Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional)

Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Establishes research centers focused on maternal health to develop and implement community-tailored interventions.

Expired RFA-HD-23-035: Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Office of AIDS Research ( OAR ) National Heart, Lung, and Blood Institute ( NHLBI ) National Human Genome Research Institute ( NHGRI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Complementary and Integrative Health ( NCCIH ) National Center for Advancing Translational Sciences ( NCATS ) Sexual and Gender Minority Research Office ( SGMRO ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

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

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Dietary Supplements ( ODS ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional) U54 Specialized Center- Cooperative Agreements Notices of Special Interest associated with this funding opportunity March 28, 2023 - Notice of Early Expiration of NOT-HD-22-043 "Notice of Special Interest ( NOSI ): Implementation Science to Advance Maternal Health and Maternal Health Equity for the IMPROVE initiative".

See Notice NOT-HD-23-008 September 22, 2022 - Notice Announcing Frequently Asked Questions (FAQs) for the Maternal Health Centers of Excellence Funding Opportunity Announcements. See Notice NOT-HD-22-048 . September 08, 2022 - Notice of Pre-Application Webinar for the Maternal Health Research Centers of Excellence Funding Opportunity Announcements.

See Notice NOT-HD-22-044 .

NOT-HD-22-022 - Notice of Intent to Publish a Funding Opportunity Announcement for Centers of Excellence in Maternal Health Research NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Resource-Related Research Project (Cooperative Agreements) Resource-Related Research Project (Cooperative Agreements) See Section III.

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

865, 93. 286, 93. 350, 93.

213, 93. 313, 93. 273, 93.

837, 93. 838, 93. 839, 93.

840, 93. 233, 93. 242, 93.

847, 93. 853, 93. 361, 93.

172, 93. 855, 93. 846, 93.

279, 93. 113 Funding Opportunity 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, decrease severe maternal morbidity, and promote maternal health equity 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. 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 but not limited to structural racism and health care system factors.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions 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 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description 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.

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 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.

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 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 Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this FOA. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to commit an estimated total of $19 million in Fiscal Year 2023 to fund 5-7 awards. Future year amounts will depend on annual appropriations. Application budgets are limited to $1.

75 million per year in direct costs. The scope of the proposed project should determine the project period. The maximum project period is 7 years.

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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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. 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: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission 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. 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) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines