Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Stillbirths account for a large proportion of perinatal mortality. According to vital statistics, stillbirth affects one in 160 pregnancies, with 24,000 babies stillborn each year. More than 60% of stillbirth cases remain unexplained, after the exclusion of common causes such as congenital abnormalities with or without known genetic cause, obstetric complications, infections, placental insufficiency or abruption, and umbilical cord complications. People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. Moreover, nearly 1 in 4 stillbirths could be preventable, and the rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. Furthermore, approximately 40% of stillbirths that occur during labor and birth are considered potentially preventable.  

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications from entities/institutions to participate as a Research Center in the Stillbirth Research Consortium. This NOFO runs in parallel with the Stillbirth Research Center Data Coordinating Center (see RFA-HD-25-011). The Research Centers and the DCC together will establish an integrated and collaborative Stillbirth Research Consortium to support cutting-edge basic, translational, clinical, and/or data sciences research to generate knowledge for advancement in stillbirth-relevant research across the United States, with a particular emphasis on approaches that utilize an equity lens to identify ways to decrease the incidence of stillbirth in vulnerable populations. International collaboration is encouraged and allowable.

Awarded Research Centers, with complementary expertise, will have specific goals and objectives in their efforts to understand and prevent stillbirth including (1) supporting the development of tools, devices, instrumentation, models, and other technologies that could have a direct clinical or health impact on the incidence of stillbirth; (2) enhancing understanding of the mechanisms underlying vulnerability to stillbirth; (3) elucidating conditions such as structural defects, genetic factors, infections, and/or complications that may contribute to stillbirth and investigation of the fetus, placenta, and maternal tissues; (4) leveraging secondary data analysis and integration of existing datasets (including national datasets) and database resources, with the ultimate aim to elucidate stillbirth risk or prediction and related outcomes; and (5) improving communication between health professionals and families in pregnancy care. Research Center applications must propose one to two research projects that may vary in scale and scope.

Research Centers may actively collaborate on studies and projects with other NICHD Networks and initiatives to strengthen research efforts. This will likely include partnerships with the Maternal Fetal Medicine Units (MFMU) Network and the NICHD Maternal and Pediatric Precision in Therapeutics (MPRINT) initiative; NIH Institutes or Offices such as All of Us; and maternal health activities with partner Federal health agencies, including the Centers for Disease Control and Prevention, the Health and Research Services Administration, and the Office of the Assistant Secretary on Women's Health. These collaborations will foster interdisciplinary approaches, facilitate data sharing, and enhance the impact of their research on maternal and fetal health.

To stimulate novel approaches, it is anticipated that key personnel in complementary disciplines (e.g., medicine, biology, nursing, environmental science, public health, biology, behavioral and social science, biostatistics/statistics, mathematics, computer science, nutrition, and engineering) will collaborate to address stillbirth-relevant research. In addition, Research Centers must include a plan for inclusion of People with Lived Experience (PWLE). The 2-page PWLE attachment must be included, or the application may be withdrawn prior to review.

Goals and Objectives

It is essential to conduct rigorous research to elucidate the specific mechanisms responsible for stillbirth and to inform evidence-based interventions that mitigate these risks. The cause of stillbirth is often multifactorial with maternal, placental, and fetal contributions. A wide variety of risk factors, including pregnancy complications, chronic health conditions, genetics, environmental factors, and social determinants of health, are associated with stillbirth and other adverse pregnancy outcomes. However, known risk factors account for a limited proportion of the variation in stillbirth rates. Investigating the factors contributing to stillbirth will provide valuable insights into the prevention of stillbirth and the promotion of maternal and fetal health across diverse populations. A goal of the Stillbirth Research Consortium is to build synergy among awarded Research Centers to maximize resources to deeply probe this serious adverse pregnancy outcome. Projects that aim to address both individual and systemic factors to reduce the incidence of stillbirth are of high programmatic interest.     

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

• Investigate the genetic contribution of parental, conceptus and fetal polymorphisms and de novo mutations in stillbirth. 
• Investigate gene function involved in stillbirth to provide the causal link between possible genetic variants and patient phenotypes.
• Conduct methodological research on improving accuracy of stillbirth data collection and other data needed to identify disparities in stillbirth. 
• Identify social, behavioral, and structural factors that impact the likelihood of experiencing stillbirth. 
• Develop entirely new technology or modify existing technology to achieve transformational improvements in real-time assessment of placental in vivo structural/functional status across pregnancy to uncover and address placental causes of stillbirth. 
• Elucidate the racial, ethnic, and nativity disparities impacting stillbirth. 
• Develop research capacity that serves specific contexts and communities with emphasis on highest burden settings. 
• Conduct clinical trials that will lead to stillbirth risk reduction through known interventions. 
• Conduct translational and implementation research to lead to a better understanding of effective interventions. 
• Determine causes of and differential susceptibility to infection, and maternal-fetal immune responses associated with stillbirth, utilizing high dimensional system biology approaches. 
• Develop novel techniques, interventions, methodologies, and computational models that could aid in stratifying and targeting high-risk populations to substantially advance research and stillbirth prevention.
• Investigate tools to assess the emotional support needed by birthing people and families after stillbirth due to pregnancy or childbirth complications.
• Investigate best practices in supporting health-care workers caring for people experiencing stillbirth.
• Develop non-invasive techniques/methods or minimally invasive autopsy techniques for detecting cause of death to increase autopsy uptake rates and contribute to the identification of cause of death to aid in the development of stillbirth prevention strategies.
• Develop predictive models to assess the likelihood of stillbirth integrating genetic, environmental, and medical status and history.
• Conduct research on neonatal and infant mortality trends and disparities in relation to stillbirths in the United States.
• Determine the relationship and quantify the effects of environmental and climate change (ECC) factors (e.g. air and water pollutants, heatwaves, infections, food insecurity) on the occurrence of stillbirth. Identify specific ECC factors associated with increased risk of stillbirth.
• Identify vulnerable populations and the social, political, economic and cultural factors that exacerbate exposure and diminish resilience to CCH resulting in increased incidence of stillbirth.
• Investigate potential interventions or adaptations that could mitigate the impact of ECC factors on stillbirth rates. Develop strategies to increase public awareness and understanding of the link between ECC and stillbirth and ways to minimize risks.

The Office of Dietary Supplements (ODS) advances and disseminates research on dietary supplements to foster knowledge and optimize health across the lifespan. Dietary supplement ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary or bioactive substances, consumed as dietary supplements to promote health and prevent disease. For this NOFO, ODS is interested in identification of maternal  dietary and nutritional factors (environmental, behavioral, mechanistic) and their associations with stillbirth, especially (but not exclusively) the following:

• Dietary intake and levels of methyl donors and other micronutrients involved in one-carbon metabolism (i.e. vitamin B6, vitamin B12, choline, betaine, methionine, thiamine, riboflavin, and zinc, individually or in combination) before and during pregnancy.
• Vitamin B supplementation and excess folic acid intake.
• Pre-pregnancy obesity, excessive gestational weight gain (GWG) during pregnancy, and associated risks of placental dysfunction, hypertension and diabetes, inflammation, and sleep apnea.
• Iron deficiency and iron deficiency anemia during pregnancy, including complications such as fetal growth restriction (FGR), and effects of excess iron intake from supplements.
• Protein intake during gestation, and the impact of low or high protein intake on FGR
• Dietary intake of omega-3 fatty acids, particularly docosahexaenoic acid (DHA)
• Poor maternal pregnancy diets (overall), including those lacking in key nutrients such as iron, iodine, calcium, vitamin D, folate and zinc, and their associations with anemia, pre-eclampsia, and hemorrhage.

The ODS does not award grants and only accepts co-funding requests from NIH Institutes and Centers; therefore, applications submitted to this NOFO must be relevant to the objectives of the NOFO. For questions regarding funding priorities, please contact the NICHD Scientific/Research Contact named in this NOFO. For additional information about ODS, please visit http://ods.od.nih.gov.  

Projects must propose research aims that are within the mission of NICHD and the scientific interest areas identified in this NOFO in order to be considered responsive to this NOFO. Applications proposing projects with any of the following characteristics will be considered non-responsive to this NOFO and will not be reviewed:

• Research that is exclusively an efficacy study.
• Comparative research on stillbirths in the United States versus other countries is within the scope of this initiative. Research that does not include a major U.S. component is not within scope.
• Research only involving populations outside the United States.

Stillbirth Research Consortium Collaborative Efforts

While each funded Research Center will be largely self-sufficient, the investigators will be expected to devote a portion of their effort to participate in collaborative activities post-award; restricted funds will be used for these activities (see R&R Budget section). Awardees may be charged with developing synergistic/collaborative projects, resources for the community, and outreach activities. All awardees will be required to interact closely with each other, engage in collaborative activities, and share resources, data, ideas and expertise that are beyond the scope of a single research team. 

Steering Committee

The Stillbirth Research Consortium will establish a governing Steering Committee composed of the PD/PI(s), key research scientists, and the NIH Project Scientist(s) for each Program to assist in monitoring and developing the scientific content and direction of the program. When included in the Steering Committee, outside experts are chosen by the PD/PI(s) in consultation with the NIH Project Scientist and Program Official. Each named member of the Steering Committee will have one vote, except the NIH Program Official. The Steering Committee members will meet periodically to review and monitor progress, plan and design research activities, and establish priorities. The Steering Committee will prioritize concepts and select the protocol(s) to be conducted in collaboration with the NIH. A decision to fund a particular Research Center(s) will not commit the Stillbirth Research Consortium to developing proposed protocol concepts by recipients into clinical protocols. 

NICHD Data Sharing Expectations and Requirements 

The NIH Policy for Data Management and Sharing expects researchers to maximize the sharing of scientific data and for data to be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan). The DMS Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014) The DMS Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved DMS Plan and any approved updates. 

For human data, 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. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy. If the use of DASH is not feasible, NICHD expects awardees to share data through other equivalent broad-sharing data repositories. 

For applications that aim to co-analyze already shared data with data that have not yet been shared with the broader research community, applicants should be aware that such primary data should be shared with the broad research community.

Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website. 

See Section VIII. Other Information for award authorities and regulations.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

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

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

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

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

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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:

Monica Longo, MD, PhD 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 240-204-4605
Email: Monica.Longo@nih.gov 

Megan Mitchell, MPH 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-7950
Email: Megan.Mitchell@nih.gov 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments: The following "Other Attachments" must be included.

Plan for Inclusion of People with Lived Experience (PWLE) 

Provide a 2-page plan for inclusion of People with Lived Experience (PWLE). Investigators are encouraged to engage with PWLE in a way that informs the scientific aims of the application and increases or validates the potential impact of the application. The Plan will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.  Possible methods of incorporating PWLE may include focus groups, community engagement boards, parent/care partner engagement boards, and other methods or a combination of methods. The plan for inclusion of PWLE will be considered as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions. There are special review criteria in the Significance section of the Overall component regarding inclusion of PWLE.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy: Provide an overview of the proposed Research Center. Address each of the specific aspects indicated below using the sub-sections as defined:

Sub-section A: Research Center Framework. Describe the overarching organizational framework and vision of the proposed Research Center, its scientific focus, strengths, and leadership in the research field. 

Sub-section B: Research Team Organization and Integration. Describe how the individual expertise of team members (e.g. obstetrics, obstetric pharmacology, clinical/experimental pathology, computational biology, bioinformatics) complement each other to support the Research Center and how the team's diverse expertise translates to a collective capability for accomplishing the goals of the proposed Center's research. Explain the roles of vital collaborations and highlight how the planned interactions among the members of the team will increase the capability for innovation, anticipating new directions and redirecting research if/when needed. Explain how this team will facilitate the integration of the Research Center project as one unified entity (i.e., how the multidisciplinary team members will function in an integrated, synergistic, and iterative fashion). Describe collective experience and capabilities in areas pertinent to leading, coordinating, managing, and understanding the various needs of the team and the proposed project and how the elements of the Research Center, including key personnel, will interact to realize this vision. Without repeating information in other sections, explain how any ongoing institutional, and/or private sector resources can augment or complement resources for which funding from this NOFO is sought. 

Sub-section C: Research Project(s). Outline the rationale for the one to two research project(s). The proposed project(s) may vary in size and scale, but must support cutting-edge basic, translational, clinical, and/or data sciences research and generate knowledge to fuel advancement of stillbirth-relevant research in the United States, with a particular emphasis on approaches that utilize an equity lens to identify ways to decrease the incidence of stillbirth. Proposed projects must be feasible for implementation across all awarded Stillbirth Research Consortium sites. 

For the proposed one to two project(s): 

• Discuss the rationale for the proposed project(s) and the potential impact of the proposed work. For a clinical trial, indicate how the trial will impact clinical outcomes of patients.
• As applicable, describe earlier studies that led to the proposed project and provide information or data from preliminary studies that support the need for the project and its feasibility.
• Outline the hypothesis, objectives, and how the proposed outcomes will address the hypothesis.
• Concisely describe the design of the proposed project. 
• Discuss the project's feasibility, difficulties that may be encountered, and offer alternative approaches to be implemented, if needed. Provide information on any competing clinical research projects underway in the community, conducted either by the PD/PI(s) or other investigators, and their potential influence on recruitment. If applicable, discuss any investigational agents with similar mechanism of action currently under development and their potential influence on the proposed clinical trial.
• Without duplicating information requested as part of the PHS Human Subjects and Clinical Trials Information Form, include general concepts for sample size calculations and statistical methodologies. 

Letters of Support

Letters of support are required from all participating Research Center sites indicating institutional willingness to participate in all aspects of the Stillbirth Research Consortium studies and related activities, including willingness to (1) use the single IRB (sIRB) selected by the Data Coordinating Center; (2) participate in a collaborative and interactive manner with other Research Centers, the Data Coordinating Center, and NICHD in all aspects of the Stillbirth Research Consortium, including sharing of biospecimens and data; and (3) use common guidelines and manual of procedures developed by the Data Coordinating Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – 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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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

Applications must include annual milestones. Applications that fail to include annual milestones and/or a plan for inclusion of People with Lived Experience will be considered incomplete and will be withdrawn. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

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

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

As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.

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

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

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.

2. Review and Selection Process

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

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

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

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

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

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

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant#146;s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of 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 (HHS) grant administration regulations at 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and 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 HHS, 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
• Monitor study progress of each participating facility and of the Consortium as a whole, through recipient's annual reports, study reports, site visits, screening logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting enrollment and participant follow-up targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting

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 recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Monica Longo, MD, PhD 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 240-204-4605
Email: Monica.Longo@nih.gov 

Megan Mitchell, MPH 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-7950
Email: Megan.Mitchell@nih.gov 

Patricia A. Haggerty, Ph.D.
NIH Office of Dietary Supplements
Email:  patricia.haggerty@nih.gov
Phone:  301-529-4884

Joanna Kubler-Kielb, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6916
Email: kielbj@mail.nih.gov

Kelly Fritz 
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5429
Email: kelly.fritz@nih.gov

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 2 CFR Part 200.