Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required)

Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required) is sponsored by National Institute on Aging (NIA). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-21-307: Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required) 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 ) Components of Participating Organizations Funding Opportunity Title Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required) R01 Research Project 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 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity R61 / R33 Phase 1 Exploratory/Developmental Grant/ Exploratory/Developmental Grants Phase II See Section III.

3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) solicits mechanism-focused dementia care and caregiver support intervention development research at Stages I through V of the NIH Stage Model to address the care needs and promote the health, function, and well-being of persons with Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) and of those providing their care.

The NIH Stage Model offers a framework to: (1) support development of efficacious interventions that are defined by their principles; and (2) ensure that these efficacious interventions can be administered in the community or in health systems with fidelity to the intervention’s principles.

This includes the development, testing, and validation of scalable training materials and procedures so that these interventions can be delivered with fidelity in community settings or health systems. Settings can include the home, community, or formal care settings, such as nursing homes, assisted living facilities, nursing and rehabilitation centers, hospitals, adult day care, and specialized hospice settings.

The overarching purpose of this FOA is to help to lay the groundwork for real-world implementation of AD/ADRD care and caregiving interventions. The principle-based interventions under development may target behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health-systems level.

Applications may propose mechanism-focused intervention research for individuals living with dementia or for individuals or systems providing care for people at any stage of AD/ADRD. Applications proposing the development of interventions that address the principles underlying the care needs and challenges for individuals from diverse racial, ethnic, and socioeconomic backgrounds are strongly encouraged.

Applications that involve interdisciplinary expertise and translational expertise (e.g., basic behavioral, social, psychological, or neurobiological science expertise relevant to hypothesized intervention mechanisms; expertise in the AD/ADRD service delivery system; and clinical psychological science expertise in areas outside of aging or AD/ADRD, but potentially relevant to AD/ADRD caregiver research, etc.) are also strongly encouraged.

Applications may propose to create, modify, and test AD/ADRD care and caregiver support interventions based upon hypothesized mechanisms of action and are encouraged to incorporate a test of essential components or mechanisms of change using an appropriate methodological approach.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) 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.

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 The NIA AD/ADRD Research Implementation Milestones highlight the need for novel and innovative dissemination and implementation methods to scale up promising practices in dementia care across settings and across disease severity spectrum (Milestone 13. H).

A recent evidence review conducted by the Agency for Healthcare Research and Quality ( AHRQ) on Care Interventions for People Living With Dementia and Their Caregivers underscored the need for rigorous, well-powered, replicable research addressing issues of intervention fidelity, efficacy, and potential intervention mechanisms, prior to dissemination and implementation on a wide scale.

This Funding Opportunity Announcement (FOA) is intended to address challenges highlighted in this evidence review by calling for activities that can lay the groundwork for principle-based Alzheimer's disease (AD) and AD-related dementias (ADRD) care and caregiving interventions that can be delivered with fidelity in the real world.

The activities called for in this FOA are designed to facilitate the success of these trials by providing additional stepping stones toward ultimate implementation. Interventions are described by their essential components, the level of training required, and fidelity.

Simple interventions are defined in this FOA as single-component interventions that can be administered easily with high fidelity, with minimal or no training required to ensure fidelity (e.g., nudge trials, default trials, pre-determined text messages etc.).

Complex interventions are defined in this FOA as single- or multi-component interventions that require training to administer with high fidelity (e.g., interventions administered by clinical personnel, such as palliative care interventions, or interventions to cope with a dementia diagnosis). Millions of people in the U.S. are afflicted with Alzheimer's disease (AD) and AD-related dementias (ADRD), and this number is increasing.

The extensive care needs of individuals with AD/ADRD are variable, and care typically involves great demands on spouses and other family members. Because care also requires coordination with a wide range of community and healthcare providers, it is often associated with high out-of-pocket costs.

While many studies have been developed to improve care or support care providers, many factors contribute to the creation of barriers between efficacy and implementation, and few interventions have been implemented at scale. Some of these are systematic barriers that impede implementation and dissemination generally.

In addition, some impediments to implementation are specific to the intervention itself, such as deficiencies in (1) knowledge of the underlying mechanism(s) or critical components of the intervention or the implementation strategy for disseminating the intervention, and (2) methods to ensure fidelity of delivery of the intervention in the community, including scalable, tested and validated training materials, that are designed specifically for use by individuals in the community, to deliver complex interventions.

This FOA solicits research to address these two major impediments to translation of AD/ADRD interventions into real world settings. Intervention Principles: The first challenge relates to the lack of knowledge regarding how and why interventions work.

An insufficient understanding of the underlying principles of interventions, or the mechanisms of action of the interventions, may impede implementation in several ways: 1) simplifying and streamlining an intervention while ensuring that it will retain its potency is not possible when the underlying principles of an intervention are unknown; 2) many interventions need to be modified for a specific population or setting, but modification may interfere with intervention potency if the active ingredients necessary for efficacy are inadvertently removed due to adaptation/modification; 3) flexible delivery of interventions is critical to implementation in the community, but interventions cannot be delivered with both flexibility and fidelity if the main underlying principles of an intervention cannot be explained to the person delivering the intervention.

Interventions that are defined by their principles could facilitate implementation by enabling simplification of the intervention and by promoting an understanding of how and when an intervention can or cannot be adapted while still retaining its positive effects.

This understanding of principles is required for a scientifically informed understanding of the boundaries in which an intervention can be delivered with flexibility while retaining fidelity, a necessity for successful translation from research to practice. Training and Fidelity: The second challenge concerns the training and expertise of those who administer intervention trials.

Complex interventions conducted in efficacy trials are typically administered by interventionists who are experts or trained by experts, often accompanied by intensive supervision and/or monitoring.

Pragmatic clinical trials and real-world implementation realistically cannot involve expert trainers, intensive training, supervision and/or monitoring, but instead may need to rely on training materials provided directly to participants or community representatives.

Very few AD/ADRD care and caregiver support interventions, however, include user-friendly, relatively low-cost training materials, geared specifically to the person in the community who will be learning and administering the intervention, and that have been tested and validated for ensuring adequate and sustained fidelity.

This PAR utilizes the NIH Stage Model as its conceptual framework and encourages causal hypothesis testing as described in the Science of Behavior Change (SOBC) experimental medicine approach, wherever appropriate. The NIH Stage Model for Behavioral Intervention Development: The NIH Stage Model has the goal of creating efficacious, ultimately implementable interventions defined by their principles.

It offers a framework for describing where an intervention is in the developmental pipeline and specifies appropriate research activities within different Stages of intervention development. The model facilitates discussion of intervention development research by applicants, reviewers, and funders with a common language.

An understanding of the mechanisms of action or the principles underlying an intervention is an inherent goal of the NIH Stage Model. The NIH Common Fund's Science of Behavior Change (SOBC) Program/Experimental Medicine Approach: The SOBC mechanism-focused, experimental medicine approach is a methodology that is compatible with the NIH Stage Model .

It encourages clear a priori specification of the intended mechanistic target(s) of an intervention, and methods that test causal hypotheses about the degree to which an experimental manipulation or intervention engages those targets.

Within the experimental medicine approach to behavior change, intervention targets may include mechanisms or processes at any level of analysis (e.g., environmental, social, contextual, interpersonal, behavioral, psychological, and/or neurobiological).

The SOBC program established the expectation that behavior change interventions are designed to explicitly test hypotheses about mechanisms of action, and that they incorporate appropriate measures to enable such tests.

This includes testing hypotheses about which components of an intervention are responsible for change in a target mechanism or process, as well as hypotheses about whether changes in that mechanism result in a change in the relevant outcome. This approach, especially when timing is considered within the design (e.g., does the hypothesized mechanism change before the anticipated outcome, or after the anticipated outcome?)

and the NIH Stage Model enable each intervention study to contribute to a cumulative science of behavior change, strengthening our understanding of the principles whereby efficacious care and caregiver interventions achieve their effects.

This FOA encourages applications that propose to modify, adapt, and conduct a preliminary test of efficacy and the principles of an existing AD/ADRD care and caregiver support intervention or an intervention originally developed in a non-caregiver population that might be adapted for use in the dementia care and caregiving context.

Applicants are expected to articulate their research aims and define the Stage of intervention development proposed using the NIH Stage Model framework. Applicants are required to use an appropriate experimental design to test hypotheses that will identify the essential components of complex interventions, or that will elucidate the mechanism(s) by which an intervention exerts its effects.

This FOA also encourages research to develop, test, and validate training materials to ensure fidelity to the principles of an intervention when it is delivered in the real world. The types of behavioral intervention development clinical trials of interest include, but are not limited to, the following: (1) Mechanism-focused research seeking to develop dementia care and caregiver support interventions defined by their principles.

This FOA solicits research to generate, modify, adapt and test interventions while simultaneously testing their hypothesized mechanism of action. Appropriate studies include the following: Stage I mechanism-focused, adequately powered studies to leverage and incorporate Stage 0 (basic science) findings to create and conduct a preliminary test of a dementia care or caregiver support intervention for efficacy and for its principles.

Stage I mechanism-focused, adequately powered studies to modify/adapt, in accordance with its principles, and to conduct a preliminary test of an intervention: Adapt and test an evidence-based non-caregiving intervention to a dementia care/caregiving context or population; Modify the form of an existing dementia care/caregiving intervention into a more scalable, streamlined, simplified, and more easily implementable form, and conduct a preliminary test; Modify the form of an existing dementia care/caregiving intervention to improve potency, and conduct a preliminary test.

Stage II or III studies testing efficacy using an adequately powered and appropriate experimental design (e.g., experimental medicine approach; factorial or partial factorial design; sequential, multiple assignment, randomized trial (SMART) approach, "MOST," or Multiphase Optimization Strategy) to determine/confirm efficacy and mechanisms of action or essential ingredients.

Stage IV studies that test effectiveness of interventions defined by their mechanisms/principles, using an adequately powered and appropriate experimental design. This may include Stage IV Rapid Pragmatic Trials. When Stage IV Rapid Pragmatic Trials are proposed, please note the following: Simple interventions (e.g., "nudge" trials, "default" trials, pre-determined text messages, etc.): must replicate results.

Complex interventions: replication is encouraged but not required. Stage V studies aimed at determining the mechanisms of AD/ADRD care and caregiver support intervention implementation strategies. Two of many possible examples of mechanistic hypotheses and the testing of these hypotheses are provided below for illustrative purposes.

Applications proposing mechanisms-focused intervention development work would be designed to test such hypotheses: Example 1: Hypothesizing, based on basic science findings, that changing (increasing or decreasing) a specific target (e.g., a type of empathy such as emotional or cognitive empathy or compassion) will lead to decreased negative affect (e.g., depressive affect or anxiety) in caregivers, and testing whether an intervention designed to change this type of empathy does so (engages the target), and determining if these changes are causally related to the hypothesized changes in caregiver anxiety.

Example 2: Hypothesizing, based on basic science findings, that a specific type of music (e.g., music that is known to be liked by the recipient; music of a certain type, like classical music; or music that was played at a critical period during brain development) when played in a specific way, engages a specific target (e.g., emotion, emotion regulation, specific types of memories, etc.) which will lead to the desired outcome (e.g., improved well-being, better emotion regulation, decreased anxiety, improved memory) in persons living with dementia; followed by testing whether a specially-designed music intervention causes the changes in the specified target, and, if so, if these changes are causally related to the hypothesized outcomes.

(2) Research that seeks to enhance fidelity and/or develop, test, and validate training materials to ensure fidelity to the principles of the interventions for those in the community who deliver the interventions .

Such projects may include, but are not limited to, the following: Modifying an Intervention to Promote Fidelity : Stage I and Stage III research, guided by the hypothesized mechanisms of change of an intervention, to modify and conduct an adequately-powered preliminary test of this modified intervention, with the goal of maximizing the real-world fidelity of delivery to the principles of the intervention while retaining the intervention’s essential ingredients (e.g., simplification of the intervention, computerization of intervention modules while retaining intervention potency, etc.).

Training Procedure Development and Testing : Within the NIH Stage Model, an efficacious intervention is considered incompletely developed until it can be delivered in the community with fidelity to its principles. Training procedures to ensure optimal fidelity may be developed and preliminarily tested within Stage I studies, and further tested within community-based Stage III trials.

Such research is meant to be guided by a focus on determining the mechanisms/principles of an intervention to produce operationalized and validated training materials that result in fidelity to those mechanisms/principles.

This FOA supports adequately powered Stage I or Stage III research to create, test, and validate user-friendly, easily deliverable interventions to train care providers in the community to deliver an intervention while maintaining fidelity to the principles of the intervention.

Applications proposing to develop training materials for such interventions would aim to ensure that the delivery of the intervention remains true to its principles of action.

Examples include, but are not limited to, the following: Modules to train community interventionists (e.g., caregivers, nursing assistants, nurses, occupational therapists, physicians) to deliver specific elements of a complex AD/ADRD care intervention with fidelity in nursing homes or assisted living settings. Modules to train community interventionists to deliver an intervention with fidelity to a family care provider.

"Gamified training materials that community interventionists enjoy, and that increase fidelity of delivery. Training modules, methods, or procedures to improve memory for the essential ingredients/elements or principles underlying an intervention, increasing memory for training materials, and thus increasing fidelity of delivery.

Training materials for any intervention that requires training to ensure fidelity to the intervention’s principles when administered in the community.

Specific Areas of Research Interest AD/ADRD care and caregiver support intervention research can be for ultimate implementation in the home, community, or formal care settings, such as primary care, nursing homes, assisted living facilities, nursing and rehabilitation centers, hospitals, adult day care, and specialized hospice settings.

These interventions may target behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health systems level. AD/ADRD care and caregiver support interventions may be studied within Stages I, II, III, or IV. Implementation strategies for AD/ADRD care and caregiver support interventions may be studied within Stage V.

Applications may propose intervention research for individuals or systems who are providing care for people at early-, mid-, or late-stage AD/ADRD. Applications that address the principles underlying the care needs and challenges for individuals from diverse racial, ethnic, geographic, and socioeconomic backgrounds are strongly encouraged.

Applications that involve interdisciplinary and translational expertise, as relevant (e.g., basic science expertise regarding questions about mechanisms; healthcare system expertise when designing interventions to be used in assisted living or nursing home settings) are strongly encouraged.

Applications are expected to propose principle-driven intervention development research with an eye toward real-world implementation, involving stakeholders and community participants wherever appropriate.

Applications are required to use an appropriate methodology (e.g., the experimental medicine approach) to identify the essential components of interventions, to determine the mechanism(s) responsible for an intervention’s effects, or to demonstrate that intervention can be delivered with fidelity to the principles or mechanisms of action.

Dementia care and caregiver support interventions can focus on a variety of outcomes for the person living with dementia and/or their caregiver, including, but not limited to improvements in sleep, subjective well-being and quality of life, stress coping and stress management, decision-making, care planning, financial planning, adherence to health-promoting behaviors, memory, relationship quality, social engagement, management of behavioral symptoms of dementia, care coordination, care quality, and care delivery.

Intervention approaches may be derived from a variety of fields, including from psychology, neuroscience, behavioral economics, behavioral medicine, health services research, communication science, psychiatry, and geriatric medicine. Digital/mHealth or other technology approaches may be harnessed.

Interventions may be at the individual, interpersonal, or systemic level and can include such things as environmental modification, electronic health record (EHR) modification, care coordination modification, etc. Examples of individual, dyadic, or group level interventions for persons living with dementia and/or their care partners include, but are not limited to, the following: Empathy/compassion-focused interventions to promote emotional well-being for care providers or recipients informed by and incorporating Stage 0 (basic) research on empathy and compassion.

Music-based interventions informed by Stage 0 basic research on music, the brain, and human development to inform dosage, type, frequency, etc. of the intervention. Interpersonal interventions (e.g., dyadic caregiver/person with dementia, or interventions with caregivers, care recipients, and providers) leveraging and incorporating Stage 0 research on social, interpersonal, or affective processes.

Memory-focused interventions, informed by basic or clinical research on cognition and/or memory, to serve as an adjunct to another health-promoting intervention (e.g., a medication adherence intervention, an intervention to treat insomnia, an intervention to minimize negative affect, etc.) to improve the potency of that intervention.

Interventions designed to decrease depression or anxiety levels, adapted for caregivers from interventions designed to decrease anxiety in other populations that are based upon basic principles of behavior change (e.g., behavioral activation, principles of extinction, inhibitory learning, etc.) Examples of interventions at the organizational or institutional level in Long Term Services and Supports (LTSS) settings, such as in-home health care, assisted living facilities, adult day cares, nursing homes, hospices, hospitals, include, but are not limited to, the following: Care coordination (within a health system or between a health system and a home or community-based system) interventions informed by and incorporating Stage 0 (basic) research on organizational and care team-level processes/mechanisms.

Patient or provider decision supportive interventions (e.g., advance care planning, de-prescribing, referral to palliative care services) informed by and incorporating Stage 0 (basic) research on features of incentives, framing, choice architectures, organizational processes/mechanisms, etc. Organizational interventions to promote well-being and quality of life and reduce distress through environmental modification or modification of programs informed by and incorporating Stage 0 (basic) research on environmental affordances, systems processes, and/or processes that impact individual well-being.

Applications Not Responsive to this FOA The following types of applications will be considered nonresponsive and will not be reviewed. This includes applications that: Do not propose a clinical trial, identified as Stage I, II, III, IV, or V as the primary specific aim.

Do not propose a hypothesized mechanism of action or hypothesized essential ingredients based upon quantitative data (hypotheses based solely upon qualitative data will not be reviewed). Do not address issues of power. For Stage IV rapid pragmatic trials only: do not identify as a simple or complex intervention.

For Stage IV rapid pragmatic trials only: do not replicate results for simple interventions. For Stage IV and V trials: Do not address generalizability to diverse populations.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator.

Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions.

Additional information is available at https://researchmethodsresources. nih. gov/ .

The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research.

This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary. 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 Resubmissions from RFA-AG-18-030 "Dementia Care and Caregiver Support Interventions (R01 - Clinical Trial Required)" are not 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. Required: Only accepting applications that 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 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) Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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