National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Cancer Institute (NCI)
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)
Office of Research on Women's Health (ORWH)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
The purpose of this notice of funding opportunity (NOFO) is to support research on interventions to improve health in Native American populations. This includes 1) etiologic research that will directly inform intervention development or adaptations, 2) research that develops, adapts, or tests interventions for health promotion, prevention, treatment, or recovery, and 3) where a sufficient body of knowledge on intervention efficacy exists, research on dissemination and implementation that develops and tests strategies to overcome barriers to the adoption, integration, scale-up, and sustainability of effective interventions. Through this initiative, intervention and related research is sought to build upon community knowledge, resources, and resilience to identify and rigorously test culturally appropriate solutions to reduce morbidity and mortality. Interventions should be designed with a consideration for sustainability within the communities where they are tested, and have the flexibility to be readily adapted, disseminated, and scaled up to other communities where culturally appropriate. This NOFO is part of the Intervention Research to Improve Native American Health (IRINAH) initiative, which also includes NOFOs using the R21 Exploratory/Developmental Research Grant mechanism (PAR-25-380) and the R34 Clinical Trial Planning Grant mechanism (PAR-25-378). Research projects may address topics within the identified interests of any of the participating Institutes or Centers; projects are not limited to substance use and addiction research.
For the purposes of this NOFO, Native Americans include the following populations: Alaska Natives, American Indians (whose ancestral lands fall at least partially within the U.S. mainland border), and Native Hawaiians. The term ‘Native Hawaiian’ means any individual any of whose ancestors were natives, prior to 1778, of the area which now comprises the State of Hawaii.
NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
October 21, 2025 | October 21, 2025 | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
October 21, 2026 | October 21, 2026 | January 07, 2027 * | March 2027 | May 2027 | July 2027 |
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.
Not Applicable
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.
The purpose of this notice of funding opportunity (NOFO) is to support research on interventions to improve health in Native American populations. This includes 1) etiologic research that will directly inform intervention development or adaptations, 2) research that develops, adapts, or tests interventions for health promotion, prevention, treatment, or recovery, and 3) where a sufficient body of knowledge on intervention efficacy exists, research on dissemination and implementation that develops and tests strategies to overcome barriers to the adoption, integration, scale-up, and sustainability of effective interventions. Through this initiative, intervention and related research is sought to build upon community knowledge, resources, and resilience to identify and rigorously test culturally appropriate solutions to reduce morbidity and mortality. Research projects may address topics within the identified interests of any of the participating Institutes or Centers. The inclusion of Native American investigators serving on the study teams or as the PD(s)/PI(s) is strongly encouraged.
For the purposes of this NOFO, Native Americans include the following populations: Alaska Natives, American Indians (whose ancestral lands fall at least partially within the U.S. mainland border), and Native Hawaiians. The term ‘Native Hawaiian’ means any individual any of whose ancestors were natives, prior to 1778, of the area, which now comprises the State of Hawaii.
Despite tremendous strengths, Native Americans have highly disparate rates of disease across many health outcomes such as chronic disease, substance use and addiction, cancer, mental illness, and sexually transmitted diseases. These disease outcomes in many cases can be traced to socio-structural factors and social and environmental determinants of health such as poverty, unemployment, pollution, and poor access to health care in combination with unique factors impacting Native people, such as historical trauma. In the face of these structural challenges, resiliencies and strengths within Native communities and individuals have been drawn upon to improve health outcomes.
There is a significant need for research that identifies malleable targets for intervention, tests the impact of new or existing intervention approaches, and identifies best practices for dissemination and implementation of effective interventions. Interventions that are theoretically grounded and built upon Indigenous Knowledge (see: https://www.whitehouse.gov/ostp/ostps-teams/climate-and-environment/indigenous-knowledge/) and empirical evidence are needed to promote health, to prevent and treat disease, and to support recovery. Given continued disparities in service access and quality, and in disease outcomes, additional efforts are needed to advance dissemination and implementation science relevant to Native communities. There is a need for research to identify, understand, and develop strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines that support the health of Native populations.
Projects proposed should 1) Clearly identify a health or disease condition for which there is need for intervention and community support and engagement to address the problem, 2) Articulate a process for ensuring cultural appropriateness and/or recognition of community strengths and resiliencies, 3) Advance knowledge toward addressing the health or disease condition through etiologic research, prevention research, treatment or recovery research or dissemination and implementation research, and 4) Be designed for sustainability in the test communities and for dissemination and scale up to other communities as indicated. Interventions may address individual behaviors, social conditions, or environmental conditions related to a disease or disorder.
Research should be designed in such a way that there is a high probability that interventions delivered can be scaled and sustained if the intervention is found to be effective. To ensure sustainability of intervention designs and service delivery strategies tested, applicants should, whenever possible, partner with tribes/communities and localities that use existing programming funds (e.g., funding from CDC, SAMHSA, Indian Health Services, Medicaid, Medicare and other insurance providers, and other program funding as appropriate) to support evidence-based programs and leverage those resources as the foundation for building infrastructure.
Qualitative data (structured, semi-structured, open-ended, and observational) can be particularly useful for understanding unique factors related to risk and resilience processes, for refining interventions and measures, for interpreting intervention research findings, and for understanding challenges in dissemination and implementation of effective strategies. Qualitative research is also helpful for assessing community or tribal-level approval and commitment. Applicants may choose to incorporate qualitative or mixed-methods approaches, including talking circles, interviews, focus groups, or other methods.
This NOFO is part of the Intervention Research to Improve Native American Health (IRINAH) initiative (see: https://cancercontrol.cancer.gov/native-american-intervention). The initiative also includes PAR-25-380, which uses the Exploratory/Developmental Grant (R21) mechanism and covers similar scientific scope to this one and PAR-25-378, which uses the Clinical Trial Planning Grant (R34) mechanism and is specifically scoped to support researchers for community-engaged intervention development and feasibility testing. PAR-25-378 may also be used for the development and piloting of protocols for future tests of intervention efficacy, effectiveness, or implementation. Not all NIH Institutes and Centers (ICs) participate in all three NOFOs. Please speak with the Scientific Contact for the IC listed in Section VII below for the IC you wish to target to discuss which NOFO might be the best fit for your proposed project.
Applicants are encouraged to consult American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications, which can be found at https://dpcpsi.nih.gov/sites/default/files/Critical_Considerations_for_Reviewing_AIAN_Research_508.pdf
Coordination across projects. Although the studies supported by the IRINAH initiative will not use a common study protocol, investigators are expected to meet regularly as part of a network to participate in activities in support of advancing research on Native American health. Such activities could include participating in cross-cutting interest groups, sharing and discussion of measures, and developing collaborative publications and products. An annual meeting will be held of all investigators with optional attendance by community partners funded by the IRINAH initiative; monthly or bi-monthly phone calls will also be held. Locations of the annual meeting will vary depending on sites funded through the initiative. Project budgets should include costs for one or more study team members to attend the annual meeting.
Etiology Research. In describing research priorities, the National Congress of American Indians has stated that research must benefit Native people. This means that the research should have tangible benefits by informing strategies for increasing health equity or otherwise provide information that can be used by the community to make improvements. As such, the etiology research supported by this NOFO should have clear implications for improving the ability to intervene. Etiology research should only be proposed when it is intended to discover a more basic understanding or add nuanced clarification, which would be helpful in designing efficacious interventions.
Conceptions of Health. While the absence of a particular disease is a critical outcome, the concept of health within many Native American communities embodies wellness and is broader than the absence of disease. All four elements of life — physical, emotional, mental, and spiritual — are intricately woven together and interact to support a strong and healthy person. In this holistic perspective, illness results from imbalance and wellness from balance in these elements. For Native people who identify strongly with tribal or indigenous culture, working with traditional healers or engaging in traditional cultural practices may be a first step taken to address disease or improve wellness. For this announcement, investigators are encouraged to consider Native concepts of health and Native practices in the study of etiology, prevention, and treatment.
Community Engagement. The appropriate conduct of research with Native American populations has been widely documented; research must be conducted in a community-engaged manner, where the community has an equal voice as a research partner. The research should be consistent with community desires and informed by these at every step of the process. Community based participatory research (CBPR) approaches are one way to ensure appropriate engagement with communities in research and the cultural appropriateness of the intervention, study design and overall approach. Where communities desire to do so, researchers should incorporate a CBPR approach. Communities may choose to pursue approaches other than CBPR, and other forms of community-engaged research are acceptable for this NOFO. The community/tribe(s) must be appropriately involved in the study design and overall approach.
Culturally Appropriate Research. Native communities and experts on Native American research have made clear the importance of culture in addressing health outcomes. Investigators are encouraged to consider culturally unique etiological factors or targets for intervention, relying on culturally relevant theories to frame research, considering culturally specific world views and Indigenous Knowledge as they relate to the research approach and design, culturally sensitive research processes, and culturally appropriate measurement strategies and processes.
Strength-Based Focus. Since many communities place a high value on the strengths and resilience of Native peoples, investigators are encouraged to incorporate community/cultural strengths and resiliencies interventions. It is appropriate to consider community resilience in addition to the resilience of individuals.
Interventions. When studies involve prevention, treatment, or recovery interventions, the interventions must be consistent with community values. Interventions should be supported by theory or empirical knowledge, which can originate from Indigenous Knowledge or from culturally appropriate non-Native paradigms. Intervention studies may test traditional health, medical, and/or cultural practices independent of or in concert with practices that have been tested in research with non-Native populations. Intervention delivery should, whenever possible and scientifically or otherwise appropriate, employ individuals from the community. Such interventionists could include behavioral professionals, community health workers, counselors, nutritionists, nurse practitioners, physician assistants, or traditional healers. The IRINAH initiative aims to strengthen health across multiple Native populations. Applicants should plan to prepare intervention manuals and other potential dissemination activities if evidence for the intervention’s effectiveness is compelling.
Beyond the Individual. Reflecting the importance of community, researchers should consider proposing studies that address community, institutional, familial, peer network, or other factors that directly influence health outcomes or that impact individual's abilities to enact health preserving practices. This could include testing multi-level intervention approaches or addressing and reporting on changes in known contextual influences while intervening to create individual level change. However, the interventions should not be so intensive or time-consuming that they would exceed the resources of the participants/community to participate or sustain the intervention. Please see the NIMHD Minority Health and Health Disparities Research Framework as one example (https://www.nimhd.nih.gov/about/overview/research-framework/).
Clinical Trial Design Considerations. Investigators are encouraged to work with Tribal partners and communities to identify potential research designs that will provide robust evidence of intervention efficacy or effectiveness. Rigorous research designs are expected, but investigators are not required to conduct randomized controlled trials.and to ensure that they have appropriate statistical expertise on the study team to address any non-independence or other potential sources of bias in the study design.
If participants are assigned to study arms, other potentially appropriate study designs with randomization include parallel group or cluster-randomized trials, individually randomized group-treatment trials, and stepped wedge group or cluster-randomized trials. When it is not possible to assign participants to study arms, alternative rigorous research designs that provide robust evidence of intervention effectiveness include, but are not limited to, multiple baseline or repeated measures designs, interrupted time series studies, or stepped-wedge cluster randomized trials in which all subjects receive the intervention.
In these studies, special methods may be warranted for analysis and sample size estimation, particularly for small samples where traditional experimental randomization is not possible without impacts on bias or contamination.
Investigators are strongly encouraged to review the NIH Clinical Trials definitions and policies ( https://grants.nih.gov/policy/clinical-trials.htm ). Applications that do not include all required documentation for clinical trials for review, but are determined to be clinical trials, may not be considered for funding.
The following types of studies are not responsive to this NOFO and will not be reviewed:
Participating NIH ICs have identified priority research areas below. Applicants are encouraged to speak with IC representatives for technical assistance (see Agency Contacts in Section VII). Applicant organizations with limited research experience are strongly encouraged to develop applications in collaboration with research organizations.
Applicants should ensure that the IC they wish to target participates in the IRINAH NOFO to which they wish to submit. Applications that do not align with the missions of any of the participating ICs will be considered non-responsive.
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse (NIDA) is interested in culturally appropriate etiology, prevention, treatment, recovery, implementation, and dissemination research focused on substance use among Native adolescents and adults. NIDA is interested in a wide array of substances including but not limited to nicotine, psychostimulants/methamphetamines, opioids, cannabis, synthetic drugs, and psychoactive prescription drugs. Research at the intersection of HIV and substance use, including research that incorporates HIV prevention and/or care, also is welcome. Investigators are encouraged to propose research in urban, rural, and reservation settings and research that utilize existing infrastructure, community resources, service systems (public and private), and health and wellness providers. NIDA also invites research on the essential components of prevention and treatment interventions (including putative treatment targets) to improve effectiveness, scalability, and personalization.
Special Considerations
NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.
National Cancer Institute (NCI)
Overall, Native Americans have higher rates of getting cancer and the lowest 5-year cancer survival rate of any subpopulation in the U.S. Poorer cancer survival rates have been attributed to many factors, including inadequate health care access, geographic isolation, later stage of detection, underutilization of treatment, and cultural barriers.
The National Cancer Institute (NCI) is committed to eliminating cancer related disparities and is interested in applications that focus on individual, familial, and community interventions that inform and promote health equity along the cancer continuum, from prevention to early detection, treatment, follow-up care, through end-of-life research. It is important that researchers consider the structural context in which people live and develop feasible, acceptable, sustainable, and scalable interventions that can improve overall health and cancer outcomes. NCI is also interested in research seeking to understand the etiology of cancer, and implementation projects that build on the existing knowledge to improve cancer prevention and control outcomes.
NCI is not participating in the R34 Planning Grant NOFO (PAR-23-285). Please use this R01 mechanism to submit applications and incorporate aims that fit within the scope of PAR-23-285 into your R01 application as needed. For further clarification, please contact the NCI Scientific Staff listed in below. Applicants are encouraged to visit the DCCPS website for more information on health disparities priorities and agendas.
National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung, and Blood Institute (NHLBI) supports research that tests culturally-appropriate and sustainable interventions to reduce cardiovascular, pulmonary, blood, or sleep-related disorders and associated morbidity and mortality across the lifespan. Interventions may address behaviors that adversely impact health and well-being, including but not limited to smoking, poor dietary behavior, physical inactivity, and poor sleep. Interventions that address health outcomes related to cardiovascular, pulmonary, blood, or sleep disorders, including but not limited to hypertension, dyslipidemia, asthma, chronic obstructive pulmonary disease (COPD) and iron-deficiency anemia are encouraged. In addition, strategies and/or interventions to accurately diagnose, treat, or prevent cardiovascular disease and its risk factors in women, including during the different stages of pregnancy, are of interest. Intervention strategies to promote the health of children including the prevention and treatment of early cardiometabolic risk factors are encouraged. Implementation research that evaluates proven modalities found effective in other populations that may be tested and evaluated in Native populations and methods to enhance the dissemination and use of evidence-based resources are additional areas of interest. Applicants are expected to include at least one social determinant of health in their applications (see NIH’s PhenX Social Determinants of Health Assessments Collection).
National Institute on Aging (NIA)
NIA supports mechanism-based intervention research to prevent, reduce, or eliminate health disparities and inequities over the life course, especially among older adults and people living with Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD). NIA encourages research on factors affecting health and longevity, such as cultural affiliation, socioeconomic and geographic inequality, gender differences, discrimination, and stress, among Native American groups. Applicants are encouraged to consider priorities outlined in NIA’s strategic directions for health disparities research and in the AD+ADRD Research Implementation Milestone Database | National Institute on Aging. In addition, applicants are strongly encouraged to consider how proposed activities might be informed by the four key levels of analysis related to health disparities research – environmental, sociocultural, behavioral, and biological — with priority focus areas in each level as reflected within NIA’s Health Disparities framework. Similarly, NIA encourages applicants to draw upon the NIH Stage Model for Behavioral Intervention Development, which offers a framework to: (1) support development and testing of effective interventions that are defined by their principles and (2) ensure that efficacious interventions can be administered in the community or in health systems with fidelity to the intervention’s principles.
National Institute on Alcoholism and Alcohol Abuse (NIAAA)
The National Institute on Alcoholism and Alcohol Abuse (NIAAA) is interested in etiology, prevention, treatment, recovery, and health services research within Native American populations. NIAAA encourages research that engages AI/AN communities, considers native practices and concepts of health, and continues building a body of culturally appropriate research to address societal and cultural needs and health disparities. Such research can include, but is not limited to the following areas:
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) is interested in culturally appropriate applications focused on transplantation, allergic, autoimmune, and infectious diseases research. Areas of programmatic interest to NIAID include, but are not limited to, research on:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this NOFO, NIAMS is interested in applications relevant to preventive and treatment interventions on both individual and community levels in Native American populations, to reduce and encourage elimination of health disparities in the NIAMS mission relevant diseases. Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Note that different from the other participating Institutes, NIAMS will not accept to this NOFO a clinical trial application that proposes to test a clinical outcome as its primary objective, but will accept clinical trial applications proposing mechanistic studies as defined in NOT-AR-21-009. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical imaging and bioengineering tools, methods, devices, and technologies for the prevention, detection, quantification, treatment, and monitoring of disease. The technology may focus on translation of methods, devices, and tools for pre-clinical research, pediatrics, and retrospective data analysis.
For this NOFO, if an application proposes a clinical trial, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this NOFO for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.
National Institute of Child Health and Human Development (NICHD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks applications that will address questions relevant to the NICHD mission and align with the NICHD Strategic Plan. Applications to NICHD that address the mission and priorities of other institutes that are not participating in this NOFO will not be prioritized for funding by NICHD.
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIDCD invites responsive applications addressing the needs of individuals with communication disorders, specifically those that align with the Institute’s scientific programs of hearing, balance, taste, smell, voice, speech, and language. For more information about NIDCD priorities, please see: https://www.nidcd.nih.gov/about/strategic-plans. Any application proposing a clinical trial must meet ALL the following criteria: not require FDA oversight, not an NIH defined Phase III Clinical Trial, have low risks to subjects, and intends to gather scientific data/evidence to inform subsequent studies. Application funded by NIDCD should have budgets less than $500,000 direct costs per year.
National Institute of Dental and Craniofacial Research (NIDCR)
The prevalence of oral diseases in Native American communities is among the highest in the U.S. Oral diseases share common behavioral and physiologic risk and protective factors with many other diseases and conditions, while those impacting health disparities and inequities are also known to be influenced by a range of social determinants of health such as education, employment, housing and food security, and distance to health care facilities. The National Institute of Dental and Craniofacial Research (NIDCR) is interested in multi-disciplinary and community-based participatory research that addresses social determinants of health contributing to oral health disparities and inequities in dental caries, periodontal disease, and oral and pharyngeal cancer in Native American populations. These studies should not focus on oral health in isolation from general health. NIDCR welcomes culturally-appropriate research that addresses structural and system level factors in Native American communities to generate and/or test holistic and sustainable intervention strategies to promote oral health and disease prevention across the lifespan.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages research within its mission that is conducted using an equity lens considering at each decision point how processes, values, assumptions, and actions may affect inclusive excellence in our research and workforce and the overall well-being and health of diverse population groups. Applicants are encouraged to review NIDDK’s Pathways to Health for All: Health Disparities & Health Equity Research Recommendations & Opportunities to learn more about NIDDK’s priorities for advancing NIDDK health equity and health disparities research programs. NIDDK is particularly interested in community-engaged approaches where investigators partner with community members and key collaborators or interested parties to identify study priorities, activities, and/or outcomes to promote equity and ensure successful strategies have optimal potential for sustainability. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK. Applicants are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the proposed project is within the goals and mission of the Institute.
National Institute of Environmental Health Sciences (NIEHS)
The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. The NIEHS is interested in applications focused on the development, adaptation, efficacy, effectiveness, implementation, or sustainability of culturally appropriate interventions to prevent or mitigate the health impacts of environmental exposures that disproportionately impact Native American populations. Inclusion of Native American investigators and/or community members in leadership roles (e.g., key personnel, Multiple Principal Investigators) is strongly encouraged in the proposed application. Applications can include, but are not limited to:
National Institute of Mental Health (NIMH)
The National Institute of Mental Health (NIMH) is interested in both non-AIDS and AIDS-related mental health interventions and services research relevant to priorities described in this NOFO and the NIMH Strategic Plan for Research. Practice-relevant research that incorporates the perspectives of community and practice partners is encouraged. Applications that propose adaptations to existing interventions should provide an empirical rationale for the need and focus of the adaptation, consistent with NAMHC Workgroup Report recommendations. Clinical trials testing individual-level interventions (i.e., the recipients are patients, family members, providers) must follow the NIMH experimental therapeutics approach and provide a plan to evaluate target engagement, including: an empirical justification for the selected target mechanism(s), measures of the targets(s), and an analytic approach to evaluate whether changes in the targets(s) are associated with changes in the outcomes.
Clinical trials testing services interventions, policy interventions, and/or implementation strategies must seek to understand how, why, for whom, and/or in what circumstances the intervention is effective, to ensure that the study results may be informative regardless of the primary outcomes. Approaches may include mediation analyses, moderator analysis, temporally organized dismantling designs, factorial designs, etc.
Applicants are encouraged to consult with the relevant NIMH Scientific/Research Contact early in the application process.
National Institute on Minority Health and Health Disparities (NIMHD)
The National Institute on Minority Health and Health Disparities (NIMHD) leads scientific research to improve minority health and reduce health disparities, to realize an America in which all populations will have an equal opportunity to live long, healthy, and productive lives. To accomplish this, NIMHD raises national awareness about the prevalence and impact of health disparities and disseminates effective individual-, community-, and population-level interventions to reduce and encourage elimination of health disparities. NIMHD is interested in projects including, but not limited to, the following:
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. 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. Observational, intervention, and implementation research are of interest.
National Library of Medicine (NLM)
For this NOFO, the National Library of Medicine (NLM) is interested in innovative research and development in biomedical informatics and data science to improve health in Native American populations through interventions.
The NLM seeks applications for novel informatics and data science approaches that can help Native American populations gather, manage, and use data and information about their personal health. To bring the benefits of big data research to Native American populations, new biomedical informatics and data science approaches are needed, shaped to meet the needs of Native American populations, whose health literacy, language skills, technical sophistication, education, and cultural traditions affect how they find, understand, and use personal health information. Novel data science approaches are needed to help Native American populations at every step, from harvesting to storing to using data and information in a personal health library.
Applicants must base their proposed work on an informed profile of the intended users among Native American populations and the work should be developed through interaction with the users. The strongest projects will provide approaches that incorporate health data and information from more than one source, such as diagnostic images and links to full-text articles or genome sequence data linked to a family health history. An application should be centered on the problem area being addressed and the intended audience among Native American populations, propose a possible solution that employs novel data science or informatics, and undertake a pilot that will result in evidence of the degree of success and/or needed next steps. Applicants should expect to involve the intended users in their work.
The Office of Research on Women’s Health (ORWH)
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director, NIH, and works with the 27 NIH ICs to advance rigorous research of relevance to the health of women. ORWH does not award grants but co-funds women’s health-related applications and research projects that have received an award from one of the participating NIH ICs listed in the announcement. Applications seeking ORWH co-funding, in response to this NOFO, should ensure that the proposed work is aligned with at least one goal and objective outlined in the Trans-NIH Strategic Plan for Women’s Health Research (https://www.nih.gov/women/strategicplan).
For this announcement, ORWH is interested in research projects that address health disparities in American Indian/Alaskan Native (AI/AN) and Native Hawaiian (NH) women and support culturally appropriate prevention and treatment interventions across the lifespan. These projects should also, when possible, leverage indigenous knowledge and expertise in the research questions being explored, and consider tribal input in implementation strategies, intervention methods, and evaluation processes. Interdisciplinary partnerships to advance maternal health research, reduce preventable causes of maternal morbidity, and propose clinical interventions to improve pregnancy outcomes within populations of AI/AN and NH women are of particular interest. Projects that build the capacity of AI/AN and NH investigators to conduct this research are also encouraged.
The Office of Disease Prevention (ODP)
The Office of Disease Prevention (ODP) is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH ICs, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2024 2028.
The ODP provides co-funding for, but does not award, grants. ODP only accepts co-funding requests from NIH ICs. Therefore, applications likely to receive 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.
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, however THRO can co-fund 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 developmental/exploratory projects that support biomedical and behavioral research addressing critical issues relevant to the health and benefit of Native American populations.
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.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F & A) should see instructions in Section IV below.
The scope of the proposed project should determine the project period. The total project period may not exceed 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Government
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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.
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.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed only when the ancestral catchment area(s) of tribe(s) cross(es) U.S. national boundary.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
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:
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.
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.
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.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
Budgets should include domestic travel funds for one or more study team members to attend the annual IRINAH investigators meeting.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Research Strategy
Applicants must provide evidence that the research question addressed is relevant to and prioritized by the Native American community partners for the study and that the project, if completed successfully, can improve the health of one or more Native American communities. Applicants should clearly articulate how their research builds fundamental knowledge relevant to Native American health. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and to use that knowledge to enhance health, lengthen life, and reduce illness and disability. Through this initiative, fundamental knowledge includes findings that may be specific to a Native American community or group of communities, even if the outcomes may not generalize broadly. Fundamental knowledge may also be defined as principles for community engaged research, or methodological innovations.
Applicants must demonstrate innovation in their proposed research. Some examples of the types of innovations that may be included are the use of Indigenous Knowledge (https://www.whitehouse.gov/ostp/ostps-teams/climate-and-environment/indigenous-knowledge/), research capacity development, novel research design and analysis, novel approaches to community engagement and/or participant recruitment, research to address the cultural appropriateness of standard measures or develop new measures, determination of culturally/clinically meaningful effect sizes, or through the development or adaptation of interventions.
Investigators
Investigators, both those from research institutions and those who work with the community, must show relevant proficiency to conduct the proposed research, including proficiency for working with Native American partners and communities. Indications of proficiency might include research publications, efforts to build relationships and trust with communities, dissemination of information to Native American communities, personal engagement in community events, provision of training to communities, knowledge of community systems and settings, and leadership roles in the community. Productivity of community-based investigators may rely on a description of their proficiency in working within the community.
Partnerships and collaborations
The community-researcher partnership must be documented in the Research Strategy section to describe the community's support for and involvement in development, design, testing, and dissemination of the study, including establishing a Community Advisory Board. If using CBPR research methods, these must be appropriately documented. The description of the community-research organization partnership must describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The application should also describe the history of the partners in collaborating on prior research projects, or other mutually beneficial activities, the mutual understanding and cooperation among the partners, procedures for resolving disagreements, and the relative contributions to the previous and current projects.
Approach
Given that prior research within Native communities is often limited, pilot/preliminary data from the community under study are not required. However, applicants are encouraged to provide such data if they are available. If not, applicants are encouraged to provide data on similar interventions that have been conducted in comparable populations or settings. Sources reflecting local knowledge that are not peer-reviewed or that are unpublished are acceptable when justified.
Whether or not preliminary data are included, the research is expected to be informed by a well-defined theory of change, logic model, or cultural source and associated hypotheses are expected. Research questions that have been addressed for other populations may still need to be specifically addressed for Native Americans if there is reason to believe that processes might operate differently for a Native American community or Native Americans more broadly. Appropriate justifications of scientific gaps areas must be provided in the applications, including, for example, the cultural adaptation of interventions or measures that have been used or validated with other populations. Justifications for the premise of the research can be established based on documentation from scientific and/or cultural sources.
Applicants must provide evidence of community support and of the feasibility of the planned research. As appropriate to the proposed project, applicants should provide evidence of their ability to recruit participants in each community involved in the study, to implement measurement and intervention protocols in the target population, to provide appropriate oversight, and to maintain high rates of retention throughout the intervention and follow-up period. Applicants should include a discussion of the study team’s prior experience working with the study population, and with the measures and methods to be used or tested in the research.
When the research involves intervention development, adaptation, or testing, the intervention (or the process of its initial development) must be described, including the theoretical and empirical evidence informing the intervention, the proposed mechanisms of action of the intervention, the health outcomes the intervention is meant to impact, and any relevant protective factors or risk factors that the intervention acts on or through for its hypothesized effects. When appropriate, the study should include plans for assessing fidelity of intervention and/or protocol implementation and/or plans for manualization or other standardization practices. The application must describe how the approach taken will support the future sustainability of the intervention, and any implications for implementing or disseminating the intervention if it is found to be effective in the future trial.
For intervention testing, the application should describe and scientifically justify the nature of any comparison/control group (e.g., whether the comparison group will receive information only, minimal treatment, delayed intervention, or some other design). Applicants should consult with collaborating communities to discuss the appropriateness of the selected approach to the comparison group, as tribal leaders and community members may believe that comparison group members should receive something more than usual care. The study design, whether a randomized controlled trial or another type of design should be scientifically rigorous and well-justified.
Evidence of the expertise of the study team to analyze the data from the proposed design must be provided. Applications should address the appropriateness of the measures for the planned study sample and their psychometrics and/or validity. While many research measures have not been validated for Native people, they may be the only measures validated to assess constructs and thus may be an appropriate tool. Research projects may use existing measures or propose research to develop new measures that reflect culturally relevant constructs. The analytic plan should address the strengths and the limitations of the study design and/or datasets used, as well as issues such as missing data, Power estimation should consider both main effects and mediated effects when relevant and should consider clinically meaningful effect sizes. When a mixed-methods approach is proposed, applicants should describe the methods by which the qualitative and quantitative data will be integrated.
Letters of Support:
Provide all appropriate letters of support, including those from community partners, collaborators, tribal resolutions, and others. Letters of support should describe the scientific, logistic, and organizational responsibilities of each of the collaborators for each aspect of the proposed project. The letter(s) of support should also describe the history of the partners in collaborating on prior research projects or other mutually beneficial activities, the mutual understanding and cooperation among the partners, and the relative contributions to the previous projects.
If the applicant(s) is working with communities, tribes/tribal governments then community/tribal resolutions of support, or equivalent documents, should accompany the application whenever possible. However, tribal resolutions and letters of support from community collaborators may be submitted as post-submission material up to 30 days before the study section meeting. The date of the study section meeting will be posted in eRA after submission. Note that this flexibility is NOT extended to letters of support from Key Personnel and consultants with academic or research organization affiliations. Letters of support from personnel with academic or research organization affiliations must be submitted with the application (on either October due date for non-AIDs applications or the January due date for AIDs applications listed in the Key Dates table above).
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.
Other Plan(s):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.
When involving human subjects research, clinical research, and/or NIH-definedclinical 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.
All instructions in the How to Apply-Application Guide must be followed.
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.
Part I. Overview Information 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.
This initiative is not subject to intergovernmental review.
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.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA and/or other participating NIH Institutes and Centers. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Specific to this NOFO:
Letters of Support/Tribal Resolutions sent as post submission materials must be submitted as PDFs by the Authorized Organization Representative (AOR) of the applicant organization. Although the post-submission materials may originate from the PD/PI, Contact PD/PI, or organizational officials, the AOR must send the materials directly to the SRO or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted. See Part 2. Section IV for which letters of support are permissable as post-submission materials.
Each Letter of Support submitted as post submission materials should contain the following:
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.
For this particular NOFO, note the following:
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 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.
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.
Significance
Innovation
Specific to this NOFO:
Significance
Innovation
Approach
Rigor:
Feasibility:
Specific to this NOFO:
Investigator(s)
Environment
Specific to this NOFO:
Investigator(s)
Environment
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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Vertebrate Animals
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Biohazards
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
Resubmissions
As applicable, evaluate the application as now presented.
Renewals
As applicable, evaluate the progress made in the last funding period.
Revisions
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
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.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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. 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:
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.
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.
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).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
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.
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.
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.
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
Sarah Vidal, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-827-5529
Email: sarah.vidal@nih.gov
Kylee Probert, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-451-7632
Email: kylee.probert@nih.gov
Mary Evans, Ph.D.
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-4578
E-mail: evansmary@mail.nih.gov
Liam O'Fallon, Ph.D.
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3298 or 919-802-6523
Email: ofallon@niehs.nih.gov
Annalise Schoonmaker, MS
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 240-669-5577
Email: annalise.schoonmaker@nih.gov
Holly Lynn Storkel
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301.451.6842
E-mail: holly.storkel@nih.gov
Dawn Morales Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-827-9668
Email: dawn.morales@nih.gov
Juanita J. Chinn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-4901
Email: juanita.chinn@nih.gov
Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Phone: 301-480-1161
E-mail: melissa.greenparker@nih.gov
Meryl Sufian, PhD
National Library of Medicine
Phone: 301-496-4671
Email: sufianm@mail.nih.gov
Hiroko Iida, DDS, MPH
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-7404
E-mail: hiroko.iida@nih.gov
Sheila Caldwell, PhD
Tribal Health Research Office
Phone: 301-480-3527
email: caldwells@mail.nih.gov
Erin R. Harrell, Ph.D., PMP
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Email: erin.harrell@nih.gov
Frank Bandiera, Ph.D.
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Email: frank.bandiera@nih.gov
Randy Lee King
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 451-0707
E-mail: randy.king@nih.gov
Angela R. Fernandez, PhD, MPH, LCSW
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: (301) 451-6950
E-mail: angela.fernandez@nih.gov
Mona Puggal, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0704
Email: mona.puggal@nih.gov
Elena K Gorodetsky, M.D., Ph.D.
ORWH - Office of Research on Women's Health
Phone: (301) 594-9004
E-mail: egorod@mail.nih.gov
Karen Marie McNamara, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-337-1372
Email: karen.mcnamara@nih.gov
Shobha Srinivasan, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: ss688k@nih.gov
Amy Kennedy, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-907-6227
Email: amy.kennedy@nih.gov
Tatiana Balachova, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5726
Email: Tatiana.Balachova@nih.gov
Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov
Chief Grants Management Officer
National Institute of Drug Abuse (NIDA)
Email: nidagmbemail@nida.nih.gov
Jenny Greer
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3332
Email: jenny.greer@nih.gov
Ann Devine
National Institute of Allergy and Infectious Disease (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
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.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
Andrea Culhane
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: andrea.culhane@nih.gov
Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov
Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov
Katie Ellis
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-451-4791
E-mail: kellis@mail.nih.gov
Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov
Leslye Fulwider
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-9544
Email: leslye.fulwider@nih.gov
Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov
Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
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.