Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) (PAR-25-233) is sponsored by National Institutes of Health (NIH) / National Cancer Institute (NCI). This funding opportunity provides small research grants to support the initiation of studies that are generally for preliminary short-term projects in dissemination and implementation in health.

PAR-25-233: Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) 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 Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and Fogarty International Center ( FIC ) Tribal Health Research Office ( THRO ) 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 ) Office of Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed) Notices of Special Interest associated with this funding opportunity 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 PAR-25-144 , R01 Small Research Grants PAR-25-143 , R21 Exploratory/Developmental Grants See Section III.

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

399, 93. 121, 93. 853, 93.

866, 93. 989, 93. 865, 93.

242, 93. 279, 93. 113, 93.

172, 93. 273, 93.

310 Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, sustainability, scale-up, and spread of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies (herein referred to collectively as evidence-based interventions).

Studies that promote the dissemination and implementation of evidence-based interventions among relevant communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged.

Applications that focus on re-implementation of evidence-based health services that may be disrupted amidst disasters remain relevant. All applications must be within the scope of the mission of one of the Institutes/Centers listed above. 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 purpose of this Notice of Funding Opportunity (NOFO) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, sustainability, scale-up, and spread of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies (herein referred to collectively as evidence-based interventions).

Studies that promote the dissemination and implementation of evidence-based interventions among relevant communities are encouraged. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged.

Applications that focus on re-implementation of evidence-based health services that may be disrupted amidst disasters remain relevant. Each year, billions of U.S. tax dollars are spent on research and hundreds of billions are spent on delivery of health interventions, healthcare services, and public health programs in clinical and community settings.

However, relatively little is spent on research to understand how best to ensure that the lessons learned from research are relevant to inform and improve the quality of health, delivery of services, and the utilization and sustainability of evidence-based interventions.

For years, we have known of the limitations of research publications in leading to widespread uptake of evidence-based interventions, but too often the scientific pathway ends prematurely, before we can determine the best ways to improve the dissemination, adoption, implementation, sustainability, scale and spread.

Given the interest and investment in intervention trials that seek to determine the optimal interventions to be used in clinical and community settings, it is essential that practitioners (e.g., healthcare providers, public health practitioners), consumers, families, caregivers, communities (e.g., workplace, school, place of worship), healthcare practice settings, and policymakers are equipped with empirically-supported strategies to integrate scientific knowledge and effective health interventions into everyday use.

The National Institutes of Health has recognized that closing the gap between biomedical or basic behavioral discovery, population health, and healthcare delivery and public health is both a complex challenge and an absolute necessity if we are to ensure that all populations benefit from the Nation’s investments in scientific discoveries.

For many years, health researchers may have assumed that interventions would be readily adopted and implemented once their evidence was established; however, compelling and robust research suggests that this has not been the case.

Even when interventions have been tested within effectiveness studies, the development of knowledge to support their broader dissemination and implementation (e.g., cost and financing of the intervention, practitioner training, availability of resources, integration into community or healthcare systems, delivery to underserved or under-resourced populations, monitoring the quality or effectiveness of intervention delivery) has often remained outside the scope of these large-scale clinical trials.

This has also been the case for the dissemination and implementation of policies and guidelines. Dissemination and implementation research intends to bridge the gap between research, practice, and policy by building a knowledge base about how health information, effective interventions, and new clinical practices, guidelines, and policies are communicated and integrated for public health and health care service use in specific settings.

For the purpose of this NOFO, we make a distinction between "dissemination research" and "implementation research", as follows: Dissemination research is defined as the scientific study of the targeted distribution of information and intervention materials to a specific public health, clinical practice, or policy audience.

The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions. We are currently missing critical information about how, when, by whom, and under what circumstances evidence spreads throughout communities, organizations, front line workers and consumers of public health and clinical services.

As a prerequisite for unpacking how information can lead to intervention or service changes, we need to understand how and why information on physical and behavioral health, preventive services, disease management, decision making, and other effective interventions may or may not reach stakeholders.

We need to understand what underlies the creation, transmission, and reception of information on evidence-based pharmacological, behavioral, psychosocial, genomic, policy, and systems interventions.

Successful dissemination of evidence for effective health interventions may occur quite differently depending on whether the audience consists of consumers, caregivers, practitioners, policymakers, employers, administrators, or other stakeholder groups.

Moving the field forward will require studies identifying mechanisms and communication approaches to package and convey the evidence necessary to improve public health, community, and healthcare services in ways relevant to local settings.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Implementation research seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation, sustainability, scale and spread of evidence-based health interventions.

Implementation studies should not assume that effective interventions can be integrated into any service setting and for consumer groups and populations without attention to local context, nor that a unidirectional flow of information (e.g., publishing a recommendation, trial, or guideline) is sufficient to achieve practice change.

Relevant studies should develop a knowledge base about "how" evidence-based interventions are integrated within a variety of practice settings and patient populations, which likely will require more than the distribution of information about the interventions.

This research announcement encourages studies to test models, theories, and conceptual frameworks of the implementation process that move away from an exclusively "top-down" or reductionist approach to a greater emphasis on the resources of local care settings and the needs of multiple key interested parties, including approaches such as systems science, team science, community engaged research, participatory action research, citizen science, and related approaches that engage stakeholders and end-users throughout the research process.

Dissemination and Implementation (D&I) Research: Broadly, studies in this field typically involve multidisciplinary teams, interdisciplinary cooperation, and even transdisciplinary collaboration, utilizing theories, empirical findings, and methods from a variety of scientific disciplines.

Relevant fields include but are not limited to: information science, organizational and management theory, health economics, behavioral science, public health, business and public administration, statistics, anthropology, psychology, epidemiology, decision science, engagement science, systems science, health disparities research, engineering, and marketing.

D&I research will often include significant and ongoing collaboration with stakeholders from multiple public health and/or clinical practice settings as well as consumers of services and their families/social networks.

This NOFO will support a variety of rigorous study designs including (but not limited to) observational, experimental, quasi-experimental, and simulation modeling that produce evidence on relevant outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability), costs, and/or unanticipated consequences of dissemination and implementation efforts.

The goal is to conduct dissemination and implementation studies utilizing research designs and measures that are rigorous, relevant, and low burden when possible. Studies of dissemination or implementation strategies should attempt to build knowledge both on the overall effectiveness of the strategies, as well as "how and why" they work.

Data on mechanisms of action, moderators and mediators, and costs of dissemination and implementation strategies will greatly aid decision-making on which strategies work for which interventions, in which settings, for what populations, and under what conditions.

For additional resources on dissemination and implementation research, including information on D&I training opportunities, funded studies, key references, past workshops and conferences, visit: http://cancercontrol. cancer. gov/is/ ; and https://prevention.

nih. gov/research-priorities/dissemination-implementation . Specific Objectives and Scope of this NOFO This NOFO invites research grant applications to advance the science of dissemination and implementation in health that are consistent with the size and scope of objectives in the R03 small research grant funding mechanism.

Studies that are larger in size, scope, and objectives are encouraged to apply to the R21 exploratory/development grant program or R01 research project grant program.

Below are examples of types of studies and focus areas that are consistent with the objectives of this NOFO and generally reflect the size and scope of the budget and timeline of the R03 small research grant program that can be carried out in a short period of time with limited resources, that may set up subsequent studies.

Examples of relevant research topics include but are not limited to: Studies that use primary data collection (e.g., surveys) or secondary data (e.g., claims data) to identify factors that contribute to the long-term sustainment of evidence-based interventions in public health and clinical practice.

Studies that conduct economic evaluations (e.g., budget impact analysis, return-on-investment analysis) of dissemination and implementation strategies. Studies of influences on the creation, packaging, transmission, and reception of information about evidence-based interventions to key partners and implementers.

Studies that use secondary data (e.g., administrative data, claims data) to understand variations in the effectiveness of strategies for de-implementing clinical and community practices that are ineffective, unproven, low-value, or harmful. Studies on the development of novel methodological, statistical, systems modeling, and analytical approaches for a range of types of D&I studies.

Studies that focus on empirical testing of theories, models, and frameworks for D&I determinants, processes, and outcomes using primary or secondary data and robust statistical modeling procedures.

Studies that develop psychometrically sound and robust D&I-related measures and instruments, which includes (but is not limited to) testing for multiple types of validity (e.g., construct validity, predictive validity) and reliability (e.g., internal consistency, temporal stability) and assessing for practicality and utility.

Studies that develop pragmatic and actionable measures to guide selection, continuation, and/or discontinuation of the use of particular implementation strategies over time. Studies to better understand the relationship between strength or level of evidence of an intervention and decision-making processes among key partners to adopt and implement (or de-adopt and de-implement) the intervention.

Studies to develop and refine tools and techniques for advancing qualitative and ethnographic methods in D&I research (e.g., rapid qualitative analysis, cross-study qualitative data collection and analytical procedures, and efficient ethnographic data collection and analysis) to enhance contextual understanding of implementation.

Studies to develop robust methods and measures to support rapid, data-driven, and effective adaptation of implementation strategies across implementation phases and implementation contexts.

Studies on effective and collaborative approaches and processes for sharing qualitative, quantitative, and/or mixed methods D&I-related data with researchers, practitioners, and clinical and community partners that is actionable and mutually beneficial. Studies on how to effectively and effectively engage researchers, practitioners, policymakers, and key partners as collaborators and co-creators in D&I studies.

Studies on policy implementation, such as identifying effective strategies for implementing health-related policies across federal, state, local and organizational settings.

Key characteristics of dissemination and implementation (D&I) research that applicants could consider including in their applications (where applicable) include but are not limited to: Description and justification of the evidence-based intervention and hypothesized implementation strategies to improve implementation outcomes (e.g., acceptability, feasibility, adoption, fidelity, penetration, sustainability) as well as health service outcomes (e.g., quality, effectiveness).

Understanding of contextual factors that can influence dissemination or implementation of the evidence-based intervention in various settings under investigation Incorporation and justification of the use of D&I theories, models, and/or frameworks to inform study hypotheses, processes, measures, and outcomes.

Consideration of the extant literature on barriers and facilitators, promising strategies, and/or putative mechanisms, of similar evidence-based interventions integrated in like settings. Identification of possible preconditions, mediators, moderators, and mechanisms of action that explain the impact of dissemination or implementation strategies on relevant outcomes.

Consideration and characterization of the multi-level context and environment in which the proposed research will be conducted, including a description of the intended implementers. Consideration of the use of qualitative, mixed and/or multi methods approaches. Development and/or use of appropriate D&I related outcomes, measures, and analyses.

Applicants are encouraged to review available resources and use standard measures and validated instruments where possible, rather than developing their own measures for each study. Attention to issues of resources expended, program costs, cost-effectiveness, or other economic outcomes related to dissemination and/or implementation.

Incorporation of engagement science (i.e., engagement-related research questions), and including outcomes relevant to patients, consumers, families, practitioners, administrators, healthcare system leaders, and/or policymakers. Formation of multidisciplinary or transdisciplinary teams of researchers and implementing partners, given the range of expertise that may be needed for conducting dissemination and implementation research.

Adequate consideration and specification of the approach and outcomes for the relevant populations. Articulation of methods for tracking changes in context and/or adaptation of implementation strategies throughout the course of the study.

Non-responsive applications Applications that propose to test therapies, imaging, diagnostics, biologics, or devices (e.g., first-in-human studies or drug/device safety trials) Applications that propose to test an intervention in an efficacy trial Information relevant to Specific Institutes/Centers In addition to the above description of the scientific objectives, resources communicating scientific interests of selected Institutes and Centers (I/Cs) are summarized below.

Applicants are encouraged to contact the Scientific/Research contact of the intended I/C to ensure that the aims of the proposed project are consistent with I/C mission. National Cancer Institute (NCI) NCI seeks implementation science projects across the cancer control continuum.

Areas of interest include prevention, detection, and in areas less represented in the NCI-funded portfolio, including in cancer diagnosis, treatment, and survivorship.

Examples include (but are not limited to) studies that seek to understand and evaluate sustainable approaches to coordinate cancer treatment across fragmented systems; optimizing survivorship care among oncology and non-oncology providers; and survivorship care delivery in a variety of settings (e.g.,community practices, rural settings).

Additionally, NCI is interested in supporting applications that focus on understanding strategies to promote sustainability and scale up of effective cancer control interventions, studies that seek to understand de-implementation, and studies that seek to advance measures and methods. Policy implementation research studies are encouraged. NCI is interested in applications that seek to advance health through implementation science.

Areas of interest include projects that promote the reach, delivery, and implementation of evidence-based interventions in/with communities and populations experiencing health disparities.

To advance the effective implementation, the NCI is interested in implementation strategies that incorporate social determinants of health or social needs in developing and testing strategies to advance adoption, adaptation, fidelity, acceptability, cost, and sustainability of evidence-based interventions in cancer prevention and control.

Implementation research aims should be guided by theoretical models and frameworks and the related outcomes or approaches clearly described. Multilevel approaches and transdisciplinary and intersectoral collaborations (e.g., transportation, housing, food systems) are encouraged.

To the extent possible, studies may include an evaluation to assess that implementation projects are not inadvertently exacerbating health disparities or inequalities. Research that engages public health practitioners in community settings (e.g., health departments, coalitions, community organizations) as well as practice-based research are encouraged.

In efforts to advance the field, NCI launched the Consortium for Cancer Implementation Science (CCIS) which broadly focuses on cancer control priorities, cross-collaborations across disciplines and institutions, and innovative solutions to advance measures and methods in implementation science. Applications that advance scientific priorities of the CCIS action groups are encouraged.

See annual meeting summaries at: https://cancercontrol. cancer. gov/is/initiatives/ccis .

We encourage applicants to contact program staff for assistance early in the application process. National Human Genome Research Institute (NHGRI) NHGRI seeks implementation science projects that maximize the usability of genomics across the continuum of healthcare, public health, and society.

NHGRI is interested in applications that develop and assess strategies for implementing the use of genomic information in clinical care, increase genomic literacy, and promote access to and outcomes from genomic information. Strategies may include (but are not limited to) informatics strategies, alternate care models, and behavioral, social, and/or educational strategies.

Multi-level approaches, transdisciplinary collaborations, and meaningful engagement of relevant communities (including clinical, familial, social, organizational) are encouraged.

To the extent possible, implementation studies should include evaluation to assess inadvertent exacerbation of disparities as well as how benefits may be experienced differently within the context of the implementation in order to further maximize health outcomes through genomic information. Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center.

NHGRI strongly encourages potential applicants to contact program staff in the early stages of developing your application. Projects funded by NHGRI though this NOFO will be invited to join the Advancing Genomic Medicine Research (AGMR) Program. AGMR participants attend an annual AGMR Grantee Meeting hosted by NHGRI.

These meetings serve as venues to facilitate sharing of research findings; promote the exchange of ideas; enable discussion of opportunities, challenges, and emerging needs; develop expertise and abilities among collaborators newer to genomic medicine; and accelerate progress in genomic medicine. Applicants to NHGRI through this NOFO may include in their budget travel costs to attend the annual AGMR Grantee Meetings in-person.

National Institute on Aging (NIA) NIA is interested in research to identify and understand barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based health interventions, tools, and policies related to aging or older adults.

For clinical trial proposals, D&I strategies studied should be limited to strategies to disseminate and/or implement interventions that have evidence of efficacy/potency, as well as evidence that the intervention can be delivered in the community with fidelity.

NIA is especially interested in receiving applications that fall within Stage V of the NIH Stage Model for Behavioral Intervention Development that focus on the mechanisms that promote the successful implementation and dissemination of interventions, consistent with the NIH Science of Behavior Change emphasis on mechanisms of change.

Information about the NIH Stage Model for Behavioral Intervention Development can be found at: https://www. nia. nih.

gov/research/dbsr/stage-model-behavioral-intervention-development . Information regarding NIH’s Science of Behavior Change (SOBC) program can be found at: https://commonfund. nih.

gov/behaviorchange . Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Applications assigned to NICHD must address one or more NICHD priority populations.

These include the following individuals: Infants, children and adolescents, including individuals transitioning from pediatric to adult health care providers Pregnant, peripartum, postpartum, lactating women Of reproductive age with regards to gynecologic and reproductive health care Of any age with intellectual and developmental disabilities Of any age with physical disabilities For more specific information on NICHD D&I priority research areas and staff contacts, please visit NICHD Priorities for Dissemination and Implementation Research .

Applicants are encouraged to speak with an NICHD program official during concept development to discuss alignment with NICHD priorities. NOTE: Applications assigned to NICHD that address the mission and priorities of other institutes will not be prioritized for funding by NICHD.

National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Mental Health (NIMH) NIMH encourages a deployment-focused model of intervention design and testing that takes into account the perspective of relevant end-users (e.g., service users, providers, administrators, payers, policy makers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows).

To this end NIMH strongly encourages meaningful inclusion of end-users in the research (e.g., member of an advisory panels and/or inclusion as key personnel). This attention to end-user perspectives is intended to help ensure the research findings will have clear utility to communities, practices, and/or policy makers who may benefit from those findings.

Adaptations or augmentations of existing implementation strategies should only be undertaken if there is (a) an empirical rationale for the adaptation/augmentation, (b) a clear hypothesis to understand how and why the adapted or augmented strategy will enhance outcomes, and (c) evidence to suggest that the adapted strategy will result in a substantial improvement in implementation outcomes (e.g. reach, adoption, scalability, sustainment) associated with the strategy and/or clinical or functional outcomes associated with the intervention.

For more information, see https://www. nimh. nih.

gov/funding/opportunities-announcements/clinical-trials-NOFOs It is strongly encouraged that applicants contact NIMH program staff prior to submission to ensure that applicants are responsive to the institute’s priorities and criteria.

Fogarty International Center (FIC) Tribal Health Research Office (THRO) The Tribal Health Research Office (THRO) serves as the central point of contact at NIH for federally recognized American Indian and Alaska Native (AI/AN) Tribes throughout the United States (U.S.) and is the synergistic hub for all Tribal health research activities and research workforce development at NIH .

The mission of THRO is to improve Native health, enhance capacity for health research in Native communities, and promote opportunities for the next generation of AI/AN researchers. THRO does not have grant-making authority or administer grants.

The office can only support grants deemed scientifically meritorious after review by one of the institutes or centers (ICs) participating in this announcement and after a co-funding request is initiated through the IC.

For this NOFO, THRO is interested in supporting studies that develop and/or test strategies to overcome barriers to adoption, adaption, integration, scale-up and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies in Tribal and/or American Indian/Alaska Native populations. See Section VIII. Other Information for award authorities and regulations.

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. Not Allowed: Only accepting applications that do not propose clinical trials. 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. A budget for direct costs of up to $50,000 per year may be requested. 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 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).

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 Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 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