The purpose of this initiative is to advance the science and implementation of innovative multi-level health care research for older adults from populations that experience health disparities. The initiative will support research designed to (1) gain a better understanding of appropriate screening, diagnostic, and clinical care guidelines in a primary care setting, (2) explore shared decision-making that is needed to enhance care planning and patient agency between clinicians and care teams with the older adult and their caregiver(s), and (3) identify effective strategies for care coordination.

Funding Opportunity Number: PAR-24-273. Assistance Listing: 93.307,93.361,93.393,93.866. Funding Instrument: G. Category: ED,HL.

PAR-24-273: Advancing Healthcare for Older Adults from Populations that Experience Health Disparities (R01 - Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Institute of Nursing Research ( NINR ) 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. Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) 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.

Funding Opportunity Title Advancing Healthcare for Older Adults from Populations that Experience Health Disparities (R01 - Clinical Trial Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 307, 93.

361, 93. 866, 93. 393 Funding Opportunity Purpose The purpose of this initiative is to advance the science and implementation of innovative multi-level health care research for older adults from populations that experience health disparities.

The initiative will support research designed to (1) gain a better understanding of appropriate screening, diagnostic, and clinical care guidelines in a primary care setting, (2) explore shared decision-making that is needed to enhance care planning and patient agency between clinicians and care teams with the older adult and their caregiver(s), and (3) identify effective strategies for care coordination.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description The term “ older adult ” refers to the chronologic definition of an older adult- arbitrarily set as individuals aged 65 and older.

The term “populations that experience health/health care disparities” refers to NIH-designated populations that experience health disparities in the United States: ( https://www. nimhd. nih.

gov/about/overview/ ). The term “multi-level” refers to the multi-dimensional framework of determinants relevant to understand and address minority health and health disparities. This concept is further described under the NIMHD Research Framework ( https://www.

nimhd. nih. gov/about/overview/research-framework/ ).

The term “care coordination” refers to deliberately organizing patient care activities and sharing information among all the participants concerned with a patient's care to achieve safer and more effective care. Examples of broad care coordination include care management, medication management, home safety, and others. The term “care transition” refers to the movement of a patient from one setting of care to another.

Settings of care are defined as acute care hospitals, ambulatory primary care practices, ambulatory specialty care practices, long-term care facilities, home health, and rehabilitation or skill nursing facilities. The term “shared decision making” refers to when a clinician and a patient/ their caregivers work together to make a health care decision that is best for the patient and consistent with the patient’s preferences.

The optimal decision takes into consideration evidence-based information about available treatment and care options, the clinician's knowledge, experience, and ethos to do no harm and minimize risks, and the patient's values and preferences. The term “caregiver” refers to a person or persons who provide care in a paid/ formal or unpaid/ informal capacity to people who need help taking care of themselves.

This may include health professionals, family members, non-family members, friends, social workers, or members of the clergy. They may provide care at home or in a hospital or other health care setting.

The term “diagnostic and clinical guidelines” refers to evidence-based and evidence-informed recommendations that summarize current medical knowledge, weigh the benefits and harms of diagnostic procedures, treatments, and follow-up, and give specific recommendations or rely on empirical approaches on how to diagnose and treat a medical condition.

In addition, within the context of the healthcare of older adults, some diagnostic and treatment decisions may be informed by expert consensus, up-to-date scientific knowledge, or patient preferences.

In clinical scenarios in which there is not sufficient evidence, the diagnostic and/or treatment course of action may be based on the patient, caregiver and clinician shared decision in which “do no harm” principle and the best patient-centered outcomes and quality of life are considered. The U.S. older adult (those aged 65 and over) population is rapidly growing.

Older adults from populations that experience health disparities are more likely to report poorer physical health, mental health, and quality of life. They also tend to have more coexisting health conditions including cognitive impairment and functional limitations, less access to timely diagnosis and optimal quality of care, and experience more hospital admissions, readmissions, and multiple care transitions.

Therefore, the current lack of preparedness to meet the challenges of caring for older adults within the healthcare system, especially those from populations that experience health disparities is a serious public health and societal concern.

There is ample research evidence indicating that there are many factors that may lead to omissions and commissions of care for older adults that often result in preventable adverse outcomes including delays in or over-screening, missed or delayed diagnoses, and untimely treatment or over-treatment.

Such factors include stereotyping based on age, mistreatment, delivery of substandard care, errors in clinical judgement, providing care that may do more harm than good, and dismissal of health concerns by clinicians and/or caregivers.

In addition, making a correct and timely diagnosis and care plan for older adults is a process influenced by a myriad of factors that can influence screening and diagnostic tests’ performance and accuracy. Some of these include: Few clinical research studies that focus on older adults, especially those over the age of 75, in clinical research.

Age-dependent variations in sensitivity and/or specificity of screening and/or diagnostic tests. Screening tests for which diagnostic and/or treatment benefit is unclear after a certain age, or within the context of health status, quality of life, and/or projected life expectancy. Screening tests recommendations that consider patient preferences and weigh benefits versus risks/ harms.

Symptoms and signs that are different from the clinical profiles observed in younger populations. Delayed recognition of health conditions by patients and caregivers/family members due to attribution of symptoms as part of the normal aging process. Family dynamics, built environment, and sociocultural environment factors that influence optimal care and quality of life.

Diagnostic protocols or guidelines that create gaps in care delivery. Diagnostic, treatment, and continuity of care complexities associated with multiple coexisting chronic conditions. Side effects and adverse events associated with complex pharmacological therapy.

Unfamiliarity or lack of proficiency in key cultural factors across different levels in the healthcare continuum and across various stages of the aging continuum. Limited health system resources and infrastructure, and health care policies that may limit coverage eligibility or access to optimal care. Lack of shared decision-making that is guided by principles of aging with dignity, self-determination, and autonomy.

Well synchronized care coordination within and across care teams and care settings can mitigate health disparities in older adults. For example, well-coordinated in-home health care can allow individuals to remain living at home and maintain their independence by receiving care and support from a family caregiver or home health aide.

Also, transitional care interventions for older adults are associated with reductions in preventable hospital and emergency room readmissions. On the other hand, many in-home caregivers may not be trained to properly handle the complex demands of providing and coordinating care.

In addition, the effectiveness of care coordination may be impaired by the fragmentation of care, and breakdowns in coordination, communication, and collaboration processes between care team members, including the older adults and caregivers. These could result in delayed or missed diagnoses and timely treatment.

Furthermore, interventions on care coordination involving in long-term care, palliative and/or end-of-life care settings -where most hospice care takes place-, and for patients from populations that experience health disparities are sparse. Hence, crucial research gaps remain for improving the prevention, diagnosis, and treatment for many health conditions that burden older adults from populations that experience health disparities.

Similarly, novel interventions that explore the role of shared decision-making and care coordination are needed. Neglect and mistreatment of older adults would be expected to impair the effectiveness of medical care/diagnostic recommendations, care coordination and shared decision making.

However, the risk and protective factors associated with mistreatment of older adults from populations that experience health disparities - and interventions to address it- are understudied.

Therefore, the design, study and/or evaluation of strategies or interventions that address neglect and/or mistreatment within the context of care coordination across care teams, care settings, and agencies (e.g., protective services, home health, financial, legal services, housing) of older adults from populations that experience health disparities is another crucial research gap to be filled.

In addition to the goals stated under the Purpose, the overarching aim of this NOFO is to identify and understand best practices to engage older adults and their caregivers in providing appropriate care that is central to the attainment of optimal physical and mental health and wellbeing of older adults and the reduction of health disparities in this population.

Projects should focus on one or more NIH-designated health disparity populations living in the 50 states, the District of Columbia, Tribal Nations, and the U.S. territories.

Applications proposing approaches which consider multi-level determinants of health (e.g., patient, clinician, health care system, community) to address health disparities while optimizing the health and well-being of older adults from populations that experience health disparities are encouraged. Projects that focus on NIMHD areas of interest will be prioritized (please refer to the NIMHD Research Framework for details).

Applications that plan to collect primary data from older adults, caregivers, clinicians and other persons are strongly encouraged to use the measures on social determinants of health in the PhenX tool kit . This initiative will support research in outpatient, inpatient, institutional-based long term care settings, home-based care, and emergency care facilities serving older adults.

In addition, research that involves a partnership with relevant agencies (such as area agencies on aging, state units on aging, senior services, advocacy organizations for older adults, faith-based services) that offer home and community-based services for the older adult such as home-delivered meals, case management, companionship programs, are welcome.

Outpatient settings include primary care, specialty clinics and specialty care settings such as dialysis or chemotherapy centers. Inpatient and institutional long-term care settings include hospitals, assisted living facilities, skilled nursing facilities, and long-term chronic care institutions.

Research within the context of transitional care (e.g., hospital to home, or rehabilitation to home), palliative care, end-of-life care, and long-term care, where patients interact with clinicians on a regular basis, is also of interest. Studies may involve in-person and/or telemedicine encounters. This initiative is not solely focused on clinical health outcomes.

Research on intermediary measures of non-clinical outcomes (e.g., trust, self-efficacy, self-autonomy, empowerment, safety, and resilience) are of interest.

This NOFO seeks to support descriptive studies, interventions (especially multi-component, multi-sectoral, and/or or multi-level interventions), clinical trials (including cluster-randomized trials, and pragmatic trials), quasi-experimental studies, natural experiments (e.g., impact of policy), quality improvement studies, mixed methods research, and simulation modeling.

Projects focused on rural populations and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and SES. Comparison groups/populations may also be included as appropriate for the research questions posed.

It is expected that lessons learned from this initiative can help build research evidence regarding approaches to improve health outcomes for older adults from populations that experience health disparities.

Specific Areas of Research Interest NIMHD areas of research interests include but are not limited to the following: Optimization of screening, diagnostic and clinical care guidelines for commonly experienced conditions Addressing gaps in timely assessment, diagnosis, and treatment of highly prevalent conditions (infectious and chronic non-communicable conditions) and coexisting conditions in this population.

This may include: Establishing or modifying diagnostic criteria or identifying phenotypes that may be different in older adults. Developing and/or tailoring, testing, and evaluating existing tools to assess symptom burden, quality of life, and/or function, or implementing diagnostic and care guidelines that are adaptable to this population.

Studies that seek to understand optimal practices for the recommendation of screening tests and assessments while considering tradeoffs of harm (e.g., false-positives, over-diagnosis) and benefits (e.g., quality of life) as well as optimal time for screening (e.g., intervals, stopping age) and discontinuation of screening. Shared medical decision-making to enhance care planning and patient agency.

Studies that explore the concept of shared decision-making between clinicians/care team and the older adult and their caregiver(s). These may include: Addressing conflicting recommendations for care as well as balancing clinician recommendations, patient preferences, and caregiver perspectives regarding harms, benefits, and outcomes.

This may include point of care interventions that incorporate clinical decision support (CDS) within electronic health records (EHRs).

Considering patient agency and the legal aspects and cultural norms of decision making (e.g., advance directives), especially within the context of major junctions in care, like invasive procedures, aggressive therapy with significant adverse reactions, or treatment or procedures for which there is insufficient prognostic evidence in older adults.

Developing, testing and/or evaluating interventions in the health care settings that mitigate age-related discrimination, and stereotypes about older adults. Developing, testing and/or evaluating culturally tailored interventions that strengthen care settings to care for older adults while being responsive to their backgrounds, preferences and wishes.

Developing, testing and/or evaluating culturally tailored interventions designed to facilitate coordination of legal assistance for older adults and their effect on strengthening patient agency, improving shared decision making, and in preventing financial exploitation. Effective strategies for coordinating care for older adults from populations that experience health disparities.

Developing, testing and/or evaluating care coordination strategies. These could address: Challenges or breakdowns in the diagnostic and care pathways from one care setting or level to another. Multiple care transitions to and from the home, care facilities, palliative care, and end-of-life care settings.

Care team functioning (e.g., communication), including the role of geriatric case managers and care coordinators. Care setting infrastructures (e.g., coordination tools) to optimize care delivery both within and across care teams (including the patient and caregivers/family), care settings, and other agencies involved in meeting the needs of older adults.

Evaluating the effect of healthcare policies that may drive disparities in older adults (e.g., affordable care, expanded coverage, drug pricing, health care accessibility and financing) on the effectiveness of optimal care coordination and health outcomes.

Studies that evaluate the role or effect of neglect, mistreatment and/or exploitation of older adults and established policies to protect them on the effectiveness of care coordination and other healthcare-based strategies.

Specific Areas of Research Interest for Participating Organizations: National Cancer Institute (NCI) NCI is interested in studies that will advance the development and implementation of innovative healthcare strategies across the cancer care continuum for older adults from populations that experience health disparities.

Research areas of interest to NCI include, but are not limited to: Increasing the integration and uptake of validated assessments (e.g., geriatric assessment, cognitive/physical function assessment) as well as refining and tailoring measures for specific older adult populations that experience health disparities to evaluate symptom burden, quality of life, and/or function across the cancer care continuum.

Recommendations for discontinuation of screening tests should consider tradeoffs of harm and benefits as well as the optimal time for screening discontinuation or for extending the interval between repeat surveillance testing. Enhancing patient-centered communication and shared decision-making processes that are personalized to the values and preferences for care, quality of life, and independence of older adults and their families.

This may include the development or cultural tailoring of communication approaches (e.g., decision aids) and efforts to balance the preferences for care and trade-offs of screening, diagnosis, cancer treatment, and end-of-life care for older adults from populations that experience health disparities.

Understanding and supporting caregiving for older adults with cancer, including care training, promote coping skills, and care management across healthcare settings.

Tailored or adapting caregiving interventions that target medically underserved patient populations are of interest Understanding and improving teamwork and coordination of comprehensive care for older adults from populations experiencing health disparities across the cancer care continuum, particularly as it relates to the management of multiple chronic conditions and during transitions in care from specialist to primary care.

This may include healthcare delivery related factors, such as organizational readiness/capacity, teamwork processes, and care delivery approaches (i.e., in-person/telehealth), as well as communication of survivorship care planning and navigation of care and services tailored to older adult cancer survivors.

Understanding and addressing barriers to cancer care among older adults from populations experiencing health disparities, especially as it relates to age-related discrimination, digital divide, and access to cancer screening, diagnosis, treatment, survivorship care, palliative care, and end-of-life care.

Examining the use of patient-reported outcomes (PROs) to stratify risk, support decision-making, and optimize cancer outcomes specific for older adult cancer survivors from populations that experience health disparities.

Addressing the rehabilitation needs of older adults before, during, and after cancer treatment to reduce the adverse impacts from cancer treatment and to increase cognitive, functional, physical, and psychological resilience.

Addressing the integration of social care into clinical care through the design and testing of interventions that adjust care to the personalized social needs of the older adult cancer survivor as well as connect and coordinate with social care services and resources.

Examples include addressing poverty, food insecurity, housing instability, transportation-related barriers, employment-related impacts, and social isolation/loneliness to optimize the delivery of quality cancer care and improve health outcomes for older adults. Identifying strategies to increase participation of older adults from populations that experience health disparities in studies of cancer survivorship.

Understanding and addressing the divide in access to and use of digital health tools and interventions where technology, online, digital, and mHealth components of interventions (e.g., PROs portals, decision aids, telehealth) can act as barriers to care and further exacerbate health disparities.

National Institute of Nursing Research (NINR) The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, and the community.

National Institute on Aging ( NIA ) The mission of NIA is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.

Work should be guided by the NIA Health Disparities Framework and intervention development aligned with the NIH Stage Model for Behavioral Intervention Development and Science of Behavior Change . NIA supports research that involves primary data collection as well as secondary data analysis.

NIA areas of research interests related to older adults from underserved populations include, but are not limited to, the following: Clinical Care for Older Adults: Improving diagnostic and clinical care guidelines for older adults from populations experiencing health disparities.

Interventions to Ameliorate Health Disparities in Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD): Research to address health disparities, including prevention, detection, and treatment of AD/ADRD. Shared Decision-Making: Enhancing shared decision-making between clinicians, care teams, older adults, and their caregivers to improve communication, care planning, and decision-making tools.

NIA is especially interested in Shared Decision-Making in Palliative Care. Care Coordination: Focus on addressing care coordination challenges for persons with multiple chronic conditions and across various care settings and transitions, aiming to mitigate delayed or missed diagnoses and treatments. Interventions that test approaches to reduce interpersonal bias and discrimination in health care settings.

Developing and assessing interventions to mitigate age-related discrimination based on stereotypes against older adults. Encouraging research focused on identifying sources of bias and discrimination, considering both individual and institutional levels. Elucidating the types of cognitive biases that can occur, such as confirmation bias, anchoring bias, etc., in interpersonal interactions.

Highlighting the contexts in which these biases arise, including clinical decision-making, diagnostic biases, and consideration/presentation of treatment options Evaluating existing methods and developing new strategies for health-system based interventions to prevent, recognize, and address various forms of elder mistreatment, including physical, sexual, emotional, or psychological abuse; neglect; abandonment; and financial or material exploitation.

RFA-AG-24-048 contains a more comprehensive description of NIA’s interest in this area. Developing and evaluating interventions to improve access to and receipt of palliative care for medically underserved older adults and their caregivers at the time of diagnosis or during treatment.

Office of Disease Prevention (ODP) The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research.

The ODP provides co-funding support for research that has strong implications for disease and injury prevention, health effectiveness, and research that includes innovative and appropriate research design, measurements, and analysis methods.

Applications Not Responsive to the NOFO: Studies without a focus on racial and ethnic minority populations and/or SES disadvantaged persons or the intersection with other populations that experience health disparities. Studies focused on accelerated or accentuated aging in people less than age 65. For example, in people living with HIV, individuals with a disability, etc. Research that is exclusively qualitative.

Projects that test interventions that do not involve more than one level of influence. Projects that prospectively test evidence-based interventions without modifications to the intervention content, delivery, or implementation specific to older adults from population that experience health disparities.

Projects that examine the financing of health care or the cost and efficiency of health care service delivery, without linking such economic analysis to measurable health outcomes (See NOT-OD-16-025 for more information). See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A financial assistance 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 How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. 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. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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).

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

Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applications for additional information. 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.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; 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 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 their organization to develop an application for 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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

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 NIH Grants