Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites applications to participate as a Research Center as part of the Maternal Health Research Centers of Excellence initiative. The purpose of this initiative is to generate innovative approaches to address preventable maternal mortality (MM), decrease severe maternal morbidity (SMM), and promote maternal health equity in partnership with communities that are most affected (i.e., Blacks/African Americans, American Indians/Alaska Natives, Hispanics/Latinos, Asian Americans, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations). Persons with disabilities are also a priority population. This initiative will use an integrated multi-level approach encompassing structural, social, and biobehavioral research strategies to address the multiple contributing factors that lead to adverse maternal health outcomes and health disparities. Significant contributing factors include comorbid conditions (e.g., hypertension, diabetes, cerebrovascular disease, chronic stress, immune-mediated diseases, sleep disorders, organ-specific diseases, mental illness, and substance use disorders) and structural and social determinants of health, which include structural racism and health care system factors.

The goal of this initiative is for trans-disciplinary research teams to conduct multi-layered novel research projects that will have the potential to drastically reduce pregnancy-related and pregnancy-associated maternal deaths and decrease SMM. Proposed research can address maternal health in the pre-pregnancy, pregnancy, or postpartum period, provided that the research outcomes directly address severe maternal morbidity and/or maternal mortality and equitable healthcare. Studies may be interventional (including testing novel interventions, effectiveness, comparative effectiveness, optimization, or dissemination and implementation studies), or observational (including health services studies, natural experiments, or policy analyses) and assess maternal health outcomes. To stimulate novel approaches, it is anticipated that key personnel in complementary disciplines (e.g., biology, medicine, nursing, environmental science, public health, behavioral and social science, biostatistics/statistics, mathematics; computer science, engineering) and community partners will jointly develop and test multi-level strategies to address overall maternal well-being and preventable contributors to SMM and MM. In addition to demonstrating disciplinary diversity of the team, applications submitted in response to this FOA will be expected to submit a Plan for Enhancing Diverse Perspectives (PEDP). The PEDP will demonstrate how diverse perspectives will be obtained throughout the course of the project and will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

The Maternal Health Research Centers of Excellence will be uniquely poised to collaborate on studies and projects with other networks and initiatives such as the NICHD Neonatal Research Network, the Maternal Fetal Medicine Units Network, the NICHD Maternal and Pediatric Precision in Therapeutics (MPRINT) initiative, the NIH Helping to End Addiction Long-term (HEAL) Initiative, the NIH Researching COVID to Enhance Recovery (RECOVER) Initiative, the Foundation for the NIH, and other NIH institutes, and maternal health activities ongoing at partner Federal health agencies, such as the Centers for Disease Control and Prevention, the Health and Research Services Administration, and the Office of the Assistant Secretary on Women's Health.

This FOA runs in parallel with companion FOAs that seek applications for an Implementation Science Hub/Resource Center (RFA-HD-23-037) and a Data Innovation and Coordinating Hub/Resource Center (RFA-HD-23-036). It is expected that all components of the Centers of Excellence, Research Centers and Hubs, work collaboratively to design and implement research projects, including data collection and data sharing. It is expected that funded investigators will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities. Annual Centers of Excellence meetings will be held. The annual meeting will foster the initiation and maintenance of collaborative efforts and resource sharing among the Centers. Centers of Excellence PD/PIs should budget funds for the PD/PI and one to -two designees to attend an annual meeting in the Bethesda, Maryland / Washington DC area or virtually, if necessary.

Background

The collaborative Maternal Health Research Centers of Excellence FOAs represent one part of the multipronged initiative, Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE), launched by the NIH in response to the rising rates of MM in the U.S. Over the past 25 years, the MM rate has more than doubled in the U.S. and is now higher than any high-income country in the world. Approximately 700 women die each year from conditions related to or associated with pregnancy or childbirth. In addition, severe maternal morbidities affect more than 65,000 women in the U.S. per year. Women experiencing SMM are at increased risk for future adverse health concerns (e.g., hypertension, diabetes, chronic stress inclusive of historical trauma, mental health conditions, strokes, and heart disease). Black/African American and American Indian/Alaskan Native women have disproportionately higher rates of maternal deaths. There are also disparities by age, education, socioeconomic status, and geographic region.

One-third of pregnancy-related deaths occur during pregnancy, one-third occur during or in the week after delivery, and one third occur between one week to one year postpartum. Causes of SMM and MM are multifaceted. In the U.S., the leading causes are cardiovascular disease, cerebrovascular disease, hemorrhage, infection, hypertensive disorders of pregnancy, and thromboembolism. Significant contributing factors include comorbid conditions (e.g., hypertension, diabetes, chronic stress, immune-mediated diseases, organ-specific diseases, mental illness, and substance use disorders) and social determinants of health, which include structural racism and health care system factors. It is estimated that 60 to 70 percent of maternal deaths in the U.S. are preventable.

Maternal Health Centers of Excellence Structure

As described above, the Maternal Health Research Centers of Excellence structure will consist of one Data Innovation and Coordinating Hub/Resource Center, one Implementation Science Hub/Resource Center, and up to seven Research Centers. The Data Innovation and Coordinating Hub, the Implementation Science Hub, and the Research Centers are each integral components of the Centers of Excellence. Success will require close, active cooperation and collaboration to assimilate these elements into a highly effective research structure.

Descriptions of Required Components

The proposed Centers must include the following required components:

Research Project(s)
Research projects must include an emphasis on developing new and improved approaches to address the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity in populations that experience health disparities as defined below. Research Center applications must propose one to three interrelated research projects that may vary in scale and scope.

Research projects must be observational (e.g., including health services studies, mechanistic, natural experiments, or policy analyses) or interventional (i.e., including effectiveness, comparative effectiveness, optimization, or dissemination and implementation studies) and are expected to use a transdisciplinary, multi-level, multi-domain perspective. At least one project must involve a prospective intervention (i.e., the intervention is implemented and evaluated by Center investigators) to reduce maternal morbidity or mortality. Studies may be focused on prevention or care delivery, such as the examination and evaluation of existing assessments, risk prediction models, treatment protocols, behavioral or social interventions, care models, treatment guidelines, or policies. For interventional studies, expected improvements in maternal health or a reduction in a maternal health disparity relative to an existing baseline measure for the population(s) under study should be provided when possible. Observational studies that are purely epidemiological (i.e., that identify incidence/prevalence of risk factors or health outcomes) are not a high priority for this RFA.

Centers are expected to support training and professional development of maternal health researchers, including those from backgrounds underrepresented in the biomedical research workforce (see NOT-OD-20-031, Notice of NIH's Interest in Diversity). Centers are also expected to partner with community collaborators as defined below, which may include but are not limited to academic institutions, clinicians, health systems, state and local public health agencies, prison bureaus, community-based organizations, community health centers, and faith-based organizations. The proposed research team may include senior and junior faculty, pre- and post-doctoral and other trainees, and community members, all with appropriate justification.

Community partnership is expected to have occurred from inception. Projects may be full-scale projects or more exploratory/developmental projects. All projects must be fully developed with detailed research plans at the time of application. There should be synergy between the research projects such that there is added value to conducting them as interrelated rather than independent projects. Therefore, planning-phase studies, in which the topic or study design is determined after award as a result of community and collaborator input, will not be supported.

Community Partnership Component
Of the community partners for each Research Center, at least one must be a community healthcare partner. A cooperative and equitable partnership between the Research Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination) must be clearly demonstrated.

Training Component
Each Research Center must include a research training program that addresses the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity. A training program for early stage investigators is of high interest. Support for visiting scientists, exchange programs between Research Centers for postdoctoral fellows, community health partners, hands on training sessions, seminars and research forums are appropriate items for inclusion in an enrichment program. In addition, travel support may be requested to allow investigators to travel to present scientific findings, to develop new collaborations, or to engage in scientific information exchanges.

Specific Objectives and Scope of this FOA

This FOA runs in parallel with companion FOAs that seek applications for an Implementation Science Hub/Resource Center (RFA-HD-23-037) and a Data Innovation and Coordinating Hub/Resource Center (RFA-HD-23-036). It is expected that all components of the Centers of Excellence, Research Centers and Hubs, work collaboratively to design and implement research projects, including data collection and data sharing. It is expected that funded investigators will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.

This initiative aims to develop transdisciplinary, innovative Maternal Health Research Centers of Excellence focused on developing new and improved approaches to address the biological, behavioral, environmental, sociocultural, health care system, and structural factors (e.g., racism) that affect pregnancy-related and pregnancy-associated morbidity and mortality by building an evidence-base for improved equitable maternal healthcare and outcomes. Proposed research can address maternal health in the pre-pregnancy, pregnancy, or postpartum period, provided that the research outcomes directly address severe maternal morbidity and/or maternal mortality and equitable healthcare.

Research projects must include a focus on one or more populations that experience maternal health disparities, including but not limited to, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in maternity care deserts), or sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.

The following are provided as research examples. Applicants are not limited to those listed here:

• Developing interventions that address underlying mechanisms of common causes of maternal morbidity and mortality, such as cardiovascular disease, stroke, hemorrhage, sepsis, intimate partner violence, suicide, and mental illness, in the perinatal and postpartum period, with a focus on improving maternal health overall
• Application of diagnostic, target engagement, and/or predictive biomarkers of common causes of maternal morbidity and mortality to improve maternal health care
• Innovative multi-disciplinary approach including bioinformatic expertise in artificial intelligence (machine learning, computer-based modeling, and simulation) leading to an integrated model of maternal risk stratification and development of decision aid tools for shared decision making, with an emphasis on approaches/models that balance ethical concerns as there is a potential for AI/ML tools to exacerbate existing health disparities
• Identifying and addressing the complex biological, genetic, behavioral, nutritional, environmental, sociocultural, structural and health system determinants of maternal health disparities, as well as identifying factors that contribute to optimal maternal outcomes in high-risk communities
• Developing comprehensive risk assessment models that incorporate biological and social determinants of SMM and MM to inform care models
• Developing and/or adapting components of comprehensive multi-level care models of evidence-based components that do not exist or require adaptation for use with specific populations
• Developing and testing innovative multi-level intervention and prevention strategies - including upstream cultural approaches, complementary and integrative health approaches, or resilience-focused interventions such as stress management - to reduce pregnancy-related or -associated poor (or adverse) maternal health outcomes and causes of SMM/MM, from pre-pregnancy through one year postpartum
• Developing and testing multi-sectoral interventions that facilitate linkages to maternal healthcare for persons in substance use or mental health treatment settings, shelters or housing programs, victims'/trauma services programs, or the criminal justice system
• Developing and testing interventions to reduce maternal health disparities within clinical settings (e.g., by addressing clinician bias, institutional racism, barriers to access to care, etc.) or across clinical settings (e.g., quality improvement initiatives, community-hospital partnerships to address social determinants of health, etc.)

• Identifying and addressing unique SGM-specific disparities in and drivers of pregnancy-associated morbidity and mortality (e.g., risk factors, forms of morbidity/mortality experienced, healthcare access and other social determinants of health) and issues shared with cisgender and/or heterosexual people, as well as improving understanding and developing culturally responsive and sensitive interventions and preventive strategies to address the concerns of SGM-specific experiences of pregnancy-associated morbidity or other adverse pregnancy-associated events

Key Definitions

The following key definitions apply:

Populations that experience health disparities: Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. Populations that experience maternal health disparities, include but are not limited to, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in maternity care deserts), or sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.

Community organization: A non-Federal, non-academic organization that provides goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood associations, labor unions, patient or consumer advocacy groups, public health departments, healthcare systems, community health centers, school systems, law enforcement or criminal justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, recreation. Governmental organizations at the local, regional, tribal, or state level fall within this definition.

Rural: For the purposes of this FOA, the follow areas are defined as rural: non-metro counties; all metro census tracts with RUCA codes 4-10; large area Metro census tracts of at least 400 sq. miles in area with population density of 35 or less per sq. mile with RUCA codes 2-3; and all outlying metro counties without an Urbanized Area (UA).

Pregnancy-associated mortality: Death while pregnant or within one year of the end of the pregnancy, irrespective of cause. This is the starting point for analyses of maternal deaths.

Pregnancy-related mortality: Death during pregnancy or within one year of the end of pregnancy from a pregnancy complication; a chain of events initiated by pregnancy; or the aggravation of an unrelated condition by the physiologic effects of pregnancy. Used by the Centers for Disease Control and Prevention (CDC) to report U.S. trends, this measure is typically reported as a ratio per 100,000 live births.

Maternity care desert: Maternity care deserts are counties in which access to maternity health care services is limited or absent, either through lack of obstetric services or barriers to a woman's ability to access that care within counties. A maternity care desert is any county in the United States without a hospital or birth center offering obstetric care and without any obstetric providers. Low access to appropriate preventive, prenatal and postpartum care is defined as counties with one or fewer hospitals or birth centers that provide obstetric care, few obstetric providers (fewer than 60 per 10,000 births) or a high proportion of women without health insurance (10 percent or more). Moderate access to care is defined as living in a county with access to few hospitals/birth centers or obstetric providers and adequate health insurance coverage (less than 10 percent of women of reproductive age uninsured). Full access to maternity care can be defined by availability of hospitals or birth centers providing obstetric care and availability of providers offering obstetric care.

Applications Not Supported by this FOA

The following types of applications will be considered non-responsive to this FOA and will not proceed to peer review.

• Applications that propose to conduct preclinical/vertebrate studies with animals
• Applications that propose research projects that propose to evaluate safety, clinical efficacy, effectiveness, or management of new or established pharmacological agents
• Applications that do not include populations that experience health disparities as defined above
• Planning-phase studies in which the topic or study design is determined after award as a result of community and stakeholder input

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

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

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

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

Applicant organizations

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

• 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 full SAM and 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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 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 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Nahida Chakhtoura, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Please include additional information for the fields described below:

Other Attachments: The following "Other Attachments" must be included with the Overall Component in order to aid in the review of applications.

Attachment 1. Plan for Enhancing Diverse Perspectives (PEDP)

Provide a summary of strategies to advance the scientific and technical merit of the proposed project(s) through expanded inclusivity as a pdf attachment using the filename Plan for Enhancing Diverse Perspectives". The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance the recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).

Attachment 2. Populations Available for Studies

Provide a summary of the Research Center's available population of obstetrical, postpartum, or lactating individuals as a pdf attachment using the filename Populations Available".

Table 2. Inclusion of Obstetrical, Postpartum or Lactating Individuals Available

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the broad objectives and goals of the proposed Center. Include the objectives for each of the Components.

Research Strategy: The Research Strategy section of the Overall Component serves to introduce the Research Centers' component of the Maternal Health Research Center of Excellence.

The Research Centers will be established by trans-disciplinary experts in maternal health in partnership with community organizations. Research Centers will propose multi-layered novel research projects that will have the potential to drastically reduce pregnancy-related and pregnancy-associated maternal deaths and decrease SMM in the communities that are at most risk. This section will address the objectives, and identify the focus or theme of research addressed in the proposed projects and how the projects will reduce severe maternal morbidity and mortality and promote health equity for pregnant or postpartum individuals in their communities. This Research Strategy also provides a sense of the overall significance of the Research Center, i.e., any unique resources it provides that will impact communities affected by severe maternal morbidity and mortality and the research to be addressed. For the purposes of this FOA, the research community includes the investigators and their community partners who will establish the Research Center. Members of the Research Center may work in the same field or related fields and interact through common meetings, collaborations and shared activities and resources. This section should describe the research community, as well as the significance, approach, and innovation of the Research Center proposed projects as well as the planned interactions among the Research Center investigators and their community partners. It should also include a summary of how the efforts of this Center will avoid duplicating institutional, local, or national efforts.

The Research Strategy section of the Overall Component should be organized in the following fashion.

Orientation to the Overall Center
Describe the goals of the Research Center and the proposed projects. Describe the scientific, organizational and management structure, including proposed plans to work collaboratively with the Data Innovation and Coordinating Hub and the Implementation Science Hub. Include the leadership structure and the individual components, including meaningful and equal community partnership throughout the research development process and training. Include the theme or focus, the research field(s) and the Research Center, any needs assessments that were conducted that led to the selection of project(s) to be developed, and unique aspects of the resources and services being offered by the components. Provide a brief summary of prior experience pertinent to this application.

Research Community
Present an overview of ongoing research on the topic/projects of focus of the Research Center in sufficient detail such that its extent and the interrelationships of ongoing research are clear. A strong multi-disciplinary research community is a fundamental requirement for establishing a Research Center. The research community should be composed of funded investigators and community partners with well-defined connections to the focus or theme of the Center and the communities they serve. Begin with a brief summary of the investigators in the research community and their strengths and continue with a descriptive narrative of how the components can enhance these projects. This narrative presentation should be organized to address the focus and interrelationships of research conducted by the Research Center Investigators (including the research community investigators and researchers leading and staffing the components) and how the research interests of the investigators in the research community are related to the focus or theme of the Center. Criteria for designating an investigator as a Center investigator should be defined in terms of the responsibilities and privileges.

The investigators of the research community of the proposed Research Center may be documented in greater detail in the Biographical Sketches and Letters of Support. If the Letters of Support and/or Biographical Sketches are used in this way, they should be explicitly referenced within this section. It may also be useful to highlight ongoing and past successful collaborations between investigators in the research community and the Center personnel and to document the outcomes (e.g., publications, grants, major scientific advances, etc.) of these collaborations.

Innovation
Address how the Center will not only evolve with the science, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions. If applicable, describe plans to develop or adapt new and/or unique state-of-the-art services through technology development and/or adaptation of technologies to meet the needs of the communities served by the Research Center. Explain how the synergy of the Research Center with the research community will lead to novel services and resources in the components and their application to important questions on the topic of focus. Describe the potential for interdisciplinary collaborations among the Research Center Investigators as well as the Innovative Data and Implementation Science Hub. If the proposed research is by its nature is not innovative, describe how it is essential to advance the field.

Approach
This section should expand on the goals of the Research Center and should describe the proposed projects/topics of focus of research and their effects on the communities served (i.e., describe how the Research Center will address the scientific needs of the community). Explain the degree to which the Research Center is expected to accelerate progress on the aims of the research community grants and projects, improve efficiency and enhance productivity of the research community investigators. If applicable, describe how the proposed Research Center will make existing resources broadly available to the research community, leverage existing resources, and fill gaps in the services available.

Environment
Describe the importance of the resources being shared and the expected effect of providing access to those resources. Describe how the Research Center aims to expand and enhance the capabilities of the pool of investigators engaged in research related to the research topic(s). For a Research Center that provides access to a unique highly specialized resource, provide examples of research projects that would be enabled and/or significantly enhanced by access to that resource. Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency or access to resources that would not otherwise be readily available. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. Provide details of any interactions between Center staff and CTSA staff and/or research personnel describing collaborative linkages being developed.

Letters of Support: Include any letters of support for the proposed Research Center by appropriate institutional officials of each performance site. These letters should include commitments of space and other resources required by the Center. A letter of agreement from existing resources (such as the CTSA PD(s)/PI(s)) should be included here if collaborative linkages are being developed between the Center and existing resources. Letters from the investigators of the research community may be provided to document their research interests, current or planned interactions with other Center investigators, the need for and impact of shared resources proposed by the Center, and likely use of Center resources. A table listing the individuals providing the letter of support and their institution is requested.

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

The following modifications also apply:

NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens

NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner, per NIH Policy, as amended.

NIH Data Management and Sharing Policy expects the timely release and sharing of data to be no later than the time of an associated publication, or the end of the award/support period, whichever comes first. Per the Policy, all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan ( the Plan ) in the Overall component of the application outlining how scientific data and any accompanying metadata will be managed and shared, regardless of whether the data are used to support scholarly publication.

Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NICHD expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Where appropriate, applicants should identify such repositories and plans for deposition. If applicants are proposing research within Indian Country or tribal communities, they must propose a data sharing plan that respects and enforces principles and practices of Tribal data sovereignty. The applicant is required to propose a data sharing plan that includes a description of how the Maternal Health Centers of Excellence will work with PD s/PI’s and respect sovereignty-based data management and sharing requirements.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Research Project

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Specific Aims: State the specific aims of the Research Project(s).

Research Strategy: Specify the objectives of the Research Project(s). Explain how the project(s) will contribute to addressing the multiple contributing factors that lead to adverse maternal health outcomes and health disparities in partnership with one or more populations that experience maternal health disparities, including but not limited to, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in maternity care deserts), or sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.

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, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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, with the following additional instructions specific to this FOA.

In Sections 2.4 "Inclusion of Women and Minorities" and 2.5 "Recruitment and Retention Plan" of the PHS Human Subjects and Clinical Trials Information Form, applicants must address the following points in addition to the G.500 instructions.

Section 2 - Study Population Characteristics

2.4 Inclusion of Women and Minorities

Application attachment Inclusion of Women and Minorities additional requirements:

• Provide data if available on the demographics of individuals affected under study in the catchment area(s) proposed in the application.
• Provide annual milestones for enrollment including numbers by sex/gender, race and ethnicity.
• Identify the person/people in the research team that will carry out the proposed outreach and their qualifications or relevant abilities such as fluency in languages other than English.

2.5 Recruitment and Retention Plan

Application attachment Recruitment and Retention Plan additional requirements:

• Describe how the proposed recruitment and retention plan is designed to overcome obstacles to study participation.
• In addition to the primary plan for recruiting sex/gender, racial, and ethnic group members, provide alternative/back-up strategies to be used if enrollment significantly deviates (more than 20% of any category for each annual milestone) from the planned numbers according to sex/gender, race or ethnicity. Back-up plans may, for example, propose to add research sites with access to additional individuals that are underrepresented in the enrollment.
• Describe what other research studies may be competing for recruitment of the same patient population in the catchment area(s) that are proposed in the application. Describe plans for communicating to potential study participants the options available to them.

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.

Community Partnership

When preparing your application, use Component Type Community Partners.

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

SF424 (R&R) Cover (Community Partnership)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Partnership)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Partnership)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Partnership)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Partnership)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Partnership)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Partnership)

Specific Aims: Describe the specific aims for the Community Partnership component.

Research Strategy: Describe how the Community Partnership component will contribute to the thematic focus of the Center. Describe plans for a cooperative and equitable partnership between the Research Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination). Provide evidence that at least one of the community partners is a community healthcare partner. Describe the leadership plan, and the principles, policies, and practices that will guide day-to-day operation. Describe the types of activities that will be conducted for the timely and appropriate dissemination of information generated, its research projects and other activities for diverse audiences, including lay community audiences, including a description of approaches or strategies to engage communities. Describe the expected outcomes of the proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. Describe dissemination activities with community members, partner organizations, and relevant service organizations or policymakers will be coordinated. Describe how stakeholders will share in the decision making on what, when, how, and to whom findings from research projects will be presented. Describe strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.

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, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Community Partnership)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Training

When preparing your application, use Component Type Training.

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

SF424 (R&R) Cover (Training)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Training)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Training)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Training)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Training)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Training)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Training)

Specific Aims: Describe the specific aims for the Training component.

Research Strategy: Describe how the Training component will contribute to the thematic focus of the Center. Provide a summary of the proposed outreach/training activities designed to address the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity. Include information about planned courses, research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed program, including a plan to train early stage investigators. Describe plans for visiting scientists, exchange programs between Research Centers for postdoctoral fellows, hands on training sessions, seminars and research forums if applicable to the planned outreach/training activities. .

Component Leader(s)
Describe the leadership plan, and the principles, policies, and practices that will guide day-to-day operation. Provide evidence that the Component Leader(s) is/are actively engaged in research and/or teaching in areas related to the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity. Include evidence that the Component Leader(s) can organize, administer, monitor, and evaluate career enhancement activities. For programs proposing multiple Component Leaders, describe the complementary and integrated expertise of the Leaders, their leadership approach, and governance appropriate for the planned Program.

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, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Training)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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.

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

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

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.

Significance

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

Specific to this FOA:

To achieve the purpose and objectives of the Centers of Excellence, how well does the applicant’s Research Center application:

• Address the communities it will serve?
• Propose a scientifically compelling project(s) and components that closely align with the overarching theme of the Center?
• Demonstrate a strong/collaborative community health partner of sufficient size that the Center can make a major impact on research in the field?
• Propose a Plan for Enhancing Diverse Perspectives (PEDP) that will further the significance of the Center?

Investigator(s)

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

Specific to this FOA:

To achieve the purpose and objectives of the Research Centers of Excellence, how well does the applicant’s team demonstrate:

• Sufficient leadership experience and time commitment to develop the Center?
• Research Project(s) and Component Investigators that have trans-disciplinary backgrounds and expertise?
• Appropriate experience in training clinical and social scientists?
• A Plan for Enhancing Diverse Perspectives (PEDP) that will strengthen and enhance the expertise required to develop the Center??

Innovation

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

Specific to this FOA:

To help further the Centers of Excellence’s purpose and objectives, how significant are the application's innovations for:

• Individual projects and components that will contribute toward success and reduction of maternal morbidities in the affected communities?
• Addressing a long-standing controversy or unresolved question in the field in a way that could settle it?

Approach

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

Specific to this FOA:

To further the Centers of Excellence's purpose and objectives, how adequately does the application demonstrate:

• An adequate approach or strategy to engage communities (i.e., an effective plan for outreach/training activities that addresses the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity)?
• Synergy and coordination among research projects and components to achieve the scientific goals of the Center?
• Potential to have a lasting and significant impact on its affected community and the topic of focus?
• Meaningful and equal community partnerships throughout the research process?
• Prior research experience relevant to the proposed centers, theme, and/or research projects?
• A willingness to work and cooperate with the Centers of Excellence Data Innovation Hub, Implementation Science Hub, study investigators, and NICHD staff in a manner summarized in this FOA?

Environment

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

Specific to this FOA:

To further the Centers of Excellence’s purpose and objectives, how well does the application demonstrate:

• Adequate resources to conduct the proposed activities?
• Fostering a culture of trans-disciplinary collaboration and inclusiveness, both within the center's team and with the research community?
• A cooperative and equitable partnership between the investigators and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination)?
• Evidence that at least one of the community partners is a community healthcare partner?
• Efforts to include training programs for early stage investigators?
• A Plan for Enhancing Diverse Perspectives (PEDP) that will?contribute to the success of proposed activities??

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

Study Timeline

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Review Criteria - Components

In addition to the above criteria, the following components of the Research Center will be scored independently AND will be considered in the determination of the overall impact score for the whole application:

Community Partnership Component:

Reviewers will consider the following criteria in the determination of an impact score for the Community Partnership Component although scores for the individual criteria will not be provided.

• Is there evidence of a cooperative and equitable partnership between the Research Center and the community partner(s) in each stage of the research process (concept, implementation, evaluation, and dissemination)?
• Is there evidence that at least one of the community partners is a community healthcare partner?
• To what extent does the application include a description of approaches or strategies to engage communities?

Training Component:

Reviewers will consider the following criteria in the determination of an impact score for the Training Component although scores for the individual criteria will not be provided.

• Does the applicant describe an effective plan for outreach/training activities that addresses the biological, behavioral, environmental, sociocultural, and/or structural factors that affect pregnancy-related and pregnancy-associated morbidity and mortality and severe maternal morbidity?
• Are efforts made to include training programs for early stage investigators?

Research Projects:

Reviewers will consider the following criteria in the determination of an impact score for each component/core, although scores for the individual criteria will not be provided. . An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a center that by its nature is not innovative may be essential to advance a field.

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

In addition, for projects involving clinical trials:

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

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

In addition, for applications involving clinical trials:

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

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

In addition, for applications involving clinical trials:

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

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for research projects involving clinical trials:

Does the research project adequately address the following, if applicable?

Study Design

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

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

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

Data Management and Statistical Analysis

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

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

In addition, for research projects proposing clinical trials:

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

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

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

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

Additional Review Criteria - Research Project

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

Study Timeline

Specific to applications proposing clinical trials:

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

2. Review and Selection Process

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

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

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

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA

• 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 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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).

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

• Federalwide Research Terms and Conditions
• 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 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 FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, 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 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.

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The planning, direction, and execution of the proposed research, including definition of objectives and approaches; implementation; data management and analysis, interpretations and publication of results;
• Participating in the planning for meetings of the U54 award recipients, to focus on infrastructure building, community participation, study initiation, and study results;
• Making drafts of manuscripts available for review (electronically) to the NIH Project Scientists and other NIH staff at the time they are circulated to coauthors and when the final manuscripts are submitted for publication. This ensures the program can maintain an up-to-date summary of program accomplishments and can prepare for press releases of findings if warranted;
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

During the performance of the award, the NIH Project Scientists, with assistance from other NIH scientific staff will provide appropriate assistance, advice and guidance in the design of the activities; the analysis of data; management and technical performance, and the preparation of publications. The Project Scientists will serve as liaison/facilitators between the recipient, the pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, and CDC) and will serve as a resource for scientific and policy information related to the goals of the awardee's research.

The NIH Project Scientist will additionally:

• Monitor study results and quality assurance across all research sites to ensure the production of high-quality, unbiased results;
• Monitor progress towards study goals and achievement of study timelines
• Facilitate access to technical resources to increase harmonization and interoperability of study datasets

The NICHD Program Official will additionally:

• Take responsibility for the normal scientific and programmatic stewardship of the award and will be named in the award notice; these responsibilities include:
• Enforcement of general statutory, regulatory, or policy requirements;
• Approval of recipient plans prior to award and review of performance after completion;
• Evaluation of progress by reviews of technical or fiscal reports, site visits, or external consultants, to determine that performance is consistent with the terms and conditions of the award;
• Technical assistance requested by recipients or unanticipated procedures to correct programmatic or financial deficiencies in recipients' performance;
• Scientific/technical discussions with recipients, or actions to facilitate or expedite interactions between recipients, e.g., organizing and holding meetings of investigators;
• The option to halt a project if technical performance and/or objectives are not met

Areas of Joint PD/PI and NIH staff Responsibility include:

• Develop a data structure that results in a findable, accessible, interoperable, and reliable dataset to be made available for controlled access public use at the end of the program;
• Coordinate and facilitate access to datasets for all approved internal and external research collaborators;
• Provide input and generate research presentations and publications of data (PD/PI and NIH Project Scientist).

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the investigator chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D, and DHHS regulation 45 CFR Part 16.

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 FOAs 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 75.113and 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 75and 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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Nahida Chakhtoura, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: [email protected]

Elena K Gorodetsky, M.D., Ph.D.
Office of Research on Women's Health (ORWH)
Phone: (301) 594-9004
E-mail: [email protected]

Afrouz Azari Anderson
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-496-4558
E-mail: [email protected]

Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-5820
E-mail: [email protected]

Marie Mancini, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: [email protected]

Leslie Jean Marshall Ph.D.

Office of AIDS Research

Phone: 301-402-1839

Email: [email protected]

Lillian Shum
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-0618
E-mail: [email protected]

Jyoti Dayal
National Human Genome Research Institute (NHGRI)
Phone: 301.480.2307
E-mail: [email protected]

Mercy PrabhuDas, Ph.D., M.B.A.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3534
Email: [email protected]

Gina Wei
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0416
E-mail: [email protected]

Keisher’s Highsmith
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1984
E-mail: [email protected]

Tamara Lewis Johnson, MPH, MBA
National Institute of Mental Health (NIMH)
Telephone: (301) 594-7963
Email: [email protected]

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

Jean Marie Lawrence, Sc.D., M.P.H., M.S.S.A.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 435-6243
E-mail: [email protected]

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

Beda Jean-Francois
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Rada K Dagher
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-451-2187
E-mail: [email protected]

Yewande A Oladeinde
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

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

Abee Boyles, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-3241
E-mail: [email protected]

Soju Chang
National Center for Advancing Translational Sciences (NCATS)
Phone: (301) 827-9206
E-mail: [email protected]

Patricia A. Haggerty, Ph.D.

Office of Dietary Supplements (ODS)

Tel. 301-529-4884

Email: [email protected]

Argenia Doss, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
301-827-1373
[email protected]

Center for Scientific Review (CSR)
Email: [email protected]

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

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4791
E-mail: [email protected]

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

Sheila Simmons
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-9812
E-mail: [email protected]

Diana Rutberg
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: [email protected]

Annmarie Brasilemejac
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8853
E-mail: [email protected]

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
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.