Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

In the United States, racial and ethnic minority women face substantially higher rates of pregnancy-related complications (i.e., severe maternal morbidity) and pregnancy-related death (i.e., maternal mortality, defined by the CDC as death from a pregnancy-related cause within one year of delivery or termination of pregnancy) compared to Non-Hispanic White (hence, White) women. Specifically, African American and American Indian/Alaska Native women are 2 to 4 times more likely to die from pregnancy-related causes compared to White women. Up to 60% of pregnancy-related deaths are preventable, highlighting inequities in health care access and quality of care- factors that contribute to racial disparities in maternal mortality and severe morbidity. Racial/ethnic minority women’s access to quality care is often limited by factors like insurance coverage, socioeconomic status, access to community resources, and site of care.

Addressing maternal health means not only reducing mortality but also reducing severe morbidity. Most women do not die from pregnancy-related complications (e.g., hemorrhage, sepsis, eclampsia, cardiovascular events), which are much more common than pregnancy-related deaths and thus are important points for intervention. African American, Hispanic/Latina, Asian, Pacific Islander, and American Indian/Alaska Native women all have higher incidence of severe maternal morbidity compared to White women. Reduction in racial and/or ethnic disparities in maternal morbidity is needed, particularly in part due to the higher prevalence of chronic conditions (e.g., hypertension, obesity, cardiovascular disease) that may exacerbate maternal morbidity among African American and American Indian women.

Researchers have made significant progress in understanding the epidemiology of racial and ethnic disparities in maternal mortality and morbidity. The primary contributing factors of these disparities, such as preconception health and site of care, are well-documented. However, disparities in maternal outcomes persist after controlling for patient characteristics (e.g., health behaviors, preconception health) and health care system factors (e.g., site and quality of care), suggesting that additional factors may be contributing to the high prevalence of maternal morbidity. For example, racial biases at the individual, community, institutional, and societal levels may play a role in perpetuating racial and ethnic disparities in maternal outcomes. Structural and organizational factors in the health care systems of ambulatory and hospital care and the availability of continuity primary care in the preconception and postpartum periods may also be affecting maternal outcomes.

Stress from chronic racial discrimination can lead to worse mental and physical health overall, though the biological pathways through which this stress influences maternal mortality and morbidity need further examination. Qualitative evidence of racial and ethnic minority women’s experiences of racial discrimination and unsatisfactory and poor care in health care settings, as well as data linking clinicians explicit and implicit racial beliefs and attitudes to quality of care, suggest racial bias in the health care system as a contributor to racial and ethnic disparities in maternal mortality and morbidity. Moreover, more research is needed on protective factors, such as those that may explain why Hispanic/Latina women have higher rates of maternal morbidity, but lower rates of maternal mortality, compared to White women, and despite disadvantaged socioeconomic status and less access to healthcare. In addition, the influence of resilience factors (e.g., social support networks) and their role in mitigating the influence of racial bias on maternal morbidity and mortality are unknown. Given these gaps in scientific understanding of why and how racial and ethnic disparities in maternal outcomes occur, further exploration of the mechanisms underlying these disparities in maternal outcomes is a high priority.

Furthermore, there has been very little progress in developing, implementing, and evaluating interventions to reduce racial and ethnic disparities in maternal mortality and morbidity. Several state and national initiatives, mainly led by the U.S Department of Health and Human Services, have sought to improve maternal outcomes overall (for example, quality improvement initiatives in California led to significant reductions in maternal mortality and severe morbidity), but few of them target racial and ethnic disparities specifically. Also, some past data indicate that overall improvements in quality of obstetric care do not necessarily translate to reductions in racial disparities in maternal outcomes. Thus, there is a strong need for researchers to develop, execute, and evaluate maternal care interventions specifically targeting racial disparities.

Research Objectives

This FOA will support original, innovative, multidisciplinary research aimed at advancing the understanding, prevention, and reduction of maternal mortality or morbidity among racial and ethnic minority women and socioeconomically disadvantaged women including those in rural settings.

Research projects can focus on any point across the continuum of care, from preconception care to postpartum care up to 1 year after labor or delivery. Research projects are expected to provide a theoretical framework that addresses the intersection of domains of influence (biological, behavioral, physical, sociocultural, psychosocial, and health care system) and levels of influence (individual, interpersonal, community, and societal). Examples of individual-level factors include pre-pregnancy obesity, maternal hypertension, gestational weight gain, peripartum obesity, pre-eclampsia, pre-diabetes, and gestational diabetes on maternal post-partum health outcomes in women from racial and/or ethnic populations. Other examples at higher levels of influence include, but are not limited to, patient-clinician communication; clinician implicit and explicit bias, availability or accessibility of healthcare; healthcare insurance and reimbursement policies; structural factors in the healthcare settings; availability of social services; social, family, and peer support; interpersonal, community, or societal-level discrimination or violence exposure; the local food environment; and the physical and chemical environment in the home, workplace, and community. Please refer to the NIMHD Research Framework for additional detail.

Projects may include intervention research to test new or adapted interventions; health services research to examine the effectiveness of new or existing programs, services, or policies; or implementation research to examine the uptake and sustainability of evidence-based interventions or practices. Health policy, health care system, social and/or behavioral, and clinical interventions are all welcome. Quantitative and mixed-methods approaches are acceptable. Reduction of racial and ethnic disparities may be measured through studies comparing outcomes of racial and ethnic minority and White women or through studies evaluating improvement in outcomes for racial and ethnic minority women only.

Outcome variables are expected to vary depending on the scale and scope of the project (e.g., maternal mortality may not be a realistic outcome in smaller scale studies), but at a minimum, it is expected that projects will include assessment of one or more severe maternal morbidity outcomes. Projects are expected to include analytic plans appropriate for multi-level conceptual models and/or interventions.

Projects should seek to involve collaborations from a variety of relevant stakeholders as appropriate, including but not limited to academic institutions, health service providers and systems, state and local public health agencies, patient advocacy organizations, community-based organizations, and/or faith-based organizations. When appropriate to the research questions proposed, inclusion of racial and ethnic minority women in the conceptualization, planning, and implementation of the research should be considered (but is not required) to generate better-informed hypotheses and to enhance the translation and acceptability of the research results into practice.

The following types of projects are considered non-responsive to this FOA: (1) projects that do not include severe maternal morbidity variables as outcomes, (2) projects involving data collection on women outside of the United States, (3) projects that are purely qualitative in nature, (4) animal studies, (5) projects that do not address a health disparity, (6) projects that do not include the racial and ethnic minority or rural populations in which the health disparity is experienced, (7) projects that do not provide a conceptual framework, and (8) projects examining factors at only one level of influence.

Examples of Specific Areas of Research Interest

Applications should be relevant to the objectives of the funding opportunity announcement and to at least one of the participating Institutes and Offices research interests. Researchers are strongly encouraged to review the general research interests and priorities of the participating ICs. Research topics of interest include but are not limited to:

• Integration of health systems and/or community-based practices into health care systems to enhance access to and continuity of care for racial and ethnic minority women, socioeconomically disadvantaged women, and women living in rural areas, during the perinatal period and up to one year after delivery (e.g., doula support from the beginning of pregnancy, task-shifting/sharing; shared decision-making; data-driven quality improvement, amelioration of unconscious biases among providers).
• Multi-level strategies to enhance self-care and self-management of racial and ethnic minority mothers in the postpartum period.
• Multi-level strategies, such as those utilizing health information technology tools, to ensure that racial and ethnic minority women and women living in rural areas receive preventative obstetric care consistent with national evidence-based recommended guidelines.
• The impact of quality improvement efforts implemented by state perinatal quality collaboratives on racial and ethnic disparities in state-level maternal mortality and morbidity rates.
• The role of access to and use of quality and affordable primary care in managing medical conditions (e.g., hypertension, obesity, cardiovascular disease) that increase risk for pregnancy-related complications (e.g., hemorrhage, preeclampsia) and adverse outcomes in the year after delivery (e.g., stroke, heart failure).
• Multi-level strategies to implement recommended guidelines of care for chronic or pre-existing health conditions during pregnancy and up to one year post-partum, and evaluate their effectiveness within the context of age, place and social determinants of health
• Development and testing of new or adapted multilevel interventions (e.g., patient, family, provider, facility, system, and community levels); health services research to examine the effectiveness of new or existing programs, services, or policies; and/or implementation research in the "real world" to examine the uptake, scale up, and sustainability of proven-effective, evidence-based interventions or practices.

In addition to the above areas of interest, interests of selected participating Institutes and Centers (ICs) are summarized below. Applicants are encouraged to contact the Scientific/Research contact at the intended IC to ensure that proposed aims of the project are consistent with IC mission and priorities.

National Institute on Minority Health and Health Disparities (NIMHD)

Projects are encouraged that encompass multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, healthcare system) and multiple levels (e.g., individual, interpersonal, community, societal) to understand racial and ethnic disparities in maternal morbidity and mortality (see the NIMHD Research Framework).

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

• Clinician trainings addressing factors such as cultural competence and patient-clinician communication to improve identification and treatment of American Indian/Native Alaskan and African American women at higher risk for pregnancy complications.
• Sociocultural protective factors and areas of resiliency (e.g., community support) within specific racial and ethnic subpopulations.
• The effectiveness of innovative payment and delivery models (e.g., episode-based or bundled payments, patient-centered medical homes) that reward high quality, evidence-based, culturally competent care and their impact on racial and ethnic disparities in maternal morbidity.
• The role of clinicians , health care systems', and social resources' implicit and explicit racial biases in identification of women at high risk for pregnancy complications and quality of preventive care given to those women.
• Provider use of evidence-based culturally appropriate decision aids for risk assessment and informed choice and their effect on racial disparities in maternal mortality and morbidity.
• Risk assessment and monitoring approaches that incorporate biological and social determinants of maternal mortality and morbidity.

National Institute of Nursing Research (NINR)

Areas of programmatic priority for NINR include the following:

• Development and evaluation of strategies, especially based on mhealth, for the care of individuals at high risk for maternal mortality/maternal morbidity during the transition period from a clinical care site (hospital or birth center) to a home setting
• Interventions testing the role of resilience in maternal health disparities, as ascertained by racial ethnic-specific molecular markers, sociocultural factors, and/or other characteristics associated with increased resilience
• Detailed phenotypic assessment of pregnant women using novel or existing culturally sensitive tools to identify symptoms, psychosocial factors or biomarkers that contribute to and predict maternal health disparities
• Characterization of factors influencing the effectiveness of birth companions such as family caregivers or doulas in reducing the risk of maternal morbidity and/or mortality

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI provides global leadership for research, research training, and educational programs to promote the prevention and treatment of heart, lung, blood, and sleep diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI seeks applications that will address questions relevant to the NHLBI mission and should align with the NHLBI’s Strategic Vision. The NHLBI has significant interests in implementation research for the prevention, control, and treatment of heart, lung, blood, and sleep disorders.

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

• Different subtypes of preeclampsia and pathophysiology of late onset of the disease that contribute to disparities in maternal morbidity and/or mortality in individuals from racial/ethnic and/or rural populations, that are at greater risk and higher incidence of the disease, and/or have a higher prevalence of cardiovascular and metabolic risk factors;
• Intervention studies focused on changing the high-risk trajectory of African American and/or American Indian/Alaska Native women who have at-risk chronic disorders (i.e., obesity, pre-diabetes, HTN) and/or have experienced a high-risk pregnancy that predicts adverse long-term CVD risk (e.g., GDM, preeclampsia, gestational hypertension, etc.)
• Ancillary studies to clinical research studies, including clinical trials, prospective observational studies, and/or registries to better understand the drivers of disparities in maternal mortality and pregnancy complications;
• Development and testing of novel interventions to increase the evidence base of effective treatments for preeclampsia and pregnancy-associated hypertension in low-resource settings and high burden populations (e.g., racial/ethnic and/or rural) within the U.S.;
• Strategies to identify and effectively target underlying psychosocial (e.g., depression, psychopathology, social support, resilience) and behavioral (e.g., tobacco use, physical activity, diet) factors among underserved pregnant women to enhance cardiovascular health and ameliorate risk for poor cardiovascular outcomes;
• Development of specific strategies for surveillance and primary prevention of maternal smoking and use of e-cigarettes during pregnancy in individuals from populations that experience disparities in maternal mortality and/or morbidity;
• Assessment of disparities in health communications to pregnant women regarding health sleep behavior and development of metrics for such communication during pregnancy (e.g., timing, sleeping position, co-sleeping, use of medications)
• Interventions addressing disparities in threshold for clinical suspicion, investigation, therapy, and follow-up to address postpartum Venous Thromboembolism and PE;
• Implementation of proven-effective, evidence-based interventions and strategies tailored to prevent, diagnose, and treat sickle cell related pregnancy complications, pre-eclampsia or excessive weight gain during pregnancy;
• Costing, affordability, and cost-effectiveness of implementation of proven-effective strategies and interventions for hypertension and/pregnancy-associated hypertension in individuals from populations that experience disparities in maternal mortality and/or morbidity (e.g., research on community health workers or other providers providing real time reporting of complications via SMS; increasing midwife ratio in continuity of care for vulnerable African American and American Indian/Alaska Native women; strengthening referral service).
• Leveraging existing strategies and interventions from low resource contexts globally for implementation within low-resource and/or high burden communities and populations within the U.S that experience disparities in maternal mortality and/or morbidity.

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 FOA.

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)

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)

• U.S. Territory or Possession

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

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 FOA. 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 SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement 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:

Maryline Laude-Sharp, PhD

Telephone: 301-451-9536

Email:mlaudesharp@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

R&R or Modular Budget

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

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

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

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

Research Strategy:

Identify and justify the target racial and ethnic minority and/or rural populations included in the project, as well as the stage(s) within the care continuum (pre-conception, pregnancy, delivery, post-partum, up to one year after delivery) to be examined. Provide a conceptual framework for the multi-level mechanism and/or intervention or program to be evaluated or examined, including maternal mortality or morbidity outcomes to be assessed. Identify how the proposed study design will allow for the examination of intervention or program effects at the multiple levels. Provide a data analytic plan that specifies how multi-level factors or interventions will be handled. Describe the roles and responsibilities of partners and collaborators. Describe how achievement of the specific aims will improve scientific knowledge, technical capability, and/or clinical practice related to health disparities in maternal mortality and/or morbidity. Please refer to the NIMHD Research Framework for more details about multi-level research.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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.

In addition, 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 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this funding opportunity: Are the stages in the care continuum to be addressed, pre-conception, pregnancy, delivery, post-partum, clearly identified and justified?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this funding opportunity: If the study evaluates an intervention, how well integrated is the conceptual framework to the proposed multi-level intervention? If the study examines mechanisms, does the conceptual framework appropriately address the proposed connections between the mechanism(s) and the outcome(s)?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

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)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

• 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.

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. 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 FOA. 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.
• Representation of health disparity population and health conditions

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 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA 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: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 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. Reporting

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions 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 threatensubmission by the due date, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(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: 301-945-7573

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

Beda Jean-Fran ois, Ph.D.
National Institute On Minority Health and Health Disparities (NIMHD)
Telephone: 301--594-9764
Email: [email protected]

Priscah Mujuru, DrPH, MPH, RN, COHN-S
National Institute On Minority Health and Health Disparities (NIMHD)
Telephone: 301--594-9765
Email: mujurup@nih.gov

Sung Sug Yoon, PhD, RN
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]v

LeShawndra N. Price, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8166
Email:[email protected]

Maryline Laude-Sharp, PhD
National Institute On Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-9536
Email: mlaudesharp@mail.nih.gov

Priscilla Grant, J.D.
National Institute On Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Randi Freundlich, RD
National Institute of Nursing Research (NINR)
Telephone: 301-402-4502
Email: freundlichr@nih.gov

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8014
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 45 CFR Part 75.