Part 1. Overview Information

Key Dates

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.

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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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 equitable dissemination and implementation of evidence-based interventions among underrepresented 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 (e.g., pandemics, climate change) remain relevant.

Background

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 equitable 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 equity 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 diverse 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 equity 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 R21 exploratory/developmental funding mechanism. Studies that are larger in size, scope, and objectives are encouraged to apply to the 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 R21 exploratory/developmental research grant program that supports early and conceptual stages of project development. 

All applications should be within the scope of the mission of at least one of the participating Institutes/Centers.

Examples of relevant research topics include but are not limited to:

• Studies that pilot test and refine implementation strategies and study procedures (e.g., data collection, recruitment) in preparation for a large, fully powered implementation trial to be conducted in a subsequent separate study.
• 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 implementation strategies in a variety of settings and across phases of implementation.
• Studies of influences on the creation, packaging, transmission, and reception of information about effective health 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 and pilot test implementation strategies that are novel, missing, or largely absent from the evidence base or published literature.
• Studies to develop robust methods and measures to support rapid, data-driven, and equitable 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 equitably 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.
• Modeling studies, including decision modeling, using administrative data (e.g. electronic healthcare system data) on the current utility and reach of implemented EBIs, to guide decision makers to iteratively improve processes.

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, equity).
• 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 equity-related approach and outcomes.
• 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 diverse 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 equity through implementation science. Areas of interest include projects that promote equitable reach, delivery, and implementation of evidence-based interventions in/with communities and populations experiencing health disparities. To advance the equitable 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 equity-oriented theoretical models and frameworks and the equity 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 equitable 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 inequities or 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, 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.

National Institute of Allergy and Infectious Diseases (NIAID)

The mission of the National Institute of Allergy and Infectious Diseases is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Applicants applying to NIAID should identify partnerships with relevant policy and/or program leaders with a stated commitment to evaluate and incorporate changes which are proven to be both successful and cost-effective and relevant to NIAID's mission. Ideally, research teams will include local experts from an implementing organization and meaningfully incorporate input from community members.

NIAID will not accept clinical trials using new drugs or diagnostic tools or using existing drugs/diagnostics for new purposes in response to this NOFO. However, trial methodology to assess the impact of new strategies for disseminating and/or implementing accepted/validated interventions for prevention or treatment will be allowed. Applicants seeking funding for clinical trials should refer to the following NIAID website: https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources

Specific areas of interest for the Division of AIDS include but are not limited to:

• Research that facilitates the scale up and delivery of FDA approved regimens to prevent and treat HIV, TB, HCV and HBV that impact people at risk for or living with HIV
• Research to advance access and equitable delivery of HIV prevention regimens with regulatory approval in pediatric and adult populations
• Research supporting implementation of epidemiologic methods that inform effective public health response to HIV transmission or outbreak events

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this NOFO, the NIAMS is interested in research related to the dissemination and implementation of research finding from clinical and translational studies. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites implementation science proposals that address questions relevant to the NICHD mission and align with the NICHD Strategic Plan.  These include studies that aim to identify, develop and test innovative strategies that promote broad implementation, uptake and sustainability of interventions with proven efficacy and/or effectiveness. NICHD’s interests also include studies that test strategies aimed at de-implementing interventions that are harmful, non-cost-effective, ineffective, or lacking adequate scientific support.

Applications assigned to NICHD must address one or more NICHD priority populations.  These include:

• Infants, children and adolescents, including individuals transitioning from pediatric to adult health care providers
• Pregnant, peripartum, postpartum and lactating persons
• Individuals of reproductive age with regards to gynecologic and reproductive health care
• Individuals of any age with intellectual and developmental disabilities
• Individuals 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 on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD) recognizes the importance of D&I research to improving the lives of individuals with sensory and communication disorders. In this vein, D&I research is a priority outlined in the NIDCD strategic plan. NIDCD supports D&I research to bridge the gap between research and practice in our seven mission areas of hearing, balance, taste, smell, voice, speech, and language. NIDCD encourages research to understand how we can change behavior of practitioners, support staff, organizations, consumers, and family members to reach our desired outcome: improved diagnosis, prevention, and treatment of sensory and communication disorders across the lifespan.  NIDCD is interested in research to generate critical information about which strategies work for which interventions, in which settings, and for what populations, including underrepresented communities. NIDCD will only accept low-risk clinical trials under this funding opportunity. NIDCD addresses risks in terms of safety, complexity, fiscal investment, and direct scientific/public health impact. Investigators are strongly encouraged to discuss their plans with the NIDCD Scientific/Research Contact well in advanced of submitting their application.

National Institute of Dental and Craniofacial Research (NIDCR)

The NIDCR is interested in D&I research applications relevant to dental, oral, or craniofacial health that align with the NIDCR Strategic Plan. Investigators proposing research that meets the NIH definition of a clinical trial should refer to NIDCR Clinical Trials NOFOs. All investigators are encouraged to contact NIDCR Scientific/Research staff well before submission to discuss scientific priorities.

National Institute of Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in applications relevant to dissemination and implementation (D&I) research that support the NIMH Strategic Plan for Research. Because NIMH requires investigative teams to study the mechanisms underlying interventions (for instance, for drugs, devices and behavioral interventions directed at patients, NIMH requires  the experimental therapeutics approach), all applications that propose clinical trials to test D&I strategies should go beyond assessing just whether a strategy is effective and should include hypotheses about how, why, for whom, and/or in what circumstances the strategy is effective.  Potential approaches include but are not limited to mediation analyses (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, and partial or full factorial designs.  For multi-component or multi-level strategies (e.g., approaches that combine multiple strategies to improve intervention reach, adoption, implementation, scalability, or sustainability of an intervention such as the Collaborative Care Model), other methods to examine the combined or dismantled effects of each of the components on the ultimate outcome(s) (versus modelling such effects through target/mediator variables) could also be employed, particularly if the study is adding a new component to enhance the effect of the combined strategy.

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.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities (i.e., African Americans or Blacks, Hispanic or Latinos, American Indians or Alaska Natives, Asians, Native Hawaiians, Pacific Islanders, Middle Eastern or Northern Africans, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minority populations, and people with disabilities). In the context of this NOFO, NIMHD is especially interested in domestic D&I research that utilizes the NIMHD Research Framework.

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 health equity, 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, justice settings, and the community.

Fogarty International Center (FIC)

FIC aims to support research in low- and middle-income countries (LMICs), including through partnerships with US institutions and investigators, that will build and enhance the capacity of the LMIC institution(s) to carry out research in dissemination and implementation science. The proposed study should explore research capacity strengthening activities at the LMIC institution through structured activities or training. See also: FIC strategic plan https://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx. For additional information regarding FIC supported implementation science research please refer to the following  https://www.fic.nih.gov/ResearchTopics/Pages/ImplementationScience.aspx. All investigators are encouraged to contact FIC Scientific/Research staff prior to submission to discuss scientific priorities.

National Center for Complementary and Integrative Health (NCCIH)

The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care (see NCCIH Strategic Plan). Examples of complementary and integrative health approaches include those with physical and/or psychological therapeutic inputs, often called mind and body interventions (e.g., yoga, tai chi, qi gong, meditation/mindfulness, hypnosis, music therapy, and art therapy), and approaches with dietary or nutritional therapeutic inputs (e.g., dietary supplements, plant-based products, and probiotics). Also of interest are multi-component interventions such as a combination of two or more complementary health approaches or integrated approaches to care in which a complementary health approach is used in combination with standard care. Applications will not be considered by NCCIH if they propose trials of regulated products (e.g., dietary supplements, devices, or biologics) for indications that have not been approved or cleared by the U.S. Food and Drug Administration. NCCIH will only support applications that include complementary and integrative health approaches.

As discussed in the NCCIH Strategic Plan, developing a robust portfolio of implementation science research for effective complementary and integrative health approaches is a top scientific priority (see also NCCIH Research Framework). Specific areas of interest include, but are not limited to, pilot or feasibility trials to evaluate implementation strategies that facilitate the uptake, adoption, integration, and sustainability of evidence-based complementary and integrative health approaches in multiple settings (e.g., schools, communities, healthcare) and in diverse samples. NCCIH is also interested in research that evaluates whether complementary and integrative health approaches can be used to de-implement drugs or other interventions that may be inappropriately used in clinical care, have significant side effects, or for which potential harms outweigh benefits. Investigators are strongly encouraged to discuss their plans with the NCCIH Scientific/Research Contact well in advanced of submitting their application. 

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 equity, and research that includes innovative and appropriate research design, measurements, and analysis methods. Information on resources for designing studies using the best available methods is available at: https://researchmethodsresources.nih.gov/. For this NOFO, the ODP is interested in studies that test implementation strategies to support the adoption, adaptation, integration, scale-up, and sustainability of evidence-based preventive interventions.

The ODP does not award or manage grants. The ODP only accepts co-funding requests from NIH Institutes and Centers (ICs). Therefore, applications likely to receive ODP co-funding must be relevant to the objectives of at least one of the participating NIH ICs listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding the IC’s research priorities and funding. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan or visit prevention.nih.gov.

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.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign 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

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.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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.

2. Cost Sharing

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

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, 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 Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy should clearly describe the following within the appropriate section (i.e., Factor 1: Importance of the Research; Factor 2: Rigor and Feasibility; Factor 3: Expertise and Resources):

Factor 1: Importance of the Research (Significance, Innovation)

• The estimated public health benefit of the research, and whether the existing data, public health and patient needs justify dissemination and implementation.
• If the aims of the proposed project are achieved, how the study results will advance dissemination and implementation knowledge. The ability of potential adopters and organizations to determine the applicability of the results to their setting.
• The reach (to the population that will benefit from the knowledge/intervention) that will be achieved and the equitability of the reach and likely outcomes through the knowledge/service delivery contexts selected.
• The resource requirements and costs of the intervention.
• How the proposed dissemination or implementation research contributes new and innovative concepts, outcomes, measures, and/or design approaches to the field.
• How the study proposed promises to speed the translation of research into practice and/or produce novel and robust findings.

Factor 2: Rigor and Feasibility (Approach)

• Demonstrate an understanding of dissemination and implementation research principles. How the dissemination or implementation approach is appropriate to the problem and population using research methods that are relevant, rigorous and practical.
• Justify the study design on the basis of the current state-of-the-art and or contextual factors relevant to dissemination and/or implementation.
• How the procedures to assess and analyze the dissemination or implementation strategies are appropriate.
• How the measurements and analysis plan are linked to the study aims, and whether the analysis incorporates the best available data to track dissemination or implementation process and impact, including cost-effectiveness.
• Where applicable, how the proposed plan for analysis takes into account hierarchical relationships among multiple levels of outcomes (e.g. patient/consumer, provider, system).

Factor 3: Expertise and Resources (Investigators, Environment)

• Whether the investigators are part of stakeholder teams or have strong links and engagement of stakeholders necessary to accomplish the project aims.
• Clear evidence of dissemination and implementation research expertise as part of the team.
• How the proposed approaches take advantage of unique features of the intervention delivery environment or employ useful, collaborative arrangements

Letters of Support: the letters of collaboration and institutional support should include the level of commitment to the project.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions, consistent with applicable law.

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Please note that reviewers will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Gila Neta, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6785
Email: Gila.Neta@nih.gov

Lori Ducharme
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-6331
E-mail: lori.ducharme@nih.gov

Rebecca Mandt, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-7695
Email: rebecca.mandt@nih.gov

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email: Elizabeth.Neilson@nih.gov

Holly Lynn Storkel
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.451.6842
E-mail: holly.storkel@nih.gov

Faye H Chen, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5055
E-mail: chenf1@mail.nih.gov

Mary Acri, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-910-8230
Email: mary.acri@nih.gov

Alanna Kulchak Rahm, PhD, MS, CGC
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: none
E-mail: alanna.kulchakrahm@nih.gov

Karen A. Kehl, PhD, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-8010
Email: karen.kehl@nih.gov
 

William N Elwood, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 402-0116
E-mail: william.elwood@nih.gov

Jennifer N. Baumgartner, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-402-4084 
Email: jennifer.baumgartner@nih.gov

Crystal Barksdale, Ph.D., MPH
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: crystal.barksdale@nih.gov

Sheila Caldwell, PhD
Tribal Health Research Office
Phone: 301-480-3527
email: caldwells@mail.nih.gov
 

Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov

Claudia Thompson, Ph.D.
NIEHS - National Institute of Environmental Health Sciences
Phone: (984) 287-3330
E-mail:  thomps14@niehs.nih.gov

Tracy M. King, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1822
Email: tracy.king@nih.gov

Lisa Onken, Ph.D. 
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Phone: 30l- 496-3131
E-mail: lisa.onken@nih.gov

Marya Levintova
FIC - FOGARTY INTERNATIONAL CENTER
Phone: 301-496-1653
E-mail: ml531h@nih.gov

Richard T Benson
NINDS - NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
Phone: 301-496-9135
E-mail: richard.benson@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 301-496-8634
Email: wolfreyc@mail.nih.gov

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: ADevine@niaid.nih.gov

Samantha J Tempchin
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-1404
E-mail: tempchins@mail.nih.gov

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email:tamara.kees@nih.gov

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: deanna.ingersoll@nih.gov

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
 

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Priscilla Grant
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Bruce R Butrum
FIC - FOGARTY INTERNATIONAL CENTER
Phone: 301-451-6830
E-mail: butrumb@mail.nih.gov

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.