Novel Approaches for Radiation Biodosimetry Assays and Devices Development (U01 Clinical Trial Not Allowed)

Background
The purpose of this notice of funding opportunity (NOFO) is to support radiation research at all stages of development for the identification of biomarkers of injury and the development of assays or devices for the purpose of triage, including assessing absorbed dose or predicting health outcomes of acute or delayed injuries resulting from radiation exposure during a public health emergency. This NOFO will support the development of these approaches, with the goal of future regulatory approval. The mission of the Radiation and Nuclear Countermeasures Program (RNCP), guided by the 2005 NIH Strategic Plan and Research Agenda for Medical Countermeasures against Radiation and Nuclear Threats (updated in 2012), is to accelerate the development of approaches to diagnose, mitigate, and treat radiation injuries resulting from a mass casualty radiological or nuclear incident. The RNCP was established in 2004 under NIAID’s Division of Allergy, Immunology, and Transplantation to help the U.S. Government ensure medical preparedness to address radiation injuries quickly and effectively during a public health emergency.

Grant Details
The focus of this NOFO is the development and validation of rapid, reliable, inexpensive, and easy-to-use techniques/assays and devices for use in all segments of the civilian population including geriatric, pediatric, and immune-compromised individuals. Research activities ranging from immediate, early, and delayed changes in radiation-related biomarkers, studies exploring the biokinetics of the proposed biomarker signature, and studies to predict the acute or chronic health outcome in one or more organs are requested. The ideal radiation signature will be measurable in a non-invasive or minimally invasive way (e.g., finger stick, urine, saliva, or skin scraping as opposed to spinal fluid or complex imaging) that will allow for repeated assays over time, is sensitive to incremental differences in radiation exposure, is specific over a wide range of radiation doses and dose rates and has utility for different qualities of radiation (high and low linear energy transfer).

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits other than institutions of higher education, for-profit organizations (including small businesses), local governments, state governments, federal agencies, U.S. territories or possessions, 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.

Period of Performance
The maximum project period is 5 years. The earliest start date is May 31, 2024.

Grant Value
NIAID intends to commit $4M in FY 2025 to fund 6-8 awards. Application budgets are not expected to exceed $350,000 in direct costs per year.