Part 1. Overview Information

Key Dates

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

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

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

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

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions:

The term “populations with health disparities” refers to NIH-designated populations in the U.S. with health disparities which currently includes: racial and ethnic minority populations (i.e., Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian American, Native Hawaiian and other Pacific Islander), people with lower socioeconomic status (SES), underserved rural communities, sexual and gender minority groups (SGM), and people with disabilities (https://www.nimhd.nih.gov/about/overview/). The National Institutes on Minority Health and Health Disparities (NIMHD primarily supports applications that study racial and ethnic minority populations, persons of less privileged socioeconomic status and/or intersectionality with other NIH-designated populations with health disparities.

For the purposes of this NOFO, “disasters” encompass presidentially declared emergencies or major disasters under the Stafford Act, a public health emergency declared by the Secretary of the HHS, or other local, regional, or national disaster(s). Disasters may be natural and/or human made. Natural disasters refer to severe weather or natural events including hurricanes, typhoons, tsunamis, floods, mudslides, tornadoes, volcano eruptions, earthquakes, snowstorms, wildfires and others., Human-made disasters include incidents involving hazardous materials (e.g., oil and chemical spills/contamination, nuclear contamination), mass violence, terrorism, human-made disruption of the infrastructure (e.g., cyber attacks, interruption of electricity and water supply, transportation or other basic services) and their long-term consequences in the infrastructure (e.g., extended power outages, extended disruptions in the water systems, food supply, communications, transportation and housing).

"Public health emergency” is a declaration by the Secretary of the Department of Health and Human services under section 319 of the Public Health Service Act determining that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious disease or bioterrorism attacks, otherwise exists.

“Long-term” is defined as one (1) year or longer after the designated disaster or sentinel event(s).

The Social Vulnerability Index, as defined by Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry Social Vulnerability Index (CDC/ATSDR SVI), indicates the relative vulnerability of every U.S. Census Tract and tracts 15 social factors pertaining to socioeconomic status (below poverty, unemployed, income, no high school diploma), household composition and disability (aged 65 or older, aged 17 or younger, civilian with a disability, single-parent households), minority status and language (minority, speaks English “less than well”), housing type (multi-unit structures, mobile homes, crowding, group quarters), and transportation (no vehicle or vehicle access) (www.atsdr.cdc.gov). 

The U.S. Climate Vulnerability Index (CVI) depicts how drivers of cumulative vulnerability disadvantage communities, and it provides a data-driven approach, using 184 indicators, to enhancing the understanding of the intersections between growing climate risks and pre-existing, long-term health, social, environmental, and economic conditions that are critical to effectively building climate resilience, deploying targeted adaptation efforts, and informing policy, advocacy, and funding (U.S. Climate Vulnerability Index).

Background

Natural and human-made disasters are common phenomena across the U.S. and its territories, and vary by geographic location, seasonal weather changes, and socio-environmental occurrences, among other factors. In addition to the physical characteristics of the events, the magnitude of the damages caused by disasters in the U.S. depends on factors of the affected communities, including those described by the CDC/ATSDR SVI, CVI, and data on general infrastructure (e.g., food supply, water, energy, roads, transportation, communications, physical security, healthcare services, emergency services, etc.).

The immediate impact of natural and human-made disasters in the U.S. on health and healthcare delivery has been considerably documented in the scientific literature, including invaluable lessons about health disparities and health policy. Most of the federal, local, and tribal government- and community-led response and recovery activities focus on the immediate individual and community needs and assessing the infrastructure and functionality of public and private non-profit healthcare facilities and their preparedness and response capacity for a future disaster. In contrast, the long-term effects of disasters on healthcare systems impacted by these events and serving populations that experience health disparities-- have not been adequately studied. For instance, newly developed or exacerbated chronic diseases and loss of medical infrastructure following disasters may trigger prolonged or increased needs for medical, mental health, and ancillary services and health care professionals. Federal and local policies (e.g., Medicaid funding, federal laws or policies on territories, disaster-related individual and public assistance, emergency preparedness) may influence the promptness of the response as well as the impact of the disaster on healthcare systems’ ability to meet the healthcare needs of diverse populations, including access to and quality of care, both in the aftermath and in the long-term. Communities comprised of populations that experience health disparities are at risk of facing a greater threat than other communities or populations with better pre-disaster health profiles and access to less fragile healthcare systems.

Lessons learned through this initiative could lead to more effective implementation of clinical care guidelines and strategies of effective healthcare delivery prior to, during, and after disaster events or periods. Further, lessons learned may enhance our understanding of mitigating factors or models that prevent increases in healthcare disparities in the communities most vulnerable to the impact of disasters or at higher risk of recurring disasters and long-term, adverse impacts. In addition, this initiative offers an opportunity to compare long-term effects of disasters, best practices, strategies, and outcomes among communities experiencing health disparities across the U.S. and its territories.

Research Objectives

The overarching goal of this NOFO is to invite robust collaborative research focused on understanding the long-term effects of disasters on healthcare systems and care delivery that serve populations that experience health disparities, including the influence of risk factors or vulnerabilities of both the systems and the communities preceding the event(s). This initiative focuses on (i) understanding the direct long-term effects of disasters on healthcare systems, and specifically on the access, delivery, coordination, safety and quality of healthcare services, physical and organizational infrastructure, health care workforce and changes in healthcare needs and disparities of the communities they serve, and (ii) identifying, testing and/or evaluating interventions based on strategies or best practices that healthcare systems or communities have implemented that promote appropriate system function and delivery of services during and after the disaster, maintenance of optimal continuity of care, and resilience of healthcare systems and populations for future events.

Healthcare systems of interest include those directly impacted and/or disrupted by the disaster(s) and serving communities affected by health/healthcare disparities and who were also affected by the disaster(s). For the purpose of this NOFO, healthcare systems could be networks of outpatient clinics (e.g., federally qualified or state-funded community-based health centers or clinics), systems that combine both outpatient and inpatient services units, or networks of clinical settings offering specific services (e.g., pharmacies, mental/behavioral health or substance use services, radiology, radiotherapy, occupational or physical rehabilitation, dialysis centers, long-term care, congregate care, palliative and hospice care). Studies could also address the long-term effects on a single clinic or hospital serving remote or underserved rural communities.

The scope of healthcare services to be studied includes pediatric, adult, and geriatric primary and preventive care, specialty care e.g., obstetrical/gynecological care, psychiatric, mental health, and substance use, etc.) subspecialty surgery, critical care, emergency care (including trauma and acute psychiatric), dental care, interventional radiology, radiotherapy, hemodialysis, chemotherapy, occupational/physical therapy, rehabilitation, services offered by licensed clinical professionals in non-clinical settings (e.g., home, nursing home, school-based health centers, group-based treatment foster care) and outpatient pharmacy services.

Research projects may address services offered by any of the settings mentioned above and collaborations with non-profit organizations (including volunteer groups), federal or local government agencies, local departments of health, academic institutions, schools, and community-based organizations. Projects may focus on healthcare systems within a single geographic location affected by a disaster (e.g., territory, state, tribe) or collaborations among multiple locations or entities affected by the same event, type of event or different events. Collaborations between investigators and institutions in areas affected by disasters and those outside of the affected areas, especially when local investigators and institutions fulfill a primary role in the research team, are encouraged. Prospective observational population studies focused on population or individual health outcomes are outside the scope of this NOFO.

This initiative will support retrospective quantitative and mixed-methods research, simulation and modeling analyses, interventions, and evaluations of existing interventions and practices in communities that experience healthcare disparities whose healthcare systems have been disrupted by one or more natural or human-made disasters.

Examples of research methods include, but are not limited to:

• Multi-level interventions based on data already collected, or strategies or best practices implemented during and/or after the disaster(s).
• Large-scale, longitudinal data analyses (e.g., public health surveillance, hospitals and outpatient health records, health insurance claims and other administrative datasets, registries), data mining techniques and integration of quantitative and qualitative frameworks and techniques to assess trends and projections on healthcare needs, access, delivery and utilization of healthcare services, patient population health profile and disparities or health care workforce.
• Decision science modeling and analyses of post-disaster recovery population demographics, social determinants of health, healthcare needs, access and utilization of healthcare services and workforce trends.
• Retrospective and/or prospective analyses (including multi-level analyses) of healthcare needs, healthcare disparities and/or health outcomes related to strategies implemented by public health entities, healthcare facilities, schools, community-based or academic institutions during and after the disaster(s).
• Retrospective analyses (including multi-level analyses) of the impact of policies on healthcare access and utilization and continuity of care before, during and after the event(s).
• Participatory engagement of collaborators/partners (healthcare facilities, patients and caregivers, clinicians, community groups, administrators, academic institutions, health care professional groups, schools, social services agencies, policymakers) in the formulation of the research and to the extent necessary, in the implementation of the research.
• Subpopulation analyses to assess differences or similarities in the impact of these events on healthcare needs or to determine which interventions work best for specific population groups (e.g., based on age, sex/gender, health/clinical profile, geographic location).

Specific Areas of Interest

Examples of potential research topic areas include, but are not limited to:

• Resilience-focused interventions that promote post-disaster rebuilding are highly encouraged. Research that focuses on health system strengthening and that incorporates organizational, or system-level lessons learned into their interventions.
• Comparative analyses of:
  • The long-term effects of disasters on different geographic locations, including sites that have endured multiple or prolonged disaster recovery and/or public health emergencies.
  • Self-contained regions (e.g., islands territories, remote or underserved rural areas) with urban locations in the mainland or that assess the impact of federal territorial policies on healthcare systems.
• Assessment of change in:
  • Demographics and/or effect of the disaster on population epidemiology and health status-including migration, return migration, and fatalities following the disaster(s) and/or public health emergencies and subsequent change in actual or projected population health profile, healthcare needs (e.g., age-specific health services including prevention and treatment, subspecialty care, home-based care, long-term and hospice care, or other congregate care) and health disparities across the lifespan.
  • Health care workforce migration and return and the effect or projections on healthcare access, delivery and quality following the disaster(s) and/or public health emergencies. This assessment may be further expanded to study the effect of workforce changes and challenges associated with increased demand for services (i.e., shortage, physical and emotional exhaustion, own healthcare needs). Workforce retention strategies, and policies or best practices to augment health care professionals’ availability are also of interest.
• Development, testing, and/or evaluation of strategies or interventions that ensure access to services and continuity of care that:
  • Enhance prevention and treatment of acute exacerbations of chronic diseases -especially among patients with multiple medical conditions, disabilities and/or complex medical needs, for example, mitigation strategies to ensure storage, availability and delivery of medications and protection of electronic health records and healthcare system functionality.
  • Involving community-, schools- or non-profit organization-led initiatives linked or not linked to the healthcare system.
• Strategies to redesign healthcare systems based on lessons learned or best practices from post natural or human-made -disaster response and recovery.
• Assessment of needs and/or best practices of healthcare delivery and coordination among healthcare systems and:
  • Health care workforce, public health units, local and federal agencies, community organizations, addiction treatment clinicians, community resources and affected communities in relation to preparedness, response to or recovery from disasters and/or public health emergencies in communities that experience health/healthcare disparities. Development, testing, and/or evaluation of interventions based on these analyses or best practices are also of interest.
  • Other sectors (e.g., water, energy, food supply, transportation, communications, housing) or the intersection of these sectors and healthcare services for populations experiencing health disparities during a major natural or human-made disaster and/or public health emergencies. Development, testing and/or evaluating interventions based on these are also of interest.
  • Surge capacity preparedness, and workforce issues associated with increased demand for services (i.e., physical and emotional exhaustion, health care needs); workforce retention strategies, and policies or best practices to augment health care professionals’ availability is also of interest.
• Assessments of the short-term shifting burden of healthcare (e.g., the intersection of social services, law enforcement, national security with healthcare during and after disasters) and its impact on continuity and quality of care.
• Evaluation (including temporary waivers) on access to or delivery of healthcare services for the general population, and for specific segments of the population [e.g., older adults, children in foster- or group home care, institutionalized or home-bound individuals, individuals with disabilities, patients with complex medical needs (including severe mental illness and/or substance use disorders)] pre-, during, and/or post-disaster and/or public health emergency. Studies evaluating the effect of changes in healthcare and public policies (e.g., modeling studies based on temporary waivers), and interventions based on those changes are also of interest.
• Socioeconomic studies on the impact of job loss, migration, economic policies and other socioeconomic factors on projected healthcare needs, access to and utilization of healthcare services, healthcare delivery and health outcomes, especially of most vulnerable populations (e.g., children, older adults, persons with complex medical needs, persons receiving substance use and/or mental health services), and potential economic models for organizing and financing healthcare services for them during and after disasters and/or public health emergencies.

National Institute on Aging (NIA)

NIA is broadly interested in research focusing on the long-term impacts of disasters on health care systems serving older populations experiencing health disparities, including research relevant to Alzheimer’s disease and related dementia (AD/ADRD) care. Applicants are encouraged to propose robust investigative and collaborative research focused on understanding the long-term effects of disasters on health disparity populations and the health care systems that serve them, including the influence of risk factors or vulnerabilities of both the systems and the communities preceding the disaster event(s). Applicants are encouraged to consider innovative methods and research designs at multiple levels of analysis to facilitate studies between groups as well as within groups (e.g., racial/ethnic), recognizing that there is heterogeneity in individuals’ access, use, and quality of care. Applicants should reference the NIA Health Disparities Research Framework and the NIA Stage Model of Behavioral Intervention Development. Examples of specific NIA-relevant research topics include, but are not limited to:

• Intersectional approaches which consider multiple populations experiencing health disparities categories simultaneously (e.g., race/ethnicity and rurality, race/ethnicity and education, etc.).
• Dynamics between formal caregiving institutions (e.g., long-term care facilities) and informal caregivers during and after disasters.
• Alternative health delivery systems to improve access to care (e.g., telemedicine, mobile health clinics, etc.) during and after disasters.
• Health care systems serving Medicare/Medicaid dual-eligible populations in the context of disasters.
• Health services delivery, staff training, healthcare infrastructure, or health system policies towards preparedness and response in the context of disasters.
• Evidence-based telehealth interventions, and the tele-mentoring of clinicians, to help manage complex and challenging health conditions before, during, and after disasters.
• Integrating disaster preparedness and resilience strategies into the care continuum for older adults to minimize disruptions in care delivery during and after disasters, and to promote better health outcomes in the long term.
• Research on effective interventions and evidence-informed practices for building resilience in health care systems serving older populations and the unique challenges and disparities that they face. This involves enhancing the capacity to respond to disasters, ensuring access to appropriate care and medications, and providing ongoing support for caregivers.
• Research on the long-term impacts of disasters and repeated or multiple disasters (e.g., wildfire during a heatwave or drought) on care for older adults to inform policy decisions and resource allocation to improve disaster planning, response, recovery, and resilience efforts for this vulnerable population. 
• Re-establishment of medical home following displacement (either voluntary or involuntary).
• Differentiation between direct (e.g., infrastructure destruction) and indirect (governmental response) effects of disasters on health care systems.
• Provision of mental health care services to address long-term disaster-related psychological trauma.
• Integration of social services addressing long-term, post-disaster needs (e.g., food security) into health care systems.

National Cancer Institute (NCI)

NCI is interested in research focusing on the long-term impacts of disasters on healthcare organizations and health systems providing care at any point on the cancer care continuum for populations experiencing health disparities. Applications to NCI should clearly focus on care and outcomes related to cancer prevention, screening, diagnosis, treatment, survivorship, supportive care, or end of life care. In addition to the areas of interest listed above, other examples of specific NCI-relevant research topics include, but are not limited to: 

1. Understanding and mitigating compounding effects of multiple disasters (e.g., climate-related disasters occurring during major public health emergencies, exposure to multiple flooding events, wildfires, etc.) 
2. Using multi-level approaches to understand the independent or interactive effects of factors or approaches at the patient/caregiver, healthcare professional, healthcare team, organization, health system, and/or community levels that influence long-term effects of disasters on health care systems providing care at phase of the cancer continuum for populations that experience health disparities. 
3. Developing and/or evaluating multi-level interventions addressing disaster resilience or adaptation by targeting at least two of the following levels: patient/caregiver, healthcare professional, healthcare team, healthcare organization, health system, community. 
4. Studies using intersectional approaches to understand and/or improve long-term disaster impacts on cancer-care access, timeliness, quality, and outcomes among populations experiencing multiple health disparity categories. 
5. Studies focused on pediatric or young adults from populations experiencing health disparities.  
6. Studies focused on rural or other safety-net settings of care, particularly those serving populations in persistent poverty areas. 
7. Studies using simulation-based or modeling based methods to understand long-term disaster effects or evaluate approaches for addressing health system disaster resilience or adaptation to improve outcomes at any phase of the cancer continuum.

Sexual & Gender Minority Research Office (SGMRO)

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

For this NOFO, SGMRO encourages research that focuses on healthcare systems that serve SGM populations across the life course, particularly those that serve SGM people experiencing housing instability, homelessness, job insecurity, and other circumstances that predispose them to worse outcomes following a disaster. When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stres. , social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework, NIMHD Research Framework),

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• U.S. Territory or Possession

Other

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

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

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

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

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 NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Carolina Solis-Sanabria, MD, MPH, FACS

National Institute on Minority Health and Health Disparities (NIMHD)

Email: carolina.solissanabria@nih.gov

Page Limitations

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

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

SF424(R&R) Cover

All instructions in the 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 Ho 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:

Describe the conceptual framework for the proposed multilevel analysis or intervention.

For collaborations and/or consortia of the investigators/ institutions outside of affected areas with investigators/institutions in areas affected by disasters, describe the involvement of the disaster-local investigators and/or institutions as contributors to leadership or key personnel.

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.

• Data management and sharing activities for scientific data generated under this NOFO must be addressed in one single Data Management and Sharing (DMS) Plan. The DMS Plan should be included with the Other Plan(s) attachment in FORMS-H application forms packages.

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 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.

7. Other Submission Requirements and Information

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, NIH. Applications that are incomplete or non-compliant 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 six (6) weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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

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

2. Review and Selection Process

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

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 ((Responsibility/Qualification in SAM.gov, formerly   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

Carolina Solis-Sanabria, MD, MPH, FACS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-346
Email: carolina.solissanabria@nih.gov

Sallie J. Weaver, PhD, MHS
National Cancer Institute (NCI)
Telephone: 240-276-6254
Email: sallie.weaver@nih.gov

Emerald T. Nguyen, Ph.D.
National Institute on Aging (NIA)
Phone: 301-555-1212
E-mail: emerald.nguyen@nih.gov

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

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: pg38h@nih.gov

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

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Section VIII. Other Information

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

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