Notice of Intent to Publish a Funding Opportunity Announcement for Diagnostic Centers of Excellence (X01 Clinical Trial Not Allowed)

Established by the National Institutes of Health (NIH) Common Fund in 2013, the Undiagnosed Diseases Network (UDN) is a network of NIH intramural and extramural researchers and clinicians whose primary goals are to use team science to improve the diagnostic journey for patients with undiagnosed diseases and to catalyze research into unknown disease mechanisms. The UDN also aims to promote the use of genomics data in disease diagnosis and to share data and approaches widely throughout the scientific community. This highly successful Common Fund program will end in July 2023. To have a broader impact on the clinical practice of undiagnosed diseases in the US, the NIH envisions the UDN evolving into a larger, self-sustained network that, with public and private partners, can provide expert diagnostic services for diverse populations across the nation and foster scientific discovery. To assist in the transition towards sustainability, the NIH intends to fund a Data Management and Coordinating Center (DMCC) to provide coordination, infrastructure, data management, and clinical research support to clinical sites with expertise in diagnosing challenging and difficult-to-diagnose diseases (see related Notice NOT-NS-22-071). A Funding Opportunity Announcement (FOA) to solicit applications for the DMCC is expected to be published in spring of 2022. This Notice informs the research community that NIH intends to publish a program announcement that solicits proposals from highly qualified clinical sites in the US to join the new network through an X01 Resource Access Program award. Successful applicants will demonstrate that they have the appropriate infrastructure, expertise, and resources needed to conduct the clinical evaluation and DNA sequencing of participants enrolled at their sites (described in more detail below). Accepted sites will be designated as a �Diagnostic Center of Excellence (DCoE)� and have access to DMCC resources and infrastructure including access to high-quality phenotypic and genotypic data and collaboration with highly skilled physicians, researchers, and bioinformaticians. DCoEs will be invited to submit their most challenging, unsolved cases for acceptance into the network, and partner in their evaluation with the network�s virtual case review committee(s), which will be coordinated by the DMCC. To qualify as a DCoE, each site will be expected to enroll a minimum of 5 participants per year, although some sites may have the capacity to enroll more participants. Unlike current UDN operations (see: UDN Manual of Operations), a DCoE may choose to specialize in an area of clinical practice (e.g., pediatrics, neurology, cardiovascular, immunologic, environmental insults, etc.). Although DCoEs will not receive direct NIH funds through the X01 mechanism, participating sites will have the opportunity to apply for small amounts of funds each year administered by the DMCC to support site coordination associated with data sharing and small, exploratory research projects needed to facilitate a participant�s diagnosis (e.g., gene function studies in model organisms and non-routine clinical genomics or metabolomics investigations in the range of $25-50K Direct Costs per project). The maximum period of performance will be 5 years. This program announcement is expected to be published in spring of 2023 with an expected application due date in early summer of 2023. This Notice is being published now, in advance of the program announcement, so that potential applicants have sufficient time to develop meaningful collaborations and responsive projects. Details of the planned program announcement are provided below.
Categories: Health.