NIH Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional)

NIH Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH) and National Endowment for the Arts (NEA). This funding opportunity aims to increase understanding of how music affects the brain when used therapeutically and to use that knowledge to develop evidence-based music interventions to enhance health or treat specific diseases and disorders.

Expired PAR-21-099: Music and Health: Understanding And Developing Music Medicine (R21 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) National Endowment for the Arts ( NEA ) Components of Participating Organizations National Institute of Neurological Disorders and National Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title Music and Health: Understanding And Developing Music Medicine (R21 Clinical Trial Optional) R21 Exploratory/Developmental Research Grant Notices of Special Interest associated with this funding opportunity NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 March 25, 2021 - Notice of NICHD Participation in PAR-21-099.

See Notice NOT-HD-21-022 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-100 - Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional) See Section III. 3.

Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 853, 93.

213, 93. 867, 93. 866, 93.

286, 93. 279, 93. 121, 93.

242, 93. 361, 93. 273, 93.

865 Funding Opportunity Purpose This FOA is intended to: (1) increase our understanding of how music affects the brain when it is used therapeutically and/or (2) use that knowledge to better develop evidence-based music interventions to enhance health or treat specific diseases and disorders.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) February 16, 2021, February 16, 2022, February 16, 2023 All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s) June 2021, June 2022, June 2023 October 2021, October 2022, October 2023 October 2021, October 2022, October 2023 Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description 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 related R01 FOA will convene a single study section once a year to review 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 R21 applications and is intended to support exploratory studies with potentially novel and/or foundational ideas to further advance 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 R01 PAR will be issued which encompasses a similar therapeutic focus but will emphasize applications with a more established scientific foundation and potentially larger scope.

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. This PAR proposes to advance basic and/or applied research demonstrating the novel benefits of music on improving health. It utilizes the R21 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 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 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 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.

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.. 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 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? The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies.

Under this FOA, NIBIB will support applications that propose to develop biomedical imaging and bioengineering techniques and devices aimed at fundamentally improving our understanding of the basic science of music and exploring its potential to enhance health and treat disease.

Topics of interest include, but are not limited to, the development of non-invasive human imaging tools and technologies to probe music’s impact on the brain and the effects of music on the quantity of sedatives and/or analgesics (administered for conscious sedation) as required during image-guided interventions and other minimally invasive procedures For applications submitted to this FOA that propose clinical trials, NIBIB will only support applications proposing either mechanistic clinical trials and/or early stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early stage technology development in the submitted application.

NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies ( https://grants. nih. gov/policy/clinical-trials.

htm ) and consistent with the types of clinical trial applications that NIBIB supports. 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. 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.

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 studiesthat 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.

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 .

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 at the end of this FOA 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 Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications The combined budget for direct costs for the two year project period may not exceed $275,000.

No more than $200,000 may be requested in any single year. The scope of the proposed project should determine the project period. The maximum project period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. 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