Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Purpose

The purpose of this NOFO is to support projects to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. These research projects will be part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, which will also include a Coordinating Center (RFA-OD-24-006). Funded under a cooperative agreement, projects participating in the MSPI Research Network will collaborate to share approaches, data, and methods, working closely with NIH Institutes, Offices and Centers. Applicants applying to this NOFO are encouraged to review the Coordinating Center NOFO to fully understand the MSPI Research Network structure and activities.

Key Definitions for this NOFO

Preventive intervention: For the purposes of this NOFO, preventive interventions include both primary and secondary prevention. Primary prevention involves interventions or policies designed to prevent or reduce risk factors for developing a new health condition before health effects occur. Secondary prevention involves interventions or policies designed to prevent the recurrence of a health condition or progression of an early-stage health condition. Preventive interventions are inclusive of interventions to prevent or reduce risk factors, screen for risk factors or signs of early disease, or provide referrals or brief treatment to prevent disease onset or progression of early-stage conditions. Projects developing technologies, such as devices and algorithms, as part of risk factor screening or preventive interventions also fall within this definition.

Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Black Americans/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians/Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities, and people living with disabilities.

Social determinants of health (SDOH): The conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life. These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH Conceptualization.

Multi-sectoral intervention: An intervention involving two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.). These sectors may include neighborhood, city, county, regional, state, national, or tribal governmental or non-governmental organizations. For the purposes of this NOFO, research teams from academic institutions or research organizations are not considered as a service sector. However, institutions of higher learning would be considered as a service sector for multi-sectoral interventions directed towards students of those institutions.

Level of Influence: The socio-ecological levels (e.g., individual, interpersonal, organizational, community, or societal) at which specific determinants operate to influence risk factors and subsequent health outcomes (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence). To constitute an intervention at the interpersonal, organizational, community, or societal level, the intervention must directly alter determinants at that level, not just be delivered in a setting at that level or help individuals manage the consequences of determinants at that level. For example, an intervention to promote better nutrition among school-aged children by adjusting available food options in the school cafeterias would be an organizational-level intervention; an intervention providing nutrition information to students within schools would be an individual-level intervention.

Background

The NIH Office of Disease Prevention (ODP) within the Office of the Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) is coordinating the new trans-NIH research effort, ADVANCE: Advancing Prevention Research for Health Equity, which grew out of the ODP’s portfolio analysis of NIH research. In an examination of NIH-funded grants and cooperative agreements between fiscal years 2012 and 2017, the ODP found that only 8.5% of all projects focused on preventing the leading risk factors or causes of death and disability (e.g., poor nutrition, low physical activity, smoking), falling well below their burden on the nation’s health. An additional analysis of the NIH research portfolio showed that between fiscal years 2016 and 2019, only 3.6% of NIH-funded prevention projects included a randomized intervention to address a leading risk factor in populations that experience health disparities.

To address this research gap, this ADVANCE initiative will support research projects to test preventive interventions addressing risk factors for chronic or acute health conditions in populations that experience health disparities. Prevention or reduction of leading risk factors in HD populations requires moving beyond addressing knowledge, attitudes, and behaviors of individuals to intervene upon social determinants of health (SDOH) that drive inequities, such as limited access to healthy food options, limited opportunities for physical activity, lack of access to healthcare, and exposure to stigma, discrimination, and violence. Multi-sectoral collaborations that span multiple service sectors and community-based organizations have great potential to develop, implement, and sustain preventive interventions that address SDOH and promote health equity. Projects will be part of a research network to share approaches, data, and methods to facilitate the generation of research evidence about the prevention of common risk factors for multiple health conditions across different populations.

Research Objectives

Proposed intervention projects are expected to have the following features:

• Designed to prevent, reduce, or screen for one or more risk factors for one or more chronic or acute health conditions, including at least one common risk factor shared across multiple conditions (e.g., poor nutrition; high body mass index; low physical activity; tobacco, alcohol, or other substance use; air pollution; occupational risks; high systolic blood pressure; high fasting plasma glucose level; high LDL cholesterol level; impaired kidney function; poor sleep quality, etc.).
• Modifies one or more SDOH beyond the individual level of influence (e.g., interpersonal, organizational, community, societal) as a mechanism of action to prevent or reduce risk factors. Interventions that only offer referrals to address an individual’s social needs (e.g., providing a patient with a referral to a food bank) rather than directly modifying SDOH beyond the individual level (e.g., improving the food environment in a community) are not responsive to this NOFO.
• Guided by a conceptual model identifying hypothesized pathways between the SDOH and other determinants being addressed, the risk factors to be modified, and health outcomes.
• Tests new or adapted interventions, novel combinations of multiple interventions, and/or new strategies to implement evidence-based interventions.
• Involves collaboration with organizations from two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.), with representatives from these organizations serving as key personnel on the project. Additional collaborations with other types of community-based organizations, such as patient or consumer advocacy organizations, professional societies, faith-based organizations, or neighborhood associations, are strongly encouraged.

Study designs are expected to include the following features:

• Be adequately powered to identify intervention effects for the HD population(s) of focus and/or the impact of the intervention on reducing or eliminating disparities in health outcomes.
• Designed to measure and test hypothesized pathways, using appropriate methods for examining the impact of multi-level or higher-level (i.e., interpersonal, organizational, community, or societal) mechanisms of action on health outcomes.
• Use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Pre-post designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or neighborhood) are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size calculation. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at https://researchmethodsresources.nih.gov/.
• Assess health outcomes at the individual, interpersonal, organizational, or community level, or a combination. Individual health outcomes are not required if higher level health outcomes are of primary interest.
• Include changes in risk factors (e.g., improvements in nutrition or physical activity) as the primary health outcome, or as an intermediate outcome that impacts downstream outcomes (e.g., onset of a health condition, engagement in health care).
• Employ a common set of tools and resources that will promote the collection of comparable data on SDOH across studies. In particular, studies are strongly encouraged to use SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit as relevant (www.phenxtoolkit.org).

MSPI Research Network Structure

The MSPI Research Network will consist of the awarded UG3/UH3 Research Projects and a Coordinating Center (CC) (see RFA-OD-24-006). The CC and each of the Research Projects will also work collaboratively with one or more Project Scientists and Program Officers from NIH institutes, centers, and offices (ICOs).

The MSPI Research Network priorities and activities will be governed by a Steering Committee (SC) which at a minimum will include at least two representatives from each Research Project (e.g., research and community organizational MPI or key personnel), the CC, and at least one NIH representative. The MSPI Research Network Steering Committee will meet at least monthly and be chaired by personnel from the CC. Based on the priorities set by the Steering Committee, relevant workgroups will be established to carry out cross-project activities or consultation. For example, NIH anticipates there will be at least three workgroups: methodology and data analysis, data harmonization, and dissemination.

UG3/UH3 Phased Innovation Awards

This UG3/UH3 Phased Innovation Award supports bi-phasic projects for up to seven years. The UG3 (Phase 1) will be a two-year award for a milestone-driven developmental/exploratory study that can demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as well as tangible deliverables/preliminary findings that could be informative to the field as appropriate.

• Scientific planning activities may include development, adaptation or refinement of interventions or strategies; feasibility, acceptability and pilot testing of a proposed intervention or strategy; and development and testing of engagement and implementation strategies (e.g., fidelity monitoring, training).
• Operational planning activities may include development of the intervention, strategy or model protocol; the intervention manual or equivalent (as appropriate); data collection and management safety and operational oversight plans; recruitment, engagement and retention strategies; obtaining all regulatory approvals prior to the end of the UG3 award (e.g., single IRB (sIRB), Data and Safety Monitoring Plan (DSMP)); and other essential documents and procedures.
• Collaborative planning activities may include finalizing MOUs with collaborators, forming additional partnerships as needed with community-based organizations or service providers, forming advisory boards, and other related activities.

The UH3 phase will provide support for five additional years to conduct the implementation phase of research that will advance knowledge of multi-sectoral preventive interventions with HD populations. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase. UG3 projects that have met the milestones for the first phase (e.g., scientific, operational, collaborative) will be programmatically considered and prioritized for transition to the UH3 phase.

Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) award for research implementation, and all funded UG3 projects may not transition to the UH3 phase. Transition to the UH3 phase will be determined by the availability of funds and the outcome of a programmatic evaluation at NIH that is based on 1) appropriate sustainability plans with successful engagement of local collaborating agencies and partners and 2) Go/No-Go Transition Milestone accomplishment specific to the project being proposed [e.g.; establishment of relevant collaborations with community and other sector partners needed to advance achievement of the research objectives as demonstrated by the execution of necessary agreements with these agencies for committed financial and/or human resources, data sharing, etc.; demonstrated ability to recruit appropriate individual and/or organizational population samples, conduct data collection, access to data for appropriate data linkages, etc.]. Continued programmatic priorities and availability of funds will impact the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.

Applications Not Responsive to the NOFO

• Applications that do not include specific aims for both a UG3 and a UH3 phase.
• Applications that do not specify Go/No-Go transition milestones for the planning phase (UG3), the transition to the UH3 phase, and annual milestones for the implementation phase (UH3).
• Projects that do not prospectively test a preventive intervention focused on NIH-designated HD populations. Observational studies and natural experiments are not responsive.
• Projects that only intervene at the individual level or use an individual-level randomized trial design.
• Projects that use, collect or analyze exclusively individual-level data or are exclusively qualitative (though mixed-methods are encouraged).
• Projects that do not involve collaborations with organizations from two or more service sectors, as indicated by the inclusion of organizational representatives as key personnel and/or proposed subcontracts to the organizations.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

Pre-application technical assistance

Information regarding a pre-application webinar and frequently asked questions (FAQs) will be provided in a forthcoming Notice published in the NIH Guide.

Areas of Research Interest:

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

Musculoskeletal diseases are the leading cause of disability and health care expenditures in the United States. NIAMS is interested in receiving research applications that design, adapt, test and/or implement culturally appropriate, multi-sectoral interventions for the primary and secondary prevention of arthritic, other rheumatic, musculoskeletal, and skin diseases, among populations experiencing health disparities. Applications centered on improving access to evidence-based interventions and strategies and with a focus on sustainability are encouraged. Applicants are strongly encouraged to discuss their proposed research interest with NIAMS program staff.

National Cancer Institute (NCI)

In the US, there are approximately 18 million cancer survivors, which includes individuals diagnosed with cancer from the time of diagnosis until the end of life. Cancer survivors from racial and ethnic minority groups and other medically underserved populations are more likely to experience cancer recurrence, secondary malignancies, multiple chronic comorbidities, physical and psychological side effects, poorer health-related quality of life and health behaviors, and higher financial toxicity than other cancer survivors. The cases of disparities in cancer prevention, screening, and management of onset of other health conditions, reoccurrence, and secondary malignancies can be attributable to factors beyond the healthcare system into other SDOH. For example, the neighborhood built and social environments shape how communities are connected via public transportation that enables timely access to healthcare, affect the walkability, safety, availability of green space or gardens, fast food density, and access to full-service grocery stores that promote physical activity and healthy eating; and determine the availability of quality healthcare services, providers, and resources. SDOH can, directly and indirectly, impact the ability of cancer survivors to engage in positive health behaviors (e.g., walking, eating healthy, survivorship care visits) to reduce their risk through various mechanistic pathways at multiple levels of influence. These direct, indirect, and synergistic interactions cause health disparities and require the collaboration of multiple sectors, including health, public health, social services, transportation, parks and recreation, environmental protection, and community-based organizations, to address and alter SDOH.

NCI invites research applications that design and test cancer preventive and survivorship interventions to address the mechanistic pathways by which SDOH impact modifiable risk factors, thereby increasing the risk for multiple chronic comorbidities or health conditions and poor health-related quality of life. Interventions must be multilevel and use the Socioecological Framework to target SDOH that indirectly, directly, and synergistically lead to poor health outcomes at two or more levels of influence (e.g., interpersonal, organizational, community, or societal). Research studies that integrate trans-disciplinary expertise are of particular interest.

Areas of research interest include, but are not limited to:

• Develop and test multilevel, multicomponent, multisectoral interventions that directly target and alter structural factor(s) and SDOH to prevent or reduce modifiable risk factors (e.g., lack of physical activity, high body mass index or adiposity, alcohol consumption, tobacco use) at various levels of influence, such as the interpersonal, community, organizational, or societal level, to mitigate adverse health outcomes among cancer survivors.
• Design and test interventions that address SDOH beyond the individual level of influence to address related social risks and lead to improved health outcomes (e.g., improving the food environment in a community). For example, food insecurity, housing instability, and transportation-related barriers at the community level hinder access, utilization, and timely delivery of quality cancer care and can lead to adverse health outcomes for cancer survivors.
• Develop and test interventions that target SDOH (e.g., income, housing, employment, food deserts or swamps) to improve diet quality, reduce comorbidities, and improve cancer outcomes at the community or societal level, such as increasing access to fruits and vegetables through the Supplemental Nutrition Assistance Program (SNAP), establishing community gardens and food pantries that can provide medically tailored meals, and providing healthy food packages/groceries among cancer survivors. Interventions that only offer referrals to address an individual’s social needs (e.g., providing a patient with a referral to a food bank) rather than directly modifying SDOH beyond the individual level (e.g., improving the food environment in a community) are not responsive to this NOFO. Cancer outcomes must be specified.
• Develop and test interventions that target SDOH at the interpersonal, organizational, community, and societal levels that directly impact access to timely and quality healthcare for cancer survivors. Areas of interest related to cancer survivorship include access to oral health screening, health insurance, employment-related mandates, laws, or regulations that reduce the economic burden of healthcare among cancer survivors.
• Evaluate policy interventions that target SDOH at the societal and organizational level to improve healthcare and health outcomes and reduce health disparities. Policy interventions involve a new law, act, or program mandated by a national or state government that impacts SDOH among cancer survivors.

National Center for Complementary and Integrative Health (NCCIH)

The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. Examples of complementary and integrative health approaches include those with physical and/or psychological therapeutic inputs, often called mind and body interventions (e.g., acupuncture, yoga, tai chi, qi gong, meditation/mindfulness, hypnosis, music therapy, art therapy, and massage), and approaches with dietary or nutritional therapeutic inputs (e.g., special diets). Applications will not be considered by NCCIH if they propose trials of regulated products (e.g., dietary supplements, devices, or biologics) for indications that have not been approved or cleared by the U.S. Food and Drug Administration. NCCIH will only accept assignment of applications that include complementary and integrative health approaches. As discussed in NCCIH’s Strategic Plan, expanding the portfolio of research on complementary and integrative health approaches to address and eliminate health disparities across the lifespan is a high priority.

Under this PAR, NCCIH is interested in supporting studies that develop, adapt, test, and/or implement culturally appropriate, multi-sectoral prevention interventions with a complementary and integrative health component in diverse settings (e.g., schools, Federally Qualified Health Centers, child welfare and juvenile justice systems, correctional and detention systems, etc.) and among populations experiencing health disparities. Research involving interventions with a high potential for sustainability and/or examinations of implementation strategies to facilitate sustainability are encouraged. In addition, a central focus of NCCIH’s Strategic Plan is whole person health, which emphasizes that health exists across multiple interconnected body systems and domains, including biological, behavioral, social, and environmental. Multi-sectoral prevention interventions that intervene on social determinants of health to reduce risk and/or enhance protective factors across multiple levels of influence are aligned with a whole person health framework. Accordingly, under this PAR, research involving multicomponent behavioral or systems-level interventions that aim to improve health and prevent disease in multiple interconnected therapeutic modalities and/or pathways are encouraged.

Investigators are encouraged to review the NCCIH Clinical Research Toolbox to learn more about NCCIH's requirements, policies, guidelines, and required templates for clinical trials. Applicants are strongly encouraged to discuss their proposed research interest with the designated NCCIH Scientific/Research Contact listed below to confirm its relevance to the NCCIH mission areas.

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI is interested in supporting multisectoral interventions that focus on heart, lung, blood, and/or sleep (HLBS) risk factors, diseases, and conditions. NHLBI has a strong interest in dissemination and implementation science studies that aim to utilize evidence-based interventions and strategies that:

• Improve access to care and resources (e.g., healthy food sources, physical activity/exercise, etc.)
• Improve screening, diagnosis, treatment, and/or management of HLBS conditions
• Promote the adoption and adherence to appropriate HLBS evidence-based guidelines

Investigators planning to submit an application are strongly encouraged to consult with the NHLBI Scientific Contact listed in Section VII of this NOFO.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The Surgeon General’s Report on Alcohol, Drugs, and Health published in 2016 calls for a public health model for addressing substance misuse and related consequences. This report identified risk and protective factors at the individual, family, school, and community levels, provided a list of evidence-based prevention programs and policies, and highlighted evidence-based community coalition-based prevention models, such as the Communities That Care and the Communities Mobilizing for Change on Alcohol. NIAAA-developed Alcohol Screening and Brief Intervention for Youth: A Practitioner’s Guide provides a tool and resources for identifying youth at risk for alcohol-related problems. CollegeAIM provides intervention matrices for addressing alcohol issues in college, and some interventions are relevant to young adults who are not in college. The Healthcare Professional’s Core Resource on Alcohol provides evidence-based context to help healthcare professionals to overcome barriers to care for patients with alcohol-related concerns. The Alcohol Policy Information System (APIS) supported by NIAAA provides detailed information on alcohol-related and recreational cannabis policies at both State and Federal levels. The Community Preventive Services Task Force reviewed and recommended numerous interventions to reduce excessive alcohol consumption in communities. Countermeasures That Work by the National Highway Traffic Safety Administration provides evidence-based interventions and policies for alcohol-impaired driving. The Sequential Intercept Model by the Substance Abuse and Mental Health Services Administration (SAMHSA) is a tool that helps communities develop strategies to divert people with substance use disorders away from the justice system into treatment. SAMHSA’s Evidence-Based Practices Resource Center provides a collection of scientifically based tools for the public to quickly identify approaches for their needs. A wide variety of resources are available, but much more needs to be done to test or implement prevention interventions and policies in the context of SDOH and assess outcomes in HD populations.

SDOH can impact the likelihood of alcohol misuse and alcohol use disorder (AUD), such as social and community context (e.g., discrimination, racism, social isolation, growing up in a home with parental AUD), neighborhood and built environment (e.g., alcohol outlet density, exposure to violence, housing affordability), health care access and quality (e.g., receiving evidence-based preventive care), economic stability (e.g., job and food security, income), and education access and quality (e.g., educational opportunities and attainment). Adverse SDOH serve as allostatic loads on the body’s stress systems, increase vulnerability to mental and physical conditions, and contribute to health disparities and inequities. Such stressors can drive alcohol misuse to cope which, in turn, exacerbates the initial problems, further fueling alcohol misuse.

Under this PAR, NIAAA is interested in multilevel and multisectoral preventive interventions that are not feasible to accomplish with the Research Project Grant (R01) mechanism. Study designs are expected to include process evaluation, assessment of barriers and facilitators to implementation and sustainability, and evaluation of any unintended negative effects. Contingent upon funding availability, NIAAA may prioritize applications with scientifically meritorious scores in the following research areas of interest:

• Comprehensive or multicomponent community-based programs focusing on environmental interventions (e.g., public policy changes, enhanced enforcement of laws, changing social norms, media advocacy, community mobilization, data-driven campaigns) for preventing or reducing underage drinking, alcohol misuse and related harms (e.g., alcohol-impaired driving, assaults, overdoses) in general and HD populations.
• Comprehensive interventions to promote abstinence from alcohol at the time surrounding pregnancy and breastfeeding, reduce stigmatization associated with AUD, alcohol use, and related conditions (e.g., fetal alcohol spectrum disorders), and improve identification and access to effective services for individuals with fetal alcohol spectrum disorders and their families.
• Community-engaged interventions to prevent alcohol misuse or treat AUD tailored to the complex and multifaceted challenges faced by youth in the juvenile justice system or the child welfare system.
• Integrative interventions and whole person health approaches to enhance neighborhood and community resources and facilitate positive changes in health and behavior in an aging population, such as screening and brief intervention for alcohol misuse, promoting drinking reduction or abstention, and increasing knowledge of common alcohol-interactive medications, in combination with smoking cessation, physical activity, and increasing health care access and quality such as screening and management of chronic conditions.

Applications submitted to NIAAA are expected to adhere to NIAAA’s expectations for Data Management and Sharing Plans described in NOT-AA-23-001, as appropriate.

National Institute on Drug Abuse (NIDA)

NIDA is interested in research to determine the extent to which interventions at the policy, community, organizational, or individual levels that address SDOH prevent substance use and associated negative outcomes. Applicants may choose to study a single intervention or a combination of interventions that impact substance use. NIDA studies must include a substance use outcome. Specific outcomes of interest include substance use risk, substance use initiation, substance misuse, and escalation from misuse to substance use disorder (SUD). NIDA prioritizes research that examines the mechanisms through which addressing the SDOH will have an impact on substance use outcomes.

Examples of research areas that would be of interest to NIDA include, but are not limited to:

• Studies of the effects on substance use of policies that enhance financial well-being within a population. Policy interventions may include implementation by multiple community-based organizations, and include efforts to provide direct cash payments, address food insecurity, promote workforce engagement, increase health insurance coverage, or other reforms to reduce economic insecurity.
• Studies of community policing and other reforms to address discrimination against racially and/or ethnically minoritized populations. Policy reforms may include efforts by police, community empowerment organizations, crisis response providers, educational entities, and other sectors.
• Studies to test the impact on substance use of policies or programs to prevent violence, including efforts by police, education, community groups, public health, and recreation organizations to reduce firearms access, increase availability of recreational opportunities for youth, or encourage healthy relationships.
• Studies to test the impact of child welfare policies or programs intended to prevent child welfare system involvement and improve family functioning on substance use, adverse childhood experiences, family separation, and other negative outcomes for the family, parent(s) and/or child(ren).
• GED, high school completion, or apprenticeship training program paired with mentorship for individuals aging out of child welfare, affected by regional job loss, or experiencing multigenerational poverty.
• Intensive case management, counseling, tutoring, and career services for high school youth in the juvenile justice system and/or experiencing risk for school dropout.
• Primary care- or school- based programs to provide services to address the mental health and/or basic needs of youth who have experienced trauma due to experiencing child welfare involvement, interpersonal or community violence, loss due to overdose, displacement from their country of origin, or another traumatic event.

In developing studies that feature collaboration of two or more sectors, applicants are encouraged to engage partners that are positioned to sustain effective strategies after study completion, especially those that use existing funds (e.g., federal block grant, entitlement programs, settlement funds) to address SDOH. To maximize the acceptability, feasibility, scalability, and sustainability of the intervention(s) being studied, applicants should also engage relevant end users in study conceptualization, design, execution, and interpretation. For this NOFO, end user is broadly defined and may include policymakers, state and local level decision makers, practitioners, intervention implementers, families, youth, and community members.

The National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR encourages the submission of applications for multi-sectoral interventions targeting social determinants of health (SDOH) and/or commercial determinants of health (CDOH) to reduce modifiable risk factors shared across multiple chronic diseases and conditions to prevent dental, oral, and craniofacial (DOC) diseases in populations that experience health disparities. Examples include coordinated efforts to implement systematic screening and referral for DOC diseases, or testing combined efforts to reduce common risk factors for preventing occurrence, recurrence, or progression of DOC diseases and comorbid conditions. Investigators planning to submit an application are strongly encouraged to consult with the NIDCR Scientific Contacts listed in Section VII of this NOFO.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities. Of specific interest are meritorious applications that focus on racial and ethnic minority populations and/or low socioeconomic status (SES) persons. The intersectionality of race and ethnicity and/or low SES with rural populations, sexual and gender minority (SGM) groups, or individuals with disabilities, as well as any other condition is also a priority.

NIMHD is interested in multisectoral preventive interventions that lead to improved health outcomes and decrease health disparities in the above populations. Interventions of particular interest are: 1) multi-level (e.g., individual, interpersonal, family, peer group, community, societal), 2) culturally appropriate, 3) intentional about which populations, time points in the life course, and risk or protective factors are targeted for reduction of health disparity outcomes, 4) utilize community-engaged approaches, and 5) address risk factors among populations that experience earlier onset of conditions or premature morbidity, and mortality.

Areas of specific interest to NIMHD include but are not limited to studies that:

• Explore common risk factors (e.g., hypertension, hypercholesterolemia/dyslipidemia, tobacco use, prediabetes) for multiple chronic conditions (e.g., cardiovascular disease, diabetes, cancer, chronic kidney disease, chronic liver disease) for which there are known health disparities for the population under study.
• Explore one or more structural factors, particularly rooted in racism, sexism, homophobia, classism, or other discriminatory systems, as a mechanism of action to prevent or reduce risk factors.
• Develop and implement health care system interventions that reduce socioecological barriers to care and promote coordination of care, quality of care and integration of preventive care, primary care, and other health services.
• Evaluate the impact of upstream interventions on distal health disparity outcomes across the lifespan and across generations (e.g., long-term impact on direct measures of health, health-related outcomes, and inter-generational transmission of health disparities)
• Develop and implement interventions in community-based settings associated with community health centers

National Institute of Nursing Research (NINR)

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.

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers (ICs), the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP co-funds research that has strong implications for disease and injury prevention and health equity and that includes innovative and appropriate research design, measurement, and analysis methods. For this NOFO, the ODP has a specific interest in projects that develop and/or test preventive interventions operating at organizational and/or community levels. The ODP does not award grants; therefore, applications 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 IC research priorities and funding. ODP only accepts co-funding requests from NIH ICs. For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

Office of Dietary Supplements (ODS)

ODS advances and disseminates research on dietary supplements to foster knowledge and optimize health across the lifespan. Dietary supplement ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary or bioactive substances, consumed as dietary supplements to promote health and prevent disease. For this NOFO, ODS is interested in interventional studies, including those involving nutrition education-related interventions aimed at addressing disparities in health-related behaviors. This includes areas such as infant feeding practices (specifically Vitamin D supplementation needs), as well as supplementation during pregnancy and lactation, among others, and interventions to determine where dietary supplements can meet nutrient gaps for different population groups.

The ODS does not award grants, therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC program contacts listed for questions related to funding.

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 Institutes and Centers 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 Institutes and Centers (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 supports research projects that address the social determinants of health and health disparities of women across the lifespan. Projects using interdisciplinary evidence-based interventions to prevent common risk factors for multiple health conditions in women historically understudied, underrepresented, and underreported in biomedical research are of particular interest. Projects considering community-based collaborations are also highly encouraged.

Sexual & Gender Minority Research Office (SGMRO)

The SGMRO coordinates research and activities related to the health and well-being of sexual and gender minority (SGM; defined for NIH research in NOT-OD-19-139) populations by working directly with the NIH Institutes and Centers (ICs) and serves as a liaison for the research community to ensure SGM populations are considered and represented in research activities across the agency. The SGMRO does not have grant-making authority and can only support grants deemed meritorious after review by one of the ICs participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant Scientific/Research Contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021-2025 and on the Office’s Research Resources webpage.

For this NOFO, SGMRO is interested in intervention research across the life course that explores and addresses SGM-relevant and -specific social and structural determinants of health to support the maintenance or improvement of health and health outcomes among SGM communities and SGM people who are members of other populations that experience health disparities and inequities. When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework, NIMHD Research Framework).

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov

Page Limitations

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

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

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicants should budget for at least one in-person meeting in the Bethesda, Maryland area per year.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims

Applications must provide the overall goals and hypotheses for the entire project and indicate separate specific aims to be accomplished in both the UG3 phase and the UH3 phase.

Research Strategy

This UG3/UH3 Phased Innovation Award has two phases. The UG3 (Phase 1) will be a two-year award for milestone-driven developmental/exploratory studies to demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as detailed in the " UG3/UH3 Phased Innovation Awards of the NOFO Background. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase.

Separate sections that describe the research strategy for the UG3 and the UH3 phases are required. Investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals, feasibility, approach, and the transition milestones are critical. It is not necessary to repeat information or details that are described in the UG3 section in the UH3 section.

Applications should clearly describe:

• The HD population(s) of focus and the need for the proposed intervention in the population(s).
• The conceptual model for the proposed intervention, including the risk factors to be addressed, the health outcomes to be impacted, and the specific type(s) and socioecological level(s) of SDOH being modified.
• The service sectors involved in the intervention and the roles of collaborators within those sectors, as well as of other community-based or research collaborators.
• The scientific, operational, and/or collaborative planning activities for the UG3 phase.
• Go/No-Go transition milestones for the planning phase (UG3) and annual milestones for the implementation phase (UH3). These milestones must be specific to the project being proposed, discrete and measurable, and must be clearly defined. Transition milestones must relate to the scientific, operational and collaborative planning activities and must demonstrate readiness to launch into the implementation phase of the research.
• The planned UH3 intervention study design that involves prospective assignment of groups or clusters (e.g., health clinics, schools, neighborhoods, etc.) and the experience of the research team using this study design.
• The analytic plans for the UG3 and the UH3 phases of the research, including statistical and other methods to be employed to address multi-level factors, intervention effects, and outcomes as appropriate.
• The potential for the intervention to be sustained after the project is over and/or scalable to other settings.
• A plan for participating in MSPI Research Network activities (e.g., participation in workgroups and Steering Committee meetings, data harmonization , cross-site dissemination products, etc.). Describe how the project team will work with the MSPI Research Network Coordinating Center (CC), considering the CC’s role to provide administrative coordination, data, measurement, analytics, and dissemination support and consultation.

Letters of Support:

Provide all appropriate letters of support, including any letters necessary to demonstrate the support of collaborators. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, and must be included in the Letters of Support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Applications submitted to NIAAA are expected to adhere to NIAAA’s expectations for Data Management and Sharing Plans described in NOT-AA-23-001, as appropriate.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

Part I. 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 SF424 (R&R) 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

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

2. Review and Selection Process

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Awards issued under this NOFO will be excluded from the Streamlined Noncompeting Award Process. NIH Grants Management Officials must review and approved all carryover requests, regardless of the size and/or dollar threshold. No automatic first no-cost extension will be allowed.

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared between the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Prior to the end of the UG3, submission of the transition package, which will include the UG3 progress report delineating progress toward achieving UG3 milestones.
• All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.
• Close coordination and cooperation with NIH staff involved in those aspects of scientific and technical management of the study, including those outlined under "NIH Staff Responsibilities" and to work cooperatively with other recipients and the Coordinating Center when it is scientifically advantageous to pursue common methods and protocols.
• Participating in annual meetings of the recipients and supporting any committees, task forces, and advisory panels related to the project, as needed, and participating in regularly scheduled conference calls with the awarding agency. Project budgets should include travel for participation in these activities.
• Following the procedures required by the protocol regarding study conduct and monitoring and data collection.
• Making project-generated publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8.2.3.1of the NIH GPS.
• Award recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH Project Scientists will have access to the data and work with the PD(s)/PI(s) to help ensure the objectives of the program are being met. The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared between the recipient and the NIH Project Scientists.
• NIH staff will act as resources and facilitators for activities of the recipient, and will coordinate activities with federal and non-federal agencies outside of the project recipients.
• The NIH reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. NIH support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding.
• NIH staff will help ensure the recipient demonstrates compliance with award terms and conditions. Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and/or negotiating an orderly close-out of this study.
• NIH staff will serve as resources to provide: scientific/programmatic support in the development and modification of study protocols and the design of project activities; advice on the selection of sources or resources; advice on management and technical performance; and assistance in the preparation of publications, as warranted.
• NIH staff will participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants, and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting to the coordinating center as needed.
• NIH Scientific Officers will interact with the PD(s)/PI(s) on a regular basis to help monitor progress. Monitoring may include: regular communication with the PD(s)/PI(s) and their staff, periodic site visits for discussion with the recipient's research team, observation of data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
• NIH project scientists will identify research questions relevant to UG3/UH3 project and network objectives. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIH Project Scientist(s) may collaborate with recipients as coauthors in preparing publications of data resulting from the research. In this regard, they will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIH staff require internal clearances.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The PD(s)/PI(s) provide, with assistance from the NIH staff, support necessary to ensure that sites and investigators, and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subject protection, informed consent, and reporting of adverse events.
• Recipients and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data.
• All recipients, with assistance from NIH, will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and relevant service systems as appropriate.
• The Steering Committee (managed by the Coordinating Center) is the primary governing body of the network. Recipients must participate in the Steering Committee. The Steering Committee reviews and approves the agenda for collaborative research activities, develops and monitors policies and procedures guiding the research activities, and oversees communications. Recipients agree to abide by the procedures and policies established by the Steering Committee.
• The Steering Committee, with the support of the Coordinating Center, will facilitate these and other joint activities including, but not limited to: coordination of research protocols when appropriate, human subjects and other regulatory protocols when appropriate, data harmonization and archiving, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products resulting from collaborative projects across the network.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. 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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

Stephanie M. George, Ph.D., MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-4974
Email: stephanie.george@nih.gov

Jennifer Alvidrez, PhD
Office of Disease Prevention
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

I-Jen Castle, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-4406
Email: i-jen.castle@nih.gov

Elena K Gorodetsky, MD, PhD
ORWH - Office of Research on Women's Health
Phone: (301) 594-9004
E-mail: egorod@mail.nih.gov

Lorena Baccaglini, DDS, MS, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-435-7908
E-mail: lorena.baccaglini@nih.gov

Hiroko Iida, DDS, MPH
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-7404
E-mail: hiroko.iida@nih.gov

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sungsug.yoon@nih.gov

Nancy L. Jones, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
nancy.jones@nih.gov

Mary Yaasedegah Masterson, PhD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: none
E-mail: mary.masterson@nih.gov

Patricia A. Haggerty, Ph.D.
Office of Dietary Supplements
Tel. 301-529-4884
Email: patricia.haggerty@nih.gov

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

Tanya Agurs-Collins, PhD, RD
National Cancer Institute (NCI)
Telephone: 240-276-6956
Email: collinsta@mail.nih.gov

Shannon Elizabeth Nicks
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
E-mail: shannon.nicks@nih.gov

Center for Scientific Review (CSR)

FOAReviewContact@csr.nih.gov

Katie Joffee
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5891
Email: joffeek@mail.nih.gov

Judy Fox
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

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

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Taryn Cobb
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-827-8025
E-mail: cobbt@mail.nih.gov

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov

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

Section VIII. Other Information

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

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