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

Key Definitions

NIH-designated Populations Experiencing Health Disparities: Racial and ethnic minority populations, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minority groups, and people living with disabilities in the U.S.

Disability: The Americans with Disabilities Act broadly defines a disability as a "physical or mental impairment that substantially limits one or more major life activities (e.g., mobility, cognition, independent living, vision, and self-care) and the ADA Amendments Act of 2008 that added "major bodily functions", to "Major Life Activities." This funding opportunity focuses on persons across the lifespan with congenital, developmental, cognitive, and physical disabilities (e.g., Down's syndrome, cerebral palsy, or injury-related physical impairment or amputation), as well as adults with early or premature onset of a major physical disability that causes long-term impairment or limit(s) functioning indefinitely.

Intersectional Approach: Intersectionality acknowledges that individuals have multiple, interconnected social identities (e.g., gender, racial group, class, sexual orientation, and disability), and these identities intersect to shape their unique experiences and positions within society. For example, intersectionality highlights how racial and ethnic minority persons living with a disability may experience a unique set of challenges that require a more comprehensive approach to addressing discrimination and promoting health equity. Taking an intersectional approach can better predict variations in health outcomes and determine individual or population needs, and ultimately lead to more inclusive and/or multi-level research.

Background

The population of persons living with disabilities in the United States is heterogeneous, estimated at 24-26% of adults and 4.3% of children from various backgrounds, life circumstances, and health conditions. Impaired mobility (13.7%), cognition (10.8%), and independent living (6.8%) are the most common disabilities among adults, and impaired cognition (4.4%) is most common among children. Data indicate that, on average, individuals living with disabilities have poorer health-related quality of life and overall health, as well as decreased healthy life expectancy and longevity compared with people without a disability. Adults living with disabilities have a higher prevalence of preventable, chronic, and complicating comorbidities compared with the overall adult population. Examples include obesity (38.2% versus 26.2%), tobacco smoking (28.2% versus 13.4%), diabetes (16.3% versus 7.2%), and heart disease (11.5% versus 3.8%). Among persons of childbearing age, 12% live with at least one disability and are at a higher risk for maternal morbidity and mortality. Additionally, the objective signs and subjective experiences of persons living with disabilities are often dynamic, changing in nature, quality, and severity over time.

Research Objectives:

The focus of this notice of funding opportunity (NOFO) is to emphasize research at the intersection of disabilities, race and ethnicity, and socioeconomic status (SES) in persons with developmental and physical disabilities. Among racial and ethnic minority groups, the prevalence of living with at least one disability is markedly greater in American Indian and Alaska Native (30%) and Black or African American (25%) populations compared to 20% of White persons. Irrespective of racial and ethnic group, economically disadvantaged persons with disabilities are more likely to experience diminished opportunities for effective independent living driven by factors such as unemployment, adverse living conditions, housing instability, food insecurity, transportation limitations, social isolation, disaster unpreparedness, and low quality of healthcare. Additionally, residents of underserved rural communities are 9% more likely to have any disability and 24% more likely to report having three or more disabilities compared with adults in urban areas. Individuals living with disabilities, who reside in rural areas may also face barriers to healthcare access, accessible transportation, and high-quality education, and vocational or rehabilitation services. Research among sexual and gender minority persons with disabilities is scarce, although it is likely that commonly experienced barriers to accessing culturally competent physical, psychiatric, and specialty healthcare are intensified.

Furthermore, adverse social determinants of health (SDOH) amplify the challenges of health and health-related quality of life (QoL) among youth and adults living with disabilities. Examples include lack of accessible transportation or building entry/navigation, discrimination related to ableism, and clinical misperceptions within healthcare systems that may greatly complicate healthcare access and quality. Moreover, inaccessible and/or non-adaptive clinical facilities, equipment, and communication mechanisms, as well as non-inclusive clinical care guidelines and procedures impede equitable access to appropriate healthcare or lead to erroneous attribution of symptoms related to the primary disability rather than a new or co-occurring diagnosis or health crisis. Greater study is needed to inform appropriate or adaptable clinical practice guidelines for persons living with disabilities with an intersectional lens, as well as to enhance the understanding of the health and health risk behaviors (e.g., alcohol and substance use, prescription misuse, self-injurious behaviors, and interpersonal violence) over the life course. Overall, more expansive research is needed to elucidate the discrete differences, areas of overlap, relationships among factors across the lifespan, and severity of health outcomes across and within populations with health disparities. Therefore, this funding opportunity strongly encourages collaborative, mechanistic, clinical, or interventional research, implementation or translational science, and/or the use of data science research approaches in intersectional areas of study.

Research Objectives:

The overarching goals of this funding opportunity are to support innovative research that focuses on the health (e.g., conditions, outcomes, trajectories, etc.) and healthcare (e.g., modalities systemic or structural factors, access/barriers, service delivery, care quality, utilization, etc.) of persons living with disabilities and the intersections with race and ethnicity, and SES. Research focused on intersections with sexual and gender minority self-identification, and living in underserved rural locations are also of interest.

Projects may include the study of comorbid or co-occurring conditions (e.g., acute infections or chronic diseases); adaptive and maladaptive behaviors; prevention of or interventions for health risks; tailored or innovative health care processes, structures, or systems; healthcare delivery model effectiveness; and clinicians and other health care workers practices and/or biases.

Applications are expected to provide a conceptual model that describes or hypothesizes causal pathways by which clinicians and other healthcare professionals, services, or systems engage persons with disabilities to mitigate health risks, improve health outcomes, reduce health disparities, or compliment health care system.

Applications are encouraged to address more than one level of analysis (e.g., individual, interpersonal, institutional, community, and policy levels), as illustrated in the NIMHD Research Framework. They should also consider factors that will facilitate or serve as barriers to sustainability and/or adoption of healthcare models, practices, or guidelines. Resulting research initiatives will support science that advances our understanding of and efforts to mitigate the underlying causes and pathways adversely impacting the populations of focus.

Research projects for this NOFO can consist of studies that are clinical science, behavioral, epidemiological, evaluative, or observational, as well as implementation studies, pragmatic trials, and cluster randomized trials to assess health care provision, models, delivery, services, and systems in metropolitan or rural areas, regionally, and/or nationally, including the U.S. territories. Projects can involve primary data collection and/or secondary analyses of linked datasets. Projects can include research collaborations across multiple health care settings and academic institutions.

Investigators are strongly encouraged to work collaboratively with community leaders, community-based organizations, and other relevant stakeholders and/or supporting persons with disabilities to support in-depth examination of physical, social, behavioral, ethical, structural, environmental, and policy factors. 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-engaged research should document existing collaboration with or support from community organizations. 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.

NCCIH Areas of Interest:

NCCIH will support research that is well aligned with the NCCIH Strategic Plan. Research areas funded by the institute broadly fall into three therapeutic areas, including nutritional, psychological, and physical approaches. These may include the array of natural products derived from plants, fungi, bacteria, marine organisms, or animals, including pro/prebiotics; as well as mind and body approaches such as yoga, massage therapy, meditation, mindfulness-based stress reduction, guided imagery, clinical hypnosis, spinal/joint manipulation, acupuncture, and art- and music-based interventions. Approaches may also be combined (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR). NCCIH is interested in research that takes a transdisciplinary approach and integrates natural, social, and health sciences and transcends traditional boundaries to investigate the multifactorial process of whole person health restoration. For the purposes of this NOFO, NCCIH is interested in research on the contributions of disability status and related factors (e.g., emotional well-being, social determinants of health such as access to affordable complementary and integrative health approaches) on the mechanisms of action of interventions that include complementary and integrative therapeutics. Only Basic and Experimental Studies with Humans (BESH) clinical trials will be supported by NCCIH for such mechanistic studies. NCCIH is also interested in research that investigates the influence of disability status on the utilization and ability of complementary and integrative approaches to improve health outcomes among people from diverse racial, ethnic, socioeconomic populations. For such studies, NCCIH will only support applications in the area of complementary and integrative health that do not propose clinical trials such as analyses of large, nationally representative datasets or registries, or epidemiological/observational studies. NCCIH will not support feasibility or efficacy trials through this NOFO (please see NCCIH Clinical Trial Funding Opportunities instead for feasibility and efficacy clinical trials). Investigators are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact prior to submitting their application to identify the most appropriate NOFO for their research.

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. For this funding opportunity, NIMHD priorities include research that employs an intersectional approach to the study of, or interventions targeting, the health and healthcare of persons living with disabilities. Areas of interest include, but are not limited to, the following:

• Population-based studies of health risks, associated SDOH, trends, potential causes of disparities that identify and address:
  • Population health strategies to reduce complicating health risks and/or to strengthen protective individual, community, and/or healthcare system factors.
  • Multilevel studies to understand the influence of factors at varying or intersecting levels (e.g., individual, interpersonal, or community).
• Multilevel examination or evaluation of healthcare systems and clinical and community infrastructures, and social and ancillary services influencing health outcomes, which address:
  • Factors and mechanisms influencing healthcare access, delivery, quality, utilization, screening, treatment, medical specialty/surgical referrals, and disaster/emergency preparedness, response and recovery.
  • Developmentally appropriate, patient-centered, and wrap-around care coordination.
  • Effectiveness of training models and practices focused on disability competencies and structural biases (e.g., ableism).
• Development, testing, implementation, and/or evaluation of integrative care models and interventions to optimize care, which address:
  • Factors affecting adaptation, inclusivity, and equity of comprehensive health care and services.
  • Specific access barriers (e.g., digital exclusion)
  • Clinical practice guidelines or processes (e.g., decision-making, communication, care coordination, behaviors, multi-specialty collaboration, healthcare system communication) for the prevention, diagnosis, care, and management of multiple and/complex conditions at different levels or components within health care systems.
  • Unique manifestation of non-communicable and chronic diseases in these populations, thus leading towards tailored and timelier preventive, diagnostic and treatment strategies, especially within the context of racial/ethnic self-identification and/or low SES.
• Studies of comprehensive behavioral interventions and social care services influencing health outcomes, and quality of life, which address:
  • Clinical, community, or home-based prevention and interventions to improve instrumental activities of daily living (e.g., self-care, domestic tasks, managing finances, and transportation) and self-agency.
  • Interventions to improve behavioral healthcare, mental healthcare care access, engagement, and quality.
  • Intervention and policy development and evaluation to support community living, inclusion, and independence.
• Community-engaged or community-based participatory research that engages persons living with disabilities and/or their families with lived experience, as well as community partners to understand or mitigate health risks and/or improve protective factors and health outcomes.
• Conceptualizations or perceptions of social norms (e.g., ableism), attitudes, and behaviors (e.g., discriminatory practices) influencing individual- and population-level healthcare engagement, health practices, quality of life, and well-being.

Specific Areas of Research Interest for Participating Organizations:

NIDDK is interested in research toward improved prevention and management of NIDDK-related diseases and conditions in intersectional communities of people with disabilities. NIDDK mission diseases and conditions include diabetes and other endocrine and metabolic diseases; gastrointestinal, liver, and pancreatic diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases. NIDDK has many research areas within its mission, but all research related to relevant diseases may not be appropriate for NIDDK. Applicants are strongly encouraged to contact NIDDK staff as soon as possible in the development of the application, so that NIDDK staff can help the applicant understand whether the proposed project is within the goals and mission of the Institute.

Specific areas of interest related to persons living with disabilities (PWD) include, but are not limited to, the following:

• Intersectional factors that improve or impede PWD’s engagement with integrated health care services and impact the effective prevention and management of diseases and conditions within NIDDK’s mission. Factors include structural (e.g., assisted technology, physical environment) and social determinants of health including attitudes and actions (e.g., empowerment models; discrimination such as ablelism, racism, homophobia).
• Multilevel research to address effective screening, referral, and navigation of PWD to medical and social care and other ancillary services to improve outcomes related to NIDDK’s mission diseases and conditions.
• Shared decision-making approaches to improve access to integrated health care services, patient engagement and satisfaction, and health outcomes related to NIDDK’s mission diseases and conditions.
• Community-based interventions to improve PWD access to health care and their health outcomes related to NIDDK diseases and outcomes.
• Integrated care models to improve the implementation of evidence-based interventions to prevent and treat the onset and progression of NIDDK’s mission diseases and outcomes.

NIDDK encourages applications that demonstrate consideration of the Tips for Pursuing Competent Health Equity Research (see Appendix G of Pathways to Health for All). This includes applications with interdisciplinary research teams comprised of individuals with a breadth of lived experiences and biomedical scientific expertise deemed necessary to positively inform the study design, research conduct, and applicability of research findings for the populations of interest. Applicants are also encouraged to review additional populations that experience health disparities that may be considered for research submitted to this PAR (see page 10 of Pathways to Health for All).

National Cancer Institute (NCI)

The NCI is interested in promoting research that addresses access and barriers to the delivery and receipt of cancer care that contribute to health disparities for persons with physical and/or sensory disabilities (PWD). Our focus on PWD who have a pre-existing/pre-cancer physical and/or sensory (e.g., vision loss, hearing loss) disability. NCI seeks to generate new knowledge that will help mitigate the stigma of disability and improve access to and delivery of guideline-concordant cancer preventive care and treatment, and utilization of cancer services, particularly for PWD who are members of medically underserved minority or marginalized groups (e.g., racial/ethnic minorities, sexual and gender minorities). Applicants should consider the architectural/environmental, structural, interpersonal, and procedural barriers that limit access to guideline-concordant cancer care.

Research areas of interest include, but are not limited to the following:

• Identify architectural, structural, interpersonal, and procedural features that are associated with PWD receiving timely guideline-concordant cancer care (including screening, testing, treatment, palliative care, and pain management)
• Develop, test, and evaluate/implement strategies to improve cancer care coordination and follow-up care for PWD, particularly medically underserved individuals, such as racial/ethnic minorities, sexual and gender minorities, members of underserved rural and urban communities, and those living far from cancer care facilities
• Examine how telehealth and technology can be employed to improve cancer screening, diagnosis, treatment, care management, and follow-up for PWD; Develop, test, and evaluate/implement technology to improve access to cancer care for PWD
• Identify models or elements of patient-provider communication that facilitate recommendations for screening and receipt of guideline-concordant cancer care for PWD
• Identify factors associated with failing to follow up with screening recommendations or adhering to treatment plans for PWD; Develop, test, evaluate/implement strategies that improve adherence to screening and treatment recommendations
• Identify characteristics or features of the hospital/clinic/doctor’s office building and office environment that facilitate access to care and contribute to patient satisfaction
• Identify multi-level barriers to participating in clinical research faced by PWD; Develop, test, evaluate/implement strategies to reduce or eliminate barriers so that PWD are eligible to be included in clinical research

National Eye Institute (NEI)

The mission of NEI is to eliminate vision loss and improve quality of life through vision research. NEI invites intersectional research applications that address the health and well-being for people with visual impairment (blindness and low vision) among populations with health disparities. More information regarding NEI priorities are detailed in the institute’s strategic plan.

Areas of specific interest include but are not limited to the following:

• Intersectional factors that disadvantage or protect access to healthcare and/or sociocultural services among populations with health disparities who are visually impaired
• Multilevel research to address comorbidities that accompany visual impairment in populations with health disparities and their integrated care management
• Development of implementation strategies and translational science approaches to address visual impairment in populations with health disparities
• Intersectional research on the impact of stigma and ableism on the health and wellness of populations with health disparities who have visual impairments

The NEI will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For additional information on NEI Clinical Trial policies, see NOT-EY-23-001. Applicants are strongly advised to reach out to the NEI Scientific Contact before submitting applications for guidance about NEI’s interests and more information regarding clinical trial designations.

National Human Genome Research Institute (NHGRI)

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

• Division of Genome Sciences: https://www.genome.gov/about-nhgri/Division-of-Genome-Sciences
• Division of Genomic Medicine: https://www.genome.gov/about-nhgri/Division-of-Genomic-Medicine
• Ethical, Legal, and Social Implications Research Program: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications
• Office of Genomic Data Science: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science
• Training, Diversity and Health Equity Office: https://www.genome.gov/about-nhgri/Office-of-the-Director/Training-Diversity-and-Health-Equity-Office

Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

Additionally, as described in NOT-HG-22-033, NHGRI strongly encourages that the request for an application requesting $500,000 or more in direct costs for any year be sent to the Scientific/Research Contact for PAR-23-309 at least eight weeks prior to the anticipated submission date.

National Institute on Aging (NIA)

The mission of NIA is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.

NIA uses the definition of disability provided in the Americans with Disabilities Act and ADA Amendments Act of 2008 that added "major bodily functions", to "Major Life Activities".

NIA has the following research interests related to persons living with disabilities:

• Aging-related studies spanning disabilities that are congenital, developmental, and/or acquired.
• Research of co-occurring Alzheimer’s Disease and Related Dementias.
• Intersections between disability status and racial/ethnic identity(ies), sexual and gender identity(ies), as well as socioeconomic status, among older Americans, utilizing the NIA Health Disparities Framework. Such research should hold the potential to illuminate the distinct challenges faced by individuals with disabilities in terms of accessing healthcare services, navigating complex healthcare systems, and enhancing their overall well-being. Particularly, NIA has an interest in the challenges people living with disabilities face, among those residing in rural areas and individuals who have been or currently are incarcerated.
• NIA is also interested in how risk and protective factors (e.g., poverty and economic vulnerability, segregation, racism, ableism, sexism, ageism, immigration, loneliness, social support, educational attainment, culture, and spirituality) play a role in disability in explaining health disparities. NIA also seeks to identify and understand how protective factors help to counteract the effects of risk factors, in studies that use an experimental medicine approach.
• Older adult adaptive and maladaptive behaviors, health risk prevention, and intervention development aligned with the NIH Stage Model for Behavioral Intervention Development and Science of Behavior Change, which can have direct relevance to older populations striving to maintain their health and independence.

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

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this NOFO, the NIAMS is interested in intersectional research into improving the health and health care of individuals living with disability among populations that experience health disparities and are patients suffering from a disease within NIAMS core mission. The NIAMS will not support clinical trials through this NOFO. Applications involving clinical trials should instead be submitted to a NIAMS clinical trial specific NOFO (see Clinical Research Grants). Applicants are encouraged to consult with the appropriate NIAMS program staff about potential applications.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

This mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB is interested in projects that address specific needs of populations with disabilities that are experiencing health disparities. Projects may span the development in research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols. Applications developing novel technologies should incorporate a universal design approach and those building on existing technologies should provide significantly improved accessibility and ease-of-use for all.

Research areas of special interest include, but are not limited to the following:

• Examine how PWD are represented in current technology development efforts; Identify multi-level barriers to technology use faced by PWD
• Develop, test, or implement technologies to reduce or eliminate barriers for PWD in clinical research
• Analyze intersectional factors that restrict access to imaging or point of care technologies

For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

Applicants are strongly advised to reach out to the NIBIB Scientific Contact before submitting applications for guidance about NIBIB’s interests and more information regarding clinical trial designations.

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

NICHD’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. NICHD is interested in projects at the intersection of disability and individuals other identities, including how multiple identities might interact to exacerbate health disparities. Applications seeking to establish the efficacy or effectiveness of novel interventions should address scalability and sustainability and fully consider the context in which such interventions will be implemented. Visit https://www.nichd.nih.gov/about/org/der/branches and https://www.nichd.nih.gov/about/org/ncmrr for more information about NICHD research priorities.

Research areas of interest include, but are not limited to:

• Access to pregnancy and reproductive health care in people living with disabilities among populations experiencing health disparities.
• Intersectionality of identities linked with health disparities and maternal health outcomes in people with disabilities.
• Prenatal and postnatal development drivers of disability in populations experiencing health disparities.
• Intersectional factors that disadvantage and/or protect access to quality services among populations experiencing health disparities who are living with disabilities.
• Drivers of disability childhood development through adolescence in populations experiencing health disparities.
• The role of multiple identities in driving accessibility barriers that disrupt health care services and constrain opportunities to seek and use of preventive and treatment services among people with disabilities.
• Interactions between multiple identities and their role in driving ableist attitudes among healthcare providers and health systems and the quality-of-care people with disabilities receive.
• Multilevel approaches to understanding intersectionality and its role in driving disparate rehabilitation outcomes among people with disabilities who also identify as a member of one or more populations experiencing disparities.

National Institute on Drug Abuse (NIDA)

The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting research relevant to advancing the understanding of the effects of substance use among people living with disabilities and experiencing health disparities. This includes the identification and development of innovative strategies, prevention, and intervention methods, as well as policy changes to reduce negative effects of substance use among this population, specifically among racial and ethnic minorities, sexual and gender minorities, and other underserved populations. Priority areas include but are not limited to research on the following:

• How limited accessibility impacts substance use treatment and services.
• What are the substance use risks and potential compounded health disparities of underserved populations living with disabilities?
• Using an intersectional lens to examine substance use risk and protective factors among underserved populations living with disabilities, including exploring availability and use (or lack thereof) of prevention services.
• Implementation science and health systems research to understand the impact of accessibility on substance use prevention and treatment efforts.
• How limited accessibility and barriers to accessibility impact seeking out and use of prevention and treatment services (transportation, adequate parking at treatment facilities, SUD counseling that isn t adapted for people with cognitive disabilities, no materials in Braille or other alternative formats, lack of staff training on technologies for communicating with people who are deaf, etc.).
• What is the impact of stress among this population that can lead to substance use and/or addiction, and how can community services alleviate stress to facilitate the substance use intervention process.
• What is the impact of stigma against underserved populations living with disabilities and how that affects seeking and use of substance use prevention and treatment services.
• What gaps exist in medical and community settings that may prevent adequate addiction services to underserved populations living with disabilities.
• Evaluating financial issues that may stem from living with a disability and lead to substance use. How unemployment due to a disability impacts substance use. How do the combined costs of substance use services and accessibility accommodations impact the uptake and use of substance use services and outcomes?
• Development of substance use prevention and intervention strategies among underserved populations living with disabilities.

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIDCD invites responsive applications addressing the needs of individuals with communication disorders, specifically those disorders that align with the Institute’s scientific programs of hearing, balance, taste, smell, voice, speech, and language. For more information, please see: https://www.nidcd.nih.gov/about/strategic-plans Any applications proposing a clinical trial must meet ALL the following criteria: not require FDA oversight, are not intended to formally establish efficacy, and have low risks to potentially cause physical or psychological harm. Application funded by NIDCD should have budgets less than $500,000 direct costs per year.

National Institute on Drug Abuse (NIDA)

The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting research relevant to advancing the understanding of the effects of substance use among people living with disabilities and experiencing health disparities. This includes the identification and development of innovative strategies, prevention, and intervention methods, as well as policy changes to reduce negative effects of substance use among this population, specifically among racial and ethnic minorities, sexual and gender minorities, and other underserved populations. Priority areas include but are not limited to research on the following:

• How limited accessibility impacts substance use treatment and services.
• What are the substance use risks and potential compounded health disparities of underserved populations living with disabilities?
• Using an intersectional lens to examine substance use risk and protective factors among underserved populations living with disabilities, including exploring the availability and use (or lack thereof) of prevention services.
• Implementation science and health systems research to understand the impact of accessibility on substance use prevention and treatment efforts.
• How limited accessibility and barriers to accessibility impact seeking out and use of prevention and treatment services (transportation, adequate parking at treatment facilities, SUD counseling that isn t adapted for people with cognitive disabilities, no materials in Braille or other alternative formats, lack of staff training on technologies for communicating with people who are deaf, etc.).
• What is the impact of stress among this population that can lead to substance use and/or addiction, and how can community services alleviate stress to facilitate the substance use intervention process?
• What is the impact of stigma against underserved populations living with disabilities and how that affects seeking and use of substance use prevention and treatment services?
• What gaps exist in medical and community settings that may prevent adequate addiction services for underserved populations living with disabilities?
• Evaluating financial issues that may stem from living with a disability and lead to substance use. How unemployment due to a disability impacts substance use. How do the combined costs of substance use services and accessibility accommodations impact the uptake and use of substance use services and outcomes?
• Development of substance use prevention and intervention strategies among underserved populations living with disabilities.

National Institute of Neurological Disorders and Stroke (NINDS)
The National Institute of Neurological Disorders and Stroke (NINDS) is interested in applications within the NINDS mission (NINDS Disorders Index: https://www.ninds.nih.gov/health-information/disorders). NINDS aims to support multidisciplinary, community-engaged health equity research to identify develop, and evaluate strategies to improve outcomes specifically related to neurological disorders in people living with disabilities among populations experiencing health disparities. Specific areas of research interest include but are not limited to:

• Identify and validate approaches to examine the role of stigma, bias, ableism, and/or discrimination as risk factors contributing to neurological health disparities in persons living with disabilities among NIH-designated HDPs.
• Identify and measure specific modifiable social determinants of health that contribute to neurological health disparities in persons living with disabilities among NIH-designated HDPs.
• Identify strategies to address structural barriers, organizational practices, policies and other social, cultural, and contextual factors that impact disparate neurological health outcomes in persons living with disabilities among NIH-designated HDPs.

Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only Basic Experimental Studies with Humans (BESH) clinical trials, defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena will be supported by NINDS. Mechanistic clinical trials or clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported under this NOFO. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. Applicants are strongly advised to consult with NINDS prior to submitting an application to this NOFO to determine the appropriate funding

National Institute of Nursing Research (NINR)

The 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 practice, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

Applications NOT responsive to this NOFO

• Projects that are exclusively qualitative.
• Projects that include populations living outside the 50 states, tribal lands, and the U.S. territories.
• Projects that do not study have an intersectional (i.e., race/ethnicity or low SES) focus on the study of health and healthcare among people with disabilities.
• Studies that focus on disabilities that are outside the definition and scope described in the Key Definitions section above.
• Projects that include prohibited policy lobbying or advocacy activities (see https://grants.nih.gov/grants/lobbying_guidance.htm for more information).
• Projects that examine the financing of health care or the cost and efficiency of health care service delivery, without linking such economic analysis to measurable health outcomes (See NOT-OD-16-025 for more information).

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.

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 Institutions) 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 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. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.

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:

Sundania J. W. Wonnum, PhD, LCSW
Email: sundania.wonnum@.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) 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&amamp;R or Modular Budget

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

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:

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.

Investigators should include applicable Data Sharing Plan(s) in the application.

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.

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 SF424 (R&R) 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.

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.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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 . 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.

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: General and 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:

• Federal-wide 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 45 CFR Part 75.205 and 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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 45 CFR Part 75 and 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

Beshaun Davis, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-5098
Email: beshaun.davis@nih.gov

Sekai Chideya-Chihota, MD, MPH
National Center for Complementary and Integrative Health (NCCIH)
Phone: 240-552-2994
Email: sekai.chideya@nih.gov

NIDDK conducts and supports medical research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and in kidney, urologic, and hematologic diseases. Visit NIDDK's Research Programs and Contacts page to identify a scientific/research contact.

Sheba K. Dunston, EdD
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1526
Email: Sheba.Dunston@nih.gov

Sundania J. W. Wonnum, PhD, LCSW
NATIONAL INSTITUTE ON MINORITY HEALTH & HEALTH DISPARITIES (NIMHD)
Email: sundania.wonnum@nih.gov

Cheryse A. Sankar, PhD
National Institute on Neurological Disorders and Stroke (NINDS)
Phone: (301) 318-2889
E-mail: cheryse.sankar@nih.gov

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

Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov

Lucia Hindorff, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509
Email: hindorffl@mail.nih.gov

Toyin Ajisafe, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-9242
Email: toyin.ajisafe@nih.gov

Moria Fisher Bittmann
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: none
E-mail: moria.bittmann@nih.gov

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

Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: liz.perruccio@nih.gov

Yan Wang, MD, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: wangy1@mail.nih.gov

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

Priscilla Novak, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-496-3136
E-mail: priscilla.novak@nih.gov

Wendy Nelson
National Cancer Institute (NCI)
Phone: (240) 276-6971
E-mail: nelsonw@mail.nih.gov

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

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:siscor@mail.nih.gov

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

Christina Rinaldi
National Institute on Drug Abuse (NIDA)
Phone: 301-827-0937
Email: christina.rinaldi@nih.gov

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

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

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

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

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

Mutema Nyankale
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 827-6317
E-mail: nyankalem@mail.nih.gov

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

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

Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: myersc@nidcd.nih.gov

Jeni Smits
NATIONAL INSTITUTE ON AGING (NIA)
E-mail: jeni.smits@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
E-mail: crystal.wolfrey@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 45 CFR Part 75 and 2 CFR Part 200.