This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.

PAR-25-266: Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)

Posted Date: December 02, 2024 Open Date (Earliest Submission Date): January 16, 2025 Expiration Date: November 17, 2027

This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

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)

Funding Opportunity Title

Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)

Activity Code

• R21 - Exploratory/Developmental Research Grant

Announcement Type

• Reissue of PAR-21-355

Related Notices

• March 31, 2025: This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 4, 2024: Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022: Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022: Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON)

• PAR-25-266

Companion Funding Opportunity

• PAR-25-265, R01 Research Project

Number of Applications

• See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

• 93.865

Funding Opportunity Purpose

This NOFO encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for conditions for which newborn screening has already been implemented, as well as for potentially fatal or disabling genetic conditions that could benefit in the near future from the early detection made possible by newborn screening. This research is especially critical given that accurate screening tests and demonstrable benefits of early intervention are often prerequisites for new conditions to be added to newborn screening panels.

Funding Opportunity Goal(s)

To conduct and support research, clinical trials, and studies with people that explore health processes. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury. To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health. The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

Key Dates

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