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

Background

Although scientific and technological discoveries have improved the health of the U.S. population overall, populations affected by health disparities such as sexual and gender minorities (SGM) from racial and ethnic minoritized populations and from less privileged socioeconomic statuses (SES) continue to experience a disproportionate burden of disease and risk factors, and unmet healthcare needs.

SGM populations experience a wide range of health disparities. Compared to heterosexual women, lesbian and bisexual women have higher odds of risk factors for cardiovascular disease (CVD) thought to be related in part to higher levels of mental distress, higher rates of current smoking, and greater obesity. Breast cancer may also be more common among SGM women in part related to higher rates of obesity and lower rates of pregnancy. Transgender adults are more likely to have elevated rates of myocardial infarction and CVD risk factors than their cisgender counterparts. SGM populations are also disproportionately affected by disparities in mental health conditions, as LGBTQ individuals experience increased anxiety, depression, and suicidality than people who identify as heterosexual and cisgender. People who identify as LGBTQ+ also experience greater substance use and behavioral health disparities than heterosexual cisgender individuals, including greater use of tobacco, alcohol, and illicit drugs. SGM populations also experience greater disparities in sleep disturbances compared to non-sexual minority persons.

Disparities are likely to be worse for members of SGM populations who possess two or more intersecting, marginalized social statuses especially racial/ethnic minority groups and those with lower SES. For example, people identifying as LGBTQ+ and intersex individuals are at high risk of violence from family members, peers, partners, and strangers, with bisexual and transgender individuals particularly transgender women of color experiencing the highest risk for violence. Further, about 40% of transgender women surveyed in seven major U.S. cities from 2019 to 2020 reported a positive HIV status, with Black/African American and Latina transgender women disproportionately represented. Cisgender gay and bisexual men accounted for 69% of new HIV diagnoses in the U.S. in 2019, with Black/African American and Latino/Hispanic gay and bisexual men accounting for 70% of new infections and of persons living with HIV.

While the extent of health disparities experienced by SGM populations is largely documented in the literature, research gaps exist in the identification and characterization of pathways and mechanisms through which disparities develop and persist. Moreover, a need exists to evaluate interventions to address disparities, especially for SGM individuals from racial and ethnic minoritized populations who report lower SES as they are under investigated. Scant are longitudinal studies on the development and evolution of structural stigma over the life course and its impact on health and healthcare disparities among SGM populations, and the consideration of intersectional characteristics. Moreover, there are research gaps concerning the origins, pathways, and health consequences of minority stress and factors that support resilience. Key research gaps also include the paucity of evidence-based interventions in SGM research, including interventions that address health disparities among racially and ethnically minoritized SGM populations. Lastly, research must test interventions to improve access to and quality of care such as promoting culturally responsive and clinically appropriate care.

Studies must examine health or healthcare outcome(s) among SGM populations. Studies among SGM populations who are also from racial and ethnic minority backgrounds (Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian or Pacific Islander populations) and socioeconomically disadvantaged populations will be the main focus of the NIMHD area of interest in this funding opportunity. Individual-level studies focusing on understudied groups among SGM populations, including SGM people of color, lesbians, bisexuals, transgender, Two-Spirit, among others are also encouraged.

NIH operationally defines SGM populations as individuals who identify as lesbian, gay, bisexual, asexual, transgender, Two-Spirit, queer, and/or intersex. Individuals with same-sex or -gender attractions or behaviors and those with a difference in sex development are also included. These populations also encompass those who do not self-identify with one of these terms but whose sexual orientation, gender identity or expression, or reproductive development is characterized by non-binary constructs of sexual orientation, gender, and/or sex.

Finally, low socioeconomic status refers to individuals with low educational achievement (less than high school completion) and/or low household income (up to 200% poverty level).

Research Objectives

The main objective of this funding opportunity is to solicit research to address health and healthcare disparities among SGM populations by identifying etiological mechanisms and pathways and developing and evaluating interventions focused on racial and ethnic minoritized populations and those of lower SES. A recent NIMHD workshop on health disparities among SGM groups (https://www.nimhd.nih.gov/news-events/conferences-events/health-disparities-among-sgm-workshop.html) highlighted key ideas for furthering research on addressing health and healthcare disparities among SGM populations. Findings emphasized the need for developing and evaluating preventative and treatment-focused interventions on multilevel mechanisms to address SGM health disparities.

For intervention-based studies, implementation science is encouraged especially in terms of integrating clinical research to facilitate the timely translation of interventions into practice to promote SGM health (e.g., hybrid trials that combine clinical effectiveness and implementation research). Specifically, when it comes to SGM populations interacting with the healthcare system, a need exists for interventions that promote culturally sensitive and supportive health care (e.g., care that addresses intergenerational trauma) to address barriers to care, including financial and systems-level barriers. Also important are community-led research approaches such as community-based participatory research to ensure the prioritization of SGM community needs and to ensure non-stigmatizing responses to these needs.

For observational and etiological studies, research is encouraged on the biological mechanisms linking chronic stress to SGM health outcomes (e.g., the effects of stress on the microbiome). Investigators should use an intersectionality perspective to acknowledge the interlocking major systems contributing to health disparities including structural racism, sexism, heterosexism, transphobia, classism, and ableism, that affect health outcomes in SGM populations with multiple intersecting identities. Longitudinal multi-level research is encouraged to investigate the roles of policies at the federal and state levels, SGM-specific, and school or educational policies on health outcomes. Research must consider the role of individual and structural social determinants of health (SDOH) such as poverty, housing instability, food insecurity, poor access to and quality of care, as potential mechanisms driving SGM health disparities. Studies focusing on examining protective and resiliency factors and promoting well-being are also encouraged.

Of particular interest are projects designed to examine pathways and mechanisms using conceptual model(s) grounded in minority health and health disparities theories that recognize that health disparities arise by multiple and overlapping contributing factors acting at multiple levels and domains of influence (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html). Of interest are evaluations of interventions or strategies that address SGM health disparities in diverse SGM populations grounded in determinant frameworks (minority stress, intersectionality, life course, syndemics, empowerment, resilience) and that utilize multi-disciplinary interventional approaches.

Intersectional approaches that consider different social identities and the embeddedness of persons within families, households, and communities are encouraged. Projects that utilize a syndemics lens (i.e., multiple disease states interlinked by social, environmental, and structural conditions) to examine SGM disparities in co-occurring health conditions are also encouraged. Studies should consider life course approaches especially in terms of critical transitional periods for SGM populations. In addition, exploring the role of inequality generating mechanisms that are implicated in SGM health disparities such as racism and discrimination, classism, sexism, ageism, and other power structures is also encouraged. Projects are encouraged to examine resiliency and protective factors as well as ways to promote health and well-being.

Additionally, projects that focus on diseases or conditions with some evidence of health or healthcare disparities in SGM populations (e.g., suicide, depression, obesity, tobacco use, substance use, COVID, cardiovascular disease, diabetes, cancer, reproductive health, COVID-19, sleep disturbances) as well as comorbidities and general indicators of health such as greater global burden of disease, lower health-related quality of life, and daily functioning are encouraged.

Also encouraged are projects exploring mechanisms implicated in healthcare disparities among SGM populations including but not limited to disparities in access to preventive and primary care, subspecialty care, and urgent and emergency care, in health insurance coverage, and in quality of healthcare. Moreover, of interest are projects that examine access to patient-centered and culturally appropriate care for SGM patients from racial and ethnic minoritized populations.

Projects may involve primary data collection and/or secondary analysis of existing datasets. Projects may utilize observational studies, natural experiments, quasi-experiments, clinical trials, simulation modeling, as well as use of large-scale longitudinal data sets, data mining techniques, registries, surveillance data, and linking to administrative data sets. Quantitative and mixed methods approaches are encouraged.

Studies involving primary data collection are strongly encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org). Moreover, secondary data analyses of datasets with Sexual Orientation and Gender Identity (SOGI) measures or with data linkages are encouraged.

As appropriate for the research questions posed, investigators should consider forging research collaborations with community partners in the conceptualization, planning and implementation of the research to generate better-informed hypotheses and enhance the translation of the research results into practice. Applicants must have a history of successful recruitment and retention of participants within the populations of focus and conduct effective communication, co-creation, and dissemination activities to inform communities about the project and its findings. Projects must have clearly defined roles for all partners. As appropriate, study budgets should include funds for community collaborations and partnerships to be fully engaged in research design and implementation. Approaches to engaging community members through the research process, such as team science, community-engaged research, participatory action research, empowerment evaluation approaches, community asset mapping, citizen science, and community health workers are strongly encouraged.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention are strongly encouraged to use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Also encouraged are pragmatic trials designed in clinical settings to show the real-world effectiveness of the intervention. Intervention designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or neighborhood) are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at: https://researchmethodsresources.nih.gov/. Applications should also delineate outcomes and how the intervention or strategies can be sustained and scaled-up to improve population health.

Areas of Research Interest

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD is interested in research studies among SGM populations who are from minoritized racial and ethnic populations and/or from SES disadvantaged groups that utilize an intersectional framework.

For observational studies, NIMHD is interested in the following research areas listed below, among others:

• The role of SDOH, including differential access to opportunities and resources, in promoting health and healthcare disparities
• The role of policies at multiple levels (e.g., federal, state, school, workplace, clinic/hospital) in contributing to health disparities
• Pathways, mechanisms, and long-term health consequences of exposure to minority stress
• Biobehavioral factors that strengthen coping, resilience, and well-being
• Biological mechanisms linking experiences of stigma and childhood trauma (e.g., adverse childhood events) to health outcomes
• The development of structural stigma and how it evolves over the life course to impact health and health care disparities
• The impact of different systems of oppression (structural racism, sexism, heterosexism, transphobia, classism, ableism) on SGM health
• The mechanisms and pathways at the interpersonal (e.g., discrimination, harassment, bullying, violence, poverty) and structural (laws, policies, rules) levels that contribute to health disparities for specific diseases or clusters of diseases (e.g., syndemics), health conditions, and general indicators of health such as quality of life and daily functioning
• The mechanisms and pathways contributing to healthcare disparities in access to and quality of primary health care including preventive services
• The role of the patient-clinician relationship on quality of care for SGM populations, including compliance with national screening guidelines and timely diagnosis of non-communicable diseases

For intervention-based studies, NIMHD is interested in the following research areas listed below, among others:

• Adaptations of evidence-based interventions that incorporate minority stress and other established conceptual frameworks
• Preventive interventions aiming to reduce risk factors (e.g., smoking, substance use, cancer screening, physical inactivity) and improve overall health
• Interventions that promote the development and maintenance of friendly social bonds among SGM children and youth at critical life stages such as school programs, community center activities, and playground initiatives
• Hybrid interventions that combine clinical effectiveness and implementation research to increase long term uptake of health promotive behaviors
• Interventions to address disparities in access to and quality of care for SGM populations
• Community-based studies to reduce stress and promote health screenings such as pap smears, mammograms, blood pressure, etc.
• Behavioral interventions to promote well-being and resiliency among SGM youth and families.

National Cancer Institute (NCI)

NCI areas of interest in research include, but are not limited to:

• Assessing the influence of intersectionality (e.g., the interaction of multiple marginalized social statuses, such as race/ethnicity, SES, disability, aging, and other cultural factors) in the context of cancer treatment and supportive care of SGM individuals
• Examining associations between experienced stigma and clinical outcomes in cancer, including quality of life, symptom management, and well-being
• Understanding the influence of stigma on the patient-level process of care-seeking behaviors and medical decision making
• Examining how stress affects treatment response and disease progression for various cancer sites or types and across different SGM sub-population groups
• Understanding the underlying mechanisms between SDOH and cancer prevention and control in SGM individuals
• Investigating how social determinants of health influence adverse gene expression that confers increased cancer risk and/or differences in disease progression

National Institute on Drug Abuse (NIDA)

NIDA areas of programmatic interest include but are not limited to:

• Consideration of social determinants of health in substance use disorder epidemiology as well as development of prevention and treatment intervention and services research among SGM populations;
• Research that considers the influence of SGM and other minority stress on substance use disorders and effective substance use treatments;
• Research that considers substance use in a syndemic framework among SGM people;
• Consideration of drug use as an identity and associated stigma in an intersectional framework that includes sexual, gender, and racial identities;
• Translational research that applies findings from epidemiology, cognitive science, neuroscience, and other domains to develop and test novel prevention interventions among SGM populations;
• Treatment development research and testing for substance use disorders, including medications, devices, and behavioral therapies among SGM populations;
• Research that looks at unique vulnerabilities to substance use disorders and their biological etiology among SGM populations;
• Behavioral and cognitive mechanisms and consequences of substance use among SGM people;
• Research that utilizes a life course perspective with respect to substance use disorders and its comorbidities and risk/protective factors among SGM populations;
• Culturally sensitive approaches to integrating substance use and primary care and/or infectious disease services to remove barriers to access and utilization among SGM people.

National Center for Complementary and Integrative Health (NCCIH)

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 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 observational studies. NCCIH will not support feasibility and 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.

Applications Not Responsive to the NOFO:

• Projects that do not utilize a clear conceptual framework(s) and/or theoretical models.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R 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:

Research Strategy:

Describe how this project will advance knowledge to identify and characterize pathways, mechanisms, and intervention-based strategies for health and health care disparities among sexual and gender minorities. Projects are expected to include a detailed conceptual model.

Describe specific rationale and how the project focuses on sexual and gender minorities specially among people who experience multiple marginalized statuses in the United States.

If the study is an intervention, describe how the project will contribute to the development and implementation of interventions addressing factors and processes that contribute to health and health disparities among sexual and gender minority populations.

If applicable, describe how the community partners plan to participate in the conceptualization, planning and implementation of the research to inform hypotheses and facilitate translation of the research into practice.

Projects are expected to include multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment) and multiple levels (e.g., individual, interpersonal, neighborhood) to elucidate and address health and health care disparities among sexual and gender minorities (see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html).

Explain how the research team has appropriate expertise in conducting multidisciplinary research without duplicating information in the biosketches.

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

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

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

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.

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 policies and practices, 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:

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

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

4. Reporting

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

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

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

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

Section VII. Agency Contacts

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

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

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

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

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

NIMHD

Rada K. Dagher, Ph.D., M.P.H.
Division of Clinical and Health Services Research
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
rada.dagher@nih.gov (mailto:rada.dagher@nih.gov)

Carlos O. Garrido, Ph.D., M.S., M.P.H.
Division of Integrative Biological and Behavioral Sciences
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7467
carlos.garrido@nih.gov

Crystal L. Barksdale, Ph.D., M.P.H.
Division of Community Health and Population Sciences
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone:301-827-4228
crystal.barksdale@nih.gov

For studies proposing a clinical trial, please contact:

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

For BESH studies, please contact:

Erin Burke Quinlan, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: (301) 451-0636
Email: erin.quinlan@nih.gov

Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: tamara.lewisjohnson@nih.gov

Richard A Jenkins
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-443-6504
E-mail: jenkinsri@mail.nih.gov

Whitney Barfield Steward, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-751-5601
Email: whtitney.barfield@nih.gov

Robert Freeman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301443-8820
E-mail: rfreeman@mail.nih.gov

Ronna Popkin, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5121
Email: ronna.popkin@nih.gov

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

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the NOFO and the IC's research portfolio.

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

NIMHD

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

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

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

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

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

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

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

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.