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 the planning phase of the Model Continuums of Care Initiative (MCCI) to Advance Health Equity and End Health Disparities Among Women and Girls in Racial/Ethnic Minority and Other Underserved Communities (MCCI).  MCCI is a multi-ICO dissemination and implementation science initiative to advance health equity and end health disparities in racial and ethnic minority and other underserved women and girls of reproductive age living in the United States, with special emphasis on those with intersecting identities that increase their risk for health disparities; i.e., NIH-designated populations with health disparities, defined as racial and ethnic minority groups (African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders), people with lower socioeconomic status, underserved rural communities,  sexual and gender minority (SGM) groups, and people with disabilities  in the U.S. and its territories:

See https://www.nimhd.nih.gov/about/overview/.

Specifically, MCCI will apply the latest dissemination and implementation science approaches to significantly reduce the prevalence and impact of multi-morbidity among racial/ethnic minority and other underserved women and girls of reproductive age at risk and living with mental health disorders, substance use disorders, chronic stress, cardiopulmonary diseases, common metabolic disorders (e.g., obesity, diabetes), cancer, and HIV/AIDS.  This concept proposes a continuum of care approach that integrates preventive health services, primary care, behavioral health, integrative care, and specialty care (e.g., cardiopulmonary, endocrine, cancer, and HIV/AIDS specialties) to fully address health care needs in each of these domains, and to have maximum impact on the overall health and well-being of racial and ethnic minority and other underserved women and girls. Women and girls ages 15-44 yrs. are centered because it is during the early reproductive period, i.e., adolescence, that multimorbidity typically begins and rapidly progresses, setting the stage for multiple chronic debilitating conditions in later life.  This focus contrasts with maternal health initiatives, specifically, in that it does not focus solely on the perinatal period but instead considers the overall health of women between adolescence and menopause. MCCI will enhance the efforts of initiatives specific to maternal health, as the health of individuals years well before initial pregnancy is critical to maternal health.

In addition to the groups highlighted above, priority populations for this research initiative include populations of women and girls who have a substance use disorder and/or serious mental illness or other mental health disorder associated with functional impairments, and women and girls with intellectual or developmental disorders and/or other disabilities. Girls in or transitioning from social service systems (e.g., foster care, group homes, etc.), girls involved in the juvenile justice system, and women involved with the criminal justice system are also a high priority.

In this trans-NIH, trans-HHS effort to improve the quality of health care available to racial and ethnic minority and other underserved women and girls of reproductive age, special emphasis will be placed on using stakeholder partnerships, provider training, and infrastructure changes to improve access for subgroups of women who experience significant impediments to high quality health care.  Applications that include a partnership between Research Centers in Minority Institutions and other institutions with extensive programs in women's health research are strongly encouraged.   

Background and Vision

Rising rates of anxiety and depression among U.S. women and girls are acting as important drivers of sharp increases in harmful alcohol and substance use.  Rates of alcohol-related emergency department visits have escalated rapidly over the past two decades, with the rate among women outpacing the rate among men in every age group.  From 2019 to 2020 alcohol-related deaths increased by 27% for women and by 25% for men, continuing a trend in alcohol-related deaths that also has been observed for the past two decades.  This has been associated with a 400% increase in overdose-related deaths among women of reproductive age (i.e., ages 15 – 44 yrs. as defined by the CDC) over the same time period.  Furthermore, the opioid crisis has disproportionately affected women from racial and ethnic minority communities.  There is a bidirectional, positive relationship between mental health conditions coupled with harmful substance use and increased risk for a range of physical conditions. For example, both major depressive disorder (MDD) and harmful use of substances, including alcohol, nicotine, and psychostimulants, independently increase the risk for cardiovascular disease (CVD) and other cardiopulmonary diseases (CPD).  Conversely, CVD increases the risk for MDD and cognitive impairment.   People living with Diabetes Mellitus Type 1 or Type 2 (DM) are at greater risk for MDD, and there is mounting evidence that people living with MDD may be at greater risk for developing Type 2 diabetes.  Alcohol and tobacco use increase cancer risk, and racial/ethnic minority women have higher rates of certain cancers and/or higher risk of dying from certain cancers.  For example, despite having similar rates of breast cancer, Black/African-American women are more likely than White women to die of the disease.   Key goals of MCCI include increasing awareness of the role of substance use in increasing cancer risk (e.g., the role of alcohol in increasing breast CA risk), implementing preventive interventions that reduce substance use-related risk, and advancing integrative care for mental health disorders and harmful substance use during cancer treatment. 

The intersection of these disorders and processes may impact the health of women and girls across the lifespan, underscoring the need to prevent and treat multi-morbidity early in the life course, ideally prior to first pregnancy; i.e., early adolescence.  Research has found multiple factors contributing to disparities in multi-morbidity among women and girls, such as variability in access to high quality healthcare, underlying chronic conditions, implicit bias, overt discrimination, and chronic stress.  Among these factors, chronic stress is uniquely addressable using evidence-based, stress management methods that have been shown to reduce sympathetic overactivity, blood pressure, oxidative stress, and systemic inflammation, as well as improve sleep and glucose metabolism.  Thus, integrating stress management techniques into the health care of racial and ethnic minority and other underserved women and girls presents an opportunity to impact many aspects of mental and physical health and to prevent or reverse multiple inter-related chronic conditions.    

This trans-NIH initiative will address gaps in the continuum of health care for racial and ethnic minority (REM) and other underserved women and girls by bringing evidence-based, integrative interventions for mental health and substance use disorders and common co-occurring physical conditions (e.g., hypertension, asthma obesity, diabetes, cancer, HIV/AIDS) to population scale across the entire continuum of women and girls’ health care and by optimizing coordination of care.  Specifically, MCCI proposes a continuum of care approach that integrates preventive health services, primary care, behavioral health, integrative care, and specialty care (e.g., cardiopulmonary, endocrine, cancer, and HIV/AIDS specialties) to fully address health care needs in each of these domains, and to have maximum impact on the overall health and well-being of racial and ethnic minority and other underserved women and girls.  By accelerating the scale-up of evidence-based interventions (EBIs) for common co-occurring conditions across multiple components of existing women’s health care continuums at the same time, MCCI is expected to have a transformative impact on women’s health care, significantly reducing longstanding inequities in the delivery of state-of-the-art prevention, diagnostic, and treatment services across racial and ethnic minority and other underserved communities.

MCCI is not a maternal health initiative.  Instead, MCCI aims to redress longstanding health inequities affecting racial and ethnic minority and other underserved women and girls of reproductive age, in recognition of their intrinsic dignity and value apart from their role as current or potential mothers.  For individuals who wish to become pregnant, it aims to address their complex health and social needs prior to pregnancy and/or between pregnancies, consistent with data showing that the health trajectory of any single pregnancy is largely determined by conditions that exist prior to pregnancy.  While the focus of MCCI is on strengthening the continuum of women and girl’s health care external to clinical maternal health care, strategies to improve linkages between maternal health care and other components of the health care continuum must be a critical element of the partnering community’s broader plan to develop a model continuum of care.

For the purposes of this RFA, a model continuum of care for racial and ethnic minority women and girls is defined as one that includes various community partners (e.g., primary care facilities, hospitals, specialized care centers, community-based organizations, faith-based organizations, community advisory groups, etc.) and that, at a minimum, optimizes access to state-of-the art, evidence-based preventive, clinical, and rehabilitative health maintenance interventions for women and girls across the full continuum of health care.  These interventions should be culturally appropriate and congruent with the changing needs and preferences of women and girls living within a given community.

Research Approach

The overarching goals of MCCI are to: 1) strengthen state and community public health surveillance system infrastructure and capacity relevant to the health of REM and other underserved women and girls; 2) promote provider education/training in the implementation of EBPs to prevent/treat multimorbidity in REM and other underserved women and girls; 3) support the integration and coordination of primary healthcare, behavioral health systems, and community-based services to meet the health and social needs of racial/ethnic minority and other underserved women and girls of reproductive age; 4) accelerate the adoption and implementation of evidence-based screening and interventions for common comorbidities affecting REM and other underserved women and girls of reproductive age across the entire continuum of women’s health care; and 5) leverage existing federal, state and local resources and collaborations for aligning community and clinical services centering REM and other underserved women and girls.

MCCI Planning Phase (U34):  This U34 NOFO supports the Planning Phase of MCCI.  During this phase, investigators will have 2 - 3 years to: 1) establish public-private scientific partnerships involving the public health leadership in selected communities and NIH and other Federal agencies; 2) identify and address facilitators of and barriers to the implementation of evidence-based mental health, substance use, cardiovascular, cardiometabolic, cancer, and HIV/AIDS interventions (EBI’s) focused on racial and ethnic minority and other underserved women, girls, and families living in communities at high risk for health disparities; 3) complete an assessment of local community surveillance, prevention and treatment needs; 4) identify a set of empirically-informed implementation research goals; 5) identify and develop plans to address essential policy, personnel, data, and other resource needs; and 6) complete a pilot implementation research project.

Awarded U34s that achieve the above milestones established for the planning phase will be eligible to apply for one or more Cooperative Agreement mechanisms during the Implementation Phase, during which awarded grantees will have up to 5 years to: 1) conduct large scale implementation studies to accelerate the translation to community practice of EBI’s to prevent and reduce multimorbidity in racial and ethnic minority and other underserved women and girls of reproductive age; and 2) disseminate and share findings and lessons learned through a data coordination center.

Given that MCCI aims to increase the adoption of an integrated set of EBPs delivered across the entire continuum of women’s health care, the Implementation Phase will involve conducting a suite of coordinated studies in multiple components of the health care continuum for women and girls, such as adolescent and adult prevention services; adolescent and adult primary care services; adolescent and adult mental and behavioral health services; adult cardiopulmonary care; adult endocrinology services; adult cancer care; adult HIV/AIDS services; and community-based wellness and health maintenance services.  Research to determine which strategies and interventions can be implemented in non-clinical community-based settings (e.g., faith-based institutions, schools, community service centers) is strongly encouraged.  In the Implementation Phase, up to 7 studies per continuum are envisioned.  

Research Areas of Special Interest

Research topics of special interest to participating NIH Institutes include, but are not limited to:   

1. Optimal strategies for assuring the sustainability of evidence-based practices (EBPs) for the prevention and treatment of common, co-occurring conditions in REM and other underserved women and girls. Specifically, research that illuminates the health infrastructure necessary to assure sustainability of data-driven, evidence-based systems of care, including but not limited to:

a. Policy requirements (e.g., health care financing; data management)

b. Data collection, integration, and harmonization requirements

c. Community partnership requirements

d. Workforce development requirements

2. Current trends in the prevalence of mental health disorders, SUDs, cardiopulmonary, and metabolic disorders, cancer, and HIV/AIDS among REM and other underserved women and girls of reproductive age in selected high-risk communities.

3. Best approaches to leveraging health information technology tools (e.g., electronic health records) and data science approaches to improve community surveillance for mental health and SUDs, cardiopulmonary disease, metabolic disorders, cancer, HIV/AIDS, and other common co-occurring conditions.

4. Effective community-specific strategies for:

a. Preventing commonly occurring diseases in REM girls and women.   Promoting adoption of evidence-based approaches to preventing mental health disorders, harmful substance use, and common, co-occurring somatic conditions among REM and other underserved women and girls in the partnering community and bringing them to population scale.

b. Improving rates and quality of screening for depression, anxiety, alcohol and other SUDs, cardiopulmonary and metabolic diseases, cancer, and HIV/AIDS.  Specifically, research examining whether cardiopulmonary and metabolic disease screening and treatment can be effectively combined with mental health and substance use screening in clinical and non-clinical settings (e.g., community-based, school-based, mobile, etc.).

c. Promoting adoption of evidence-based brief interventions for harmful alcohol and other substance use.

d. Improving treatment engagement and retention for REM and other underserved women and girls with mental health and SUDs and common, co-occurring, somatic conditions. Research to improve treatment outcomes by providing targeted, evidence-based services for comorbid conditions with high prevalence among women and girls who use alcohol and other substances at harmful levels (e.g., comorbid psychiatric conditions, including posttraumatic stress disorder; trauma history; chronic stress; chronic pain) is an area of special interest.   

5. Best approaches to implementing evidence-based telemedicine models and other EBIs (e.g., spiritually based interventions; mind/body approaches; complementary and integrative health care approaches, etc.) with potential to significantly reduce disparities in access to care.

6. Evidence-based implementation strategies for stepped care to increase reach, uptake, and implementation of integrative, evidence-based, stepped care for common co-occurring conditions in racial and ethnic minority and other underserved women and girls (e.g., Practice Facilitation; Intervention Mapping).

7. Best approaches to health maintenance in racial and ethnic minority and other underserved community settings, both before onset and after stabilization of disease is achieved (e.g., community health workers, evidence-based stress management, digital health monitoring devices, health-focused artificial intelligence).

Model Continuum Description:

Beyond supporting research that will significantly increase access to state-of-the-art health care among racial and ethnic minority and other underserved women and girls of reproductive age, MCCI seeks to catalyze broader efforts within partnering communities to develop optimized systems of care that can serve as regional models replicable by communities with similar demographic, cultural, and structural characteristics.  Each model continuum will ideally be:     

1) Sustainable. Strategies and interventions to be evaluated must be implementable beyond the anticipated period of involvement by the federal government.  Given that the overarching goal of MCCI is to have a transformative and lasting impact on the quality of health care available to racial and ethnic minority and other underserved women and girls, sustainability planning must begin as early as possible in the planning process and show evidence of substantial progress at the end of each reporting period.

2) Inclusive. Recruiting and outreach efforts to encourage women from minority and other underserved groups to consider participating in the program's organization, such as applying for open organizational leadership or advisory/oversight positions.

3) Trustworthy.  Comprising personnel, programs and interventions that are and are perceived as respectful, safe, and affirming of personal autonomy.  Model continuums develop, implement, and continuously evaluate and modify plans to destigmatize mental and behavioral health disorders.

4) Person-centered. Model continuums embrace care of the whole person, cura personalis, as a central value.  Embracing the principle of providing care for the whole person includes acknowledging the importance of a woman or girl’s spiritual and religious beliefs and practices and including these in the care plan.

5) Wellness, prevention, and recovery-centered.  While state-of-the-art care for acute disease is an integral part of any model continuum of care, maintenance of good health (i.e., preventing first episodes of disease and, when disease occurs, achieving and maintaining remission) will be the central organizing principle.  Model continuums of care will employ evidence-based strategies to promote wellness and prevent disease, and to promote long-term recovery after acute illness.

6) Trauma-informed. Trauma-informed systems of care will, at a minimum, consistently provide staff training to:  a) increase awareness of the widespread impact of trauma; b) enhance skills necessary to recognize the signs and symptoms of trauma in patients, families, and staff; c) promote integration of knowledge about trauma into organizational and clinical policies, procedures, and practices; and d) actively avoid re-traumatization by implementing universal trauma precautions.  Adopting trauma-informed practices can facilitate women and girls’ experience of safety, and potentially improve treatment engagement, adherence, and health outcomes, as well as wellness.

7) Culturally Competent. A model continuum of care is cognizant and affirming of both the culture of individual women and girls and of the local community, and able to effectively deliver health care services that meet their social, cultural, linguistic, and health literacy needs. This requires continuous staff training on cultural competence and cross-cultural issues and developing policies that reduce administrative, linguistic, and health literacy barriers to care.  A culturally competent health care system can help improve health outcomes and quality of care, and can contribute to the elimination of racial and ethnic health disparities.

8) Empowering of individual women and girls, their families, and the communities where they reside. A continuum of care that empowers women will, at a minimum, have a patient bill of rights developed and continuously reviewed and modified in collaboration with participating patients. This bill of rights seeks to give every woman and girl a right to care that is safe, respectful, and affirming of her autonomy (e.g., the right to choose among available treatment options for the ones that are a best fit with her lifestyle and life circumstances).  The bill of rights is intended to reinforce the role of care providers as consultants, as opposed to authority figures with control over a woman or girl’s healthcare options or choices.          

9) Guided by principles of care-integration, featuring evidence-based, integrative treatments for multiple chronic conditions and delivery of care by multidisciplinary teams.  Integrating stress management techniques into the health care of women presents an opportunity to impact many aspects of mental and physical health and prevent or reverse multiple inter-related chronic conditions.

10) Well-coordinated and resourceful, with clear plans in place to help women successfully transition from one component of the care continuum to the next when necessary.  A plan to strengthen linkages between the continuum of care for women who are not pregnant and maternal health services is a critically important component of the broader plan to develop a model continuum of care.

11) Community-partnered and collaborative.  Partnerships with organizations that provide a wide range of social services and operate and oversee community infrastructure (e.g., hospitals; community-based health care provider organizations; churches; health policy agencies; public safety organizations; housing agencies; departments of transportation; nutrition support services; schools and education associations; family and other social service providers; Medicaid; community-based membership organizations are an essential feature of a model continuum of care that is able to provide care for the whole person (i.e., cura personalis).

12) Evidence-based, flexible, and responsive to real time data.  To the greatest extent possible, the choice of prevention and treatment options is informed by empirical evidence, and cognizant of the fact that the evidence is constantly changing.   Model continuums of care are flexible and responsive to changing epidemiological, environmental, health systems, and clinical outcome data.

NIAAA Interests

MCCI is a trans-NIH Initiative whereby partnering ICOs will support only those applications that are aligned with their ICO-specific mission and goals, as outlined in their respective Strategic Plans.

NIAAA will support meritorious applications proposing, as a primary theme, dissemination and implementation research on EBIs/strategies to prevent, intervene early, effectively treat, and support recovery from alcohol and co-occurring substance use and mental health disorders among racial and ethnic minority and other underserved women and girls.  While addressing alcohol and co-occurring substance use and mental health disorders among racial and ethnic minority and other underserved women and girls will be the primary focus of successful applications, during the Implementation Phase of the Initiative (i.e., after the 3-year planning phase supported by this NOFO), we will strongly encourage the inclusion of research on integrative prevention, screening, treatment, and recovery support strategies targeting other health conditions that commonly co-occur in these populations, including but not limited to hypertension and other cardiovascular diseases; asthma; obesity; diabetes; cancer; and HIV/AIDS.

Study budgets should provide appropriate levels of funding for community partners commensurate with the roles and level of effort of the community partners in research design and implementation, if applicable.

Applicants are encouraged to discuss their specific aims with the NIAAA contact listed prior to submission.

NINR Interests

The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectional research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest to NINR.

NIMHD Areas of Research Interest

The mission of the National Institute of Minority Health and Health Disparities (NIMHD) is to lead scientific research to improve minority health and reduce health disparities. NIMHD considers race/ethnicity and socioeconomic status as the two pillars of health disparities science. Thus, NIMHD prioritizes novel and innovative research that examines, addresses, and mitigates the underlying causes, pathways, risks, and inequities adversely impacting the health and well-being of women and girls, particularly among  minority health populations (i.e., African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders) and socioeconomically disadvantaged populations. NIMHD also supports research at the intersection of such populations along with other  NIH-designated populations experiencing health disparities, (i.e.,  underserved rural populations, sexual and gender minorities (SGM), and people with disabilities) within the U.S. and its territories. See https://www.nimhd.nih.gov/about/overview/.

While MCCI is an implementation and dissemination science initiative, NIMHD encourages studies that use multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities. See the NIMHD Research Framework:

See https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html).

To meet the intersectional aims of research, investigators are encouraged to collaborate with community leaders, community-based organizations, and other relevant stakeholders to support the study and incorporation of physical, social, behavioral, cultural, ethical, structural, environmental, historical and policy factors into research designs, implementation, and dissemination. Community partnerships (e.g., tribal leadership, academic, private, safety-net health systems, community organizations, public health departments, state and local governments, health care professionals, faith-based organizations, and school or childcare settings) are strongly encouraged. Applicants proposing community-based research, should document existing collaboration with or support from community organizations.

In addition to the Research Areas of Interest delineated above, examples of research topics of special interest to the NIMHD include:

• Studies that include multidisciplinary, multi-level interventions with engagement of community members and collaborators
• Studies that address SDoH that impact access to care and health outcomes, such as structural barriers, medical insurance, racism, discrimination, stigma, and biases, e.g., on health outcomes.
• Studies that address cultural humility, literacy, numeracy, misinformation, and family models on perceptions, barriers, and adherence to care
• Studies that involve group-based innovative models in special populations that include SGM adults and persons living with disabilities.
• Studies that use novel technologies and mechanisms to address multiple and chronic conditions among racial and ethnic minority women and girls residing in underserved rural communities. 

Study budgets should provide appropriate levels of funding for community partners commensurate with the roles and level of effort of the community partners in research design and implementation, if applicable.

Applicants are encouraged to discuss their specific aims with the NIMHD contact listed prior to submission. 

NCCIH Areas of Interest

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 support 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. 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.

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.

NCCIH welcomes pilot studies to prepare for future larger trials. The link, https://www.nccih.nih.gov/grants/mind-and-body-clinical-trials-funding-opportunities, provides more information about NCCIH funding for intervention refinement and optimization.

Areas of interest to NCCIH include but are not limited to:

• Trials that evaluate implementation strategies for adopting and delivering evidence-based mind and body interventions to prevent and address chronic stress among racial and ethnic minority women and girls in diverse settings (e.g., schools, criminal justice, primary health care, community health care centers, rural communities, faith-based organizations) to reduce risk of multi-morbidity and enhance whole person health, including (but not limited to) the promotion of physical functioning, sleep, resilience, pain management, mental health and well-being.
• Trials that evaluate implementation strategies to promote adherence to care using complementary and integrative health approaches.
• Hybrid effectiveness implementation trials that evaluate a combination of effectiveness and implementation outcomes for adopting and delivering promising complementary and integrative health interventions in diverse settings to prevent and/or intervene on risk or protective factors associated with multi-morbidity and whole person health for underserved racial and ethnic minority women and girls.
• Trials that assess multilevel factors – including social determinants of heath- which impact implementation of complementary and integrative health approaches to mitigate risk of multi-morbidity and/or enhance protective factors to improve whole person health for underserved racial and ethnic minority women and girls – including sexual gender minority and immigrants.
• Studies that leverage health information technology tools (e.g., mobile apps, wearables, and other devices) to implement complementary and integrative health interventions to reduce risk of multi-morbidity among racial and ethnic minority women and girls.
• Studies that assess novel continuum care models to implement complementary health approaches in conjunction with conventional care therapies to address risk of multi-morbidity and enhance wellness for racial and ethnic minority women and girls.

Research Scope Not Responsive to NOFO:

MCCI is a dissemination and implementation science initiative aimed at supporting Type 1, 2, and 3 Hybrid Implementation Trials (i.e., those that evaluate a combination of effectiveness and implementation outcomes or a combination of implementation and clinical outcomes) .  Therefore, preclinical and efficacy studies will be considered non-responsive.

MCCI is not a maternal health initiative.  Instead, MCCI aims to redress longstanding health inequities affecting racial and ethnic minority and other underserved women and girls of reproductive age, in recognition of their intrinsic dignity and value apart from their role as current or potential mothers.  For individuals who wish to become pregnant, it aims to address their complex health and social needs prior to conception and/or between pregnancies, congruent with data showing that the health trajectory of any single pregnancy is largely determined by conditions that exist prior to pregnancy.  While the focus of MCCI is on strengthening the continuum of women and girl’s health care external to clinical maternal health care, strategies to improve linkages between maternal health care and other components of the health care continuum must be a critical element of the partnering community’s broader plan to develop a model continuum of care.

Given this focus on non-pregnant women and girls, applications that propose to focus on populations during the pre-, peri-, and postpartum periods and/or on hypotheses related to maternal health will be deemed non-responsive. While not a maternal health initiative, MCCI is a women's and girls’ health initiative that, by using an ecological systems approach to strengthening the continuum of health care for women and girls of reproductive age, may potentially significantly improve maternal health and birth outcomes among women and girls most severely affected by health disparities.

Diversity Statement

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust..(See: NOT-OD-20-031) 

Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

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

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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:

Philippe Marmillot, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-2861
Email:  [email protected]

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

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

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

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PEDP implementation costs:

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Multiple PD/PI Leadership Plan 

Without duplicating information in the biosketch(es), describe the following: (1) PD(s)/PI(s)' expertise, experience, and ability to organize, manage and implement the proposed dissemination and implementation study and meet timelines, (2) PD(s)/PI(s)' expertise in study coordination, data management and statistics, and (3) PD(s)/PI(s)' capacity and commitment to enroll subjects.

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

Other Plan(s): 

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

• 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.
• For NIAAA-specific Data Management and Sharing Plan elements see NOT-AA-23-001.
• For additional NIAAA-specific information on submitting scientific data from studies with human subjects see NOT-AA-23-002.  

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

Awards issued under this NOFO will be incrementally funded awards for each budget period with a project period of up to 3 years. NIH will not issue any awards under this NOFO for a single budget period for multiple years.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

In order to expedite review, applicants are requested to notify the appropriate IC Referral Office by email at the address below when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the appropriate IC {NIAAA; NINR; NIMHD} 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

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 among the recipients and NIH as defined below.

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

• 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 HHS, PHS, and NIH policies. 
• Recipients will regularly provide updates, progress, new/pending publications, new developments and changes in future plans to the ICO Project Scientist(s). 
•  
• Coordinate a regular schedule of meetings with ICO Project Scientist(s) for review and consultation.
• Coordinate project activities with their institutions, with collaborators, and with the ICO Project Scientist(s).
• Accept assistance and seek input from ICO Project Scientist(s) to inform the pursuit of project goals.
• Publish, publicly presenting, and disseminating results of the research project, as consistent with NIH policy.

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

A designated ICO Program staff, acting as a Project Scientist, will have substantial programmatic involvement, as described below.

• Coordinate and facilitate the interactions among the U34 award recipients under this initiative;
• Serve as liaison between the U34 award recipients under this initiative and ICO staff members and investigators involved in the program, facilitating interactions and scientific integration between the recipients;
• Promote and help coordinate collaborative research efforts that involve interactions with other ICO-sponsored programs, projects, and centers;
• Participate in program meetings;
• Provide technical assistance and advice to the recipients as appropriate;
• Assist in the interaction between the U34 award recipients under this initiative and investigators at other institutions, as appropriate for the program;
• Assist in avoiding unwarranted duplication of effort with other NIH efforts;
• Monitor institutional commitments and resources to the recipients;
• Develop working groups and trans-project efforts as needed; and organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the recipients.
• The ICO Project Scientist(s) will monitor the progress of ongoing research
• The ICO Project Scientist(s) may assist in the analysis, interpretation, and reporting of findings in the scientific literature and is subject to the same publication/authorship policies governing all participants in the research, as well as to the official NIH publication policy governing extramural employees.
• The ICO Project Scientist(s) will have full voting membership (one vote each) on the Steering Committee and will attend all meetings of the Steering Committee.
• The ICO Project Scientist(s) will serve as liaison between the research recipients, the Steering Committee, and ICO.
• The ICO Project Scientist(s) may not attend peer review meetings and shall not be involved in funding decisions
• 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.
• ICO Program Staff may not have dual role as Project Scientist and Program Director.
   

Areas of Joint Responsibility include:

•  
• The ICO  Project Scientist(s) and the award recipients will be responsible for forming a Steering Committee which will be the main governing board of the Model Continuums of Care Initiative.  
• The Steering Committee should comprise the PI(s); the ICO Project Scientist(s); a representative of the local Department of Public Health; a representative of the local Department of Behavioral Health; a representative of the local Department of Social Services; a representative of the local Administration for Child and Family Services; a representative from the local health care financing administration; a representative of the local Department of Education; a representative of the local Department of Employment Services; a representative of the local Department of Housing; a representative of the local Department of Recreation; a representative of participating non-governmental stakeholder organizations; and the Coordinator for Community Engagement.
• The Steering Committee may, by majority vote, add additional representatives from critical health and/or social service organizations not to exceed 15.
• Primary responsibilities of the Steering Committee include: 1) establishing and strengthening a public-private scientific partnerships involving the public health leadership in the partnering community and NIH and other Federal agencies; 2) identifying and addressing facilitators of and barriers to the implementation of evidence-based mental health, substance use, cardiovascular, and cardiometabolic interventions (EBI’s) focused on racial and ethnic minority and other underserved women, girls, and families living in the partnering community; 3) completing an assessment of local community surveillance, prevention and treatment needs; 4) identifying a set of empirically-informed implementation research goals; 5) identifying and developing plans to address essential policy, personnel, data, and other resource needs; and 6) completing a pilot implementation research project.
• In addition, the Steering Committee will develop and execute plans for data harmonization and synchronization; identify opportunities for collaborative research and develop collaborative proposals and protocols; and identify and exploit opportunities for technological and administrative resource sharing. 

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.

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

4. Reporting

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

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

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (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: [email protected]

Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5820
Email: [email protected] 

Nadra Tyus, DrPH, MPH
National Institute of Nursing Research (NINR)
Telephone: 240-278-9178
Email: [email protected]
 

Sundania Jw Wonnum, Ph.D., BCD, LCSW
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: [email protected]

Beda Jean-Francois, Ph.D. 
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: [email protected]

Weigun Li, Ph.D.
National Institute on Nursing Research (NINR)
Telephone: 301-594-5966
Email: [email protected]

Yujing Lui, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
 

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

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.