Letters of Intent are usually requested 30 days before the duet date, the letters of intent for this FOA are requested on January 15, 2019.

Application Due Date(s)

February 28, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

February 28, 2019 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 these dates.

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

June 2019

Advisory Council Review

August 2019

Earliest Start Date

September 2019

Expiration Date

March 1, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. 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 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


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

    The purpose of this FOA is to promote innovative research on music and health with an emphasis on developing music interventions aimed at understanding their mechanisms of action and clinical applications with little or no preliminary data. Because of the need for a multidisciplinary approach, collaborations among basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers are encouraged.   The FOA utilizes a phased R61/R33 funding mechanism to support mechanistic research and to evaluate the clinical relevance of music interventions. The R61 phase may either investigate the biological mechanisms or behavioral processes underlying music interventions in relevant animal models, healthy human subjects, and/or clinical populations, or be used to develop innovative technology or approaches to enhance music intervention research.   The second R33 phase will provide support for further mechanistic investigations, intervention development, or pilot clinical studies. The pilot clinical studies may focus on intervention optimization/refinement, feasibility, adherence, and/or identification of appropriate outcome measures to inform future clinical research. Transition from the R61 to the R33 phase of the award will depend on successful completion of pre-specified milestones established in the R61.

    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. 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, NIH is issuing 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 impacts normal health and development; and iii) facilitate rigorous studies of music interventions to treat disease symptoms.

    In 2016, NIH, John F. Kennedy Center for the Performing Arts (KC), and National Endowment for the Arts (NEA)  formed a collaborative partnership (Sound Health) and 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 goal, NIH is issuing three related funding opportunity announcements (FOAs) that fall into two categories. The first two FOAs will support R01 and R21 awards, respectively, that are intended to broadly support any research areas related to the fundamentals and application of music in health. The third FOA will utilize a phased R61/R33 mechanism to support research on music and health geared toward 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.

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

    See each FOA for further details and contact the scientific contacts listed prior to preparing an application to determine the most suitable FOA for a given application.

    Research Objectives and Specific Requirements

    Current research findings suggest that the auditory cortex in the brain is the key region to process many of the unique sound features of music, such as pitch, rhythm, and harmonic structures, although much more remains to be investigated to fully understand the neural correlates of music listening and music performance. Preliminary evidence has emerged to suggest that brain regions involved in emotional regulation, reward, cognitive and motor function, and other sensory functions such as pain, as well as regulation of many internal bodily functions and activities, may be coactivated with the auditory cortex during music listening or music performance. As these brain regions have been implicated in a broad range of organ dysfunctions and nervous system disorders, these preliminary studies provide a theoretical premise to investigate the potential of music interventions for relevant medical conditions and disorders. 

    The R61 Phase

    The primary objective of the R61 phase supported under this FOA is to promote innovative basic/mechanistic research on music interventions. The R61 phase can be a basic, mechanistic, or technology development study in relevant animal models, human subjects, or both. Preliminary data are not required for an R61 phase application. However, applicants may include preliminary data if they are available.

    Examples of topics considered responsive for the R61 phase include, but are not limited to:

    • The mechanisms of music interventions for pain, opioid misuse, management of other symptoms, or palliative care
    • The mechanisms of music interventions for visual impairments, hearing restoration; voice, speech, language rehabilitation; or spatial orientation

    • The mechanisms of music interventions for obesity treatment and appetite control or parasympathetic neural stimulation for stress relief for patients or caregivers 

    • The mechanisms of music interventions on promoting well-being or behaviors associated with health and well-being, such as exercise; or improving the emotional/behavioral status of individuals with dementia, Alzheimer’s Disease (AD), or AD-Related Diseases

    • The mechanisms of music interventions for motor disorders across the lifespan, including stroke and Parkinson’s disease

    • The mechanisms of music interventions for general brain disorders or memory improvement

    • Individual differences in the mechanisms and outcome effects of music interventions

    • Development and testing of new technology for music intervention delivery

    Applicants are expected to develop a detailed description of the music intervention they propose to use in the study. The proposed mechanism(s) or process(es), when appropriate, are expected to be assessed using objective, quantifiable, and reproducible measures. Applicants are also expected to provide detailed descriptions of the measures and a strong rationale for choosing such measures. 


    If the R61 phase includes a mechanistic clinical trial, applicants are encouraged to refer to https://www.ClinicalTrials.gov for a review of the registered trials already under way or completed to help determine whether: 1) the results of ongoing trials can inform the design of the proposed study, and 2) the proposed study is innovative. In addition, a randomized intervention design is encouraged for this phase of study with human subjects. An intended clinical or functional outcome for the proposed intervention is not required for the R61 phase but may be included to give a preliminary assessment of the relevance of the putative mechanism to the intended influence on a functional or clinical outcome. While more than one mechanism or process may be proposed for and examined under the R61 phase, investigators are encouraged to focus on one or two primary measures for the mechanism(s) of action or process(es), with other potential mechanisms as either alternatives or secondary. The effect of the intervention on the primary mechanisms should be adequately powered statistically in animal model or human subject studies.

    The R33 Phase

    The primary objective of the R33 phase is to support the development and implementation of rigorous, evidence-based proof-of-concept studies of music interventions in healthy human subjects or appropriate clinical populations. Examples of R33 phase projects include, but are not limited to:

    • Human mechanistic studies of music interventions, if the R61 phase focuses on a basic mechanistic study in animal models. For instance, the R61 phase may examine whether specific musical structures (i.e., pitch, rhythm, harmonic structures, chord) may activate discrete neural correlates in a relevant animal model, while the R33 phase would explore the mechanistic effects of such musical structures in modulating parallel brain activities in a relevant clinical population.

    • Optimization or in-depth studies of mechanistic effects of music interventions, if the R61 phase focuses on a preliminary mechanistic study in human subjects. For instance, the R61 phase may examine whether active music engagement coactivates auditory and motor cortices in a clinical population, while the R33 phase may study whether additional brain stimulation of the cortical connections may enhance or impair the auditory/motor connectivity as well as the associated clinical effects.

    • Pilot feasibility studies of music interventions, if the R61 phase focuses on novel technology development or basic research. For instance, if the R61 phase develops an app-delivered music intervention, the R33 phase could involve a randomized trial of the music intervention app vs. a comparator app in the target population to assess feasibility (i.e., recruitment and retention rates, fidelity of implementation, participant adherence rates, data collection procedures, etc.) and acceptability (i.e., qualitative assessments, reasons for dropouts, preference ratings, participant burden, credibility).

    • Pilot clinical studies of music interventions including proof of principle, if the R61 phase focuses on a basic mechanistic study in human models. For instance, if the R61 phase examines whether a music intervention is associated with basal ganglia activity, the R33 phase could involve a randomized trial of the music intervention vs. a standard care comparator among Parkinson’s disease patients to assess feasibility and acceptability parameters, examine within-group pre-post changes in clinically relevant measures, and/or examine correlations between changes in basal ganglia activity and clinically relevant measures as proof-of-principle.

    In the R33 phase, human mechanistic studies are encouraged to be powered for the hypothesized mechanisms or processes. Pilot feasibility studies are not expected to be powered for the proposed mechanistic or clinical outcomes; instead they should be primarily focused on examining important questions about feasibility and acceptability that will directly inform the design and conduct of a future fully-powered clinical efficacy or effectiveness study. Examination of within group pre-post changes in clinical outcomes or the correlation of mechanistic outcomes with clinical outcomes may be included in pilot clinical studies as indication of proof-of-principle of the proposed music intervention on hypothesized clinical outcomes. Pilot clinical studies are not meant to be definitive trials and should not propose to examine clinical efficacy or effectiveness in an underpowered sample. 

    In many cases, including feasibility work, a randomized clinical trial design may be appropriate for the R33 phase, with the choice of the control group determined by the needs for testing the specific outcomes or by the research question to be answered in a future fully powered efficacy trial. Masking of subjects and objective methods of assessment using masked raters should be employed whenever possible. Masking procedures should be clearly specified for the study participants/patients, instructors/practitioners, outcome assessors, data analysts/statisticians, and principal investigators.

    R61/R33 Transition Milestones and Processes

    In the R61 phase application, investigators are expected to describe a set of “Go/No-Go milestones” that will allow for a definitive assessment of whether the R61 phase provides sufficient evidence to support the subsequent R33 phase study as proposed in the grant application. Because the R61 phase fundamentally serves as the phase to collect key preliminary data for the proposed R33 phase study, the proposed R61/R33 transition “milestones” should specify the quantifiable metrics that would determine the successful completion of such key preliminary data, preferably with a timeline.

    Progress under the R61 phase will be administratively reviewed by NIH program officials. Funding for and transition to the R33 phase are contingent on the following: 1) meeting the “Go/No-Go milestones” articulated in the R61 phase, 2) the availability of funds, and 3) regulatory approval of the planned R33 activities by the administrating NIH Institute or Center. If the R61 phase study is not able to complete the “milestones” as defined at the initial award stage, the investigators will not be able to transition to the R33 phase.  

    The Research Team

    To transform knowledge and practice in music and health research programs, collaboration across fields was recommended by the participants in the NIH/KC/NEA workshop to evaluate the state of basic and applied music research (Music and the Brain).

    This FOA strongly encourages applications that assemble an interdisciplinary, collaborative team of creative, independent investigators to address the complex and important research questions relevant to the science of music interventions. The team should be able to provide an integrative plan for working together to effectively address the complex challenge at hand. The team science approach encouraged by this FOA will inform discovery-based or hypothesis-generative approaches, to advance the science of music interventions and its impact on health. Examples of collaborative teams for this FOA include, but are not limited to:

    • Basic research scientist, music health professional, intervention expert
    • Clinical researcher, music therapist, neurologist or other medical profession expert
    • Biomedical, behavioral, and/or social scientist, intervention expert, musician, music therapist
    • Technology development researcher (i.e., mhealth, novel delivery system), neuroscientist, music health professional
    Scope and Specific Areas of Research Interest

    This FOA supports a broad range of research on music interventions and health. In addition, specific Areas of Research Interest from the participating NIH ICs of this FOA are listed below. Applicants are strongly encouraged to contact the Scientific/Research Contacts from various NIH ICs listed in Section VII prior to submission to discuss IC program relevance.

    National Center for Complementary and Integrative Health (NCCIH)

    NCCIH is broadly interested in supporting research aimed at understanding the mechanisms by which music interventions may influence symptom management with high-priority interest in pain, stress-related disorders, and sleep disorders, as well as opioid misuse and enhancement of emotional well-being. NCCIH is also interested in supporting early phase clinical studies for intervention optimization and refinement, feasibility, and acceptability testing, to prepare for future large-scale definitive efficacy studies of music interventions related to pain, management of other symptoms, or enhancement of emotional well-being. While the early phase clinical studies supported in the R33 phase of this FOA may include evaluation of within group pre-post changes in clinical outcomes or the correlation of mechanistic outcomes with clinical outcomes as useful proof-of-principle information, NCCIH will not support research proposing to examine preliminary efficacy or effectiveness in an underpowered sample via this FOA. Investigators who are ready to propose a fully powered efficacy or effectiveness clinical trial 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.

    National Institute of Neurological Disorders and Stroke (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.  NINDS is 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. Music interventions may be studied alone, in conjunction with, or in comparison to other interventions.

    National Institute on Aging (NIA)

    NIA is interested in Stage I 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), or 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 (SOBC) experimental medicine methodology (for more information about the SOBC program, please see: https://commonfund.nih.gov/behaviorchange). 

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    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?

    National Institute on Deafness and Other Communication Disorders (NIDCD)

    NIDCD seeks to conduct and support biomedical and behavioral research on 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 investigating music mechanistic and intervention studies. Relevant studies may focus on areas such as voice, speech, language, balance, or processing of complex sounds. NIDCD encourages applications that could result in clinical outcomes and/or explore the mechanisms underlying music interventions through human studies. These investigations can propose interventions and treatments designed 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. 

    National Institute of Mental Health (NIMH)

    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.

    Examples of research areas of interest to NIMH:

    Mechanistic studies to address the question of how listening to or performing music promotes brain health through the rhythmic entrainment of neural activity in the brain and, importantly, how rhythmic entrainment may have ancillary benefits for neural systems supporting cognition, learning, mood, and social/affiliative behavior.

    Investigations of the neural networks that might underlie atypical music processing (e.g., pitch discrimination, pitch memory, memory for tone/picture) in subgroups of individuals with neuropsychiatric disorders, including but not limited to autism spectrum disorders (ASD). Where there is preliminary evidence of atypical music processing in subgroups of individuals with neuropsychiatric disorders, further evaluation of large-scale networks relevant to music processing is of interest. These studies must be supported by empirical evidence that the networks under study are relevant to music processing and to the neuropsychiatric condition under study.

    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 requirement will be stated in the notice of grant award.

    Office of Behavioral and Social Sciences Research (OBSSR)

    OBSSR is broadly interested behavioral neuroscience and social science research that investigates 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/psychiatric disorders.  OBSSR does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed for inquiries regarding the suitability of the proposed project for the FOA and the IC’s research portfolio.

    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.

    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

    Issuing IC and partner components intend to fund up to an estimate of 9-12 awards, corresponding to a total of $5,000,000 for fiscal year 2019 across all three related RFAs.

    Award Budget

    Application budgets for the R61 and R33 phases must reflect the actual needs of the proposed project. The R61 phase cannot exceed $350,000 in direct costs in any given year. If awarded, the R33 phase cannot exceed $350,000 in direct costs in any given year.

    Award Project Period

    The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with 1 to 2 years for the R61 phase and up to 4 years for the R33 phase.  

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Martina Schmidt, Ph.D.
    Telephone: 301-594-3456
    Fax: 301-480-2419
    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: 

    Specific Aims:

    In the single attachment allowed for the specific aims, applicants should provide brief background information, justify the importance of the topic area, outline the knowledge gap relevant to the proposed study, and provide the rationale for the proposed hypotheses or objectives. This page should also include headers titled R61 Specific Aims and R33 Specific Aims with brief descriptions of key elements for each aim in the two phases of this project. The investigators should also have at least one statement about innovation of the proposed study and the general impact of the proposed study.

    Research Strategy:

    Note: Discuss the following without duplicating information collected in the PHS Human Subjects and Clinical Trials Information Form.

    The application should include sections such as clinical significance, rationale/background/prior studies, R61 phase research approaches, R33 phase research approaches, Go/No-Go milestones for the R61, data management and quality control, power and statistical analysis if relevant, and subsequent studies beyond the R61/R33 as appropriate.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    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. 

    Foreign Institutions

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement and procedures for foreign institutions.

    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, noncompliant, and/or nonresponsive will not be reviewed.

    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. 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.

    This R61/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research related to music and health. While highly innovative work often inherently carries a substantial scientific risk (i.e., the original hypothesis may not be proven), this risk can be substantially mitigated by properly designed “milestones” that would help determine whether at the end of the R61 phase the study is ready to move forward to the R33 phase. A well-planned R33 phase is only meaningful if the R61 phase is both innovative and well designed. An R61/R33 grant application need not have preliminary data, extensive background material, or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, the rigor of proposed experimental designs, and the potential to significantly advance our knowledge or understanding of the biological mechanisms and behavioral processes underlying music interventions or to develop innovative technology or approaches to enhance music intervention research. Reviewers will assign a single impact score for the entire application, which includes both the R61 and R33 phases.

    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.

    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? How will the proposed research foster our understanding of the biological mechanisms or behavioral processes underlying music interventions or, as appropriate, how will it enhance music intervention research through the development of new technologies or approaches? Will a more in-depth understanding of potential mechanisms of action of music interventions or their feasibility or effects in human subjects or clinical populations be gained to justify further research in this area?

    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?

    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? 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 among 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 

    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? Is innovative exploratory research on music and health proposed? As applicable, are innovative technology or approaches to enhance music intervention research described? Does the proposed research have the potential to advance or transform the field by breaking ground for future clinical research on music and health?   

    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?

    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? Will the R61 phase provide appropriate preliminary data to support the R33 phase of the application?

    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? Have the needs for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences in the intervention effect due to sex/gender and race/ethnicity addressed, if applicable?

    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 the 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?  

    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? 

    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.

    Go/No-Go Milestones: 

    Are the “Go/No-Go milestones” adequate to assess the success of the R61 phase for the transition to the R33 phase? Do they include quantifiable metrics and a timeline?  

    Study Timeline

    Specifically for 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)?

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and 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.

    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:

    • 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.

    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.

    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.

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

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

    Cooperative Agreement Terms and Conditions of Award

    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 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)

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

    Robert Riddle, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-5745
    Email: riddler@ninds.nih.gov

    Lisa Onken, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-3136  
    Email: lisa.onken@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

    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 (OBSSR)
    Phone: 301-451-3975
    Email: dana.schloesser@nih.gov

    Peer Review Contact(s)

    Pamela Jeter, Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-435-2591
    Email: pamela.jeter@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

    Tijuanna DeCoster, Ph.D.
    National Institute of Neurological Disorders and Stroke
    Telephone: 301-496-9231
    Email: decostert@ninds.nih.gov

    Nia Pree
    National Institute on Aging (NIA)
    Telephone: 301-827-6374
    Email: nia.pree@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Christopher Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713 
    Email: myersc@nidcd.nih.gov

    Rebecca Claycamp, MS, CRA
    National Institute of Mental Health
    Phone: (301) 443-2811
    Email: rclaycam@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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