Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional)

Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This Notice of Funding Opportunity (NOFO) supports multidisciplinary and innovative intervention research to understand and address maternal morbidity and mortality in the United States, particularly among racial and ethnic minority, socioeconomically disadvantaged, and underser…

Expired PAR-24-059: Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity May 9, 2025 - Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils.

See Notice NOT-OD-25-116 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 April 11, 2024 - Notice of Change to Key Dates for PAR-24-059, "Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional)".

See Notice NOT-MD-24-012 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 307, 93.

865, 93. 313, 93. 242, 93.

361, 93. 846 Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support multidisciplinary and innovative intervention research to understand and address maternal morbidity and mortality in the United States, particularly but not exclusively among racial and/or ethnic minority, low socioeconomic status (SES), and low-resourced rural populations, with a focus on understudied healthcare factors.

This is a new funding opportunity to advance the goals of the NIH Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone ( IMPROVE ) Initiative. IMPROVE aims to understand the biological, behavioral, environmental, sociocultural, clinical, and structural factors that affect pregnancy-related and pregnancy-associated severe morbidity and mortality and build an evidence base for improved care and outcomes.

The IMPROVE initiative supports research to reduce preventable causes of maternal deaths and improve health for women before, during, and after delivery. It includes a special emphasis on populations that are disproportionately affected, such as women from racial and ethnic minority groups, very young women and women of advanced maternal age, and women with disabilities.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. Dates in bold and italics reflect changes per NOT-MD-24-012 Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

New Date May 24, 2025 per NOT-OD-25-113 (Originally January 08, 2027) Required Application Instructions 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. Part 1. Overview Information 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 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 disparities for racial and ethnic minorities, low-resourced rural residents, and women 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 s evere 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 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. 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 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.

The scientific literature suggests that factors such as quality of care in hospitals that mostly serve African American/Black patients, healthcare system factors and policies (payment mechanisms, health insurance policies, care coordination) and clinician factors (e.g., communication, diagnosis of complications, timing of performance of diagnostic tests, specialty referrals) influence the risk of 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, unconscious prejudice, and discrimination. Women’s access to care is directly related to insurance coverage, socioeconomic status, community resources, and site of care.

In addition, depending on the geographic location (rural versus urban), pregnant women may experience differences in access to and quality of care they receive.

Rural communities with a significant proportion of African American/Black, Hispanic/Latina residents with a significant proportion of women from racial and ethnic minority groups and who are unemployed, have been shown to experience a higher likelihood of occurrence of hospital closures and loss of hospital obstetric services.

On the other hand, 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 populations experiencing health disparities.

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 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 experienced by women of reproductive age from racial and ethnic minority, low SES, and low-resourced rural populations, 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.

Very importantly, these examinations and evaluations need to consider the influence of both patient factors (e.g., lifestyle behaviors, substance use, attendance to prenatal care follow-up, co-morbid conditions, beliefs and assumptions about health care) and clinician factors (e.g., patient-clinician communication, postpartum coordination of care).

Projects that evaluate novel patient-centered and culturally appropriate care 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 such as cognitive behavioral, social influence, community mobilization, implementation science, health communication,. Projects 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 mellitus.

Interpersonal and healthcare system examples include, but are not limited to, patient-clinician communication, clinician conscious or unconscious prejudice, availability or accessibility of clinical staff; healthcare coordination, healthcare insurance and reimbursement; care that may affect pregnant women who have substance use disorders; and structural factors in the healthcare system.

Approaches that consider different social identities (e.g., intersections of race and ethnicity and socioeconomic status, with sexual identity or rurality) are encouraged. Projects that use a syndemics lens to examine disparities in MMM due to co-occurring health conditions are 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 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 community implementation; 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 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 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, patient clinician communication, and strategies to address cultural competence in relation to disparities in MMM, while taking into consideration healthcare system.

Examination of the role of access to and use of quality primary care in managing chronic health 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.

Examination of the integration of healthcare systems and community-based practices to enhance access to and continuity of care 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).

Examination of multi-level strategies, such as those utilizing health information technology tools, to ensure that 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 factors that limit access to perinatal mental health services by leveraging technology to promote better health outcomes 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 clinicians 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): High priority topics from this NOFO will focus on services research that improves access, continuity, quality, fairness, 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, fairness, value, and outcomes associated with mental health care and disparities 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 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 better health outcomes during the perinatal period.

Research that improves the coordination of perinatal mental health services between clinicians (e.g., obstetricians, midwives, pediatricians, HIV care clinicians) and mental health clinicians 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, 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 Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 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.

Eligible Individuals (Program Director/Principal Investigator) 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.

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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility 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. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission 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.

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

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