Part 1. Overview Information

Key Dates

Dates in bold and italics reflect changes per NOT-MD-24-012

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The maternal mortality rate in the United States is an urgent public health problem, as it surpasses rates in similarly large, and high-income countries, and is characterized by stark disparities for racial and ethnic minorities, underserved rural residents, and people with low socioeconomic status. Every year, over 1200 U.S. women die from pregnancy and its complications, with African American or Black women and American Indian or Alaska Native women having three times and two times the maternal mortality rates of White women, respectively. In addition, maternal mortality rates are 80% higher in rural areas compared to large metropolitan areas. Per the CDC, more than 80% of pregnancy-related deaths are preventable (e.g., 93% of such deaths in American Indian/Alaska Native women are preventable).

Addressing maternal health means not only reducing mortality but also reducing severe maternal morbidity (SMM). SMM, defined by the Centers for Disease Control and Prevention (CDC) as unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman’s health, affects around 50,000 U.S. women per year and has similar racial and ethnic disparities. Most women do not die from acute pregnancy-related complications (e.g., hemorrhage, sepsis, eclampsia, cardiovascular events, and maternal depression), which are much more common than pregnancy-related deaths, largely preventable, and are treatable. African American/Black, Hispanic/Latina, Asian, Native Hawaiian or Pacific Islander, and American Indian/Alaska Native women all have higher incidence of SMM compared to White women. Reduction in racial and ethnic disparities in SMM is needed, in part due to the higher prevalence of chronic conditions (e.g., hypertension, moderate or severe obesity, cardiovascular disease) that may exacerbate maternal morbidity among African American/Black and American Indian/Alaska Native women. In addition, SMM disparities at the intersections of race and ethnicity and socioeconomic status in the context of rural geographic locations should be addressed.

This initiative will focus on healthcare access and quality, emphasizing individual and structural social determinants of health (SDOH) that may impact maternal mortality and SMM in the United States. Adverse SDOH such as lack of access to quality and affordable care may increase maternal mortality and morbidity (MMM) risk, especially among African American/Black and American Indian/Alaska Native women. The scientific literature suggests that factors such as quality of care in hospitals with majority African American/Black patients, healthcare system factors and policies (payment mechanisms, health insurance policies, care coordination) and clinician factors (e.g., poor communication with patients, failure to diagnose potential complications, delays in diagnostic tests, lack of appropriate referrals) are related to SMM. Additional research is warranted to understand and address these and other important issues such as racial and ethnic disparities in health care quality within the same hospital, implicit bias, and discrimination.

Pregnant people may experience differences in access and quality of care they receive. Racial and ethnic minority women’s access to care is often limited by factors such as insurance coverage, socioeconomic status, community resources, and site of care. In addition, depending on the geographic location (rural versus urban), pregnant people may experience differences in access to and quality of care they receive. Rural communities composed of a higher percentage of African American/Black, Hispanic/Latina, and unemployed residents have been shown to experience a higher likelihood of occurrence of hospital closures and loss of hospital obstetric services. Medicaid expansion under the Affordable Care Act has demonstrated promise in lowering the total Maternal Mortality Ratio (MMR) and reducing racial and ethnic disparities. Thus, research opportunities exist to examine the mechanisms through which Medicaid expansion may contribute to decreases in maternal mortality rates and corresponding decreases in racial and ethnic, as well as geographic disparities.

Improving access to care by validating care coordination models between specialty and primary care clinicians in the pregnancy and postpartum period or collaborative partnerships between hospital-based clinicians and community-based service providers such as doulas and midwives, could potentially improve maternal outcomes for racial and ethnic minority, socioeconomically disadvantaged, and underserved rural and urban populations. With that, efforts to improve quality of care such as diversifying the clinical workforce to enhance opportunities for racially concordant care and implementing patient safety bundles are also promising areas for evidence generation and improved outcomes.

Research Objectives

The objective of this initiative is to solicit grant applications (R01s) seeking to bridge the knowledge gap about understudied healthcare system and clinician factors across the full spectrum of maternal care prenatal, perinatal, and up to 1 year postpartum in the United States. Of particular interest are intervention studies (e.g., clinical trials, quasi-experiments, stepped-wedge designs) designed to evaluate and address these disparities. Preliminary observational studies (primary/secondary data) or mixed-methods studies are encouraged to support the proposed intervention targets and outcomes. Secondary goals of the research can include examination of mechanisms/pathways through which these healthcare factors contribute to MMM disparities.

Research projects can focus on one or more points across the continuum of care, from prenatal care to postpartum care up to 1 year after labor or delivery. Projects should be guided by evidence-based conceptual model(s) of relevance to minority health and health disparities research, and recognize the overlapping and multilevel factors that contribute to health outcomes (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html). Projects are encouraged to test interventions designed to address MMM disparities among minoritized racial and ethnic, socioeconomically disadvantaged, and underserved rural and urban populations of reproductive age, with a focus on healthcare system, clinician, and clinical factors. These include but not limited to access and quality of preventive, specialty, and emergency care, as well as health insurance coverage. Research examining the role(s) of health insurance may focus on public and/or private insurance plans. Also of interest are studies on care coordination and early detection and diagnosis of underlying health problems and timely referrals, taking into consideration both patient (e.g., substance use, smoking, prenatal care follow-up, co-morbid conditions) and clinician factors (e.g., patient-clinician communication, clinician bias, postpartum coordination of care). Projects that evaluate novel patient-centered and culturally appropriate care for racial and ethnic minoritized women are also of interest.

Projects should prioritize intervention research to test new or adapted interventions. Health services research should examine the effectiveness of new or existing programs, services, or policies. Implementation research designs should examine the uptake and sustainability of evidence-based interventions or practices. Evaluation of health policies and changes in healthcare delivery systems, as well as social and/or behavioral, and clinical interventions are all of interest. Researchers are encouraged to use applicable intervention approaches (cognitive behavioral, social influence, community mobilization, implementation science, health communication, policy advocacy and change), and are required to include rigorous estimates of sample size, follow-up of at least one year, and well-defined health outcomes.

For projects seeking to understand the effects of mechanisms implicated in racial and ethnic and rural and urban MMM disparities, the range of potentially relevant factors to examine is vast. Individual level examples include English proficiency, immigration status, smoking history, trauma and violence history, pre-pregnancy or peri-partum obesity, maternal hypertension, excess gestational weight gain, pre-eclampsia, and gestational diabetes. Interpersonal, healthcare system, and policy-level examples include, but are not limited to, patient-clinician communication, clinician implicit and explicit bias, availability or accessibility of clinical staff; healthcare coordination, type of healthcare insurance and reimbursement policies; state reproductive health policies, policies that may affect pregnant people who have substance use disorders; and structural racism or discrimination in the healthcare system.

Intersectional approaches that consider different social identities (e.g., intersections of race and ethnicity and socioeconomic status, with sexual/gender identity or rurality) are encouraged. Projects that use a syndemics lens (i.e., multiple disease states that are interlinked because of social, environmental, and structural conditions), to examine disparities in MMM due to co-occurring health conditions are also encouraged. In addition, exploring the role of inequality generating mechanisms that are implicated in MMM disparities such as racism and discrimination, classism, ageism, ableism, and other power structures is also encouraged. Projects are encouraged to examine resiliency and protective factors as well as ways to promote maternal health (selecting an appropriate reference population).

Studies involving primary data collection with human participants are strongly encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org). Where appropriate to examine intervention outcomes, projects may utilize observational data, simulation modeling, large-scale longitudinal datasets, data mining techniques, registries, surveillance data, and linked administrative datasets.

Investigators are encouraged as appropriate for the research questions posed, to forge research collaborations with community partners and collaborators in the conceptualization, planning and implementation of the research to generate better-informed hypotheses and enhance the translation of the research results into practice. Applicants are encouraged to: 1) have a history of successful recruitment and retention of participants within the populations of focus, 2) create sustainable collaborations and implementation in communities disproportionately affected by illnesses; and 3) conduct effective communication, co-creation, and dissemination activities to inform communities about the project and its findings. Projects must have clearly defined roles for all partners. As appropriate, study budgets should include funds for community collaborations and partnerships to be fully engaged in research design and implementation (for example, an advisory board of patients from the target population women who have experience with pregnancy). Approaches to engaging community collaborators through the research process, such as team science, community-engaged research, participatory action research, empowerment evaluation approaches, community asset mapping, and community health workers are strongly encouraged.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Interventions should use appropriate study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Demonstration projects, especially projects that are evaluative without comparison groups are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at: https://researchmethodsresources.nih.gov/ . Applications should also delineate health outcomes and how the intervention or strategies can be sustained and scaled-up to improve population health.

Areas of Research Interest

National Institute on Minority Health and Health Disparities (NIMHD):

• Evaluation of strategies to improve the quality of maternal healthcare for racial and ethnic minority, socioeconomically disadvantaged, and underserved rural and urban women, including emerging innovative strategies such as but not limited to evidence-based healthcare safety bundles, health improvement collaboratives, and innovative primary care models.
• Investigation of the mechanisms through which health insurance coverage expansions impact racial and ethnic, socioeconomic, and rural/urban disparities in MMM, including private insurance coverage.
• Investigation of care coordination challenges or breakdowns in the diagnostic or care pathways between primary care clinicians and specialists, including the transition from the pregnancy to post-partum periods and during the postpartum period, and impacts on access and quality of care.
• Examination of clinician-level factors such as implicit bias, patient clinician communication, racial and ethnic concordance between the clinician and patient, and strategies to improve cultural competence in relation to disparities in MMM, while taking into consideration healthcare facilities factors such as size of hospitals, proportion of specialists, health professionals in training versus more experienced health professionals, and coordination with larger and better equipped health facilities.
• Examination of the role of access to and use of quality and affordable primary care in managing chronic medical conditions (e.g., hypertension, substance use disorder, depression, cardiovascular disease) that increase risk for pregnancy-related complications (e.g., hemorrhage, preeclampsia) and adverse outcomes one year post-partum (e.g., stroke, heart failure, major depressive disorder), while taking into consideration patient’s family, medical, and obstetrical history.
• Examination of how intergenerational transmission of biological and social risks, interacts with access to and use of quality care to influence maternal outcomes.
• Investigation of the contribution of differential access to and quality of obstetric and perinatal care (including telehealth and workforce shortages) to rural and urban disparities in MMM, especially in terms of the interactions between race and ethnicity and rural/urban residential status.
• Examination of the integration of healthcare systems and community-based practices to enhance access to and continuity of care for racial and ethnic minority, socioeconomically disadvantaged, and underserved rural and urban women 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).
• Examination of multi-level strategies, such as those utilizing health information technology tools, to ensure that racial and ethnic minority, socioeconomically disadvantaged, and underserved rural and urban women receive preventative obstetric care consistent with national evidence-based recommended guidelines.
• Testing implementation strategies of evidence-based interventions to address health disparities in mental health services for perinatal mental disorders.
• Addressing structural factors that limit access to perinatal mental health services by leveraging technology to promote greater health equity for racial, ethnic, and gender diverse women during the reproductive years.
• Examination of the coordination of perinatal mental health services between clinicians (e.g., obstetricians, midwives, pediatricians, general internists, family medicine physicians) and mental health providers to address continuity of mental healthcare for women and to ensure feasibility within extant public and employer-based financing of perinatal mental health services.

National Institute on Mental Health (NIMH):

NIMH invites research that aligns to priorities in this NOFO and explicitly aligns to priorities in Goal 4 of the NIMH Strategic Plan for Research. https://www.nimh.nih.gov/about/strategic-planning-reports/goal-4-advance-mental-health-services-to-strengthen-public-health.

High priority topics from this NOFO will focus on services research that improves access, continuity, quality, equity, and value of mental health care and that holds promise to reduce disparities in maternal morbidity and mortality. Projects can focus on development and evaluation of mental health policy, strategies to disseminate information about and implement evidence-based mental health interventions, and the development and testing of services interventions.

Applications are encouraged to have strong research-practice partnerships. The meaningful involvement of perspectives from a broad range of research partners including patients/service users, clinicians, health system leaders, state policy leaders, and other healthcare decision makers at every stage of the research project is encouraged in order to yield findings that are relevant and that can be rapidly integrated into practice and policy.

Consistent with the NIMH experimental therapeutics approach, all applications that involve clinical trials, including (but not limited to) applications to test mental health screening and services interventions and strategies to implement evidence-based treatments, should be designed to not only examine the intervention effects on outcomes of interest, but to also inform understanding of the intervention’s mechanisms of action (i.e., targets). As such, applications are expected to pre-specify intervention targets (i.e., mechanisms of action) and measure the impact of the intervention on both the hypothesized targets and more distal clinical or services outcomes. Furthermore, projects seeking to adapt established evidence-based practices are required to provide an empirical rationale for the adaptation; a clear hypothesis and plan to address the mechanism by which the adapted intervention will enhance outcomes; and evidence to suggest that the adapted intervention will result in a substantial improvement in outcomes. Investigators should review NIMH guidance: Support for Clinical Trials at NIMH.

Applicants are encouraged to contact NIMH program officials regarding the match between the potential application and current priorities.

The following are examples of services research encouraged by NIMH:

• Research that identifies mutable provider- and system-level factors to improve access, continuity, quality, equity, value, and outcomes associated with mental health care and inequities in maternal morbidity and mortality.
• Studies that test implementation strategies of evidence-based interventions to reduce health disparities in mental health services during the perinatal period.
• Research that examines and addresses structural factors (e.g., structural racism) that limit access to and/or engagement in perinatal mental health services.
• Research that leverages and improves use of digital health and other patient, provider, or system-level technological solutions to promote greater health equity for racial, ethnic, and gender diverse women during the perinatal period.
• Research that improves the coordination of perinatal mental health services between clinicians (e.g., obstetricians, midwives, pediatricians, HIV care providers) and mental health providers to address engagement in and continuity of mental health care for women and to ensure feasibility within extant public and employer-based financing of perinatal mental health services.
• Research that pragmatically incorporates cultural preferences, gender, social systems, and social networks to increase appropriate help-seeking, use and provision of services, and effectiveness, quality, and outcomes of services to improve perinatal mental health outcomes.
• Studies that address necessary features for rapid dissemination, adoption, and implementation of new perinatal mental health screening and service delivery approaches in clinical and community settings.

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

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

Other

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

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Not applicable

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

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

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, 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 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

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

Section V. Application Review Information

1. Criteria

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

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

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

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

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

2. Review and Selection Process

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

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

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

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

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

Rada K. Dagher, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: [email protected]

Yewande Oladeinde, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-4307
Email: [email protected]

Monica Longo, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 240-204-4605
Email: [email protected]

Marie Mancini, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-5032
E-mail: [email protected]

Mary Catherine Acri
NIMH - NATIONAL INSTITUTE OF MENTAL HEALTH
Phone: (301) 910-8230
E-mail: [email protected]

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

Damiya Eve Whitaker, PsyD, MA
ORWH - Office of Research on Women's Health
Phone: 301-451-8206
E-mail: [email protected]

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

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

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

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Sheila Simmons
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-9812
E-mail: [email protected]

Tamara A Kees
NIMH - NATIONAL INSTITUTE OF MENTAL HEALTH
Phone: 301-443-8811
E-mail: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
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 and 2 CFR Part 200.