Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)
National Institutes of Health (NIH)
Estimated funding amount: $200,000 per year
Maximum project duration: 2 years
To develop novel screening approaches and therapeutic interventions for conditions identified through newborn screening.
To ensure that every person is born healthy and has the opportunity for a healthy life.
Infants with genetic disorders
Healthcare systems involved in newborn screening
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments.
Organizations must complete registrations with SAM, eRA Commons, and Grants.gov.
Eligible organizations can be based in the U.S. or be foreign entities.
Non-domestic components of U.S. organizations are allowed.
Projects must focus on developing screening technologies or therapeutic interventions for conditions included in newborn screening panels.
Research must address conditions that could benefit from early detection.
The combined budget for direct costs may not exceed $275,000 over the two-year project period.
No more than $200,000 may be requested in any single year.
Applications are due by 5:00 PM local time on specified due dates.
The earliest submission date is January 16, 2025, with subsequent deadlines every four months until November 16, 2027.
Applicants may submit more than one application, provided each is scientifically distinct.
The NIH will not accept duplicate or overlapping applications under review.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
A Data Management and Sharing Plan is required.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications will undergo peer review and receive a written critique.
Funding decisions will consider scientific merit and relevance to program priorities.
Applications must demonstrate potential for significant impact on biomedical research.
Projects must address conditions that are currently part of newborn screening panels or could be included in the near future.
Development of effective treatments may lag behind screening technologies.
Collaboration with state health agencies is encouraged for scaling up screening methods.
Innovative applications leveraging existing technologies may have a competitive edge.
Demonstrating the feasibility and effectiveness of proposed screening methods.
Submitting overlapping applications or failing to comply with application instructions.
Engage with NIH staff prior to submission for guidance on clinical trials.
Focus on innovative applications that address gaps in current newborn screening practices.