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

The overarching purpose of this funding opportunity announcement is to solicit innovative multidisciplinary minority health and health disparities research and interventions at the interpersonal level, especially within and at the family level.

While the NIMHD Research Framework identifies interpersonal level factors as one of several levels contributing to minority health and health disparities. Interpersonal level research studies often focus on health risks and protective factors and health outcomes associated with specific dyads (i.e., parent-child, patient-physician), family environment and experiences (i.e., adverse childhood experiences, sibling, and peer relationships), and across healthcare settings (i.e., family roles in care giving, care management, and health-care related decision-making). Research on patient populations has centered on the health of the individual or patient level focusing on their condition and treatment or their risk and resilience while ignoring the health and well-being of other family members and the overall health of the family unit. Outside the caregiving and family studies literature, few studies explore the interaction of family level risk and protective factors (functioning, cohesion or resilience) or family level factors associated with family health outcome measures, such as family well-being, family health behaviors (nutritional practices, health beliefs and practices, physical activity/exercise, preventive screenings, healthcare utilization, or health outcomes). Research is lacking on how, when, and why families leverage various resources at the neighborhood, community, organizational or health services levels, and how technology or other resources have been leveraged to promote and protect family health or prevent or mitigate internal and external threats to family health or the health of family members.

For the purpose of this funding opportunity, the following definitions are listed below:

Family: two or more individuals, of any gender or who identify with more than one gender, where one is from a population NIH recognizes as experiencing health disparities. These families share enduring intimate social relationships that may be characterized by blood or legal ties, shared residence, economic cooperation within or across borders, shared responsibilities, and a sense of mutual or collective obligation. This is inclusive of nuclear, extended, blended, adopted, foster, and chosen families. We recognize that researchers may define family unit differently and thus responsive applications will either use this definition or clearly define the term within the context of the proposed research.

Family level: encompassing collective measures of family health behaviors and processes or pathways or performing interventions with multiple family members. Applications not including family health measures (i.e., not including health outcome measures for 2 or more family members) or family level research (i.e., not including family level health behaviors or processes) will be considered non-responsive.

Research Objectives

The goal of this initiative is to support family level health observational and intervention studies in the biomedical, clinical, population, behavioral or social sciences. Projects are expected to include family health measures. Projects must include a focus on families from one or more NIH-designated  populations that experience health disparities in the United States: racial and/or ethnic minority populations, less privileged socioeconomic status (SES), underserved rural populations, persons with disabilities, and sexual and gender minority (SGM) groups. Projects focused on rural populations, SGM groups, and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and/or SES. 

Studies to investigate mechanisms underlying family resilience or susceptibility to disease, observational studies, epidemiologic studies, and family intervention research may utilize tissues and biomarkers from individuals within a family unit. Studies using animal models will not be supported under this PAR.

Since health disparities are complex, multidisciplinary approaches encompassing multiple domains of influence (e.g., biological, behavioral, socio-cultural, environmental, physical environment) and multiple levels of influence (e.g., individual, interpersonal, neighborhood) to understand and address minority health and health disparities within the context which families are embedded (see the NIMHD Research Framework for more information) are encouraged. Studies involving primary data collection with human participants are strongly encouraged to incorporate Social Determinants of Health measures from the Core and Specialty collections that are available in the PhenX Toolkit (www.phenxtoolkit.org). Use of these standardized measures for individual demographic factors is required.

Studies should provide a conceptual model indicating the pathways and/or mechanisms between the family level, other determinants, and health outcomes. A life course perspective is encouraged with interventions focusing attention on transition points across the lifespan and associated risk and protective factors. Interventions that include health information technology applications (e.g. wearable, decision aids, health information portals) and/or social media elements to improve family health are encouraged.

Projects are encouraged to involve research collaborations with relevant stakeholders, such as community organizations, clinicians, public health, and social and human service organizations, special interest groups, and faith-based organizations.  As appropriate for the research questions posed, inclusion of key community members in the conceptualization, planning and implementation of the research is encouraged (but not required) to generate better-informed hypotheses and enhance the translation of the research results into practice.

Specific Areas of Research Interest

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD is interested in the following research areas listed below, among others for observational and intervention studies.

• Family health and well-being during sexual and/or gender developmental periods or coming out processes of SGM populations.
• Family resiliency, coping, and functioning during extreme stressors (e.g., parental incarceration, suicide, substance abuse, violent behavior, divorce, death of a sibling or child, death of the spouse/partner, physical or mental abuse in a household, deportation due to immigration status, racism/discrimination, and natural and accidental disasters, and public health emergencies).
• Examination of family resilience (including religiosity, spirituality, and other shared common values), and coping on future generations, attained educational level and socioeconomic status, and subsequent health outcomes.
• Family decision making associated with seeking, accessing, and utilizing internal family and external resources and services (e.g., social support, child support, financial resources, education, food, parenting, and mental health and other health services) to protect, maintain, or promote family health.
• Family-level determinants of sleep health and sleep disparities.
• Biological pathways (e.g., epigenome or microbiome) between family-level stressors and family health.
• The interaction between family stressors over time and stressors in other domains (e.g., school, work, community) and their impact on family health.
• The impact of family stressors and resilience strategies and their relationship to family risk for chronic diseases, especially among adults.
• Studies addressing the processes and pathways families use to adapt to change in their environments, policies, practices, and procedures and their effect on family health outcomes.
• The role and contributions of social and community-based organizations (e.g., community groups, educational activities and educational enrichment programs, team sports, social affinity groups, empowerment activities, volunteer activities, faith-based organizations) on family health outcomes.
• The influence of neighborhood factors and local, state, and Federal policies; and the health and/or social and human services landscape and their influence on family health and wellbeing.
• The influence of family structure, dynamics, and other factors on successful aging and health self-management.
• Family-based studies on chronic disease prevention, recommended health screenings, or chronic disease self-management.
• Research on the effect of the patient/family-clinician relationship or family-health care system communication on clinical and non-clinical outcomes (e.g., clinic attendance, school/work absenteeism).
• The role of the family-clinician relationship on clinical research participation.
• Studies to understand the influence of family health on health pregnancies, maternal morbidity and mortality, postpartum health, and neonatal/infant mortality.
• Studies to enhance or facilitate the care of family members with complex medical needs (including children with complex health conditions including developmental disabilities, use of insulin, use or operation of medical devices, care of older adults) and their effect on clinical/health outcomes, including continuity of care, reduction or prevention of complications, and family engagement.
• Studies on prompt urgent/emergent health care for the family unit, including preparedness for disasters.
• The role or timing of family-clinician communication of disease prognosis and care decisions (chronic or long-term care, palliative care, and end-of-life care) while considering sociocultural determinants and religion/spirituality/faith preferences or traditions.

The National Cancer Institute (NCI)

NCI supports observational, experimental, and intervention research to understand mechanisms through which family health, family well-being, and family resilience influence cancer along multiple points in the cancer continuum. These include etiology, prevention, detection, diagnosis, treatment, survivorship, and end-of-life among families of health disparity populations (i.e., segments of the US population that have been typically underserved, underrepresented, and excluded from biomedical, clinical, behavioral, and social sciences research). NCI is interested in understanding ways in which family-level, and other factors that affect families (e.g., family health, structures and processes, culture, social support, family dynamics, adverse conditions, racism and discrimination, stressors, Limited English Proficiency, family separation, immigration challenges, coping, resilience, strengths and resources, well-being, and social and developmental contexts, among others) may independently, or interactively with individual-level and systems-level (e.g., structural racism/ bias) factors, influence cancer prevention and control outcomes in recognized health disparity populations. NCI research interests also include interventions targeting families and designed to leverage resources (e.g., community-based, technology, etc.) and improve outcomes along the cancer continuum among health disparity populations. Outcomes and topics of primary interest include, but are not limited to:

• Health behaviors and decision-making integral to effective cancer prevention and control, and for which family relationships and family-level factors are an important determinant, including energy balance (diet, exercise, sedentariness); alcohol consumption; substance use; smoking/tobacco initiation and cessation; and sun safety (e.g., sunscreen use);
• Sleep and circadian rhythms;
• Receipt of appropriate cancer screening and surveillance;
• Receipt of appropriate genetic/ genomic testing and sharing results with family members;
• Cancer-related health communication within families, or between the family and other entities (e.g., healthcare providers);
• Decisions about and/ or adherence to cancer prevention (e.g., HPV vaccination), screening, surveillance, treatment regimens, palliative care, survivorship, end-of-life;
• Shared decision making in cancer care delivery settings;
• Cancer care delivery and outcomes such as receipt of guideline concordant care, decisions about where and when to access care, care utilization, and quality of care received;
• Health outcomes such as symptoms, functioning, and well being;
• Aging-related consequences of cancer and cancer treatment on symptoms and symptom management;
• Caregiver outcomes, including health and healthcare utilization, quality of life, psychosocial (e.g., distress, resilience), optimizing use of supportive care resources, and economic outcomes;
• Whole of family behavior change or adoption or adaptation of evidence-based cancer prevention and control family-based interventions for diverse family backgrounds and structures.

The National Institute of Nursing Research (NINR)

NINR supports research that advances the prevention, detection, and management of disease and disability for individuals and populations, and informs practice and policy across clinical and community settings. Drawing on nursing’s holistic, contextualized perspective, NINR funds observational, intervention, and implementation research that integrates factors at multiple levels, including social determinants of health, to identify their role in health, health improvement, and health inequities across many settings, including homes, schools, workplaces, clinics, criminal justice facilities, and the community.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA is interested in observational, experimental/intervention, and secondary analysis studies that address family risk and protective factors associated with alcohol misuse and alcohol use disorders (AUD) in multiple interconnected domains (individual, community, and policy), with the goal of developing and implementing effective interventions to improve outcomes in populations that experience health disparities in the U.S. Family level factors are important contributors to alcohol misuse, the course of AUD, and recovery across the lifespan. Research may address factors associated with spouse, parent, child, and sibling relationships in diverse family environments (e.g., same-sex couple, kinship family, single family) and experiences (e.g., separation and divorce, violence, unemployment, child abuse and neglect). Family-based alcohol prevention and intervention studies in a variety of settings (e.g., healthcare, education, justice, and child welfare systems) are encouraged. Areas of interest include, but are not limited to:

• Family level determinants of alcohol misuse and decision-making related to alcohol use initiation, progression to misuse, AUD treatment, and recovery.
• Family impact on the effectiveness of FASD prevention interventions.
• Family interventions to improve functions and quality of life for individuals with FASD across the lifespan.
• Family sources of resilience that modify the relationships between stress, alcohol misuse, and AUD.
• Family studies of strength and vulnerability to alcohol misuse in the context of whole person health.
• Family-based youth alcohol use preventive interventions.
• Family-level interventions to reduce alcohol misuse, facilitate recovery, and improve treatment engagement and outcomes.
• Integrative interventions that simultaneously address alcohol misuse/AUD and comorbidities.
• Long-term effects of child abuse and neglect on alcohol misuse/AUD in adulthood and recovery.
• Family-based prevention and treatment interventions to mitigate impact of trauma and adverse childhood experiences on alcohol misuse/AUD.
• Spirituality, religion, and mutual support groups in family-focused alcohol prevention and treatment interventions.
• Impacts of changes in parents’ alcohol use patterns and recovery from AUD on parenting and child health and well-being.

Sexual & Gender Minority Research Office (SGMRO)

The SGMRO develops and coordinates health- and research-related activities for sexual and gender minority (SGM; defined for NIH research in (NOT-OD-24-169) populations independently and in conjunction with the NIH institutes, centers, and offices. The office also serves as a liaison with the public and the research community to ensure SGM populations are considered and represented in relevant activities across the agency. The SGMRO does not have grant-making authority or administer grants. The office can only support grants approved for funding after review by one of the institutes or centers (ICs) participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant scientific/research contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021-2025 and on the office’s Research Resources webpage.

For this NOFO, SGMRO is interested in research across the life course (especially prevention, intervention, and clinical research) that explores and addresses family health in SGM communities and SGM people who are members of other populations that experience health disparities and inequities. For more information about SGMRO interest in families and family-related research, please see NOT-OD-23-166: Notice of Special Interest in Research on Family Support and Rejection in the Health and Well-Being of SGM Populations. When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework, NIMHD Research Framework).

The Office of Research on Women’s Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director, NIH, and works with the 27 NIH Institutes and Centers to advance rigorous research addressing women’s health issues. ORWH invites applications to supplement active NIH awards from any of the NIH Institutes and Centers (ICs) listed in the announcement to conduct research on women’s health across the lifespan.

Family Health Care plays an essential role in addressing women’s unique health needs throughout the lifespan and in bridging care during life transitions, from puberty, reproductive years through menopause and elderly years. Applications seeking ORWH co-funding in response to this PAR, should ensure that the proposed work is aligned with at least one goal and objective outlined in the NIH-Wide Strategic Plan for Research on the Health of Women.  ORWH encourages interdisciplinary approaches to leverage knowledge and expertise in the research questions being explored. For this PAR, topics of interest to ORWH include, but are not limited to research on:

• Structural barriers that inhibit Family Health Care from meeting the needs of women of all ages, races, and socioeconomic backgrounds, with a focus on populations of women experiencing health disparities.  These populations include Blacks or African Americans, Hispanics or Latinos, Native Americans and Alaska Natives, Asians, Native Hawaiians and Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, persons with disabilities.
• Prioritizing women’s health through women’s health innovations to close the gaps and barriers in Family Health Care.
• Research addressing women’s health needs as a family caregiver.
• How gender-based violence against women is addressed in Family Health Care. 

Tribal Health Research Office (THRO)

The Tribal Health Research Office (THRO) serves as the central point of contact at NIH for federally recognized American Indian and Alaska Native (AI/AN) Tribes throughout the United States (U.S.) and is the synergistic hub for all Tribal health research activities and research workforce development at NIH. The mission of THRO is to improve Native health, enhance capacity for health research in Native communities, and promote opportunities for the next generation of American Indian and Alaska Native (AI/AN) researchers. THRO does not have grant-making authority or administer grants. The office can only support grants deemed scientifically meritorious after review by one of the institutes or centers (ICs) participating in this announcement and after a co-funding request is initiated through the IC.

For this NOFO, THRO is interested in observational and intervention studies examining the role of family health, family well-being, and family resilience toward health in AI/AN populations.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Describe how this project will advance knowledge of family-level health disparities and add to the literature on family level risk and protective factors or family level factors associated with family health outcome measures. Projects are expected to include a detailed conceptual model.

For NIMHD, if there are foreign component(s), describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States.

Explain how the research team has appropriate expertise in conducting multidisciplinary research without duplicating information in the bio-sketches. If applicable, describe how the community partners participated 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 families from populations experiencing health disparities. 

Projects are expected to include family level measures and family level research.

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 understand and address minority health and health disparities within the context of families (see the NIMHD Research Framework: https://www.nimhd.nih.gov/about/overview/research-framework.html).

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.

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

Other Plan(s): 

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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.

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 How to Apply-Application Guide.

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

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

Post Submission Materials

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

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following: 

For applications involving clinical trials: 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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

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

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

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

Study Timeline

Specific to applications involving clinical trials:

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

Not Applicable

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

4. Reporting

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

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

Not applicable. 

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Arundhati Gogineni, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-9545
Email: [email protected] 

Priscah Mujuru, DR.PH, MPH, RN
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9765
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-0095
Email: [email protected]
 

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Phone: 301-827-0071
Email: [email protected]

Sheila Caldwell, PhD
Tribal Health Research Office
Phone: 301-480-3527
email: [email protected]
 

Anil Wali, MSc, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6183
Email: [email protected]

Rebecca Ferrer, PhD
National Cancer Institute
Telephone: 301-852-1167
Email: [email protected]

Regine Douthard, M.D., M.P.H.
ORWH - Office of Research on Women's Health
Phone: 301.451.2729
E-mail: [email protected]

Tatiana Balachova, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5726
Email: [email protected]

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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

Section VIII. Other Information

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

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