Department of Health
and Human Services (HHS)
and Human Services (HHS)
July 14, 2020
PA 18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
National Institute of Allergy and Infectious Diseases (NIAID)
The NIAID/Radiation and Nuclear Countermeasures Program (RNCP) has been tasked with developing safe and effective medical countermeasures (MCMs) and biodosimetry tools for civilians, which can be used at least 24 hours post-exposure during a radiological or nuclear public health emergency. Although the pediatric population makes up ~25% of the total population; research and development in these areas has focused primarily on adults. Additional efforts are needed to develop the radiation pediatric animal models necessary to study MCMs and to generate samples for biodosimetry tool validation. The goal of this initiative is to promote pediatric-specific research to enable the advancement of pediatric MCMs and biodosimetry tools. This is currently an unmet need that impacts the safety and public health of the pediatric population.
Background
In 2010, the National Commission on Children and Disasters Assessment highlighted the lack of disaster readiness for the pediatric population. This is of grave concern considering children can be disproportionately affected by chemical, biological, radiological, nuclear, or explosive agents due to their small size and other differences such as metabolic rate and skin permeability. Since children are not small adults, they require special equipment and care.
The NIAID/RNCP sponsors early-stage/applied research, product development programs and targeted initiatives focused on development of drugs to mitigate and/or treat complications of Acute Radiation Syndrome (ARS) and Delayed Effects of Acute Radiation Exposure (DEARE). Investment in this portfolio has led to the establishment of both adult and pediatric rodent models. To date, only adult, irradiated nonhuman primate animal models exist. These models are critical for licensure of radiation MCMs under the U.S. Food and Drug Administration (FDA) Animal Rule. In fact, studies funded by the RNCP led to FDA approval of both Neupogen (filgrastim) and Neulasta (pegfilgrastim) for the hematopoietic (H)-ARS indication in March 2015 and November 2015, respectively.
With a history of pediatric use for myelosuppressive chemotherapy and supporting pediatric H-ARS mouse studies generated by research funded by NIAID/RNCP, Neupogen and Neulasta , were approved for the H-ARS indication in the both the adult and pediatric population. While having these MCMs provides a certain level of preparedness, other MCMs in the product development pipeline lack a pediatric component due to the limited availability of pediatric models. Existing research portfolios have now matured to the point that the pediatric indication needs to be more adequately addressed.
Another area of interest in the RNCP portfolio includes the radiation biodosimetry program, which supports: 1) basic mechanistic research to elucidate novel approaches for rapid and accurate assessment of radiation exposure, 2) the advanced development of promising devices/approaches; 3) research to identify biomarkers and/or assays to predict delayed radiation injuries to tissues/organs, and 4) a proactive outreach effort to facilitate interactions with emerging leaders of cutting edge biodosimetry concepts. To date, the biodosimetry program has not addressed concerns about differences between adult and pediatric populations and most tools have only been developed using adult samples for reference and validation. Given the large number of children that can potentially be affected by radiation exposure, validation of biodosimetry tools in the pediatric space is also needed because biomarkers and measurements may differ between populations.
In an effort to improve the government’s emergency response in the pediatric population, NIAID and the Biomedical Advanced Research and Development Authority (BARDA) hosted a workshop in 2015 on Pediatric Radiation and Chemical Medical Countermeasures: Policy and Regulatory Considerations. This open dialogue between emergency preparedness and response policy personnel and pediatric research experts helped identify gaps and potential solutions for the development of MCMs to treat radiation/nuclear and chemical injuries for the pediatric population. Moreover, it was clear that set-aside funding was needed to establish relevant pediatric models to advance the development of MCMs and biodosimetry tools with a pediatric indication towards FDA licensure.
Scope of Support
Administrative supplements can be used to meet increased costs associated with the development of pediatric models, pediatric sample collection, and analysis that are within the scope of the approved award. Applicants should propose research that, if successful, would contribute to a greater understanding of the health and well-being of the pediatric population after a radiation incident.
Specific Considerations
Applicants are strongly encouraged to discuss their proposed supplement project with the NIAID Program Official of the approved award prior to submission of a supplement application in order to ensure that the proposed activity fits with the scientific priorities of NIAID and is within the scope of the approved award.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:
Lanyn P. Taliaferro, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-5479
Email: lanyn.taliaferro@nih.gov