Part 1. Overview Information

Key Dates

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.

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 for the treatment of many diseases, disorders, and conditions. Given the emphasis on innovation, little or no preliminary data are needed to apply under this FOA. with. 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/or 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 in human subjects or animal models, 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 diseases, disorders, and conditions. To capitalize on these opportunities, NIH has issued 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 rigorous 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 issued three related funding opportunity announcements (FOAs) in 2019 that fall into two categories. The first two FOAs (RFA-NS-19-008, R01 and RFA-NS-19-009, R21) supported R01 and R21 awards, respectively, that were intended to broadly support any research areas related to the fundamentals and application of music in health. The third FOA (RFA-AT-19-001, R61/R33) utilized a phased R61/R33 mechanism to support research on music and health geared toward music intervention.

This FOA has similar objectives to that of a prior FOA, RFA-AT-19-001 (R61/R33), to support phased innovation research on music interventions in human subjects or appropriate animal models. While no preliminary data are required 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 convened by the NIH to review progress of the funded research and highlight advances on the science of music and health and should therefore budget accordingly.

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 diseases, disorders, and conditions.

Research Objectives and Specific Requirements

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 a R61 phase application. However, applicants may include preliminary data if they are available.

Examples of topics of high interests for the R61 phase include, but are not limited to:

• Assessing feasibility to enroll and retain study population, deliver and/or implement proposed music-based inventions, collect data, etc, and/or assess acceptability using qualitative or quantitative measuress, that may determine reasons for dropouts, such as preference ratings, assessmets of participant burden, and perceived credibility/value of the interventions.
• 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 (e.g. Alzheimer’s disease (AD) or Alzheimer’s disease related dementias (ADRD))
• 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. For mechanistic studies, in animal models or human subjects, investigators are encouraged to properly define the distinct components of a complex music intervention or provide adequate description and justification of focusing on a specific component (e.g., rhythm, melody, harmonic structure, pitch, or other individual motor or components) of complex music interventions. 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, or innovative in-depth mechanistic studies in relevant animal models to investigate how components of music interventions may work. Examples of R33 phase projects include, but are not limited to:

• Mechanistic studies examing music-based interventions in research participants, if the R61 phase focuses on feasibility and/or acceptability of the planned (R33) randomized mechanistic clinical trial.
• Further mechanistic studies of music interventions in human subjects or in-depth analysis in animal models, if the R61 phase focuses on a basic mechanistic study in animal models. For instance, the R61 phase may examine whether specific musical structures (e.g., pitch, rhythm, harmonic structures, and/or 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 versus a comparator app in the target population to assess feasibility (e.g., recruitment and retention rates, fidelity of implementation, participant adherence rates, data collection procedures, etc.) and acceptability (e.g., 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 statistically 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 is 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, then 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 (e.g., 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.

National Cancer Institute (NCI)

NCI is interested in supporting research within the mission of NCI. The following are example research areas of interest:

• Identify the biological mechanisms or behavioral processes to understand how music interventions improve tolerance to or increase effectiveness of various cancer therapy modalities (e.g., through modulation of immune tone).
• Identify biological mechanisms or behavioral processes to understand how music interventions prevent or ameliorate cancer related symptoms and toxicities.
• Develop novel music-based interventions including in combination with other integrative medicine modalities to improve tolerance or increase effectiveness of various cancer therapy modalities.
• Develop novel music-based interventions to improve symptom management in patients through the cancer control continuum (i.e., those receiving active treatment, during survivorship, or those receiving palliative or end-of-life care). Symptoms include but are not limited to anxiety, depression, altered sleep, fatigue, pain, generalized coping with cancer and its treatment, and other symptoms that can decrease quality of life.
• Develop strategies to promote music-based cancer therapy augmentation to improve tolerance and increase effectiveness of various cancer therapy modalities for low resource settings.

National Institute on Aging (NIA)

NIA supports research to improve the health and well-being of older adults and is interested in studies that integrate basic research on music to inform the development of efficacious interventions for individuals as they age and on intervention development research which attempt to understand the basic behavioral, affective, cognitive, social and biological mechanisms of behavior change. 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 and/or physical function of individuals with neurodegenerative disorders such as Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) and Parkinson’s disease, or help older individuals with declining memory improve their memory. Applicants are encouraged to review the NIH Stage Model for intervention development (https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development) and the NIH Science of Behavior Change (SOBC) experimental medicine methodology (https://commonfund.nih.gov/behaviorchange) as they prepare their applications.

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 the alcohol use disorder (AUD)? 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 AUD? Which types of music might promote sustained abstinence?

National Institute of Mental Health (NIMH)

NIMH supports research to discover the causes of mental illness and to develop more effective and safer interventions. Under this FOA, NIMH will accept applications that propose mechanistic clinical trials (see NOT-MH-19-006) but not applications proposing tests of clinical efficacy and/or safety of novel interventions. According to NIMH’s definition, a mechanistic clinical trial is a study that uses clinical trial methodology in order to test hypotheses about biological or behavioral processes, pathophysiology of a disease, or the mechanism of action of an established intervention. Regarding mechanistic clinical trials, NIMH is interested in applications proposing two types of studies, including 1) mechanistic clinical trials using an intervention of known efficacy to investigate the pathophysiology, and/or psychopathology of mental disorders or the mechanisms of therapeutic responses; and to advance biomarkers of basic neurobiological processes, and 2) mechanistic clinical trials utilizing an experimental manipulation focused on understanding brain function in healthy individuals or those with disorders, by measuring responses to the experimental manipulation. Additionally, for the R33 phase NIMH will accept applications proposing innovative in-depth mechanistic studies or further mechanistic investigations in relevant animal models to investigate how components of music interventions may work. Applications that propose a clinical trial for the purpose of testing the safety and/clinical efficacy of novel interventions are outside of the scope of NIMH research interests for this FOA and will not be referred for review. 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 clinical trials RFAs and a list of frequently asked questions (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 clinical trial as defined 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. Where there is preliminary evidence of atypical music processing in subgroups of individuals with neuropsychiatric disorders, further evaluation of 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(s) under study.
• Mechanistic studies to address the question of how listening to or performing music promotes brain health through mood induction (for example inducing anxiolytic effects) or physical exercise.

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). 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 on NDA’s webpage (see Cost Estimation) 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 NOT-MH-19-027). 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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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.

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

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

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

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

R&R Budget

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

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

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

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.

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.

When involving human subjects research, clinical research, and/or NIH-defined 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.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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

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.

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).

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?

Specific to this FOA:

How will the proposed research foster understanding of the biological mechanisms and/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?

Specific to this FOA:

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?

Specific to this FOA:

Does proposed exploratory research on music and health proposed contain innovative concepts or methodology related to music and health? As applicable, are innovative technology or approaches to enhance music intervention research well described?

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?

Specific to this FOA:

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?

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?

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?

Specific to this FOA:

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

• 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

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

Section VI. Award Administration Information

1. Award Notices

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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• 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.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

3. Reporting

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.

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Wen G. Chen, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: [email protected]

Coryse St. Hillaire-Clarke, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Alexis Bakos, Ph.D., M.P.H, R.N.
National Cancer Institute (NCI)
Telephone: 240-276-6609
Email: [email protected]

Benjamin Xu, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-6545
Email:[email protected]

David I. Leitman, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:301-827-6131
Email:[email protected]

Pamela Jeter, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-435-2591
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: [email protected]

Mahasin Ingram
National Institute on Aging (NIA)
Telephone: 301-402-7736
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Theresa Mercogliano
National Institute of Mental Health (NIMH)
Telephone: 301-451-4940
Email: [email protected]

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.

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.