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

Background

Music has a unique and remarkable ability to ameliorate the symptoms of a broad range of disorders that occur throughout the lifespan, deliver palliative care during serious advanced illness, improve recovery from a variety of neurological disorders, and improve health throughout all our lives. Music can clearly act as an effective medicine, but its means of action are poorly understood.

Recent scientific advances provide us with opportunities to understand the mechanisms through which music acts, and to develop new music interventions for a variety of human conditions. In 2016, the NIH, John F. Kennedy Center for the Performing Arts (KC), and National Endowment for the Arts (NEA) formed a collaborative partnership (Sound Health) with the goal of understanding the healing abilities of music and use them more effectively and broadly.

In 2017, the NIH organized a workshop to examine the ability of music to improve human health (Music and the Brain) and subsequently developed a set of priorities to foster both basic and applied music-based research. In 2019 the NIH issued three RFAs (using R01, R21 or R61/R33 mechanisms) encouraging research aimed at understanding the processing of music in the brain and use that information to improve public health. Many proposals were submitted, and a broad range of grants were ultimately awarded via a trans-IC, NIH Office of the Director and National Endowment for the Arts coordinated effort.

The large number of submissions to the three FY19 initiatives demonstrated that music-related neuroscience research and music therapy have tremendous potential for new and innovative approaches. This FOA and the companion FOA for R21 applications will convene a single study section once a year to review both R01 and R21 applications focused on the best uses of music to improve heath and treat a variety of disorders.

This Program Announcement with special Review (PAR) will accept R01 applications and is intended to support studies with a strong scientific foundation and potentially strong impact on advancing the science of music and health. All proposed projects must be within the mission and interests of the participating institutes, offices and agencies. A companion R21 PAR will be issued which encompasses a similar therapeutic focus but will emphasize exploratory projects which may be more high risk and high payoff. Additionally, PAR-20-266 utilizes a phased R61/R33 mechanism to support research that can best be facilitated through milestone-driven awards on music and health geared towards music intervention.

Scope of Research

This PAR proposes to build upon basic and applied research demonstrating the novel benefits of music on improving health. It utilizes the R01 mechanism and special annual review panel. All proposed projects should have the potential to enhance human health and well-being in healthy individuals and/or improve the health of individuals with many relevant diseases and disorders. All proposed projects must be within the mission and interests of the participating institutes, offices and agencies.

Applications using animal models and/or human subjects are both within the scope of this PAR. Applications that propose multidisciplinary research and collaborative studies involving musicians, music therapists, biomedical, behavioral, and/or social scientists are encouraged. All projects should be rigorously designed, reproducible and within the mission of the participating institutes, centers and offices.

IC and NIH Office Interest Areas and Specific Requirements:

The Trans-NIH Music and Health Working group has identified many areas of interests for their individual ICs and believe that coordinated reviews will be the best means to benefit their missions. Because applications will be assigned to participating ICs before review, it is important that applicants are able to link their proposed studies to the mission and specific requirements of the participating ICs. Applications proposing clinical trials should be within the guidelines of the NIH and the sponsoring institute. Investigators are strongly encouraged to contact the program staff (listed at the end of this FOA) for the sponsoring institute during the development of their proposal and submit a letter of intent prior to submitting a complete application. Applications that propose research outside of the specific requirements of the sponsoring institute will be not be supported.

Below is a list of areas that are of interest to participating ICs:

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.
• Identify biological mechanisms or behavioral processes to understand how music interventions prevent or ameliorate cancer related symptoms and toxicities.
• Develop precision/personalized music-based interventions including in combination with other integrative medicine modalities to improve tolerance or increase effectiveness of various cancer therapy modalities.
• Develop precision/personalized music-based interventions to improve symptom management in patients through the cancer control continuum (i.e., those receiving active treatment 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.

Investigators are strongly encouraged to contact program staff to discuss their aims prior to submission.

NEI

NEI supports research on visual disorders and the special health problems and requirements of the blind. NEI has particular interest in studies that address rehabilitative strategies and goals for low vision and/or loss of vision. Studies examining music intervention and cross-modal plasticity and/or cortical reorganization in visually impaired individuals are acceptable.

NEI will support Clinical Trial applications proposing mechanistic studies and/or those designated as minimal risk interventions as defined by 45 CFR 46. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Applications must include a clear, detailed plan for monitoring safety that is commensurate with the risks to study participants. In addition to the minimal risk designation from the Institutional Review Board, other reporting to the NEI may be required and will be outlined in the Notice of Award Terms and Conditions. Applicants are strongly advised to contact NEI staff before submitting applications to this FOA.

Interventional clinical trials involving greater than minimal risk as defined by 45 CFR 46 as well as complex, large-scale, or high resource-clinical trials that propose to test efficacy, effectiveness, or safety will be not be supported..

NIA

The National Institute on Aging will support applications proposing aging-relevant basic research (in animal models and human subjects) and mechanism-focused, aging-relevant clinical trials. This includes but is not limited to studies that:

• Investigate the neural pathways and circuits involved in music processing and how these may be altered in aging and AD/ADRD.
• Explore the mechanisms by which the experience of music may affect brain structure and function in aging and AD/ADRD.
• Investigate the potential for music to induce neural and behavioral plasticity in aging and in the context of AD/ADRD and the underlying mechanisms.
• Develop behavioral interventions in accordance with the NIH Stage Model that capitalizes on and integrates basic research on music to inform the development of efficacious interventions for individuals as they age. For example, studies can investigate the mechanisms of music interventions on promoting well-being or behaviors associated with health and well-being, such as exercise in any older population; or improving the emotional/behavioral status of care providers or individuals with or without dementia or AD/ADR.
• Clinical trial applications will not be supported if they:
  • do not propose an experimental design testing this hypothesized mechanism of change.
  • do not include power analyses for both efficacy and the hypothesized mechanism though which the intervention is proposed to work.

NIAAA

NIAAA is interested in supporting research within the mission of NIAAA. Example research areas of interest to NIAAA include those related to the following questions: 1) How does music modulate negative emotional states associated with alcohol misuse and withdrawal? What are the biological and neurological underpinnings of the modulation? 2) Can music facilitate cognitive recovery following heavy chronic alcohol misuse, and what are the underlying mechanisms? How does music interact with other treatment efforts? 3) How does music impact recovery from alcohol use disorder? Which types of music might promote sustained abstinence? How might culturally relevant differences in music preference come into play in recovery and sustained abstinence?

NCCIH

The National Center for Complementary and Integrative Health (NCCIH) is interested in supporting research aimed at understanding the mechanisms by which music-based interventions impact resilience, health promotion, disease prevention, and symptom management in high-priority topics such as pain, stress-related disorders, and sleep disorders. NICCH is also interested in the mechanisms by which music-based intervention could be used to address opioid misuse and enhancement of well-being. In addition to basic animal model work, NCCIH supports mechanistic clinical trials under this FOA, as well as technological or methodological development supporting mechanistic understanding of music-based interventions. However, NCCIH will not support grant applications proposing efficacy or effectiveness research with primary clinical outcomes or with any specific aims assessing the effect sizes of interventions on clinical outcomes under this FOA. Investigators who are ready to propose a fully powered efficacy or effectiveness clinical trials can apply to appropriate NCCIH Clinical Trial FOAs. Investigators are strongly encouraged to contact program staff to discuss their aims prior to submission

NIDA

The mission of the National Institute on Drug Abuse is to advance science on the causes, consequences, prevention and treatment of substance use and addiction and to apply that knowledge to improve individual and public health. NIDA will support both mechanistic and interventional clinical trials, but applicants are strongly encouraged to contact NIDA program staff prior to submission to discuss appropriateness. In the context of this FOA, NIDA is particularly interested in how music (listening to or performing), in combination with, or compared to other interventions, predicts treatment outcomes and/or resilience to substance use. This includes investigations of how music intervention might alter neural networks involved in reward processing.

Applicants are strongly encouraged to consider the risk for spurious findings when conducting multiple analyses and/or using large data sets and are encouraged to address this potential concern in the application. Applicants are also strongly encouraged to calculate and report effect size (e.g., percentage of variance explained), in addition to statistical significance, whenever possible.

Applicants are strongly encouraged to pre-register hypotheses, aim(s), design and plans for statistical analyses to journals for peer review prior to beginning their project.

NIDCR

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

NIMH

National Institute of Mental Health (NIMH) supports research to discover the causes of mental illness and to develop more effective and safer interventions. For applications proposing a clinical trial in response to this FOA, NIMH will support studies that propose mechanistic clinical trials, 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. 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 supported. 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.

NIMHD

The National Institute on Minority and Health Disparity (NIMHD) is interested in Sound Health research that focuses on racial and ethnic minority and other populations with health disparities. Research projects can consist of epidemiologic, experimental or intervention studies and incorporate constructs and measurement of social determinants of health across multiple domains and levels of influence (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health-care system) and multiple levels (e.g., individual, interpersonal, community, societal; [see the NIMHD Research Framework for more information: https://www.nimhd.nih.gov/about/overview/research-framework.html]. Examples of topics may include but are not limited to the following:

• Studies that address the effects of music interventions to enhance function and improve health, Alzheimer’s disease or mild cognitive impairment, sleep disorders, and how they differ across health disparities population groups.
• Studies that explore the role and effect of music together with dance in major life events (bereavement, stress or mental health, cancer, surgery, pain) in health disparities population groups.
• Studies that examine the effects of interventions using music together with dance and type of music on health and function in multiple regions and across the US cultures in health disparities population groups.
• Studies that examine the effects of music and health function by generational groups, and in family cohesiveness including in high risk health disparities population groups (e.g., adolescents at risk for substance use disorders, sexual & gender minority [SGM] populations).

NINDS

The National Institute of Neurological Disorders and Stroke will support applications for research studies to inform the understanding, management, and/or treatment of neurological diseases and disorders, and/or accompanying symptoms. This includes studies aimed to understand and facilitate recovery processes (e.g. after injury or stroke) or maintain function (e.g. slow cognitive decline). Studies aimed at understanding neuronal processing in healthy brains would be acceptable if they are clearly focused on the fundamentals of understanding and/or treating specific neurological conditions. Investigators are encouraged to use NIH established common data elements where applicable. Music interventions may be studied alone, in conjunction with, or in comparison to other interventions.

Applicants proposing clinical trials are strongly encouraged to contact program staff for advice regarding this FOA well in advance of submitting an application. NINDS will accept mechanistic clinical trials designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Basic Experimental Studies with Humans (BESH) are allowed. NINDS will not support clinical trials designed to test safety or efficacy of a therapeutic intervention to this FOA. applications containing clinical trials designed to test safety or efficacy of an intervention are directed to the funding opportunities and guidelines sponsored by the Division of Clinical Research to determine if there is an appropriate mechanism for their proposed research. Finally, studies intended to optimize interventions or develop biomarkers aredirected to the appropriate programs supported by the Division of Translational Research.

NINR

• NINR supports research in areas that explore strategies to prevent, reduce, or comfort the symptoms of advanced illness across the lifespan, particularly developing and testing strategies to minimize the physical and psychological burdens on individuals and their caregivers.
• NINR will consider studies involving the evaluation of the efficacy or effectiveness of music-based interventions in the clinical management of individuals with serious, advanced illness and their families/caregivers that are consistent with the NINR's research goals.
• NINR also supports research on the impact of music interventions to promote health and prevent illness, as well as music interventions that prevent exacerbation or complications of existing chronic conditions.
• NINR accepts non-clinical and clinical trials, including mechanistic studies.
• NINR will not support pharmacologic clinical trials.

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

There are two main types of clinical trials relevant to this FOA: Mechanistic Clinical Trials and Clinical Outcome Clinical Trials. Mechanistic Clinical Trials are studies with primary outcomes designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Clinical Outcome Clinical Trials are studies with primary outcomes designed to assess the safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, surgical, or device interventions.

Applicants are encouraged to review the current NIH Definition of a Clinical Trial, the sub definition of an intervention, and the numerous case studies provided. For example, administering a stimulus (such as music) for the purposes of measuring or describing brain activity but NOT to modify it, is not considered an intervention under the NIH definition, and would thus not be a clinical trial. In contrast, the NIH definition of an intervention states that an intervention is a manipulation of a subject or their environment with the intent to modify a health-related outcome.

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

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

• 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

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.

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

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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:

Robert Riddle
Telephone: 301-496-5745

Email:SoundHealth@ninds.nih.gov

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 or Modular 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:

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.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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.

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.

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. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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.

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.

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?

If the aims of the study are achieved, will the results of the proposed study substantially and fundamentally increase our understanding of the science of music as it pertains to improving human health? How will the project: 1) increase our understanding of music's ability to positively affect health outcomes, 2) inform interventions to enhance normal function and/or development, and/or 3) enhance its use to better treat disorders and disease?

In addition, for applications involving clinical trials

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

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?

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

In addition, for applications involving clinical trials

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

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?

What specific areas of health-related research and care will be advanced from these studies?

In addition, for applications involving clinical trials

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

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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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.

Study Timeline

Specific to applications involving clinical trials

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

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

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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications 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.

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. 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

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.

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

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: GrantsInfo@nih.gov (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: support@grants.gov

NINDS

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

NEI

Cheri Wiggs
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: wiggsc@mail.nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

NIA

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

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

NIAAA

Benjamin Xu, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-6545
Email: benxu1@mail.nih.gov

NCCIH

Wen G. Chen
National Center For Complementary & Integrative Health (NCCIH)
Phone: 301-451-3989
E-mail: chenw@mail.nih.gov

Shelley Carow
National Center For Complementary & Integrative Health (NCCIH)
Phone: 301.594.3788
E-mail: carows@mail.nih.gov

NCI

Alexis Bakos, Ph.D., M.P.H., R.N.
National Cancer Institute (NCI)
Phone: 301-921-5970
E-mail:Alexis.Bakos@nih.gov

NIDA

Elizabeth A. Hoffman, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-2265
Email: elizabeth.hoffman@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

NIDCR

Margaret Grisius
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone:301-451-5096
Email: margaret.grisius@nih.gov

Diana Rutberg
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

NIMH

Mi Hillefors, MD, Ph.D.
National Institute of Mental Health (NIMH)
E-mail:mi.hillefors@nih.gov
Telephone: 301-443-273

Theresa A. Merocgliano
National Institute of Mental Health (NIMH)
Phone: 301-451-4940
E-mail: theresa.mercogliano@nih.go

NIMHD

Priscah Mujuru DR.PH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail: mujurup@mail.nih.gov

Priscilla Grant, JD
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: grantp@mail.nih.gov

NINR

Lynn Adams, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: lynn.adams@nih.gov

Kelli Oster
National Institute Of Nursing Research (NINR)
Phone: 301.594.2177
E-mail: osterk@mail.nih.gov

OBSSR

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

National Endowment for the Arts

Sunil Iyengar
National Endowment for the Arts (NEA)
E-mail: iyengars@arts.gov
Telephone: 202-682-5654

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Email: nindsreview@nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Shelley Carow
National Center For Complementary & Integrative Health (NCCIH)
Phone: 301.594.3788
E-mail: carows@mail.nih.gov

Amy Bartosch
National Cancer Institute (NCI)
Phone: 240-276-6375
E-mail:amy.bartosch@nih.gov

Karen Robinson-Smith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

Mahasin Ingram
National Institute on Aging (NIA)
Phone: 301-402-7736
Email: mahasin.ingram@nih.gov

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

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Diana Rutberg
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Theresa A. Merocgliano
National Institute of Mental Health (NIMH)
Phone: 301-451-4940
E-mail: theresa.mercogliano@nih.gov

Priscilla Grant, JD
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: grantp@mail.nih.gov

Kelli Oster
National Institute Of Nursing Research (NINR)
Phone: 301.594.2177
E-mail: osterk@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.

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.