PAR-23-298

PAR-23-298 is a grant from the National Cancer Institute and multiple NIH institutes that funds intervention research to improve Native American health.

The program supports R01-level research projects including clinical trials aimed at addressing health disparities and chronic disease burdens in Native American communities, covering areas such as cardiovascular disease, aging, substance use, mental health, dental health, environmental health, and more.

Participating institutes include NHLBI, NIA, NIDA, NIAAA, NIAID, NIAMS, NIBIB, NIDCD, NIDCR, NICHD, NIDDK, NIEHS, NIMH, NINR, NIMHD, NLM, and NCI. Both US and non-US organizations are eligible. Award amounts vary; the deadline for submissions is January 8, 2027.

Note: this notice has expired and applications may be accepted on a case-by-case basis.

Expired PAR-23-298: Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Aging ( NIA ) Participation Added May 30, 2024 ( NOT-AG-24-018 ) National Institute on Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD) 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 ) 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 ) Funding Opportunity Title Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) R01 Research Project Grant January 22, 2025 - This PAR has been reissued as PAR-25-379 .

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 May 30, 2024 - Notice of Participation of the National Institute on Aging in PAR-23-285, PAR-23-298, and PAR-23-299.

See Notice NOT-AG-24-018 March 6, 2023 - Notice of Question and Answer "Office Hours" with NIH Staff for Intervention Research to Improve Native American Health (IRINAH): PAR-23-298, PAR-23-285, PAR-23-299. See Notice NOT-DA-24-015 . January 16, 2024 - Notice of NIDCD Participation in PAR-23-298 Intervention Research to Improve Native American Health (R01 Clinical Trial Optional).

See Notice NOT-DC-24-018 December 28, 2023 - Notice of NHLBI Participation in PAR-23-298 Intervention Research to Improve Native American Health (R01 Clinical Trial Optional). See Notice NOT-HL-23-127 November 16, 2023 - Notice of Informational Webinar: Intervention Research to Improve Native American Health: Whats New with PAR-23-298, PAR-23-285, PAR-23-299".

See Notice NOT-DA-23-045 September 29, 2023 - Notice of NICHD Participation in PAR-23-298 Intervention Research to Improve Native American Health (R01 Clinical Trial Optional).

See Notice NOT-HD-23-030 September 21, 2022 - Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data see Notice NOT-OD-22-214 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity Exploratory/Developmental Grants See Section III.

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

279, 93. 113, 93. 313, 93.

121, 93. 855, 93. 361, 93.

273, 93. 286, 93. 393, 93.

399, 93. 846, 93. 242, 93.

879, 93. 307, 93. 847, 93.

865, 93. 837, 93. 838, 93.

839, 93. 840, 93. 233, 93.

866 Funding Opportunity Purpose 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-23-299 ) and the Clinical Trial Planning Grant mechanism ( PAR-23-285 ).

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.

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date January 22, 2025 per issuance of PAR-25-379 .

(Original Expiration Date: January 08, 2027 ) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

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

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The purpose of this notice of funding opportunity (NOFO) is to support 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. 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.

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-23-285 , which uses the Exploratory/Developmental Grant (R21) mechanism and covers similar scientific scope to this one and PAR-23-299 , 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-23-285 xmay 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.

Additional Considerations for Proposed Research 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 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 who are 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) should 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 affect sustainability.

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. Applicants are strongly encouraged to consult the NIH Research Methods Resources page ( https://researchmethodsresources. nih.

gov/ ) 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 or hard to reach populations 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.

Non-Responsive Applications Applications with the following attributes will be deemed non-responsive and will not be reviewed: Applications that propose research objectives that are not aligned with the mission of any of the participating ICs Applications that do not propose community-engaged projects Applications that do not propose research with Native Americans 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.

National Institute on Alcoholism and Alcohol Abuse (NIAAA) Although abstinence from alcohol is prevalent among Native American populations, there are also higher rates of alcohol use disorder (AUD) compared to other racial and ethnic groups in the United States.

We need to engage communities and continue building a body of culturally appropriate empirically supported prevention, treatment, recovery, and health services research within Native American populations, and how they can be modified to better address societal and cultural needs and health disparities.

The National Institute on Alcoholism and Alcohol Abuse (NIAAA) is interested in novel prevention and clinical interventions as well as research that seeks to understand processes of recovery and health services usage among Native American populations.

Such research can include, but is not limited to the following areas: Interventions to reduce heavy alcohol use and binge-drinking Interventions to promote abstinence or reduction of alcohol use Interventions to postpone onset of drinking among youth Development, adaptation, evaluation, and implementation of health promotion and AUD prevention interventions Comprehensive, multicomponent, community-based environmental interventions to reduce underage and binge-drinking and related harmful behaviors Interventions that address alcohol misuse and co-occurring conditions Adaptation of existing behavioral treatments among Native Americans to reduce heavy and problematic drinking Interventions designed for vulnerable groups (e.g., youth and young adults in rural and urban areas, pregnant people and women of childbearing age, and individuals with disabilities) Precipitants of relapse and interventions to address these risk factors in the course of recovery Interventions that integrate clients, families, communities, and other local support institutions into the prevention, treatment, and recovery process Models and methods that enhance the diffusion, implementation, and adoption of evidence-based alcohol-related treatment practices across the full spectrum of services for individuals with AUD Innovative health services research to understand and expand the availability and acceptability of existing alcohol prevention and treatment services or/and increase uptake in both rural and urban dwelling Native American populations 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 allergic, autoimmune, and infectious diseases research.

Areas of programmatic interest to NIAID include, but are not limited to, the following: Innovative strategies to scale up HIV prevention, including pre-exposure prophylaxis and other HIV prevention services in conjunction with care for sexually transmitted infections (STIs), mental health/substance use and reproductive health using Native American appropriate approaches.

Research to understand the current gaps in the HIV prevention and care continuums and develop approaches to more effectively engage and retain people in care and prevention programs. Studies to understand HIV transmission, including studies to identify important risk factors in the Native American context and how to intervene to reduce HIV incidence.

Research that seeks to unravel syndemics of risk in Native American communities and which proposes novel ways to reduce HIV incidence. Research to evaluate the full context of HIV risk particularly as it relates to communities of risk versus individual risk behaviors and how to implement interventions at the community as well as the individual level.

Studies that utilize data science, network analysis and geographic analysis are of particular interest. Research that will lead to improved and new strategies for HIV testing and entry into optimized treatment and prevention services that will reduce HIV incidence. Implementation research designed to evaluate approaches to expedite more timely linkage to HIV care and earlier treatment initiation for persons diagnosed with HIV.

Implementation research designed to evaluate approaches to facilitate continuity of HIV care in Native American populations and address challenges around access to care particularly for urban Indians.

Research on STIs in Native American populations, including 1) research to understand risk factors and population dynamics that promote transmission of STIs, to include but not be limited to syphilis, gonococcal and chlamydial infections; 2) studies to improve detection, diagnosis and treatment strategies of STIs, most importantly for congenital syphilis; and 3) implementation of STI prevention strategies.

Research to test innovative strategies to improve diagnosis, prevention, and treatment of tuberculosis. Research to understand the impact of RSV and other respiratory viral infections in Native American populations and to mitigate their impact. Studies to better understand the factors that lead to a higher burden of parasitic and vector-borne diseases in some Native American communities compared to other U.S. populations.

Strategies to characterize and mitigate the disproportionate burden of water- or food-borne infectious diseases in Native American populations. Studies to understand the immunologic basis of asthma and allergic disease in Native American populations, including studies to identify important risk factors and how to intervene to mitigate disease morbidity.

Research that will lead to improved and new strategies for early identification of allergic disease and entry into optimized treatment and prevention services that will reduce disease morbidities. Research into the immunologic basis of autoimmune diseases, including the development of markers of preclinical and clinical disease stages and research aimed at disease prevention.

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 support clinical trial applications in response to this NOFO.

NIAMS only supports clinical trial applications when they are in response to NIAMS clinical trial specific NOFOs. A current list of active NIAMS clinical trials NOFOs is available at https://www. niams.

nih. gov/grants-funding/conducting-clinical-research/grants. 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 Dental and Craniofacial Research (NIDCR) The prevalence of oral diseases in Native American communities is amongst 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 conducted using an equity lens, which considers 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.

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. To be assigned to the NIDDK, applications must be directly related to the mission of the NIDDK ( https://www. niddk.

nih. gov/about-niddk/meet-director/mission-vision ). 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.

Appropriate topics for investigation would include but are not limited: Better understanding of screening, diagnosis, incidence, and prevalence of NIDDK diseases in Native American populations with an emphasis on identifying factors that help inform treatment development, practices, or policies designed to reduce or eliminate disparities; Testing approaches that influence healthcare delivery in Native American populations to reduce disparities in prevention and treatment of NIDDK diseases or conditions; Studies of effects of medications or other therapies for prevention or treatment of NIDDK diseases or conditions in Native American populations; Studies of interventions targeting social, environmental or behavioral determinants of health that may contribute to risk for development and progression of NIDDK diseases and related complications in Native American populations; and Evaluation of natural experiments, including the influence of new policies or programs implemented in Native communities, within healthcare organizations, or other entities that are likely to influence risk for the development and progression of NIDDK diseases and related complications.

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.