Notice of Intent to Publish a Funding Opportunity Announcement for The Road to Prevention of Stillbirth (UM2 Clinical Trial Not Allowed)
Notice Number:
NOT-HD-24-010

Key Dates

Release Date:
March 15, 2024
Estimated Publication Date of Notice of Funding Opportunity :
July 05, 2024
First Estimated Application Due Date:
November 01, 2024
Earliest Estimated Award Date:
June 30, 2025
Earliest Estimated Start Date:
July 31, 2025
Related Announcements

March 15, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for The Road to Prevention of Stillbirth (UG1 Clinical Trial Optional). NOT-HD-24-009

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development intends to publish a Notice of Funding Opportunity (NOFO) to invite applications for a Data Coordinating Center to support the work of the research projects funded under the Stillbirth Research Consortium described in the companion announcement NOT-HD-24-009.

This Notice is being provided to allow potential applicants additional time to develop meaningful collaborations, interdisciplinary teams, and prepare responsive applications.

The NOFO is expected to be published in Summer 2024 with an expected application due date in Fall 2024.

This NOFO will utilize the UM2 activity code. Details of the planned NOFO are provided below.

Research Initiative Details

The Stillbirth Research Consortium Data Coordinating Center (SRCDCC) is intended to conduct the following activities:

Supporting the Stillbirth Research Consortium. The SRCDCC is expected to collaborate with the recipients awarded under the RFA presented in the companion Notice (NOT-HD-24-009) to facilitate cross-network communication and collaboration across the awarded research centers. The SRCDCC is also expected to support recurring conference calls and research investigators meetings, as applicable.

Innovative Technologies. In addition to data coordination activities, applicants will be expected to have additional expertise in basic science or innovative technologies and methodologies, including cutting edge biomedical research technologies, informatics and data science, and provide that expertise to accelerate progress in stillbirth research, maximize data comparability and facilitate data harmonization and data sharing. The SRCDCC will not generate new experimental data, but rather will serve as a resource, and link stillbirth consortium data with national data sets such as NCHS or CMS. The needs for innovative technologies/methodologies may include development and validation of tools, technologies and approaches, including artificial intelligence and machine learning. This includes, but is not limited to, development of tools and technologies that:

  • Measure factors associated with increased risk for stillbirth, including but not limited to maternal/placental/fetal physiology
  • Measure biometrics associated with the onset and exacerbation of pregnancy complications, including but not limited to preeclampsia
  • Predict risk from a variety of data sources, for example, medical charts and electronic health records
  • Alert patients and clinicians to potential risk factors
  • Suggest various prevention and treatment approaches

The SRCDCC will work closely with recipients awarded under the funding opportunity presented in the companion Notice (NOT-HD-24-009) to optimize harmonization, combine and store data from projects, and monitor data to identify and address potential biases. The data analyses specific to the awards funded under the companion NOFO will be the responsibility of the grantees; however, the DCC will provide support and guidance to grantees as needed, and the DCC will conduct analyses of aggregated data sets, as appropriate.

Establish and manage a Biorepository

  • Support storage and use of high quality biospecimens
  • Leverage, when possible, existing resources and expertise for biospecimen storage

Facilitate biospecimen collection and processing

  • Lead development of new procedures or revision of existing procedures, in collaboration with Stillbirth Research Consortium centers, for collection and processing of biospecimens, including remote collection; and ensure that these procedures are appropriate for diverse populations.
  • Establish standard operating procedures for biospecimen collection, processing, shipping/batch shipments, specimen labeling/barcoding, etc.

Research Team Expertise

It is expected that a PD/PI (or multiple PD/PIs) of the SRCDCC will have a strong track record, including peer-reviewed research publications and independent funding support, as well as a strong record of successful leadership of multi-site clinical research studies, including success in meeting project milestones and timelines. SRCDCC team members are expected to have expertise in bioinformatics and data processing appropriate for establishing and carrying out proposed methods for collecting, processing, and analyzing clinical practice data of various types.

Potential applicants are strongly encouraged to consult with NICHD program staff when developing plans for an application.

Further details will be included in the forthcoming NOFO.

Funding Information

Estimated Total Funding

TBD

Expected Number of Awards

1 award

Estimated Award Ceiling

TBD

Primary Assistance Listing Number(s)

93.865

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

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

Megan Mitchell, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-7950
Email: [email protected]