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

Background
The Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional) funding opportunity is issued by the National Institutes of Health (NIH), specifically through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The purpose of this funding opportunity is to encourage research that develops novel screening approaches and therapeutic interventions for potentially fatal or disabling conditions identified through newborn screening. The initiative aims to enhance early detection and treatment, which are critical for improving health outcomes in newborns.

Grant Details
This funding opportunity supports exploratory or developmental research projects that focus on:
1. Development, optimization, and validation of new screening technologies and assays;
2. Creation of higher-tier screening assays to reduce false positive rates;
3. Adaptation of existing technologies for low-resource settings;
4. Use of artificial intelligence to improve screening algorithms;
5. Investigations to optimize treatment regimens or develop new therapeutic interventions;
6. Comparative effectiveness studies;
7. Preclinical testing for safety and efficacy in animal models;
8. Clinical trials using validated health outcome markers;
9. Identification of genetic and environmental factors influencing disease outcomes;
10. Research on access to care for infants with genetic disorders, particularly in underserved communities.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and foreign organizations.

Special encouragement is given to institutions serving underrepresented populations such as Hispanic-serving institutions and Historically Black Colleges and Universities (HBCUs). Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The total project period may not exceed two years, with a combined budget for direct costs not exceeding $275,000 over this period. No more than $200,000 may be requested in any single year.

Grant Value
The total value of the grant is up to $275,000 over a maximum period of two years, with individual awards contingent upon NIH appropriations and the submission of meritorious applications.

Place of Performance
The grant can be performed at various locations as specified by the applicant organization.